Joseph S. Sanfilippo, MD, MBA

CASE Surgeon accused of operating outside her scope of expertise

A 38-year-old woman (G2 P2002) presented to the emergency department (ED) with acute pelvic pain involving the right lower quadrant (RLQ). The patient had a history of stage IV endometriosis and chronic pelvic pain, primarily affecting the RLQ, that was treated by total laparoscopic hysterectomy with bilateral salpingo-oophorectomy 6 months earlier. Pertinent findings on physical examination included hypoactive bowel sounds and rebound tenderness. The ED physician ordered a computed tomography (CT) scan of the abdomen, which showed no evidence of ureteral injury or other abnormality. The gynecologist who performed the surgery 6 months ago evaluated the patient in the ED.

The gynecologist decided to perform operative laparoscopy because of the severity of the patient’s pain and duration of symptoms. Informed consent obtained in the ED before the patient received analgesics included a handwritten note that said “and other indicated procedures.” The patient signed the document prior to being taken to the operating room (OR). Time out occurred in the OR before anesthesia induction. The gynecologist proceeded with laparoscopic adhesiolysis with planned appendectomy, as she was trained. A normal appendix was noted and left intact. RLQ adhesions involving the colon and abdominal wall were treated with electrosurgical cautery. When the gynecologist found adhesions between the liver and diaphragm in the right upper quadrant (RUQ), she continued adhesiolysis. However, the diaphragm was inadvertently punctured.

As the gynecologist attempted to suture the defect laparoscopically, she encountered difficulty and converted to laparotomy. Adhesions were dense and initially precluded adequate closure of the diaphragmatic defect. The gynecologist persisted and ultimately the closure was adequate; laparotomy concluded. Postoperatively, the patient was given a diagnosis of atelectasis, primarily on the right side; a chest tube was placed by the general surgery team. The patient had an uneventful postoperative period and was discharged on postoperative day 5. One month later she returned to the ED with evidence of pneumonia; she was given a diagnosis of empyema, and antibiotics were administered. She responded well and was discharged after 6 days.

The patient filed a malpractice lawsuit against the gynecologist, the hospital, and associated practitioners. The suit made 3 negligence claims: 1) the surgery was improperly performed, as evidenced by the diaphragmatic perforation; 2) the gynecologist was not adequately trained for RUQ surgery, and 3) the hospital should not have permitted RUQ surgery to proceed. The liability claim cited the lack of qualification of a gynecologic surgeon to proceed with surgical intervention near the diaphragm and the associated consequences of practicing outside the scope of expertise.

Fitz-Hugh Curtis syndrome, a complication of pelvic inflammatory disease that may cause adhesions, was raised as the initial finding at the second surgical procedure and documented as such in the operative report. The plaintiff’s counsel questioned whether surgical correction of this syndrome was within the realm of a gynecologic surgeon. The plaintiff’s counsel argued that the laparoscopic surgical procedure involved bowel and liver; diaphragmatic adhesiolysis was not indicated, especially with normal abdominal CT scan results and the absence of RUQ symptoms. The claim specified that the surgery and care, as a consequence of the RUQ adhesiolysis, resulted in atelectasis, pneumonia, and empyema, with pain and suffering. The plaintiff sought unspecified monetary damages for these results.

What’s the verdict?

The case is in negotiation prior to trial.

Legal and medical considerations

“To err is not just human but intrinsically biological and no profession is exempt from fallibility.”¹

Error and liability

To err may be human, but human error is not necessarily the cause of every suboptimal medical outcome. In fact, the overall surgical complication rate has been reported at 3.4%.² Even when there is an error, it may not have been the kind of error that gives rise to medical malpractice liability. When it comes to surgical errors, the most common are those that actually relate to medications given at surgery that appear to be more common—one recent study found that 1 in 20 perioperative medication administrations resulted in a medication error or an adverse drug event.³

Medical error vs medical malpractice

The fact is that medical error and medical malpractice (or professional negligence) are not the same thing. It is critical to understand the difference.

Medical error is the third leading cause of death in the United States.⁴ It is defined as “the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim,”⁵ or, in the Canadian literature, “an act of omission or commission in planning or execution that contributes or could contribute to an unintended result.”⁶ The gamut of medical errors spans (among others) problems with technique, judgment, medication administration, diagnostic and surgical errors, and incomplete record keeping.⁵

Negligent error, on the other hand, is generally a subset of medical error recognized by the law. It is error that occurs because of carelessness. Technically, to give rise to liability for negligence (or malpractice) there must be duty, breach, causation, and injury. That is, the physician must owe a duty to the patient, the duty must have been breached, and that breach must have caused an injury.⁷

Usually the duty in medical practice is that the physician must have acted as a reasonable and prudent professional would have performed under the circumstances. For the most part, malpractice is a level of practice that the profession itself would not view as reasonable practice.⁸ Specialists usually are held to the higher standards of the specialty. It also can be negligent to undertake practice or a procedure for which the physician is not adequately trained, or for failing to refer the patient to another more qualified physician.

The duty in medicine usually arises from the physician-patient relationship (clearly present here). It is reasonably clear in this case that there was an injury, but, in fact, the question is whether the physician acted carelessly in a way that caused that injury. Our facts leave some ambiguity—unfortunately,a common problem in the real world.

It is possible that the gynecologist was negligent in puncturing the diaphragm. It may have been carelessness, for example, in the way the procedure was performed, or in the decision to proceed despite the difficulties encountered. It is also possible that the gynecologist was not appropriately trained and experienced in the surgery that was undertaken, in which case the decision to do the surgery (rather than to refer to another physician) could well have been negligent. In either of those cases, negligence liability (malpractice) is a possibility.

Proving negligence. It is the plaintiff (the patient) who must prove the elements of negligence (including causation).⁸ The plaintiff will have to demonstrate not only carelessness, but that carelessness is what caused the injuries for which she is seeking compensation. In this case, the injuries are the consequence of puncturing the diaphragm. The potential damages would be the money to cover the additional medical costs and other expenses, lost wages, and noneconomic damages such as pain and suffering.

The hospital’s role in negligence

The issue of informed consent is also raised in this case, with a handwritten note prior to surgery (but the focus of this article is on medical errors). In addition to the gynecologist, the hospital and other medical personnelwere sued. The hospital is responsible for the acts of its agents, notably its employees. Even if the physicians are not technically hospital employees, the hospital may in some cases be responsible. Among other things, the hospital likely has an obligation to prevent physicians from undertaking inappropriate procedures, including those for which the physician is not appropriately trained. If the gynecologist in this case did not have privileges to perform surgery in this category, the hospital may have an obligation to not schedule the surgery or to intraoperatively question her credentials for such a procedure. In any event, the hospital will have a major role in this case and its interests may, in some instances, be inconsistent with the interests of the physician.

Why settlement discussions?

The case description ends with a note that settlement discussions were underway. If the plaintiff must prove all of the elements of negligence, why have these discussions? First, such discussions are common in almost all negligence cases. This does not mean that the case actually will be settled by the insurance company representing the physician or hospital; many malpractice cases simply fade away because the patient drops the action. Second, there are ambiguities in the facts, and it is sometimes impossible to determine whether or not a jury would find negligence. The hospital may be inclined to settle if there is any realistic chance of a jury ruling against it. Paying a small settlement may be worth avoiding high legal expenses and the risk of an adverse outcome at trial.⁹

Reducing medical/surgical error through a team approach

Recognizing that “human performance can be affected by many factors that include circadian rhythms, state of mind, physical health, attitude, emotions, propensity for certain common mistakes and errors, and cognitive biases,”¹⁰ health care professionals have a commitment to reduce the errors in the interest of patient safety and best practice.

The surgical environment is an opportunity to provide a team approach to patient safety. Surgical risk is a reflection of operative performance, the main factor in the development of postoperative complications.¹¹ We wish to broaden the perspective that gynecologic surgeons, like all surgeons, must keep in mind a number of concerns that can be associated with problems related to surgical procedures, including¹²:

• visual perception difficulties
• stress
• loss of haptic perception (feedback using touch), as with robot-assisted procedures
• lack of situational awareness (a term we borrow from the aviation industry)
• long-term (and short-term) memory problems.

Analysis of surgical errors shows that they are related to, in order of frequency ¹:

• surgical technique
• judgment
• inattention to detail
• incomplete understanding of the problem or surgical situation.

Medical errors: Caring for the second victim (you)

Patrice M. Weiss, MD

We use the term “victim” to refer to the patient and her family following a medical error. The phrase “the second victim” was coined by Dr. Albert Wu in an article in the British Medical Journal¹ and describes how a clinician and team of health care professionals also can be affected by medical errors.

 

What signs and symptoms identify a second victim?Those suffering as a second victim may show signs of depression, loss of joy in work, and difficulty sleeping. They also may replay the events, question their own ability, and feel fearful about making another error. These reactions can lead to burnout—a serious issue that 46% of physicians report.²

As colleagues of those involved in a medical error, we should be cognizant of changes in behavior such as excessive irritability, showing up late for work, or agitation. It may be easier to recognize these symptoms in others rather than in ourselves because we often do not take time to examine how our experiences may affect us personally. Heightening awareness can help us recognize those suffering as second victims and identify the second victim symptoms in ourselves.
 

How can we help second victims?One challenge second victims face is not being allowed to discuss a medical error. Certainly, due to confidentiality requirements during professional liability cases, we should not talk freely about the event. However, silence creates a barrier that prevents a second victim from processing the incident.

Some hospitals offer forums to discuss medical errors, with the goal of preventing reoccurrence: morbidity and mortality conferences, morning report, Quality Assurance and Performance Improvement meetings, and root cause analyses. These forums often are not perceived by institutions’ employees in a positive way. Are they really meant to improve patient care or do they single out an individual or group in a “name/blame/shame game”? An intimidating process will only worsen a second victim’s symptoms. It is not necessary, however, to create a whole new process; it is possible to restructure, reframe, and change the culture of an existing practice.

Some institutions have developed a formalized program to help second victims. The University of Missouri has a “forYOU team,” an internal, rapid response group that provides emotional first aid to the entire team involved in a medical error case. These responders are not from human resources and do not need to be sought out; they are peers who have been educated about the struggles of the second victim. They will not discuss the case or how care was rendered; they naturally and instinctively provide emotional support to their colleagues.

At my institution, the Carilion Clinic at the Virginia Tech Carilion School of Medicine, “The Trust Program” encourages truth, respectfulness, understanding, support, and transparency. All health care clinicians receive basic training, but many have volunteered for additional instruction to become mentors because they have experienced second-victim symptoms themselves.

Clinicians want assistance when dealing with a medical error. One poll reports that 90% of physicians felt that health care organizations did not adequately help them cope with the stresses associated with a medical error.³ The goal is to have all institutions recognize that clinicians can be affected by a medical error and offer support.

To hear an expanded audiocast from Dr. Weiss on “the second victim” click here.

---

Dr. Weiss is Professor, Department of Obstetrics & Gynecology, Virginia Tech Carilion School of Medicine, and Chief Medical Officer and Executive Vice President, Carilion Clinic, Roanoke, Virginia.

The author reports no financial relationships relevant to this article.

 

---

References

1. Wu AW. Medical error: the second victim. BMJ. 2000;320(7237):726–727.
2. Peckham C. Medscape Physician Lifestyle Report 2015. Medscape website. http://www.medscape.com/features/slideshow/lifestyle/2015/public/overview#1. Published January 26, 2015. Accessed May 24, 2016.
3. White AA, Waterman AD, McCotter P, Boyle DJ, Gallagher TH. Supporting health care workers after medical error: considerations for health care leaders. JCOM. 2008;15(5):240–247.

“Inadequacy” with regard to surgical proceduresIndication for surgery is intrinsic to provision of appropriate care. Surgery inherently poses the possibility of unexpected problems. Adequate training and skill, therefore, must include the ability to deal with a range of problems that arise in the course of surgery. The spectrum related to inadequacy as related to surgical problems includes “failed surgery,” defined as “if despite the utmost care of everyone involved and with the responsible consideration of all knowledge, the designed aim is not achieved, surgery by itself has failed.”⁵ Of paramount importance is the surgeon’s knowledge of technology and the ability to troubleshoot, as well as the OR team’s responsibility for proper maintenance of equipment to ensure optimal functionality.¹

Aviation industry studies indicate that “high performing cockpit crews have been shown to devote one third of their communications to discuss threats and mistakes in their environment, while poor performing teams devoted much less, about 5%, of their time to such.”^1,13 A well-trained and well-motivated OR nursing team has been equated with reduction in operative time and rate of conversion to laparotomy.¹⁴ Outdated instruments may also contribute to surgical errors.¹

Moving the “learning curve” out of the OR and into the simulation lab remains valuable, which is also confirmed by the aviation industry.¹⁵ The significance of loss of haptic perception continues to be debated between laparoscopic (straight-stick) surgeons and those performing robotic approaches. Does haptic perception play a major role in surgical intervention? Most surgeons do not view loss of haptic perception, as with minimally invasive procedures, as a major impediment to successful surgery. From the legal perspective, loss of haptic perception has not been well addressed.

The American College of Obstetricians and Gynecologists has focused on patient safety in the surgical environment including concerns for wrong-patient surgery, wrong-side surgery, wrong-level surgery, and wrong-part surgery.¹⁶ The Joint Commission has identified factors that may enhance the risk of wrong-site surgery: multiple surgeons involved in the case, multiple procedures during a single surgical visit, unusual time pressures to start or complete the surgery, and unusual physical characteristics including morbid obesity or physical deformity.¹⁶

10 starting points for medical error preventionSo what are we to do? Consider:

Set the stage for best outcomesA true team approach is an excellent modus operandi before, during, and after surgery,setting the stage for best outcomes for patients.

“As human beings, surgeons will commit errors and for this reason they have to adopt and utilize stringent defense systems to minimize the incidence of these adverse events … Transparency is the first step on the way to a new safety culture with the acknowledgement of errors when they occur with adoption of systems destined to establish their cause and future prevention.”¹

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

CASE Surgeon accused of operating outside her scope of expertise

A 38-year-old woman (G2 P2002) presented to the emergency department (ED) with acute pelvic pain involving the right lower quadrant (RLQ). The patient had a history of stage IV endometriosis and chronic pelvic pain, primarily affecting the RLQ, that was treated by total laparoscopic hysterectomy with bilateral salpingo-oophorectomy 6 months earlier. Pertinent findings on physical examination included hypoactive bowel sounds and rebound tenderness. The ED physician ordered a computed tomography (CT) scan of the abdomen, which showed no evidence of ureteral injury or other abnormality. The gynecologist who performed the surgery 6 months ago evaluated the patient in the ED.

The gynecologist decided to perform operative laparoscopy because of the severity of the patient’s pain and duration of symptoms. Informed consent obtained in the ED before the patient received analgesics included a handwritten note that said “and other indicated procedures.” The patient signed the document prior to being taken to the operating room (OR). Time out occurred in the OR before anesthesia induction. The gynecologist proceeded with laparoscopic adhesiolysis with planned appendectomy, as she was trained. A normal appendix was noted and left intact. RLQ adhesions involving the colon and abdominal wall were treated with electrosurgical cautery. When the gynecologist found adhesions between the liver and diaphragm in the right upper quadrant (RUQ), she continued adhesiolysis. However, the diaphragm was inadvertently punctured.

As the gynecologist attempted to suture the defect laparoscopically, she encountered difficulty and converted to laparotomy. Adhesions were dense and initially precluded adequate closure of the diaphragmatic defect. The gynecologist persisted and ultimately the closure was adequate; laparotomy concluded. Postoperatively, the patient was given a diagnosis of atelectasis, primarily on the right side; a chest tube was placed by the general surgery team. The patient had an uneventful postoperative period and was discharged on postoperative day 5. One month later she returned to the ED with evidence of pneumonia; she was given a diagnosis of empyema, and antibiotics were administered. She responded well and was discharged after 6 days.

The patient filed a malpractice lawsuit against the gynecologist, the hospital, and associated practitioners. The suit made 3 negligence claims: 1) the surgery was improperly performed, as evidenced by the diaphragmatic perforation; 2) the gynecologist was not adequately trained for RUQ surgery, and 3) the hospital should not have permitted RUQ surgery to proceed. The liability claim cited the lack of qualification of a gynecologic surgeon to proceed with surgical intervention near the diaphragm and the associated consequences of practicing outside the scope of expertise.

Fitz-Hugh Curtis syndrome, a complication of pelvic inflammatory disease that may cause adhesions, was raised as the initial finding at the second surgical procedure and documented as such in the operative report. The plaintiff’s counsel questioned whether surgical correction of this syndrome was within the realm of a gynecologic surgeon. The plaintiff’s counsel argued that the laparoscopic surgical procedure involved bowel and liver; diaphragmatic adhesiolysis was not indicated, especially with normal abdominal CT scan results and the absence of RUQ symptoms. The claim specified that the surgery and care, as a consequence of the RUQ adhesiolysis, resulted in atelectasis, pneumonia, and empyema, with pain and suffering. The plaintiff sought unspecified monetary damages for these results.

What’s the verdict?

The case is in negotiation prior to trial.

Legal and medical considerations

“To err is not just human but intrinsically biological and no profession is exempt from fallibility.”¹

Error and liability

To err may be human, but human error is not necessarily the cause of every suboptimal medical outcome. In fact, the overall surgical complication rate has been reported at 3.4%.² Even when there is an error, it may not have been the kind of error that gives rise to medical malpractice liability. When it comes to surgical errors, the most common are those that actually relate to medications given at surgery that appear to be more common—one recent study found that 1 in 20 perioperative medication administrations resulted in a medication error or an adverse drug event.³

Medical error vs medical malpractice

The fact is that medical error and medical malpractice (or professional negligence) are not the same thing. It is critical to understand the difference.

Medical error is the third leading cause of death in the United States.⁴ It is defined as “the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim,”⁵ or, in the Canadian literature, “an act of omission or commission in planning or execution that contributes or could contribute to an unintended result.”⁶ The gamut of medical errors spans (among others) problems with technique, judgment, medication administration, diagnostic and surgical errors, and incomplete record keeping.⁵

Negligent error, on the other hand, is generally a subset of medical error recognized by the law. It is error that occurs because of carelessness. Technically, to give rise to liability for negligence (or malpractice) there must be duty, breach, causation, and injury. That is, the physician must owe a duty to the patient, the duty must have been breached, and that breach must have caused an injury.⁷

Usually the duty in medical practice is that the physician must have acted as a reasonable and prudent professional would have performed under the circumstances. For the most part, malpractice is a level of practice that the profession itself would not view as reasonable practice.⁸ Specialists usually are held to the higher standards of the specialty. It also can be negligent to undertake practice or a procedure for which the physician is not adequately trained, or for failing to refer the patient to another more qualified physician.

The duty in medicine usually arises from the physician-patient relationship (clearly present here). It is reasonably clear in this case that there was an injury, but, in fact, the question is whether the physician acted carelessly in a way that caused that injury. Our facts leave some ambiguity—unfortunately,a common problem in the real world.

It is possible that the gynecologist was negligent in puncturing the diaphragm. It may have been carelessness, for example, in the way the procedure was performed, or in the decision to proceed despite the difficulties encountered. It is also possible that the gynecologist was not appropriately trained and experienced in the surgery that was undertaken, in which case the decision to do the surgery (rather than to refer to another physician) could well have been negligent. In either of those cases, negligence liability (malpractice) is a possibility.

Proving negligence. It is the plaintiff (the patient) who must prove the elements of negligence (including causation).⁸ The plaintiff will have to demonstrate not only carelessness, but that carelessness is what caused the injuries for which she is seeking compensation. In this case, the injuries are the consequence of puncturing the diaphragm. The potential damages would be the money to cover the additional medical costs and other expenses, lost wages, and noneconomic damages such as pain and suffering.

The hospital’s role in negligence

The issue of informed consent is also raised in this case, with a handwritten note prior to surgery (but the focus of this article is on medical errors). In addition to the gynecologist, the hospital and other medical personnelwere sued. The hospital is responsible for the acts of its agents, notably its employees. Even if the physicians are not technically hospital employees, the hospital may in some cases be responsible. Among other things, the hospital likely has an obligation to prevent physicians from undertaking inappropriate procedures, including those for which the physician is not appropriately trained. If the gynecologist in this case did not have privileges to perform surgery in this category, the hospital may have an obligation to not schedule the surgery or to intraoperatively question her credentials for such a procedure. In any event, the hospital will have a major role in this case and its interests may, in some instances, be inconsistent with the interests of the physician.

Why settlement discussions?

The case description ends with a note that settlement discussions were underway. If the plaintiff must prove all of the elements of negligence, why have these discussions? First, such discussions are common in almost all negligence cases. This does not mean that the case actually will be settled by the insurance company representing the physician or hospital; many malpractice cases simply fade away because the patient drops the action. Second, there are ambiguities in the facts, and it is sometimes impossible to determine whether or not a jury would find negligence. The hospital may be inclined to settle if there is any realistic chance of a jury ruling against it. Paying a small settlement may be worth avoiding high legal expenses and the risk of an adverse outcome at trial.⁹

Reducing medical/surgical error through a team approach

Recognizing that “human performance can be affected by many factors that include circadian rhythms, state of mind, physical health, attitude, emotions, propensity for certain common mistakes and errors, and cognitive biases,”¹⁰ health care professionals have a commitment to reduce the errors in the interest of patient safety and best practice.

The surgical environment is an opportunity to provide a team approach to patient safety. Surgical risk is a reflection of operative performance, the main factor in the development of postoperative complications.¹¹ We wish to broaden the perspective that gynecologic surgeons, like all surgeons, must keep in mind a number of concerns that can be associated with problems related to surgical procedures, including¹²:

• visual perception difficulties
• stress
• loss of haptic perception (feedback using touch), as with robot-assisted procedures
• lack of situational awareness (a term we borrow from the aviation industry)
• long-term (and short-term) memory problems.

Analysis of surgical errors shows that they are related to, in order of frequency ¹:

• surgical technique
• judgment
• inattention to detail
• incomplete understanding of the problem or surgical situation.

Medical errors: Caring for the second victim (you)

Patrice M. Weiss, MD

We use the term “victim” to refer to the patient and her family following a medical error. The phrase “the second victim” was coined by Dr. Albert Wu in an article in the British Medical Journal¹ and describes how a clinician and team of health care professionals also can be affected by medical errors.

 

What signs and symptoms identify a second victim?Those suffering as a second victim may show signs of depression, loss of joy in work, and difficulty sleeping. They also may replay the events, question their own ability, and feel fearful about making another error. These reactions can lead to burnout—a serious issue that 46% of physicians report.²

As colleagues of those involved in a medical error, we should be cognizant of changes in behavior such as excessive irritability, showing up late for work, or agitation. It may be easier to recognize these symptoms in others rather than in ourselves because we often do not take time to examine how our experiences may affect us personally. Heightening awareness can help us recognize those suffering as second victims and identify the second victim symptoms in ourselves.
 

How can we help second victims?One challenge second victims face is not being allowed to discuss a medical error. Certainly, due to confidentiality requirements during professional liability cases, we should not talk freely about the event. However, silence creates a barrier that prevents a second victim from processing the incident.

Some hospitals offer forums to discuss medical errors, with the goal of preventing reoccurrence: morbidity and mortality conferences, morning report, Quality Assurance and Performance Improvement meetings, and root cause analyses. These forums often are not perceived by institutions’ employees in a positive way. Are they really meant to improve patient care or do they single out an individual or group in a “name/blame/shame game”? An intimidating process will only worsen a second victim’s symptoms. It is not necessary, however, to create a whole new process; it is possible to restructure, reframe, and change the culture of an existing practice.

Some institutions have developed a formalized program to help second victims. The University of Missouri has a “forYOU team,” an internal, rapid response group that provides emotional first aid to the entire team involved in a medical error case. These responders are not from human resources and do not need to be sought out; they are peers who have been educated about the struggles of the second victim. They will not discuss the case or how care was rendered; they naturally and instinctively provide emotional support to their colleagues.

At my institution, the Carilion Clinic at the Virginia Tech Carilion School of Medicine, “The Trust Program” encourages truth, respectfulness, understanding, support, and transparency. All health care clinicians receive basic training, but many have volunteered for additional instruction to become mentors because they have experienced second-victim symptoms themselves.

Clinicians want assistance when dealing with a medical error. One poll reports that 90% of physicians felt that health care organizations did not adequately help them cope with the stresses associated with a medical error.³ The goal is to have all institutions recognize that clinicians can be affected by a medical error and offer support.

To hear an expanded audiocast from Dr. Weiss on “the second victim” click here.

---

Dr. Weiss is Professor, Department of Obstetrics & Gynecology, Virginia Tech Carilion School of Medicine, and Chief Medical Officer and Executive Vice President, Carilion Clinic, Roanoke, Virginia.

The author reports no financial relationships relevant to this article.

 

---

References

1. Wu AW. Medical error: the second victim. BMJ. 2000;320(7237):726–727.
2. Peckham C. Medscape Physician Lifestyle Report 2015. Medscape website. http://www.medscape.com/features/slideshow/lifestyle/2015/public/overview#1. Published January 26, 2015. Accessed May 24, 2016.
3. White AA, Waterman AD, McCotter P, Boyle DJ, Gallagher TH. Supporting health care workers after medical error: considerations for health care leaders. JCOM. 2008;15(5):240–247.

“Inadequacy” with regard to surgical proceduresIndication for surgery is intrinsic to provision of appropriate care. Surgery inherently poses the possibility of unexpected problems. Adequate training and skill, therefore, must include the ability to deal with a range of problems that arise in the course of surgery. The spectrum related to inadequacy as related to surgical problems includes “failed surgery,” defined as “if despite the utmost care of everyone involved and with the responsible consideration of all knowledge, the designed aim is not achieved, surgery by itself has failed.”⁵ Of paramount importance is the surgeon’s knowledge of technology and the ability to troubleshoot, as well as the OR team’s responsibility for proper maintenance of equipment to ensure optimal functionality.¹

Aviation industry studies indicate that “high performing cockpit crews have been shown to devote one third of their communications to discuss threats and mistakes in their environment, while poor performing teams devoted much less, about 5%, of their time to such.”^1,13 A well-trained and well-motivated OR nursing team has been equated with reduction in operative time and rate of conversion to laparotomy.¹⁴ Outdated instruments may also contribute to surgical errors.¹

Moving the “learning curve” out of the OR and into the simulation lab remains valuable, which is also confirmed by the aviation industry.¹⁵ The significance of loss of haptic perception continues to be debated between laparoscopic (straight-stick) surgeons and those performing robotic approaches. Does haptic perception play a major role in surgical intervention? Most surgeons do not view loss of haptic perception, as with minimally invasive procedures, as a major impediment to successful surgery. From the legal perspective, loss of haptic perception has not been well addressed.

The American College of Obstetricians and Gynecologists has focused on patient safety in the surgical environment including concerns for wrong-patient surgery, wrong-side surgery, wrong-level surgery, and wrong-part surgery.¹⁶ The Joint Commission has identified factors that may enhance the risk of wrong-site surgery: multiple surgeons involved in the case, multiple procedures during a single surgical visit, unusual time pressures to start or complete the surgery, and unusual physical characteristics including morbid obesity or physical deformity.¹⁶

10 starting points for medical error preventionSo what are we to do? Consider:

Set the stage for best outcomesA true team approach is an excellent modus operandi before, during, and after surgery,setting the stage for best outcomes for patients.

“As human beings, surgeons will commit errors and for this reason they have to adopt and utilize stringent defense systems to minimize the incidence of these adverse events … Transparency is the first step on the way to a new safety culture with the acknowledgement of errors when they occur with adoption of systems destined to establish their cause and future prevention.”¹

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

CASE Surgeon accused of operating outside her scope of expertise

A 38-year-old woman (G2 P2002) presented to the emergency department (ED) with acute pelvic pain involving the right lower quadrant (RLQ). The patient had a history of stage IV endometriosis and chronic pelvic pain, primarily affecting the RLQ, that was treated by total laparoscopic hysterectomy with bilateral salpingo-oophorectomy 6 months earlier. Pertinent findings on physical examination included hypoactive bowel sounds and rebound tenderness. The ED physician ordered a computed tomography (CT) scan of the abdomen, which showed no evidence of ureteral injury or other abnormality. The gynecologist who performed the surgery 6 months ago evaluated the patient in the ED.

The gynecologist decided to perform operative laparoscopy because of the severity of the patient’s pain and duration of symptoms. Informed consent obtained in the ED before the patient received analgesics included a handwritten note that said “and other indicated procedures.” The patient signed the document prior to being taken to the operating room (OR). Time out occurred in the OR before anesthesia induction. The gynecologist proceeded with laparoscopic adhesiolysis with planned appendectomy, as she was trained. A normal appendix was noted and left intact. RLQ adhesions involving the colon and abdominal wall were treated with electrosurgical cautery. When the gynecologist found adhesions between the liver and diaphragm in the right upper quadrant (RUQ), she continued adhesiolysis. However, the diaphragm was inadvertently punctured.

As the gynecologist attempted to suture the defect laparoscopically, she encountered difficulty and converted to laparotomy. Adhesions were dense and initially precluded adequate closure of the diaphragmatic defect. The gynecologist persisted and ultimately the closure was adequate; laparotomy concluded. Postoperatively, the patient was given a diagnosis of atelectasis, primarily on the right side; a chest tube was placed by the general surgery team. The patient had an uneventful postoperative period and was discharged on postoperative day 5. One month later she returned to the ED with evidence of pneumonia; she was given a diagnosis of empyema, and antibiotics were administered. She responded well and was discharged after 6 days.

The patient filed a malpractice lawsuit against the gynecologist, the hospital, and associated practitioners. The suit made 3 negligence claims: 1) the surgery was improperly performed, as evidenced by the diaphragmatic perforation; 2) the gynecologist was not adequately trained for RUQ surgery, and 3) the hospital should not have permitted RUQ surgery to proceed. The liability claim cited the lack of qualification of a gynecologic surgeon to proceed with surgical intervention near the diaphragm and the associated consequences of practicing outside the scope of expertise.

Fitz-Hugh Curtis syndrome, a complication of pelvic inflammatory disease that may cause adhesions, was raised as the initial finding at the second surgical procedure and documented as such in the operative report. The plaintiff’s counsel questioned whether surgical correction of this syndrome was within the realm of a gynecologic surgeon. The plaintiff’s counsel argued that the laparoscopic surgical procedure involved bowel and liver; diaphragmatic adhesiolysis was not indicated, especially with normal abdominal CT scan results and the absence of RUQ symptoms. The claim specified that the surgery and care, as a consequence of the RUQ adhesiolysis, resulted in atelectasis, pneumonia, and empyema, with pain and suffering. The plaintiff sought unspecified monetary damages for these results.

What’s the verdict?

The case is in negotiation prior to trial.

Legal and medical considerations

“To err is not just human but intrinsically biological and no profession is exempt from fallibility.”¹

Error and liability

To err may be human, but human error is not necessarily the cause of every suboptimal medical outcome. In fact, the overall surgical complication rate has been reported at 3.4%.² Even when there is an error, it may not have been the kind of error that gives rise to medical malpractice liability. When it comes to surgical errors, the most common are those that actually relate to medications given at surgery that appear to be more common—one recent study found that 1 in 20 perioperative medication administrations resulted in a medication error or an adverse drug event.³

Medical error vs medical malpractice

The fact is that medical error and medical malpractice (or professional negligence) are not the same thing. It is critical to understand the difference.

Medical error is the third leading cause of death in the United States.⁴ It is defined as “the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim,”⁵ or, in the Canadian literature, “an act of omission or commission in planning or execution that contributes or could contribute to an unintended result.”⁶ The gamut of medical errors spans (among others) problems with technique, judgment, medication administration, diagnostic and surgical errors, and incomplete record keeping.⁵

Negligent error, on the other hand, is generally a subset of medical error recognized by the law. It is error that occurs because of carelessness. Technically, to give rise to liability for negligence (or malpractice) there must be duty, breach, causation, and injury. That is, the physician must owe a duty to the patient, the duty must have been breached, and that breach must have caused an injury.⁷

Usually the duty in medical practice is that the physician must have acted as a reasonable and prudent professional would have performed under the circumstances. For the most part, malpractice is a level of practice that the profession itself would not view as reasonable practice.⁸ Specialists usually are held to the higher standards of the specialty. It also can be negligent to undertake practice or a procedure for which the physician is not adequately trained, or for failing to refer the patient to another more qualified physician.

The duty in medicine usually arises from the physician-patient relationship (clearly present here). It is reasonably clear in this case that there was an injury, but, in fact, the question is whether the physician acted carelessly in a way that caused that injury. Our facts leave some ambiguity—unfortunately,a common problem in the real world.

It is possible that the gynecologist was negligent in puncturing the diaphragm. It may have been carelessness, for example, in the way the procedure was performed, or in the decision to proceed despite the difficulties encountered. It is also possible that the gynecologist was not appropriately trained and experienced in the surgery that was undertaken, in which case the decision to do the surgery (rather than to refer to another physician) could well have been negligent. In either of those cases, negligence liability (malpractice) is a possibility.

Proving negligence. It is the plaintiff (the patient) who must prove the elements of negligence (including causation).⁸ The plaintiff will have to demonstrate not only carelessness, but that carelessness is what caused the injuries for which she is seeking compensation. In this case, the injuries are the consequence of puncturing the diaphragm. The potential damages would be the money to cover the additional medical costs and other expenses, lost wages, and noneconomic damages such as pain and suffering.

The hospital’s role in negligence

The issue of informed consent is also raised in this case, with a handwritten note prior to surgery (but the focus of this article is on medical errors). In addition to the gynecologist, the hospital and other medical personnelwere sued. The hospital is responsible for the acts of its agents, notably its employees. Even if the physicians are not technically hospital employees, the hospital may in some cases be responsible. Among other things, the hospital likely has an obligation to prevent physicians from undertaking inappropriate procedures, including those for which the physician is not appropriately trained. If the gynecologist in this case did not have privileges to perform surgery in this category, the hospital may have an obligation to not schedule the surgery or to intraoperatively question her credentials for such a procedure. In any event, the hospital will have a major role in this case and its interests may, in some instances, be inconsistent with the interests of the physician.

Why settlement discussions?

The case description ends with a note that settlement discussions were underway. If the plaintiff must prove all of the elements of negligence, why have these discussions? First, such discussions are common in almost all negligence cases. This does not mean that the case actually will be settled by the insurance company representing the physician or hospital; many malpractice cases simply fade away because the patient drops the action. Second, there are ambiguities in the facts, and it is sometimes impossible to determine whether or not a jury would find negligence. The hospital may be inclined to settle if there is any realistic chance of a jury ruling against it. Paying a small settlement may be worth avoiding high legal expenses and the risk of an adverse outcome at trial.⁹

Reducing medical/surgical error through a team approach

Recognizing that “human performance can be affected by many factors that include circadian rhythms, state of mind, physical health, attitude, emotions, propensity for certain common mistakes and errors, and cognitive biases,”¹⁰ health care professionals have a commitment to reduce the errors in the interest of patient safety and best practice.

The surgical environment is an opportunity to provide a team approach to patient safety. Surgical risk is a reflection of operative performance, the main factor in the development of postoperative complications.¹¹ We wish to broaden the perspective that gynecologic surgeons, like all surgeons, must keep in mind a number of concerns that can be associated with problems related to surgical procedures, including¹²:

• visual perception difficulties
• stress
• loss of haptic perception (feedback using touch), as with robot-assisted procedures
• lack of situational awareness (a term we borrow from the aviation industry)
• long-term (and short-term) memory problems.

Analysis of surgical errors shows that they are related to, in order of frequency ¹:

• surgical technique
• judgment
• inattention to detail
• incomplete understanding of the problem or surgical situation.

Medical errors: Caring for the second victim (you)

Patrice M. Weiss, MD

We use the term “victim” to refer to the patient and her family following a medical error. The phrase “the second victim” was coined by Dr. Albert Wu in an article in the British Medical Journal¹ and describes how a clinician and team of health care professionals also can be affected by medical errors.

 

What signs and symptoms identify a second victim?Those suffering as a second victim may show signs of depression, loss of joy in work, and difficulty sleeping. They also may replay the events, question their own ability, and feel fearful about making another error. These reactions can lead to burnout—a serious issue that 46% of physicians report.²

As colleagues of those involved in a medical error, we should be cognizant of changes in behavior such as excessive irritability, showing up late for work, or agitation. It may be easier to recognize these symptoms in others rather than in ourselves because we often do not take time to examine how our experiences may affect us personally. Heightening awareness can help us recognize those suffering as second victims and identify the second victim symptoms in ourselves.
 

How can we help second victims?One challenge second victims face is not being allowed to discuss a medical error. Certainly, due to confidentiality requirements during professional liability cases, we should not talk freely about the event. However, silence creates a barrier that prevents a second victim from processing the incident.

Some hospitals offer forums to discuss medical errors, with the goal of preventing reoccurrence: morbidity and mortality conferences, morning report, Quality Assurance and Performance Improvement meetings, and root cause analyses. These forums often are not perceived by institutions’ employees in a positive way. Are they really meant to improve patient care or do they single out an individual or group in a “name/blame/shame game”? An intimidating process will only worsen a second victim’s symptoms. It is not necessary, however, to create a whole new process; it is possible to restructure, reframe, and change the culture of an existing practice.

Some institutions have developed a formalized program to help second victims. The University of Missouri has a “forYOU team,” an internal, rapid response group that provides emotional first aid to the entire team involved in a medical error case. These responders are not from human resources and do not need to be sought out; they are peers who have been educated about the struggles of the second victim. They will not discuss the case or how care was rendered; they naturally and instinctively provide emotional support to their colleagues.

At my institution, the Carilion Clinic at the Virginia Tech Carilion School of Medicine, “The Trust Program” encourages truth, respectfulness, understanding, support, and transparency. All health care clinicians receive basic training, but many have volunteered for additional instruction to become mentors because they have experienced second-victim symptoms themselves.

Clinicians want assistance when dealing with a medical error. One poll reports that 90% of physicians felt that health care organizations did not adequately help them cope with the stresses associated with a medical error.³ The goal is to have all institutions recognize that clinicians can be affected by a medical error and offer support.

To hear an expanded audiocast from Dr. Weiss on “the second victim” click here.

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Dr. Weiss is Professor, Department of Obstetrics & Gynecology, Virginia Tech Carilion School of Medicine, and Chief Medical Officer and Executive Vice President, Carilion Clinic, Roanoke, Virginia.

The author reports no financial relationships relevant to this article.

 

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References

1. Wu AW. Medical error: the second victim. BMJ. 2000;320(7237):726–727.
2. Peckham C. Medscape Physician Lifestyle Report 2015. Medscape website. http://www.medscape.com/features/slideshow/lifestyle/2015/public/overview#1. Published January 26, 2015. Accessed May 24, 2016.
3. White AA, Waterman AD, McCotter P, Boyle DJ, Gallagher TH. Supporting health care workers after medical error: considerations for health care leaders. JCOM. 2008;15(5):240–247.

“Inadequacy” with regard to surgical proceduresIndication for surgery is intrinsic to provision of appropriate care. Surgery inherently poses the possibility of unexpected problems. Adequate training and skill, therefore, must include the ability to deal with a range of problems that arise in the course of surgery. The spectrum related to inadequacy as related to surgical problems includes “failed surgery,” defined as “if despite the utmost care of everyone involved and with the responsible consideration of all knowledge, the designed aim is not achieved, surgery by itself has failed.”⁵ Of paramount importance is the surgeon’s knowledge of technology and the ability to troubleshoot, as well as the OR team’s responsibility for proper maintenance of equipment to ensure optimal functionality.¹

Aviation industry studies indicate that “high performing cockpit crews have been shown to devote one third of their communications to discuss threats and mistakes in their environment, while poor performing teams devoted much less, about 5%, of their time to such.”^1,13 A well-trained and well-motivated OR nursing team has been equated with reduction in operative time and rate of conversion to laparotomy.¹⁴ Outdated instruments may also contribute to surgical errors.¹

Moving the “learning curve” out of the OR and into the simulation lab remains valuable, which is also confirmed by the aviation industry.¹⁵ The significance of loss of haptic perception continues to be debated between laparoscopic (straight-stick) surgeons and those performing robotic approaches. Does haptic perception play a major role in surgical intervention? Most surgeons do not view loss of haptic perception, as with minimally invasive procedures, as a major impediment to successful surgery. From the legal perspective, loss of haptic perception has not been well addressed.

The American College of Obstetricians and Gynecologists has focused on patient safety in the surgical environment including concerns for wrong-patient surgery, wrong-side surgery, wrong-level surgery, and wrong-part surgery.¹⁶ The Joint Commission has identified factors that may enhance the risk of wrong-site surgery: multiple surgeons involved in the case, multiple procedures during a single surgical visit, unusual time pressures to start or complete the surgery, and unusual physical characteristics including morbid obesity or physical deformity.¹⁶

10 starting points for medical error preventionSo what are we to do? Consider:

Set the stage for best outcomesA true team approach is an excellent modus operandi before, during, and after surgery,setting the stage for best outcomes for patients.

“As human beings, surgeons will commit errors and for this reason they have to adopt and utilize stringent defense systems to minimize the incidence of these adverse events … Transparency is the first step on the way to a new safety culture with the acknowledgement of errors when they occur with adoption of systems destined to establish their cause and future prevention.”¹

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

CASE: Patient discloses personal information in electronic communication. How to respond and what’s at stake?
Your nurse comes to you with a dilemma. Last Friday she received an email from a patient, sent to the nurse’s personal email account (G-mail) that conveyed information regarding the patient’s recent treatment for a herpetic vulvar lesion. The text details presumed exposure, date and time, number of sexual partners, concernfor “spread of disease,” and the patient’s desire to have a comprehensive sexually transmitted infection screening as soon as possible.

Your nurse has years of professional experience, but she is perhaps not the most savvy with regard to current information technology and social media. Nonetheless, she knows it is best not to immediately respond to the patient’s email without checking with you. She tracks you down on Monday morning to review the email and the dilemma she feels she has been placed in. What’s the best next step?

While discussing the general question with the staff, another nurse notes that there have been some reviews of the office on social media. It seems that this second nurse tweets and texts with patients all the time. The office manager strongly suggests that the office “join the 21st Century” by setting up a Facebook page and using their webpage to attract new patients and communicate with current patients.

How do you prepare for this? Is your staff knowledgeable about the dos and don’ts of social media?

The use of social media by health care providers has been growing for several years. Back in 2011 a large survey by QuantiaMD revealed that 87% of physicians used social media for personal reasons, and 67% of them used it professionally.¹ How they used it for professional purposes also was explored in 2011, with almost 3 of 4 physicians using it for social networking and more than half engaging with their own institution’s social media (FIGURE).² In 2013, 53% of physicians indicated that their practice had a Facebook platform, 28% had a presence on LinkedIn, and 21% were on Twitter.³ Not surprisingly, social media use is higher among younger physicians⁴; the 2016 equivalents to these percentages most likely are higher.
 

Health providers’ use of social media for professional reasons2

In 2011, a survey found that most health providers used social networking, their institutions’ own social media, and Internet forums, boards, and communities for professional reasons.

Patients’ outreach through social media regarding health care information continues to grow, with 33.8% asking for health advice using social media.⁵ While email and other social media open the possibility of improved communication with patients, they also present a number of important professional and legal issues that deserve special consideration.⁶ Each medium presents its own challenges, but there are 4 categories of concern related to basic values and rights that we consider important to review:

Confidentiality
Few values of the medical profession are of longer standing than the commitment to maintain patient privacy. Fifth Century BC obligations continue to apply to the technology of the 21st Century AD. And the challenges are significant.

Email is not secure
In the opening case, the choice to email her clinician was apparently the patient’s. She probably does not realize that email is not very confidential, although it is undoubtedly in the Terms of Service Agreement she clicked through. Her email was likely scanned by her email service provider—Google, in this case—as well as the nurse. If, however, the physician’s office responds by email, it may well compound the confidentiality problem by further distributing the information through yet another email provider.

If, as a physician, you encourage email communication by your patients, a smart approach is to emphasize that such communications are not very confidential. At a minimum, until a secure email system can be established, it is best not to transmit medical information via email and to inform patients of the risk of such communication. In the case above, the nurse who received the email should respond to the patient by telephone (much more secure). Or she can respond to the patient by email (not including the patient’s message in the return), writing that, because email communications are inherently not confidential, she suggests a phone call or personal visit.

This case also notes that the patient sent the email to the nurse’s personal account, not to an office email account. Sending medical emails to an employee’s personal account raises additional problems of confidentiality and appropriate controls. It should be made clear that employees should not be discussing private medical matters via their own email accounts.

Other forms of social media are also not secure
Similar concerns arise about texting and using Twitter by the second nurse. These activities apparently had been unknown to the physician, but the practice still may be responsible for her actions. These are insecure forms of communication and raise serious ethical and legal concerns.

Other social media pose confidentiality risks as well. For example, a physician was dismissed from a position and reprimanded by the medical board for posting patient information on Facebook,⁷ and an ObGyn caused problems by posting a nasty note about a patient who showed up late for an appointment.⁸ Too many patients may not understand that posting on social media is the equivalent of standing on a street corner yelling private information. Social media sites that invite the discussion of personal matters are an invitation to trouble.

Physicians are ethically obliged to protect confidentiality
Professional standards place significant ethical obligations on physicians to protect patient confidentiality. The American Medical Association (AMA) has an ethics opinion on professionalism with social media,⁹ as does the American College of Obstetricians and Gynecologists (ACOG).¹⁰ Another excellent discussion of ethical and practical issues is a joint position paper by the American College of Physicians and the Federation of State Medical Boards.¹¹ Both documents focus attention on issues of confidentiality.

Physicians are legally obliged to protect confidentiality
There are many legal protections for confidentiality that can be implicated by electronic communications and social media. All states provide protection for unwarranted disclosure of private patient information. Such disclosures made electronically are included.¹² Indeed, because electronic disclosures may be broadcast more widely, they may be especially dangerous. The misuse of social media may result in license discipline by the state board, regulatory sanctions, or civil liability (rare, but criminal sanctions are a possibility in extreme circumstances).

In addition to state laws regarding confidentiality, there are a number of federal laws that cover confidential medical information. None is more important than the Health Insurance Portability and Accountability Act (HIPAA) and the more recent HITECH amendments (Health Information Technology for Economic and Clinical Health).¹³ These laws have both privacy provisions and security (including “encryption”) requirements. These are complicated laws but at their core are the notions that health care providers and some others:

A good source of step-by-step information about these laws is “Health information privacy: Covered entities and business associates,” on the US Health and Human Services website.¹⁴

HITECH also provides for notice to patients when health information is inappropriately transmitted. Thus, a missing USB flash drive with patient information may require notification to thousands of patients.¹⁵ Any consideration of the use of email or social media in medical practice must take into account the HIPAA/HITECH obligations to protect the security of patient health information. There can be serious professional consequences for failing to follow the HIPAA requirements.¹⁶

Dual relationships and conflicts of interest
In our hypothetical case, the office manager’s suggestion that the office use Facebook and their website to attract new patients also may raise confidentiality problems. The Facebook suggestion especially needs to be considered carefully. Facebook use is estimated to be 63% to 96% among students and 13% to 47% among health care professionals.¹⁷ Facebook is most often seen as an interactive social site; it risks blurring the lines between personal and professional relationships.⁹ There is a consensus that a physician should not “friend” patients on Facebook. The AMA ethics opinion notes that “physicians must maintain appropriate boundaries of the patient-physician relationship in accordance with professional ethical guidelines, just as they would in any other context.”⁹

Separate personal and professional contacts
Difficulties with interactive social media are not limited to the physicians in a practice. The problems increase with the number of staff members who post or respond on social media. Control of social media is essential. The practice must ensure that staff members do not slip into inappropriate personal comments and relationships. Staff should understand (and be reminded of) the necessity of separating personal and professional contacts.

Avoid misunderstandings
In addition, whatever the intent of the physician and staff may be, it is essentially impossible to know how patients will interpret interactions on these social media. The very informal, off-the-cuff, chatty way in which Facebook and similar sites are used invites misunderstandings, and maintaining professional boundaries is necessary.

Ground rules
All of this is not to say that professionals should never use Facebook or similar sites. Rather, if used, ground rules need to be established.

Social media communications must:

Staff training
Particularly for interactive social media (email, texts, Twitter, Facebook, etc), it is essential that there be both clear policies and good staff training (TABLE).^9–11,18 There really should be no “making it up as we go along.” Staff on a social media lark of their own can be disastrous for the practice. Policies need to be updated frequently, and staff training reinforced and repeated periodically.

Quality of care and advice
Start with your website
Institutions’ websites are major sources of health care information: Nearly 32% of US adults would be very likely to prefer a hospital based on its website.⁵ Your website can be an important face of your practice to the community—for good or for bad. On one hand, the practice can control what is on a website and, unlike some social media, it will not be directed to individual patients. Done well, it “provides golden opportunities for marketing physician services, as well as for contributing to public health by providing high-quality online content that is both accurate and understandable to laypeople.”¹⁹ Done badly, it can convey incorrect and harmful information and discredit the medical practice that established it.

Your website introduces the practice and settings, but it will serve another purpose to thousands of people who likely will see it over time as a source of credible health information. The importance of ensuring that your website is carefully constructed to provide, or link to, good medical advice that contributes to quality of care cannot be overstated.

A good website begins with a clear statement of the reasons and goals for having the site. Professional design assistance generally is used to create the site, but that design process needs to be overseen by a medical professional to ensure that it conveys the sense of the practice and provides completely accurate information. A homepage of dancing clowns with stethoscopes may seem good to a 20-something-year-old designer, but it is not appropriate for a physician. It will be the practice, not the designer, who is held accountable for the site content. Links to other sites need to be vetted and used with care. Patients and other members of the public may well take the links as carrying the endorsement of the practice and its physicians.

Perhaps the greatest risk of a website is that it will not be kept current. Unfortunately, they do not update themselves. Some knowledgeable staff member must frequently review it to update everything from office hours and personnel to links to other sites. In addition, the physicians periodically must review it to ensure that all medical information is up to date and accurate. Old, outdated information about the office can put off potential patients. Outdated medical information may be harmful to patients who rely on it.

Any professional website should include disclaimers informing users that the site is not intended to establish a professional relationship or to give professional advice. The nature and extent of the disclaimer will depend on the type of information on the site. An example of a particularly thorough disclaimer is the Mayo Clinic disclaimer and terms of use (http://www.mayoclinic.org/about-this-site/terms-conditions-use-policy).

General professionalism
At the end of the day, social media are an outreach from a medical practice and from the profession to the public.²⁰ Failure to treat these platforms with appropriate professional standards may result in professional discipline, damages, or civil penalties. Almost all of the reviews of social media use in health care practice note that the risks of inappropriate use are not only to the individual physician but also to the general medical profession, which may be undermined. Consider posting policies of the relevent state medical boards, the AMA, and ACOG in your office after you have had a discussion with your staff about them.²¹

The AMA statement includes a provision that a physician seeing unprofessional social media conduct by a colleague has the responsibility to bring that to the attention of the colleague. If the colleague does not correct a significant problem, “the physician should report the matter to appropriate authorities.”⁹

Bottom line
Any practitioner considering the use of social media must view it as a major step that requires caution, expert assistance, and constant attention to potential privacy, quality, and professionalism issues. If you are considering it, ensure that all staff associated with the practice understand and agree to the established limits on social media use.

Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

CASE: Patient discloses personal information in electronic communication. How to respond and what’s at stake?
Your nurse comes to you with a dilemma. Last Friday she received an email from a patient, sent to the nurse’s personal email account (G-mail) that conveyed information regarding the patient’s recent treatment for a herpetic vulvar lesion. The text details presumed exposure, date and time, number of sexual partners, concernfor “spread of disease,” and the patient’s desire to have a comprehensive sexually transmitted infection screening as soon as possible.

Your nurse has years of professional experience, but she is perhaps not the most savvy with regard to current information technology and social media. Nonetheless, she knows it is best not to immediately respond to the patient’s email without checking with you. She tracks you down on Monday morning to review the email and the dilemma she feels she has been placed in. What’s the best next step?

While discussing the general question with the staff, another nurse notes that there have been some reviews of the office on social media. It seems that this second nurse tweets and texts with patients all the time. The office manager strongly suggests that the office “join the 21st Century” by setting up a Facebook page and using their webpage to attract new patients and communicate with current patients.

How do you prepare for this? Is your staff knowledgeable about the dos and don’ts of social media?

The use of social media by health care providers has been growing for several years. Back in 2011 a large survey by QuantiaMD revealed that 87% of physicians used social media for personal reasons, and 67% of them used it professionally.¹ How they used it for professional purposes also was explored in 2011, with almost 3 of 4 physicians using it for social networking and more than half engaging with their own institution’s social media (FIGURE).² In 2013, 53% of physicians indicated that their practice had a Facebook platform, 28% had a presence on LinkedIn, and 21% were on Twitter.³ Not surprisingly, social media use is higher among younger physicians⁴; the 2016 equivalents to these percentages most likely are higher.
 

Health providers’ use of social media for professional reasons2

In 2011, a survey found that most health providers used social networking, their institutions’ own social media, and Internet forums, boards, and communities for professional reasons.

Patients’ outreach through social media regarding health care information continues to grow, with 33.8% asking for health advice using social media.⁵ While email and other social media open the possibility of improved communication with patients, they also present a number of important professional and legal issues that deserve special consideration.⁶ Each medium presents its own challenges, but there are 4 categories of concern related to basic values and rights that we consider important to review:

Confidentiality
Few values of the medical profession are of longer standing than the commitment to maintain patient privacy. Fifth Century BC obligations continue to apply to the technology of the 21st Century AD. And the challenges are significant.

Email is not secure
In the opening case, the choice to email her clinician was apparently the patient’s. She probably does not realize that email is not very confidential, although it is undoubtedly in the Terms of Service Agreement she clicked through. Her email was likely scanned by her email service provider—Google, in this case—as well as the nurse. If, however, the physician’s office responds by email, it may well compound the confidentiality problem by further distributing the information through yet another email provider.

If, as a physician, you encourage email communication by your patients, a smart approach is to emphasize that such communications are not very confidential. At a minimum, until a secure email system can be established, it is best not to transmit medical information via email and to inform patients of the risk of such communication. In the case above, the nurse who received the email should respond to the patient by telephone (much more secure). Or she can respond to the patient by email (not including the patient’s message in the return), writing that, because email communications are inherently not confidential, she suggests a phone call or personal visit.

This case also notes that the patient sent the email to the nurse’s personal account, not to an office email account. Sending medical emails to an employee’s personal account raises additional problems of confidentiality and appropriate controls. It should be made clear that employees should not be discussing private medical matters via their own email accounts.

Other forms of social media are also not secure
Similar concerns arise about texting and using Twitter by the second nurse. These activities apparently had been unknown to the physician, but the practice still may be responsible for her actions. These are insecure forms of communication and raise serious ethical and legal concerns.

Other social media pose confidentiality risks as well. For example, a physician was dismissed from a position and reprimanded by the medical board for posting patient information on Facebook,⁷ and an ObGyn caused problems by posting a nasty note about a patient who showed up late for an appointment.⁸ Too many patients may not understand that posting on social media is the equivalent of standing on a street corner yelling private information. Social media sites that invite the discussion of personal matters are an invitation to trouble.

Physicians are ethically obliged to protect confidentiality
Professional standards place significant ethical obligations on physicians to protect patient confidentiality. The American Medical Association (AMA) has an ethics opinion on professionalism with social media,⁹ as does the American College of Obstetricians and Gynecologists (ACOG).¹⁰ Another excellent discussion of ethical and practical issues is a joint position paper by the American College of Physicians and the Federation of State Medical Boards.¹¹ Both documents focus attention on issues of confidentiality.

Physicians are legally obliged to protect confidentiality
There are many legal protections for confidentiality that can be implicated by electronic communications and social media. All states provide protection for unwarranted disclosure of private patient information. Such disclosures made electronically are included.¹² Indeed, because electronic disclosures may be broadcast more widely, they may be especially dangerous. The misuse of social media may result in license discipline by the state board, regulatory sanctions, or civil liability (rare, but criminal sanctions are a possibility in extreme circumstances).

In addition to state laws regarding confidentiality, there are a number of federal laws that cover confidential medical information. None is more important than the Health Insurance Portability and Accountability Act (HIPAA) and the more recent HITECH amendments (Health Information Technology for Economic and Clinical Health).¹³ These laws have both privacy provisions and security (including “encryption”) requirements. These are complicated laws but at their core are the notions that health care providers and some others:

A good source of step-by-step information about these laws is “Health information privacy: Covered entities and business associates,” on the US Health and Human Services website.¹⁴

HITECH also provides for notice to patients when health information is inappropriately transmitted. Thus, a missing USB flash drive with patient information may require notification to thousands of patients.¹⁵ Any consideration of the use of email or social media in medical practice must take into account the HIPAA/HITECH obligations to protect the security of patient health information. There can be serious professional consequences for failing to follow the HIPAA requirements.¹⁶

Dual relationships and conflicts of interest
In our hypothetical case, the office manager’s suggestion that the office use Facebook and their website to attract new patients also may raise confidentiality problems. The Facebook suggestion especially needs to be considered carefully. Facebook use is estimated to be 63% to 96% among students and 13% to 47% among health care professionals.¹⁷ Facebook is most often seen as an interactive social site; it risks blurring the lines between personal and professional relationships.⁹ There is a consensus that a physician should not “friend” patients on Facebook. The AMA ethics opinion notes that “physicians must maintain appropriate boundaries of the patient-physician relationship in accordance with professional ethical guidelines, just as they would in any other context.”⁹

Separate personal and professional contacts
Difficulties with interactive social media are not limited to the physicians in a practice. The problems increase with the number of staff members who post or respond on social media. Control of social media is essential. The practice must ensure that staff members do not slip into inappropriate personal comments and relationships. Staff should understand (and be reminded of) the necessity of separating personal and professional contacts.

Avoid misunderstandings
In addition, whatever the intent of the physician and staff may be, it is essentially impossible to know how patients will interpret interactions on these social media. The very informal, off-the-cuff, chatty way in which Facebook and similar sites are used invites misunderstandings, and maintaining professional boundaries is necessary.

Ground rules
All of this is not to say that professionals should never use Facebook or similar sites. Rather, if used, ground rules need to be established.

Social media communications must:

Staff training
Particularly for interactive social media (email, texts, Twitter, Facebook, etc), it is essential that there be both clear policies and good staff training (TABLE).^9–11,18 There really should be no “making it up as we go along.” Staff on a social media lark of their own can be disastrous for the practice. Policies need to be updated frequently, and staff training reinforced and repeated periodically.

Quality of care and advice
Start with your website
Institutions’ websites are major sources of health care information: Nearly 32% of US adults would be very likely to prefer a hospital based on its website.⁵ Your website can be an important face of your practice to the community—for good or for bad. On one hand, the practice can control what is on a website and, unlike some social media, it will not be directed to individual patients. Done well, it “provides golden opportunities for marketing physician services, as well as for contributing to public health by providing high-quality online content that is both accurate and understandable to laypeople.”¹⁹ Done badly, it can convey incorrect and harmful information and discredit the medical practice that established it.

Your website introduces the practice and settings, but it will serve another purpose to thousands of people who likely will see it over time as a source of credible health information. The importance of ensuring that your website is carefully constructed to provide, or link to, good medical advice that contributes to quality of care cannot be overstated.

A good website begins with a clear statement of the reasons and goals for having the site. Professional design assistance generally is used to create the site, but that design process needs to be overseen by a medical professional to ensure that it conveys the sense of the practice and provides completely accurate information. A homepage of dancing clowns with stethoscopes may seem good to a 20-something-year-old designer, but it is not appropriate for a physician. It will be the practice, not the designer, who is held accountable for the site content. Links to other sites need to be vetted and used with care. Patients and other members of the public may well take the links as carrying the endorsement of the practice and its physicians.

Perhaps the greatest risk of a website is that it will not be kept current. Unfortunately, they do not update themselves. Some knowledgeable staff member must frequently review it to update everything from office hours and personnel to links to other sites. In addition, the physicians periodically must review it to ensure that all medical information is up to date and accurate. Old, outdated information about the office can put off potential patients. Outdated medical information may be harmful to patients who rely on it.

Any professional website should include disclaimers informing users that the site is not intended to establish a professional relationship or to give professional advice. The nature and extent of the disclaimer will depend on the type of information on the site. An example of a particularly thorough disclaimer is the Mayo Clinic disclaimer and terms of use (http://www.mayoclinic.org/about-this-site/terms-conditions-use-policy).

General professionalism
At the end of the day, social media are an outreach from a medical practice and from the profession to the public.²⁰ Failure to treat these platforms with appropriate professional standards may result in professional discipline, damages, or civil penalties. Almost all of the reviews of social media use in health care practice note that the risks of inappropriate use are not only to the individual physician but also to the general medical profession, which may be undermined. Consider posting policies of the relevent state medical boards, the AMA, and ACOG in your office after you have had a discussion with your staff about them.²¹

The AMA statement includes a provision that a physician seeing unprofessional social media conduct by a colleague has the responsibility to bring that to the attention of the colleague. If the colleague does not correct a significant problem, “the physician should report the matter to appropriate authorities.”⁹

Bottom line
Any practitioner considering the use of social media must view it as a major step that requires caution, expert assistance, and constant attention to potential privacy, quality, and professionalism issues. If you are considering it, ensure that all staff associated with the practice understand and agree to the established limits on social media use.

Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

CASE: Patient discloses personal information in electronic communication. How to respond and what’s at stake?
Your nurse comes to you with a dilemma. Last Friday she received an email from a patient, sent to the nurse’s personal email account (G-mail) that conveyed information regarding the patient’s recent treatment for a herpetic vulvar lesion. The text details presumed exposure, date and time, number of sexual partners, concernfor “spread of disease,” and the patient’s desire to have a comprehensive sexually transmitted infection screening as soon as possible.

Your nurse has years of professional experience, but she is perhaps not the most savvy with regard to current information technology and social media. Nonetheless, she knows it is best not to immediately respond to the patient’s email without checking with you. She tracks you down on Monday morning to review the email and the dilemma she feels she has been placed in. What’s the best next step?

While discussing the general question with the staff, another nurse notes that there have been some reviews of the office on social media. It seems that this second nurse tweets and texts with patients all the time. The office manager strongly suggests that the office “join the 21st Century” by setting up a Facebook page and using their webpage to attract new patients and communicate with current patients.

How do you prepare for this? Is your staff knowledgeable about the dos and don’ts of social media?

The use of social media by health care providers has been growing for several years. Back in 2011 a large survey by QuantiaMD revealed that 87% of physicians used social media for personal reasons, and 67% of them used it professionally.¹ How they used it for professional purposes also was explored in 2011, with almost 3 of 4 physicians using it for social networking and more than half engaging with their own institution’s social media (FIGURE).² In 2013, 53% of physicians indicated that their practice had a Facebook platform, 28% had a presence on LinkedIn, and 21% were on Twitter.³ Not surprisingly, social media use is higher among younger physicians⁴; the 2016 equivalents to these percentages most likely are higher.
 

Health providers’ use of social media for professional reasons2

In 2011, a survey found that most health providers used social networking, their institutions’ own social media, and Internet forums, boards, and communities for professional reasons.

Patients’ outreach through social media regarding health care information continues to grow, with 33.8% asking for health advice using social media.⁵ While email and other social media open the possibility of improved communication with patients, they also present a number of important professional and legal issues that deserve special consideration.⁶ Each medium presents its own challenges, but there are 4 categories of concern related to basic values and rights that we consider important to review:

Confidentiality
Few values of the medical profession are of longer standing than the commitment to maintain patient privacy. Fifth Century BC obligations continue to apply to the technology of the 21st Century AD. And the challenges are significant.

Email is not secure
In the opening case, the choice to email her clinician was apparently the patient’s. She probably does not realize that email is not very confidential, although it is undoubtedly in the Terms of Service Agreement she clicked through. Her email was likely scanned by her email service provider—Google, in this case—as well as the nurse. If, however, the physician’s office responds by email, it may well compound the confidentiality problem by further distributing the information through yet another email provider.

If, as a physician, you encourage email communication by your patients, a smart approach is to emphasize that such communications are not very confidential. At a minimum, until a secure email system can be established, it is best not to transmit medical information via email and to inform patients of the risk of such communication. In the case above, the nurse who received the email should respond to the patient by telephone (much more secure). Or she can respond to the patient by email (not including the patient’s message in the return), writing that, because email communications are inherently not confidential, she suggests a phone call or personal visit.

This case also notes that the patient sent the email to the nurse’s personal account, not to an office email account. Sending medical emails to an employee’s personal account raises additional problems of confidentiality and appropriate controls. It should be made clear that employees should not be discussing private medical matters via their own email accounts.

Other forms of social media are also not secure
Similar concerns arise about texting and using Twitter by the second nurse. These activities apparently had been unknown to the physician, but the practice still may be responsible for her actions. These are insecure forms of communication and raise serious ethical and legal concerns.

Other social media pose confidentiality risks as well. For example, a physician was dismissed from a position and reprimanded by the medical board for posting patient information on Facebook,⁷ and an ObGyn caused problems by posting a nasty note about a patient who showed up late for an appointment.⁸ Too many patients may not understand that posting on social media is the equivalent of standing on a street corner yelling private information. Social media sites that invite the discussion of personal matters are an invitation to trouble.

Physicians are ethically obliged to protect confidentiality
Professional standards place significant ethical obligations on physicians to protect patient confidentiality. The American Medical Association (AMA) has an ethics opinion on professionalism with social media,⁹ as does the American College of Obstetricians and Gynecologists (ACOG).¹⁰ Another excellent discussion of ethical and practical issues is a joint position paper by the American College of Physicians and the Federation of State Medical Boards.¹¹ Both documents focus attention on issues of confidentiality.

Physicians are legally obliged to protect confidentiality
There are many legal protections for confidentiality that can be implicated by electronic communications and social media. All states provide protection for unwarranted disclosure of private patient information. Such disclosures made electronically are included.¹² Indeed, because electronic disclosures may be broadcast more widely, they may be especially dangerous. The misuse of social media may result in license discipline by the state board, regulatory sanctions, or civil liability (rare, but criminal sanctions are a possibility in extreme circumstances).

In addition to state laws regarding confidentiality, there are a number of federal laws that cover confidential medical information. None is more important than the Health Insurance Portability and Accountability Act (HIPAA) and the more recent HITECH amendments (Health Information Technology for Economic and Clinical Health).¹³ These laws have both privacy provisions and security (including “encryption”) requirements. These are complicated laws but at their core are the notions that health care providers and some others:

A good source of step-by-step information about these laws is “Health information privacy: Covered entities and business associates,” on the US Health and Human Services website.¹⁴

HITECH also provides for notice to patients when health information is inappropriately transmitted. Thus, a missing USB flash drive with patient information may require notification to thousands of patients.¹⁵ Any consideration of the use of email or social media in medical practice must take into account the HIPAA/HITECH obligations to protect the security of patient health information. There can be serious professional consequences for failing to follow the HIPAA requirements.¹⁶

Dual relationships and conflicts of interest
In our hypothetical case, the office manager’s suggestion that the office use Facebook and their website to attract new patients also may raise confidentiality problems. The Facebook suggestion especially needs to be considered carefully. Facebook use is estimated to be 63% to 96% among students and 13% to 47% among health care professionals.¹⁷ Facebook is most often seen as an interactive social site; it risks blurring the lines between personal and professional relationships.⁹ There is a consensus that a physician should not “friend” patients on Facebook. The AMA ethics opinion notes that “physicians must maintain appropriate boundaries of the patient-physician relationship in accordance with professional ethical guidelines, just as they would in any other context.”⁹

Separate personal and professional contacts
Difficulties with interactive social media are not limited to the physicians in a practice. The problems increase with the number of staff members who post or respond on social media. Control of social media is essential. The practice must ensure that staff members do not slip into inappropriate personal comments and relationships. Staff should understand (and be reminded of) the necessity of separating personal and professional contacts.

Avoid misunderstandings
In addition, whatever the intent of the physician and staff may be, it is essentially impossible to know how patients will interpret interactions on these social media. The very informal, off-the-cuff, chatty way in which Facebook and similar sites are used invites misunderstandings, and maintaining professional boundaries is necessary.

Ground rules
All of this is not to say that professionals should never use Facebook or similar sites. Rather, if used, ground rules need to be established.

Social media communications must:

Staff training
Particularly for interactive social media (email, texts, Twitter, Facebook, etc), it is essential that there be both clear policies and good staff training (TABLE).^9–11,18 There really should be no “making it up as we go along.” Staff on a social media lark of their own can be disastrous for the practice. Policies need to be updated frequently, and staff training reinforced and repeated periodically.

Quality of care and advice
Start with your website
Institutions’ websites are major sources of health care information: Nearly 32% of US adults would be very likely to prefer a hospital based on its website.⁵ Your website can be an important face of your practice to the community—for good or for bad. On one hand, the practice can control what is on a website and, unlike some social media, it will not be directed to individual patients. Done well, it “provides golden opportunities for marketing physician services, as well as for contributing to public health by providing high-quality online content that is both accurate and understandable to laypeople.”¹⁹ Done badly, it can convey incorrect and harmful information and discredit the medical practice that established it.

Your website introduces the practice and settings, but it will serve another purpose to thousands of people who likely will see it over time as a source of credible health information. The importance of ensuring that your website is carefully constructed to provide, or link to, good medical advice that contributes to quality of care cannot be overstated.

A good website begins with a clear statement of the reasons and goals for having the site. Professional design assistance generally is used to create the site, but that design process needs to be overseen by a medical professional to ensure that it conveys the sense of the practice and provides completely accurate information. A homepage of dancing clowns with stethoscopes may seem good to a 20-something-year-old designer, but it is not appropriate for a physician. It will be the practice, not the designer, who is held accountable for the site content. Links to other sites need to be vetted and used with care. Patients and other members of the public may well take the links as carrying the endorsement of the practice and its physicians.

Perhaps the greatest risk of a website is that it will not be kept current. Unfortunately, they do not update themselves. Some knowledgeable staff member must frequently review it to update everything from office hours and personnel to links to other sites. In addition, the physicians periodically must review it to ensure that all medical information is up to date and accurate. Old, outdated information about the office can put off potential patients. Outdated medical information may be harmful to patients who rely on it.

Any professional website should include disclaimers informing users that the site is not intended to establish a professional relationship or to give professional advice. The nature and extent of the disclaimer will depend on the type of information on the site. An example of a particularly thorough disclaimer is the Mayo Clinic disclaimer and terms of use (http://www.mayoclinic.org/about-this-site/terms-conditions-use-policy).

General professionalism
At the end of the day, social media are an outreach from a medical practice and from the profession to the public.²⁰ Failure to treat these platforms with appropriate professional standards may result in professional discipline, damages, or civil penalties. Almost all of the reviews of social media use in health care practice note that the risks of inappropriate use are not only to the individual physician but also to the general medical profession, which may be undermined. Consider posting policies of the relevent state medical boards, the AMA, and ACOG in your office after you have had a discussion with your staff about them.²¹

The AMA statement includes a provision that a physician seeing unprofessional social media conduct by a colleague has the responsibility to bring that to the attention of the colleague. If the colleague does not correct a significant problem, “the physician should report the matter to appropriate authorities.”⁹

Bottom line
Any practitioner considering the use of social media must view it as a major step that requires caution, expert assistance, and constant attention to potential privacy, quality, and professionalism issues. If you are considering it, ensure that all staff associated with the practice understand and agree to the established limits on social media use.

Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

You might ask, why do I need to know what the Supreme Court does, it will not affect me! Well, we all know that is not exactly true. We chose these 6 cases because of their importance to ObGyns. In a number of them, the American Medical Association (AMA) or specific specialty board filed amicus curiae briefs, which suggested that the profession felt these were especially critical cases. (An amicus brief is a “friend of the Court” brief filed not by one of the affected parties, but by an organization or person with an interest or special expertise in the case.) You can find additional analysis of the 2015 term of the Supreme Court at the website of the National Register (http://www.nationalregister.org/pub/the-national-registerreport-pub/the-register-report-fall-2015/the-aca-survives-and-same-sex-marriage-thrives-the-2014-2015-supreme-court/).

1. Affordable Care Act upheld
King v Burwell was likely the Court’s most important case for physicians and their patients during the 2015 term.
At stake. The question was whether or not people who use the federal Affordable Care Act (ACA) Exchange could receive the same subsidy as those who use the state established Exchanges.¹
Final ruling. The Court said “yes,” they could receive the same subsidy, ruling in favor of King.

Key points of the case
The ACA provides for state Exchanges (an electronic marketplace in which people can compare and purchase health insurance policies), but most states did not establish Exchanges. As a result, in many states the federal Exchange became the default. Because the ACA subsidies (which help many people afford mandated insurance coverage) are processed through exchanges, the question of whether those who used the federal Exchange received the subsidy was enormously important. Subsidies for millions of individuals depended on it.

The language of the ACA provides that the insurance subsidy is available only if the person(s) enroll in “an Exchange established by the State” (emphasis added).¹ This case was about what “Exchange established by the State” means. A 6-justice majority held that the best interpretation of the statute was that it permitted subsidies through the federal Exchange. This was a difficult decision because, as the majority noted, the ACA is sloppily written. Nonetheless, the Court had to do its best to read the language in the context of the whole statute. Six justices held that the statute meant that the subsidies would cover people who signed up through federal as well as state Exchanges.

The dissenting justices essentially took the position that the language of the statute is clear. Among other things, the dissent said, it means that the words “established by the state” have no meaning at all in the statute, and it is unclear why Congress did not say “Exchange” instead of “Exchange established by the state.”

The results of the case were that the subsidies granted through the federal Exchange will continue. It will not expand the subsidies. Had the decision gone the other way, there would have been a real challenge to the future of the ACA. For that reason a number of medical and health care organizations filed amicus briefs with the Court in this case.

2. State licensing boards and antitrust
At stake. Antitrust laws prohibit combinations and conspiracies in restraint of trade. Competitors cannot come together to seek to set prices, divide the market, or prevent new competitors from entering the market. Since the 1940s, however, the Supreme Court has recognized a “state action” exception to the antitrust laws. The question before the Court this term was whether or not a state licensing board is included in the state-action immunity.²

The AMA and others filed an amicus brief in this case, noting threat to the public health if the Court disrupted state medical boards’ regulation of professional licensing and unauthorized practice.

Final ruling. The Court rejected this argument. It held that, where a state board is “controlled by active market participants” (as most state professional boards are), antitrust immunity is not automatic. For the immunity to protect boards, 2 conditions must exist, the Court held:

1. The state must have articulated a clear policy to allow the regulation that is an anticompetitive conduct (eg, licensing)

2. The state must have provided active supervision of the anticompetitive conduct. This requires that the state appoint someone or some group to approve policies of the board.

The first of these requirements often would be met by the statute setting up the board. The Court focused some attention on the second requirement. It concluded that “the adequacy of supervision otherwise will depend on all the circumstances of a case.”²

Key points of the case
In most states, this decision will require some kind of restructuring so that the professional boards are not the final decision makers but, in effect, only make recommendations to a “supervisor.” The Court gave short shrift to the AMA’s concerns that the decision might make it more difficult to attract really good professionals to the boards. The possibility of personal liability probably can be dealt with, but it deserves attention. The problems with litigation and antitrust claims, and reviews of decisions of a board (potentially by nonprofessionals) hardly can be a plus in attracting the right professionals to the boards.

This case will give rise to considerable litigation for many years. Medical boards should endeavor to get ahead of the issue by immediately studying ways in which the concerns of the Federal Trade Commissioncan be accommodated without significantly reducing the public protection that is part of well-administered professional licensing.

3. State reimbursement for Medicaid services
Medicaid is a federal-state program, and federal law requires, in part, that states must “assure that payments are … sufficient to enlist enough providers so that care and services are available under the plan at least to the extent that such care and services are available to the general population in the geographic area.”³ Providers claimed that the state had failed to establish such a payment system. A number of medical groups, including the AMA, filed amicus briefs in support of the providers.

At stake. State funding for various Medicaid services has been a problem for many health care professionals for some time. But the Medicaid law does not clearly give providers the right to file lawsuits claiming inadequate reimbursement,_⁴ so the question in this case was whether or not there was an implied right to do so.

Final ruling. The Court, in a 5-4 decision, held that Medicaid providers do not have the authority to sue states in federal courts torequire that the states provide higher Medicaid rates for services.⁴ As a practical matter, this decision leaves with the states broad authority to set Medicaid reimbursement rates. It is possible, of course, that in the future Congress would change the law to grant such rights or more clearly set reimbursement rates.

4. False Claims Act cases
Unfortunately, False Claims Act cases occur in health care. False claims transpire when someone (or an organization) presents to the government a claim for payment that is not legitimate or is for inadequate or low quality services. False claims include everything from fraudulent billing for services never performed to a pharmaceutical company’s promotion of a drug for off-label use.

The federal False Claims Act incentivizes private whistleblowers (often disgruntled employees) to initiate false claims lawsuits. (The government may then choose to take over the false claims or allow the private whistleblower to pursue them.)

At stake. Because Medicare and Medicaid are federally financed programs, it is common for providers who participate in those programs to be subject to false claims.⁵ This term the Court heard an important False Claims Act case involving the statute of limitations and multiple claims based on the same activity. The AMA joined an amicus brief urging the Court to prohibit both kinds of expansion.

Final ruling. The Court agreed that the statute of limitations for these claims should not be extended, but it did determine that the “first-to-file” limitation in the statute “keeps new claims out of court only while related claims are still alive, not in perpetuity.”⁵ The result of this second holding is that the “firstto-file” rule does not preclude another false claims suit that is duplicative to be filed as soon as the prior suit is no longer pending.

It is not clear that the practical effect of the decision will be great, but it may in some cases open up clinicians to multiple, serial lawsuits over the same claims.

5. Pregnancy and employment discrimination
The federal Pregnancy Discrimination Act (PDA) prohibits discrimination “because of or on the basis of pregnancy, childbirth, or related medical conditions.” It also requires that employers treat “women affected by pregnancy . . . the same for all employment-related purposes . . . as other persons not so affected but similar in their ability or inability to work.”

At stake. United Parcel Service (UPS) declined to give a pregnant employee a “light duty” accommodation during pregnancy so that she could avoid having to lift heavy packages. But it had given other employees just that kind of accommodation when they were injured or lost certification to drive a delivery truck. The suit claimed violation of the PDA.⁶

Final ruling. The Court held that UPS violated the PDA by giving some employees this accommodation but refusing it to pregnant workers who requested it.6 Once an organization voluntarily grants a particular accommodation to, for example, a temporarily injured worker, it may be required to provide similar accommodation to pregnant workers. The case probably will increase employment protection for pregnant women.

6. Children “testifying” in abuse cases
All states require physicians and teachers, among others, to report suspected child abuse. An ongoing question has been whether those reporters may be called to testify about what the child said at the time of abuse discovery/suspicion. This case involved a teacher, but it could as easily have been a physician.⁷

Key points of the case. Teachers found suspicious injuries on 3-year-old L.P. The child gave conflicting statements about what happened, but claimed that Clark had hurt him. At Clark’s criminal trial, L.P. did not testify, but the state wanted to introduce L.P.’s statements to the teachers as evidence of Clark’s guilt.

At stake. The question was whether or not this introduction would violate the right of Clark to “confront his accuser” as guaranteed by the Constitution.

Final ruling. All 9 justices said it was proper to allow L.P.’s statements to be introduced at trial.⁷ Essentially this was permitted because the primary purpose of L.P.’s statements was not to gather testimony to be presented at trial.

The final opinion creates incentives for some prosecutors to make abuse victims unavailable in order to allow their testimony by hearsay. Aside from the legal technicalities, the likelihood of wrongful convictions under such a system must be considered for the long run.

Other major 2015 Supreme Court decisions
- The Constitution requires states to recognize same-sex marriages and also accept such marriages performed in other states.¹ (The American Medical Association joined an amicus brief in this case.)
- The Court turned down the appeal of several inmates who had received lethal injection death sentences. They challenged the mix of drugs that Oklahoma planned to use to execute them.²
- In 2 cases justices went out of the way to raise questions about the constitutionality of the death penalty. This may suggest that the Court will take up this issue in the near future.^2,3
- Federal housing discrimination laws were expanded to cases in which there is “disparate impact” discrimination.⁴
- The Court narrowed prosecution for “threatening” statements in social network/Internet communications by holding that negligence in the communication is not sufficient for conviction under federal law.⁵
- The Court held that the Environmental Protection Agency violated the Clean Air Act with its power plant emission regulations because it failed to do a proper cost-benefit analysis.⁶

References
1. Obergefell et al v Hodges, Director, Ohio Department of Health et al, No. 14–556 (2015). http://www.supremecourt.gov/opinions/14pdf/14-556_3204.pdf. Accessed December 14, 2015.
2. Glossip et al v Gross et al, No. 14–7955 (2015). http://www.supremecourt.gov/opinions/14pdf/14-7955_aplc.pdf. Accessed December 14, 2015.
3. Davis, Acting Worden v Ayala, No. 13–1428 (2015). http://www.supremecourt.gov/opinions/14pdf/13-1428_1a7d.pdf. Accessed December 14, 2015.
4. Texas Department of Housing and Community Affairs et al v Inclusive Communities Project, Inc et al, No. 13–1371 (2015). http://www.supremecourt.gov/opinions/14pdf/13-1371_8m58.pdf. Accessed December 14, 2015.
5. Elonis v United States, No. 13–983 (2015). http://www.supremecourt.gov/opinions/14pdf/13-983_7148.pdf. Accessed December 14, 2015.
6. Michigan et al v Environmental Protection Agency et al, No. 14–46 (2015). http://www.supremecourt.gov/opinions/14pdf/14-46_bqmc.pdf. Accessed December 14, 2015.

What’s coming in 2016
This term of the Supreme Court is a reminder of how important the decisions of the Court are to the work of physicians and ObGyns in particular. This trend is continuing—the Court already has, for the next term, accepted cases regarding abortion, contraception, and health care delivery. It will, therefore, be worthwhile to follow the developments at the nation’s highest court.

Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

You might ask, why do I need to know what the Supreme Court does, it will not affect me! Well, we all know that is not exactly true. We chose these 6 cases because of their importance to ObGyns. In a number of them, the American Medical Association (AMA) or specific specialty board filed amicus curiae briefs, which suggested that the profession felt these were especially critical cases. (An amicus brief is a “friend of the Court” brief filed not by one of the affected parties, but by an organization or person with an interest or special expertise in the case.) You can find additional analysis of the 2015 term of the Supreme Court at the website of the National Register (http://www.nationalregister.org/pub/the-national-registerreport-pub/the-register-report-fall-2015/the-aca-survives-and-same-sex-marriage-thrives-the-2014-2015-supreme-court/).

1. Affordable Care Act upheld
King v Burwell was likely the Court’s most important case for physicians and their patients during the 2015 term.
At stake. The question was whether or not people who use the federal Affordable Care Act (ACA) Exchange could receive the same subsidy as those who use the state established Exchanges.¹
Final ruling. The Court said “yes,” they could receive the same subsidy, ruling in favor of King.

Key points of the case
The ACA provides for state Exchanges (an electronic marketplace in which people can compare and purchase health insurance policies), but most states did not establish Exchanges. As a result, in many states the federal Exchange became the default. Because the ACA subsidies (which help many people afford mandated insurance coverage) are processed through exchanges, the question of whether those who used the federal Exchange received the subsidy was enormously important. Subsidies for millions of individuals depended on it.

The language of the ACA provides that the insurance subsidy is available only if the person(s) enroll in “an Exchange established by the State” (emphasis added).¹ This case was about what “Exchange established by the State” means. A 6-justice majority held that the best interpretation of the statute was that it permitted subsidies through the federal Exchange. This was a difficult decision because, as the majority noted, the ACA is sloppily written. Nonetheless, the Court had to do its best to read the language in the context of the whole statute. Six justices held that the statute meant that the subsidies would cover people who signed up through federal as well as state Exchanges.

The dissenting justices essentially took the position that the language of the statute is clear. Among other things, the dissent said, it means that the words “established by the state” have no meaning at all in the statute, and it is unclear why Congress did not say “Exchange” instead of “Exchange established by the state.”

The results of the case were that the subsidies granted through the federal Exchange will continue. It will not expand the subsidies. Had the decision gone the other way, there would have been a real challenge to the future of the ACA. For that reason a number of medical and health care organizations filed amicus briefs with the Court in this case.

2. State licensing boards and antitrust
At stake. Antitrust laws prohibit combinations and conspiracies in restraint of trade. Competitors cannot come together to seek to set prices, divide the market, or prevent new competitors from entering the market. Since the 1940s, however, the Supreme Court has recognized a “state action” exception to the antitrust laws. The question before the Court this term was whether or not a state licensing board is included in the state-action immunity.²

The AMA and others filed an amicus brief in this case, noting threat to the public health if the Court disrupted state medical boards’ regulation of professional licensing and unauthorized practice.

Final ruling. The Court rejected this argument. It held that, where a state board is “controlled by active market participants” (as most state professional boards are), antitrust immunity is not automatic. For the immunity to protect boards, 2 conditions must exist, the Court held:

1. The state must have articulated a clear policy to allow the regulation that is an anticompetitive conduct (eg, licensing)

2. The state must have provided active supervision of the anticompetitive conduct. This requires that the state appoint someone or some group to approve policies of the board.

The first of these requirements often would be met by the statute setting up the board. The Court focused some attention on the second requirement. It concluded that “the adequacy of supervision otherwise will depend on all the circumstances of a case.”²

Key points of the case
In most states, this decision will require some kind of restructuring so that the professional boards are not the final decision makers but, in effect, only make recommendations to a “supervisor.” The Court gave short shrift to the AMA’s concerns that the decision might make it more difficult to attract really good professionals to the boards. The possibility of personal liability probably can be dealt with, but it deserves attention. The problems with litigation and antitrust claims, and reviews of decisions of a board (potentially by nonprofessionals) hardly can be a plus in attracting the right professionals to the boards.

This case will give rise to considerable litigation for many years. Medical boards should endeavor to get ahead of the issue by immediately studying ways in which the concerns of the Federal Trade Commissioncan be accommodated without significantly reducing the public protection that is part of well-administered professional licensing.

3. State reimbursement for Medicaid services
Medicaid is a federal-state program, and federal law requires, in part, that states must “assure that payments are … sufficient to enlist enough providers so that care and services are available under the plan at least to the extent that such care and services are available to the general population in the geographic area.”³ Providers claimed that the state had failed to establish such a payment system. A number of medical groups, including the AMA, filed amicus briefs in support of the providers.

At stake. State funding for various Medicaid services has been a problem for many health care professionals for some time. But the Medicaid law does not clearly give providers the right to file lawsuits claiming inadequate reimbursement,_⁴ so the question in this case was whether or not there was an implied right to do so.

Final ruling. The Court, in a 5-4 decision, held that Medicaid providers do not have the authority to sue states in federal courts torequire that the states provide higher Medicaid rates for services.⁴ As a practical matter, this decision leaves with the states broad authority to set Medicaid reimbursement rates. It is possible, of course, that in the future Congress would change the law to grant such rights or more clearly set reimbursement rates.

4. False Claims Act cases
Unfortunately, False Claims Act cases occur in health care. False claims transpire when someone (or an organization) presents to the government a claim for payment that is not legitimate or is for inadequate or low quality services. False claims include everything from fraudulent billing for services never performed to a pharmaceutical company’s promotion of a drug for off-label use.

The federal False Claims Act incentivizes private whistleblowers (often disgruntled employees) to initiate false claims lawsuits. (The government may then choose to take over the false claims or allow the private whistleblower to pursue them.)

At stake. Because Medicare and Medicaid are federally financed programs, it is common for providers who participate in those programs to be subject to false claims.⁵ This term the Court heard an important False Claims Act case involving the statute of limitations and multiple claims based on the same activity. The AMA joined an amicus brief urging the Court to prohibit both kinds of expansion.

Final ruling. The Court agreed that the statute of limitations for these claims should not be extended, but it did determine that the “first-to-file” limitation in the statute “keeps new claims out of court only while related claims are still alive, not in perpetuity.”⁵ The result of this second holding is that the “firstto-file” rule does not preclude another false claims suit that is duplicative to be filed as soon as the prior suit is no longer pending.

It is not clear that the practical effect of the decision will be great, but it may in some cases open up clinicians to multiple, serial lawsuits over the same claims.

5. Pregnancy and employment discrimination
The federal Pregnancy Discrimination Act (PDA) prohibits discrimination “because of or on the basis of pregnancy, childbirth, or related medical conditions.” It also requires that employers treat “women affected by pregnancy . . . the same for all employment-related purposes . . . as other persons not so affected but similar in their ability or inability to work.”

At stake. United Parcel Service (UPS) declined to give a pregnant employee a “light duty” accommodation during pregnancy so that she could avoid having to lift heavy packages. But it had given other employees just that kind of accommodation when they were injured or lost certification to drive a delivery truck. The suit claimed violation of the PDA.⁶

Final ruling. The Court held that UPS violated the PDA by giving some employees this accommodation but refusing it to pregnant workers who requested it.6 Once an organization voluntarily grants a particular accommodation to, for example, a temporarily injured worker, it may be required to provide similar accommodation to pregnant workers. The case probably will increase employment protection for pregnant women.

6. Children “testifying” in abuse cases
All states require physicians and teachers, among others, to report suspected child abuse. An ongoing question has been whether those reporters may be called to testify about what the child said at the time of abuse discovery/suspicion. This case involved a teacher, but it could as easily have been a physician.⁷

Key points of the case. Teachers found suspicious injuries on 3-year-old L.P. The child gave conflicting statements about what happened, but claimed that Clark had hurt him. At Clark’s criminal trial, L.P. did not testify, but the state wanted to introduce L.P.’s statements to the teachers as evidence of Clark’s guilt.

At stake. The question was whether or not this introduction would violate the right of Clark to “confront his accuser” as guaranteed by the Constitution.

Final ruling. All 9 justices said it was proper to allow L.P.’s statements to be introduced at trial.⁷ Essentially this was permitted because the primary purpose of L.P.’s statements was not to gather testimony to be presented at trial.

The final opinion creates incentives for some prosecutors to make abuse victims unavailable in order to allow their testimony by hearsay. Aside from the legal technicalities, the likelihood of wrongful convictions under such a system must be considered for the long run.

Other major 2015 Supreme Court decisions
- The Constitution requires states to recognize same-sex marriages and also accept such marriages performed in other states.¹ (The American Medical Association joined an amicus brief in this case.)
- The Court turned down the appeal of several inmates who had received lethal injection death sentences. They challenged the mix of drugs that Oklahoma planned to use to execute them.²
- In 2 cases justices went out of the way to raise questions about the constitutionality of the death penalty. This may suggest that the Court will take up this issue in the near future.^2,3
- Federal housing discrimination laws were expanded to cases in which there is “disparate impact” discrimination.⁴
- The Court narrowed prosecution for “threatening” statements in social network/Internet communications by holding that negligence in the communication is not sufficient for conviction under federal law.⁵
- The Court held that the Environmental Protection Agency violated the Clean Air Act with its power plant emission regulations because it failed to do a proper cost-benefit analysis.⁶

References
1. Obergefell et al v Hodges, Director, Ohio Department of Health et al, No. 14–556 (2015). http://www.supremecourt.gov/opinions/14pdf/14-556_3204.pdf. Accessed December 14, 2015.
2. Glossip et al v Gross et al, No. 14–7955 (2015). http://www.supremecourt.gov/opinions/14pdf/14-7955_aplc.pdf. Accessed December 14, 2015.
3. Davis, Acting Worden v Ayala, No. 13–1428 (2015). http://www.supremecourt.gov/opinions/14pdf/13-1428_1a7d.pdf. Accessed December 14, 2015.
4. Texas Department of Housing and Community Affairs et al v Inclusive Communities Project, Inc et al, No. 13–1371 (2015). http://www.supremecourt.gov/opinions/14pdf/13-1371_8m58.pdf. Accessed December 14, 2015.
5. Elonis v United States, No. 13–983 (2015). http://www.supremecourt.gov/opinions/14pdf/13-983_7148.pdf. Accessed December 14, 2015.
6. Michigan et al v Environmental Protection Agency et al, No. 14–46 (2015). http://www.supremecourt.gov/opinions/14pdf/14-46_bqmc.pdf. Accessed December 14, 2015.

What’s coming in 2016
This term of the Supreme Court is a reminder of how important the decisions of the Court are to the work of physicians and ObGyns in particular. This trend is continuing—the Court already has, for the next term, accepted cases regarding abortion, contraception, and health care delivery. It will, therefore, be worthwhile to follow the developments at the nation’s highest court.

Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

You might ask, why do I need to know what the Supreme Court does, it will not affect me! Well, we all know that is not exactly true. We chose these 6 cases because of their importance to ObGyns. In a number of them, the American Medical Association (AMA) or specific specialty board filed amicus curiae briefs, which suggested that the profession felt these were especially critical cases. (An amicus brief is a “friend of the Court” brief filed not by one of the affected parties, but by an organization or person with an interest or special expertise in the case.) You can find additional analysis of the 2015 term of the Supreme Court at the website of the National Register (http://www.nationalregister.org/pub/the-national-registerreport-pub/the-register-report-fall-2015/the-aca-survives-and-same-sex-marriage-thrives-the-2014-2015-supreme-court/).

1. Affordable Care Act upheld
King v Burwell was likely the Court’s most important case for physicians and their patients during the 2015 term.
At stake. The question was whether or not people who use the federal Affordable Care Act (ACA) Exchange could receive the same subsidy as those who use the state established Exchanges.¹
Final ruling. The Court said “yes,” they could receive the same subsidy, ruling in favor of King.

Key points of the case
The ACA provides for state Exchanges (an electronic marketplace in which people can compare and purchase health insurance policies), but most states did not establish Exchanges. As a result, in many states the federal Exchange became the default. Because the ACA subsidies (which help many people afford mandated insurance coverage) are processed through exchanges, the question of whether those who used the federal Exchange received the subsidy was enormously important. Subsidies for millions of individuals depended on it.

The language of the ACA provides that the insurance subsidy is available only if the person(s) enroll in “an Exchange established by the State” (emphasis added).¹ This case was about what “Exchange established by the State” means. A 6-justice majority held that the best interpretation of the statute was that it permitted subsidies through the federal Exchange. This was a difficult decision because, as the majority noted, the ACA is sloppily written. Nonetheless, the Court had to do its best to read the language in the context of the whole statute. Six justices held that the statute meant that the subsidies would cover people who signed up through federal as well as state Exchanges.

The dissenting justices essentially took the position that the language of the statute is clear. Among other things, the dissent said, it means that the words “established by the state” have no meaning at all in the statute, and it is unclear why Congress did not say “Exchange” instead of “Exchange established by the state.”

The results of the case were that the subsidies granted through the federal Exchange will continue. It will not expand the subsidies. Had the decision gone the other way, there would have been a real challenge to the future of the ACA. For that reason a number of medical and health care organizations filed amicus briefs with the Court in this case.

2. State licensing boards and antitrust
At stake. Antitrust laws prohibit combinations and conspiracies in restraint of trade. Competitors cannot come together to seek to set prices, divide the market, or prevent new competitors from entering the market. Since the 1940s, however, the Supreme Court has recognized a “state action” exception to the antitrust laws. The question before the Court this term was whether or not a state licensing board is included in the state-action immunity.²

The AMA and others filed an amicus brief in this case, noting threat to the public health if the Court disrupted state medical boards’ regulation of professional licensing and unauthorized practice.

Final ruling. The Court rejected this argument. It held that, where a state board is “controlled by active market participants” (as most state professional boards are), antitrust immunity is not automatic. For the immunity to protect boards, 2 conditions must exist, the Court held:

1. The state must have articulated a clear policy to allow the regulation that is an anticompetitive conduct (eg, licensing)

2. The state must have provided active supervision of the anticompetitive conduct. This requires that the state appoint someone or some group to approve policies of the board.

The first of these requirements often would be met by the statute setting up the board. The Court focused some attention on the second requirement. It concluded that “the adequacy of supervision otherwise will depend on all the circumstances of a case.”²

Key points of the case
In most states, this decision will require some kind of restructuring so that the professional boards are not the final decision makers but, in effect, only make recommendations to a “supervisor.” The Court gave short shrift to the AMA’s concerns that the decision might make it more difficult to attract really good professionals to the boards. The possibility of personal liability probably can be dealt with, but it deserves attention. The problems with litigation and antitrust claims, and reviews of decisions of a board (potentially by nonprofessionals) hardly can be a plus in attracting the right professionals to the boards.

This case will give rise to considerable litigation for many years. Medical boards should endeavor to get ahead of the issue by immediately studying ways in which the concerns of the Federal Trade Commissioncan be accommodated without significantly reducing the public protection that is part of well-administered professional licensing.

3. State reimbursement for Medicaid services
Medicaid is a federal-state program, and federal law requires, in part, that states must “assure that payments are … sufficient to enlist enough providers so that care and services are available under the plan at least to the extent that such care and services are available to the general population in the geographic area.”³ Providers claimed that the state had failed to establish such a payment system. A number of medical groups, including the AMA, filed amicus briefs in support of the providers.

At stake. State funding for various Medicaid services has been a problem for many health care professionals for some time. But the Medicaid law does not clearly give providers the right to file lawsuits claiming inadequate reimbursement,_⁴ so the question in this case was whether or not there was an implied right to do so.

Final ruling. The Court, in a 5-4 decision, held that Medicaid providers do not have the authority to sue states in federal courts torequire that the states provide higher Medicaid rates for services.⁴ As a practical matter, this decision leaves with the states broad authority to set Medicaid reimbursement rates. It is possible, of course, that in the future Congress would change the law to grant such rights or more clearly set reimbursement rates.

4. False Claims Act cases
Unfortunately, False Claims Act cases occur in health care. False claims transpire when someone (or an organization) presents to the government a claim for payment that is not legitimate or is for inadequate or low quality services. False claims include everything from fraudulent billing for services never performed to a pharmaceutical company’s promotion of a drug for off-label use.

The federal False Claims Act incentivizes private whistleblowers (often disgruntled employees) to initiate false claims lawsuits. (The government may then choose to take over the false claims or allow the private whistleblower to pursue them.)

At stake. Because Medicare and Medicaid are federally financed programs, it is common for providers who participate in those programs to be subject to false claims.⁵ This term the Court heard an important False Claims Act case involving the statute of limitations and multiple claims based on the same activity. The AMA joined an amicus brief urging the Court to prohibit both kinds of expansion.

Final ruling. The Court agreed that the statute of limitations for these claims should not be extended, but it did determine that the “first-to-file” limitation in the statute “keeps new claims out of court only while related claims are still alive, not in perpetuity.”⁵ The result of this second holding is that the “firstto-file” rule does not preclude another false claims suit that is duplicative to be filed as soon as the prior suit is no longer pending.

It is not clear that the practical effect of the decision will be great, but it may in some cases open up clinicians to multiple, serial lawsuits over the same claims.

5. Pregnancy and employment discrimination
The federal Pregnancy Discrimination Act (PDA) prohibits discrimination “because of or on the basis of pregnancy, childbirth, or related medical conditions.” It also requires that employers treat “women affected by pregnancy . . . the same for all employment-related purposes . . . as other persons not so affected but similar in their ability or inability to work.”

At stake. United Parcel Service (UPS) declined to give a pregnant employee a “light duty” accommodation during pregnancy so that she could avoid having to lift heavy packages. But it had given other employees just that kind of accommodation when they were injured or lost certification to drive a delivery truck. The suit claimed violation of the PDA.⁶

Final ruling. The Court held that UPS violated the PDA by giving some employees this accommodation but refusing it to pregnant workers who requested it.6 Once an organization voluntarily grants a particular accommodation to, for example, a temporarily injured worker, it may be required to provide similar accommodation to pregnant workers. The case probably will increase employment protection for pregnant women.

6. Children “testifying” in abuse cases
All states require physicians and teachers, among others, to report suspected child abuse. An ongoing question has been whether those reporters may be called to testify about what the child said at the time of abuse discovery/suspicion. This case involved a teacher, but it could as easily have been a physician.⁷

Key points of the case. Teachers found suspicious injuries on 3-year-old L.P. The child gave conflicting statements about what happened, but claimed that Clark had hurt him. At Clark’s criminal trial, L.P. did not testify, but the state wanted to introduce L.P.’s statements to the teachers as evidence of Clark’s guilt.

At stake. The question was whether or not this introduction would violate the right of Clark to “confront his accuser” as guaranteed by the Constitution.

Final ruling. All 9 justices said it was proper to allow L.P.’s statements to be introduced at trial.⁷ Essentially this was permitted because the primary purpose of L.P.’s statements was not to gather testimony to be presented at trial.

The final opinion creates incentives for some prosecutors to make abuse victims unavailable in order to allow their testimony by hearsay. Aside from the legal technicalities, the likelihood of wrongful convictions under such a system must be considered for the long run.

Other major 2015 Supreme Court decisions
- The Constitution requires states to recognize same-sex marriages and also accept such marriages performed in other states.¹ (The American Medical Association joined an amicus brief in this case.)
- The Court turned down the appeal of several inmates who had received lethal injection death sentences. They challenged the mix of drugs that Oklahoma planned to use to execute them.²
- In 2 cases justices went out of the way to raise questions about the constitutionality of the death penalty. This may suggest that the Court will take up this issue in the near future.^2,3
- Federal housing discrimination laws were expanded to cases in which there is “disparate impact” discrimination.⁴
- The Court narrowed prosecution for “threatening” statements in social network/Internet communications by holding that negligence in the communication is not sufficient for conviction under federal law.⁵
- The Court held that the Environmental Protection Agency violated the Clean Air Act with its power plant emission regulations because it failed to do a proper cost-benefit analysis.⁶

References
1. Obergefell et al v Hodges, Director, Ohio Department of Health et al, No. 14–556 (2015). http://www.supremecourt.gov/opinions/14pdf/14-556_3204.pdf. Accessed December 14, 2015.
2. Glossip et al v Gross et al, No. 14–7955 (2015). http://www.supremecourt.gov/opinions/14pdf/14-7955_aplc.pdf. Accessed December 14, 2015.
3. Davis, Acting Worden v Ayala, No. 13–1428 (2015). http://www.supremecourt.gov/opinions/14pdf/13-1428_1a7d.pdf. Accessed December 14, 2015.
4. Texas Department of Housing and Community Affairs et al v Inclusive Communities Project, Inc et al, No. 13–1371 (2015). http://www.supremecourt.gov/opinions/14pdf/13-1371_8m58.pdf. Accessed December 14, 2015.
5. Elonis v United States, No. 13–983 (2015). http://www.supremecourt.gov/opinions/14pdf/13-983_7148.pdf. Accessed December 14, 2015.
6. Michigan et al v Environmental Protection Agency et al, No. 14–46 (2015). http://www.supremecourt.gov/opinions/14pdf/14-46_bqmc.pdf. Accessed December 14, 2015.

What’s coming in 2016
This term of the Supreme Court is a reminder of how important the decisions of the Court are to the work of physicians and ObGyns in particular. This trend is continuing—the Court already has, for the next term, accepted cases regarding abortion, contraception, and health care delivery. It will, therefore, be worthwhile to follow the developments at the nation’s highest court.

Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

CASE: Physician defames sedated patient

Our case takes us to the Commonwealth of Virginia. A male patient preparing to undergo a colonoscopy was concerned that, because of grogginess brought on by anesthesia, he might misunderstand postprocedure instructions or advice. He, therefore, turned his cell phone’s record function “on” and put it with his clothes. His clothes were put in a plastic bag, which ended up under the table with him in the operating room.

Following the procedure, as his wife drove him home, the patient replayed the instructions on the cell phone and realized that it had recorded the entire procedure. It quickly became apparent that the medical personnel had engaged in a series of inappropriate and insulting comments at the patient’s expense.

The anesthesiologist, talking to the now-unconscious patient, said, “after five minutes of talking to you in pre-op, I wanted to punch you in the face.” The patient had reported he was taking medication for a mild penile rash. The anesthesiologist warned an assistant not to touch it or “you might get syphilis on your arm or something,” but then noted, “it’s probably tuberculosis of the penis, so you’ll be all right.” There was further mocking of the patient, including a question of whether he was homosexual.

The anesthesiologist and gastroenterologist wanted to avoid talking to the patient after the procedure, and the gastroenterologist instructed an assistant to lie to the patient and convince the patient that the gastroenterologist had already spoken to him following the colonoscopy but, “you just don’t remember it.” In addition, the anesthesiologist announced that she was going to mark “hemorrhoids” on the patient’s chart, which she knew was a 
false diagnosis.

The patient, who is identified only by 
initials, is an attorney.¹ Of course, the smartphone was “good documentation” of what came out of what the health care team said.

The lawsuit

The patient (now plaintiff) claimed that he was verbally brutalized and suffered anxiety, embarrassment, and loss of sleep for 
several months.

On the first day of trial, the gastroenterologist was dismissed from the case. The trial went on against the anesthesiologist and the anesthesia practice.

What’s the verdict?

The patient was awarded $500,000, as follows:

• $100,000 for defamation, ($50,000 each for the syphilis and tuberculosis comments),
• $200,000 for medical malpractice
• $200,000 in punitive damages (including $50,000 the jury found that the anesthesia practice should pay).

Caveat. The above facts about this case come from the plaintiff’s complaint¹ and various professional commentaries and news sources.^2–5 Such sources are not always reliable, so they may not describe accurately all of the relevant events and statements.

Neither of the authors of this column attended the trial or heard the testimony presented. For the purposes of discussing the issues below, however, we treat as true the facts stated above. In addition, some of the legal claims in this case are uncertain. It is entirely possible that an appeal will be made and accepted, and some or all of the damages could be reduced by the trial court or an appellate court. The jury award, therefore, is not necessarily the last word.

Medicolegal takeaways 
from this case

This case raises a number of professional, ethical, and legal issues. Most fundamentally, the health care team is always expected to prioritize the patient’s best interest. Respect for the patient is an essential element of that.

Behaviors such as those reported about these physicians are “absolutely not to engage in any time,” stated President of the American Society of Anesthesiologists 
John Absentein, MD.⁶ A former president of the Academy of Anesthesiology, 
Kathryn McGoldrick, MD, added some common sense advice that such discussions are “not only offensive but frankly stupid.” As she notes, “we can never be certain that our patients are asleep and wouldn’t have recall.”⁷

The actions of the physicians also may violate ethical obligations. The very first principle of medical ethics is that the physician shall provide care “with compassion and respect for human dignity and rights.”⁸

The legal claims included defamation, infliction of emotional distress, privacy (related to medical records), and malpractice. We will take a very brief look at each of those causes of action and then say a word about punitive damages (which the jury awarded in this case).

It is important to remember that state law, rather than federal, is providing the legal principles on which these claims were decided. Federal law might provide some relevant principles in such cases (for example, the First Amendment freedom of speech limits the state defamation rules), but that is the exception. State law is the rule.

Defamation—award of damages

At its core, defamation is publishing (that is, telling someone other than the plaintiff) something untrue that may be harmful to another person. Generally the harm is reputational and the plaintiff may be affected by loss of business, mental suffering, or loss of esteem in the community.⁹

Defamation claims are not typical in health care cases. However, these claims are not rare: instances of health care professionals defaming other health care professionals, patients giving negative “reviews,” or health care professionals releasing false information to employers certainly do exist.

In this case, in addition to saying that the patient had syphilis and tuberculosis (both untrue), the physicians said he was a “wimp.” One interesting concept of 
defamation law that has developed over the centuries is “negligence per se.” This means a falsehood has been published about someone and the falsehood is likely to cause serious reputational harm. Claims that someone has a contagious disease traditionally have been considered negligence per se. Syphilis and tuberculosis fall in that category. On the other hand, saying someone needs to “man up” is usually a matter of opinion, so defamation for such comments is unlikely without special circumstances.

From the anesthesiologist’s perspective, the question is whether anyone who heard the publication really believed that the patient had either of the diseases. A joke that nobody believes to be based on fact generally is not defamatory because it has not harmed the plaintiff.¹⁰ It is apparent that the jury felt the patient had been defamed, however, given the $100,000 award for defamation.

In the United States there is special sensitivity to defamation awards because they may implicate the First Amendment’s protection of free speech. That being the case, this award may be particularly open to review by the judge and appellate courts.

Emotional distress—no award 
of damages

There are 2 kinds of “emotional distress” claimed in this case:

• intentional infliction
• negligent infliction.

Intentional infliction usually requires outrageous conduct by the defendant who acts intentionally or recklessly to inflict severe mental pain on the plaintiff.¹¹ In this case, the element of “intentional” or “reckless” is interesting. While the conduct was outrageous, it is doubtful that there was any way the anesthesiologist could have imagined that these outrageous statements would have been transmitted to the patient/plaintiff.

As for negligent infliction of emotional distress, most states have been wary of opening a Pandora’s Box of litigation. Therefore, they generally require significant physical manifestations of great stress to allow recovery.¹² It appears that the jury did not find the elements of either intentional or negligent infliction of emotional distress in this case.

As a side-note, this kind of emotional distress is viewed by the law as different from emotional distress that is incidental to a physical injury (pain and suffering). All states recognize that form of emotional distress.

Privacy—no award of damages

The privacy of medical records has, of course, become a major concern in the last few years. Both federal and state law provides significant penalties for the unauthorized release of medical information. However, in this case, it does not appear ­that medical information was improp-
erly revealed.¹³

The patient’s complaint suggested that the anesthesiologist’s discussion during the colonoscopy of the medication for the penile rash was unnecessary for health care purposes.¹ Therefore, it claims, the discussion violated the state health records privacy law. At the same time there was no indication in the public reports that this caused any harm 
to the patient.

Medical malpractice—award 
of damages

Malpractice usually involves professional practice that is unacceptable to the profession itself. It most commonly is negligence, or carelessness, that causes injury to the patient. The gross disregard for professional medical standards here was certainly negligence.¹⁴ The plaintiff claimed that discussing the medication for the penile rash and falsification of the medical records 
constituted malpractice.¹

Presumably the jury award for medical malpractice means the jury found that the misconduct of the medical staff caused the emotional harm that the plaintiff experienced (described as embarrassment, loss of sleep, mental anguish, and anxiety), and that those injuries warranted a 
$200,000 award.

Punitive damage—award of damages

The jury also awarded $200,000 in “punitive” or “exemplary” damages. These are unusual damages, given not so much to compensate the victim but rather as a deterrent for the future. Generally the defendant’s conduct must have been egregious and completely unacceptable.¹⁵ Those elements were apparent to the jury from the facts of this case.

What about loss of practice privileges?

It is not unlikely that one or more of the medical professionals might, beyond civil liability, be subject to licensure discipline by the Virginia board. In addition, there are other secondary consequences of this lawsuit. The employment of those involved may be interrupted. (The anesthesiologist is said to have moved to another state, for example.) Hospital privileges also may be affected, as may insurance rates. The results of this award likely will have to be reported to the National Practitioner Data Bank.

As physicians, what’s 
our takeaway?

Conduct unbecoming a physician remains front and center with a recent essay published in the internal medicine literature.¹⁶ The anonymous author attests to witnessing a male gynecologist making sexual comments regarding the patient at the time of vaginal surgery preparation and an obstetrician singing and dancing to a Mexican song while treating his Hispanic patient for postpartum bleeding.

The unusual case of the anesthesiologist that we address was made even more unusual by the fact that it was recorded. Recordings, however, are likely to become ever more common. The advice of everyone’s grandmother is well taken: “Always act as though what you do will be published on the front page of the newspaper.” The ubiquitous presence of video and audio cameras and untold other devices means that someone may well be watching.

Aside from the risk of getting caught, respect for patients and clients is the very foundation of respect and professional care. It is distressing that the anesthesiologist was so disrespectful of a patient. It is equally disappointing that nobody put a stop to it.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

CASE: Physician defames sedated patient

Our case takes us to the Commonwealth of Virginia. A male patient preparing to undergo a colonoscopy was concerned that, because of grogginess brought on by anesthesia, he might misunderstand postprocedure instructions or advice. He, therefore, turned his cell phone’s record function “on” and put it with his clothes. His clothes were put in a plastic bag, which ended up under the table with him in the operating room.

Following the procedure, as his wife drove him home, the patient replayed the instructions on the cell phone and realized that it had recorded the entire procedure. It quickly became apparent that the medical personnel had engaged in a series of inappropriate and insulting comments at the patient’s expense.

The anesthesiologist, talking to the now-unconscious patient, said, “after five minutes of talking to you in pre-op, I wanted to punch you in the face.” The patient had reported he was taking medication for a mild penile rash. The anesthesiologist warned an assistant not to touch it or “you might get syphilis on your arm or something,” but then noted, “it’s probably tuberculosis of the penis, so you’ll be all right.” There was further mocking of the patient, including a question of whether he was homosexual.

The anesthesiologist and gastroenterologist wanted to avoid talking to the patient after the procedure, and the gastroenterologist instructed an assistant to lie to the patient and convince the patient that the gastroenterologist had already spoken to him following the colonoscopy but, “you just don’t remember it.” In addition, the anesthesiologist announced that she was going to mark “hemorrhoids” on the patient’s chart, which she knew was a 
false diagnosis.

The patient, who is identified only by 
initials, is an attorney.¹ Of course, the smartphone was “good documentation” of what came out of what the health care team said.

The lawsuit

The patient (now plaintiff) claimed that he was verbally brutalized and suffered anxiety, embarrassment, and loss of sleep for 
several months.

On the first day of trial, the gastroenterologist was dismissed from the case. The trial went on against the anesthesiologist and the anesthesia practice.

What’s the verdict?

The patient was awarded $500,000, as follows:

• $100,000 for defamation, ($50,000 each for the syphilis and tuberculosis comments),
• $200,000 for medical malpractice
• $200,000 in punitive damages (including $50,000 the jury found that the anesthesia practice should pay).

Caveat. The above facts about this case come from the plaintiff’s complaint¹ and various professional commentaries and news sources.^2–5 Such sources are not always reliable, so they may not describe accurately all of the relevant events and statements.

Neither of the authors of this column attended the trial or heard the testimony presented. For the purposes of discussing the issues below, however, we treat as true the facts stated above. In addition, some of the legal claims in this case are uncertain. It is entirely possible that an appeal will be made and accepted, and some or all of the damages could be reduced by the trial court or an appellate court. The jury award, therefore, is not necessarily the last word.

Medicolegal takeaways 
from this case

This case raises a number of professional, ethical, and legal issues. Most fundamentally, the health care team is always expected to prioritize the patient’s best interest. Respect for the patient is an essential element of that.

Behaviors such as those reported about these physicians are “absolutely not to engage in any time,” stated President of the American Society of Anesthesiologists 
John Absentein, MD.⁶ A former president of the Academy of Anesthesiology, 
Kathryn McGoldrick, MD, added some common sense advice that such discussions are “not only offensive but frankly stupid.” As she notes, “we can never be certain that our patients are asleep and wouldn’t have recall.”⁷

The actions of the physicians also may violate ethical obligations. The very first principle of medical ethics is that the physician shall provide care “with compassion and respect for human dignity and rights.”⁸

The legal claims included defamation, infliction of emotional distress, privacy (related to medical records), and malpractice. We will take a very brief look at each of those causes of action and then say a word about punitive damages (which the jury awarded in this case).

It is important to remember that state law, rather than federal, is providing the legal principles on which these claims were decided. Federal law might provide some relevant principles in such cases (for example, the First Amendment freedom of speech limits the state defamation rules), but that is the exception. State law is the rule.

Defamation—award of damages

At its core, defamation is publishing (that is, telling someone other than the plaintiff) something untrue that may be harmful to another person. Generally the harm is reputational and the plaintiff may be affected by loss of business, mental suffering, or loss of esteem in the community.⁹

Defamation claims are not typical in health care cases. However, these claims are not rare: instances of health care professionals defaming other health care professionals, patients giving negative “reviews,” or health care professionals releasing false information to employers certainly do exist.

In this case, in addition to saying that the patient had syphilis and tuberculosis (both untrue), the physicians said he was a “wimp.” One interesting concept of 
defamation law that has developed over the centuries is “negligence per se.” This means a falsehood has been published about someone and the falsehood is likely to cause serious reputational harm. Claims that someone has a contagious disease traditionally have been considered negligence per se. Syphilis and tuberculosis fall in that category. On the other hand, saying someone needs to “man up” is usually a matter of opinion, so defamation for such comments is unlikely without special circumstances.

From the anesthesiologist’s perspective, the question is whether anyone who heard the publication really believed that the patient had either of the diseases. A joke that nobody believes to be based on fact generally is not defamatory because it has not harmed the plaintiff.¹⁰ It is apparent that the jury felt the patient had been defamed, however, given the $100,000 award for defamation.

In the United States there is special sensitivity to defamation awards because they may implicate the First Amendment’s protection of free speech. That being the case, this award may be particularly open to review by the judge and appellate courts.

Emotional distress—no award 
of damages

There are 2 kinds of “emotional distress” claimed in this case:

• intentional infliction
• negligent infliction.

Intentional infliction usually requires outrageous conduct by the defendant who acts intentionally or recklessly to inflict severe mental pain on the plaintiff.¹¹ In this case, the element of “intentional” or “reckless” is interesting. While the conduct was outrageous, it is doubtful that there was any way the anesthesiologist could have imagined that these outrageous statements would have been transmitted to the patient/plaintiff.

As for negligent infliction of emotional distress, most states have been wary of opening a Pandora’s Box of litigation. Therefore, they generally require significant physical manifestations of great stress to allow recovery.¹² It appears that the jury did not find the elements of either intentional or negligent infliction of emotional distress in this case.

As a side-note, this kind of emotional distress is viewed by the law as different from emotional distress that is incidental to a physical injury (pain and suffering). All states recognize that form of emotional distress.

Privacy—no award of damages

The privacy of medical records has, of course, become a major concern in the last few years. Both federal and state law provides significant penalties for the unauthorized release of medical information. However, in this case, it does not appear ­that medical information was improp-
erly revealed.¹³

The patient’s complaint suggested that the anesthesiologist’s discussion during the colonoscopy of the medication for the penile rash was unnecessary for health care purposes.¹ Therefore, it claims, the discussion violated the state health records privacy law. At the same time there was no indication in the public reports that this caused any harm 
to the patient.

Medical malpractice—award 
of damages

Malpractice usually involves professional practice that is unacceptable to the profession itself. It most commonly is negligence, or carelessness, that causes injury to the patient. The gross disregard for professional medical standards here was certainly negligence.¹⁴ The plaintiff claimed that discussing the medication for the penile rash and falsification of the medical records 
constituted malpractice.¹

Presumably the jury award for medical malpractice means the jury found that the misconduct of the medical staff caused the emotional harm that the plaintiff experienced (described as embarrassment, loss of sleep, mental anguish, and anxiety), and that those injuries warranted a 
$200,000 award.

Punitive damage—award of damages

The jury also awarded $200,000 in “punitive” or “exemplary” damages. These are unusual damages, given not so much to compensate the victim but rather as a deterrent for the future. Generally the defendant’s conduct must have been egregious and completely unacceptable.¹⁵ Those elements were apparent to the jury from the facts of this case.

What about loss of practice privileges?

It is not unlikely that one or more of the medical professionals might, beyond civil liability, be subject to licensure discipline by the Virginia board. In addition, there are other secondary consequences of this lawsuit. The employment of those involved may be interrupted. (The anesthesiologist is said to have moved to another state, for example.) Hospital privileges also may be affected, as may insurance rates. The results of this award likely will have to be reported to the National Practitioner Data Bank.

As physicians, what’s 
our takeaway?

Conduct unbecoming a physician remains front and center with a recent essay published in the internal medicine literature.¹⁶ The anonymous author attests to witnessing a male gynecologist making sexual comments regarding the patient at the time of vaginal surgery preparation and an obstetrician singing and dancing to a Mexican song while treating his Hispanic patient for postpartum bleeding.

The unusual case of the anesthesiologist that we address was made even more unusual by the fact that it was recorded. Recordings, however, are likely to become ever more common. The advice of everyone’s grandmother is well taken: “Always act as though what you do will be published on the front page of the newspaper.” The ubiquitous presence of video and audio cameras and untold other devices means that someone may well be watching.

Aside from the risk of getting caught, respect for patients and clients is the very foundation of respect and professional care. It is distressing that the anesthesiologist was so disrespectful of a patient. It is equally disappointing that nobody put a stop to it.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

CASE: Physician defames sedated patient

Our case takes us to the Commonwealth of Virginia. A male patient preparing to undergo a colonoscopy was concerned that, because of grogginess brought on by anesthesia, he might misunderstand postprocedure instructions or advice. He, therefore, turned his cell phone’s record function “on” and put it with his clothes. His clothes were put in a plastic bag, which ended up under the table with him in the operating room.

Following the procedure, as his wife drove him home, the patient replayed the instructions on the cell phone and realized that it had recorded the entire procedure. It quickly became apparent that the medical personnel had engaged in a series of inappropriate and insulting comments at the patient’s expense.

The anesthesiologist, talking to the now-unconscious patient, said, “after five minutes of talking to you in pre-op, I wanted to punch you in the face.” The patient had reported he was taking medication for a mild penile rash. The anesthesiologist warned an assistant not to touch it or “you might get syphilis on your arm or something,” but then noted, “it’s probably tuberculosis of the penis, so you’ll be all right.” There was further mocking of the patient, including a question of whether he was homosexual.

The anesthesiologist and gastroenterologist wanted to avoid talking to the patient after the procedure, and the gastroenterologist instructed an assistant to lie to the patient and convince the patient that the gastroenterologist had already spoken to him following the colonoscopy but, “you just don’t remember it.” In addition, the anesthesiologist announced that she was going to mark “hemorrhoids” on the patient’s chart, which she knew was a 
false diagnosis.

The patient, who is identified only by 
initials, is an attorney.¹ Of course, the smartphone was “good documentation” of what came out of what the health care team said.

The lawsuit

The patient (now plaintiff) claimed that he was verbally brutalized and suffered anxiety, embarrassment, and loss of sleep for 
several months.

On the first day of trial, the gastroenterologist was dismissed from the case. The trial went on against the anesthesiologist and the anesthesia practice.

What’s the verdict?

The patient was awarded $500,000, as follows:

• $100,000 for defamation, ($50,000 each for the syphilis and tuberculosis comments),
• $200,000 for medical malpractice
• $200,000 in punitive damages (including $50,000 the jury found that the anesthesia practice should pay).

Caveat. The above facts about this case come from the plaintiff’s complaint¹ and various professional commentaries and news sources.^2–5 Such sources are not always reliable, so they may not describe accurately all of the relevant events and statements.

Neither of the authors of this column attended the trial or heard the testimony presented. For the purposes of discussing the issues below, however, we treat as true the facts stated above. In addition, some of the legal claims in this case are uncertain. It is entirely possible that an appeal will be made and accepted, and some or all of the damages could be reduced by the trial court or an appellate court. The jury award, therefore, is not necessarily the last word.

Medicolegal takeaways 
from this case

This case raises a number of professional, ethical, and legal issues. Most fundamentally, the health care team is always expected to prioritize the patient’s best interest. Respect for the patient is an essential element of that.

Behaviors such as those reported about these physicians are “absolutely not to engage in any time,” stated President of the American Society of Anesthesiologists 
John Absentein, MD.⁶ A former president of the Academy of Anesthesiology, 
Kathryn McGoldrick, MD, added some common sense advice that such discussions are “not only offensive but frankly stupid.” As she notes, “we can never be certain that our patients are asleep and wouldn’t have recall.”⁷

The actions of the physicians also may violate ethical obligations. The very first principle of medical ethics is that the physician shall provide care “with compassion and respect for human dignity and rights.”⁸

The legal claims included defamation, infliction of emotional distress, privacy (related to medical records), and malpractice. We will take a very brief look at each of those causes of action and then say a word about punitive damages (which the jury awarded in this case).

It is important to remember that state law, rather than federal, is providing the legal principles on which these claims were decided. Federal law might provide some relevant principles in such cases (for example, the First Amendment freedom of speech limits the state defamation rules), but that is the exception. State law is the rule.

Defamation—award of damages

At its core, defamation is publishing (that is, telling someone other than the plaintiff) something untrue that may be harmful to another person. Generally the harm is reputational and the plaintiff may be affected by loss of business, mental suffering, or loss of esteem in the community.⁹

Defamation claims are not typical in health care cases. However, these claims are not rare: instances of health care professionals defaming other health care professionals, patients giving negative “reviews,” or health care professionals releasing false information to employers certainly do exist.

In this case, in addition to saying that the patient had syphilis and tuberculosis (both untrue), the physicians said he was a “wimp.” One interesting concept of 
defamation law that has developed over the centuries is “negligence per se.” This means a falsehood has been published about someone and the falsehood is likely to cause serious reputational harm. Claims that someone has a contagious disease traditionally have been considered negligence per se. Syphilis and tuberculosis fall in that category. On the other hand, saying someone needs to “man up” is usually a matter of opinion, so defamation for such comments is unlikely without special circumstances.

From the anesthesiologist’s perspective, the question is whether anyone who heard the publication really believed that the patient had either of the diseases. A joke that nobody believes to be based on fact generally is not defamatory because it has not harmed the plaintiff.¹⁰ It is apparent that the jury felt the patient had been defamed, however, given the $100,000 award for defamation.

In the United States there is special sensitivity to defamation awards because they may implicate the First Amendment’s protection of free speech. That being the case, this award may be particularly open to review by the judge and appellate courts.

Emotional distress—no award 
of damages

There are 2 kinds of “emotional distress” claimed in this case:

• intentional infliction
• negligent infliction.

Intentional infliction usually requires outrageous conduct by the defendant who acts intentionally or recklessly to inflict severe mental pain on the plaintiff.¹¹ In this case, the element of “intentional” or “reckless” is interesting. While the conduct was outrageous, it is doubtful that there was any way the anesthesiologist could have imagined that these outrageous statements would have been transmitted to the patient/plaintiff.

As for negligent infliction of emotional distress, most states have been wary of opening a Pandora’s Box of litigation. Therefore, they generally require significant physical manifestations of great stress to allow recovery.¹² It appears that the jury did not find the elements of either intentional or negligent infliction of emotional distress in this case.

As a side-note, this kind of emotional distress is viewed by the law as different from emotional distress that is incidental to a physical injury (pain and suffering). All states recognize that form of emotional distress.

Privacy—no award of damages

The privacy of medical records has, of course, become a major concern in the last few years. Both federal and state law provides significant penalties for the unauthorized release of medical information. However, in this case, it does not appear ­that medical information was improp-
erly revealed.¹³

The patient’s complaint suggested that the anesthesiologist’s discussion during the colonoscopy of the medication for the penile rash was unnecessary for health care purposes.¹ Therefore, it claims, the discussion violated the state health records privacy law. At the same time there was no indication in the public reports that this caused any harm 
to the patient.

Medical malpractice—award 
of damages

Malpractice usually involves professional practice that is unacceptable to the profession itself. It most commonly is negligence, or carelessness, that causes injury to the patient. The gross disregard for professional medical standards here was certainly negligence.¹⁴ The plaintiff claimed that discussing the medication for the penile rash and falsification of the medical records 
constituted malpractice.¹

Presumably the jury award for medical malpractice means the jury found that the misconduct of the medical staff caused the emotional harm that the plaintiff experienced (described as embarrassment, loss of sleep, mental anguish, and anxiety), and that those injuries warranted a 
$200,000 award.

Punitive damage—award of damages

The jury also awarded $200,000 in “punitive” or “exemplary” damages. These are unusual damages, given not so much to compensate the victim but rather as a deterrent for the future. Generally the defendant’s conduct must have been egregious and completely unacceptable.¹⁵ Those elements were apparent to the jury from the facts of this case.

What about loss of practice privileges?

It is not unlikely that one or more of the medical professionals might, beyond civil liability, be subject to licensure discipline by the Virginia board. In addition, there are other secondary consequences of this lawsuit. The employment of those involved may be interrupted. (The anesthesiologist is said to have moved to another state, for example.) Hospital privileges also may be affected, as may insurance rates. The results of this award likely will have to be reported to the National Practitioner Data Bank.

As physicians, what’s 
our takeaway?

Conduct unbecoming a physician remains front and center with a recent essay published in the internal medicine literature.¹⁶ The anonymous author attests to witnessing a male gynecologist making sexual comments regarding the patient at the time of vaginal surgery preparation and an obstetrician singing and dancing to a Mexican song while treating his Hispanic patient for postpartum bleeding.

The unusual case of the anesthesiologist that we address was made even more unusual by the fact that it was recorded. Recordings, however, are likely to become ever more common. The advice of everyone’s grandmother is well taken: “Always act as though what you do will be published on the front page of the newspaper.” The ubiquitous presence of video and audio cameras and untold other devices means that someone may well be watching.

Aside from the risk of getting caught, respect for patients and clients is the very foundation of respect and professional care. It is distressing that the anesthesiologist was so disrespectful of a patient. It is equally disappointing that nobody put a stop to it.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

Case: Patient becomes a liability when nonadherant to prescribed tests
MC, a 42-year-old woman (G1P1001), presents for an office visit. As the medical assistant hands you the chart, she says, “Good luck with this one. She yelled at me because you were 20 minutes behind schedule. She didn’t like sitting in the waiting room.” You greet the patient, obtain her medical history, proceed with a physical examination, and outline a management plan. You recall from the chart that you operated on her 8 months ago and there was a complication/maloccurrence in which postoperative bleeding necessitated return to the operating room (OR) for a laparotomy to control bleeding. The patient has not brought this up since being discharged from the hospital. 

During the current office visit, the esprit de corps in the consultation room is a bit uncomfortable, and you sense the patient is not happy. You leave the examination room and discuss the management plan with the nurse, who then returns to the patient to review the plan. The patient is unhappy with the battery of tests you have ordered but tells the nurse that she will comply.

One week later the nurse follows up with the patient by phone because she has not obtained the requested lab tests. The nurse reports to you, “She read me the riot act: ‘Why do I need all these tests? They are expensive.’ The patient indicated that she has no understanding as to why the tests were ordered in the first place.” After a discussion with you, the nurse calls the patient back in an effort to clarify her understanding of the need for the tests. The patient hangs up on her in the middle of the conversation.

The office manager tracks you down to discuss this patient. “Enough is enough,” she exclaims. “This patient is harassing the staff. She told the nurse what tests she herself believes are best and that those are the only ones she will comply with.” Your office manager states that this patient is “a liability.”

What are your choices at this point? You have thought about picking up the phone and calling her. You have considered ending her relationship with your practice. You ask yourself again, what is the best approach?

Patients have the legal right to “dismiss” or change health care providers at any time and for almost any reason without notice. But that right is not reciprocal—clinicians have a legal duty not to abandon a patient and an ethical duty to promote continuity of patient care. A clinician may dismiss a patient from his or her practice (other than for a discriminatory reason that violates ethical or legal limitations), but it must be done in the proper way.

We examine the legal, practical, and ethical issues in dismissing a patient, and how to do it without unnecessary risk. In addition, we will look at a new issue that sometimes arises in these circumstances—managed care limitations.
 

Legal and medical issues
Why would you end a clinician−patient relationship?
There are a number of reasons for dismissing a patient, including^1,2:

The legal details vary from state to state, but fortunately there is sufficient similarity that best practices can be determined. The law starts with the proposition that ordinarily professionals may choose their patients or clients. There are limits, however, in state and federal law. A clinician may not discriminate based, for example, on ethnicity, religion, gender, or sexual orientation. In addition, the Americans with Disabilities Act limits the basis for not providing care to a patient.³

Limiting factors when dismissing a patient
Once a patient has been accepted and a professional relationship has begun, the clinician has a duty of continued care and must act reasonably to end the relationship in a way that protects the patient’s well-being. 

Other recognized limitations to the ending of a treatment relationship exist. These are:

Abandonment
The legal and ethical issues are essentially related to “abandonment”—dismissing a patient improperly. Technically, abandonment is a form of negligence (the clinician does not act reasonably to protect the patient’s interests). The Oklahoma Supreme Court put it clearly: “When further medical and/or surgical attention is needed, a physician may terminate the doctor−patient relationship only after giving reasonable notice and affording an ample opportunity for the patient to secure other medical attention from other physicians” (emphasis added).^4–6

How to end a patient relationship
Always send a letter
Two elements must be taken into account when dismissing a patient:

Together, these elements mean that the intention of ending the clinician−patient relationship and the importance of finding an alternative care provider must be clearly communicated to the patient. That communication needs to be in writing—both to get the patient’s attention and as clear proof of what was said.

Some experts suggest that the best process is to have a face-to-face meeting with the patient followed by a letter. A goal of such a meeting is to make the parting as amicable as possible. It may seem more professional for a clinician to communicate such an important matter in person. The risk is that it may become a confrontation that exacerbates the situation because one or both parties may have some built-up emotion. It, therefore, depends on the circumstances as to whether such a meeting is desirable. Even if there is an oral conversation, it must be followed up with a letter to the patient.

A reasonable time frame to give the patient to find another clinician is commonly a maximum of 30 days of follow-up and emergency care. A set period of time may be a legitimate starting point but it needs to be adjusted in lieu of special circumstances, such as the availability of other similar specialists in the vicinity who are taking new patients or managed care complications. A specific time period should be indicated, along with an agreement to provide care during that time period in “emergency” or “urgent” circumstances. Of course, ongoing care also should be continued for a reasonable time (30 days is often reasonable, as mentioned). It may be best to also discuss any specific ongoing issues that should be attended to (such as the recommended tests in our opening case). 

There is disagreement among experts as to whether a general statement of the reasons for ending the care relationship should be included in the letter. The argument for doing so is that, without a stated reason, the patient may call to ask why. The other side of the argument is that it adds an element of accusation; the patient undoubtedly knows what the problem is. Not writing down the reasons seems the better part of valor, especially if there has been an oral conversation.^7,8

The box above provides an example of a letter to a patient (but not a model). Experts agree that the letter should be sent by certified mail with return receipt. Should the patient reject the letter, a regular delivery letter should be sent with full documentation kept in the file of the time and place it was mailed.

Managed care considerations
A consideration of increasing importance is managed care. Before taking any action, ensure that the managed care contract(s) (including federal or state government programs) have provisions concerning patient dismissals. These may be as simple as notifying the organization as to any time limits for care or of the process of dismissal. 

Make sure your staff knows
Your scheduling staff needs to know with clarity the rules for scheduling (or not scheduling) this patient in the future. As a general matter, the better course of action is to allow an appointment if the patient reports that it is an emergency, whether the staff believes it is or not. In such cases it may be good to document to the patient that the emergency care does not constitute reestablishing a regular clinician−patient relationship.

Document everything
The patient’s record, at a minimum, should contain a copy of the letter sent to the patient and a log of any conversations with her about ending the relationship. Keep your own notes concerning the disruption or problems with the patient over time. 

Are there risks of a malpractice lawsuit?
The abandonment claim is, of course, one possibility for a malpractice lawsuit. That is why documentation and careful communication are so important. This is one area in which having legal advice when developing a letter template should be part of the ongoing relationship with a health law attorney. 

There is another malpractice risk illustrated in our hypothetical case. The physician “operated on her 8 months ago and there was a complication/maloccurrence in which postoperative bleeding necessitated return to the OR and laparotomy to control bleeding.”  Malpractice claims (as opposed to actual malpractice occurrences) most often arise because of bad communication with patients or when patients feel ignored. The clinician is thus between a rock and a hard place. On one hand, by ending this relationship, the clinician could well precipitate a claim based primarily on the earlier “maloccurrence.” On the other hand, continuing to treat a patient who is resisting care and creating problems with the staff has its own difficulties. It may be time for the health care professional to discuss the matter with an attorney.

Although not present in this hypothetical case, ending a patient relationship because of nonpayment of professional fees is also a touchy situation. It can be one of the other precipitating events for malpractice claims, and calls for special care.

Tread with care
Having to dismiss a patient is almost always a difficult process. The decision neither can be made lightly nor implemented sloppily. Because it is difficult, it calls on professionals to be particularly careful to not cut essential corners.⁹ 

Case: Resolved
You ask the nurse to note the details of her follow-up phone conversation with the patient in the chart. You then call MC to explain the importance of the tests. She says she is unavailable to talk right now, so you ask her to come in for an appointment, free of charge. The patient makes an appointment but does not show.

You send a letter by certified mail describing the medical necessity for the tests and that her lack of adherence and refusal to come to the office have compelled you to end your clinician−patient relationship. You write that she should immediately identify another health care professional and suggest that she contact her managed care organization for assistance. You note that, should there be a medical emergency or urgent care needed in the next 30 days, you will provide that care. You enclose a release of medical records form in the letter.

In the patient’s record you note the details of the phone conversation and ask the office manager to add that the patient was a no show for her appointment. You include a copy of the certified letter and proof of mailing in the chart.

Two weeks later, the office manager reports that she is sending the patient’s records to another physician upon receipt of the release of medical records form from the patient.

Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

Case: Patient becomes a liability when nonadherant to prescribed tests
MC, a 42-year-old woman (G1P1001), presents for an office visit. As the medical assistant hands you the chart, she says, “Good luck with this one. She yelled at me because you were 20 minutes behind schedule. She didn’t like sitting in the waiting room.” You greet the patient, obtain her medical history, proceed with a physical examination, and outline a management plan. You recall from the chart that you operated on her 8 months ago and there was a complication/maloccurrence in which postoperative bleeding necessitated return to the operating room (OR) for a laparotomy to control bleeding. The patient has not brought this up since being discharged from the hospital. 

During the current office visit, the esprit de corps in the consultation room is a bit uncomfortable, and you sense the patient is not happy. You leave the examination room and discuss the management plan with the nurse, who then returns to the patient to review the plan. The patient is unhappy with the battery of tests you have ordered but tells the nurse that she will comply.

One week later the nurse follows up with the patient by phone because she has not obtained the requested lab tests. The nurse reports to you, “She read me the riot act: ‘Why do I need all these tests? They are expensive.’ The patient indicated that she has no understanding as to why the tests were ordered in the first place.” After a discussion with you, the nurse calls the patient back in an effort to clarify her understanding of the need for the tests. The patient hangs up on her in the middle of the conversation.

The office manager tracks you down to discuss this patient. “Enough is enough,” she exclaims. “This patient is harassing the staff. She told the nurse what tests she herself believes are best and that those are the only ones she will comply with.” Your office manager states that this patient is “a liability.”

What are your choices at this point? You have thought about picking up the phone and calling her. You have considered ending her relationship with your practice. You ask yourself again, what is the best approach?

Patients have the legal right to “dismiss” or change health care providers at any time and for almost any reason without notice. But that right is not reciprocal—clinicians have a legal duty not to abandon a patient and an ethical duty to promote continuity of patient care. A clinician may dismiss a patient from his or her practice (other than for a discriminatory reason that violates ethical or legal limitations), but it must be done in the proper way.

We examine the legal, practical, and ethical issues in dismissing a patient, and how to do it without unnecessary risk. In addition, we will look at a new issue that sometimes arises in these circumstances—managed care limitations.
 

Legal and medical issues
Why would you end a clinician−patient relationship?
There are a number of reasons for dismissing a patient, including^1,2:

The legal details vary from state to state, but fortunately there is sufficient similarity that best practices can be determined. The law starts with the proposition that ordinarily professionals may choose their patients or clients. There are limits, however, in state and federal law. A clinician may not discriminate based, for example, on ethnicity, religion, gender, or sexual orientation. In addition, the Americans with Disabilities Act limits the basis for not providing care to a patient.³

Limiting factors when dismissing a patient
Once a patient has been accepted and a professional relationship has begun, the clinician has a duty of continued care and must act reasonably to end the relationship in a way that protects the patient’s well-being. 

Other recognized limitations to the ending of a treatment relationship exist. These are:

Abandonment
The legal and ethical issues are essentially related to “abandonment”—dismissing a patient improperly. Technically, abandonment is a form of negligence (the clinician does not act reasonably to protect the patient’s interests). The Oklahoma Supreme Court put it clearly: “When further medical and/or surgical attention is needed, a physician may terminate the doctor−patient relationship only after giving reasonable notice and affording an ample opportunity for the patient to secure other medical attention from other physicians” (emphasis added).^4–6

How to end a patient relationship
Always send a letter
Two elements must be taken into account when dismissing a patient:

Together, these elements mean that the intention of ending the clinician−patient relationship and the importance of finding an alternative care provider must be clearly communicated to the patient. That communication needs to be in writing—both to get the patient’s attention and as clear proof of what was said.

Some experts suggest that the best process is to have a face-to-face meeting with the patient followed by a letter. A goal of such a meeting is to make the parting as amicable as possible. It may seem more professional for a clinician to communicate such an important matter in person. The risk is that it may become a confrontation that exacerbates the situation because one or both parties may have some built-up emotion. It, therefore, depends on the circumstances as to whether such a meeting is desirable. Even if there is an oral conversation, it must be followed up with a letter to the patient.

A reasonable time frame to give the patient to find another clinician is commonly a maximum of 30 days of follow-up and emergency care. A set period of time may be a legitimate starting point but it needs to be adjusted in lieu of special circumstances, such as the availability of other similar specialists in the vicinity who are taking new patients or managed care complications. A specific time period should be indicated, along with an agreement to provide care during that time period in “emergency” or “urgent” circumstances. Of course, ongoing care also should be continued for a reasonable time (30 days is often reasonable, as mentioned). It may be best to also discuss any specific ongoing issues that should be attended to (such as the recommended tests in our opening case). 

There is disagreement among experts as to whether a general statement of the reasons for ending the care relationship should be included in the letter. The argument for doing so is that, without a stated reason, the patient may call to ask why. The other side of the argument is that it adds an element of accusation; the patient undoubtedly knows what the problem is. Not writing down the reasons seems the better part of valor, especially if there has been an oral conversation.^7,8

The box above provides an example of a letter to a patient (but not a model). Experts agree that the letter should be sent by certified mail with return receipt. Should the patient reject the letter, a regular delivery letter should be sent with full documentation kept in the file of the time and place it was mailed.

Managed care considerations
A consideration of increasing importance is managed care. Before taking any action, ensure that the managed care contract(s) (including federal or state government programs) have provisions concerning patient dismissals. These may be as simple as notifying the organization as to any time limits for care or of the process of dismissal. 

Make sure your staff knows
Your scheduling staff needs to know with clarity the rules for scheduling (or not scheduling) this patient in the future. As a general matter, the better course of action is to allow an appointment if the patient reports that it is an emergency, whether the staff believes it is or not. In such cases it may be good to document to the patient that the emergency care does not constitute reestablishing a regular clinician−patient relationship.

Document everything
The patient’s record, at a minimum, should contain a copy of the letter sent to the patient and a log of any conversations with her about ending the relationship. Keep your own notes concerning the disruption or problems with the patient over time. 

Are there risks of a malpractice lawsuit?
The abandonment claim is, of course, one possibility for a malpractice lawsuit. That is why documentation and careful communication are so important. This is one area in which having legal advice when developing a letter template should be part of the ongoing relationship with a health law attorney. 

There is another malpractice risk illustrated in our hypothetical case. The physician “operated on her 8 months ago and there was a complication/maloccurrence in which postoperative bleeding necessitated return to the OR and laparotomy to control bleeding.”  Malpractice claims (as opposed to actual malpractice occurrences) most often arise because of bad communication with patients or when patients feel ignored. The clinician is thus between a rock and a hard place. On one hand, by ending this relationship, the clinician could well precipitate a claim based primarily on the earlier “maloccurrence.” On the other hand, continuing to treat a patient who is resisting care and creating problems with the staff has its own difficulties. It may be time for the health care professional to discuss the matter with an attorney.

Although not present in this hypothetical case, ending a patient relationship because of nonpayment of professional fees is also a touchy situation. It can be one of the other precipitating events for malpractice claims, and calls for special care.

Tread with care
Having to dismiss a patient is almost always a difficult process. The decision neither can be made lightly nor implemented sloppily. Because it is difficult, it calls on professionals to be particularly careful to not cut essential corners.⁹ 

Case: Resolved
You ask the nurse to note the details of her follow-up phone conversation with the patient in the chart. You then call MC to explain the importance of the tests. She says she is unavailable to talk right now, so you ask her to come in for an appointment, free of charge. The patient makes an appointment but does not show.

You send a letter by certified mail describing the medical necessity for the tests and that her lack of adherence and refusal to come to the office have compelled you to end your clinician−patient relationship. You write that she should immediately identify another health care professional and suggest that she contact her managed care organization for assistance. You note that, should there be a medical emergency or urgent care needed in the next 30 days, you will provide that care. You enclose a release of medical records form in the letter.

In the patient’s record you note the details of the phone conversation and ask the office manager to add that the patient was a no show for her appointment. You include a copy of the certified letter and proof of mailing in the chart.

Two weeks later, the office manager reports that she is sending the patient’s records to another physician upon receipt of the release of medical records form from the patient.

Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

Case: Patient becomes a liability when nonadherant to prescribed tests
MC, a 42-year-old woman (G1P1001), presents for an office visit. As the medical assistant hands you the chart, she says, “Good luck with this one. She yelled at me because you were 20 minutes behind schedule. She didn’t like sitting in the waiting room.” You greet the patient, obtain her medical history, proceed with a physical examination, and outline a management plan. You recall from the chart that you operated on her 8 months ago and there was a complication/maloccurrence in which postoperative bleeding necessitated return to the operating room (OR) for a laparotomy to control bleeding. The patient has not brought this up since being discharged from the hospital. 

During the current office visit, the esprit de corps in the consultation room is a bit uncomfortable, and you sense the patient is not happy. You leave the examination room and discuss the management plan with the nurse, who then returns to the patient to review the plan. The patient is unhappy with the battery of tests you have ordered but tells the nurse that she will comply.

One week later the nurse follows up with the patient by phone because she has not obtained the requested lab tests. The nurse reports to you, “She read me the riot act: ‘Why do I need all these tests? They are expensive.’ The patient indicated that she has no understanding as to why the tests were ordered in the first place.” After a discussion with you, the nurse calls the patient back in an effort to clarify her understanding of the need for the tests. The patient hangs up on her in the middle of the conversation.

The office manager tracks you down to discuss this patient. “Enough is enough,” she exclaims. “This patient is harassing the staff. She told the nurse what tests she herself believes are best and that those are the only ones she will comply with.” Your office manager states that this patient is “a liability.”

What are your choices at this point? You have thought about picking up the phone and calling her. You have considered ending her relationship with your practice. You ask yourself again, what is the best approach?

Patients have the legal right to “dismiss” or change health care providers at any time and for almost any reason without notice. But that right is not reciprocal—clinicians have a legal duty not to abandon a patient and an ethical duty to promote continuity of patient care. A clinician may dismiss a patient from his or her practice (other than for a discriminatory reason that violates ethical or legal limitations), but it must be done in the proper way.

We examine the legal, practical, and ethical issues in dismissing a patient, and how to do it without unnecessary risk. In addition, we will look at a new issue that sometimes arises in these circumstances—managed care limitations.
 

Legal and medical issues
Why would you end a clinician−patient relationship?
There are a number of reasons for dismissing a patient, including^1,2:

The legal details vary from state to state, but fortunately there is sufficient similarity that best practices can be determined. The law starts with the proposition that ordinarily professionals may choose their patients or clients. There are limits, however, in state and federal law. A clinician may not discriminate based, for example, on ethnicity, religion, gender, or sexual orientation. In addition, the Americans with Disabilities Act limits the basis for not providing care to a patient.³

Limiting factors when dismissing a patient
Once a patient has been accepted and a professional relationship has begun, the clinician has a duty of continued care and must act reasonably to end the relationship in a way that protects the patient’s well-being. 

Other recognized limitations to the ending of a treatment relationship exist. These are:

Abandonment
The legal and ethical issues are essentially related to “abandonment”—dismissing a patient improperly. Technically, abandonment is a form of negligence (the clinician does not act reasonably to protect the patient’s interests). The Oklahoma Supreme Court put it clearly: “When further medical and/or surgical attention is needed, a physician may terminate the doctor−patient relationship only after giving reasonable notice and affording an ample opportunity for the patient to secure other medical attention from other physicians” (emphasis added).^4–6

How to end a patient relationship
Always send a letter
Two elements must be taken into account when dismissing a patient:

Together, these elements mean that the intention of ending the clinician−patient relationship and the importance of finding an alternative care provider must be clearly communicated to the patient. That communication needs to be in writing—both to get the patient’s attention and as clear proof of what was said.

Some experts suggest that the best process is to have a face-to-face meeting with the patient followed by a letter. A goal of such a meeting is to make the parting as amicable as possible. It may seem more professional for a clinician to communicate such an important matter in person. The risk is that it may become a confrontation that exacerbates the situation because one or both parties may have some built-up emotion. It, therefore, depends on the circumstances as to whether such a meeting is desirable. Even if there is an oral conversation, it must be followed up with a letter to the patient.

A reasonable time frame to give the patient to find another clinician is commonly a maximum of 30 days of follow-up and emergency care. A set period of time may be a legitimate starting point but it needs to be adjusted in lieu of special circumstances, such as the availability of other similar specialists in the vicinity who are taking new patients or managed care complications. A specific time period should be indicated, along with an agreement to provide care during that time period in “emergency” or “urgent” circumstances. Of course, ongoing care also should be continued for a reasonable time (30 days is often reasonable, as mentioned). It may be best to also discuss any specific ongoing issues that should be attended to (such as the recommended tests in our opening case). 

There is disagreement among experts as to whether a general statement of the reasons for ending the care relationship should be included in the letter. The argument for doing so is that, without a stated reason, the patient may call to ask why. The other side of the argument is that it adds an element of accusation; the patient undoubtedly knows what the problem is. Not writing down the reasons seems the better part of valor, especially if there has been an oral conversation.^7,8

The box above provides an example of a letter to a patient (but not a model). Experts agree that the letter should be sent by certified mail with return receipt. Should the patient reject the letter, a regular delivery letter should be sent with full documentation kept in the file of the time and place it was mailed.

Managed care considerations
A consideration of increasing importance is managed care. Before taking any action, ensure that the managed care contract(s) (including federal or state government programs) have provisions concerning patient dismissals. These may be as simple as notifying the organization as to any time limits for care or of the process of dismissal. 

Make sure your staff knows
Your scheduling staff needs to know with clarity the rules for scheduling (or not scheduling) this patient in the future. As a general matter, the better course of action is to allow an appointment if the patient reports that it is an emergency, whether the staff believes it is or not. In such cases it may be good to document to the patient that the emergency care does not constitute reestablishing a regular clinician−patient relationship.

Document everything
The patient’s record, at a minimum, should contain a copy of the letter sent to the patient and a log of any conversations with her about ending the relationship. Keep your own notes concerning the disruption or problems with the patient over time. 

Are there risks of a malpractice lawsuit?
The abandonment claim is, of course, one possibility for a malpractice lawsuit. That is why documentation and careful communication are so important. This is one area in which having legal advice when developing a letter template should be part of the ongoing relationship with a health law attorney. 

There is another malpractice risk illustrated in our hypothetical case. The physician “operated on her 8 months ago and there was a complication/maloccurrence in which postoperative bleeding necessitated return to the OR and laparotomy to control bleeding.”  Malpractice claims (as opposed to actual malpractice occurrences) most often arise because of bad communication with patients or when patients feel ignored. The clinician is thus between a rock and a hard place. On one hand, by ending this relationship, the clinician could well precipitate a claim based primarily on the earlier “maloccurrence.” On the other hand, continuing to treat a patient who is resisting care and creating problems with the staff has its own difficulties. It may be time for the health care professional to discuss the matter with an attorney.

Although not present in this hypothetical case, ending a patient relationship because of nonpayment of professional fees is also a touchy situation. It can be one of the other precipitating events for malpractice claims, and calls for special care.

Tread with care
Having to dismiss a patient is almost always a difficult process. The decision neither can be made lightly nor implemented sloppily. Because it is difficult, it calls on professionals to be particularly careful to not cut essential corners.⁹ 

Case: Resolved
You ask the nurse to note the details of her follow-up phone conversation with the patient in the chart. You then call MC to explain the importance of the tests. She says she is unavailable to talk right now, so you ask her to come in for an appointment, free of charge. The patient makes an appointment but does not show.

You send a letter by certified mail describing the medical necessity for the tests and that her lack of adherence and refusal to come to the office have compelled you to end your clinician−patient relationship. You write that she should immediately identify another health care professional and suggest that she contact her managed care organization for assistance. You note that, should there be a medical emergency or urgent care needed in the next 30 days, you will provide that care. You enclose a release of medical records form in the letter.

In the patient’s record you note the details of the phone conversation and ask the office manager to add that the patient was a no show for her appointment. You include a copy of the certified letter and proof of mailing in the chart.

Two weeks later, the office manager reports that she is sending the patient’s records to another physician upon receipt of the release of medical records form from the patient.

Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

CASE: Lost needle tip
A 36-year-old woman (G3 P2012) with stress urinary incontinence (SUI) and abnormal uterine bleeding presented to a gynecologist. She had explored medical therapy for her SUI with no symptom improvement. She had a previous tubal ligation, and the gynecologist ordered urodynamic testing, the results of which led to a discussion of vaginal hysterectomy; anterior, posterior colporrhaphy; and mesh placement. It was felt that the patient had a number of risk factors for incontinence (including pregnancy with vaginal delivery, well-controlled diabetes mellitus, and obesity). She had a long-standing history of chronic pelvic pain, with an established diagnosis of diverticulosis with episodes of diverticulitis in the past.

The gynecologist had the patient keep a bladder diary for 1 week. When asked, the patient reported no problems with sexual dysfunction, stating that her quality of life was “fine” except for the vaginal bleeding and loss of urine refractory to medical therapy. The Urogenital Distress Inventory was administered, and it identified frequent urination, leakage, and incontinence related to activities. An Incontinence Impact Questionnaire also was administered. Physical examination included cotton-tipped swab urethral, or Q-tip, test and cough stress test as part of POP-Q (Pelvic Organ Prolapse Quantification system) evaluation. Urinary tract infection was ruled out. The gynecologist counseled the patient about possible medical therapies for urinary incontinence, and she requested definitive surgery.

The gynecologist obtained informed consent for surgery that included preoperative discussion of potential surgical complications, including bleeding, infection, trauma to surrounding structures, and the possibility of additional surgical procedures secondary to complications. The gynecologist also discussed transvaginal tape versus transobturator tape (TOT) placement, including potential complications and sequelae. The final planned procedure, which was performed by the gynecologist, included vaginal hysterectomy, anterior colporrhaphy, and TOT placement.

Intraoperatively, the patient was identified (upon entering the operating room [OR]); time-out occurred, and the gynecologist proceeded with surgery. During the procedure, the tip of a needle broke off. The gynecologist noted the broken tip as he removed the needle and handed it to the surgical technician. The gynecologist palpated the sidewall in the presumed area of the needle tip and felt it easily. He attempted to remove the tip, but his effort was fruitless. He made the intraoperative decision to leave the tip in situ. A needle and sponge count was performed, reported as correct, and it was felt there was no indication for imaging of the pelvis. The circulating nurse filled out an incident report immediately following the surgery, noting the missing needle tip. The occurrence was discussed by the surgical committee at the hospital.

Postoperatively, while the patient was in the hospital, she was informed of the intra-operative incident.

Three months later, the patient reported vaginal and pelvic pain on the sidewall in the area of the lost needle tip, with radiating pain down the involved extremity. A segment of the TOT was noted to be protruding into the vagina, and this was addressed in the OR with “trimming of such.”

Postoperatively, again the patient reported pain on the involved side. She sought the opinion of another gynecologist, who subsequently performed surgical intervention to remove the needle tip. Her symptoms improved.

The patient sued the original gynecologic surgeon, alleging pain and suffering from the surgery involving the lost needle tip.

What’s the verdict?
A defense verdict was awarded.

Medical teaching points
Medical evaluation seemed appropriate. Parity is associated with SUI (but not urge incontinence). In general, urinary incontinence is more commonly associated with a history of lower urinary tract infections. The patient in this case was asked about and evaluated for:

Was information on the broken needle handled appropriately? This case explores the question of what, if any, obligation the surgeon and hospital system have to the patient when informing her of a broken needle and the intraoperative decision-making process that led to its staying in place. When such a situation occurs, which is very uncommon, should an intraoperative x-ray be performed to assess the location of the needle tip? Should the patient automatically be brought back to the OR for removal?

The surgeon’s concern was a legitimate one—that additional attempts at removal could lead to complications far worse than having a small segment of a needle left in place. After all, shrapnel, bullets, etc, remain lodged in various locations throughout the body without subsequent ill effects. He did discuss with the patient the fact that a needle segment was left in the muscle wall. But how do you assess postoperative pelvic pain in a patient who had preoperative chronic pelvic pain? These are questions we as clinicians ask. Clearly, there are no black-and-white answers, and we will call upon our legal consultants for their expertise in addressing these queries.

From the gynecologic perspective, however, it is of paramount importance to address the patient’s postoperative vaginal pain and determine the best management approach. In this case the TOT, and its association with a 21.5% complication rate, including reported vaginal extrusion, introduces a whole new set of concerns.¹ The TOT use in itself raises the question of liability on the part of the surgeon. This mesh has more than 150 associated complications, including obturator nerve injuries, extensive blood loss, and ischiorectal fossa abscesses.² Once a device comes upon the radar screen of the US Food and Drug Administration for ­signi­ficant complications, where does that leave the clinician in regard to litigation? Let’s look to our legal colleagues for their insight and expertise.

Legal considerations
Given the facts in this case, it is not surprising that it resulted in a defense verdict. The majority of cases filed are ultimately disposed of in favor of the medical defendants, and the majority of medical malpractice cases that go to trial result in defense verdicts.

Medical malpractice, or “professional negligence,” consists of a claim that a medical professional had a duty of care to the patient, a breach of that duty, injury to the patient, and a causal connection (“causation”) between the breach of duty and the injury. It is the obligation of the plaintiff to prove the elements of negligence by a preponderance of the evidence.

Were the surgeon’s actions in line with other surgeons’ expected actions? The issue of the breach of the duty of care essentially is the question of whether the physician acted similarly to a reasonably careful practitioner of the same specialty under the same circumstances. Doctors are not held to a standard of perfection. That is, not every injury or bad outcome is negligence—only those injuries that result from actions, or inactions, that were not within the level of care acceptable in the profession.

Why would this patient file a lawsuit? The injury was not trivial (it had both pain and cost associated with it), but it was not catastrophic, and the negligence was going to be difficult to prove. Furthermore, lawsuits are expensive in terms of time, energy, and emotional commitment—few people file them for the fun of it. We can only speculate on the answer to the question but, frequently, such claims are a search for the answer to “What happened, and why?” or a reaction to feeling ignored or disrespected. There is little in the case facts that we have to work with to indicate what the communication was between the gynecologist and the patient and her family. The statement of facts, however, leaves the impression that communication deteriorated as the postoperative pain endured.

Some additional areas of potential claims for liability in this case include:

What factors could have tipped the case toward the defense?
The defense verdict indicates that the jury determined there was no negligence, or that the patient could not prove any of these potential bases of liability. As noted above, what may have helped the defense is the fact that the surgeon documented the details of the informed consent conversation, including that “discussion was carried out regarding” the tape. The informed consent process is an important opportunity for communication with the patient, and a chance to make sure that expectations are reasonable. Liability for the failure of informed consent is not common. When something has gone wrong, however, it can matter whether the problem was something mentioned in the informed consent process. In addition, it was positive that postoperatively the patient was informed of the broken needle—although it is not clear who informed her about it.

A couple of other legal issues are worth noting. From our fact scenario we do not know what was documented in the incident report filed by the circulating nurse and reviewed by the surgical committee. We also do not know whether the plaintiff was privy to the incident report document. The surgical committee is likely a peer-review committee, and most states provide some privilege for such committees (to avoid disclosure of committee information for discovery or at trial). The deliberations and conclusions of the committee, therefore, were likely privileged. However, incident reports are frequently used for other purposes, such as administrative reports, that are not privileged—so the incident report often is determined to be discoverable depending on the interpretation of the state’s law.

No winner in this case
Despite the defense verdict, the physician was not really the “winner” after having spent a great deal of time, energy, money, and emotion defending this suit. Ultimately, the goal is not to win malpractice cases but to avoid them—in this case, among other things, by being frank with patients about expectations, keeping an open line of communication with patients when they are concerned with an outcome that is less than ideal, and referring a patient when it may be appropriate.

Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

CASE: Lost needle tip
A 36-year-old woman (G3 P2012) with stress urinary incontinence (SUI) and abnormal uterine bleeding presented to a gynecologist. She had explored medical therapy for her SUI with no symptom improvement. She had a previous tubal ligation, and the gynecologist ordered urodynamic testing, the results of which led to a discussion of vaginal hysterectomy; anterior, posterior colporrhaphy; and mesh placement. It was felt that the patient had a number of risk factors for incontinence (including pregnancy with vaginal delivery, well-controlled diabetes mellitus, and obesity). She had a long-standing history of chronic pelvic pain, with an established diagnosis of diverticulosis with episodes of diverticulitis in the past.

The gynecologist had the patient keep a bladder diary for 1 week. When asked, the patient reported no problems with sexual dysfunction, stating that her quality of life was “fine” except for the vaginal bleeding and loss of urine refractory to medical therapy. The Urogenital Distress Inventory was administered, and it identified frequent urination, leakage, and incontinence related to activities. An Incontinence Impact Questionnaire also was administered. Physical examination included cotton-tipped swab urethral, or Q-tip, test and cough stress test as part of POP-Q (Pelvic Organ Prolapse Quantification system) evaluation. Urinary tract infection was ruled out. The gynecologist counseled the patient about possible medical therapies for urinary incontinence, and she requested definitive surgery.

The gynecologist obtained informed consent for surgery that included preoperative discussion of potential surgical complications, including bleeding, infection, trauma to surrounding structures, and the possibility of additional surgical procedures secondary to complications. The gynecologist also discussed transvaginal tape versus transobturator tape (TOT) placement, including potential complications and sequelae. The final planned procedure, which was performed by the gynecologist, included vaginal hysterectomy, anterior colporrhaphy, and TOT placement.

Intraoperatively, the patient was identified (upon entering the operating room [OR]); time-out occurred, and the gynecologist proceeded with surgery. During the procedure, the tip of a needle broke off. The gynecologist noted the broken tip as he removed the needle and handed it to the surgical technician. The gynecologist palpated the sidewall in the presumed area of the needle tip and felt it easily. He attempted to remove the tip, but his effort was fruitless. He made the intraoperative decision to leave the tip in situ. A needle and sponge count was performed, reported as correct, and it was felt there was no indication for imaging of the pelvis. The circulating nurse filled out an incident report immediately following the surgery, noting the missing needle tip. The occurrence was discussed by the surgical committee at the hospital.

Postoperatively, while the patient was in the hospital, she was informed of the intra-operative incident.

Three months later, the patient reported vaginal and pelvic pain on the sidewall in the area of the lost needle tip, with radiating pain down the involved extremity. A segment of the TOT was noted to be protruding into the vagina, and this was addressed in the OR with “trimming of such.”

Postoperatively, again the patient reported pain on the involved side. She sought the opinion of another gynecologist, who subsequently performed surgical intervention to remove the needle tip. Her symptoms improved.

The patient sued the original gynecologic surgeon, alleging pain and suffering from the surgery involving the lost needle tip.

What’s the verdict?
A defense verdict was awarded.

Medical teaching points
Medical evaluation seemed appropriate. Parity is associated with SUI (but not urge incontinence). In general, urinary incontinence is more commonly associated with a history of lower urinary tract infections. The patient in this case was asked about and evaluated for:

Was information on the broken needle handled appropriately? This case explores the question of what, if any, obligation the surgeon and hospital system have to the patient when informing her of a broken needle and the intraoperative decision-making process that led to its staying in place. When such a situation occurs, which is very uncommon, should an intraoperative x-ray be performed to assess the location of the needle tip? Should the patient automatically be brought back to the OR for removal?

The surgeon’s concern was a legitimate one—that additional attempts at removal could lead to complications far worse than having a small segment of a needle left in place. After all, shrapnel, bullets, etc, remain lodged in various locations throughout the body without subsequent ill effects. He did discuss with the patient the fact that a needle segment was left in the muscle wall. But how do you assess postoperative pelvic pain in a patient who had preoperative chronic pelvic pain? These are questions we as clinicians ask. Clearly, there are no black-and-white answers, and we will call upon our legal consultants for their expertise in addressing these queries.

From the gynecologic perspective, however, it is of paramount importance to address the patient’s postoperative vaginal pain and determine the best management approach. In this case the TOT, and its association with a 21.5% complication rate, including reported vaginal extrusion, introduces a whole new set of concerns.¹ The TOT use in itself raises the question of liability on the part of the surgeon. This mesh has more than 150 associated complications, including obturator nerve injuries, extensive blood loss, and ischiorectal fossa abscesses.² Once a device comes upon the radar screen of the US Food and Drug Administration for ­signi­ficant complications, where does that leave the clinician in regard to litigation? Let’s look to our legal colleagues for their insight and expertise.

Legal considerations
Given the facts in this case, it is not surprising that it resulted in a defense verdict. The majority of cases filed are ultimately disposed of in favor of the medical defendants, and the majority of medical malpractice cases that go to trial result in defense verdicts.

Medical malpractice, or “professional negligence,” consists of a claim that a medical professional had a duty of care to the patient, a breach of that duty, injury to the patient, and a causal connection (“causation”) between the breach of duty and the injury. It is the obligation of the plaintiff to prove the elements of negligence by a preponderance of the evidence.

Were the surgeon’s actions in line with other surgeons’ expected actions? The issue of the breach of the duty of care essentially is the question of whether the physician acted similarly to a reasonably careful practitioner of the same specialty under the same circumstances. Doctors are not held to a standard of perfection. That is, not every injury or bad outcome is negligence—only those injuries that result from actions, or inactions, that were not within the level of care acceptable in the profession.

Why would this patient file a lawsuit? The injury was not trivial (it had both pain and cost associated with it), but it was not catastrophic, and the negligence was going to be difficult to prove. Furthermore, lawsuits are expensive in terms of time, energy, and emotional commitment—few people file them for the fun of it. We can only speculate on the answer to the question but, frequently, such claims are a search for the answer to “What happened, and why?” or a reaction to feeling ignored or disrespected. There is little in the case facts that we have to work with to indicate what the communication was between the gynecologist and the patient and her family. The statement of facts, however, leaves the impression that communication deteriorated as the postoperative pain endured.

Some additional areas of potential claims for liability in this case include:

What factors could have tipped the case toward the defense?
The defense verdict indicates that the jury determined there was no negligence, or that the patient could not prove any of these potential bases of liability. As noted above, what may have helped the defense is the fact that the surgeon documented the details of the informed consent conversation, including that “discussion was carried out regarding” the tape. The informed consent process is an important opportunity for communication with the patient, and a chance to make sure that expectations are reasonable. Liability for the failure of informed consent is not common. When something has gone wrong, however, it can matter whether the problem was something mentioned in the informed consent process. In addition, it was positive that postoperatively the patient was informed of the broken needle—although it is not clear who informed her about it.

A couple of other legal issues are worth noting. From our fact scenario we do not know what was documented in the incident report filed by the circulating nurse and reviewed by the surgical committee. We also do not know whether the plaintiff was privy to the incident report document. The surgical committee is likely a peer-review committee, and most states provide some privilege for such committees (to avoid disclosure of committee information for discovery or at trial). The deliberations and conclusions of the committee, therefore, were likely privileged. However, incident reports are frequently used for other purposes, such as administrative reports, that are not privileged—so the incident report often is determined to be discoverable depending on the interpretation of the state’s law.

No winner in this case
Despite the defense verdict, the physician was not really the “winner” after having spent a great deal of time, energy, money, and emotion defending this suit. Ultimately, the goal is not to win malpractice cases but to avoid them—in this case, among other things, by being frank with patients about expectations, keeping an open line of communication with patients when they are concerned with an outcome that is less than ideal, and referring a patient when it may be appropriate.

Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

CASE: Lost needle tip
A 36-year-old woman (G3 P2012) with stress urinary incontinence (SUI) and abnormal uterine bleeding presented to a gynecologist. She had explored medical therapy for her SUI with no symptom improvement. She had a previous tubal ligation, and the gynecologist ordered urodynamic testing, the results of which led to a discussion of vaginal hysterectomy; anterior, posterior colporrhaphy; and mesh placement. It was felt that the patient had a number of risk factors for incontinence (including pregnancy with vaginal delivery, well-controlled diabetes mellitus, and obesity). She had a long-standing history of chronic pelvic pain, with an established diagnosis of diverticulosis with episodes of diverticulitis in the past.

The gynecologist had the patient keep a bladder diary for 1 week. When asked, the patient reported no problems with sexual dysfunction, stating that her quality of life was “fine” except for the vaginal bleeding and loss of urine refractory to medical therapy. The Urogenital Distress Inventory was administered, and it identified frequent urination, leakage, and incontinence related to activities. An Incontinence Impact Questionnaire also was administered. Physical examination included cotton-tipped swab urethral, or Q-tip, test and cough stress test as part of POP-Q (Pelvic Organ Prolapse Quantification system) evaluation. Urinary tract infection was ruled out. The gynecologist counseled the patient about possible medical therapies for urinary incontinence, and she requested definitive surgery.

The gynecologist obtained informed consent for surgery that included preoperative discussion of potential surgical complications, including bleeding, infection, trauma to surrounding structures, and the possibility of additional surgical procedures secondary to complications. The gynecologist also discussed transvaginal tape versus transobturator tape (TOT) placement, including potential complications and sequelae. The final planned procedure, which was performed by the gynecologist, included vaginal hysterectomy, anterior colporrhaphy, and TOT placement.

Intraoperatively, the patient was identified (upon entering the operating room [OR]); time-out occurred, and the gynecologist proceeded with surgery. During the procedure, the tip of a needle broke off. The gynecologist noted the broken tip as he removed the needle and handed it to the surgical technician. The gynecologist palpated the sidewall in the presumed area of the needle tip and felt it easily. He attempted to remove the tip, but his effort was fruitless. He made the intraoperative decision to leave the tip in situ. A needle and sponge count was performed, reported as correct, and it was felt there was no indication for imaging of the pelvis. The circulating nurse filled out an incident report immediately following the surgery, noting the missing needle tip. The occurrence was discussed by the surgical committee at the hospital.

Postoperatively, while the patient was in the hospital, she was informed of the intra-operative incident.

Three months later, the patient reported vaginal and pelvic pain on the sidewall in the area of the lost needle tip, with radiating pain down the involved extremity. A segment of the TOT was noted to be protruding into the vagina, and this was addressed in the OR with “trimming of such.”

Postoperatively, again the patient reported pain on the involved side. She sought the opinion of another gynecologist, who subsequently performed surgical intervention to remove the needle tip. Her symptoms improved.

The patient sued the original gynecologic surgeon, alleging pain and suffering from the surgery involving the lost needle tip.

What’s the verdict?
A defense verdict was awarded.

Medical teaching points
Medical evaluation seemed appropriate. Parity is associated with SUI (but not urge incontinence). In general, urinary incontinence is more commonly associated with a history of lower urinary tract infections. The patient in this case was asked about and evaluated for:

Was information on the broken needle handled appropriately? This case explores the question of what, if any, obligation the surgeon and hospital system have to the patient when informing her of a broken needle and the intraoperative decision-making process that led to its staying in place. When such a situation occurs, which is very uncommon, should an intraoperative x-ray be performed to assess the location of the needle tip? Should the patient automatically be brought back to the OR for removal?

The surgeon’s concern was a legitimate one—that additional attempts at removal could lead to complications far worse than having a small segment of a needle left in place. After all, shrapnel, bullets, etc, remain lodged in various locations throughout the body without subsequent ill effects. He did discuss with the patient the fact that a needle segment was left in the muscle wall. But how do you assess postoperative pelvic pain in a patient who had preoperative chronic pelvic pain? These are questions we as clinicians ask. Clearly, there are no black-and-white answers, and we will call upon our legal consultants for their expertise in addressing these queries.

From the gynecologic perspective, however, it is of paramount importance to address the patient’s postoperative vaginal pain and determine the best management approach. In this case the TOT, and its association with a 21.5% complication rate, including reported vaginal extrusion, introduces a whole new set of concerns.¹ The TOT use in itself raises the question of liability on the part of the surgeon. This mesh has more than 150 associated complications, including obturator nerve injuries, extensive blood loss, and ischiorectal fossa abscesses.² Once a device comes upon the radar screen of the US Food and Drug Administration for ­signi­ficant complications, where does that leave the clinician in regard to litigation? Let’s look to our legal colleagues for their insight and expertise.

Legal considerations
Given the facts in this case, it is not surprising that it resulted in a defense verdict. The majority of cases filed are ultimately disposed of in favor of the medical defendants, and the majority of medical malpractice cases that go to trial result in defense verdicts.

Medical malpractice, or “professional negligence,” consists of a claim that a medical professional had a duty of care to the patient, a breach of that duty, injury to the patient, and a causal connection (“causation”) between the breach of duty and the injury. It is the obligation of the plaintiff to prove the elements of negligence by a preponderance of the evidence.

Were the surgeon’s actions in line with other surgeons’ expected actions? The issue of the breach of the duty of care essentially is the question of whether the physician acted similarly to a reasonably careful practitioner of the same specialty under the same circumstances. Doctors are not held to a standard of perfection. That is, not every injury or bad outcome is negligence—only those injuries that result from actions, or inactions, that were not within the level of care acceptable in the profession.

Why would this patient file a lawsuit? The injury was not trivial (it had both pain and cost associated with it), but it was not catastrophic, and the negligence was going to be difficult to prove. Furthermore, lawsuits are expensive in terms of time, energy, and emotional commitment—few people file them for the fun of it. We can only speculate on the answer to the question but, frequently, such claims are a search for the answer to “What happened, and why?” or a reaction to feeling ignored or disrespected. There is little in the case facts that we have to work with to indicate what the communication was between the gynecologist and the patient and her family. The statement of facts, however, leaves the impression that communication deteriorated as the postoperative pain endured.

Some additional areas of potential claims for liability in this case include:

What factors could have tipped the case toward the defense?
The defense verdict indicates that the jury determined there was no negligence, or that the patient could not prove any of these potential bases of liability. As noted above, what may have helped the defense is the fact that the surgeon documented the details of the informed consent conversation, including that “discussion was carried out regarding” the tape. The informed consent process is an important opportunity for communication with the patient, and a chance to make sure that expectations are reasonable. Liability for the failure of informed consent is not common. When something has gone wrong, however, it can matter whether the problem was something mentioned in the informed consent process. In addition, it was positive that postoperatively the patient was informed of the broken needle—although it is not clear who informed her about it.

A couple of other legal issues are worth noting. From our fact scenario we do not know what was documented in the incident report filed by the circulating nurse and reviewed by the surgical committee. We also do not know whether the plaintiff was privy to the incident report document. The surgical committee is likely a peer-review committee, and most states provide some privilege for such committees (to avoid disclosure of committee information for discovery or at trial). The deliberations and conclusions of the committee, therefore, were likely privileged. However, incident reports are frequently used for other purposes, such as administrative reports, that are not privileged—so the incident report often is determined to be discoverable depending on the interpretation of the state’s law.

No winner in this case
Despite the defense verdict, the physician was not really the “winner” after having spent a great deal of time, energy, money, and emotion defending this suit. Ultimately, the goal is not to win malpractice cases but to avoid them—in this case, among other things, by being frank with patients about expectations, keeping an open line of communication with patients when they are concerned with an outcome that is less than ideal, and referring a patient when it may be appropriate.

Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

CASE: COST-CONSCIOUS LAPAROSCOPIC HYSTERECTOMY
A 43-year-old woman undergoes laparoscopic hysterectomy for treatment of uterine fibroids and menorrhagia. Once she is prepped with ChloraPrep, a RUMI II uterine manipulator is placed. Laparoscopic ports include a Structural Balloon Trocar, a VersaStep Plus trocar, and two Versaport trocars. The surgeon uses an Olympus Thunderbeat device—a combination of ultrasonic and bipolar energy—to perform the majority of the procedure. The uterus is morcellated using the disposable Gynecare Morcellex, and the vaginal cuff is closed using a series of 2-0 PDS II sutures. The skin ­incisions are closed using Dermabond skin adhesive.

The total cost of the products used in this case: $1,705.60.

Could different product choices have reduced this figure?

As health-care costs continue to rise faster than inflation, with total health-care expenditures accounting for about 18% of the US gross domestic product, we face increasing pressure to take cost into account in the management of our patients.¹ Not surprisingly, cost-effectiveness and outcome quality have become measures in many clinical trials that compare standard and alternative therapies. The field of women’s health—and, specifically, minimally invasive gynecologic surgery—is not immune to such comparisons.

Overall, conventional laparoscopic gynecologic procedures tend to have lower costs than laparotomy, due to shorter hospital stays, faster recovery, and fewer complications.^2–4 What is not fully appreciated is how the choice of laparoscopic instrumentation and associated products affects surgical costs. In this article, we review these costs with the goal of raising awareness among minimally invasive gynecologic surgeons.

In the sections that follow, we highlight several aspects of laparoscopic gynecologic surgery that may affect your selection of instruments and products, describing the difference in cost as well as some unique characteristics of the products. Please note that our comparison focuses solely on cost, not ease of utility, effectiveness, surgical technique, risk of complications, or any other assessment. We’d also like to point out that numerous other instruments and devices are commercially available besides those listed in this article.

A few variables to keep in mind
Even when taking cost into consideration, tailor the selection of instruments and supplies to your capabilities and comfort, as well as characteristics particular to the patient and the planned procedure. Also keep in mind that your institution may have arrangements with companies that supply minimally invasive instruments, and such arrangements may limit your options to some degree. Be aware that reprocessed ports and instruments are now available at a reduced cost.

We believe it is crucial for surgeons to be cognizant of all products potentially available to them prior to attending a surgical case.

Related article: Update on Technology Barbara S. Levy, MD (September 2013)

Skin preparation and other preoperative considerations
Multiple preoperative skin preparations are available (TABLE 1). Traditionally, a povidone-iodine topical ­antiseptic such as Betadine has been used for skin and vaginal preparation prior to gynecologic surgery. Hibaclens and ChloraPrep are different combinations of chlorhexidine gluconate and isopropyl alcohol that act as broad-spectrum antiseptics. ChloraPrep is applied with a wand-like applicator and contains a much higher concentration of isopropyl alcohol than Hibaclens (70% vs 4%), rendering it more flammable. It also requires more drying time before the case is started. Clear and tinted ChloraPrep formulations are available.

It makes good sense to have instruments and devices readily available in the operating room (OR) at the start of a case, to avoid unnecessary surgical delays, but we recommend that you refrain from opening these tools until they are required intraoperatively. It is possible that the case will require conversion to laparotomy or that, after direct visualization of the pathology, different ports or instruments will be required.

Uterine manipulators
Cannulation of the cervical canal allows for uterine manipulation, increasing ­intraoperative traction and exposure and visualization of the adnexae and peritoneal surfaces.

The Hulka and Pelosi reusable uterine manipulators are fairly standard and easy to apply. Specialized, single-use manipulators also are available, including the VCare uterine manipulator/elevator, which consists of two opposing cups. One cup (available in four sizes, from small to extra-large) fits around the cervix and defines the site for colpotomy, and the other cup helps maintain pneumoperitoneum once a colpotomy is created.

The Zinnanti Uterine Manipulator Injector (ZUMI) is a rigid, curved shaft with an intrauterine balloon to help prevent expulsion. It also has an integrated injection channel to allow for intraoperative chromotubation.

The RUMI System fits individual patient anatomy with various tip lengths and colpotomy cup sizes (TABLE 2).

Related article: Tips and techniques for robot-assisted laparoscopic myomectomy Arnold P. Advincula, MD, and Bich-Van Tran, MD (August 2013)

Entry style and ports
The peritoneal cavity can be entered using either a closed (Veress needle) or open (Hasson) technique.⁵ Closed entry may allow for quicker access to the peritoneal cavity. A recent Cochrane review of 28 randomized, controlled trials, including 4,860 patients undergoing laparoscopy, compared outcomes between laparoscopic entry techniques.⁶ It found no difference in major vascular or visceral injury between closed and open techniques at the umbilicus. However, open entry was associated with greater successful entry into the peritoneal cavity, as well as less extraperitoneal insufflation and a lower omental injury rate, compared with closed entry.⁶ 

Left-upper-quadrant entry is another option when adhesions are anticipated or abnormal anatomy is encountered at the umbilicus.

In general, complications related to laparoscopic entry are quite rare in gynecologic surgery, ranging from 0.18% to 0.5%.^7,8 A minimally invasive surgeon may prefer one entry technique over the other, but should be able to perform both methods competently and recognize when a particular technique is warranted.

Choosing a port
Laparoscopic ports usually range from 5 mm to 12 mm and can be fixed or variable in size. The primary port, usually placed through the umbilicus, can be a standard, blunt, 10-mm (Hasson) port, or it can be specialized to ease entry of the port or stabilize the port once it is introduced through the skin incision.

Optical trocars have a transparent tip that allows the surgeon to visualize the abdominal-wall entry layer by layer using a 0° laparoscope, usually after pneumoperitoneum is created with a Veress needle. Other specialized ports include those that have balloons or foam collars, or both, to secure the port without traditional stay sutures on the fascia and minimize leakage of pneumoperitoneum.

Accessory ports
When choosing an accessory port type and size, it is important to anticipate what instruments and devices, such as an Endo Catch bag, suture, needle, or morcellator, will need to pass through it. Also know whether 5-mm and 10-mm laparoscopes are available, and anticipate whether a second port with insufflation capabilities will be required.

Related article: Update on Minimally Invasive Surgery Amy Garcia, MD (April 2011)

Pediport trocars are user-friendly 5-mm bladed ports that deploy a mushroom-shaped stabilizer to prevent ­dislodgement. A ­Versaport bladed trocar has a spring-loaded entry shield, which slides over to protect the blade once the peritoneal cavity is entered.

VersaStep bladeless trocars are introduced after a Step insufflation needle has been inserted. These trocars create a smaller fascial defect than conventional bladed trocars for an equivalent cannula size (TABLE 3).

Cutting and coagulating
Both monopolar and bipolar electrosurgical techniques are commonly employed in gynecologic laparoscopy. A wide variety of disposable and reusable instruments are available for monopolar energy, such as scissors, a hook, and a spatula.

Bipolar devices also can be disposable or reusable. Although bipolar electrosurgery minimizes injury to surrounding tissues by containing the current within the jaws of the forceps, it cannot cut or seal large vessels. As a result, several advanced bipolar devices with sealing and transecting capabilities have emerged (LigaSure, ENSEAL). Ultrasonic devices also can coagulate and cut at lower temperatures by converting electrical energy to mechanical energy (TABLE 4).

Sutures
Aspects of minimally invasive gynecologic surgery that require the use of suture include, but are not limited to, closure of the vaginal cuff, oophoropexy, and reapproximation of the ovarian cortex after cystectomy. Syntheticand delayed absorbable sutures, such as PDS II, are used frequently.

Recently, a new class of suture emerged and continues to gain popularity: barbed suture. This type of suture anchors to the tissue without the need for intra- or extracorporeal knots (TABLE 5).

Related article: Ins and outs of straight-stick laparoscopic myomectomy James Robinson, MD, MS, and Gaby Moawad, MD (September 2012)

Tissue removal
Adnexae and pathologic tissue, such as dermoid cysts, can be removed intact from the peritoneal cavity using an Endo Catch Single-Use Specimen Pouch, a polyurethane sac. Careful use, with placement of the ovary with the cyst into the pouch prior to cystectomy, can prevent spillage beyond the bag.

Large uteri that cannot be extracted through a colpotomy can be morcellated into smaller pieces to ease removal through a small laparoscopic incision or the colpotomy. Both reusable and disposable morcellator hand pieces are available (TABLE 6).

Skin closure
Final subcuticular closure can be accomplished using sutures or skin adhesive. Sutures may be synthetic, absorbable monofilament (eg, Caprosyn), or synthetic, absorbable, braided multifilament (eg, PolySorb).

Related article: 10 practical, evidence-based recommendations for improving maternal outcomes of cesarean delivery Baha M. Sibai, MD (March 2012)

Skin adhesives close incisions quickly, avoid inflammation related to foreign bodies, and ease patient concerns that sometimes arise when absorbable suture persists postoperatively (TABLE 5).

Take-home points
As health-care third-party payers and hospitals continue to evaluate surgeons individually and compare procedures between surgeons, reimbursements may be stratified, favoring physicians who demonstrate both quality outcomes and cost-containment.   

There are many ways a minimally invasive surgeon can implement cost-conscious choices that have little to no impact on the quality of the outcome.

Surgeons who are familiar with the instruments and models available for use at their institution are better prepared to make wise cost-conscious decisions.

Cost is not the only indicator of value, however. The surgeon must know how to apply tools correctly and be familiar with their limitations, and should choose instruments and products for their safety and ease of use. More often than not, a surgeon’s training and personal experience define—and sometimes restrict—the choice of devices.

CASE: SAME OUTCOME, LOWER COST
The patient undergoes laparoscopic hysterectomy for treatment of uterine fibroids and menorrhagia. However, in this scenario, the surgeon makes the following product choices: The patient is prepped with Betadine, and a reusable Pelosi uterine manipulator is placed. Laparoscopic ports include a Kii Balloon Blunt Tip, a reprocessed VersaStep Plus trocar, and two Pediport trocars. The surgeon uses the PKS Lyons Dissecting Forceps and reprocessed EndoShears to perform the hysterectomy, incorporating the Karl Storz Rotocut G1 Morcellator, a reusable system with single-use blades, to morcellate the uterus. The vaginal cuff is closed using V-Loc barbed suture, and skin incisions are closed with 4-0 Polysorb, a polyglycolic acid, absorbable suture.

The cost of these products: $1,005.68, or roughly $700 less than the set-up described at the beginning of this article (TABLE 7).

Acknowledgment
The authors thank Susan Wykoop, BSN, RN, and Anna Emery, MSN, RN, for their assistance in gathering specific cost-related information.

We want to hear from you! Tell us what you think.

CASE: COST-CONSCIOUS LAPAROSCOPIC HYSTERECTOMY
A 43-year-old woman undergoes laparoscopic hysterectomy for treatment of uterine fibroids and menorrhagia. Once she is prepped with ChloraPrep, a RUMI II uterine manipulator is placed. Laparoscopic ports include a Structural Balloon Trocar, a VersaStep Plus trocar, and two Versaport trocars. The surgeon uses an Olympus Thunderbeat device—a combination of ultrasonic and bipolar energy—to perform the majority of the procedure. The uterus is morcellated using the disposable Gynecare Morcellex, and the vaginal cuff is closed using a series of 2-0 PDS II sutures. The skin ­incisions are closed using Dermabond skin adhesive.

The total cost of the products used in this case: $1,705.60.

Could different product choices have reduced this figure?

As health-care costs continue to rise faster than inflation, with total health-care expenditures accounting for about 18% of the US gross domestic product, we face increasing pressure to take cost into account in the management of our patients.¹ Not surprisingly, cost-effectiveness and outcome quality have become measures in many clinical trials that compare standard and alternative therapies. The field of women’s health—and, specifically, minimally invasive gynecologic surgery—is not immune to such comparisons.

Overall, conventional laparoscopic gynecologic procedures tend to have lower costs than laparotomy, due to shorter hospital stays, faster recovery, and fewer complications.^2–4 What is not fully appreciated is how the choice of laparoscopic instrumentation and associated products affects surgical costs. In this article, we review these costs with the goal of raising awareness among minimally invasive gynecologic surgeons.

In the sections that follow, we highlight several aspects of laparoscopic gynecologic surgery that may affect your selection of instruments and products, describing the difference in cost as well as some unique characteristics of the products. Please note that our comparison focuses solely on cost, not ease of utility, effectiveness, surgical technique, risk of complications, or any other assessment. We’d also like to point out that numerous other instruments and devices are commercially available besides those listed in this article.

A few variables to keep in mind
Even when taking cost into consideration, tailor the selection of instruments and supplies to your capabilities and comfort, as well as characteristics particular to the patient and the planned procedure. Also keep in mind that your institution may have arrangements with companies that supply minimally invasive instruments, and such arrangements may limit your options to some degree. Be aware that reprocessed ports and instruments are now available at a reduced cost.

We believe it is crucial for surgeons to be cognizant of all products potentially available to them prior to attending a surgical case.

Related article: Update on Technology Barbara S. Levy, MD (September 2013)

Skin preparation and other preoperative considerations
Multiple preoperative skin preparations are available (TABLE 1). Traditionally, a povidone-iodine topical ­antiseptic such as Betadine has been used for skin and vaginal preparation prior to gynecologic surgery. Hibaclens and ChloraPrep are different combinations of chlorhexidine gluconate and isopropyl alcohol that act as broad-spectrum antiseptics. ChloraPrep is applied with a wand-like applicator and contains a much higher concentration of isopropyl alcohol than Hibaclens (70% vs 4%), rendering it more flammable. It also requires more drying time before the case is started. Clear and tinted ChloraPrep formulations are available.

It makes good sense to have instruments and devices readily available in the operating room (OR) at the start of a case, to avoid unnecessary surgical delays, but we recommend that you refrain from opening these tools until they are required intraoperatively. It is possible that the case will require conversion to laparotomy or that, after direct visualization of the pathology, different ports or instruments will be required.

Uterine manipulators
Cannulation of the cervical canal allows for uterine manipulation, increasing ­intraoperative traction and exposure and visualization of the adnexae and peritoneal surfaces.

The Hulka and Pelosi reusable uterine manipulators are fairly standard and easy to apply. Specialized, single-use manipulators also are available, including the VCare uterine manipulator/elevator, which consists of two opposing cups. One cup (available in four sizes, from small to extra-large) fits around the cervix and defines the site for colpotomy, and the other cup helps maintain pneumoperitoneum once a colpotomy is created.

The Zinnanti Uterine Manipulator Injector (ZUMI) is a rigid, curved shaft with an intrauterine balloon to help prevent expulsion. It also has an integrated injection channel to allow for intraoperative chromotubation.

The RUMI System fits individual patient anatomy with various tip lengths and colpotomy cup sizes (TABLE 2).

Related article: Tips and techniques for robot-assisted laparoscopic myomectomy Arnold P. Advincula, MD, and Bich-Van Tran, MD (August 2013)

Entry style and ports
The peritoneal cavity can be entered using either a closed (Veress needle) or open (Hasson) technique.⁵ Closed entry may allow for quicker access to the peritoneal cavity. A recent Cochrane review of 28 randomized, controlled trials, including 4,860 patients undergoing laparoscopy, compared outcomes between laparoscopic entry techniques.⁶ It found no difference in major vascular or visceral injury between closed and open techniques at the umbilicus. However, open entry was associated with greater successful entry into the peritoneal cavity, as well as less extraperitoneal insufflation and a lower omental injury rate, compared with closed entry.⁶ 

Left-upper-quadrant entry is another option when adhesions are anticipated or abnormal anatomy is encountered at the umbilicus.

In general, complications related to laparoscopic entry are quite rare in gynecologic surgery, ranging from 0.18% to 0.5%.^7,8 A minimally invasive surgeon may prefer one entry technique over the other, but should be able to perform both methods competently and recognize when a particular technique is warranted.

Choosing a port
Laparoscopic ports usually range from 5 mm to 12 mm and can be fixed or variable in size. The primary port, usually placed through the umbilicus, can be a standard, blunt, 10-mm (Hasson) port, or it can be specialized to ease entry of the port or stabilize the port once it is introduced through the skin incision.

Optical trocars have a transparent tip that allows the surgeon to visualize the abdominal-wall entry layer by layer using a 0° laparoscope, usually after pneumoperitoneum is created with a Veress needle. Other specialized ports include those that have balloons or foam collars, or both, to secure the port without traditional stay sutures on the fascia and minimize leakage of pneumoperitoneum.

Accessory ports
When choosing an accessory port type and size, it is important to anticipate what instruments and devices, such as an Endo Catch bag, suture, needle, or morcellator, will need to pass through it. Also know whether 5-mm and 10-mm laparoscopes are available, and anticipate whether a second port with insufflation capabilities will be required.

Related article: Update on Minimally Invasive Surgery Amy Garcia, MD (April 2011)

Pediport trocars are user-friendly 5-mm bladed ports that deploy a mushroom-shaped stabilizer to prevent ­dislodgement. A ­Versaport bladed trocar has a spring-loaded entry shield, which slides over to protect the blade once the peritoneal cavity is entered.

VersaStep bladeless trocars are introduced after a Step insufflation needle has been inserted. These trocars create a smaller fascial defect than conventional bladed trocars for an equivalent cannula size (TABLE 3).

Cutting and coagulating
Both monopolar and bipolar electrosurgical techniques are commonly employed in gynecologic laparoscopy. A wide variety of disposable and reusable instruments are available for monopolar energy, such as scissors, a hook, and a spatula.

Bipolar devices also can be disposable or reusable. Although bipolar electrosurgery minimizes injury to surrounding tissues by containing the current within the jaws of the forceps, it cannot cut or seal large vessels. As a result, several advanced bipolar devices with sealing and transecting capabilities have emerged (LigaSure, ENSEAL). Ultrasonic devices also can coagulate and cut at lower temperatures by converting electrical energy to mechanical energy (TABLE 4).

Sutures
Aspects of minimally invasive gynecologic surgery that require the use of suture include, but are not limited to, closure of the vaginal cuff, oophoropexy, and reapproximation of the ovarian cortex after cystectomy. Syntheticand delayed absorbable sutures, such as PDS II, are used frequently.

Recently, a new class of suture emerged and continues to gain popularity: barbed suture. This type of suture anchors to the tissue without the need for intra- or extracorporeal knots (TABLE 5).

Related article: Ins and outs of straight-stick laparoscopic myomectomy James Robinson, MD, MS, and Gaby Moawad, MD (September 2012)

Tissue removal
Adnexae and pathologic tissue, such as dermoid cysts, can be removed intact from the peritoneal cavity using an Endo Catch Single-Use Specimen Pouch, a polyurethane sac. Careful use, with placement of the ovary with the cyst into the pouch prior to cystectomy, can prevent spillage beyond the bag.

Large uteri that cannot be extracted through a colpotomy can be morcellated into smaller pieces to ease removal through a small laparoscopic incision or the colpotomy. Both reusable and disposable morcellator hand pieces are available (TABLE 6).

Skin closure
Final subcuticular closure can be accomplished using sutures or skin adhesive. Sutures may be synthetic, absorbable monofilament (eg, Caprosyn), or synthetic, absorbable, braided multifilament (eg, PolySorb).

Related article: 10 practical, evidence-based recommendations for improving maternal outcomes of cesarean delivery Baha M. Sibai, MD (March 2012)

Skin adhesives close incisions quickly, avoid inflammation related to foreign bodies, and ease patient concerns that sometimes arise when absorbable suture persists postoperatively (TABLE 5).

Take-home points
As health-care third-party payers and hospitals continue to evaluate surgeons individually and compare procedures between surgeons, reimbursements may be stratified, favoring physicians who demonstrate both quality outcomes and cost-containment.   

There are many ways a minimally invasive surgeon can implement cost-conscious choices that have little to no impact on the quality of the outcome.

Surgeons who are familiar with the instruments and models available for use at their institution are better prepared to make wise cost-conscious decisions.

Cost is not the only indicator of value, however. The surgeon must know how to apply tools correctly and be familiar with their limitations, and should choose instruments and products for their safety and ease of use. More often than not, a surgeon’s training and personal experience define—and sometimes restrict—the choice of devices.

CASE: SAME OUTCOME, LOWER COST
The patient undergoes laparoscopic hysterectomy for treatment of uterine fibroids and menorrhagia. However, in this scenario, the surgeon makes the following product choices: The patient is prepped with Betadine, and a reusable Pelosi uterine manipulator is placed. Laparoscopic ports include a Kii Balloon Blunt Tip, a reprocessed VersaStep Plus trocar, and two Pediport trocars. The surgeon uses the PKS Lyons Dissecting Forceps and reprocessed EndoShears to perform the hysterectomy, incorporating the Karl Storz Rotocut G1 Morcellator, a reusable system with single-use blades, to morcellate the uterus. The vaginal cuff is closed using V-Loc barbed suture, and skin incisions are closed with 4-0 Polysorb, a polyglycolic acid, absorbable suture.

The cost of these products: $1,005.68, or roughly $700 less than the set-up described at the beginning of this article (TABLE 7).

Acknowledgment
The authors thank Susan Wykoop, BSN, RN, and Anna Emery, MSN, RN, for their assistance in gathering specific cost-related information.

We want to hear from you! Tell us what you think.

CASE: COST-CONSCIOUS LAPAROSCOPIC HYSTERECTOMY
A 43-year-old woman undergoes laparoscopic hysterectomy for treatment of uterine fibroids and menorrhagia. Once she is prepped with ChloraPrep, a RUMI II uterine manipulator is placed. Laparoscopic ports include a Structural Balloon Trocar, a VersaStep Plus trocar, and two Versaport trocars. The surgeon uses an Olympus Thunderbeat device—a combination of ultrasonic and bipolar energy—to perform the majority of the procedure. The uterus is morcellated using the disposable Gynecare Morcellex, and the vaginal cuff is closed using a series of 2-0 PDS II sutures. The skin ­incisions are closed using Dermabond skin adhesive.

The total cost of the products used in this case: $1,705.60.

Could different product choices have reduced this figure?

As health-care costs continue to rise faster than inflation, with total health-care expenditures accounting for about 18% of the US gross domestic product, we face increasing pressure to take cost into account in the management of our patients.¹ Not surprisingly, cost-effectiveness and outcome quality have become measures in many clinical trials that compare standard and alternative therapies. The field of women’s health—and, specifically, minimally invasive gynecologic surgery—is not immune to such comparisons.

Overall, conventional laparoscopic gynecologic procedures tend to have lower costs than laparotomy, due to shorter hospital stays, faster recovery, and fewer complications.^2–4 What is not fully appreciated is how the choice of laparoscopic instrumentation and associated products affects surgical costs. In this article, we review these costs with the goal of raising awareness among minimally invasive gynecologic surgeons.

In the sections that follow, we highlight several aspects of laparoscopic gynecologic surgery that may affect your selection of instruments and products, describing the difference in cost as well as some unique characteristics of the products. Please note that our comparison focuses solely on cost, not ease of utility, effectiveness, surgical technique, risk of complications, or any other assessment. We’d also like to point out that numerous other instruments and devices are commercially available besides those listed in this article.

A few variables to keep in mind
Even when taking cost into consideration, tailor the selection of instruments and supplies to your capabilities and comfort, as well as characteristics particular to the patient and the planned procedure. Also keep in mind that your institution may have arrangements with companies that supply minimally invasive instruments, and such arrangements may limit your options to some degree. Be aware that reprocessed ports and instruments are now available at a reduced cost.

We believe it is crucial for surgeons to be cognizant of all products potentially available to them prior to attending a surgical case.

Related article: Update on Technology Barbara S. Levy, MD (September 2013)

Skin preparation and other preoperative considerations
Multiple preoperative skin preparations are available (TABLE 1). Traditionally, a povidone-iodine topical ­antiseptic such as Betadine has been used for skin and vaginal preparation prior to gynecologic surgery. Hibaclens and ChloraPrep are different combinations of chlorhexidine gluconate and isopropyl alcohol that act as broad-spectrum antiseptics. ChloraPrep is applied with a wand-like applicator and contains a much higher concentration of isopropyl alcohol than Hibaclens (70% vs 4%), rendering it more flammable. It also requires more drying time before the case is started. Clear and tinted ChloraPrep formulations are available.

It makes good sense to have instruments and devices readily available in the operating room (OR) at the start of a case, to avoid unnecessary surgical delays, but we recommend that you refrain from opening these tools until they are required intraoperatively. It is possible that the case will require conversion to laparotomy or that, after direct visualization of the pathology, different ports or instruments will be required.

Uterine manipulators
Cannulation of the cervical canal allows for uterine manipulation, increasing ­intraoperative traction and exposure and visualization of the adnexae and peritoneal surfaces.

The Hulka and Pelosi reusable uterine manipulators are fairly standard and easy to apply. Specialized, single-use manipulators also are available, including the VCare uterine manipulator/elevator, which consists of two opposing cups. One cup (available in four sizes, from small to extra-large) fits around the cervix and defines the site for colpotomy, and the other cup helps maintain pneumoperitoneum once a colpotomy is created.

The Zinnanti Uterine Manipulator Injector (ZUMI) is a rigid, curved shaft with an intrauterine balloon to help prevent expulsion. It also has an integrated injection channel to allow for intraoperative chromotubation.

The RUMI System fits individual patient anatomy with various tip lengths and colpotomy cup sizes (TABLE 2).

Related article: Tips and techniques for robot-assisted laparoscopic myomectomy Arnold P. Advincula, MD, and Bich-Van Tran, MD (August 2013)

Entry style and ports
The peritoneal cavity can be entered using either a closed (Veress needle) or open (Hasson) technique.⁵ Closed entry may allow for quicker access to the peritoneal cavity. A recent Cochrane review of 28 randomized, controlled trials, including 4,860 patients undergoing laparoscopy, compared outcomes between laparoscopic entry techniques.⁶ It found no difference in major vascular or visceral injury between closed and open techniques at the umbilicus. However, open entry was associated with greater successful entry into the peritoneal cavity, as well as less extraperitoneal insufflation and a lower omental injury rate, compared with closed entry.⁶ 

Left-upper-quadrant entry is another option when adhesions are anticipated or abnormal anatomy is encountered at the umbilicus.

In general, complications related to laparoscopic entry are quite rare in gynecologic surgery, ranging from 0.18% to 0.5%.^7,8 A minimally invasive surgeon may prefer one entry technique over the other, but should be able to perform both methods competently and recognize when a particular technique is warranted.

Choosing a port
Laparoscopic ports usually range from 5 mm to 12 mm and can be fixed or variable in size. The primary port, usually placed through the umbilicus, can be a standard, blunt, 10-mm (Hasson) port, or it can be specialized to ease entry of the port or stabilize the port once it is introduced through the skin incision.

Optical trocars have a transparent tip that allows the surgeon to visualize the abdominal-wall entry layer by layer using a 0° laparoscope, usually after pneumoperitoneum is created with a Veress needle. Other specialized ports include those that have balloons or foam collars, or both, to secure the port without traditional stay sutures on the fascia and minimize leakage of pneumoperitoneum.

Accessory ports
When choosing an accessory port type and size, it is important to anticipate what instruments and devices, such as an Endo Catch bag, suture, needle, or morcellator, will need to pass through it. Also know whether 5-mm and 10-mm laparoscopes are available, and anticipate whether a second port with insufflation capabilities will be required.

Related article: Update on Minimally Invasive Surgery Amy Garcia, MD (April 2011)

Pediport trocars are user-friendly 5-mm bladed ports that deploy a mushroom-shaped stabilizer to prevent ­dislodgement. A ­Versaport bladed trocar has a spring-loaded entry shield, which slides over to protect the blade once the peritoneal cavity is entered.

VersaStep bladeless trocars are introduced after a Step insufflation needle has been inserted. These trocars create a smaller fascial defect than conventional bladed trocars for an equivalent cannula size (TABLE 3).

Cutting and coagulating
Both monopolar and bipolar electrosurgical techniques are commonly employed in gynecologic laparoscopy. A wide variety of disposable and reusable instruments are available for monopolar energy, such as scissors, a hook, and a spatula.

Bipolar devices also can be disposable or reusable. Although bipolar electrosurgery minimizes injury to surrounding tissues by containing the current within the jaws of the forceps, it cannot cut or seal large vessels. As a result, several advanced bipolar devices with sealing and transecting capabilities have emerged (LigaSure, ENSEAL). Ultrasonic devices also can coagulate and cut at lower temperatures by converting electrical energy to mechanical energy (TABLE 4).

Sutures
Aspects of minimally invasive gynecologic surgery that require the use of suture include, but are not limited to, closure of the vaginal cuff, oophoropexy, and reapproximation of the ovarian cortex after cystectomy. Syntheticand delayed absorbable sutures, such as PDS II, are used frequently.

Recently, a new class of suture emerged and continues to gain popularity: barbed suture. This type of suture anchors to the tissue without the need for intra- or extracorporeal knots (TABLE 5).

Related article: Ins and outs of straight-stick laparoscopic myomectomy James Robinson, MD, MS, and Gaby Moawad, MD (September 2012)

Tissue removal
Adnexae and pathologic tissue, such as dermoid cysts, can be removed intact from the peritoneal cavity using an Endo Catch Single-Use Specimen Pouch, a polyurethane sac. Careful use, with placement of the ovary with the cyst into the pouch prior to cystectomy, can prevent spillage beyond the bag.

Large uteri that cannot be extracted through a colpotomy can be morcellated into smaller pieces to ease removal through a small laparoscopic incision or the colpotomy. Both reusable and disposable morcellator hand pieces are available (TABLE 6).

Skin closure
Final subcuticular closure can be accomplished using sutures or skin adhesive. Sutures may be synthetic, absorbable monofilament (eg, Caprosyn), or synthetic, absorbable, braided multifilament (eg, PolySorb).

Related article: 10 practical, evidence-based recommendations for improving maternal outcomes of cesarean delivery Baha M. Sibai, MD (March 2012)

Skin adhesives close incisions quickly, avoid inflammation related to foreign bodies, and ease patient concerns that sometimes arise when absorbable suture persists postoperatively (TABLE 5).

Take-home points
As health-care third-party payers and hospitals continue to evaluate surgeons individually and compare procedures between surgeons, reimbursements may be stratified, favoring physicians who demonstrate both quality outcomes and cost-containment.   

There are many ways a minimally invasive surgeon can implement cost-conscious choices that have little to no impact on the quality of the outcome.

Surgeons who are familiar with the instruments and models available for use at their institution are better prepared to make wise cost-conscious decisions.

Cost is not the only indicator of value, however. The surgeon must know how to apply tools correctly and be familiar with their limitations, and should choose instruments and products for their safety and ease of use. More often than not, a surgeon’s training and personal experience define—and sometimes restrict—the choice of devices.

CASE: SAME OUTCOME, LOWER COST
The patient undergoes laparoscopic hysterectomy for treatment of uterine fibroids and menorrhagia. However, in this scenario, the surgeon makes the following product choices: The patient is prepped with Betadine, and a reusable Pelosi uterine manipulator is placed. Laparoscopic ports include a Kii Balloon Blunt Tip, a reprocessed VersaStep Plus trocar, and two Pediport trocars. The surgeon uses the PKS Lyons Dissecting Forceps and reprocessed EndoShears to perform the hysterectomy, incorporating the Karl Storz Rotocut G1 Morcellator, a reusable system with single-use blades, to morcellate the uterus. The vaginal cuff is closed using V-Loc barbed suture, and skin incisions are closed with 4-0 Polysorb, a polyglycolic acid, absorbable suture.

The cost of these products: $1,005.68, or roughly $700 less than the set-up described at the beginning of this article (TABLE 7).

Acknowledgment
The authors thank Susan Wykoop, BSN, RN, and Anna Emery, MSN, RN, for their assistance in gathering specific cost-related information.

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