S.Y. Tan, MD, JD

(This column is the second in a three-part series.)

Question: A penicillin-allergic patient died from massive hemolysis after receiving the antibiotic ceftriaxone (Rocephin). The plaintiff alleged that the defendant was grossly negligent in administering the drug and subsequently refusing to treat or to readmit the decedent.

If this case is referred to the state’s medical board, which of the following statements is best?

A. The outcome depends on the jurisdiction.

B. Substandard medical care is not part of professional misconduct, which is what a medical board is supposed to look at.

C. Disciplinary action requires a simple showing of ordinary negligence.

D. Disciplinary action requires more than one act of ordinary negligence.

E. Disciplinary action requires proof of gross negligence.

Answer: A. Under the Medical Practice Act, each state authorizes its medical board to issue licenses and regulate physician practice. Professional misconduct is about unprofessional behavior, and covers both ethical breach and substandard care.

Medical boards do not typically adjudicate single acts of ordinary negligence, leaving them instead to the tort system and civil lawsuits. However, grossly culpable misconduct – even in a single instance – or a recurring pattern of ordinary negligence can come under medical board review. And it is common practice for boards to use malpractice data as a tool to trigger further investigations, such as a certain number of malpractice settlements over a given span of time.

States vary somewhat over when to investigate a complaint of alleged substandard practice. In California, the term “unprofessional conduct” is codified under section 2234 of the California Business and Professions Code, and the errant doctor is subject to disciplinary sanction if there is gross negligence, repeated negligent acts (defined as two or more negligent acts or omissions), or incompetence.

In Hawaii, the disciplinary law is set up under Hawaii Revised Statutes section 453-8, which lists 15 situations of wrongdoing. In the malpractice category, Hawaii’s law uses the terms hazardous misconduct, hazardous negligence, incompetence, or multiple instances of negligence.

The state of New York defines professional misconduct by reference to a comprehensive list of 49 categories under section 6530, which include gross incompetence or gross negligence on a single occasion, or negligence or incompetence on more than one occasion.

However, Maryland is an example of a jurisdiction that does not require gross or repeated negligence; the state considers any failure to meet the appropriate medical standards as professional misconduct.¹

But what constitutes gross negligence?

The vast majority of medical malpractice lawsuits allege ordinary, not gross negligence. Ordinary negligence is a well-defined legal term, as illustrated in Prosser’s Textbook on Torts: “The formula under which this usually is put to the jury is that the doctor must have and use the knowledge, skill, and care ordinarily possessed and employed by members of the profession in good standing.”²

In contrast, there is no universal definition for the term gross negligence. Everyone recognizes it denotes a greater degree of culpability than ordinary negligence, but how much greater?

According to the California Supreme Court, gross negligence may be said to be “the want of even scant care or an extreme departure from the ordinary standard of conduct.”³ The law in Texas stipulates: “Gross negligence means more than momentary thoughtlessness, inadvertence, or error of judgment. It means an entire want of care as to establish that the act or omission was the result of actual, conscious indifference to the rights, safety, and welfare of the person affected.”⁴

Examples in case law of gross negligence (or where punitive damages were awarded, which usually signify egregious conduct) include a doctor’s wanton failure to provide follow-up care for a child who developed fever and gangrenous toes following foot surgery,⁵ the prescription of an excessive number of birth control pills (more than 1,000 pills within a time period when less than 200 were sufficient) with resulting liver complications,⁶ and leaving behind a 6.5-inch clamp in a surgical incision.⁷

On the other hand, a Connecticut court (which decided the case in the hypothetical above) ruled that, under the facts, the defendant’s conduct did not meet the high threshold of egregiousness that defines gross negligence.⁸

As in any malpractice lawsuit, a medical board investigation involves determining whether the accused physician has met the standard of care in his or her specialty, and boards usually look to expert community physicians to articulate that requisite standard.

Compared with a civil lawsuit, a disciplinary hearing has the physician at a disadvantage. Medical board complaints are easier to file; the complaining party does not need an attorney; impartial expert witnesses are the responsibility of the board, not the complainant; and no patient injury needs to be shown.

Furthermore, a settlement is rarely reached or negotiated, and penalties are potentially far more serious, such as public posting of an adverse decision and restriction or actual loss of licensure.

Reputational loss also is arguably more devastating with board censure, because an adverse action taken by a medical board indicates a violation of the Medical Practice Act. In contrast, malpractice settlements or verdicts are regularly viewed as unreliable measures of a physician’s competence.

Still, two features work in favor of the doctor facing a board hearing. First, the misconduct typically has to be recurrent or grossly negligent, rather than an isolated case of carelessness. And second, some boards (only a small minority) require evidentiary proof of fault to be “clear and convincing,” instead of the familiar “more probable than not” standard that is used in a civil negligence suit. This makes it theoretically harder to reach a finding of culpability against the doctor.

References

1. Md. Code Ann. Health Occ. section 14-404.

2. Prosser and Keeton on Torts, 5th ed., 1984.

3. Van Meter v. Bent Construction Co., 297 P.2d 644 (Cal. 1956).

4. Texas Civil Practice & Remedies Code section 41.001(7).

5. Dempsey v. Phelps, 700 So.2d 1340 (Ala. 1997).

6. Jackson v. Taylor, 912 F.2d 795 (5th Cir. 1990).

7. Fox v. Oklahoma Memorial Hospital, 774 P.2d 459 (Ok. 1989).

8. Boone v. William W. Backus Hospital, 864 A.2d 1 (Conn. 2005).

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at siang@hawaii.edu.

(This column is the second in a three-part series.)

Question: A penicillin-allergic patient died from massive hemolysis after receiving the antibiotic ceftriaxone (Rocephin). The plaintiff alleged that the defendant was grossly negligent in administering the drug and subsequently refusing to treat or to readmit the decedent.

If this case is referred to the state’s medical board, which of the following statements is best?

A. The outcome depends on the jurisdiction.

B. Substandard medical care is not part of professional misconduct, which is what a medical board is supposed to look at.

C. Disciplinary action requires a simple showing of ordinary negligence.

D. Disciplinary action requires more than one act of ordinary negligence.

E. Disciplinary action requires proof of gross negligence.

Answer: A. Under the Medical Practice Act, each state authorizes its medical board to issue licenses and regulate physician practice. Professional misconduct is about unprofessional behavior, and covers both ethical breach and substandard care.

Medical boards do not typically adjudicate single acts of ordinary negligence, leaving them instead to the tort system and civil lawsuits. However, grossly culpable misconduct – even in a single instance – or a recurring pattern of ordinary negligence can come under medical board review. And it is common practice for boards to use malpractice data as a tool to trigger further investigations, such as a certain number of malpractice settlements over a given span of time.

States vary somewhat over when to investigate a complaint of alleged substandard practice. In California, the term “unprofessional conduct” is codified under section 2234 of the California Business and Professions Code, and the errant doctor is subject to disciplinary sanction if there is gross negligence, repeated negligent acts (defined as two or more negligent acts or omissions), or incompetence.

In Hawaii, the disciplinary law is set up under Hawaii Revised Statutes section 453-8, which lists 15 situations of wrongdoing. In the malpractice category, Hawaii’s law uses the terms hazardous misconduct, hazardous negligence, incompetence, or multiple instances of negligence.

The state of New York defines professional misconduct by reference to a comprehensive list of 49 categories under section 6530, which include gross incompetence or gross negligence on a single occasion, or negligence or incompetence on more than one occasion.

However, Maryland is an example of a jurisdiction that does not require gross or repeated negligence; the state considers any failure to meet the appropriate medical standards as professional misconduct.¹

But what constitutes gross negligence?

The vast majority of medical malpractice lawsuits allege ordinary, not gross negligence. Ordinary negligence is a well-defined legal term, as illustrated in Prosser’s Textbook on Torts: “The formula under which this usually is put to the jury is that the doctor must have and use the knowledge, skill, and care ordinarily possessed and employed by members of the profession in good standing.”²

In contrast, there is no universal definition for the term gross negligence. Everyone recognizes it denotes a greater degree of culpability than ordinary negligence, but how much greater?

According to the California Supreme Court, gross negligence may be said to be “the want of even scant care or an extreme departure from the ordinary standard of conduct.”³ The law in Texas stipulates: “Gross negligence means more than momentary thoughtlessness, inadvertence, or error of judgment. It means an entire want of care as to establish that the act or omission was the result of actual, conscious indifference to the rights, safety, and welfare of the person affected.”⁴

Examples in case law of gross negligence (or where punitive damages were awarded, which usually signify egregious conduct) include a doctor’s wanton failure to provide follow-up care for a child who developed fever and gangrenous toes following foot surgery,⁵ the prescription of an excessive number of birth control pills (more than 1,000 pills within a time period when less than 200 were sufficient) with resulting liver complications,⁶ and leaving behind a 6.5-inch clamp in a surgical incision.⁷

On the other hand, a Connecticut court (which decided the case in the hypothetical above) ruled that, under the facts, the defendant’s conduct did not meet the high threshold of egregiousness that defines gross negligence.⁸

As in any malpractice lawsuit, a medical board investigation involves determining whether the accused physician has met the standard of care in his or her specialty, and boards usually look to expert community physicians to articulate that requisite standard.

Compared with a civil lawsuit, a disciplinary hearing has the physician at a disadvantage. Medical board complaints are easier to file; the complaining party does not need an attorney; impartial expert witnesses are the responsibility of the board, not the complainant; and no patient injury needs to be shown.

Furthermore, a settlement is rarely reached or negotiated, and penalties are potentially far more serious, such as public posting of an adverse decision and restriction or actual loss of licensure.

Reputational loss also is arguably more devastating with board censure, because an adverse action taken by a medical board indicates a violation of the Medical Practice Act. In contrast, malpractice settlements or verdicts are regularly viewed as unreliable measures of a physician’s competence.

Still, two features work in favor of the doctor facing a board hearing. First, the misconduct typically has to be recurrent or grossly negligent, rather than an isolated case of carelessness. And second, some boards (only a small minority) require evidentiary proof of fault to be “clear and convincing,” instead of the familiar “more probable than not” standard that is used in a civil negligence suit. This makes it theoretically harder to reach a finding of culpability against the doctor.

References

1. Md. Code Ann. Health Occ. section 14-404.

2. Prosser and Keeton on Torts, 5th ed., 1984.

3. Van Meter v. Bent Construction Co., 297 P.2d 644 (Cal. 1956).

4. Texas Civil Practice & Remedies Code section 41.001(7).

5. Dempsey v. Phelps, 700 So.2d 1340 (Ala. 1997).

6. Jackson v. Taylor, 912 F.2d 795 (5th Cir. 1990).

7. Fox v. Oklahoma Memorial Hospital, 774 P.2d 459 (Ok. 1989).

8. Boone v. William W. Backus Hospital, 864 A.2d 1 (Conn. 2005).

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at siang@hawaii.edu.

(This column is the second in a three-part series.)

Question: A penicillin-allergic patient died from massive hemolysis after receiving the antibiotic ceftriaxone (Rocephin). The plaintiff alleged that the defendant was grossly negligent in administering the drug and subsequently refusing to treat or to readmit the decedent.

If this case is referred to the state’s medical board, which of the following statements is best?

A. The outcome depends on the jurisdiction.

B. Substandard medical care is not part of professional misconduct, which is what a medical board is supposed to look at.

C. Disciplinary action requires a simple showing of ordinary negligence.

D. Disciplinary action requires more than one act of ordinary negligence.

E. Disciplinary action requires proof of gross negligence.

Answer: A. Under the Medical Practice Act, each state authorizes its medical board to issue licenses and regulate physician practice. Professional misconduct is about unprofessional behavior, and covers both ethical breach and substandard care.

Medical boards do not typically adjudicate single acts of ordinary negligence, leaving them instead to the tort system and civil lawsuits. However, grossly culpable misconduct – even in a single instance – or a recurring pattern of ordinary negligence can come under medical board review. And it is common practice for boards to use malpractice data as a tool to trigger further investigations, such as a certain number of malpractice settlements over a given span of time.

States vary somewhat over when to investigate a complaint of alleged substandard practice. In California, the term “unprofessional conduct” is codified under section 2234 of the California Business and Professions Code, and the errant doctor is subject to disciplinary sanction if there is gross negligence, repeated negligent acts (defined as two or more negligent acts or omissions), or incompetence.

In Hawaii, the disciplinary law is set up under Hawaii Revised Statutes section 453-8, which lists 15 situations of wrongdoing. In the malpractice category, Hawaii’s law uses the terms hazardous misconduct, hazardous negligence, incompetence, or multiple instances of negligence.

The state of New York defines professional misconduct by reference to a comprehensive list of 49 categories under section 6530, which include gross incompetence or gross negligence on a single occasion, or negligence or incompetence on more than one occasion.

However, Maryland is an example of a jurisdiction that does not require gross or repeated negligence; the state considers any failure to meet the appropriate medical standards as professional misconduct.¹

But what constitutes gross negligence?

The vast majority of medical malpractice lawsuits allege ordinary, not gross negligence. Ordinary negligence is a well-defined legal term, as illustrated in Prosser’s Textbook on Torts: “The formula under which this usually is put to the jury is that the doctor must have and use the knowledge, skill, and care ordinarily possessed and employed by members of the profession in good standing.”²

In contrast, there is no universal definition for the term gross negligence. Everyone recognizes it denotes a greater degree of culpability than ordinary negligence, but how much greater?

According to the California Supreme Court, gross negligence may be said to be “the want of even scant care or an extreme departure from the ordinary standard of conduct.”³ The law in Texas stipulates: “Gross negligence means more than momentary thoughtlessness, inadvertence, or error of judgment. It means an entire want of care as to establish that the act or omission was the result of actual, conscious indifference to the rights, safety, and welfare of the person affected.”⁴

Examples in case law of gross negligence (or where punitive damages were awarded, which usually signify egregious conduct) include a doctor’s wanton failure to provide follow-up care for a child who developed fever and gangrenous toes following foot surgery,⁵ the prescription of an excessive number of birth control pills (more than 1,000 pills within a time period when less than 200 were sufficient) with resulting liver complications,⁶ and leaving behind a 6.5-inch clamp in a surgical incision.⁷

On the other hand, a Connecticut court (which decided the case in the hypothetical above) ruled that, under the facts, the defendant’s conduct did not meet the high threshold of egregiousness that defines gross negligence.⁸

As in any malpractice lawsuit, a medical board investigation involves determining whether the accused physician has met the standard of care in his or her specialty, and boards usually look to expert community physicians to articulate that requisite standard.

Compared with a civil lawsuit, a disciplinary hearing has the physician at a disadvantage. Medical board complaints are easier to file; the complaining party does not need an attorney; impartial expert witnesses are the responsibility of the board, not the complainant; and no patient injury needs to be shown.

Furthermore, a settlement is rarely reached or negotiated, and penalties are potentially far more serious, such as public posting of an adverse decision and restriction or actual loss of licensure.

Reputational loss also is arguably more devastating with board censure, because an adverse action taken by a medical board indicates a violation of the Medical Practice Act. In contrast, malpractice settlements or verdicts are regularly viewed as unreliable measures of a physician’s competence.

Still, two features work in favor of the doctor facing a board hearing. First, the misconduct typically has to be recurrent or grossly negligent, rather than an isolated case of carelessness. And second, some boards (only a small minority) require evidentiary proof of fault to be “clear and convincing,” instead of the familiar “more probable than not” standard that is used in a civil negligence suit. This makes it theoretically harder to reach a finding of culpability against the doctor.

References

1. Md. Code Ann. Health Occ. section 14-404.

2. Prosser and Keeton on Torts, 5th ed., 1984.

3. Van Meter v. Bent Construction Co., 297 P.2d 644 (Cal. 1956).

4. Texas Civil Practice & Remedies Code section 41.001(7).

5. Dempsey v. Phelps, 700 So.2d 1340 (Ala. 1997).

6. Jackson v. Taylor, 912 F.2d 795 (5th Cir. 1990).

7. Fox v. Oklahoma Memorial Hospital, 774 P.2d 459 (Ok. 1989).

8. Boone v. William W. Backus Hospital, 864 A.2d 1 (Conn. 2005).

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at siang@hawaii.edu.

(This column is the first in a three-part series.)

Question: Which of the following statements about state medical boards is best?

A. They are made up exclusively of doctors.

B. Disciplinary actions are on the rise.

C. They investigate narrowly defined areas of clinical practice.

D. They usually end with physician suspension.

E. They are insufficiently vigilant, according to critics.

Answer: E. The 10th Amendment of the U.S. Constitution authorizes states to establish laws protecting the health, safety, and general welfare of their citizens.

All 50 states have enacted legislation under the Medical Practice Act authorizing medical boards to issue licenses and regulate physician conduct. The structure and authority of these boards vary from state to state, with some retaining all licensing and disciplinary powers, while others are more advisory in nature and report to the department of health.

Medical boards consist primarily of appointed volunteer physicians and may employ an administrative staff that includes an executive officer and support personnel.¹

State statutes, rules, and regulations govern the disciplinary function of medical boards, which receive, review, and investigate complaints directly from patients and other sources.

There are six main categories of complaints: substandard patient care, alcohol and substance abuse, fraud and other criminal conduct, dishonesty, sexual misconduct, and failure to meet CME requirements. Whether a board can sanction a physician for misconduct outside the realm of medical practice is frequently at issue.

In Maryland, for example, conduct that has merely a general or associative relationship to the physician in his or her capacity as a member of the medical profession is not sanctionable by the state board of physicians.

On the other hand, if it relates to the effective delivery of patient care, then the misconduct can be said to occur in the “practice of medicine,” even if there is no issue of the individual’s grasp of particular technical skills.

However, the term “practice of medicine” is liberally construed in most jurisdictions, and both boards and courts tend to take a dim view of physician dishonesty and lack of integrity.

For example, the California Court of Appeals in Windham v. Board of Medical Quality Assurance rejected a defendant’s position that his conviction for tax evasion was not the type of transgression that reflected on his professional standing.² Instead, the court held that such dishonesty necessarily involves moral turpitude, and is sufficiently related to the practice of medicine as to justify revocation of licensure.

The court stated that it was difficult to “compartmentalize dishonesty in such a way that a person who is willing to cheat his government out of $65,000 in taxes may yet be considered honest in his dealings with his patients.”

Likewise, the Washington Supreme Court in an older case upheld the suspension of a doctor’s license following his conviction for tax fraud.³ In taking a broad view of the requirement that improper conduct relates to the practice of medicine, the court held that conviction for tax fraud, which goes to the issue of trustworthiness, is a valid reason for taking disciplinary action against a physician.

The number of adverse actions taken by boards nationwide appears to be stabilizing. In 2009, they affected some 4,560 errant physicians. In some states, both the number of complaints and actions may even be subsiding.

For example, the 2014 report by the Texas Medical Board showed that the number of complaints had fallen 17% after reaching a peak in 2009. In 2012, the year with the latest published nationwide data, there were 9,219 total board actions affecting 4,479 physicians. However, only a minority – some 275 doctors – faced the most severe disciplinary sanction, i.e., license revocation. The others either saw their licenses denied (170) or suspended (739), or faced lesser sanctions such as reprimands, probations, restrictions, and fines.

Critics have labeled medical boards “a good old boys network” where any private admonition is never made public. A stinging report of medical licensing and discipline in the state of New York, using data from 1982 through 1989, concluded, “the structure and functioning of the process as they now exist are seriously deficient in these areas and that major reforms are urgently needed.”⁴

The consumer group Public Citizen has bemoaned the fact that most states are not living up to their obligations to protect patients from doctors who are practicing medicine in a substandard manner. Advocacy groups worry about insufficient vigilance, and cite the case of Dr. Farid Fata, an oncologist whose license was finally removed by the Michigan board in 2013 for giving chemotherapy to healthy patients. The board had received an earlier complaint from a nurse in 2010, but it took no action until federal authorities charged the doctor following a tip from a whistleblower.⁵

To be sure, there are troubling observations. For one thing, there is an inexplicably wide variability in the rates of disciplinary actions. During 2007-2009, for example, Minnesota had the lowest rate per 1,000 physicians (1.07), whereas Alaska had the highest rate of 7.89, some seven times higher. State rankings also change drastically from year to year without apparent good reason.

For another, criminal convictions for insurance fraud and violation of controlled substances prescriptions frequently end up with only mild or modest discipline.

In 1999, Public Citizen began publishing yearly rankings that purportedly showed each board’s effectiveness, based on its number of “serious actions.” The rankings were based on yearly data released by the Federation of State Medical Boards (FSMB), a national nonprofit organization that represents the 70 medical and osteopathic boards of the United States and its territories.

The federation protested the way its data were being used, but the rankings apparently caused some board executives to lose their jobs. In 2012, the FSMB stopped reporting state actions, thus ending this type of public disclosure.

To be seen as unbiased guardians of the public trust, boards now have nonphysician members, some of whom are health care attorneys. The state governor who appoints the board members is answerable to the voters for any delay or decision that permits a rogue physician to keep on practicing.

Accordingly, Michigan has instituted a process that allows it to overrule a disciplinary decision by the board, which raises an issue of due process rights. Theoretically, physicians would clear themselves in a formal hearing and be officially exonerated by the board, only to see the decision overruled by an administrative department.

Some medical boards have been accused of going too far. In Rhode Island, state legislator Rep. Michael W. Chippendale (R) is heading a commission to look into its medical board. The controversy arose from an “outlandish” and “personal” accusation against a physician in a gastroenterology group, which was forced to stop work for a week.

All the facts have not been made public, but a civil suit against the complainant is apparently in the works. The accused physician reportedly had to undergo three board-ordered psychiatric evaluations, and a fourth is pending.

Elsewhere, Oklahoma state lawmaker Rep. Richard Morrissette (D) is said to be introducing legislation limiting the powers of Oklahoma’s medical board.⁶

These are probably isolated events, however, and may not necessarily signal the development of any backlash across the country.

References

1. U.S. Medical Regulatory Trends and Actions, May 2014.

2. Windham v. Board of Medical Quality Assurance, 104 Cal. App.3d 461 (1980).

3. In Re Kindschi, 52 Wn.2d 8 (1958).

4. Post, J. “Medical Discipline and Licensing in the State of New York: A Critical Review.” Bull NY Acad Med. 1991;67:66-98.

5. “One nurse’s gutsy effort to protect patients.” Detroit News, Feb. 6, 2015.

6. “The Black Cloud of a Medical Board Investigation.” Medscape, Dec. 23, 2015.

Dr. Tan is emeritus professor of medicine and a former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at siang@hawaii.edu.

(This column is the first in a three-part series.)

Question: Which of the following statements about state medical boards is best?

A. They are made up exclusively of doctors.

B. Disciplinary actions are on the rise.

C. They investigate narrowly defined areas of clinical practice.

D. They usually end with physician suspension.

E. They are insufficiently vigilant, according to critics.

Answer: E. The 10th Amendment of the U.S. Constitution authorizes states to establish laws protecting the health, safety, and general welfare of their citizens.

All 50 states have enacted legislation under the Medical Practice Act authorizing medical boards to issue licenses and regulate physician conduct. The structure and authority of these boards vary from state to state, with some retaining all licensing and disciplinary powers, while others are more advisory in nature and report to the department of health.

Medical boards consist primarily of appointed volunteer physicians and may employ an administrative staff that includes an executive officer and support personnel.¹

State statutes, rules, and regulations govern the disciplinary function of medical boards, which receive, review, and investigate complaints directly from patients and other sources.

There are six main categories of complaints: substandard patient care, alcohol and substance abuse, fraud and other criminal conduct, dishonesty, sexual misconduct, and failure to meet CME requirements. Whether a board can sanction a physician for misconduct outside the realm of medical practice is frequently at issue.

In Maryland, for example, conduct that has merely a general or associative relationship to the physician in his or her capacity as a member of the medical profession is not sanctionable by the state board of physicians.

On the other hand, if it relates to the effective delivery of patient care, then the misconduct can be said to occur in the “practice of medicine,” even if there is no issue of the individual’s grasp of particular technical skills.

However, the term “practice of medicine” is liberally construed in most jurisdictions, and both boards and courts tend to take a dim view of physician dishonesty and lack of integrity.

For example, the California Court of Appeals in Windham v. Board of Medical Quality Assurance rejected a defendant’s position that his conviction for tax evasion was not the type of transgression that reflected on his professional standing.² Instead, the court held that such dishonesty necessarily involves moral turpitude, and is sufficiently related to the practice of medicine as to justify revocation of licensure.

The court stated that it was difficult to “compartmentalize dishonesty in such a way that a person who is willing to cheat his government out of $65,000 in taxes may yet be considered honest in his dealings with his patients.”

Likewise, the Washington Supreme Court in an older case upheld the suspension of a doctor’s license following his conviction for tax fraud.³ In taking a broad view of the requirement that improper conduct relates to the practice of medicine, the court held that conviction for tax fraud, which goes to the issue of trustworthiness, is a valid reason for taking disciplinary action against a physician.

The number of adverse actions taken by boards nationwide appears to be stabilizing. In 2009, they affected some 4,560 errant physicians. In some states, both the number of complaints and actions may even be subsiding.

For example, the 2014 report by the Texas Medical Board showed that the number of complaints had fallen 17% after reaching a peak in 2009. In 2012, the year with the latest published nationwide data, there were 9,219 total board actions affecting 4,479 physicians. However, only a minority – some 275 doctors – faced the most severe disciplinary sanction, i.e., license revocation. The others either saw their licenses denied (170) or suspended (739), or faced lesser sanctions such as reprimands, probations, restrictions, and fines.

Critics have labeled medical boards “a good old boys network” where any private admonition is never made public. A stinging report of medical licensing and discipline in the state of New York, using data from 1982 through 1989, concluded, “the structure and functioning of the process as they now exist are seriously deficient in these areas and that major reforms are urgently needed.”⁴

The consumer group Public Citizen has bemoaned the fact that most states are not living up to their obligations to protect patients from doctors who are practicing medicine in a substandard manner. Advocacy groups worry about insufficient vigilance, and cite the case of Dr. Farid Fata, an oncologist whose license was finally removed by the Michigan board in 2013 for giving chemotherapy to healthy patients. The board had received an earlier complaint from a nurse in 2010, but it took no action until federal authorities charged the doctor following a tip from a whistleblower.⁵

To be sure, there are troubling observations. For one thing, there is an inexplicably wide variability in the rates of disciplinary actions. During 2007-2009, for example, Minnesota had the lowest rate per 1,000 physicians (1.07), whereas Alaska had the highest rate of 7.89, some seven times higher. State rankings also change drastically from year to year without apparent good reason.

For another, criminal convictions for insurance fraud and violation of controlled substances prescriptions frequently end up with only mild or modest discipline.

In 1999, Public Citizen began publishing yearly rankings that purportedly showed each board’s effectiveness, based on its number of “serious actions.” The rankings were based on yearly data released by the Federation of State Medical Boards (FSMB), a national nonprofit organization that represents the 70 medical and osteopathic boards of the United States and its territories.

The federation protested the way its data were being used, but the rankings apparently caused some board executives to lose their jobs. In 2012, the FSMB stopped reporting state actions, thus ending this type of public disclosure.

To be seen as unbiased guardians of the public trust, boards now have nonphysician members, some of whom are health care attorneys. The state governor who appoints the board members is answerable to the voters for any delay or decision that permits a rogue physician to keep on practicing.

Accordingly, Michigan has instituted a process that allows it to overrule a disciplinary decision by the board, which raises an issue of due process rights. Theoretically, physicians would clear themselves in a formal hearing and be officially exonerated by the board, only to see the decision overruled by an administrative department.

Some medical boards have been accused of going too far. In Rhode Island, state legislator Rep. Michael W. Chippendale (R) is heading a commission to look into its medical board. The controversy arose from an “outlandish” and “personal” accusation against a physician in a gastroenterology group, which was forced to stop work for a week.

All the facts have not been made public, but a civil suit against the complainant is apparently in the works. The accused physician reportedly had to undergo three board-ordered psychiatric evaluations, and a fourth is pending.

Elsewhere, Oklahoma state lawmaker Rep. Richard Morrissette (D) is said to be introducing legislation limiting the powers of Oklahoma’s medical board.⁶

These are probably isolated events, however, and may not necessarily signal the development of any backlash across the country.

References

1. U.S. Medical Regulatory Trends and Actions, May 2014.

2. Windham v. Board of Medical Quality Assurance, 104 Cal. App.3d 461 (1980).

3. In Re Kindschi, 52 Wn.2d 8 (1958).

4. Post, J. “Medical Discipline and Licensing in the State of New York: A Critical Review.” Bull NY Acad Med. 1991;67:66-98.

5. “One nurse’s gutsy effort to protect patients.” Detroit News, Feb. 6, 2015.

6. “The Black Cloud of a Medical Board Investigation.” Medscape, Dec. 23, 2015.

Dr. Tan is emeritus professor of medicine and a former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at siang@hawaii.edu.

(This column is the first in a three-part series.)

Question: Which of the following statements about state medical boards is best?

A. They are made up exclusively of doctors.

B. Disciplinary actions are on the rise.

C. They investigate narrowly defined areas of clinical practice.

D. They usually end with physician suspension.

E. They are insufficiently vigilant, according to critics.

Answer: E. The 10th Amendment of the U.S. Constitution authorizes states to establish laws protecting the health, safety, and general welfare of their citizens.

All 50 states have enacted legislation under the Medical Practice Act authorizing medical boards to issue licenses and regulate physician conduct. The structure and authority of these boards vary from state to state, with some retaining all licensing and disciplinary powers, while others are more advisory in nature and report to the department of health.

Medical boards consist primarily of appointed volunteer physicians and may employ an administrative staff that includes an executive officer and support personnel.¹

State statutes, rules, and regulations govern the disciplinary function of medical boards, which receive, review, and investigate complaints directly from patients and other sources.

There are six main categories of complaints: substandard patient care, alcohol and substance abuse, fraud and other criminal conduct, dishonesty, sexual misconduct, and failure to meet CME requirements. Whether a board can sanction a physician for misconduct outside the realm of medical practice is frequently at issue.

In Maryland, for example, conduct that has merely a general or associative relationship to the physician in his or her capacity as a member of the medical profession is not sanctionable by the state board of physicians.

On the other hand, if it relates to the effective delivery of patient care, then the misconduct can be said to occur in the “practice of medicine,” even if there is no issue of the individual’s grasp of particular technical skills.

However, the term “practice of medicine” is liberally construed in most jurisdictions, and both boards and courts tend to take a dim view of physician dishonesty and lack of integrity.

For example, the California Court of Appeals in Windham v. Board of Medical Quality Assurance rejected a defendant’s position that his conviction for tax evasion was not the type of transgression that reflected on his professional standing.² Instead, the court held that such dishonesty necessarily involves moral turpitude, and is sufficiently related to the practice of medicine as to justify revocation of licensure.

The court stated that it was difficult to “compartmentalize dishonesty in such a way that a person who is willing to cheat his government out of $65,000 in taxes may yet be considered honest in his dealings with his patients.”

Likewise, the Washington Supreme Court in an older case upheld the suspension of a doctor’s license following his conviction for tax fraud.³ In taking a broad view of the requirement that improper conduct relates to the practice of medicine, the court held that conviction for tax fraud, which goes to the issue of trustworthiness, is a valid reason for taking disciplinary action against a physician.

The number of adverse actions taken by boards nationwide appears to be stabilizing. In 2009, they affected some 4,560 errant physicians. In some states, both the number of complaints and actions may even be subsiding.

For example, the 2014 report by the Texas Medical Board showed that the number of complaints had fallen 17% after reaching a peak in 2009. In 2012, the year with the latest published nationwide data, there were 9,219 total board actions affecting 4,479 physicians. However, only a minority – some 275 doctors – faced the most severe disciplinary sanction, i.e., license revocation. The others either saw their licenses denied (170) or suspended (739), or faced lesser sanctions such as reprimands, probations, restrictions, and fines.

Critics have labeled medical boards “a good old boys network” where any private admonition is never made public. A stinging report of medical licensing and discipline in the state of New York, using data from 1982 through 1989, concluded, “the structure and functioning of the process as they now exist are seriously deficient in these areas and that major reforms are urgently needed.”⁴

The consumer group Public Citizen has bemoaned the fact that most states are not living up to their obligations to protect patients from doctors who are practicing medicine in a substandard manner. Advocacy groups worry about insufficient vigilance, and cite the case of Dr. Farid Fata, an oncologist whose license was finally removed by the Michigan board in 2013 for giving chemotherapy to healthy patients. The board had received an earlier complaint from a nurse in 2010, but it took no action until federal authorities charged the doctor following a tip from a whistleblower.⁵

To be sure, there are troubling observations. For one thing, there is an inexplicably wide variability in the rates of disciplinary actions. During 2007-2009, for example, Minnesota had the lowest rate per 1,000 physicians (1.07), whereas Alaska had the highest rate of 7.89, some seven times higher. State rankings also change drastically from year to year without apparent good reason.

For another, criminal convictions for insurance fraud and violation of controlled substances prescriptions frequently end up with only mild or modest discipline.

In 1999, Public Citizen began publishing yearly rankings that purportedly showed each board’s effectiveness, based on its number of “serious actions.” The rankings were based on yearly data released by the Federation of State Medical Boards (FSMB), a national nonprofit organization that represents the 70 medical and osteopathic boards of the United States and its territories.

The federation protested the way its data were being used, but the rankings apparently caused some board executives to lose their jobs. In 2012, the FSMB stopped reporting state actions, thus ending this type of public disclosure.

To be seen as unbiased guardians of the public trust, boards now have nonphysician members, some of whom are health care attorneys. The state governor who appoints the board members is answerable to the voters for any delay or decision that permits a rogue physician to keep on practicing.

Accordingly, Michigan has instituted a process that allows it to overrule a disciplinary decision by the board, which raises an issue of due process rights. Theoretically, physicians would clear themselves in a formal hearing and be officially exonerated by the board, only to see the decision overruled by an administrative department.

Some medical boards have been accused of going too far. In Rhode Island, state legislator Rep. Michael W. Chippendale (R) is heading a commission to look into its medical board. The controversy arose from an “outlandish” and “personal” accusation against a physician in a gastroenterology group, which was forced to stop work for a week.

All the facts have not been made public, but a civil suit against the complainant is apparently in the works. The accused physician reportedly had to undergo three board-ordered psychiatric evaluations, and a fourth is pending.

Elsewhere, Oklahoma state lawmaker Rep. Richard Morrissette (D) is said to be introducing legislation limiting the powers of Oklahoma’s medical board.⁶

These are probably isolated events, however, and may not necessarily signal the development of any backlash across the country.

References

1. U.S. Medical Regulatory Trends and Actions, May 2014.

2. Windham v. Board of Medical Quality Assurance, 104 Cal. App.3d 461 (1980).

3. In Re Kindschi, 52 Wn.2d 8 (1958).

4. Post, J. “Medical Discipline and Licensing in the State of New York: A Critical Review.” Bull NY Acad Med. 1991;67:66-98.

5. “One nurse’s gutsy effort to protect patients.” Detroit News, Feb. 6, 2015.

6. “The Black Cloud of a Medical Board Investigation.” Medscape, Dec. 23, 2015.

Dr. Tan is emeritus professor of medicine and a former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at siang@hawaii.edu.

Question: In July 2002, a patient in California underwent surgery for a herniated T8-9 disk, but the surgeon instead removed the T6-7 and T7-8 disks. On Sept. 11, 2002, the surgeon discussed with the patient the MRI findings showing his mistake. On Sept. 17, 2003, the patient filed a malpractice lawsuit, just 6 days beyond California’s 1-year limitations period. California subscribes to the discovery rule, that is, a cause of action accrues only when a claimant discovers or should have discovered injury was the result of negligence.

Which of the following choices is best?

A. The lawsuit filed Sept. 17, 2003, is time barred, as the negligent surgery took place in July 2002.

B. On its face, the lawsuit was filed too late, being 1 year and 6 days after the Sept. 11, 2002, discussion date.

C. The lawsuit was timely filed, so long as the claimant can prove he was out of town for more than 6 days of that year.

D. The patient should sue as an action in battery, which has a longer statute of limitations.

E. All choices except A are correct.

Answer: E. At common law, there was no time limit that barred a plaintiff from bringing a claim, although an equitable doctrine of laches existed to foreclose an action that had long lapsed. Statutory changes in the law now require that lawsuits be brought in a timely manner so that the evidence remains fresh, accurate, and reliable.

Another reason is to provide repose to the wrongdoer, that is, relief from worrying for an indefinite period of time whether a lawsuit will be brought. This time period, during which a lawsuit must be filed or it will be barred, is termed the statute of limitations. It is 2 years for the tort of negligence in most jurisdictions, with states such as California and Tennessee placing a 1-year limit on medical malpractice claims. In California, the running of the statute is tolled (temporarily halted) for the days a claimant is out of state.

The above case scenario is taken from Kaplan v. Mamelak,¹ where the plaintiff’s lawsuit was not barred to allow him to identify the number of days he was out of town. The court also permitted a cause of action in battery, which is covered under a longer statute of limitations, as well as one sounding in malpractice.

Patients who are injured from malpractice may not always be aware that a negligent act had taken place, and some injuries may remain latent for a long period. Recognizing this, statutes of limitation emphasize the date when the plaintiff first discovered that the injury resulted from negligence. This is termed the discovery rule.

Stated more formally, the limitations period commences at the time the cause of action (negligence or other wrongs) accrues, and this usually means when the claimant knew (actual knowledge) or should have known (constructive knowledge).

The rule, in the words of one court, is meant to balance the need for “prompt assertion of claims” against a policy “favoring adjudication of claims on the merits and ensuring that a party with a valid claim will be given an opportunity to present it.”

As is typical of other jurisdictions, Hawaii sought to clarify the discovery rule in a series of court cases, beginning with Yoshizaki v. Hilo Hospital,² where the court deemed a cause of action “does not begin to run until the plaintiff knew or should have known of the defendant’s negligence.”

Subsequently, Hawaii’s Intermediate Court of Appeals explained that the state’s 2-year limitations statute commences when the plaintiff discovers, or through the use of reasonable diligence should have discovered, 1) the damage; 2) the violation of the duty; and 3) the causal connection between the violation of the duty and the damage.³

The court subsequently held that the rule prevents the running of the limitations period until “the plaintiff [has] knowledge of those facts which are necessary for an actionable claim.”⁴ In 1999, the Hawaii Supreme Court clarified that it was “factual knowledge,” rather than “legal knowledge,” that starts the clock running, and that legal knowledge of a defendant’s negligence was not required.⁵

More recently, litigation over the time barring of claims was evident in Moon v. Rhode,⁶ where Dr. Clarissa Rhode and Central Illinois Radiological Associates were sued for negligently misreading a patient’s CT scans.

The 90-year-old patient, Kathryn Moon, was admitted to Proctor Hospital May 18, 2009, and died 11 days later following surgery and complications of fluid overload and a pneumoperitoneum. Dr. Rhode, a radiologist, interpreted two CT scans, which an independent expert in 2013 determined were negligently misread. A lawsuit was then brought against Dr. Rhode, who was not a named defendant when the plaintiff had timely filed a medical negligence action back in 2011 against the surgeon and the attending doctor.

The court of appeals held that the discovery rule can be applied to wrongful death and survival actions, and that the statute of limitations begins to run when the plaintiff knows or should have known that the death was “wrongfully caused.” However, this did not necessarily mean knowledge of a specific defendant’s negligent conduct or knowledge of the existence of a cause of action.

The court stated: “Plaintiff filed his complaint long after he became possessed with sufficient information, which put him on inquiry to determine whether actionable conduct was involved.” The court ruled that the relevant inquiry was not when the plaintiff became aware that Dr. Rhode may have committed medical negligence, but when any defendant may have committed medical negligence against the patient Kathryn. The case is currently on appeal to the Supreme Court of Illinois.

In addition to the discovery rule, other situations may toll the limitations period. One example is fraudulent concealment of a right of action, where the statute may be tolled during the period of concealment. And in all jurisdictions, the running of the time period is halted in malpractice complaints involving treatment of a minor until that minor reaches a certain age, such as age of majority, or after a stipulated number of years, for example, 6 years.

Occasionally, a health care provider may overlook an important tolling provision. California, for example, has a rule that any “payment” made to an injured party must be accompanied by a written statement regarding the applicable statute of limitations.

In the recent Coastal Surgical Institute v. Blevins case,⁷ the defendant surgeon made a payment of $4,118.23 for medical expenses incurred by an unrepresented plaintiff, but had neglected to attach a release or a written notice regarding the statute of limitations. The plaintiff subsequently decided to file a lawsuit, even though more than a year – the statutory period – had lapsed.

Under the facts, the limitation period was tolled, and the trial court allowed the case to go forward, ultimately finding liability and awarding damages of $500,000, later reduced to $285,114. The court of appeals affirmed the decision.

This case has prompted MIEC, a malpractice insurance carrier, to emphasize putting in writing the restrictions imposed by the limitations statute to any unrepresented patient. MIEC also warned that the term “payment” might be construed liberally, citing case examples that include a free counseling session and the provision of specialized care for a student injured by a school’s gym equipment.

References

1. Kaplan v. Mamelak, 162 Cal. App. 4th 637 (2008).

2. Yoshizaki v. Hilo Hospital, 433 P.2d 220 (1967).

3. Jacoby v. Kaiser Foundation Hospital, 622 P.2d 613 (1981).

4. Yamaguchi v. Queen’s Medical Center, 648 P.2d 689 (1982).

5. Buck v. Miles, 971 P.2d 717 (1999).

6. Moon v. Rhode, IL. 2015 App. 3d 130613.

7. Coastal Surgical Institute v. Blevins, 232 Cal. App. 4th 1321 (2015).

Dr. Tan is emeritus professor of medicine and a former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. It is adapted from the author’s book, “Medical Malpractice: Understanding the Law, Managing the Risk” (2006). For additional information, readers may contact the author at siang@hawaii.edu.

Question: In July 2002, a patient in California underwent surgery for a herniated T8-9 disk, but the surgeon instead removed the T6-7 and T7-8 disks. On Sept. 11, 2002, the surgeon discussed with the patient the MRI findings showing his mistake. On Sept. 17, 2003, the patient filed a malpractice lawsuit, just 6 days beyond California’s 1-year limitations period. California subscribes to the discovery rule, that is, a cause of action accrues only when a claimant discovers or should have discovered injury was the result of negligence.

Which of the following choices is best?

A. The lawsuit filed Sept. 17, 2003, is time barred, as the negligent surgery took place in July 2002.

B. On its face, the lawsuit was filed too late, being 1 year and 6 days after the Sept. 11, 2002, discussion date.

C. The lawsuit was timely filed, so long as the claimant can prove he was out of town for more than 6 days of that year.

D. The patient should sue as an action in battery, which has a longer statute of limitations.

E. All choices except A are correct.

Answer: E. At common law, there was no time limit that barred a plaintiff from bringing a claim, although an equitable doctrine of laches existed to foreclose an action that had long lapsed. Statutory changes in the law now require that lawsuits be brought in a timely manner so that the evidence remains fresh, accurate, and reliable.

Another reason is to provide repose to the wrongdoer, that is, relief from worrying for an indefinite period of time whether a lawsuit will be brought. This time period, during which a lawsuit must be filed or it will be barred, is termed the statute of limitations. It is 2 years for the tort of negligence in most jurisdictions, with states such as California and Tennessee placing a 1-year limit on medical malpractice claims. In California, the running of the statute is tolled (temporarily halted) for the days a claimant is out of state.

The above case scenario is taken from Kaplan v. Mamelak,¹ where the plaintiff’s lawsuit was not barred to allow him to identify the number of days he was out of town. The court also permitted a cause of action in battery, which is covered under a longer statute of limitations, as well as one sounding in malpractice.

Patients who are injured from malpractice may not always be aware that a negligent act had taken place, and some injuries may remain latent for a long period. Recognizing this, statutes of limitation emphasize the date when the plaintiff first discovered that the injury resulted from negligence. This is termed the discovery rule.

Stated more formally, the limitations period commences at the time the cause of action (negligence or other wrongs) accrues, and this usually means when the claimant knew (actual knowledge) or should have known (constructive knowledge).

The rule, in the words of one court, is meant to balance the need for “prompt assertion of claims” against a policy “favoring adjudication of claims on the merits and ensuring that a party with a valid claim will be given an opportunity to present it.”

As is typical of other jurisdictions, Hawaii sought to clarify the discovery rule in a series of court cases, beginning with Yoshizaki v. Hilo Hospital,² where the court deemed a cause of action “does not begin to run until the plaintiff knew or should have known of the defendant’s negligence.”

Subsequently, Hawaii’s Intermediate Court of Appeals explained that the state’s 2-year limitations statute commences when the plaintiff discovers, or through the use of reasonable diligence should have discovered, 1) the damage; 2) the violation of the duty; and 3) the causal connection between the violation of the duty and the damage.³

The court subsequently held that the rule prevents the running of the limitations period until “the plaintiff [has] knowledge of those facts which are necessary for an actionable claim.”⁴ In 1999, the Hawaii Supreme Court clarified that it was “factual knowledge,” rather than “legal knowledge,” that starts the clock running, and that legal knowledge of a defendant’s negligence was not required.⁵

More recently, litigation over the time barring of claims was evident in Moon v. Rhode,⁶ where Dr. Clarissa Rhode and Central Illinois Radiological Associates were sued for negligently misreading a patient’s CT scans.

The 90-year-old patient, Kathryn Moon, was admitted to Proctor Hospital May 18, 2009, and died 11 days later following surgery and complications of fluid overload and a pneumoperitoneum. Dr. Rhode, a radiologist, interpreted two CT scans, which an independent expert in 2013 determined were negligently misread. A lawsuit was then brought against Dr. Rhode, who was not a named defendant when the plaintiff had timely filed a medical negligence action back in 2011 against the surgeon and the attending doctor.

The court of appeals held that the discovery rule can be applied to wrongful death and survival actions, and that the statute of limitations begins to run when the plaintiff knows or should have known that the death was “wrongfully caused.” However, this did not necessarily mean knowledge of a specific defendant’s negligent conduct or knowledge of the existence of a cause of action.

The court stated: “Plaintiff filed his complaint long after he became possessed with sufficient information, which put him on inquiry to determine whether actionable conduct was involved.” The court ruled that the relevant inquiry was not when the plaintiff became aware that Dr. Rhode may have committed medical negligence, but when any defendant may have committed medical negligence against the patient Kathryn. The case is currently on appeal to the Supreme Court of Illinois.

In addition to the discovery rule, other situations may toll the limitations period. One example is fraudulent concealment of a right of action, where the statute may be tolled during the period of concealment. And in all jurisdictions, the running of the time period is halted in malpractice complaints involving treatment of a minor until that minor reaches a certain age, such as age of majority, or after a stipulated number of years, for example, 6 years.

Occasionally, a health care provider may overlook an important tolling provision. California, for example, has a rule that any “payment” made to an injured party must be accompanied by a written statement regarding the applicable statute of limitations.

In the recent Coastal Surgical Institute v. Blevins case,⁷ the defendant surgeon made a payment of $4,118.23 for medical expenses incurred by an unrepresented plaintiff, but had neglected to attach a release or a written notice regarding the statute of limitations. The plaintiff subsequently decided to file a lawsuit, even though more than a year – the statutory period – had lapsed.

Under the facts, the limitation period was tolled, and the trial court allowed the case to go forward, ultimately finding liability and awarding damages of $500,000, later reduced to $285,114. The court of appeals affirmed the decision.

This case has prompted MIEC, a malpractice insurance carrier, to emphasize putting in writing the restrictions imposed by the limitations statute to any unrepresented patient. MIEC also warned that the term “payment” might be construed liberally, citing case examples that include a free counseling session and the provision of specialized care for a student injured by a school’s gym equipment.

References

1. Kaplan v. Mamelak, 162 Cal. App. 4th 637 (2008).

2. Yoshizaki v. Hilo Hospital, 433 P.2d 220 (1967).

3. Jacoby v. Kaiser Foundation Hospital, 622 P.2d 613 (1981).

4. Yamaguchi v. Queen’s Medical Center, 648 P.2d 689 (1982).

5. Buck v. Miles, 971 P.2d 717 (1999).

6. Moon v. Rhode, IL. 2015 App. 3d 130613.

7. Coastal Surgical Institute v. Blevins, 232 Cal. App. 4th 1321 (2015).

Dr. Tan is emeritus professor of medicine and a former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. It is adapted from the author’s book, “Medical Malpractice: Understanding the Law, Managing the Risk” (2006). For additional information, readers may contact the author at siang@hawaii.edu.

Question: In July 2002, a patient in California underwent surgery for a herniated T8-9 disk, but the surgeon instead removed the T6-7 and T7-8 disks. On Sept. 11, 2002, the surgeon discussed with the patient the MRI findings showing his mistake. On Sept. 17, 2003, the patient filed a malpractice lawsuit, just 6 days beyond California’s 1-year limitations period. California subscribes to the discovery rule, that is, a cause of action accrues only when a claimant discovers or should have discovered injury was the result of negligence.

Which of the following choices is best?

A. The lawsuit filed Sept. 17, 2003, is time barred, as the negligent surgery took place in July 2002.

B. On its face, the lawsuit was filed too late, being 1 year and 6 days after the Sept. 11, 2002, discussion date.

C. The lawsuit was timely filed, so long as the claimant can prove he was out of town for more than 6 days of that year.

D. The patient should sue as an action in battery, which has a longer statute of limitations.

E. All choices except A are correct.

Answer: E. At common law, there was no time limit that barred a plaintiff from bringing a claim, although an equitable doctrine of laches existed to foreclose an action that had long lapsed. Statutory changes in the law now require that lawsuits be brought in a timely manner so that the evidence remains fresh, accurate, and reliable.

Another reason is to provide repose to the wrongdoer, that is, relief from worrying for an indefinite period of time whether a lawsuit will be brought. This time period, during which a lawsuit must be filed or it will be barred, is termed the statute of limitations. It is 2 years for the tort of negligence in most jurisdictions, with states such as California and Tennessee placing a 1-year limit on medical malpractice claims. In California, the running of the statute is tolled (temporarily halted) for the days a claimant is out of state.

The above case scenario is taken from Kaplan v. Mamelak,¹ where the plaintiff’s lawsuit was not barred to allow him to identify the number of days he was out of town. The court also permitted a cause of action in battery, which is covered under a longer statute of limitations, as well as one sounding in malpractice.

Patients who are injured from malpractice may not always be aware that a negligent act had taken place, and some injuries may remain latent for a long period. Recognizing this, statutes of limitation emphasize the date when the plaintiff first discovered that the injury resulted from negligence. This is termed the discovery rule.

Stated more formally, the limitations period commences at the time the cause of action (negligence or other wrongs) accrues, and this usually means when the claimant knew (actual knowledge) or should have known (constructive knowledge).

The rule, in the words of one court, is meant to balance the need for “prompt assertion of claims” against a policy “favoring adjudication of claims on the merits and ensuring that a party with a valid claim will be given an opportunity to present it.”

As is typical of other jurisdictions, Hawaii sought to clarify the discovery rule in a series of court cases, beginning with Yoshizaki v. Hilo Hospital,² where the court deemed a cause of action “does not begin to run until the plaintiff knew or should have known of the defendant’s negligence.”

Subsequently, Hawaii’s Intermediate Court of Appeals explained that the state’s 2-year limitations statute commences when the plaintiff discovers, or through the use of reasonable diligence should have discovered, 1) the damage; 2) the violation of the duty; and 3) the causal connection between the violation of the duty and the damage.³

The court subsequently held that the rule prevents the running of the limitations period until “the plaintiff [has] knowledge of those facts which are necessary for an actionable claim.”⁴ In 1999, the Hawaii Supreme Court clarified that it was “factual knowledge,” rather than “legal knowledge,” that starts the clock running, and that legal knowledge of a defendant’s negligence was not required.⁵

More recently, litigation over the time barring of claims was evident in Moon v. Rhode,⁶ where Dr. Clarissa Rhode and Central Illinois Radiological Associates were sued for negligently misreading a patient’s CT scans.

The 90-year-old patient, Kathryn Moon, was admitted to Proctor Hospital May 18, 2009, and died 11 days later following surgery and complications of fluid overload and a pneumoperitoneum. Dr. Rhode, a radiologist, interpreted two CT scans, which an independent expert in 2013 determined were negligently misread. A lawsuit was then brought against Dr. Rhode, who was not a named defendant when the plaintiff had timely filed a medical negligence action back in 2011 against the surgeon and the attending doctor.

The court of appeals held that the discovery rule can be applied to wrongful death and survival actions, and that the statute of limitations begins to run when the plaintiff knows or should have known that the death was “wrongfully caused.” However, this did not necessarily mean knowledge of a specific defendant’s negligent conduct or knowledge of the existence of a cause of action.

The court stated: “Plaintiff filed his complaint long after he became possessed with sufficient information, which put him on inquiry to determine whether actionable conduct was involved.” The court ruled that the relevant inquiry was not when the plaintiff became aware that Dr. Rhode may have committed medical negligence, but when any defendant may have committed medical negligence against the patient Kathryn. The case is currently on appeal to the Supreme Court of Illinois.

In addition to the discovery rule, other situations may toll the limitations period. One example is fraudulent concealment of a right of action, where the statute may be tolled during the period of concealment. And in all jurisdictions, the running of the time period is halted in malpractice complaints involving treatment of a minor until that minor reaches a certain age, such as age of majority, or after a stipulated number of years, for example, 6 years.

Occasionally, a health care provider may overlook an important tolling provision. California, for example, has a rule that any “payment” made to an injured party must be accompanied by a written statement regarding the applicable statute of limitations.

In the recent Coastal Surgical Institute v. Blevins case,⁷ the defendant surgeon made a payment of $4,118.23 for medical expenses incurred by an unrepresented plaintiff, but had neglected to attach a release or a written notice regarding the statute of limitations. The plaintiff subsequently decided to file a lawsuit, even though more than a year – the statutory period – had lapsed.

Under the facts, the limitation period was tolled, and the trial court allowed the case to go forward, ultimately finding liability and awarding damages of $500,000, later reduced to $285,114. The court of appeals affirmed the decision.

This case has prompted MIEC, a malpractice insurance carrier, to emphasize putting in writing the restrictions imposed by the limitations statute to any unrepresented patient. MIEC also warned that the term “payment” might be construed liberally, citing case examples that include a free counseling session and the provision of specialized care for a student injured by a school’s gym equipment.

References

1. Kaplan v. Mamelak, 162 Cal. App. 4th 637 (2008).

2. Yoshizaki v. Hilo Hospital, 433 P.2d 220 (1967).

3. Jacoby v. Kaiser Foundation Hospital, 622 P.2d 613 (1981).

4. Yamaguchi v. Queen’s Medical Center, 648 P.2d 689 (1982).

5. Buck v. Miles, 971 P.2d 717 (1999).

6. Moon v. Rhode, IL. 2015 App. 3d 130613.

7. Coastal Surgical Institute v. Blevins, 232 Cal. App. 4th 1321 (2015).

Dr. Tan is emeritus professor of medicine and a former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. It is adapted from the author’s book, “Medical Malpractice: Understanding the Law, Managing the Risk” (2006). For additional information, readers may contact the author at siang@hawaii.edu.

Question: A patient was admitted with heart failure, developed deep vein thrombosis, and was started on warfarin and Lovenox as “bridge” therapy. On day 4, the patient achieved anticoagulation with a prothrombin time of 29.8 and international normalized ratio (INR) of 2.86, but continued to receive both warfarin and Lovenox for a total of 13 days. Both medications were dispensed and administered for 2 days when the PT was greater than 50; the supratherapeutic coagulation profile result was overlooked. Medications held on day 14 (PT, 68; INR, 8.35). The patient developed a right subdural hematoma and was transferred to a tertiary care facility for neurosurgery consult.

Given these facts, which of the following statements is best?

A. The hospital is under a legal obligation to disclose the error.

B. The doctor should be sympathetic and apologize for the injury, but not admit fault.

C. All jurisdictions have so-called “apology statutes,” which encourage error disclosure in return for immunity.

D. This is a case of medication, not medical, error.

E. Silence is golden.

Answer: B. A recent publication concluded, “If medical error were a disease, it would rank as the third leading cause of death in the United States.”¹ This is the latest follow through on the original landmark report from the Institute of Medicine in 2000, which drew the public’s attention to the fact that medical errors were responsible for between 44,000 and 98,000 annual fatalities in the United States.

A medical error denotes a preventable adverse event, which in turn can be described as an injury caused by medical mismanagement rather than the underlying condition of the patient. It is more formally defined as “the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim.”² The term is not synonymous with medical negligence, which is a legal term of art encompassing four separate elements: duty, breach, causation, and damages.

The most common type of medical error is a medication error, which is any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health professional, patient, or consumer.

Medication errors account for 6.3%-30% of all malpractice claims, and a 1999 Texas case is an example.³ A 43-year-old Hispanic man with chest pain was prescribed the anti-angina drug Isordil (isosorbide dinitrate) by his cardiologist, to be taken four times a day in doses of 20 mg. The pharmacist misread the order as Plendil (felodipine), a calcium channel blocker for treatment of hypertension. This exceeded the drug’s top dose, and the patient suffered a heart attack and died several days later.

The cardiologist’s illegible prescription was the sole reason for the error, and his overall quality of care was not at issue. The jury returned a verdict for the plaintiff, awarding $450,000 to his estate: $225,000 from the cardiologist, and $225,000 from the pharmacist.

Many, but not all, jurisdictions now require some form of reporting of medical errors occurring in a hospital setting. States such as California and Florida mandate disclosure to patients. Pennsylvania actually requires hospitals to issue a written disclosure within 7 days of a serious event.

Most states have enacted “apology statutes” to encourage open discussions with patients and their families about adverse results. The apologies may cover expressions of regret, sympathy, and compassion, and they are barred from being presented to the jury should a trial ensue. However, an acknowledgment of fault remains admissible into evidence.

Typical is California’s Evidence Code 1160(a), which provides that only “the portions of statements or benevolent gestures expressing sympathy” are inadmissible against a treating physician. On the other hand, some states have chosen to exclude all disclosures, including admissions of fault. An example is Colorado’s Apology Statute (Colo. Rev. Stat. Ann. 13-25-135), which provides that “any and all statements, affirmations, gestures, or conduct expressing apology, fault, sympathy, commiseration, condolence, compassion, or a general sense of benevolence ... shall be inadmissible as evidence of an admission of liability or as evidence of an admission against interest.”

Ohio is one of only a few states whose apology statutes fail to clearly distinguish between the admissibility of a physician’s statement of sympathy and one acknowledging fault. R.C. 2317.43, enacted by the Ohio General Assembly in 2004, renders inadmissible “statements, affirmations, gestures, or conduct expressing apology, sympathy, commiseration, condolence, compassion, or a general sense of benevolence.”

In Davis v. Wooster Orthopaedics & Sports Medicine,⁴ the plaintiff alleged that Dr. Michael Knapic, an orthopedic surgeon, negligently performed a lumbar microdiscectomy, severing the patient’s common iliac artery. The surgeon allegedly then said to the patient’s husband, “It’s my fault. I take full responsibility.”

In a wrongful-death action, the plaintiff argued that the statute did not prohibit the use of statements of fault, responsibility, or liability as compared to statements of sympathy or condolence.

Ohio’s Ninth Appellate District concluded that the intent behind the apology statute was to protect pure expressions of sympathy but not admissions of fault. The court held that Dr. Knapic’s statements constituted an admission of liability that could be admitted into evidence. The jury awarded damages of $3 million.

More recently, the Ohio Supreme Court ruled that Dr. Randall Smith’s alleged confession regarding accidentally sectioning his patient’s common bile duct was properly excluded from evidence, even though the incident took place before the Ohio law went into effect.⁵

The patient had to be readmitted within 3 weeks for obstructive jaundice. After the doctor informed her that she would have to undergo additional surgery, she became very emotional. He reportedly took her hand, saying, “I take full responsibility for this.”

The Ohio Supreme Court ruled, “The trial court had determined that Dr. Smith was faced with a distressed patient who was upset and made a statement that was designed to comfort his patient. This is precisely the type of evidence that R.C. 2317.43 was designed to exclude as evidence of liability in a medical-malpractice case.”

Do disclosures and apologies work?

Both claim frequency and severity have diminished following the adoption of a humanistic risk management policy at the Lexington Veterans Affairs Medical Center since 1987.⁶ The protocol includes early injury review, steadfast maintenance of the relationship between the hospital and the patient, proactive disclosure to patients who have been injured because of accidents or medical negligence, and fair compensation for injuries.

Other institutions such as the University of Michigan have adopted “disclosure and offer” in place of “denial and defend” policies, but these have yet to achieve widespread use.

Many health care providers continue to heed the traditional legal advice to say and admit nothing, believing that it is unsettled whether an apology will influence any decision to sue the doctor. They argue that the odds of a lawsuit are low to begin with.

In the oft-cited Harvard study, there was only one malpractice claim for every 7.6 adverse events caused by negligence among the 3.7% of hospitalized patients who suffered significant iatrogenic injuries, typically from errors or negligence.⁷

Notwithstanding the controversy, the AMA has properly taken the moral high ground: It asserts that error disclosure is the right thing to do.

References

1. BMJ. 2016 May 3;353:i2139.

2. Institute of Medicine: To Err is Human: Building a Safer Health System. National Academy Press, Washington, 2000.

3. Estate of Velasquez v. Albertsons, Inc. et al., Civ. No. A-103-042 (Ector Cnty, TX 1999).

4. Davis v. Wooster Orthopaedics & Sports Medicine, Inc., 193 Ohio App.3d 581 (2011).

5. Estate of Johnson v. Randall Smith, Inc., 131 Ohio St.3d 1543 (2013).

6. N Engl J Med. 2010 Apr 15;362(15):1353-6.

7. N Engl J Med. 1991 Jul 25;325(4):245-51.

Dr. Tan is emeritus professor of medicine and a former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical or legal advice. It is adapted from the author’s book, “Medical Malpractice: Understanding the Law, Managing the Risk” (2006). For additional information, readers may contact the author at siang@hawaii.edu.

Question: A patient was admitted with heart failure, developed deep vein thrombosis, and was started on warfarin and Lovenox as “bridge” therapy. On day 4, the patient achieved anticoagulation with a prothrombin time of 29.8 and international normalized ratio (INR) of 2.86, but continued to receive both warfarin and Lovenox for a total of 13 days. Both medications were dispensed and administered for 2 days when the PT was greater than 50; the supratherapeutic coagulation profile result was overlooked. Medications held on day 14 (PT, 68; INR, 8.35). The patient developed a right subdural hematoma and was transferred to a tertiary care facility for neurosurgery consult.

Given these facts, which of the following statements is best?

A. The hospital is under a legal obligation to disclose the error.

B. The doctor should be sympathetic and apologize for the injury, but not admit fault.

C. All jurisdictions have so-called “apology statutes,” which encourage error disclosure in return for immunity.

D. This is a case of medication, not medical, error.

E. Silence is golden.

Answer: B. A recent publication concluded, “If medical error were a disease, it would rank as the third leading cause of death in the United States.”¹ This is the latest follow through on the original landmark report from the Institute of Medicine in 2000, which drew the public’s attention to the fact that medical errors were responsible for between 44,000 and 98,000 annual fatalities in the United States.

A medical error denotes a preventable adverse event, which in turn can be described as an injury caused by medical mismanagement rather than the underlying condition of the patient. It is more formally defined as “the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim.”² The term is not synonymous with medical negligence, which is a legal term of art encompassing four separate elements: duty, breach, causation, and damages.

The most common type of medical error is a medication error, which is any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health professional, patient, or consumer.

Medication errors account for 6.3%-30% of all malpractice claims, and a 1999 Texas case is an example.³ A 43-year-old Hispanic man with chest pain was prescribed the anti-angina drug Isordil (isosorbide dinitrate) by his cardiologist, to be taken four times a day in doses of 20 mg. The pharmacist misread the order as Plendil (felodipine), a calcium channel blocker for treatment of hypertension. This exceeded the drug’s top dose, and the patient suffered a heart attack and died several days later.

The cardiologist’s illegible prescription was the sole reason for the error, and his overall quality of care was not at issue. The jury returned a verdict for the plaintiff, awarding $450,000 to his estate: $225,000 from the cardiologist, and $225,000 from the pharmacist.

Many, but not all, jurisdictions now require some form of reporting of medical errors occurring in a hospital setting. States such as California and Florida mandate disclosure to patients. Pennsylvania actually requires hospitals to issue a written disclosure within 7 days of a serious event.

Most states have enacted “apology statutes” to encourage open discussions with patients and their families about adverse results. The apologies may cover expressions of regret, sympathy, and compassion, and they are barred from being presented to the jury should a trial ensue. However, an acknowledgment of fault remains admissible into evidence.

Typical is California’s Evidence Code 1160(a), which provides that only “the portions of statements or benevolent gestures expressing sympathy” are inadmissible against a treating physician. On the other hand, some states have chosen to exclude all disclosures, including admissions of fault. An example is Colorado’s Apology Statute (Colo. Rev. Stat. Ann. 13-25-135), which provides that “any and all statements, affirmations, gestures, or conduct expressing apology, fault, sympathy, commiseration, condolence, compassion, or a general sense of benevolence ... shall be inadmissible as evidence of an admission of liability or as evidence of an admission against interest.”

Ohio is one of only a few states whose apology statutes fail to clearly distinguish between the admissibility of a physician’s statement of sympathy and one acknowledging fault. R.C. 2317.43, enacted by the Ohio General Assembly in 2004, renders inadmissible “statements, affirmations, gestures, or conduct expressing apology, sympathy, commiseration, condolence, compassion, or a general sense of benevolence.”

In Davis v. Wooster Orthopaedics & Sports Medicine,⁴ the plaintiff alleged that Dr. Michael Knapic, an orthopedic surgeon, negligently performed a lumbar microdiscectomy, severing the patient’s common iliac artery. The surgeon allegedly then said to the patient’s husband, “It’s my fault. I take full responsibility.”

In a wrongful-death action, the plaintiff argued that the statute did not prohibit the use of statements of fault, responsibility, or liability as compared to statements of sympathy or condolence.

Ohio’s Ninth Appellate District concluded that the intent behind the apology statute was to protect pure expressions of sympathy but not admissions of fault. The court held that Dr. Knapic’s statements constituted an admission of liability that could be admitted into evidence. The jury awarded damages of $3 million.

More recently, the Ohio Supreme Court ruled that Dr. Randall Smith’s alleged confession regarding accidentally sectioning his patient’s common bile duct was properly excluded from evidence, even though the incident took place before the Ohio law went into effect.⁵

The patient had to be readmitted within 3 weeks for obstructive jaundice. After the doctor informed her that she would have to undergo additional surgery, she became very emotional. He reportedly took her hand, saying, “I take full responsibility for this.”

The Ohio Supreme Court ruled, “The trial court had determined that Dr. Smith was faced with a distressed patient who was upset and made a statement that was designed to comfort his patient. This is precisely the type of evidence that R.C. 2317.43 was designed to exclude as evidence of liability in a medical-malpractice case.”

Do disclosures and apologies work?

Both claim frequency and severity have diminished following the adoption of a humanistic risk management policy at the Lexington Veterans Affairs Medical Center since 1987.⁶ The protocol includes early injury review, steadfast maintenance of the relationship between the hospital and the patient, proactive disclosure to patients who have been injured because of accidents or medical negligence, and fair compensation for injuries.

Other institutions such as the University of Michigan have adopted “disclosure and offer” in place of “denial and defend” policies, but these have yet to achieve widespread use.

Many health care providers continue to heed the traditional legal advice to say and admit nothing, believing that it is unsettled whether an apology will influence any decision to sue the doctor. They argue that the odds of a lawsuit are low to begin with.

In the oft-cited Harvard study, there was only one malpractice claim for every 7.6 adverse events caused by negligence among the 3.7% of hospitalized patients who suffered significant iatrogenic injuries, typically from errors or negligence.⁷

Notwithstanding the controversy, the AMA has properly taken the moral high ground: It asserts that error disclosure is the right thing to do.

References

1. BMJ. 2016 May 3;353:i2139.

2. Institute of Medicine: To Err is Human: Building a Safer Health System. National Academy Press, Washington, 2000.

3. Estate of Velasquez v. Albertsons, Inc. et al., Civ. No. A-103-042 (Ector Cnty, TX 1999).

4. Davis v. Wooster Orthopaedics & Sports Medicine, Inc., 193 Ohio App.3d 581 (2011).

5. Estate of Johnson v. Randall Smith, Inc., 131 Ohio St.3d 1543 (2013).

6. N Engl J Med. 2010 Apr 15;362(15):1353-6.

7. N Engl J Med. 1991 Jul 25;325(4):245-51.

Dr. Tan is emeritus professor of medicine and a former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical or legal advice. It is adapted from the author’s book, “Medical Malpractice: Understanding the Law, Managing the Risk” (2006). For additional information, readers may contact the author at siang@hawaii.edu.

Question: A patient was admitted with heart failure, developed deep vein thrombosis, and was started on warfarin and Lovenox as “bridge” therapy. On day 4, the patient achieved anticoagulation with a prothrombin time of 29.8 and international normalized ratio (INR) of 2.86, but continued to receive both warfarin and Lovenox for a total of 13 days. Both medications were dispensed and administered for 2 days when the PT was greater than 50; the supratherapeutic coagulation profile result was overlooked. Medications held on day 14 (PT, 68; INR, 8.35). The patient developed a right subdural hematoma and was transferred to a tertiary care facility for neurosurgery consult.

Given these facts, which of the following statements is best?

A. The hospital is under a legal obligation to disclose the error.

B. The doctor should be sympathetic and apologize for the injury, but not admit fault.

C. All jurisdictions have so-called “apology statutes,” which encourage error disclosure in return for immunity.

D. This is a case of medication, not medical, error.

E. Silence is golden.

Answer: B. A recent publication concluded, “If medical error were a disease, it would rank as the third leading cause of death in the United States.”¹ This is the latest follow through on the original landmark report from the Institute of Medicine in 2000, which drew the public’s attention to the fact that medical errors were responsible for between 44,000 and 98,000 annual fatalities in the United States.

A medical error denotes a preventable adverse event, which in turn can be described as an injury caused by medical mismanagement rather than the underlying condition of the patient. It is more formally defined as “the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim.”² The term is not synonymous with medical negligence, which is a legal term of art encompassing four separate elements: duty, breach, causation, and damages.

The most common type of medical error is a medication error, which is any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health professional, patient, or consumer.

Medication errors account for 6.3%-30% of all malpractice claims, and a 1999 Texas case is an example.³ A 43-year-old Hispanic man with chest pain was prescribed the anti-angina drug Isordil (isosorbide dinitrate) by his cardiologist, to be taken four times a day in doses of 20 mg. The pharmacist misread the order as Plendil (felodipine), a calcium channel blocker for treatment of hypertension. This exceeded the drug’s top dose, and the patient suffered a heart attack and died several days later.

The cardiologist’s illegible prescription was the sole reason for the error, and his overall quality of care was not at issue. The jury returned a verdict for the plaintiff, awarding $450,000 to his estate: $225,000 from the cardiologist, and $225,000 from the pharmacist.

Many, but not all, jurisdictions now require some form of reporting of medical errors occurring in a hospital setting. States such as California and Florida mandate disclosure to patients. Pennsylvania actually requires hospitals to issue a written disclosure within 7 days of a serious event.

Most states have enacted “apology statutes” to encourage open discussions with patients and their families about adverse results. The apologies may cover expressions of regret, sympathy, and compassion, and they are barred from being presented to the jury should a trial ensue. However, an acknowledgment of fault remains admissible into evidence.

Typical is California’s Evidence Code 1160(a), which provides that only “the portions of statements or benevolent gestures expressing sympathy” are inadmissible against a treating physician. On the other hand, some states have chosen to exclude all disclosures, including admissions of fault. An example is Colorado’s Apology Statute (Colo. Rev. Stat. Ann. 13-25-135), which provides that “any and all statements, affirmations, gestures, or conduct expressing apology, fault, sympathy, commiseration, condolence, compassion, or a general sense of benevolence ... shall be inadmissible as evidence of an admission of liability or as evidence of an admission against interest.”

Ohio is one of only a few states whose apology statutes fail to clearly distinguish between the admissibility of a physician’s statement of sympathy and one acknowledging fault. R.C. 2317.43, enacted by the Ohio General Assembly in 2004, renders inadmissible “statements, affirmations, gestures, or conduct expressing apology, sympathy, commiseration, condolence, compassion, or a general sense of benevolence.”

In Davis v. Wooster Orthopaedics & Sports Medicine,⁴ the plaintiff alleged that Dr. Michael Knapic, an orthopedic surgeon, negligently performed a lumbar microdiscectomy, severing the patient’s common iliac artery. The surgeon allegedly then said to the patient’s husband, “It’s my fault. I take full responsibility.”

In a wrongful-death action, the plaintiff argued that the statute did not prohibit the use of statements of fault, responsibility, or liability as compared to statements of sympathy or condolence.

Ohio’s Ninth Appellate District concluded that the intent behind the apology statute was to protect pure expressions of sympathy but not admissions of fault. The court held that Dr. Knapic’s statements constituted an admission of liability that could be admitted into evidence. The jury awarded damages of $3 million.

More recently, the Ohio Supreme Court ruled that Dr. Randall Smith’s alleged confession regarding accidentally sectioning his patient’s common bile duct was properly excluded from evidence, even though the incident took place before the Ohio law went into effect.⁵

The patient had to be readmitted within 3 weeks for obstructive jaundice. After the doctor informed her that she would have to undergo additional surgery, she became very emotional. He reportedly took her hand, saying, “I take full responsibility for this.”

The Ohio Supreme Court ruled, “The trial court had determined that Dr. Smith was faced with a distressed patient who was upset and made a statement that was designed to comfort his patient. This is precisely the type of evidence that R.C. 2317.43 was designed to exclude as evidence of liability in a medical-malpractice case.”

Do disclosures and apologies work?

Both claim frequency and severity have diminished following the adoption of a humanistic risk management policy at the Lexington Veterans Affairs Medical Center since 1987.⁶ The protocol includes early injury review, steadfast maintenance of the relationship between the hospital and the patient, proactive disclosure to patients who have been injured because of accidents or medical negligence, and fair compensation for injuries.

Other institutions such as the University of Michigan have adopted “disclosure and offer” in place of “denial and defend” policies, but these have yet to achieve widespread use.

Many health care providers continue to heed the traditional legal advice to say and admit nothing, believing that it is unsettled whether an apology will influence any decision to sue the doctor. They argue that the odds of a lawsuit are low to begin with.

In the oft-cited Harvard study, there was only one malpractice claim for every 7.6 adverse events caused by negligence among the 3.7% of hospitalized patients who suffered significant iatrogenic injuries, typically from errors or negligence.⁷

Notwithstanding the controversy, the AMA has properly taken the moral high ground: It asserts that error disclosure is the right thing to do.

References

1. BMJ. 2016 May 3;353:i2139.

2. Institute of Medicine: To Err is Human: Building a Safer Health System. National Academy Press, Washington, 2000.

3. Estate of Velasquez v. Albertsons, Inc. et al., Civ. No. A-103-042 (Ector Cnty, TX 1999).

4. Davis v. Wooster Orthopaedics & Sports Medicine, Inc., 193 Ohio App.3d 581 (2011).

5. Estate of Johnson v. Randall Smith, Inc., 131 Ohio St.3d 1543 (2013).

6. N Engl J Med. 2010 Apr 15;362(15):1353-6.

7. N Engl J Med. 1991 Jul 25;325(4):245-51.

Dr. Tan is emeritus professor of medicine and a former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical or legal advice. It is adapted from the author’s book, “Medical Malpractice: Understanding the Law, Managing the Risk” (2006). For additional information, readers may contact the author at siang@hawaii.edu.

Question: An injured patient alleges that her eye doctor was negligent in failing to adhere to national treatment guidelines and in not using modern medical equipment. The encounter took place in a rural setting, with the nearest hospital 100 miles away.

In her malpractice lawsuit, which of the following choices is incorrect?

A. One of the doctor’s defenses may be the locality rule.

B. The plaintiff’s strongest argument is that community standards should parallel national standards for a specialist doctor such as an ophthalmologist.

C. Her expert witness must be a practicing ophthalmologist from the area.

D. The expert must be familiar with the local standards but does not have to practice there.

E. It all depends on what the state statute says, because the locality rule is not uniform settled law.

Answer: C. In traditional medical tort law, courts would rely on the standard of the particular locale where the tortious act took place, the so-called locality rule. This was based on the belief that different standards of care were applicable in different areas of the country, e.g., urban vs. rural. The rule can be traced to Small v. Howard,¹ an 1880 Massachusetts opinion, which was subsequently overruled in 1968.

Factors favoring the trend away from a local standard toward a national standard include conformity in medical school and residency curricula, and prescribed board certification requirements. Internet access and telemedicine have further propagated this uniformity. Finally, two additional facets of modern medicine – continuing medical education and published clinical practice guidelines – are at odds with a rule geared toward local standards.

One argument against the locality rule is that undue reliance on an outdated mode of practice will perpetuate substandard care. In an older New York malpractice case where a newborn became blind, the pediatrician cited local custom to defend the prolonged use of oxygen to treat preterm infants, despite evidence that this practice might have serious consequences. However, the court of appeals held that the pediatrician’s superior knowledge of the increased risk of hyperoxygenation should have enabled him to use his best judgment instead of relying on the indefensible local custom.

Under a strict version of the locality rule, otherwise qualified expert witnesses may be excluded if they are not practitioners in the locale in question. Still, some courts may allow out-of-state experts to offer their opinions. This has been especially helpful to plaintiffs who are far less likely to be able to secure willing local experts, given the reluctance of many physicians to testify against a fellow doctor in their community.

Take Tennessee as an example. It once excluded the expert testimony of an orthopedic surgeon from Johnson City because the expert witness testified about the national standard and did not have actual knowledge of the standard of care in Nashville, the community where the alleged malpractice occurred.

The Tennessee Court of Appeals later ruled that expert witnesses had to have “personal” or “firsthand knowledge” of the community standard of care, and that interviewing other physicians in the area did not suffice. It subsequently clarified that an expert witness need not actually practice in the same or similar locale, and that professional contact with physicians from comparable communities, such as through referrals, would be acceptable.

Two well-known cases touching on the locality rule bear summarizing: In Swink v. Weintraub,² Mrs. Swink bled into her pericardium during repair of a defective pacemaker electric lead. She died as a result, and her family pursued a wrongful death action, alleging negligence including delayed pericardiocentesis and surgical intervention.

The jury returned a verdict for the plaintiff, awarding damages in the amount of $1,047,732.20. On appeal, the defendants argued that North Carolina’s locality rule extended to all aspects of a negligence action, and that the trial court erred in admitting expert opinions without regard to whether those opinions reflected the “same or similar community” standard of care.

But the court of appeals disagreed, emphasizing that compliance with the “same or similar community” standard does not necessarily exonerate a defendant from an allegation of medical negligence. The court said liability can be established if the defendant did not exercise his “best judgment” in the treatment of the patient or if the defendant failed to use “reasonable care and diligence” in his efforts to render medical assistance.

In McClure v. Inova Medical Group, a Virginia jury found that a family practice resident had failed to meet the Virginia community standard of care when he did not order the prostate-specific antigen (PSA) test in a 53-year-old patient who was subsequently diagnosed with prostate cancer. The doctor had discussed the risks and benefits of PSA testing, but the patient declined taking the test. Jurors sided with the plaintiff’s argument that according to the local or statewide standard, Virginia doctors simply ordered the test as a matter of routine for men older than 50 years without necessarily discussing risks and benefits. The court awarded $1 million to the patient.³

Although the majority of jurisdictions have abandoned the locality rule, several continue to adhere to either a strict or modified version.⁴ Examples are Arizona, Idaho, New York, Tennessee, Virginia, and Washington. A modified rule exists in Louisiana, which holds general practitioners to a community standard and specialists to a national standard.

Finally, many authors have recommended a narrowly constructed rule based not on geographic boundaries, but on the availability of local resources. Courts would then look at the totality of circumstances, but remember that there is always the duty to refer or transfer to an available specialist/facility – and that the failure to do so may form the basis of liability.

As one physician put it: Location should not come into play with respect to the knowledge or skill of the treating physician; and even if a physician may not have the facilities to perform an emergency cesarean section, he or she should still know when it’s called for.

References

1. Small v. Howard, 128 Mass 131 (1880).

2. Swink v. Weintraub, 672 S.E.2d 53 (N.C. Court of Appeals 2009).

3. JAMA. 2004 Jan 7;291(1):15-6.

4. JAMA. 2007 Jun 20;297(23):2633-7.

Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at siang@hawaii.edu.

Question: An injured patient alleges that her eye doctor was negligent in failing to adhere to national treatment guidelines and in not using modern medical equipment. The encounter took place in a rural setting, with the nearest hospital 100 miles away.

In her malpractice lawsuit, which of the following choices is incorrect?

A. One of the doctor’s defenses may be the locality rule.

B. The plaintiff’s strongest argument is that community standards should parallel national standards for a specialist doctor such as an ophthalmologist.

C. Her expert witness must be a practicing ophthalmologist from the area.

D. The expert must be familiar with the local standards but does not have to practice there.

E. It all depends on what the state statute says, because the locality rule is not uniform settled law.

Answer: C. In traditional medical tort law, courts would rely on the standard of the particular locale where the tortious act took place, the so-called locality rule. This was based on the belief that different standards of care were applicable in different areas of the country, e.g., urban vs. rural. The rule can be traced to Small v. Howard,¹ an 1880 Massachusetts opinion, which was subsequently overruled in 1968.

Factors favoring the trend away from a local standard toward a national standard include conformity in medical school and residency curricula, and prescribed board certification requirements. Internet access and telemedicine have further propagated this uniformity. Finally, two additional facets of modern medicine – continuing medical education and published clinical practice guidelines – are at odds with a rule geared toward local standards.

One argument against the locality rule is that undue reliance on an outdated mode of practice will perpetuate substandard care. In an older New York malpractice case where a newborn became blind, the pediatrician cited local custom to defend the prolonged use of oxygen to treat preterm infants, despite evidence that this practice might have serious consequences. However, the court of appeals held that the pediatrician’s superior knowledge of the increased risk of hyperoxygenation should have enabled him to use his best judgment instead of relying on the indefensible local custom.

Under a strict version of the locality rule, otherwise qualified expert witnesses may be excluded if they are not practitioners in the locale in question. Still, some courts may allow out-of-state experts to offer their opinions. This has been especially helpful to plaintiffs who are far less likely to be able to secure willing local experts, given the reluctance of many physicians to testify against a fellow doctor in their community.

Take Tennessee as an example. It once excluded the expert testimony of an orthopedic surgeon from Johnson City because the expert witness testified about the national standard and did not have actual knowledge of the standard of care in Nashville, the community where the alleged malpractice occurred.

The Tennessee Court of Appeals later ruled that expert witnesses had to have “personal” or “firsthand knowledge” of the community standard of care, and that interviewing other physicians in the area did not suffice. It subsequently clarified that an expert witness need not actually practice in the same or similar locale, and that professional contact with physicians from comparable communities, such as through referrals, would be acceptable.

Two well-known cases touching on the locality rule bear summarizing: In Swink v. Weintraub,² Mrs. Swink bled into her pericardium during repair of a defective pacemaker electric lead. She died as a result, and her family pursued a wrongful death action, alleging negligence including delayed pericardiocentesis and surgical intervention.

The jury returned a verdict for the plaintiff, awarding damages in the amount of $1,047,732.20. On appeal, the defendants argued that North Carolina’s locality rule extended to all aspects of a negligence action, and that the trial court erred in admitting expert opinions without regard to whether those opinions reflected the “same or similar community” standard of care.

But the court of appeals disagreed, emphasizing that compliance with the “same or similar community” standard does not necessarily exonerate a defendant from an allegation of medical negligence. The court said liability can be established if the defendant did not exercise his “best judgment” in the treatment of the patient or if the defendant failed to use “reasonable care and diligence” in his efforts to render medical assistance.

In McClure v. Inova Medical Group, a Virginia jury found that a family practice resident had failed to meet the Virginia community standard of care when he did not order the prostate-specific antigen (PSA) test in a 53-year-old patient who was subsequently diagnosed with prostate cancer. The doctor had discussed the risks and benefits of PSA testing, but the patient declined taking the test. Jurors sided with the plaintiff’s argument that according to the local or statewide standard, Virginia doctors simply ordered the test as a matter of routine for men older than 50 years without necessarily discussing risks and benefits. The court awarded $1 million to the patient.³

Although the majority of jurisdictions have abandoned the locality rule, several continue to adhere to either a strict or modified version.⁴ Examples are Arizona, Idaho, New York, Tennessee, Virginia, and Washington. A modified rule exists in Louisiana, which holds general practitioners to a community standard and specialists to a national standard.

Finally, many authors have recommended a narrowly constructed rule based not on geographic boundaries, but on the availability of local resources. Courts would then look at the totality of circumstances, but remember that there is always the duty to refer or transfer to an available specialist/facility – and that the failure to do so may form the basis of liability.

As one physician put it: Location should not come into play with respect to the knowledge or skill of the treating physician; and even if a physician may not have the facilities to perform an emergency cesarean section, he or she should still know when it’s called for.

References

1. Small v. Howard, 128 Mass 131 (1880).

2. Swink v. Weintraub, 672 S.E.2d 53 (N.C. Court of Appeals 2009).

3. JAMA. 2004 Jan 7;291(1):15-6.

4. JAMA. 2007 Jun 20;297(23):2633-7.

Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at siang@hawaii.edu.

Question: An injured patient alleges that her eye doctor was negligent in failing to adhere to national treatment guidelines and in not using modern medical equipment. The encounter took place in a rural setting, with the nearest hospital 100 miles away.

In her malpractice lawsuit, which of the following choices is incorrect?

A. One of the doctor’s defenses may be the locality rule.

B. The plaintiff’s strongest argument is that community standards should parallel national standards for a specialist doctor such as an ophthalmologist.

C. Her expert witness must be a practicing ophthalmologist from the area.

D. The expert must be familiar with the local standards but does not have to practice there.

E. It all depends on what the state statute says, because the locality rule is not uniform settled law.

Answer: C. In traditional medical tort law, courts would rely on the standard of the particular locale where the tortious act took place, the so-called locality rule. This was based on the belief that different standards of care were applicable in different areas of the country, e.g., urban vs. rural. The rule can be traced to Small v. Howard,¹ an 1880 Massachusetts opinion, which was subsequently overruled in 1968.

Factors favoring the trend away from a local standard toward a national standard include conformity in medical school and residency curricula, and prescribed board certification requirements. Internet access and telemedicine have further propagated this uniformity. Finally, two additional facets of modern medicine – continuing medical education and published clinical practice guidelines – are at odds with a rule geared toward local standards.

One argument against the locality rule is that undue reliance on an outdated mode of practice will perpetuate substandard care. In an older New York malpractice case where a newborn became blind, the pediatrician cited local custom to defend the prolonged use of oxygen to treat preterm infants, despite evidence that this practice might have serious consequences. However, the court of appeals held that the pediatrician’s superior knowledge of the increased risk of hyperoxygenation should have enabled him to use his best judgment instead of relying on the indefensible local custom.

Under a strict version of the locality rule, otherwise qualified expert witnesses may be excluded if they are not practitioners in the locale in question. Still, some courts may allow out-of-state experts to offer their opinions. This has been especially helpful to plaintiffs who are far less likely to be able to secure willing local experts, given the reluctance of many physicians to testify against a fellow doctor in their community.

Take Tennessee as an example. It once excluded the expert testimony of an orthopedic surgeon from Johnson City because the expert witness testified about the national standard and did not have actual knowledge of the standard of care in Nashville, the community where the alleged malpractice occurred.

The Tennessee Court of Appeals later ruled that expert witnesses had to have “personal” or “firsthand knowledge” of the community standard of care, and that interviewing other physicians in the area did not suffice. It subsequently clarified that an expert witness need not actually practice in the same or similar locale, and that professional contact with physicians from comparable communities, such as through referrals, would be acceptable.

Two well-known cases touching on the locality rule bear summarizing: In Swink v. Weintraub,² Mrs. Swink bled into her pericardium during repair of a defective pacemaker electric lead. She died as a result, and her family pursued a wrongful death action, alleging negligence including delayed pericardiocentesis and surgical intervention.

The jury returned a verdict for the plaintiff, awarding damages in the amount of $1,047,732.20. On appeal, the defendants argued that North Carolina’s locality rule extended to all aspects of a negligence action, and that the trial court erred in admitting expert opinions without regard to whether those opinions reflected the “same or similar community” standard of care.

But the court of appeals disagreed, emphasizing that compliance with the “same or similar community” standard does not necessarily exonerate a defendant from an allegation of medical negligence. The court said liability can be established if the defendant did not exercise his “best judgment” in the treatment of the patient or if the defendant failed to use “reasonable care and diligence” in his efforts to render medical assistance.

In McClure v. Inova Medical Group, a Virginia jury found that a family practice resident had failed to meet the Virginia community standard of care when he did not order the prostate-specific antigen (PSA) test in a 53-year-old patient who was subsequently diagnosed with prostate cancer. The doctor had discussed the risks and benefits of PSA testing, but the patient declined taking the test. Jurors sided with the plaintiff’s argument that according to the local or statewide standard, Virginia doctors simply ordered the test as a matter of routine for men older than 50 years without necessarily discussing risks and benefits. The court awarded $1 million to the patient.³

Although the majority of jurisdictions have abandoned the locality rule, several continue to adhere to either a strict or modified version.⁴ Examples are Arizona, Idaho, New York, Tennessee, Virginia, and Washington. A modified rule exists in Louisiana, which holds general practitioners to a community standard and specialists to a national standard.

Finally, many authors have recommended a narrowly constructed rule based not on geographic boundaries, but on the availability of local resources. Courts would then look at the totality of circumstances, but remember that there is always the duty to refer or transfer to an available specialist/facility – and that the failure to do so may form the basis of liability.

As one physician put it: Location should not come into play with respect to the knowledge or skill of the treating physician; and even if a physician may not have the facilities to perform an emergency cesarean section, he or she should still know when it’s called for.

References

1. Small v. Howard, 128 Mass 131 (1880).

2. Swink v. Weintraub, 672 S.E.2d 53 (N.C. Court of Appeals 2009).

3. JAMA. 2004 Jan 7;291(1):15-6.

4. JAMA. 2007 Jun 20;297(23):2633-7.

Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at siang@hawaii.edu.

Question: When a doctor could not find a dislodged biopsy guide wire, he abandoned his search after informing the patient of his intention to retrieve it at a later date. Two months later, he was successful in locating and removing the foreign body, but the patient alleged she suffered pain and anxiety in the interim. She filed a negligence lawsuit and, based on the “obvious” nature of her injuries, called no expert witness to testify on her behalf.

Which of the following choices is best?

A. Expert testimony is always needed to establish the applicable standard of care in medical negligence lawsuits.

B. Although a plaintiff is not qualified to expound on medical matters, he/she can offer evidence from learned treatises and medical texts.

C. The jury is the one who determines whether a plaintiff can invoke either the res ipsa loquitur doctrine or the “common knowledge” rule to obviate the need for an expert witness.

D. This patient will likely win her case.

E. All are incorrect.

Answer: E. It is well-established law that the question of negligence must be decided by reference to relevant medical standards of care for which the plaintiff carries the burden of proving through expert medical testimony. Only a professional, duly qualified by the court as an expert witness, is allowed to offer medical testimony – whereas the plaintiff typically will be disqualified from playing this role because of the complexity of issues involved.

However, under either the doctrine of res ipsa loquitur (“the thing speaks for itself”) or the “common knowledge” rule, a court (i.e., the judge) may allow the jury to infer negligence in the absence of expert testimony.

The res doctrine is invoked where there is only circumstantial but no direct evidence, and three conditions are met: 1) The injury would not have occurred in the absence of someone’s negligence; 2) the plaintiff was not at fault; and 3) the defendant had total control of the instrumentality that led to the injury.

The closely related “common knowledge” rule relies on the everyday knowledge and experience of the layperson to identify plain and obvious negligent conduct, which then allows the judge to waive the expert requirement.

The two principles are frequently used interchangeably, ultimately favoring the plaintiff by dispensing with the difficult and expensive task of securing a qualified expert willing to testify against a doctor defendant.

The best example of res in action is the surgeon who inadvertently leaves behind a sponge or instrument inside a body cavity. Other successfully litigated examples include a cardiac arrest in the operating room, hypoxia in the recovery room, burns to the buttock, gangrene after the accidental injection of penicillin into an artery, air trapped subcutaneously from a displaced needle, and a pierced eyeball during a procedure.

A particularly well-known example is Ybarra v. Spangard, in which the patient developed shoulder injuries during an appendectomy.¹ The Supreme Court of California felt it was appropriate to place the burden on the operating room defendants to explain how the patient, unconscious under general anesthesia throughout the procedure, sustained the shoulder injury.

The scenario provided in the opening question is taken from a 2013 New York case, James v. Wormuth, in which the plaintiff relied on the res doctrine.² The defendant doctor had left a guide wire in the plaintiff’s chest following a biopsy and was unable to locate it after a 20-minute search. However, he was able to retrieve the wire 2 months later under C-arm imaging.

The plaintiff sued the doctor for pain and anxiety, but did not call any expert witness, relying instead on the “foreign object” basis for invoking the res doctrine. The lower court ruled for the doctor, and the court of appeals affirmed.

It reasoned that the object was left behind deliberately, not unintentionally, and that under the circumstances of the case, an expert witness was needed to set out the applicable standard of care, without which a jury could not determine whether the doctor’s professional judgment breached the requisite standard. The court also ruled that the plaintiff failed to satisfy the “exclusive control” requirement of the res doctrine, because several other individuals participated to an extent in the medical procedure.

Hawaii’s case of Barbee v. Queen’s Medical Center is illustrative of the “common knowledge” rule.³ Mr. Barbee, age 75 years, underwent laparoscopic nephrectomy for a malignancy. Massive bleeding complicated his postoperative course, the hemoglobin falling into the 3 range, and he required emergent reoperation. Over the next 18 months, the patient progressively deteriorated, eventually requiring dialysis and dying from a stroke and intestinal volvulus.

Notwithstanding an initial jury verdict in favor of the plaintiff’s children, awarding each of the three children $365,000, the defendants filed a so-called JNOV motion (current term is “judgment as a matter of law”) to negate the jury verdict, on the basis that the plaintiffs failed to present competent expert testimony at trial to prove causation.

The plaintiffs countered that the cause of death was within the realm of common knowledge, thus no expert was necessary. They asserted that “any lay person can easily grasp the concept that a person dies from losing so much blood that multiple organs fail to perform their functions.” Mr. Barbee’s death thus was not “of such a technical nature that lay persons are incompetent to draw their own conclusions from facts presented without aid.”

Hawaii’s Intermediate Court of Appeals disagreed with the plaintiffs, holding that although “Hawaii does recognize a ‘common knowledge’ exception to the requirement that a plaintiff must introduce expert medical testimony on causation … this exception is rare in application.” The court asserted that the causal link between any alleged negligence and Mr. Barbee’s death 17 months later is not within the realm of common knowledge.

It reasoned that the long-term effects of internal bleeding are not so widely known as to be analogous to leaving a sponge within a patient or removing the wrong limb during an amputation. Moreover, Mr. Barbee had a long history of preexisting conditions, including hypertension, diabetes, and cancer. He also suffered numerous and serious postoperative medical conditions, including a stroke and surgery to remove part of his intestine, which had become gangrenous.

Thus, the role that preexisting conditions and/or the subsequent complications of this type played in Mr. Barbee’s death was not within the knowledge of the average layperson.

The “common knowledge” rule is aligned with, though not identical to, the res doctrine, but courts are known to conflate the two legal principles, often using them interchangeably.⁴

Strictly speaking, the “common knowledge” waiver comes into play where direct evidence of negligent conduct lies within the realm of everyday lay knowledge that the physician had deviated from common practice. It may or may not address the causation issue.

On the other hand, res is successfully invoked when, despite no direct evidence of negligence and causation, the circumstances surrounding the injury are such that the plaintiff’s case can go to the jury without expert testimony.

References

1. Ybarra v. Spangard, 154 P.2d 687 (Cal. 1944).

2. James v. Wormuth, 997 N.E.2d 133 (N.Y. 2013).

3. Barbee v. Queen’s Medical Center, 119 Haw 136 (2008).

4. Spinner, Amanda E. Common Ignorance: Medical Malpractice Law and the Misconceived Application of the “Common Knowledge” and “Res Ipsa Loquitur” Doctrines.” Touro Law Review: Vol. 31: No. 3, Article 15. Available at http://digitalcommons.tourolaw.edu/lawreview/vol31/iss3/15.

Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at siang@hawaii.edu.

Question: When a doctor could not find a dislodged biopsy guide wire, he abandoned his search after informing the patient of his intention to retrieve it at a later date. Two months later, he was successful in locating and removing the foreign body, but the patient alleged she suffered pain and anxiety in the interim. She filed a negligence lawsuit and, based on the “obvious” nature of her injuries, called no expert witness to testify on her behalf.

Which of the following choices is best?

A. Expert testimony is always needed to establish the applicable standard of care in medical negligence lawsuits.

B. Although a plaintiff is not qualified to expound on medical matters, he/she can offer evidence from learned treatises and medical texts.

C. The jury is the one who determines whether a plaintiff can invoke either the res ipsa loquitur doctrine or the “common knowledge” rule to obviate the need for an expert witness.

D. This patient will likely win her case.

E. All are incorrect.

Answer: E. It is well-established law that the question of negligence must be decided by reference to relevant medical standards of care for which the plaintiff carries the burden of proving through expert medical testimony. Only a professional, duly qualified by the court as an expert witness, is allowed to offer medical testimony – whereas the plaintiff typically will be disqualified from playing this role because of the complexity of issues involved.

However, under either the doctrine of res ipsa loquitur (“the thing speaks for itself”) or the “common knowledge” rule, a court (i.e., the judge) may allow the jury to infer negligence in the absence of expert testimony.

The res doctrine is invoked where there is only circumstantial but no direct evidence, and three conditions are met: 1) The injury would not have occurred in the absence of someone’s negligence; 2) the plaintiff was not at fault; and 3) the defendant had total control of the instrumentality that led to the injury.

The closely related “common knowledge” rule relies on the everyday knowledge and experience of the layperson to identify plain and obvious negligent conduct, which then allows the judge to waive the expert requirement.

The two principles are frequently used interchangeably, ultimately favoring the plaintiff by dispensing with the difficult and expensive task of securing a qualified expert willing to testify against a doctor defendant.

The best example of res in action is the surgeon who inadvertently leaves behind a sponge or instrument inside a body cavity. Other successfully litigated examples include a cardiac arrest in the operating room, hypoxia in the recovery room, burns to the buttock, gangrene after the accidental injection of penicillin into an artery, air trapped subcutaneously from a displaced needle, and a pierced eyeball during a procedure.

A particularly well-known example is Ybarra v. Spangard, in which the patient developed shoulder injuries during an appendectomy.¹ The Supreme Court of California felt it was appropriate to place the burden on the operating room defendants to explain how the patient, unconscious under general anesthesia throughout the procedure, sustained the shoulder injury.

The scenario provided in the opening question is taken from a 2013 New York case, James v. Wormuth, in which the plaintiff relied on the res doctrine.² The defendant doctor had left a guide wire in the plaintiff’s chest following a biopsy and was unable to locate it after a 20-minute search. However, he was able to retrieve the wire 2 months later under C-arm imaging.

The plaintiff sued the doctor for pain and anxiety, but did not call any expert witness, relying instead on the “foreign object” basis for invoking the res doctrine. The lower court ruled for the doctor, and the court of appeals affirmed.

It reasoned that the object was left behind deliberately, not unintentionally, and that under the circumstances of the case, an expert witness was needed to set out the applicable standard of care, without which a jury could not determine whether the doctor’s professional judgment breached the requisite standard. The court also ruled that the plaintiff failed to satisfy the “exclusive control” requirement of the res doctrine, because several other individuals participated to an extent in the medical procedure.

Hawaii’s case of Barbee v. Queen’s Medical Center is illustrative of the “common knowledge” rule.³ Mr. Barbee, age 75 years, underwent laparoscopic nephrectomy for a malignancy. Massive bleeding complicated his postoperative course, the hemoglobin falling into the 3 range, and he required emergent reoperation. Over the next 18 months, the patient progressively deteriorated, eventually requiring dialysis and dying from a stroke and intestinal volvulus.

Notwithstanding an initial jury verdict in favor of the plaintiff’s children, awarding each of the three children $365,000, the defendants filed a so-called JNOV motion (current term is “judgment as a matter of law”) to negate the jury verdict, on the basis that the plaintiffs failed to present competent expert testimony at trial to prove causation.

The plaintiffs countered that the cause of death was within the realm of common knowledge, thus no expert was necessary. They asserted that “any lay person can easily grasp the concept that a person dies from losing so much blood that multiple organs fail to perform their functions.” Mr. Barbee’s death thus was not “of such a technical nature that lay persons are incompetent to draw their own conclusions from facts presented without aid.”

Hawaii’s Intermediate Court of Appeals disagreed with the plaintiffs, holding that although “Hawaii does recognize a ‘common knowledge’ exception to the requirement that a plaintiff must introduce expert medical testimony on causation … this exception is rare in application.” The court asserted that the causal link between any alleged negligence and Mr. Barbee’s death 17 months later is not within the realm of common knowledge.

It reasoned that the long-term effects of internal bleeding are not so widely known as to be analogous to leaving a sponge within a patient or removing the wrong limb during an amputation. Moreover, Mr. Barbee had a long history of preexisting conditions, including hypertension, diabetes, and cancer. He also suffered numerous and serious postoperative medical conditions, including a stroke and surgery to remove part of his intestine, which had become gangrenous.

Thus, the role that preexisting conditions and/or the subsequent complications of this type played in Mr. Barbee’s death was not within the knowledge of the average layperson.

The “common knowledge” rule is aligned with, though not identical to, the res doctrine, but courts are known to conflate the two legal principles, often using them interchangeably.⁴

Strictly speaking, the “common knowledge” waiver comes into play where direct evidence of negligent conduct lies within the realm of everyday lay knowledge that the physician had deviated from common practice. It may or may not address the causation issue.

On the other hand, res is successfully invoked when, despite no direct evidence of negligence and causation, the circumstances surrounding the injury are such that the plaintiff’s case can go to the jury without expert testimony.

References

1. Ybarra v. Spangard, 154 P.2d 687 (Cal. 1944).

2. James v. Wormuth, 997 N.E.2d 133 (N.Y. 2013).

3. Barbee v. Queen’s Medical Center, 119 Haw 136 (2008).

4. Spinner, Amanda E. Common Ignorance: Medical Malpractice Law and the Misconceived Application of the “Common Knowledge” and “Res Ipsa Loquitur” Doctrines.” Touro Law Review: Vol. 31: No. 3, Article 15. Available at http://digitalcommons.tourolaw.edu/lawreview/vol31/iss3/15.

Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at siang@hawaii.edu.

Question: When a doctor could not find a dislodged biopsy guide wire, he abandoned his search after informing the patient of his intention to retrieve it at a later date. Two months later, he was successful in locating and removing the foreign body, but the patient alleged she suffered pain and anxiety in the interim. She filed a negligence lawsuit and, based on the “obvious” nature of her injuries, called no expert witness to testify on her behalf.

Which of the following choices is best?

A. Expert testimony is always needed to establish the applicable standard of care in medical negligence lawsuits.

B. Although a plaintiff is not qualified to expound on medical matters, he/she can offer evidence from learned treatises and medical texts.

C. The jury is the one who determines whether a plaintiff can invoke either the res ipsa loquitur doctrine or the “common knowledge” rule to obviate the need for an expert witness.

D. This patient will likely win her case.

E. All are incorrect.

Answer: E. It is well-established law that the question of negligence must be decided by reference to relevant medical standards of care for which the plaintiff carries the burden of proving through expert medical testimony. Only a professional, duly qualified by the court as an expert witness, is allowed to offer medical testimony – whereas the plaintiff typically will be disqualified from playing this role because of the complexity of issues involved.

However, under either the doctrine of res ipsa loquitur (“the thing speaks for itself”) or the “common knowledge” rule, a court (i.e., the judge) may allow the jury to infer negligence in the absence of expert testimony.

The res doctrine is invoked where there is only circumstantial but no direct evidence, and three conditions are met: 1) The injury would not have occurred in the absence of someone’s negligence; 2) the plaintiff was not at fault; and 3) the defendant had total control of the instrumentality that led to the injury.

The closely related “common knowledge” rule relies on the everyday knowledge and experience of the layperson to identify plain and obvious negligent conduct, which then allows the judge to waive the expert requirement.

The two principles are frequently used interchangeably, ultimately favoring the plaintiff by dispensing with the difficult and expensive task of securing a qualified expert willing to testify against a doctor defendant.

The best example of res in action is the surgeon who inadvertently leaves behind a sponge or instrument inside a body cavity. Other successfully litigated examples include a cardiac arrest in the operating room, hypoxia in the recovery room, burns to the buttock, gangrene after the accidental injection of penicillin into an artery, air trapped subcutaneously from a displaced needle, and a pierced eyeball during a procedure.

A particularly well-known example is Ybarra v. Spangard, in which the patient developed shoulder injuries during an appendectomy.¹ The Supreme Court of California felt it was appropriate to place the burden on the operating room defendants to explain how the patient, unconscious under general anesthesia throughout the procedure, sustained the shoulder injury.

The scenario provided in the opening question is taken from a 2013 New York case, James v. Wormuth, in which the plaintiff relied on the res doctrine.² The defendant doctor had left a guide wire in the plaintiff’s chest following a biopsy and was unable to locate it after a 20-minute search. However, he was able to retrieve the wire 2 months later under C-arm imaging.

The plaintiff sued the doctor for pain and anxiety, but did not call any expert witness, relying instead on the “foreign object” basis for invoking the res doctrine. The lower court ruled for the doctor, and the court of appeals affirmed.

It reasoned that the object was left behind deliberately, not unintentionally, and that under the circumstances of the case, an expert witness was needed to set out the applicable standard of care, without which a jury could not determine whether the doctor’s professional judgment breached the requisite standard. The court also ruled that the plaintiff failed to satisfy the “exclusive control” requirement of the res doctrine, because several other individuals participated to an extent in the medical procedure.

Hawaii’s case of Barbee v. Queen’s Medical Center is illustrative of the “common knowledge” rule.³ Mr. Barbee, age 75 years, underwent laparoscopic nephrectomy for a malignancy. Massive bleeding complicated his postoperative course, the hemoglobin falling into the 3 range, and he required emergent reoperation. Over the next 18 months, the patient progressively deteriorated, eventually requiring dialysis and dying from a stroke and intestinal volvulus.

Notwithstanding an initial jury verdict in favor of the plaintiff’s children, awarding each of the three children $365,000, the defendants filed a so-called JNOV motion (current term is “judgment as a matter of law”) to negate the jury verdict, on the basis that the plaintiffs failed to present competent expert testimony at trial to prove causation.

The plaintiffs countered that the cause of death was within the realm of common knowledge, thus no expert was necessary. They asserted that “any lay person can easily grasp the concept that a person dies from losing so much blood that multiple organs fail to perform their functions.” Mr. Barbee’s death thus was not “of such a technical nature that lay persons are incompetent to draw their own conclusions from facts presented without aid.”

Hawaii’s Intermediate Court of Appeals disagreed with the plaintiffs, holding that although “Hawaii does recognize a ‘common knowledge’ exception to the requirement that a plaintiff must introduce expert medical testimony on causation … this exception is rare in application.” The court asserted that the causal link between any alleged negligence and Mr. Barbee’s death 17 months later is not within the realm of common knowledge.

It reasoned that the long-term effects of internal bleeding are not so widely known as to be analogous to leaving a sponge within a patient or removing the wrong limb during an amputation. Moreover, Mr. Barbee had a long history of preexisting conditions, including hypertension, diabetes, and cancer. He also suffered numerous and serious postoperative medical conditions, including a stroke and surgery to remove part of his intestine, which had become gangrenous.

Thus, the role that preexisting conditions and/or the subsequent complications of this type played in Mr. Barbee’s death was not within the knowledge of the average layperson.

The “common knowledge” rule is aligned with, though not identical to, the res doctrine, but courts are known to conflate the two legal principles, often using them interchangeably.⁴

Strictly speaking, the “common knowledge” waiver comes into play where direct evidence of negligent conduct lies within the realm of everyday lay knowledge that the physician had deviated from common practice. It may or may not address the causation issue.

On the other hand, res is successfully invoked when, despite no direct evidence of negligence and causation, the circumstances surrounding the injury are such that the plaintiff’s case can go to the jury without expert testimony.

References

1. Ybarra v. Spangard, 154 P.2d 687 (Cal. 1944).

2. James v. Wormuth, 997 N.E.2d 133 (N.Y. 2013).

3. Barbee v. Queen’s Medical Center, 119 Haw 136 (2008).

4. Spinner, Amanda E. Common Ignorance: Medical Malpractice Law and the Misconceived Application of the “Common Knowledge” and “Res Ipsa Loquitur” Doctrines.” Touro Law Review: Vol. 31: No. 3, Article 15. Available at http://digitalcommons.tourolaw.edu/lawreview/vol31/iss3/15.

Dr. Tan is professor emeritus of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at siang@hawaii.edu.

Question: Doctors are more prone to lawsuits if they:

A. Have been sued before.

B. Spend fewer dollars per hospitalized patient.

C. Show poor communication skills.

D. A and C only.

E. A, B, and C.

Answer: E. Two very recent studies, one by David M. Studdert and the other by Dr. Anupam B. Jena, offer fresh insights into factors linked to the likelihood of a malpractice lawsuit.

The Studdert study concluded that doctors with prior paid claims are at increased risk of incurring yet another lawsuit.¹ Instead of simply relying on data from a single insurer or state, the researchers accessed the National Practitioner Data Bank (NPDB) from 2005 through 2014 and identified 66,426 claims paid against 54,099 physicians.

Over that 10-year period, only 1% of physicians accounted for 32% of paid claims. Of all the physicians, 84% incurred only one paid claim during the study period, and 16% had at least two. Four percent of the physicians had at least three. In adjusted analyses, the risk of recurrence increased with the number of previous paid claims.

For example, compared with physicians with a single claim, the 2,160 physicians who had three paid claims had three times the risk of incurring another (hazard ratio, 3.11); this corresponded in absolute terms to a 24% risk within 2 years.

Likelihood of recurrence also varied widely according to specialty. For example, the risk among neurosurgeons was four times greater than that of psychiatrists. As for internists, the risk of recurrence was approximately double that of neurosurgeons, orthopedic surgeons, general surgeons, plastic surgeons, or obstetrician-gynecologists. The lowest risks of recurrence were seen among psychiatrists (HR, 0.60) and pediatricians (HR, 0.71).

Male physicians had a 38% higher risk of recurrence than did female physicians, and the risk among physicians younger than 35 years was approximately one-third that of their older colleagues (after adjustment for age). Residents had a lower risk of recurrence than did nonresidents, and MDs had a lower risk than did DOs.

Using all 915,564 active physicians in the United States as a denominator, the authors calculated that over the 10-year study period, only 6% of physicians had a paid claim. Note that the 6% figure refers to paid claims reported to the NPDB, which can be expected to be lower than statistics derived from published surveys. These latter studies typically feature self-reported malpractice claims made over a given time period; but it is well known that the majority of such claims are dropped or decided in favor of the doctor, and so will not be reported to the NPDB.

For example, in 2010, the American Medical Association found that 42.2% of 5,825 physicians who responded to its Physician Practice Information survey reported having been sued, with 22.4% sued twice or more.² The report headlined that by mid career, 61% of doctor have been sued.

Rates varied by specialty, with general surgeons and obstetrician-gynecologists being most likely to be sued (69.2%). Family physicians and general internists had similar rates (38.9% and 34%), and pediatricians and psychiatrists were sued the least.

In that report, male doctors were twice as likely to be sued as were their female counterparts, and physicians in solo and specialty practices were sued more often than those in multispecialty practices. Physicians who had an ownership interest in a practice were also at greater risk, with 47.5% reporting being sued, compared with 33.4% for those with no ownership interest.

The second recent study, reported by Dr. Jena of Harvard Medical School, Boston, and his colleagues, analyzed Florida hospital admissions data covering some 24,000 physicians.³ They found that higher spending by physicians was associated with reduced malpractice claims made the following year.

This pattern held true for physicians in all specialties but one (family practice). For example, among internists, the malpractice risk probability was 1.5% in the bottom spending fifth ($19,725 per admission) and 0.3% in the top fifth ($39,379 per admission). Among obstetricians, the comparable figures were 1.9% and 0.4% respectively.

In addition, a separate subgroup analysis of cesarean-section rates revealed that malpractice claims were approximately halved among obstetricians with rates in the highest fifth, compared with the lowest fifth.

Unfortunately, the Jena study lacked information on illness severity and past malpractice history, and it remains speculative whether increased resource utilization could be attributed entirely to defensive medical practice.⁴

As interesting as these new reports may be, it is worth remembering that what prompts a lawsuit are poor communication and patient perception that the physician is uncaring and at fault for the bad result.

It is well known that quality of medical care correlates poorly with the filing of malpractice lawsuits, as illustrated in the conclusion of the landmark Harvard study that “medical malpractice litigation infrequently compensates patients injured by medical negligence and rarely identifies, and holds providers accountable for, substandard care.”⁵ The authors estimated that there was only 1 malpractice claim for every 7.6 adverse events caused by negligence.

In another retrospective chart review study, the quality of treatment as judged by independent peer review was no different in frequently sued versus never-sued obstetricians.⁶

Communication problems exist in more than 70% of malpractice cases, centering around four themes: 1) deserting the patient; 2) devaluing patient/family views; 3) delivering information poorly; and 4) failing to understand the patient/family perspective.⁷

Anger, either from the adverse result itself or perceived lack of caring, turns an injured patient into a plaintiff, and lies at the root of all malpractice claims. The patients may not even have a serious injury or a meritorious claim, but they are so frustrated with their physician or the hospital that they contact an attorney to vent their anger.

One experienced attorney volunteered that close to half his malpractice cases could have been avoided through disclosure or apology, noting: “What the patients really wanted was simply an honest explanation of what happened, and, if appropriate, an apology. Unfortunately, when they were not only offered neither, but were rejected as well, they felt doubly wronged and then sought legal counsel.”⁸

Communicating well begins with active listening. Patients want their doctors to listen to them and to explain their conditions and treatment plans in simple, understandable language. The physician should give them ample opportunity to tell their story and to ask questions.

In one well-publicized study, only 23% of patients were able to complete their opening statement before the doctor interrupted, which occurred, on the average, 18 seconds after the patient began to speak!⁹

References

1. N Engl J Med. 2016 Jan 28;374(4):354-62.

2. “Medical liability: By late career, 61% of doctors have been sued,” Aug. 16, 2010, American Medical News.

3. BMJ. 2015 Nov 4;351:h5516.

4. “Law & Medicine: Health care costs and defensive medicine,” Jan. 19, 2016, Internal Medicine News.

5. N Engl J Med. 1991 Jul 25;325(4):245-51.

6. JAMA. 1994 Nov 23-30;272(20):1588-91.

7. Arch Intern Med. 1994 Jun 27;154(12):1365-70.

8. Ann Intern Med. 1999 Dec 21;131(12):970-2.

9. Ann Intern Med. 1984 Nov;101(5):692-6.

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at siang@hawaii.edu

Question: Doctors are more prone to lawsuits if they:

A. Have been sued before.

B. Spend fewer dollars per hospitalized patient.

C. Show poor communication skills.

D. A and C only.

E. A, B, and C.

Answer: E. Two very recent studies, one by David M. Studdert and the other by Dr. Anupam B. Jena, offer fresh insights into factors linked to the likelihood of a malpractice lawsuit.

The Studdert study concluded that doctors with prior paid claims are at increased risk of incurring yet another lawsuit.¹ Instead of simply relying on data from a single insurer or state, the researchers accessed the National Practitioner Data Bank (NPDB) from 2005 through 2014 and identified 66,426 claims paid against 54,099 physicians.

Over that 10-year period, only 1% of physicians accounted for 32% of paid claims. Of all the physicians, 84% incurred only one paid claim during the study period, and 16% had at least two. Four percent of the physicians had at least three. In adjusted analyses, the risk of recurrence increased with the number of previous paid claims.

For example, compared with physicians with a single claim, the 2,160 physicians who had three paid claims had three times the risk of incurring another (hazard ratio, 3.11); this corresponded in absolute terms to a 24% risk within 2 years.

Likelihood of recurrence also varied widely according to specialty. For example, the risk among neurosurgeons was four times greater than that of psychiatrists. As for internists, the risk of recurrence was approximately double that of neurosurgeons, orthopedic surgeons, general surgeons, plastic surgeons, or obstetrician-gynecologists. The lowest risks of recurrence were seen among psychiatrists (HR, 0.60) and pediatricians (HR, 0.71).

Male physicians had a 38% higher risk of recurrence than did female physicians, and the risk among physicians younger than 35 years was approximately one-third that of their older colleagues (after adjustment for age). Residents had a lower risk of recurrence than did nonresidents, and MDs had a lower risk than did DOs.

Using all 915,564 active physicians in the United States as a denominator, the authors calculated that over the 10-year study period, only 6% of physicians had a paid claim. Note that the 6% figure refers to paid claims reported to the NPDB, which can be expected to be lower than statistics derived from published surveys. These latter studies typically feature self-reported malpractice claims made over a given time period; but it is well known that the majority of such claims are dropped or decided in favor of the doctor, and so will not be reported to the NPDB.

For example, in 2010, the American Medical Association found that 42.2% of 5,825 physicians who responded to its Physician Practice Information survey reported having been sued, with 22.4% sued twice or more.² The report headlined that by mid career, 61% of doctor have been sued.

Rates varied by specialty, with general surgeons and obstetrician-gynecologists being most likely to be sued (69.2%). Family physicians and general internists had similar rates (38.9% and 34%), and pediatricians and psychiatrists were sued the least.

In that report, male doctors were twice as likely to be sued as were their female counterparts, and physicians in solo and specialty practices were sued more often than those in multispecialty practices. Physicians who had an ownership interest in a practice were also at greater risk, with 47.5% reporting being sued, compared with 33.4% for those with no ownership interest.

The second recent study, reported by Dr. Jena of Harvard Medical School, Boston, and his colleagues, analyzed Florida hospital admissions data covering some 24,000 physicians.³ They found that higher spending by physicians was associated with reduced malpractice claims made the following year.

This pattern held true for physicians in all specialties but one (family practice). For example, among internists, the malpractice risk probability was 1.5% in the bottom spending fifth ($19,725 per admission) and 0.3% in the top fifth ($39,379 per admission). Among obstetricians, the comparable figures were 1.9% and 0.4% respectively.

In addition, a separate subgroup analysis of cesarean-section rates revealed that malpractice claims were approximately halved among obstetricians with rates in the highest fifth, compared with the lowest fifth.

Unfortunately, the Jena study lacked information on illness severity and past malpractice history, and it remains speculative whether increased resource utilization could be attributed entirely to defensive medical practice.⁴

As interesting as these new reports may be, it is worth remembering that what prompts a lawsuit are poor communication and patient perception that the physician is uncaring and at fault for the bad result.

It is well known that quality of medical care correlates poorly with the filing of malpractice lawsuits, as illustrated in the conclusion of the landmark Harvard study that “medical malpractice litigation infrequently compensates patients injured by medical negligence and rarely identifies, and holds providers accountable for, substandard care.”⁵ The authors estimated that there was only 1 malpractice claim for every 7.6 adverse events caused by negligence.

In another retrospective chart review study, the quality of treatment as judged by independent peer review was no different in frequently sued versus never-sued obstetricians.⁶

Communication problems exist in more than 70% of malpractice cases, centering around four themes: 1) deserting the patient; 2) devaluing patient/family views; 3) delivering information poorly; and 4) failing to understand the patient/family perspective.⁷

Anger, either from the adverse result itself or perceived lack of caring, turns an injured patient into a plaintiff, and lies at the root of all malpractice claims. The patients may not even have a serious injury or a meritorious claim, but they are so frustrated with their physician or the hospital that they contact an attorney to vent their anger.

One experienced attorney volunteered that close to half his malpractice cases could have been avoided through disclosure or apology, noting: “What the patients really wanted was simply an honest explanation of what happened, and, if appropriate, an apology. Unfortunately, when they were not only offered neither, but were rejected as well, they felt doubly wronged and then sought legal counsel.”⁸

Communicating well begins with active listening. Patients want their doctors to listen to them and to explain their conditions and treatment plans in simple, understandable language. The physician should give them ample opportunity to tell their story and to ask questions.

In one well-publicized study, only 23% of patients were able to complete their opening statement before the doctor interrupted, which occurred, on the average, 18 seconds after the patient began to speak!⁹

References

1. N Engl J Med. 2016 Jan 28;374(4):354-62.

2. “Medical liability: By late career, 61% of doctors have been sued,” Aug. 16, 2010, American Medical News.

3. BMJ. 2015 Nov 4;351:h5516.

4. “Law & Medicine: Health care costs and defensive medicine,” Jan. 19, 2016, Internal Medicine News.

5. N Engl J Med. 1991 Jul 25;325(4):245-51.

6. JAMA. 1994 Nov 23-30;272(20):1588-91.

7. Arch Intern Med. 1994 Jun 27;154(12):1365-70.

8. Ann Intern Med. 1999 Dec 21;131(12):970-2.

9. Ann Intern Med. 1984 Nov;101(5):692-6.

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at siang@hawaii.edu

Question: Doctors are more prone to lawsuits if they:

A. Have been sued before.

B. Spend fewer dollars per hospitalized patient.

C. Show poor communication skills.

D. A and C only.

E. A, B, and C.

Answer: E. Two very recent studies, one by David M. Studdert and the other by Dr. Anupam B. Jena, offer fresh insights into factors linked to the likelihood of a malpractice lawsuit.

The Studdert study concluded that doctors with prior paid claims are at increased risk of incurring yet another lawsuit.¹ Instead of simply relying on data from a single insurer or state, the researchers accessed the National Practitioner Data Bank (NPDB) from 2005 through 2014 and identified 66,426 claims paid against 54,099 physicians.

Over that 10-year period, only 1% of physicians accounted for 32% of paid claims. Of all the physicians, 84% incurred only one paid claim during the study period, and 16% had at least two. Four percent of the physicians had at least three. In adjusted analyses, the risk of recurrence increased with the number of previous paid claims.

For example, compared with physicians with a single claim, the 2,160 physicians who had three paid claims had three times the risk of incurring another (hazard ratio, 3.11); this corresponded in absolute terms to a 24% risk within 2 years.

Likelihood of recurrence also varied widely according to specialty. For example, the risk among neurosurgeons was four times greater than that of psychiatrists. As for internists, the risk of recurrence was approximately double that of neurosurgeons, orthopedic surgeons, general surgeons, plastic surgeons, or obstetrician-gynecologists. The lowest risks of recurrence were seen among psychiatrists (HR, 0.60) and pediatricians (HR, 0.71).

Male physicians had a 38% higher risk of recurrence than did female physicians, and the risk among physicians younger than 35 years was approximately one-third that of their older colleagues (after adjustment for age). Residents had a lower risk of recurrence than did nonresidents, and MDs had a lower risk than did DOs.

Using all 915,564 active physicians in the United States as a denominator, the authors calculated that over the 10-year study period, only 6% of physicians had a paid claim. Note that the 6% figure refers to paid claims reported to the NPDB, which can be expected to be lower than statistics derived from published surveys. These latter studies typically feature self-reported malpractice claims made over a given time period; but it is well known that the majority of such claims are dropped or decided in favor of the doctor, and so will not be reported to the NPDB.

For example, in 2010, the American Medical Association found that 42.2% of 5,825 physicians who responded to its Physician Practice Information survey reported having been sued, with 22.4% sued twice or more.² The report headlined that by mid career, 61% of doctor have been sued.

Rates varied by specialty, with general surgeons and obstetrician-gynecologists being most likely to be sued (69.2%). Family physicians and general internists had similar rates (38.9% and 34%), and pediatricians and psychiatrists were sued the least.

In that report, male doctors were twice as likely to be sued as were their female counterparts, and physicians in solo and specialty practices were sued more often than those in multispecialty practices. Physicians who had an ownership interest in a practice were also at greater risk, with 47.5% reporting being sued, compared with 33.4% for those with no ownership interest.

The second recent study, reported by Dr. Jena of Harvard Medical School, Boston, and his colleagues, analyzed Florida hospital admissions data covering some 24,000 physicians.³ They found that higher spending by physicians was associated with reduced malpractice claims made the following year.

This pattern held true for physicians in all specialties but one (family practice). For example, among internists, the malpractice risk probability was 1.5% in the bottom spending fifth ($19,725 per admission) and 0.3% in the top fifth ($39,379 per admission). Among obstetricians, the comparable figures were 1.9% and 0.4% respectively.

In addition, a separate subgroup analysis of cesarean-section rates revealed that malpractice claims were approximately halved among obstetricians with rates in the highest fifth, compared with the lowest fifth.

Unfortunately, the Jena study lacked information on illness severity and past malpractice history, and it remains speculative whether increased resource utilization could be attributed entirely to defensive medical practice.⁴

As interesting as these new reports may be, it is worth remembering that what prompts a lawsuit are poor communication and patient perception that the physician is uncaring and at fault for the bad result.

It is well known that quality of medical care correlates poorly with the filing of malpractice lawsuits, as illustrated in the conclusion of the landmark Harvard study that “medical malpractice litigation infrequently compensates patients injured by medical negligence and rarely identifies, and holds providers accountable for, substandard care.”⁵ The authors estimated that there was only 1 malpractice claim for every 7.6 adverse events caused by negligence.

In another retrospective chart review study, the quality of treatment as judged by independent peer review was no different in frequently sued versus never-sued obstetricians.⁶

Communication problems exist in more than 70% of malpractice cases, centering around four themes: 1) deserting the patient; 2) devaluing patient/family views; 3) delivering information poorly; and 4) failing to understand the patient/family perspective.⁷

Anger, either from the adverse result itself or perceived lack of caring, turns an injured patient into a plaintiff, and lies at the root of all malpractice claims. The patients may not even have a serious injury or a meritorious claim, but they are so frustrated with their physician or the hospital that they contact an attorney to vent their anger.

One experienced attorney volunteered that close to half his malpractice cases could have been avoided through disclosure or apology, noting: “What the patients really wanted was simply an honest explanation of what happened, and, if appropriate, an apology. Unfortunately, when they were not only offered neither, but were rejected as well, they felt doubly wronged and then sought legal counsel.”⁸

Communicating well begins with active listening. Patients want their doctors to listen to them and to explain their conditions and treatment plans in simple, understandable language. The physician should give them ample opportunity to tell their story and to ask questions.

In one well-publicized study, only 23% of patients were able to complete their opening statement before the doctor interrupted, which occurred, on the average, 18 seconds after the patient began to speak!⁹

References

1. N Engl J Med. 2016 Jan 28;374(4):354-62.

2. “Medical liability: By late career, 61% of doctors have been sued,” Aug. 16, 2010, American Medical News.

3. BMJ. 2015 Nov 4;351:h5516.

4. “Law & Medicine: Health care costs and defensive medicine,” Jan. 19, 2016, Internal Medicine News.

5. N Engl J Med. 1991 Jul 25;325(4):245-51.

6. JAMA. 1994 Nov 23-30;272(20):1588-91.

7. Arch Intern Med. 1994 Jun 27;154(12):1365-70.

8. Ann Intern Med. 1999 Dec 21;131(12):970-2.

9. Ann Intern Med. 1984 Nov;101(5):692-6.

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at siang@hawaii.edu

Question: Oral contraceptives are prescription drugs sold with highly specific manufacturer instructions on how and when to take them, because the sequence of pill ingestion is critical to their anovulatory efficacy.

Suppose a manufacturing mishap resulted in improper labeling and sequencing of the pills, and some women, relying on the product, became pregnant. In a lawsuit against the manufacturer, which of the following choices is best?

A. This is a case of product liability.

B. Affected plaintiffs should consider filing a class-action lawsuit.

C. Mothers can sue for wrongful pregnancy.

D. Children can sue for wrongful life.

E. All are possible legal causes of action.

Answer: E. This hypothetical is adapted from a recent report that the use of mispackaged oral contraceptives had resulted in more than 100 women becoming pregnant. The prescription drugs, available in blister packs, were erroneously sequenced such that the daily use of active or inactive drug was asynchronous with the woman’s ovulatory cycle, thus foiling the drug’s pregnancy prevention efficacy.

Typically, each packet of oral contraceptives comes with 28 days’ worth of color-coded pills, with the first 21 containing the active principle to inhibit ovulation, followed by 7 inert pills. Each monthly pack begins with the same strict pill sequence.

In 2011, the manufacturer of several brands of oral contraceptives recalled half a million such packs when it was discovered that some of them had the pill sequence reversed. Foreseeably, this debacle resulted in a number of unplanned pregnancies – and live births. Legal action soon followed.

▶ Product liability: A simple negligence lawsuit would typically cover a situation in which a wrongdoer has breached the requisite standard of care, as appears to be the case here. However, when a product such as a prescription drug leads to “harm,” an injured party, using the law of product liability, can sue the manufacturer that had placed it into the stream of commerce. This allows the plaintiff to rely on legal theories other than negligence, including breach of warranty and strict liability.

Under the latter legal theory, there is no need to prove fault or contractual breach, and the significant part of the complaint is whether the product is both defective and unreasonably dangerous. “Defective” is usually defined as product quality that is less than what a reasonable consumer expects, and “unreasonably dangerous” is a conclusion that the risks that result from its condition outweigh the product’s advantages.

Although the medication itself in this case is not defective or unreasonably dangerous, the assembly and labeling fiasco would suffice to keep the lawsuit within the product liability category. According to Section 102(2) of the Uniform Product Liability Act, product liability includes “all claims or action brought for personal injury, death, or property damage caused by the manufacture, design, formula, preparation, assembly, installation, testing, warnings, instructions, marketing, packaging, or labeling of any product.”

▶ Class action: A class action lawsuit, governed by Rule 23 of the Federal Rules of Civil Procedure, describes a legal cause of action where a representative plaintiff asserts claims on behalf of a large class of similarly injured members, who then give up their rights to pursue an individual lawsuit. It confers several advantages upon the plaintiffs, including the potential of higher damages.

However, four prerequisites must be present before a lawsuit can be certified a class action: numerosity, commonality, typicality, and adequacy.

Although there is the possibility of going forward with a class action suit, a federal judge in Georgia refused to certify class action status in the 2011 recall case. The judge stated that only 53 of the half-million recalled blister packs had the pills arranged in reverse order, and each woman’s case should be individually adjudicated given the controlling laws in her state, the need to prove use of the product, and whether she became pregnant and carried the pregnancy to term.

▶ Wrongful life: Strictly speaking, tort issues in this case can be divided into two categories: wrongful pregnancy (sometimes confusingly referred to as wrongful birth) alleged by the mother, and wrongful life by the child. Unfortunately, these claims are frequently lumped together under the rubric of wrongful life.

The women affected by this mix-up are reportedly seeking damages for lost income, medical costs, and, in some cases, the cost of raising their children, including the cost of college. However, the common law has traditionally barred a wrongful life action, although state laws have evolved over the years. So, court decisions and statutes in each state should be carefully consulted for any individual case.

The prime reason for disallowing a wrongful life action is that life, even if imperfect, is always preferable to non-life. Besides, it will be impossible to assess the quantum of damages, because this necessarily requires placing a monetary worth on human existence.

The seminal case is the 1967 New Jersey decision of Gleitman v. Cosgrove (227 A.2d 689 [N.J. 1967]), but the state’s position has since changed. In Berman v. Allan (404 A.2d 8 [N.J. 1979]), the court allowed damages for maternal emotional distress, though not for medical and other expenses of raising the child.

Overall, the law of wrongful life appears to be increasingly willing to award damages to the mother for the physical, emotional, and financial costs of pregnancy and delivery, but not the cost associated with the normal rearing of a healthy child.

The legal situation is quite different for a lawsuit filed by the child, who in essence is arguing that he/she should not have been born at all. Courts continue to refuse a claim brought by a healthy infant for wrongful life, adopting the reasoning in Berman that the infant has not suffered any damage cognizable at law by being brought into existence. Even an infant with birth disabilities will not prevail in the majority of jurisdictions, with California being a notable exception.

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at siang@hawaii.edu.

Question: Oral contraceptives are prescription drugs sold with highly specific manufacturer instructions on how and when to take them, because the sequence of pill ingestion is critical to their anovulatory efficacy.

Suppose a manufacturing mishap resulted in improper labeling and sequencing of the pills, and some women, relying on the product, became pregnant. In a lawsuit against the manufacturer, which of the following choices is best?

A. This is a case of product liability.

B. Affected plaintiffs should consider filing a class-action lawsuit.

C. Mothers can sue for wrongful pregnancy.

D. Children can sue for wrongful life.

E. All are possible legal causes of action.

Answer: E. This hypothetical is adapted from a recent report that the use of mispackaged oral contraceptives had resulted in more than 100 women becoming pregnant. The prescription drugs, available in blister packs, were erroneously sequenced such that the daily use of active or inactive drug was asynchronous with the woman’s ovulatory cycle, thus foiling the drug’s pregnancy prevention efficacy.

Typically, each packet of oral contraceptives comes with 28 days’ worth of color-coded pills, with the first 21 containing the active principle to inhibit ovulation, followed by 7 inert pills. Each monthly pack begins with the same strict pill sequence.

In 2011, the manufacturer of several brands of oral contraceptives recalled half a million such packs when it was discovered that some of them had the pill sequence reversed. Foreseeably, this debacle resulted in a number of unplanned pregnancies – and live births. Legal action soon followed.

▶ Product liability: A simple negligence lawsuit would typically cover a situation in which a wrongdoer has breached the requisite standard of care, as appears to be the case here. However, when a product such as a prescription drug leads to “harm,” an injured party, using the law of product liability, can sue the manufacturer that had placed it into the stream of commerce. This allows the plaintiff to rely on legal theories other than negligence, including breach of warranty and strict liability.

Under the latter legal theory, there is no need to prove fault or contractual breach, and the significant part of the complaint is whether the product is both defective and unreasonably dangerous. “Defective” is usually defined as product quality that is less than what a reasonable consumer expects, and “unreasonably dangerous” is a conclusion that the risks that result from its condition outweigh the product’s advantages.

Although the medication itself in this case is not defective or unreasonably dangerous, the assembly and labeling fiasco would suffice to keep the lawsuit within the product liability category. According to Section 102(2) of the Uniform Product Liability Act, product liability includes “all claims or action brought for personal injury, death, or property damage caused by the manufacture, design, formula, preparation, assembly, installation, testing, warnings, instructions, marketing, packaging, or labeling of any product.”

▶ Class action: A class action lawsuit, governed by Rule 23 of the Federal Rules of Civil Procedure, describes a legal cause of action where a representative plaintiff asserts claims on behalf of a large class of similarly injured members, who then give up their rights to pursue an individual lawsuit. It confers several advantages upon the plaintiffs, including the potential of higher damages.

However, four prerequisites must be present before a lawsuit can be certified a class action: numerosity, commonality, typicality, and adequacy.

Although there is the possibility of going forward with a class action suit, a federal judge in Georgia refused to certify class action status in the 2011 recall case. The judge stated that only 53 of the half-million recalled blister packs had the pills arranged in reverse order, and each woman’s case should be individually adjudicated given the controlling laws in her state, the need to prove use of the product, and whether she became pregnant and carried the pregnancy to term.

▶ Wrongful life: Strictly speaking, tort issues in this case can be divided into two categories: wrongful pregnancy (sometimes confusingly referred to as wrongful birth) alleged by the mother, and wrongful life by the child. Unfortunately, these claims are frequently lumped together under the rubric of wrongful life.

The women affected by this mix-up are reportedly seeking damages for lost income, medical costs, and, in some cases, the cost of raising their children, including the cost of college. However, the common law has traditionally barred a wrongful life action, although state laws have evolved over the years. So, court decisions and statutes in each state should be carefully consulted for any individual case.

The prime reason for disallowing a wrongful life action is that life, even if imperfect, is always preferable to non-life. Besides, it will be impossible to assess the quantum of damages, because this necessarily requires placing a monetary worth on human existence.

The seminal case is the 1967 New Jersey decision of Gleitman v. Cosgrove (227 A.2d 689 [N.J. 1967]), but the state’s position has since changed. In Berman v. Allan (404 A.2d 8 [N.J. 1979]), the court allowed damages for maternal emotional distress, though not for medical and other expenses of raising the child.

Overall, the law of wrongful life appears to be increasingly willing to award damages to the mother for the physical, emotional, and financial costs of pregnancy and delivery, but not the cost associated with the normal rearing of a healthy child.

The legal situation is quite different for a lawsuit filed by the child, who in essence is arguing that he/she should not have been born at all. Courts continue to refuse a claim brought by a healthy infant for wrongful life, adopting the reasoning in Berman that the infant has not suffered any damage cognizable at law by being brought into existence. Even an infant with birth disabilities will not prevail in the majority of jurisdictions, with California being a notable exception.

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at siang@hawaii.edu.

Question: Oral contraceptives are prescription drugs sold with highly specific manufacturer instructions on how and when to take them, because the sequence of pill ingestion is critical to their anovulatory efficacy.

Suppose a manufacturing mishap resulted in improper labeling and sequencing of the pills, and some women, relying on the product, became pregnant. In a lawsuit against the manufacturer, which of the following choices is best?

A. This is a case of product liability.

B. Affected plaintiffs should consider filing a class-action lawsuit.

C. Mothers can sue for wrongful pregnancy.

D. Children can sue for wrongful life.

E. All are possible legal causes of action.

Answer: E. This hypothetical is adapted from a recent report that the use of mispackaged oral contraceptives had resulted in more than 100 women becoming pregnant. The prescription drugs, available in blister packs, were erroneously sequenced such that the daily use of active or inactive drug was asynchronous with the woman’s ovulatory cycle, thus foiling the drug’s pregnancy prevention efficacy.

Typically, each packet of oral contraceptives comes with 28 days’ worth of color-coded pills, with the first 21 containing the active principle to inhibit ovulation, followed by 7 inert pills. Each monthly pack begins with the same strict pill sequence.

In 2011, the manufacturer of several brands of oral contraceptives recalled half a million such packs when it was discovered that some of them had the pill sequence reversed. Foreseeably, this debacle resulted in a number of unplanned pregnancies – and live births. Legal action soon followed.

▶ Product liability: A simple negligence lawsuit would typically cover a situation in which a wrongdoer has breached the requisite standard of care, as appears to be the case here. However, when a product such as a prescription drug leads to “harm,” an injured party, using the law of product liability, can sue the manufacturer that had placed it into the stream of commerce. This allows the plaintiff to rely on legal theories other than negligence, including breach of warranty and strict liability.

Under the latter legal theory, there is no need to prove fault or contractual breach, and the significant part of the complaint is whether the product is both defective and unreasonably dangerous. “Defective” is usually defined as product quality that is less than what a reasonable consumer expects, and “unreasonably dangerous” is a conclusion that the risks that result from its condition outweigh the product’s advantages.

Although the medication itself in this case is not defective or unreasonably dangerous, the assembly and labeling fiasco would suffice to keep the lawsuit within the product liability category. According to Section 102(2) of the Uniform Product Liability Act, product liability includes “all claims or action brought for personal injury, death, or property damage caused by the manufacture, design, formula, preparation, assembly, installation, testing, warnings, instructions, marketing, packaging, or labeling of any product.”

▶ Class action: A class action lawsuit, governed by Rule 23 of the Federal Rules of Civil Procedure, describes a legal cause of action where a representative plaintiff asserts claims on behalf of a large class of similarly injured members, who then give up their rights to pursue an individual lawsuit. It confers several advantages upon the plaintiffs, including the potential of higher damages.

However, four prerequisites must be present before a lawsuit can be certified a class action: numerosity, commonality, typicality, and adequacy.

Although there is the possibility of going forward with a class action suit, a federal judge in Georgia refused to certify class action status in the 2011 recall case. The judge stated that only 53 of the half-million recalled blister packs had the pills arranged in reverse order, and each woman’s case should be individually adjudicated given the controlling laws in her state, the need to prove use of the product, and whether she became pregnant and carried the pregnancy to term.

▶ Wrongful life: Strictly speaking, tort issues in this case can be divided into two categories: wrongful pregnancy (sometimes confusingly referred to as wrongful birth) alleged by the mother, and wrongful life by the child. Unfortunately, these claims are frequently lumped together under the rubric of wrongful life.

The women affected by this mix-up are reportedly seeking damages for lost income, medical costs, and, in some cases, the cost of raising their children, including the cost of college. However, the common law has traditionally barred a wrongful life action, although state laws have evolved over the years. So, court decisions and statutes in each state should be carefully consulted for any individual case.

The prime reason for disallowing a wrongful life action is that life, even if imperfect, is always preferable to non-life. Besides, it will be impossible to assess the quantum of damages, because this necessarily requires placing a monetary worth on human existence.

The seminal case is the 1967 New Jersey decision of Gleitman v. Cosgrove (227 A.2d 689 [N.J. 1967]), but the state’s position has since changed. In Berman v. Allan (404 A.2d 8 [N.J. 1979]), the court allowed damages for maternal emotional distress, though not for medical and other expenses of raising the child.

Overall, the law of wrongful life appears to be increasingly willing to award damages to the mother for the physical, emotional, and financial costs of pregnancy and delivery, but not the cost associated with the normal rearing of a healthy child.

The legal situation is quite different for a lawsuit filed by the child, who in essence is arguing that he/she should not have been born at all. Courts continue to refuse a claim brought by a healthy infant for wrongful life, adopting the reasoning in Berman that the infant has not suffered any damage cognizable at law by being brought into existence. Even an infant with birth disabilities will not prevail in the majority of jurisdictions, with California being a notable exception.

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at siang@hawaii.edu.