Steven R. Smith, JD

Last month, we began consideration of the obligations of physicians and health-care organizations to take action concerning colleagues who are out of line. In part 1, we looked at a recently reported case of “The gynecologist who wore an unusual pen.” He admitted taking more than 1,000 videos and images of patients using a tiny camera embedded in a pen or key fob that he wore around his neck. This serious ­misconduct continued for many years without being noticed.

A class-action lawsuit against the medical center and physician resulted in a settlement of $190 million, despite the fact that the physician had not transferred the images to others. Here, we look at the obligation of the medical profession to notice and manage colleagues who are creating a risk to patients or the institution. What are the legal consequences of your relationships with your colleagues, and why is it so important for physicians and health-care centers to be alert to inappropriate conduct and deal promptly with those problems?

CASE: Well-respected clinician turns increasingly grumpy toward colleagues and patients
In your role as president of the practice, you have been asked to comment on a colleague’s behavior. You’ve known him for a long time. Dr. X has been in practice for more than 20 years, and always has been well respected in the community. Over his career he has served as residency program director for a large community hospital. He has been, in essence, a role model for physicians in training.

Over the past 6 months, a number of complaints have been brought to your attention as practice president. The primary concern is Dr. X’s temper, which he seems to be having trouble controlling. Nurses have stopped you in the hallway to discuss his change in attitude. “What’s with Dr. X?” they ask. “We are noticing a change in the way he ­handles patients and residents in the program.”

Now, the threat of a lawsuit because of his negative behavior has been brought to your attention.

Vicarious liability
This case scenario is becoming more frequent as time and reimbursement pressures mount.  Learning to deal with it all in a meaningful manner can be a challenge.

What “checks and balances” do you have regarding colleagues’ behavior in your practice? Ethics come into play here, as we all hear about the cases, although not typical, of the clinician who has sex with his patient, sexual abuse accusations, and so forth. But there are significant legal issues even in much less extreme cases. 

When the clinician is not an employee
In part 1, we discussed how and why an employer is responsible for the actions of its employees. In many circumstances, however, hospitals grant privileges to physicians who are not employees. Suppose the gynecologist in “The case of the unusual pen” had not been an employee of the hospital, but had staff privileges. Would the hospital have been liable? 

Typically, a clinician with hospital privileges who is not an employee is an “independent contractor” rather than an “agent” of the hospital. As such, the vicarious liability that is a hallmark of a principal-agent arrangement is absent. However, the hospital still may be responsible for the clinician’s misconduct if that liability arises from the hospital’s own carelessness. For example, suppose the hospital had given privileges to a clinician without adequately reviewing his or her credentials, qualifications, and past conduct. Imagine that this clinician had a history of abusing patients but the hospital had failed to ascertain that fact. 

A hospital that unreasonably fails to find information that would have prevented a clinician from being given privileges or that would have resulted in the limitation or removal of privileges may be liable for the harm done by the clinician, even when that person is an independent contractor. Furthermore, the failure to observe and assess the professional practice of the independent contractor may result in liability to the ­hospital.

Review process for hospital privileges. The National Practitioner Data Bank (NPDB) was developed to help hospitals find information about physicians who have been disciplined or had malpractice problems. A query to the NPDB may not be sufficient to discover all relevant information, however. Indeed, the NPDB itself notes that “the information from the Data Bank should be used in conjunction with, not in replacement of, information from other sources.”¹ Most institutions have standard protocols for performing background checks on anyone applying for privileges; those processes must be followed carefully and reviewed on a regular basis.

The appointment procedure is the beginning, not the end, of the review process. An ongoing assessment of performance is formalized in committees in all hospitals. In addition, there are formal reappointment processes to assure continued competency and compliance with hospital standards and regulations.

And all of this is good—but still not enough.
 

In some cases an apology may be in order when things go wrong with patient care—and sometimes it can help defuse the tensions that arise when a bad outcome happens. For example, in an article titled, “The Last Word: The Power of Apology” a clinician’s thoughts are depicted as follows¹:

The physician came up with a plan, reviewed it one last time right outside the door, took a deep breath and entered the room, “I’m so, so, so, sorry this happened to you.”¹

The hour that followed focused on what had happened and what other physicians had told the family when they weighed in. Bottom line? There was agreement that it was a complex and tragic case. As the doctor exited, the family inquired, “You’ll still be our doctor, won’t you? We love you. You are our friend.”¹ 

The tension left his shoulders as the physician reflected on the importance of honesty and humility and apologizing appropriately.¹

Saying “I’m sorry” can be a rewarding experience.

References

Are you responsible for reporting your colleagues’ behavior?
An important part of a hospital’s or practice’s quality assurance is the day-to-day observations of physicians, nurses, and staff members. Courts have been increasingly insistent that an institution may be liable when its physicians or nurses witness inappropriate medical practice but fail to take action to protect patients. Inappropriate practices include:

• undertaking procedures for which the clinician is not qualified or credentialed
• violating hospital or practice policy or
  procedures
• causing problems for patients or others. 

In “The case of the unusual pen,” the plaintiffs claimed that the institution failed to “discover, stop and report” the physician because its staff was not trained to recognize and report inappropriate conduct. For example, the physician routinely may have performed gynecologic exams without a medial assistant in the room. The hospital described the physician as a “rogue” employee whose actions could not have been discovered, according to the facts we know—but the plaintiffs claimed that the hospital should have known what the physician was doing. Whatever the details of this actual case, the continued, undiscovered misconduct of a physician is, at best, bound to raise questions as to why the hospital or practice did not know about it and take action.

That brings us back to the hypothetical situation that began this article:

CASE: Next steps to confront the issue
In your role as president of the practice, you are asked to comment on a colleague’s questionable behavior.

Do you issue a statement regarding that behavior and let the matter ride, or is more action advisable?

From a legal standpoint, the suggestion that a clinician’s problem behavior is being brought to the attention of the president of the practice is positive. Identifying the problem is only the first step, however. Being asked to comment on the colleague will not be enough. Your responsibility to the practice has now been triggered and you must undertake appropriate procedures. Summarily (and inappropriately) dismissing the colleague may result in all kinds of problems, not to mention a lawsuit. Yet just observing the situation for a few months carries other legal risks. The practice or institution undoubtedly has a standard set of procedures, and you immediately should begin implementing them. These procedures usually involve informal steps—investigating the situation and giving the physician the opportunity to respond. 

When the matter is outside of routine, as this case may be, we believe that it is worthwhile to consult a legal expert. Beyond the duty to patients, there are likely to be contractual obligations and complex business law issues. Ideally, the practice has an ongoing relationship with an attorney who is an expert in health matters. Knowing your practice, the attorney can be invaluable in helping you avoid problems and find a resolution to the problems that arise, and he or she should provide consultation if the matter requires formal processes.

These obligations are supported by sound legal principles. It is always important to remember that the purpose of these obligations is to avoid unnecessary harm, stress, and expense to patients who are putting their trust in your practice.

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.

Last month, we began consideration of the obligations of physicians and health-care organizations to take action concerning colleagues who are out of line. In part 1, we looked at a recently reported case of “The gynecologist who wore an unusual pen.” He admitted taking more than 1,000 videos and images of patients using a tiny camera embedded in a pen or key fob that he wore around his neck. This serious ­misconduct continued for many years without being noticed.

A class-action lawsuit against the medical center and physician resulted in a settlement of $190 million, despite the fact that the physician had not transferred the images to others. Here, we look at the obligation of the medical profession to notice and manage colleagues who are creating a risk to patients or the institution. What are the legal consequences of your relationships with your colleagues, and why is it so important for physicians and health-care centers to be alert to inappropriate conduct and deal promptly with those problems?

CASE: Well-respected clinician turns increasingly grumpy toward colleagues and patients
In your role as president of the practice, you have been asked to comment on a colleague’s behavior. You’ve known him for a long time. Dr. X has been in practice for more than 20 years, and always has been well respected in the community. Over his career he has served as residency program director for a large community hospital. He has been, in essence, a role model for physicians in training.

Over the past 6 months, a number of complaints have been brought to your attention as practice president. The primary concern is Dr. X’s temper, which he seems to be having trouble controlling. Nurses have stopped you in the hallway to discuss his change in attitude. “What’s with Dr. X?” they ask. “We are noticing a change in the way he ­handles patients and residents in the program.”

Now, the threat of a lawsuit because of his negative behavior has been brought to your attention.

Vicarious liability
This case scenario is becoming more frequent as time and reimbursement pressures mount.  Learning to deal with it all in a meaningful manner can be a challenge.

What “checks and balances” do you have regarding colleagues’ behavior in your practice? Ethics come into play here, as we all hear about the cases, although not typical, of the clinician who has sex with his patient, sexual abuse accusations, and so forth. But there are significant legal issues even in much less extreme cases. 

When the clinician is not an employee
In part 1, we discussed how and why an employer is responsible for the actions of its employees. In many circumstances, however, hospitals grant privileges to physicians who are not employees. Suppose the gynecologist in “The case of the unusual pen” had not been an employee of the hospital, but had staff privileges. Would the hospital have been liable? 

Typically, a clinician with hospital privileges who is not an employee is an “independent contractor” rather than an “agent” of the hospital. As such, the vicarious liability that is a hallmark of a principal-agent arrangement is absent. However, the hospital still may be responsible for the clinician’s misconduct if that liability arises from the hospital’s own carelessness. For example, suppose the hospital had given privileges to a clinician without adequately reviewing his or her credentials, qualifications, and past conduct. Imagine that this clinician had a history of abusing patients but the hospital had failed to ascertain that fact. 

A hospital that unreasonably fails to find information that would have prevented a clinician from being given privileges or that would have resulted in the limitation or removal of privileges may be liable for the harm done by the clinician, even when that person is an independent contractor. Furthermore, the failure to observe and assess the professional practice of the independent contractor may result in liability to the ­hospital.

Review process for hospital privileges. The National Practitioner Data Bank (NPDB) was developed to help hospitals find information about physicians who have been disciplined or had malpractice problems. A query to the NPDB may not be sufficient to discover all relevant information, however. Indeed, the NPDB itself notes that “the information from the Data Bank should be used in conjunction with, not in replacement of, information from other sources.”¹ Most institutions have standard protocols for performing background checks on anyone applying for privileges; those processes must be followed carefully and reviewed on a regular basis.

The appointment procedure is the beginning, not the end, of the review process. An ongoing assessment of performance is formalized in committees in all hospitals. In addition, there are formal reappointment processes to assure continued competency and compliance with hospital standards and regulations.

And all of this is good—but still not enough.
 

In some cases an apology may be in order when things go wrong with patient care—and sometimes it can help defuse the tensions that arise when a bad outcome happens. For example, in an article titled, “The Last Word: The Power of Apology” a clinician’s thoughts are depicted as follows¹:

The physician came up with a plan, reviewed it one last time right outside the door, took a deep breath and entered the room, “I’m so, so, so, sorry this happened to you.”¹

The hour that followed focused on what had happened and what other physicians had told the family when they weighed in. Bottom line? There was agreement that it was a complex and tragic case. As the doctor exited, the family inquired, “You’ll still be our doctor, won’t you? We love you. You are our friend.”¹ 

The tension left his shoulders as the physician reflected on the importance of honesty and humility and apologizing appropriately.¹

Saying “I’m sorry” can be a rewarding experience.

References

Are you responsible for reporting your colleagues’ behavior?
An important part of a hospital’s or practice’s quality assurance is the day-to-day observations of physicians, nurses, and staff members. Courts have been increasingly insistent that an institution may be liable when its physicians or nurses witness inappropriate medical practice but fail to take action to protect patients. Inappropriate practices include:

• undertaking procedures for which the clinician is not qualified or credentialed
• violating hospital or practice policy or
  procedures
• causing problems for patients or others. 

In “The case of the unusual pen,” the plaintiffs claimed that the institution failed to “discover, stop and report” the physician because its staff was not trained to recognize and report inappropriate conduct. For example, the physician routinely may have performed gynecologic exams without a medial assistant in the room. The hospital described the physician as a “rogue” employee whose actions could not have been discovered, according to the facts we know—but the plaintiffs claimed that the hospital should have known what the physician was doing. Whatever the details of this actual case, the continued, undiscovered misconduct of a physician is, at best, bound to raise questions as to why the hospital or practice did not know about it and take action.

That brings us back to the hypothetical situation that began this article:

CASE: Next steps to confront the issue
In your role as president of the practice, you are asked to comment on a colleague’s questionable behavior.

Do you issue a statement regarding that behavior and let the matter ride, or is more action advisable?

From a legal standpoint, the suggestion that a clinician’s problem behavior is being brought to the attention of the president of the practice is positive. Identifying the problem is only the first step, however. Being asked to comment on the colleague will not be enough. Your responsibility to the practice has now been triggered and you must undertake appropriate procedures. Summarily (and inappropriately) dismissing the colleague may result in all kinds of problems, not to mention a lawsuit. Yet just observing the situation for a few months carries other legal risks. The practice or institution undoubtedly has a standard set of procedures, and you immediately should begin implementing them. These procedures usually involve informal steps—investigating the situation and giving the physician the opportunity to respond. 

When the matter is outside of routine, as this case may be, we believe that it is worthwhile to consult a legal expert. Beyond the duty to patients, there are likely to be contractual obligations and complex business law issues. Ideally, the practice has an ongoing relationship with an attorney who is an expert in health matters. Knowing your practice, the attorney can be invaluable in helping you avoid problems and find a resolution to the problems that arise, and he or she should provide consultation if the matter requires formal processes.

These obligations are supported by sound legal principles. It is always important to remember that the purpose of these obligations is to avoid unnecessary harm, stress, and expense to patients who are putting their trust in your practice.

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.

Last month, we began consideration of the obligations of physicians and health-care organizations to take action concerning colleagues who are out of line. In part 1, we looked at a recently reported case of “The gynecologist who wore an unusual pen.” He admitted taking more than 1,000 videos and images of patients using a tiny camera embedded in a pen or key fob that he wore around his neck. This serious ­misconduct continued for many years without being noticed.

A class-action lawsuit against the medical center and physician resulted in a settlement of $190 million, despite the fact that the physician had not transferred the images to others. Here, we look at the obligation of the medical profession to notice and manage colleagues who are creating a risk to patients or the institution. What are the legal consequences of your relationships with your colleagues, and why is it so important for physicians and health-care centers to be alert to inappropriate conduct and deal promptly with those problems?

CASE: Well-respected clinician turns increasingly grumpy toward colleagues and patients
In your role as president of the practice, you have been asked to comment on a colleague’s behavior. You’ve known him for a long time. Dr. X has been in practice for more than 20 years, and always has been well respected in the community. Over his career he has served as residency program director for a large community hospital. He has been, in essence, a role model for physicians in training.

Over the past 6 months, a number of complaints have been brought to your attention as practice president. The primary concern is Dr. X’s temper, which he seems to be having trouble controlling. Nurses have stopped you in the hallway to discuss his change in attitude. “What’s with Dr. X?” they ask. “We are noticing a change in the way he ­handles patients and residents in the program.”

Now, the threat of a lawsuit because of his negative behavior has been brought to your attention.

Vicarious liability
This case scenario is becoming more frequent as time and reimbursement pressures mount.  Learning to deal with it all in a meaningful manner can be a challenge.

What “checks and balances” do you have regarding colleagues’ behavior in your practice? Ethics come into play here, as we all hear about the cases, although not typical, of the clinician who has sex with his patient, sexual abuse accusations, and so forth. But there are significant legal issues even in much less extreme cases. 

When the clinician is not an employee
In part 1, we discussed how and why an employer is responsible for the actions of its employees. In many circumstances, however, hospitals grant privileges to physicians who are not employees. Suppose the gynecologist in “The case of the unusual pen” had not been an employee of the hospital, but had staff privileges. Would the hospital have been liable? 

Typically, a clinician with hospital privileges who is not an employee is an “independent contractor” rather than an “agent” of the hospital. As such, the vicarious liability that is a hallmark of a principal-agent arrangement is absent. However, the hospital still may be responsible for the clinician’s misconduct if that liability arises from the hospital’s own carelessness. For example, suppose the hospital had given privileges to a clinician without adequately reviewing his or her credentials, qualifications, and past conduct. Imagine that this clinician had a history of abusing patients but the hospital had failed to ascertain that fact. 

A hospital that unreasonably fails to find information that would have prevented a clinician from being given privileges or that would have resulted in the limitation or removal of privileges may be liable for the harm done by the clinician, even when that person is an independent contractor. Furthermore, the failure to observe and assess the professional practice of the independent contractor may result in liability to the ­hospital.

Review process for hospital privileges. The National Practitioner Data Bank (NPDB) was developed to help hospitals find information about physicians who have been disciplined or had malpractice problems. A query to the NPDB may not be sufficient to discover all relevant information, however. Indeed, the NPDB itself notes that “the information from the Data Bank should be used in conjunction with, not in replacement of, information from other sources.”¹ Most institutions have standard protocols for performing background checks on anyone applying for privileges; those processes must be followed carefully and reviewed on a regular basis.

The appointment procedure is the beginning, not the end, of the review process. An ongoing assessment of performance is formalized in committees in all hospitals. In addition, there are formal reappointment processes to assure continued competency and compliance with hospital standards and regulations.

And all of this is good—but still not enough.
 

In some cases an apology may be in order when things go wrong with patient care—and sometimes it can help defuse the tensions that arise when a bad outcome happens. For example, in an article titled, “The Last Word: The Power of Apology” a clinician’s thoughts are depicted as follows¹:

The physician came up with a plan, reviewed it one last time right outside the door, took a deep breath and entered the room, “I’m so, so, so, sorry this happened to you.”¹

The hour that followed focused on what had happened and what other physicians had told the family when they weighed in. Bottom line? There was agreement that it was a complex and tragic case. As the doctor exited, the family inquired, “You’ll still be our doctor, won’t you? We love you. You are our friend.”¹ 

The tension left his shoulders as the physician reflected on the importance of honesty and humility and apologizing appropriately.¹

Saying “I’m sorry” can be a rewarding experience.

References

Are you responsible for reporting your colleagues’ behavior?
An important part of a hospital’s or practice’s quality assurance is the day-to-day observations of physicians, nurses, and staff members. Courts have been increasingly insistent that an institution may be liable when its physicians or nurses witness inappropriate medical practice but fail to take action to protect patients. Inappropriate practices include:

• undertaking procedures for which the clinician is not qualified or credentialed
• violating hospital or practice policy or
  procedures
• causing problems for patients or others. 

In “The case of the unusual pen,” the plaintiffs claimed that the institution failed to “discover, stop and report” the physician because its staff was not trained to recognize and report inappropriate conduct. For example, the physician routinely may have performed gynecologic exams without a medial assistant in the room. The hospital described the physician as a “rogue” employee whose actions could not have been discovered, according to the facts we know—but the plaintiffs claimed that the hospital should have known what the physician was doing. Whatever the details of this actual case, the continued, undiscovered misconduct of a physician is, at best, bound to raise questions as to why the hospital or practice did not know about it and take action.

That brings us back to the hypothetical situation that began this article:

CASE: Next steps to confront the issue
In your role as president of the practice, you are asked to comment on a colleague’s questionable behavior.

Do you issue a statement regarding that behavior and let the matter ride, or is more action advisable?

From a legal standpoint, the suggestion that a clinician’s problem behavior is being brought to the attention of the president of the practice is positive. Identifying the problem is only the first step, however. Being asked to comment on the colleague will not be enough. Your responsibility to the practice has now been triggered and you must undertake appropriate procedures. Summarily (and inappropriately) dismissing the colleague may result in all kinds of problems, not to mention a lawsuit. Yet just observing the situation for a few months carries other legal risks. The practice or institution undoubtedly has a standard set of procedures, and you immediately should begin implementing them. These procedures usually involve informal steps—investigating the situation and giving the physician the opportunity to respond. 

When the matter is outside of routine, as this case may be, we believe that it is worthwhile to consult a legal expert. Beyond the duty to patients, there are likely to be contractual obligations and complex business law issues. Ideally, the practice has an ongoing relationship with an attorney who is an expert in health matters. Knowing your practice, the attorney can be invaluable in helping you avoid problems and find a resolution to the problems that arise, and he or she should provide consultation if the matter requires formal processes.

These obligations are supported by sound legal principles. It is always important to remember that the purpose of these obligations is to avoid unnecessary harm, stress, and expense to patients who are putting their trust in your practice.

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.

What obligations do physicians and medical facilities have when it comes to dealing with troubled or troublesome clinicians? In this 2-part column, we look at a recently reported case of a gynecologist who engaged in serious misconduct without being noticed. In part 2, we will discuss the obligation of the medical profession to notice and deal with colleagues who are creating a risk to patients or the institution.

CASE: Medical center blamed for negligence when rogue physician records pelvic exams
Dr. A, a gynecologist, had been a physician at a leading academic medical center for many years. His employment was terminated in February 2013 when he admitted taking more than 1,000 videos and images using a tiny camera embedded in a pen or key fob that he wore around his neck. He stored the images on his home computer. It seems that he had been secretly recording pelvic examinations since 2005.

A class-action lawsuit initiated against the academic medical center and the physician suggested invasion of privacy, emotional distress, and negligence in oversight on the part of the academic institution. (This case was settled before trial and most of the records are not publicly available. The facts used here are based on press releases and published articles and, therefore, are incomplete and may be subject to interpretation.)

Breach of trust
Talk about a violation of the doctor-patient relationship! The suit claims, among other things, “harmful and offensive sexual contact with patients.” The hospital identified 12,700 patients that the gynecologist might have seen during his 25-year-span as an employee.

Some victims report posttraumatic stress disorder (PTSD). In addition to feeling betrayed by their physician, the victims feel the action was a breach of faith, of trust. They report being fearful of being examined by another physician, and some have refused to seek medical care. The sense of mistrust of the medical profession has resulted in some victims’ reluctance to allow their children to be seen by pediatricians.¹

CASE: SETTLED
This lawsuit, possibly the largest medical malpractice case of its kind, resulted in a $190 million settlement. The academic medical center will disperse the funds to more than 7,000 possible victims.¹ A special hotline Web site and a toll-free number have been established to facilitate victim reporting. A board-certified psychologist will work with victims.

Similar suits have settled
Other lawsuits involving physicians who have secretly recorded patients also have been settled:

• A Connecticut endocrinologist who took photos of patients nude settled for $50 million in 2012.¹
• A pediatrician pedophile in Delaware was associated with a $123-million settlement with long-term follow-up of victims.²

WHAT ARE THE ETHICAL OBLIGATIONS?
Ethics in medicine can be discussed at great length (see “Issues of ethics in medicine”). An important question related to this case concerns the investigators’ obligations to make their findings public with the scenario that the patient/victims are not aware that a crime occurred.³ This is among the issues that will be considered in part 2 of this article that will be published next month. One concern is that publicly identifying the victims may lead to the development of PTSD and its intrinsic consequences. How can one prosecute the perpetrator and yet prevent psychological consequences of the victims?

What do ACOG and the AMA say about sexual misconduct in medicine?
ACOG. The American College of Obstetricians and Gynecologists (ACOG) is explicit about sexual misconduct. Specifically, the physician-patient relationship can be damaged when there is “confusion regarding professional roles and behavior or clear lack of integrity”¹ that results in sexual exploitation and harm. ACOG further states that¹:

The request by either a patient or a physician to have a chaperone present during a physical examination should be accommodated regardless of the physician’s sex. If a chaperone is present during the physical examination, the physician should provide a separate opportunity for private conversation.

The AMA. The American Medical Association’s Council on Ethical and Judicial Affairs developed a report titled “Sexual Misconduct in the Practice of Medicine.” The Council concluded that²:

References

UNUSUAL ELEMENTS OF THIS CASE
The case of “The gynecologist who wore an unusual pen” is extraordinary in terms of the financial consequences for the medical center. Indeed, the $190 million class-action settlement is probably a record in cases of this kind. The facts (insofar as we know them, and we certainly do not know them all) are sufficiently unusual to seem more like fiction than reality.

An unusual element of the case is that the images were apparently not shared with others, but retained by the gynecologist. Thus, the $190 million settlement was not for disclosing confidential information, but for the unauthorized and inappropriate act of taking the videos and storing them at home. This case was a violation of professional obligations and clearly unethical and likely illegal. It was not associated with the distribution of images that is so often the hallmark of breach of privacy cases.

Another very unusual condition of this case was that there was no way to identify the victims. The faces of the women were not in the videos, so the subjects of the 1,200 videos and 140 images found on the physician’s home computer could have been any of more than 7,000 patients.¹ The distribution of funds, therefore, may encompass all of these former patients, and the size of an individual’s recovery may depend largely on the degree of emotional upset she experiences. The victims will be asked how much time they spent with the physician, whether a nurse was present, whether there was any verbal or sexual abuse, and details about emotional harm they experienced.

VICARIOUS LIABILITY
Why was the medical center responsible?
At first blush it may seem puzzling that the medical center, rather than the gynecologist, was responsible for the damages. In fact, the gynecologist might well have been both criminally and civilly responsible, but sadly, he committed suicide after his wrongdoing was discovered.³

The hospital was civilly responsible. In this instance it appears (again, from our limited facts) that the gynecologist was an employee of the medical center. Employees are generally considered agents of their employers (“principals”). By definition, a principal has the right and obligation to oversee and control the actions of its agents. As such, the principal is generally legally liable for the actions of an employee within the course of employment. Vicarious liability essentially allows someone harmed by an agent to seek compensation from the principal because the principal selected and appointed the agent.

The vicarious responsibility of an agency relationship applies even when the employee is not following the direct instructions of the employer. For example, even if a trucking company tells its employee, “Do not drink at all and do not drive over the speed limit for any reason,” the company can still be liable when an employee becomes drunk or speeds and causes an accident. At some point, however, the employee may so deviate from tasks related to employment that the employee is off on a “lark of his own.” For example, if the driver is supposed to travel from New York City to Buffalo, but instead takes a personal side trip to Baltimore, where the truck hits a pedestrian, that side trip is probably not the responsibility of the employer.

Applying these principles to this case (assuming the physician was an employee of the medical center), the center would generally be legally responsible for the torts (wrongful acts) of the gynecologist. Now you ask, “what about the ‘lark of his own’? Wasn’t taking all those pictures and videos for his own purposes not really part of the job?” (Now you are thinking like a lawyer—that was meant as a compliment.) It is a good question. First, this involved serious misconduct, which was a violation of basic professional ethics. Second, this videotaping was not part of the job the physician was supposed to be doing. Although it may have been for his own benefit, this deviation of good practice was closely related to and entangled with the purpose of his employment. It is perhaps analogous to the truck driver who drank at lunch and then caused the accident. It made sense, therefore, for the medical center to conclude that it would likely be responsible for the actions of this employee, and settle the case.

As a side note, this vicarious liability does not just apply to medical centers. Physicians have agents in their offices (employees: nurses, interns, and even volunteers). Your medical practice is likely responsible for the actions of your staff members via the concept of vicarious liability.

In hospitals, it is common for physicians to have staff privileges without being employees. Would this case have a different result if the physician had staff privileges but was not an employee? Another good question. We are going to look at that in the next installment—and the answer has significant implications for physicians and nurses as well as for medical facilities.

We want to hear from you! Share your thoughts on this article. Send your Letter to the Editor to: rbarbieri@frontlinemedcom.com

What obligations do physicians and medical facilities have when it comes to dealing with troubled or troublesome clinicians? In this 2-part column, we look at a recently reported case of a gynecologist who engaged in serious misconduct without being noticed. In part 2, we will discuss the obligation of the medical profession to notice and deal with colleagues who are creating a risk to patients or the institution.

CASE: Medical center blamed for negligence when rogue physician records pelvic exams
Dr. A, a gynecologist, had been a physician at a leading academic medical center for many years. His employment was terminated in February 2013 when he admitted taking more than 1,000 videos and images using a tiny camera embedded in a pen or key fob that he wore around his neck. He stored the images on his home computer. It seems that he had been secretly recording pelvic examinations since 2005.

A class-action lawsuit initiated against the academic medical center and the physician suggested invasion of privacy, emotional distress, and negligence in oversight on the part of the academic institution. (This case was settled before trial and most of the records are not publicly available. The facts used here are based on press releases and published articles and, therefore, are incomplete and may be subject to interpretation.)

Breach of trust
Talk about a violation of the doctor-patient relationship! The suit claims, among other things, “harmful and offensive sexual contact with patients.” The hospital identified 12,700 patients that the gynecologist might have seen during his 25-year-span as an employee.

Some victims report posttraumatic stress disorder (PTSD). In addition to feeling betrayed by their physician, the victims feel the action was a breach of faith, of trust. They report being fearful of being examined by another physician, and some have refused to seek medical care. The sense of mistrust of the medical profession has resulted in some victims’ reluctance to allow their children to be seen by pediatricians.¹

CASE: SETTLED
This lawsuit, possibly the largest medical malpractice case of its kind, resulted in a $190 million settlement. The academic medical center will disperse the funds to more than 7,000 possible victims.¹ A special hotline Web site and a toll-free number have been established to facilitate victim reporting. A board-certified psychologist will work with victims.

Similar suits have settled
Other lawsuits involving physicians who have secretly recorded patients also have been settled:

• A Connecticut endocrinologist who took photos of patients nude settled for $50 million in 2012.¹
• A pediatrician pedophile in Delaware was associated with a $123-million settlement with long-term follow-up of victims.²

WHAT ARE THE ETHICAL OBLIGATIONS?
Ethics in medicine can be discussed at great length (see “Issues of ethics in medicine”). An important question related to this case concerns the investigators’ obligations to make their findings public with the scenario that the patient/victims are not aware that a crime occurred.³ This is among the issues that will be considered in part 2 of this article that will be published next month. One concern is that publicly identifying the victims may lead to the development of PTSD and its intrinsic consequences. How can one prosecute the perpetrator and yet prevent psychological consequences of the victims?

What do ACOG and the AMA say about sexual misconduct in medicine?
ACOG. The American College of Obstetricians and Gynecologists (ACOG) is explicit about sexual misconduct. Specifically, the physician-patient relationship can be damaged when there is “confusion regarding professional roles and behavior or clear lack of integrity”¹ that results in sexual exploitation and harm. ACOG further states that¹:

The request by either a patient or a physician to have a chaperone present during a physical examination should be accommodated regardless of the physician’s sex. If a chaperone is present during the physical examination, the physician should provide a separate opportunity for private conversation.

The AMA. The American Medical Association’s Council on Ethical and Judicial Affairs developed a report titled “Sexual Misconduct in the Practice of Medicine.” The Council concluded that²:

References

UNUSUAL ELEMENTS OF THIS CASE
The case of “The gynecologist who wore an unusual pen” is extraordinary in terms of the financial consequences for the medical center. Indeed, the $190 million class-action settlement is probably a record in cases of this kind. The facts (insofar as we know them, and we certainly do not know them all) are sufficiently unusual to seem more like fiction than reality.

An unusual element of the case is that the images were apparently not shared with others, but retained by the gynecologist. Thus, the $190 million settlement was not for disclosing confidential information, but for the unauthorized and inappropriate act of taking the videos and storing them at home. This case was a violation of professional obligations and clearly unethical and likely illegal. It was not associated with the distribution of images that is so often the hallmark of breach of privacy cases.

Another very unusual condition of this case was that there was no way to identify the victims. The faces of the women were not in the videos, so the subjects of the 1,200 videos and 140 images found on the physician’s home computer could have been any of more than 7,000 patients.¹ The distribution of funds, therefore, may encompass all of these former patients, and the size of an individual’s recovery may depend largely on the degree of emotional upset she experiences. The victims will be asked how much time they spent with the physician, whether a nurse was present, whether there was any verbal or sexual abuse, and details about emotional harm they experienced.

VICARIOUS LIABILITY
Why was the medical center responsible?
At first blush it may seem puzzling that the medical center, rather than the gynecologist, was responsible for the damages. In fact, the gynecologist might well have been both criminally and civilly responsible, but sadly, he committed suicide after his wrongdoing was discovered.³

The hospital was civilly responsible. In this instance it appears (again, from our limited facts) that the gynecologist was an employee of the medical center. Employees are generally considered agents of their employers (“principals”). By definition, a principal has the right and obligation to oversee and control the actions of its agents. As such, the principal is generally legally liable for the actions of an employee within the course of employment. Vicarious liability essentially allows someone harmed by an agent to seek compensation from the principal because the principal selected and appointed the agent.

The vicarious responsibility of an agency relationship applies even when the employee is not following the direct instructions of the employer. For example, even if a trucking company tells its employee, “Do not drink at all and do not drive over the speed limit for any reason,” the company can still be liable when an employee becomes drunk or speeds and causes an accident. At some point, however, the employee may so deviate from tasks related to employment that the employee is off on a “lark of his own.” For example, if the driver is supposed to travel from New York City to Buffalo, but instead takes a personal side trip to Baltimore, where the truck hits a pedestrian, that side trip is probably not the responsibility of the employer.

Applying these principles to this case (assuming the physician was an employee of the medical center), the center would generally be legally responsible for the torts (wrongful acts) of the gynecologist. Now you ask, “what about the ‘lark of his own’? Wasn’t taking all those pictures and videos for his own purposes not really part of the job?” (Now you are thinking like a lawyer—that was meant as a compliment.) It is a good question. First, this involved serious misconduct, which was a violation of basic professional ethics. Second, this videotaping was not part of the job the physician was supposed to be doing. Although it may have been for his own benefit, this deviation of good practice was closely related to and entangled with the purpose of his employment. It is perhaps analogous to the truck driver who drank at lunch and then caused the accident. It made sense, therefore, for the medical center to conclude that it would likely be responsible for the actions of this employee, and settle the case.

As a side note, this vicarious liability does not just apply to medical centers. Physicians have agents in their offices (employees: nurses, interns, and even volunteers). Your medical practice is likely responsible for the actions of your staff members via the concept of vicarious liability.

In hospitals, it is common for physicians to have staff privileges without being employees. Would this case have a different result if the physician had staff privileges but was not an employee? Another good question. We are going to look at that in the next installment—and the answer has significant implications for physicians and nurses as well as for medical facilities.

We want to hear from you! Share your thoughts on this article. Send your Letter to the Editor to: rbarbieri@frontlinemedcom.com

What obligations do physicians and medical facilities have when it comes to dealing with troubled or troublesome clinicians? In this 2-part column, we look at a recently reported case of a gynecologist who engaged in serious misconduct without being noticed. In part 2, we will discuss the obligation of the medical profession to notice and deal with colleagues who are creating a risk to patients or the institution.

CASE: Medical center blamed for negligence when rogue physician records pelvic exams
Dr. A, a gynecologist, had been a physician at a leading academic medical center for many years. His employment was terminated in February 2013 when he admitted taking more than 1,000 videos and images using a tiny camera embedded in a pen or key fob that he wore around his neck. He stored the images on his home computer. It seems that he had been secretly recording pelvic examinations since 2005.

A class-action lawsuit initiated against the academic medical center and the physician suggested invasion of privacy, emotional distress, and negligence in oversight on the part of the academic institution. (This case was settled before trial and most of the records are not publicly available. The facts used here are based on press releases and published articles and, therefore, are incomplete and may be subject to interpretation.)

Breach of trust
Talk about a violation of the doctor-patient relationship! The suit claims, among other things, “harmful and offensive sexual contact with patients.” The hospital identified 12,700 patients that the gynecologist might have seen during his 25-year-span as an employee.

Some victims report posttraumatic stress disorder (PTSD). In addition to feeling betrayed by their physician, the victims feel the action was a breach of faith, of trust. They report being fearful of being examined by another physician, and some have refused to seek medical care. The sense of mistrust of the medical profession has resulted in some victims’ reluctance to allow their children to be seen by pediatricians.¹

CASE: SETTLED
This lawsuit, possibly the largest medical malpractice case of its kind, resulted in a $190 million settlement. The academic medical center will disperse the funds to more than 7,000 possible victims.¹ A special hotline Web site and a toll-free number have been established to facilitate victim reporting. A board-certified psychologist will work with victims.

Similar suits have settled
Other lawsuits involving physicians who have secretly recorded patients also have been settled:

• A Connecticut endocrinologist who took photos of patients nude settled for $50 million in 2012.¹
• A pediatrician pedophile in Delaware was associated with a $123-million settlement with long-term follow-up of victims.²

WHAT ARE THE ETHICAL OBLIGATIONS?
Ethics in medicine can be discussed at great length (see “Issues of ethics in medicine”). An important question related to this case concerns the investigators’ obligations to make their findings public with the scenario that the patient/victims are not aware that a crime occurred.³ This is among the issues that will be considered in part 2 of this article that will be published next month. One concern is that publicly identifying the victims may lead to the development of PTSD and its intrinsic consequences. How can one prosecute the perpetrator and yet prevent psychological consequences of the victims?

What do ACOG and the AMA say about sexual misconduct in medicine?
ACOG. The American College of Obstetricians and Gynecologists (ACOG) is explicit about sexual misconduct. Specifically, the physician-patient relationship can be damaged when there is “confusion regarding professional roles and behavior or clear lack of integrity”¹ that results in sexual exploitation and harm. ACOG further states that¹:

The request by either a patient or a physician to have a chaperone present during a physical examination should be accommodated regardless of the physician’s sex. If a chaperone is present during the physical examination, the physician should provide a separate opportunity for private conversation.

The AMA. The American Medical Association’s Council on Ethical and Judicial Affairs developed a report titled “Sexual Misconduct in the Practice of Medicine.” The Council concluded that²:

References

UNUSUAL ELEMENTS OF THIS CASE
The case of “The gynecologist who wore an unusual pen” is extraordinary in terms of the financial consequences for the medical center. Indeed, the $190 million class-action settlement is probably a record in cases of this kind. The facts (insofar as we know them, and we certainly do not know them all) are sufficiently unusual to seem more like fiction than reality.

An unusual element of the case is that the images were apparently not shared with others, but retained by the gynecologist. Thus, the $190 million settlement was not for disclosing confidential information, but for the unauthorized and inappropriate act of taking the videos and storing them at home. This case was a violation of professional obligations and clearly unethical and likely illegal. It was not associated with the distribution of images that is so often the hallmark of breach of privacy cases.

Another very unusual condition of this case was that there was no way to identify the victims. The faces of the women were not in the videos, so the subjects of the 1,200 videos and 140 images found on the physician’s home computer could have been any of more than 7,000 patients.¹ The distribution of funds, therefore, may encompass all of these former patients, and the size of an individual’s recovery may depend largely on the degree of emotional upset she experiences. The victims will be asked how much time they spent with the physician, whether a nurse was present, whether there was any verbal or sexual abuse, and details about emotional harm they experienced.

VICARIOUS LIABILITY
Why was the medical center responsible?
At first blush it may seem puzzling that the medical center, rather than the gynecologist, was responsible for the damages. In fact, the gynecologist might well have been both criminally and civilly responsible, but sadly, he committed suicide after his wrongdoing was discovered.³

The hospital was civilly responsible. In this instance it appears (again, from our limited facts) that the gynecologist was an employee of the medical center. Employees are generally considered agents of their employers (“principals”). By definition, a principal has the right and obligation to oversee and control the actions of its agents. As such, the principal is generally legally liable for the actions of an employee within the course of employment. Vicarious liability essentially allows someone harmed by an agent to seek compensation from the principal because the principal selected and appointed the agent.

The vicarious responsibility of an agency relationship applies even when the employee is not following the direct instructions of the employer. For example, even if a trucking company tells its employee, “Do not drink at all and do not drive over the speed limit for any reason,” the company can still be liable when an employee becomes drunk or speeds and causes an accident. At some point, however, the employee may so deviate from tasks related to employment that the employee is off on a “lark of his own.” For example, if the driver is supposed to travel from New York City to Buffalo, but instead takes a personal side trip to Baltimore, where the truck hits a pedestrian, that side trip is probably not the responsibility of the employer.

Applying these principles to this case (assuming the physician was an employee of the medical center), the center would generally be legally responsible for the torts (wrongful acts) of the gynecologist. Now you ask, “what about the ‘lark of his own’? Wasn’t taking all those pictures and videos for his own purposes not really part of the job?” (Now you are thinking like a lawyer—that was meant as a compliment.) It is a good question. First, this involved serious misconduct, which was a violation of basic professional ethics. Second, this videotaping was not part of the job the physician was supposed to be doing. Although it may have been for his own benefit, this deviation of good practice was closely related to and entangled with the purpose of his employment. It is perhaps analogous to the truck driver who drank at lunch and then caused the accident. It made sense, therefore, for the medical center to conclude that it would likely be responsible for the actions of this employee, and settle the case.

As a side note, this vicarious liability does not just apply to medical centers. Physicians have agents in their offices (employees: nurses, interns, and even volunteers). Your medical practice is likely responsible for the actions of your staff members via the concept of vicarious liability.

In hospitals, it is common for physicians to have staff privileges without being employees. Would this case have a different result if the physician had staff privileges but was not an employee? Another good question. We are going to look at that in the next installment—and the answer has significant implications for physicians and nurses as well as for medical facilities.

We want to hear from you! Share your thoughts on this article. Send your Letter to the Editor to: rbarbieri@frontlinemedcom.com

Case: Did the gynecologist have the right to not remove the ovaries?
A 36-year-old woman (G3 P3003) presented to her gynecologist with dysmenorrhea and abnormal uterine bleeding. She reported a family history of ovarian cancer for two generations. She was evaluated and underwent physical examination and preoperative ultrasound examination of pelvic organs. All findings were unremarkable. The gynecologist prescribed oral contraceptives (OCs). After an initial excellent response, the patient reported a reoccurrence of pelvic pain and abnormal bleeding 6 years later. The gynecologist suggested options including operative hysteroscopy, dilatation and curettage (D&C), endometrial ablation, off-label use of an intrauterine contraceptive system, or hysterectomy performed via a minimally invasive, vaginal, or abdominal approach. The patient opted for hysteroscopy, D&C, and endometrial ablation and operative laparoscopy. The patient received a diagnosis of stage I endometriosis, which was treated with fulguration.

Two years later, she reported menorrhagia and pelvic pain. The gynecologist suggested trying an OC again, and the patient was given a prescription for a low-dose estrogen/desogestrel combination pill. The patient then changed her mind within 72 hours, never took the OC, and contacted her gynecologist to schedule surgery with him. Upon a return visit to the office, the patient and gynecologist decided to proceed with laparoscopic-assisted vaginal hysterectomy (LAVH) with bilateral salpingo-oophorectomy (BSO). The written consent included laparoscopic hysterectomy with removal of ovary or ovaries and bilateral fallopian tubes, with a possibility of abdominal hysterectomy.

The gynecologist met with the patient preoperatively to update the history, which was unchanged from her prior office visit. In the ­operating room, “time out” occurred and was documented appropriately—concerns were to be provided to the gynecologist; none were noted.

Intraoperatively, the ovaries were normal in appearance and no endometriosis was noted. The gynecologist proceeded with LAVH and, because the ovaries were normal, did not remove them or the fallopian tubes.

The patient sued the gynecologist on the grounds that, because the originally planned BSO was not performed, she was fearful of developing ovarian cancer in the future.

Preoperative documentation was “sketchy”at best and did not reflect the preoperative discussion and options presented to the patient. There was no documentation of anyone accompanying the patient at the preoperative office visit.

The case went to trial.

What’s the verdict?

CASE: Final verdict was for the patient
The jury awarded damages to the patient based on the absence of adequate consent and failure to perform what was preoperatively agreed to in the consent form.

Legal takeaways from this case
This is an unusual case. Absent something else, it is unusual for there to be liability for not doing a procedure, where the procedure seemed medically unnecessary based on observations during surgery and where language of the signed written consent form created ambiguity about the plan for the removal of the ovaries. Here the patient alleged that her consent was not “informed.” Although informed consent claims are fairly common in malpractice litigation, they are generally appended to an underlying count (or counts) of negligent care; it is uncommon for there to be recovery of damages based solely on the absence of informed consent.

A signed consent form may not be sufficient. In general, a patient’s signature on a consent form alone is not sufficient evidence of informed consent. Whether the patient was truly informed will be judged by the ­circumstances during which the patient’s consent was obtained.

State laws vary on the specifics of informed consent. Many states have specific statutes or regulations dealing with informed consent. The “informed” part of informed consent generally requires that the patient be informed of:

• the nature of the procedure proposed
• the risks and benefits of the procedure
• the alternative forms of treatment
• the consequences of not undertaking the proposed procedure or an alternative.

In this case, the lawsuit alleges damages based on the fear of future ovarian cancer. It is likely that the patient offered credible testimony that she decided to proceed with surgery specifically because of her fear of ovarian cancer. The patient may have offered testimony about her specific request for her ovaries to be removed because of this fear, or she may have offered testimony about her belief or understanding that the ovaries were going to be removed based on her preoperative discussion with the gynecologist.

Related article: Sound strategies to avoid malpractice hazards on labor and delivery. Martin L. Gimovsky, MD, and Alexis C. Gimosky, MD (Professional Liability; January 2011)

Written consent must reflect the actual preoperative discussion
The written consent stated: “hysterectomy with removal of ovary or ovaries,” creating some ambiguity regarding whether the gynecologist had latitude in deciding whether or not to remove the ovaries. However, certain “facts” in this case scenario support the claim that the written consent form was meant to have reflected a decision and agreement between the doctor and patient that the ovaries were to be removed, including:

• the patient had a significant family history of ovarian cancer, making the fear of future ovarian cancer reasonable
• the patient opted out of a conservative treatment plan within 3 days and asked instead to schedule major surgery.

The gynecologist may have testified that the preoperative discussion included only the possibility of removing the ovaries, to be determined based upon what was observed in the course of the surgery. However, in the case description, we are told that the “preoperative documentation was ‘sketchy’ at best.” The jury may have concluded that the gynecologist did not know the wishes of the patient in the event that the ovaries appeared normal during the surgery.

We also know that when the patient returned to the gynecologist’s office after requesting surgery, a “discussion occurred to ‘proceed with LAVH with BSO.’” If this precise language was noted in the patient’s chart, the jury may have concluded that the gynecologist ignored the patient’s wishes!

A claim that the patient was adequately informed prior to treatment can be difficult to address if the informed consent process has not been adequately documented. Often in litigation the decisive question is not whether the right thing was done but whether that can be demonstrated. This case emphasizes the need for good documentation reflecting the specific discussions with the patient.

Clinical takeaways
The importance of a good rapport with patients as well as clear discussion of clinical findings, test results, and options for treatment remains paramount. This includes documentation of discussions, recording of who is present during the discussion (including witnesses), as well as the patient’s response to various treatment offerings.

The informed consent process from the clinician’s perspective should reflect discussion of risks, benefits, alternatives, sequelae of complications, and an appropriate risk of refusal. It is most important to pay attention to detail, and record that detail which will reflect your effort to be thorough. Make sure that the surgical consent form includes the operating physician’s name, the name(s) of the assisting physician(s), and no blank spaces.

Related article: More strategies to avoid malpractice hazards on labor and delivery. Martin L. Gimovsky, MD, and Alexis C. Gimosky, MD (Professional Liability; January 2011)

Open communication plus complete documentation are key
A well-designed history form—without blanks but with documentation of the physical examination and reflection of the impression and plan—can serve to avert litigation. Ideally, the operative report will reflect not only what was done but also the intraoperative decision-making process on the part of the gynecologist. Documentation of the physician’s thoroughness with intraoperative assessment may well avoid acceptance of a case by a patient’s attorney. Most importantly, transparent postoperative discussions with the patient and family detailing what occurred and the intraoperative decision-making process may convince the patient and family that the clinician has nothing to hide and has the patient’s best interest in mind. 

WE WANT TO HEAR FROM YOU! Share your thoughts on this article. Send your Letter to the Editor to: rbarbieri@frontlinemedcom.com
Please include the city and state in which you practice.

Case: Did the gynecologist have the right to not remove the ovaries?
A 36-year-old woman (G3 P3003) presented to her gynecologist with dysmenorrhea and abnormal uterine bleeding. She reported a family history of ovarian cancer for two generations. She was evaluated and underwent physical examination and preoperative ultrasound examination of pelvic organs. All findings were unremarkable. The gynecologist prescribed oral contraceptives (OCs). After an initial excellent response, the patient reported a reoccurrence of pelvic pain and abnormal bleeding 6 years later. The gynecologist suggested options including operative hysteroscopy, dilatation and curettage (D&C), endometrial ablation, off-label use of an intrauterine contraceptive system, or hysterectomy performed via a minimally invasive, vaginal, or abdominal approach. The patient opted for hysteroscopy, D&C, and endometrial ablation and operative laparoscopy. The patient received a diagnosis of stage I endometriosis, which was treated with fulguration.

Two years later, she reported menorrhagia and pelvic pain. The gynecologist suggested trying an OC again, and the patient was given a prescription for a low-dose estrogen/desogestrel combination pill. The patient then changed her mind within 72 hours, never took the OC, and contacted her gynecologist to schedule surgery with him. Upon a return visit to the office, the patient and gynecologist decided to proceed with laparoscopic-assisted vaginal hysterectomy (LAVH) with bilateral salpingo-oophorectomy (BSO). The written consent included laparoscopic hysterectomy with removal of ovary or ovaries and bilateral fallopian tubes, with a possibility of abdominal hysterectomy.

The gynecologist met with the patient preoperatively to update the history, which was unchanged from her prior office visit. In the ­operating room, “time out” occurred and was documented appropriately—concerns were to be provided to the gynecologist; none were noted.

Intraoperatively, the ovaries were normal in appearance and no endometriosis was noted. The gynecologist proceeded with LAVH and, because the ovaries were normal, did not remove them or the fallopian tubes.

The patient sued the gynecologist on the grounds that, because the originally planned BSO was not performed, she was fearful of developing ovarian cancer in the future.

Preoperative documentation was “sketchy”at best and did not reflect the preoperative discussion and options presented to the patient. There was no documentation of anyone accompanying the patient at the preoperative office visit.

The case went to trial.

What’s the verdict?

CASE: Final verdict was for the patient
The jury awarded damages to the patient based on the absence of adequate consent and failure to perform what was preoperatively agreed to in the consent form.

Legal takeaways from this case
This is an unusual case. Absent something else, it is unusual for there to be liability for not doing a procedure, where the procedure seemed medically unnecessary based on observations during surgery and where language of the signed written consent form created ambiguity about the plan for the removal of the ovaries. Here the patient alleged that her consent was not “informed.” Although informed consent claims are fairly common in malpractice litigation, they are generally appended to an underlying count (or counts) of negligent care; it is uncommon for there to be recovery of damages based solely on the absence of informed consent.

A signed consent form may not be sufficient. In general, a patient’s signature on a consent form alone is not sufficient evidence of informed consent. Whether the patient was truly informed will be judged by the ­circumstances during which the patient’s consent was obtained.

State laws vary on the specifics of informed consent. Many states have specific statutes or regulations dealing with informed consent. The “informed” part of informed consent generally requires that the patient be informed of:

• the nature of the procedure proposed
• the risks and benefits of the procedure
• the alternative forms of treatment
• the consequences of not undertaking the proposed procedure or an alternative.

In this case, the lawsuit alleges damages based on the fear of future ovarian cancer. It is likely that the patient offered credible testimony that she decided to proceed with surgery specifically because of her fear of ovarian cancer. The patient may have offered testimony about her specific request for her ovaries to be removed because of this fear, or she may have offered testimony about her belief or understanding that the ovaries were going to be removed based on her preoperative discussion with the gynecologist.

Related article: Sound strategies to avoid malpractice hazards on labor and delivery. Martin L. Gimovsky, MD, and Alexis C. Gimosky, MD (Professional Liability; January 2011)

Written consent must reflect the actual preoperative discussion
The written consent stated: “hysterectomy with removal of ovary or ovaries,” creating some ambiguity regarding whether the gynecologist had latitude in deciding whether or not to remove the ovaries. However, certain “facts” in this case scenario support the claim that the written consent form was meant to have reflected a decision and agreement between the doctor and patient that the ovaries were to be removed, including:

• the patient had a significant family history of ovarian cancer, making the fear of future ovarian cancer reasonable
• the patient opted out of a conservative treatment plan within 3 days and asked instead to schedule major surgery.

The gynecologist may have testified that the preoperative discussion included only the possibility of removing the ovaries, to be determined based upon what was observed in the course of the surgery. However, in the case description, we are told that the “preoperative documentation was ‘sketchy’ at best.” The jury may have concluded that the gynecologist did not know the wishes of the patient in the event that the ovaries appeared normal during the surgery.

We also know that when the patient returned to the gynecologist’s office after requesting surgery, a “discussion occurred to ‘proceed with LAVH with BSO.’” If this precise language was noted in the patient’s chart, the jury may have concluded that the gynecologist ignored the patient’s wishes!

A claim that the patient was adequately informed prior to treatment can be difficult to address if the informed consent process has not been adequately documented. Often in litigation the decisive question is not whether the right thing was done but whether that can be demonstrated. This case emphasizes the need for good documentation reflecting the specific discussions with the patient.

Clinical takeaways
The importance of a good rapport with patients as well as clear discussion of clinical findings, test results, and options for treatment remains paramount. This includes documentation of discussions, recording of who is present during the discussion (including witnesses), as well as the patient’s response to various treatment offerings.

The informed consent process from the clinician’s perspective should reflect discussion of risks, benefits, alternatives, sequelae of complications, and an appropriate risk of refusal. It is most important to pay attention to detail, and record that detail which will reflect your effort to be thorough. Make sure that the surgical consent form includes the operating physician’s name, the name(s) of the assisting physician(s), and no blank spaces.

Related article: More strategies to avoid malpractice hazards on labor and delivery. Martin L. Gimovsky, MD, and Alexis C. Gimosky, MD (Professional Liability; January 2011)

Open communication plus complete documentation are key
A well-designed history form—without blanks but with documentation of the physical examination and reflection of the impression and plan—can serve to avert litigation. Ideally, the operative report will reflect not only what was done but also the intraoperative decision-making process on the part of the gynecologist. Documentation of the physician’s thoroughness with intraoperative assessment may well avoid acceptance of a case by a patient’s attorney. Most importantly, transparent postoperative discussions with the patient and family detailing what occurred and the intraoperative decision-making process may convince the patient and family that the clinician has nothing to hide and has the patient’s best interest in mind. 

WE WANT TO HEAR FROM YOU! Share your thoughts on this article. Send your Letter to the Editor to: rbarbieri@frontlinemedcom.com
Please include the city and state in which you practice.

Case: Did the gynecologist have the right to not remove the ovaries?
A 36-year-old woman (G3 P3003) presented to her gynecologist with dysmenorrhea and abnormal uterine bleeding. She reported a family history of ovarian cancer for two generations. She was evaluated and underwent physical examination and preoperative ultrasound examination of pelvic organs. All findings were unremarkable. The gynecologist prescribed oral contraceptives (OCs). After an initial excellent response, the patient reported a reoccurrence of pelvic pain and abnormal bleeding 6 years later. The gynecologist suggested options including operative hysteroscopy, dilatation and curettage (D&C), endometrial ablation, off-label use of an intrauterine contraceptive system, or hysterectomy performed via a minimally invasive, vaginal, or abdominal approach. The patient opted for hysteroscopy, D&C, and endometrial ablation and operative laparoscopy. The patient received a diagnosis of stage I endometriosis, which was treated with fulguration.

Two years later, she reported menorrhagia and pelvic pain. The gynecologist suggested trying an OC again, and the patient was given a prescription for a low-dose estrogen/desogestrel combination pill. The patient then changed her mind within 72 hours, never took the OC, and contacted her gynecologist to schedule surgery with him. Upon a return visit to the office, the patient and gynecologist decided to proceed with laparoscopic-assisted vaginal hysterectomy (LAVH) with bilateral salpingo-oophorectomy (BSO). The written consent included laparoscopic hysterectomy with removal of ovary or ovaries and bilateral fallopian tubes, with a possibility of abdominal hysterectomy.

The gynecologist met with the patient preoperatively to update the history, which was unchanged from her prior office visit. In the ­operating room, “time out” occurred and was documented appropriately—concerns were to be provided to the gynecologist; none were noted.

Intraoperatively, the ovaries were normal in appearance and no endometriosis was noted. The gynecologist proceeded with LAVH and, because the ovaries were normal, did not remove them or the fallopian tubes.

The patient sued the gynecologist on the grounds that, because the originally planned BSO was not performed, she was fearful of developing ovarian cancer in the future.

Preoperative documentation was “sketchy”at best and did not reflect the preoperative discussion and options presented to the patient. There was no documentation of anyone accompanying the patient at the preoperative office visit.

The case went to trial.

What’s the verdict?

CASE: Final verdict was for the patient
The jury awarded damages to the patient based on the absence of adequate consent and failure to perform what was preoperatively agreed to in the consent form.

Legal takeaways from this case
This is an unusual case. Absent something else, it is unusual for there to be liability for not doing a procedure, where the procedure seemed medically unnecessary based on observations during surgery and where language of the signed written consent form created ambiguity about the plan for the removal of the ovaries. Here the patient alleged that her consent was not “informed.” Although informed consent claims are fairly common in malpractice litigation, they are generally appended to an underlying count (or counts) of negligent care; it is uncommon for there to be recovery of damages based solely on the absence of informed consent.

A signed consent form may not be sufficient. In general, a patient’s signature on a consent form alone is not sufficient evidence of informed consent. Whether the patient was truly informed will be judged by the ­circumstances during which the patient’s consent was obtained.

State laws vary on the specifics of informed consent. Many states have specific statutes or regulations dealing with informed consent. The “informed” part of informed consent generally requires that the patient be informed of:

• the nature of the procedure proposed
• the risks and benefits of the procedure
• the alternative forms of treatment
• the consequences of not undertaking the proposed procedure or an alternative.

In this case, the lawsuit alleges damages based on the fear of future ovarian cancer. It is likely that the patient offered credible testimony that she decided to proceed with surgery specifically because of her fear of ovarian cancer. The patient may have offered testimony about her specific request for her ovaries to be removed because of this fear, or she may have offered testimony about her belief or understanding that the ovaries were going to be removed based on her preoperative discussion with the gynecologist.

Related article: Sound strategies to avoid malpractice hazards on labor and delivery. Martin L. Gimovsky, MD, and Alexis C. Gimosky, MD (Professional Liability; January 2011)

Written consent must reflect the actual preoperative discussion
The written consent stated: “hysterectomy with removal of ovary or ovaries,” creating some ambiguity regarding whether the gynecologist had latitude in deciding whether or not to remove the ovaries. However, certain “facts” in this case scenario support the claim that the written consent form was meant to have reflected a decision and agreement between the doctor and patient that the ovaries were to be removed, including:

• the patient had a significant family history of ovarian cancer, making the fear of future ovarian cancer reasonable
• the patient opted out of a conservative treatment plan within 3 days and asked instead to schedule major surgery.

The gynecologist may have testified that the preoperative discussion included only the possibility of removing the ovaries, to be determined based upon what was observed in the course of the surgery. However, in the case description, we are told that the “preoperative documentation was ‘sketchy’ at best.” The jury may have concluded that the gynecologist did not know the wishes of the patient in the event that the ovaries appeared normal during the surgery.

We also know that when the patient returned to the gynecologist’s office after requesting surgery, a “discussion occurred to ‘proceed with LAVH with BSO.’” If this precise language was noted in the patient’s chart, the jury may have concluded that the gynecologist ignored the patient’s wishes!

A claim that the patient was adequately informed prior to treatment can be difficult to address if the informed consent process has not been adequately documented. Often in litigation the decisive question is not whether the right thing was done but whether that can be demonstrated. This case emphasizes the need for good documentation reflecting the specific discussions with the patient.

Clinical takeaways
The importance of a good rapport with patients as well as clear discussion of clinical findings, test results, and options for treatment remains paramount. This includes documentation of discussions, recording of who is present during the discussion (including witnesses), as well as the patient’s response to various treatment offerings.

The informed consent process from the clinician’s perspective should reflect discussion of risks, benefits, alternatives, sequelae of complications, and an appropriate risk of refusal. It is most important to pay attention to detail, and record that detail which will reflect your effort to be thorough. Make sure that the surgical consent form includes the operating physician’s name, the name(s) of the assisting physician(s), and no blank spaces.

Related article: More strategies to avoid malpractice hazards on labor and delivery. Martin L. Gimovsky, MD, and Alexis C. Gimosky, MD (Professional Liability; January 2011)

Open communication plus complete documentation are key
A well-designed history form—without blanks but with documentation of the physical examination and reflection of the impression and plan—can serve to avert litigation. Ideally, the operative report will reflect not only what was done but also the intraoperative decision-making process on the part of the gynecologist. Documentation of the physician’s thoroughness with intraoperative assessment may well avoid acceptance of a case by a patient’s attorney. Most importantly, transparent postoperative discussions with the patient and family detailing what occurred and the intraoperative decision-making process may convince the patient and family that the clinician has nothing to hide and has the patient’s best interest in mind. 

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