S.Y. TAN

Question: As a family physician with a large practice, you own your own x-ray machine, and you regularly obtain and interpret your patients' x-rays instead of having a radiologist read them. Assume that the community standard is for radiologists rather than generalists to read x-rays. What level of accuracy or standard of care will you be held to?

A. That of a generalist.

B. That of a reasonable doctor using his or her best judgment.

C. That of a radiologist.

D. A standard between that of a radiologist and a generalist.

E. That of an x-ray technician whose expertise in radiology is similar to yours.

Answer: C. A doctor is usually held to the objective standards of fellow doctors, given the circumstances of the case. Specialists will be held to a higher standard: that ordinarily expected of fellow doctors in that specialty. However, if you, a generalist, assume the duties normally performed by a specialist, the law will consider that you are representing yourself as capable of functioning at that level. In the above case, if generalists do not regularly read their own x-rays and you, a family physician, choose to do so, you will be held to the standard of a radiologist. Choice B is incorrect because “best judgment” is not a legal standard that governs malpractice matters.

The legal duty owed by doctors to their patients is that of reasonable care, defined as that level of care expected of the reasonably competent doctor—that is, a professional standard, not that of a reasonably prudent layperson, the latter being the standard used in negligence actions. Thus, Alabama has held that physicians must “exercise such reasonable care, diligence, and skill as reasonably competent physicians” would exercise in the same or similar circumstances (Keebler v. Winfield Carraway Hospital, 531 So.2d 841 [Ala. 1988]). An Illinois court used similar words: “[A] physician must possess and apply the knowledge, skill, and care of a reasonably well-qualified physician in the relevant medical community” (Purtill v. Hess, 489 N.E.2d 867 [Ill. 1986]). And in Hawaii, “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” (Craft v. Peebles, 893 P.2d 138 [Haw. 1995]).

While the professional standard applies to injuries arising out of medical care, the “reasonable person” standard continues to govern non–health care activities such as falls on slippery hospital floors. Unfortunately, the distinction may not always be clear. As one author put it, “Sometimes it is difficult to differentiate bad housekeeping and bad medical care, as where rats in a hospital repeatedly bit a comatose patient” (Dobbs, D.B. 2000. The Law of Torts. St. Paul, Minn.: West Group. Chapter 14, referring to Lejeunee v. Rayne Branch Hospital, 556 So.2d 559 [La. 1990]).

The doctor's specialty does matter in legal proceedings addressing the standard of care. The surgeon will be judged according to the community standard of the ordinarily skilled surgeon, and the generalists according to that of other generalists. But there is a separate duty to refer if the case is outside the doctor's field of expertise. If the standard is to refer to a specialist, the family physician who undertakes to personally treat the patient within that specialty will be held to that higher standard. In Simpson v. Davis, for example, a general dentist performed root canal work and was therefore held to the standard of an endodontist (Simpson v. Davis, 549 P.2d 950 [Kan. 1976]).

The law expects doctors to provide reasonable care to their patients, even for conditions arguably outside their specialty. In a recent lawsuit, a gynecologist failed to consider appendicitis in a 32-year-old woman who presented with fever, chills, nausea, and lower abdominal pain. This delay in diagnosis led to rupture. The defendant-gynecologist argued that the diagnosis of a urinary tract infection or a pelvic condition was appropriate given the doctor's specialty. The gynecologist did not document the abdominal and pelvic examinations in detail, and did not obtain an ultrasound study. The trial court entered a verdict for the plaintiff; jury members later confided that the verdict would have been different had the doctor simply included appendicitis in the differential diagnosis (“Not My Specialty.” The Doctor's Advocate, Third Quarter, 2006).

In medicine, there is frequently a minority view as to how things ought to be done, so the standard of care need not necessarily be unanimous. So long as the minority view is held by a respectable group of doctors, the law will accept it as a legitimate alternative. However, this does not mean that any “on-the-fringe” publication on an issue will suffice. A minority view is reflective of a different approach to the same problem, but the care rendered must still comply with the standard of care espoused. In a Texas case, the court was not concerned with whether the practice was that of a respectable minority or a considerable number of physicians, but whether it met the standard. The case involved an augmentation mammoplasty procedure that resulted in silicone leakage. A number of qualified physicians had used that procedure, and this satisfied the court that the standard had been met (Henderson v. Heyer-Schulte Corp. of Santa Barbara, 600 S.W.2d 844 [Tex Civ. App. 1980]).

Finally, courts have in the past considered the locale where the tortious act took place, invoking the so-called “locality rule.” This was based on the belief that different standards of care were applicable in different areas of the country, for example, urban vs. rural. However, this rule has been largely abandoned in favor of a uniform standard, because current medical training and board certifications all adhere to a national standard. But geographic considerations are not entirely irrelevant. Where the local medical facilities lack state-of-the-art equipment or specialists, courts will give due consideration to such conditions. Still, there is always the duty to reasonably transfer to an available specialist or facility, and failure to do so may form the basis of liability.

Question: As a family physician with a large practice, you own your own x-ray machine, and you regularly obtain and interpret your patients' x-rays instead of having a radiologist read them. Assume that the community standard is for radiologists rather than generalists to read x-rays. What level of accuracy or standard of care will you be held to?

A. That of a generalist.

B. That of a reasonable doctor using his or her best judgment.

C. That of a radiologist.

D. A standard between that of a radiologist and a generalist.

E. That of an x-ray technician whose expertise in radiology is similar to yours.

Answer: C. A doctor is usually held to the objective standards of fellow doctors, given the circumstances of the case. Specialists will be held to a higher standard: that ordinarily expected of fellow doctors in that specialty. However, if you, a generalist, assume the duties normally performed by a specialist, the law will consider that you are representing yourself as capable of functioning at that level. In the above case, if generalists do not regularly read their own x-rays and you, a family physician, choose to do so, you will be held to the standard of a radiologist. Choice B is incorrect because “best judgment” is not a legal standard that governs malpractice matters.

The legal duty owed by doctors to their patients is that of reasonable care, defined as that level of care expected of the reasonably competent doctor—that is, a professional standard, not that of a reasonably prudent layperson, the latter being the standard used in negligence actions. Thus, Alabama has held that physicians must “exercise such reasonable care, diligence, and skill as reasonably competent physicians” would exercise in the same or similar circumstances (Keebler v. Winfield Carraway Hospital, 531 So.2d 841 [Ala. 1988]). An Illinois court used similar words: “[A] physician must possess and apply the knowledge, skill, and care of a reasonably well-qualified physician in the relevant medical community” (Purtill v. Hess, 489 N.E.2d 867 [Ill. 1986]). And in Hawaii, “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” (Craft v. Peebles, 893 P.2d 138 [Haw. 1995]).

While the professional standard applies to injuries arising out of medical care, the “reasonable person” standard continues to govern non–health care activities such as falls on slippery hospital floors. Unfortunately, the distinction may not always be clear. As one author put it, “Sometimes it is difficult to differentiate bad housekeeping and bad medical care, as where rats in a hospital repeatedly bit a comatose patient” (Dobbs, D.B. 2000. The Law of Torts. St. Paul, Minn.: West Group. Chapter 14, referring to Lejeunee v. Rayne Branch Hospital, 556 So.2d 559 [La. 1990]).

The doctor's specialty does matter in legal proceedings addressing the standard of care. The surgeon will be judged according to the community standard of the ordinarily skilled surgeon, and the generalists according to that of other generalists. But there is a separate duty to refer if the case is outside the doctor's field of expertise. If the standard is to refer to a specialist, the family physician who undertakes to personally treat the patient within that specialty will be held to that higher standard. In Simpson v. Davis, for example, a general dentist performed root canal work and was therefore held to the standard of an endodontist (Simpson v. Davis, 549 P.2d 950 [Kan. 1976]).

The law expects doctors to provide reasonable care to their patients, even for conditions arguably outside their specialty. In a recent lawsuit, a gynecologist failed to consider appendicitis in a 32-year-old woman who presented with fever, chills, nausea, and lower abdominal pain. This delay in diagnosis led to rupture. The defendant-gynecologist argued that the diagnosis of a urinary tract infection or a pelvic condition was appropriate given the doctor's specialty. The gynecologist did not document the abdominal and pelvic examinations in detail, and did not obtain an ultrasound study. The trial court entered a verdict for the plaintiff; jury members later confided that the verdict would have been different had the doctor simply included appendicitis in the differential diagnosis (“Not My Specialty.” The Doctor's Advocate, Third Quarter, 2006).

In medicine, there is frequently a minority view as to how things ought to be done, so the standard of care need not necessarily be unanimous. So long as the minority view is held by a respectable group of doctors, the law will accept it as a legitimate alternative. However, this does not mean that any “on-the-fringe” publication on an issue will suffice. A minority view is reflective of a different approach to the same problem, but the care rendered must still comply with the standard of care espoused. In a Texas case, the court was not concerned with whether the practice was that of a respectable minority or a considerable number of physicians, but whether it met the standard. The case involved an augmentation mammoplasty procedure that resulted in silicone leakage. A number of qualified physicians had used that procedure, and this satisfied the court that the standard had been met (Henderson v. Heyer-Schulte Corp. of Santa Barbara, 600 S.W.2d 844 [Tex Civ. App. 1980]).

Finally, courts have in the past considered the locale where the tortious act took place, invoking the so-called “locality rule.” This was based on the belief that different standards of care were applicable in different areas of the country, for example, urban vs. rural. However, this rule has been largely abandoned in favor of a uniform standard, because current medical training and board certifications all adhere to a national standard. But geographic considerations are not entirely irrelevant. Where the local medical facilities lack state-of-the-art equipment or specialists, courts will give due consideration to such conditions. Still, there is always the duty to reasonably transfer to an available specialist or facility, and failure to do so may form the basis of liability.

Question: As a family physician with a large practice, you own your own x-ray machine, and you regularly obtain and interpret your patients' x-rays instead of having a radiologist read them. Assume that the community standard is for radiologists rather than generalists to read x-rays. What level of accuracy or standard of care will you be held to?

A. That of a generalist.

B. That of a reasonable doctor using his or her best judgment.

C. That of a radiologist.

D. A standard between that of a radiologist and a generalist.

E. That of an x-ray technician whose expertise in radiology is similar to yours.

Answer: C. A doctor is usually held to the objective standards of fellow doctors, given the circumstances of the case. Specialists will be held to a higher standard: that ordinarily expected of fellow doctors in that specialty. However, if you, a generalist, assume the duties normally performed by a specialist, the law will consider that you are representing yourself as capable of functioning at that level. In the above case, if generalists do not regularly read their own x-rays and you, a family physician, choose to do so, you will be held to the standard of a radiologist. Choice B is incorrect because “best judgment” is not a legal standard that governs malpractice matters.

The legal duty owed by doctors to their patients is that of reasonable care, defined as that level of care expected of the reasonably competent doctor—that is, a professional standard, not that of a reasonably prudent layperson, the latter being the standard used in negligence actions. Thus, Alabama has held that physicians must “exercise such reasonable care, diligence, and skill as reasonably competent physicians” would exercise in the same or similar circumstances (Keebler v. Winfield Carraway Hospital, 531 So.2d 841 [Ala. 1988]). An Illinois court used similar words: “[A] physician must possess and apply the knowledge, skill, and care of a reasonably well-qualified physician in the relevant medical community” (Purtill v. Hess, 489 N.E.2d 867 [Ill. 1986]). And in Hawaii, “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” (Craft v. Peebles, 893 P.2d 138 [Haw. 1995]).

While the professional standard applies to injuries arising out of medical care, the “reasonable person” standard continues to govern non–health care activities such as falls on slippery hospital floors. Unfortunately, the distinction may not always be clear. As one author put it, “Sometimes it is difficult to differentiate bad housekeeping and bad medical care, as where rats in a hospital repeatedly bit a comatose patient” (Dobbs, D.B. 2000. The Law of Torts. St. Paul, Minn.: West Group. Chapter 14, referring to Lejeunee v. Rayne Branch Hospital, 556 So.2d 559 [La. 1990]).

The doctor's specialty does matter in legal proceedings addressing the standard of care. The surgeon will be judged according to the community standard of the ordinarily skilled surgeon, and the generalists according to that of other generalists. But there is a separate duty to refer if the case is outside the doctor's field of expertise. If the standard is to refer to a specialist, the family physician who undertakes to personally treat the patient within that specialty will be held to that higher standard. In Simpson v. Davis, for example, a general dentist performed root canal work and was therefore held to the standard of an endodontist (Simpson v. Davis, 549 P.2d 950 [Kan. 1976]).

The law expects doctors to provide reasonable care to their patients, even for conditions arguably outside their specialty. In a recent lawsuit, a gynecologist failed to consider appendicitis in a 32-year-old woman who presented with fever, chills, nausea, and lower abdominal pain. This delay in diagnosis led to rupture. The defendant-gynecologist argued that the diagnosis of a urinary tract infection or a pelvic condition was appropriate given the doctor's specialty. The gynecologist did not document the abdominal and pelvic examinations in detail, and did not obtain an ultrasound study. The trial court entered a verdict for the plaintiff; jury members later confided that the verdict would have been different had the doctor simply included appendicitis in the differential diagnosis (“Not My Specialty.” The Doctor's Advocate, Third Quarter, 2006).

In medicine, there is frequently a minority view as to how things ought to be done, so the standard of care need not necessarily be unanimous. So long as the minority view is held by a respectable group of doctors, the law will accept it as a legitimate alternative. However, this does not mean that any “on-the-fringe” publication on an issue will suffice. A minority view is reflective of a different approach to the same problem, but the care rendered must still comply with the standard of care espoused. In a Texas case, the court was not concerned with whether the practice was that of a respectable minority or a considerable number of physicians, but whether it met the standard. The case involved an augmentation mammoplasty procedure that resulted in silicone leakage. A number of qualified physicians had used that procedure, and this satisfied the court that the standard had been met (Henderson v. Heyer-Schulte Corp. of Santa Barbara, 600 S.W.2d 844 [Tex Civ. App. 1980]).

Finally, courts have in the past considered the locale where the tortious act took place, invoking the so-called “locality rule.” This was based on the belief that different standards of care were applicable in different areas of the country, for example, urban vs. rural. However, this rule has been largely abandoned in favor of a uniform standard, because current medical training and board certifications all adhere to a national standard. But geographic considerations are not entirely irrelevant. Where the local medical facilities lack state-of-the-art equipment or specialists, courts will give due consideration to such conditions. Still, there is always the duty to reasonably transfer to an available specialist or facility, and failure to do so may form the basis of liability.

Question: Regarding physician liability arising from medication injuries, which of the following is most accurate?

A. Doctor is liable if drug was prescribed for unapproved off-label use.

B. Doctor is liable for failing to warn of significant risks.

C. Doctor is liable for failing to warn of all complications.

D. Patient did not ask about side effects and therefore was contributorily negligent.

E. Liability will attach to manufacturer for a “defective product.”

Answer: B. The informed consent doctrine requires that physicians discuss all material risks, including rare but serious risks. Choice A is incorrect because prescribing a drug for an “off-label” use may be an acceptable practice. However, it is prudent for the doctor to document in the records the reason for using the drug. Choice C is overly broad. A warning is required for all material risks (i.e., those that significantly affect the patient's decision to accept or reject the recommended treatment), but a warning is not necessary for all risks.

Patients are assumed to have little or no knowledge of medications, and they have no legal duty to inquire about side effects. The doctor, on the other hand, has an affirmative duty to warn of these side effects. In a malpractice case alleging lack of informed consent due to failure to warn, the defense cannot plead contributory negligence, so choice D is incorrect. Finally, E is also incorrect. The “learned intermediary” doctrine stipulates that the doctor, not the pharmaceutical company, is liable for medication-related injuries as he/she is a learned professional who directly communicates with the patient and who does the actual prescribing. This puts the doctor in the hot seat for an adverse drug reaction, unless the drug company has been negligent in identifying and/or communicating the risk.

Disclosure of Material Risks

In order for patients to meaningfully give their consent to treatment, they should have sufficient information regarding the doctor's treatment plans. The consent must also be given voluntarily. The notion of patient autonomy is so entrenched that the law imposes upon the practitioner the duty to disclose three fundamental aspects of treatment, easily remembered by the mnemonic PAR (P = procedure [or medication/device], A = alternatives, R = risks).

What constitutes a material risk is at the heart of the controversy surrounding the informed consent doctrine. Generally, the patient should be informed of all serious risks, even if unusual or rare. However, in one court case, a 1% risk of hearing loss required disclosure (Scott v. Wilson, 396 S.W.2d 532 [Tex. Civ. App. 1965]), whereas in another, the court appeared to say that a 1.5% chance of visual loss did not (Yeats v. Harms, 393 P.2d 982 [Kan. 1964]). The California Supreme Court has stated that “material information is that which the physician knows or should know would be regarded as significant by a reasonable person in the patient's position when deciding to accept or reject the recommended medical procedure,” that “a (material) fact must also be one which is not commonly appreciated,” and that the scope of disclosure may be expanded in patients with “unique concerns or lack of familiarity with medical procedures” (Truman v. Thomas, 27 Cal.3d 285 [1980]). There is, however, no legal requirement to deliver a “mini-course in medical science” (Cobbs v. Grant, 8 Cal.3d 229 [1972]).

Warren v. Schecter is one of the most dramatic cases to confront the material risk issue. The plaintiff won a $9.6 million judgment against the doctor for his failure to disclose risk of osteoporosis (Warren v. Schecter, 67 Cal.Rptr.2d 573 [Cal. 1997]). Dr. Schecter had performed gastric surgery on Janet Warren for peptic ulcer disease, and had warned the patient of the risks of bowel obstruction, dumping syndrome, and anesthetic death. He did not believe osteoporosis, osteomalacia, and bone pain were risks of surgery, and so did not discuss those risks with her. The plaintiff testified at trial that had Dr. Schecter warned of the risk of metabolic bone disease, she would not have consented to surgery. A second operation was undertaken because she developed postoperative dumping syndrome and alkaline reflux gastritis, and the surgeon again failed to advise her of the risk of metabolic bone disease. She again asserted that she would not have consented to the second surgery had she been duly advised.

The plaintiff subsequently developed severe osteoporotic fractures, and filed a malpractice lawsuit alleging that Dr. Schecter was liable under an informed consent theory for performing surgery without advising her of the risk of bone complications. The jury found that Dr. Schecter did not disclose to Ms. Warren all relevant information that would have enabled her to make an informed decision regarding surgery and that a reasonably prudent person in her position would not have consented to surgery if adequately informed of all the significant perils.

Other Aspects of Disclosure

Besides risks associated with surgery or a medication, courts have also looked at other aspects of disclosure in the doctor-patient relationship. Some litigated examples include disclosing the limited experience of a neurosurgeon (Johnson v. Kokemoor, 545 N.W.2d 495 [Wis. 1996]), financial incentives amounting to a breach of fiduciary responsibility (Moore v. The Regents of the University of California, 793 P.2d 479 [Cal. 1990]), and a surgeon's disclosure of his positive HIV status (Estate of Behringer v. The Medical Center at Princeton, 192 A.2d 1251 [N.J. Super. 1991]) or alcoholism (Hidding v. Williams, 578 So.2d 1192 [La.App. 1991]). However, in Arato v. Avedon, the California Supreme Court held that the law did not require physicians to inform their terminally ill patients of their prognosis and life expectancy (Arato v. Avedon, 858 P.2d 598 [Cal. 1993]).

An example of statutory law regarding informed consent is found in Hawaii Revised Statutes §671-3. Amended by the 2003 legislature, the statute mandates disclosure of “recognized material risks of serious complications or mortality” but does not define the word “material.” This amended language replaced the earlier version's “recognized, serious, possible risks, complications and anticipated benefits,” arguably lightening the doctor's duty regarding risk disclosure. In reality, the new language is unlikely to have a significant practical effect. An earlier 1976 version of the law merely required the disclosure of “probable risks and effects.”

Contact the author at [email protected].

Question: Regarding physician liability arising from medication injuries, which of the following is most accurate?

A. Doctor is liable if drug was prescribed for unapproved off-label use.

B. Doctor is liable for failing to warn of significant risks.

C. Doctor is liable for failing to warn of all complications.

D. Patient did not ask about side effects and therefore was contributorily negligent.

E. Liability will attach to manufacturer for a “defective product.”

Answer: B. The informed consent doctrine requires that physicians discuss all material risks, including rare but serious risks. Choice A is incorrect because prescribing a drug for an “off-label” use may be an acceptable practice. However, it is prudent for the doctor to document in the records the reason for using the drug. Choice C is overly broad. A warning is required for all material risks (i.e., those that significantly affect the patient's decision to accept or reject the recommended treatment), but a warning is not necessary for all risks.

Patients are assumed to have little or no knowledge of medications, and they have no legal duty to inquire about side effects. The doctor, on the other hand, has an affirmative duty to warn of these side effects. In a malpractice case alleging lack of informed consent due to failure to warn, the defense cannot plead contributory negligence, so choice D is incorrect. Finally, E is also incorrect. The “learned intermediary” doctrine stipulates that the doctor, not the pharmaceutical company, is liable for medication-related injuries as he/she is a learned professional who directly communicates with the patient and who does the actual prescribing. This puts the doctor in the hot seat for an adverse drug reaction, unless the drug company has been negligent in identifying and/or communicating the risk.

Disclosure of Material Risks

In order for patients to meaningfully give their consent to treatment, they should have sufficient information regarding the doctor's treatment plans. The consent must also be given voluntarily. The notion of patient autonomy is so entrenched that the law imposes upon the practitioner the duty to disclose three fundamental aspects of treatment, easily remembered by the mnemonic PAR (P = procedure [or medication/device], A = alternatives, R = risks).

What constitutes a material risk is at the heart of the controversy surrounding the informed consent doctrine. Generally, the patient should be informed of all serious risks, even if unusual or rare. However, in one court case, a 1% risk of hearing loss required disclosure (Scott v. Wilson, 396 S.W.2d 532 [Tex. Civ. App. 1965]), whereas in another, the court appeared to say that a 1.5% chance of visual loss did not (Yeats v. Harms, 393 P.2d 982 [Kan. 1964]). The California Supreme Court has stated that “material information is that which the physician knows or should know would be regarded as significant by a reasonable person in the patient's position when deciding to accept or reject the recommended medical procedure,” that “a (material) fact must also be one which is not commonly appreciated,” and that the scope of disclosure may be expanded in patients with “unique concerns or lack of familiarity with medical procedures” (Truman v. Thomas, 27 Cal.3d 285 [1980]). There is, however, no legal requirement to deliver a “mini-course in medical science” (Cobbs v. Grant, 8 Cal.3d 229 [1972]).

Warren v. Schecter is one of the most dramatic cases to confront the material risk issue. The plaintiff won a $9.6 million judgment against the doctor for his failure to disclose risk of osteoporosis (Warren v. Schecter, 67 Cal.Rptr.2d 573 [Cal. 1997]). Dr. Schecter had performed gastric surgery on Janet Warren for peptic ulcer disease, and had warned the patient of the risks of bowel obstruction, dumping syndrome, and anesthetic death. He did not believe osteoporosis, osteomalacia, and bone pain were risks of surgery, and so did not discuss those risks with her. The plaintiff testified at trial that had Dr. Schecter warned of the risk of metabolic bone disease, she would not have consented to surgery. A second operation was undertaken because she developed postoperative dumping syndrome and alkaline reflux gastritis, and the surgeon again failed to advise her of the risk of metabolic bone disease. She again asserted that she would not have consented to the second surgery had she been duly advised.

The plaintiff subsequently developed severe osteoporotic fractures, and filed a malpractice lawsuit alleging that Dr. Schecter was liable under an informed consent theory for performing surgery without advising her of the risk of bone complications. The jury found that Dr. Schecter did not disclose to Ms. Warren all relevant information that would have enabled her to make an informed decision regarding surgery and that a reasonably prudent person in her position would not have consented to surgery if adequately informed of all the significant perils.

Other Aspects of Disclosure

Besides risks associated with surgery or a medication, courts have also looked at other aspects of disclosure in the doctor-patient relationship. Some litigated examples include disclosing the limited experience of a neurosurgeon (Johnson v. Kokemoor, 545 N.W.2d 495 [Wis. 1996]), financial incentives amounting to a breach of fiduciary responsibility (Moore v. The Regents of the University of California, 793 P.2d 479 [Cal. 1990]), and a surgeon's disclosure of his positive HIV status (Estate of Behringer v. The Medical Center at Princeton, 192 A.2d 1251 [N.J. Super. 1991]) or alcoholism (Hidding v. Williams, 578 So.2d 1192 [La.App. 1991]). However, in Arato v. Avedon, the California Supreme Court held that the law did not require physicians to inform their terminally ill patients of their prognosis and life expectancy (Arato v. Avedon, 858 P.2d 598 [Cal. 1993]).

An example of statutory law regarding informed consent is found in Hawaii Revised Statutes §671-3. Amended by the 2003 legislature, the statute mandates disclosure of “recognized material risks of serious complications or mortality” but does not define the word “material.” This amended language replaced the earlier version's “recognized, serious, possible risks, complications and anticipated benefits,” arguably lightening the doctor's duty regarding risk disclosure. In reality, the new language is unlikely to have a significant practical effect. An earlier 1976 version of the law merely required the disclosure of “probable risks and effects.”

Contact the author at [email protected].

Question: Regarding physician liability arising from medication injuries, which of the following is most accurate?

A. Doctor is liable if drug was prescribed for unapproved off-label use.

B. Doctor is liable for failing to warn of significant risks.

C. Doctor is liable for failing to warn of all complications.

D. Patient did not ask about side effects and therefore was contributorily negligent.

E. Liability will attach to manufacturer for a “defective product.”

Answer: B. The informed consent doctrine requires that physicians discuss all material risks, including rare but serious risks. Choice A is incorrect because prescribing a drug for an “off-label” use may be an acceptable practice. However, it is prudent for the doctor to document in the records the reason for using the drug. Choice C is overly broad. A warning is required for all material risks (i.e., those that significantly affect the patient's decision to accept or reject the recommended treatment), but a warning is not necessary for all risks.

Patients are assumed to have little or no knowledge of medications, and they have no legal duty to inquire about side effects. The doctor, on the other hand, has an affirmative duty to warn of these side effects. In a malpractice case alleging lack of informed consent due to failure to warn, the defense cannot plead contributory negligence, so choice D is incorrect. Finally, E is also incorrect. The “learned intermediary” doctrine stipulates that the doctor, not the pharmaceutical company, is liable for medication-related injuries as he/she is a learned professional who directly communicates with the patient and who does the actual prescribing. This puts the doctor in the hot seat for an adverse drug reaction, unless the drug company has been negligent in identifying and/or communicating the risk.

Disclosure of Material Risks

In order for patients to meaningfully give their consent to treatment, they should have sufficient information regarding the doctor's treatment plans. The consent must also be given voluntarily. The notion of patient autonomy is so entrenched that the law imposes upon the practitioner the duty to disclose three fundamental aspects of treatment, easily remembered by the mnemonic PAR (P = procedure [or medication/device], A = alternatives, R = risks).

What constitutes a material risk is at the heart of the controversy surrounding the informed consent doctrine. Generally, the patient should be informed of all serious risks, even if unusual or rare. However, in one court case, a 1% risk of hearing loss required disclosure (Scott v. Wilson, 396 S.W.2d 532 [Tex. Civ. App. 1965]), whereas in another, the court appeared to say that a 1.5% chance of visual loss did not (Yeats v. Harms, 393 P.2d 982 [Kan. 1964]). The California Supreme Court has stated that “material information is that which the physician knows or should know would be regarded as significant by a reasonable person in the patient's position when deciding to accept or reject the recommended medical procedure,” that “a (material) fact must also be one which is not commonly appreciated,” and that the scope of disclosure may be expanded in patients with “unique concerns or lack of familiarity with medical procedures” (Truman v. Thomas, 27 Cal.3d 285 [1980]). There is, however, no legal requirement to deliver a “mini-course in medical science” (Cobbs v. Grant, 8 Cal.3d 229 [1972]).

Warren v. Schecter is one of the most dramatic cases to confront the material risk issue. The plaintiff won a $9.6 million judgment against the doctor for his failure to disclose risk of osteoporosis (Warren v. Schecter, 67 Cal.Rptr.2d 573 [Cal. 1997]). Dr. Schecter had performed gastric surgery on Janet Warren for peptic ulcer disease, and had warned the patient of the risks of bowel obstruction, dumping syndrome, and anesthetic death. He did not believe osteoporosis, osteomalacia, and bone pain were risks of surgery, and so did not discuss those risks with her. The plaintiff testified at trial that had Dr. Schecter warned of the risk of metabolic bone disease, she would not have consented to surgery. A second operation was undertaken because she developed postoperative dumping syndrome and alkaline reflux gastritis, and the surgeon again failed to advise her of the risk of metabolic bone disease. She again asserted that she would not have consented to the second surgery had she been duly advised.

The plaintiff subsequently developed severe osteoporotic fractures, and filed a malpractice lawsuit alleging that Dr. Schecter was liable under an informed consent theory for performing surgery without advising her of the risk of bone complications. The jury found that Dr. Schecter did not disclose to Ms. Warren all relevant information that would have enabled her to make an informed decision regarding surgery and that a reasonably prudent person in her position would not have consented to surgery if adequately informed of all the significant perils.

Other Aspects of Disclosure

Besides risks associated with surgery or a medication, courts have also looked at other aspects of disclosure in the doctor-patient relationship. Some litigated examples include disclosing the limited experience of a neurosurgeon (Johnson v. Kokemoor, 545 N.W.2d 495 [Wis. 1996]), financial incentives amounting to a breach of fiduciary responsibility (Moore v. The Regents of the University of California, 793 P.2d 479 [Cal. 1990]), and a surgeon's disclosure of his positive HIV status (Estate of Behringer v. The Medical Center at Princeton, 192 A.2d 1251 [N.J. Super. 1991]) or alcoholism (Hidding v. Williams, 578 So.2d 1192 [La.App. 1991]). However, in Arato v. Avedon, the California Supreme Court held that the law did not require physicians to inform their terminally ill patients of their prognosis and life expectancy (Arato v. Avedon, 858 P.2d 598 [Cal. 1993]).

An example of statutory law regarding informed consent is found in Hawaii Revised Statutes §671-3. Amended by the 2003 legislature, the statute mandates disclosure of “recognized material risks of serious complications or mortality” but does not define the word “material.” This amended language replaced the earlier version's “recognized, serious, possible risks, complications and anticipated benefits,” arguably lightening the doctor's duty regarding risk disclosure. In reality, the new language is unlikely to have a significant practical effect. An earlier 1976 version of the law merely required the disclosure of “probable risks and effects.”

Contact the author at [email protected].

Question: Your patient tests positive for HIV and, despite repeated counseling, refuses to disclose this to his wife, who is also your patient. You assume husband and wife engage in unprotected sex. Select the single best answer:

A. You have both a moral and legal duty to inform your patient's wife.

B. The patient will successfully sue you if you breach confidentiality.

C. The patient's wife will successfully sue you if you do not warn her and she suffers harm.

D. You are legally obligated to disclose the information to health authorities.

E. All choices are incorrect.

Answer: E. Because a doctor must respect a patient's confidential information, medical information generally cannot be disclosed without consent. However, under some circumstances, a doctor is obligated by law or because of a higher competing interest to breach confidentiality. Examples include cases of suspected child abuse and certain public health hazards such as infectious diseases.

State law forbids the release of HIV records except in very special situations, and frequently permits but does not mandate reporting to state health authorities. Direct disclosure to third parties at risk is generally not provided by statute. However, California is an exception; the state allows the attending physician to disclose such information to “a person reasonably believed to be the spouse … a sexual partner or a person with whom the patient has shared the use of hypodermic needles, or to the local health officer” (California Health and Safety Code §121015[a]). This law is permissive, allowing but not requiring the physician to disclose.

In the hypothetical scenario described above, choice E is best. Although it could be argued that there may be a moral duty for the physician to directly inform the wife, especially since she is also a patient, legal duty is a different matter. Neither the wife nor the infected patient will necessarily be successful in a lawsuit against the doctor, depending in part on the jurisdiction and the prescribed manner of reporting/disclosure. Because statutes vary, physicians would do well to consult with state health authorities or a malpractice risk manager on the proper course of action in any given case.

Historically, patient confidentiality was part of an ethical code that all doctors abided in. The tradition dates back to the Hippocratic Oath, which states in part: “Whatever in connection with my professional practice, or not in connection with it, I see or hear, in the life of men, which ought not to be spoken of abroad, I will not divulge as reckoning that all should be kept secret.”

Notwithstanding Hippocrates (and HIPAA, its modern progeny, which protects personal health information), the professional duty to protect the secrets of a patient is not an absolute one, and in some situations limited disclosure is morally defensible and legally permissible or even obligatory. Most states require reporting in cases of suspected communicable diseases, impaired driving, child and elder abuse, domestic violence, or weapon injuries.

Even if there is no relevant state regulation, a doctor may have a legal duty to disclose sensitive information to named third parties if actual harm can be prevented through such disclosure. The well-known case of Tarasoff v. Regents of University of California established that where there is threatened harm to a named third party, the practitioner is required to reveal the information to the intended victim (this has been termed the Tarasoff rule). In Tarasoff, a patient confided in the university psychologist his intention to kill his ex-girlfriend. The information, though shared with campus security, was not released to the intended victim, and the patient stabbed her to death 2 months later. The court found the psychologist and the University of California (under respondeat superior) liable, reasoning that the protection of public safety was more important than the sanctity of doctor-patient confidentiality: “We recognize the public interest in supporting effective treatment of mental illness and in protecting the rights of patients to privacy and the consequent public importance of safeguarding the confidential character of psychotherapeutic communication. Against this interest, however, we must weigh the public interest in safety from violent assault…. In this risk-infested society, we can hardly tolerate the further exposure to danger that would result from a concealed knowledge of the therapist that his patient was lethal” (Tarasoff v. Regents of University of California, 551 P.2d 334 [S. Ct. Calif.1976]).

Disclosure to third parties of sensitive patient information may constitute defamation, which is defined as harming a person's reputation through communicating to others a verbal or written falsehood. However, truth is an absolute defense against a defamation claim; alternatively, the doctor may have a qualified privilege where there is a public health interest. For example, in Simonsen v. Swenson, a physician disclosed a positive syphilis test result that turned out to be an error. In the defamation suit that followed, the court declined to impose liability on the doctor, finding that he was protected in discharging his duty to disclose (Simonsen v. Swenson, 177 N.W. 831 [Neb. 1920]).

As a group, health care professionals ought to be far more circumspect in observing confidentiality. Loose talk, gossip, disclosure of patient identity, or indiscriminate release of medical records are all examples of confidentiality breach. We too often discuss cases, sometimes identifying the patient by name or room and bed number, in public places within earshot of strangers. In a 1995 study that observed 259 one-way elevator trips in five U.S. hospitals, the authors overheard a total of 39 inappropriate comments that took place on 36 rides (13.9% of the trips) (Am. J. Med. 1995;99:190-4). Many of the comments clearly breached patient confidentiality.

Contact the author at [email protected].

Question: Your patient tests positive for HIV and, despite repeated counseling, refuses to disclose this to his wife, who is also your patient. You assume husband and wife engage in unprotected sex. Select the single best answer:

A. You have both a moral and legal duty to inform your patient's wife.

B. The patient will successfully sue you if you breach confidentiality.

C. The patient's wife will successfully sue you if you do not warn her and she suffers harm.

D. You are legally obligated to disclose the information to health authorities.

E. All choices are incorrect.

Answer: E. Because a doctor must respect a patient's confidential information, medical information generally cannot be disclosed without consent. However, under some circumstances, a doctor is obligated by law or because of a higher competing interest to breach confidentiality. Examples include cases of suspected child abuse and certain public health hazards such as infectious diseases.

State law forbids the release of HIV records except in very special situations, and frequently permits but does not mandate reporting to state health authorities. Direct disclosure to third parties at risk is generally not provided by statute. However, California is an exception; the state allows the attending physician to disclose such information to “a person reasonably believed to be the spouse … a sexual partner or a person with whom the patient has shared the use of hypodermic needles, or to the local health officer” (California Health and Safety Code §121015[a]). This law is permissive, allowing but not requiring the physician to disclose.

In the hypothetical scenario described above, choice E is best. Although it could be argued that there may be a moral duty for the physician to directly inform the wife, especially since she is also a patient, legal duty is a different matter. Neither the wife nor the infected patient will necessarily be successful in a lawsuit against the doctor, depending in part on the jurisdiction and the prescribed manner of reporting/disclosure. Because statutes vary, physicians would do well to consult with state health authorities or a malpractice risk manager on the proper course of action in any given case.

Historically, patient confidentiality was part of an ethical code that all doctors abided in. The tradition dates back to the Hippocratic Oath, which states in part: “Whatever in connection with my professional practice, or not in connection with it, I see or hear, in the life of men, which ought not to be spoken of abroad, I will not divulge as reckoning that all should be kept secret.”

Notwithstanding Hippocrates (and HIPAA, its modern progeny, which protects personal health information), the professional duty to protect the secrets of a patient is not an absolute one, and in some situations limited disclosure is morally defensible and legally permissible or even obligatory. Most states require reporting in cases of suspected communicable diseases, impaired driving, child and elder abuse, domestic violence, or weapon injuries.

Even if there is no relevant state regulation, a doctor may have a legal duty to disclose sensitive information to named third parties if actual harm can be prevented through such disclosure. The well-known case of Tarasoff v. Regents of University of California established that where there is threatened harm to a named third party, the practitioner is required to reveal the information to the intended victim (this has been termed the Tarasoff rule). In Tarasoff, a patient confided in the university psychologist his intention to kill his ex-girlfriend. The information, though shared with campus security, was not released to the intended victim, and the patient stabbed her to death 2 months later. The court found the psychologist and the University of California (under respondeat superior) liable, reasoning that the protection of public safety was more important than the sanctity of doctor-patient confidentiality: “We recognize the public interest in supporting effective treatment of mental illness and in protecting the rights of patients to privacy and the consequent public importance of safeguarding the confidential character of psychotherapeutic communication. Against this interest, however, we must weigh the public interest in safety from violent assault…. In this risk-infested society, we can hardly tolerate the further exposure to danger that would result from a concealed knowledge of the therapist that his patient was lethal” (Tarasoff v. Regents of University of California, 551 P.2d 334 [S. Ct. Calif.1976]).

Disclosure to third parties of sensitive patient information may constitute defamation, which is defined as harming a person's reputation through communicating to others a verbal or written falsehood. However, truth is an absolute defense against a defamation claim; alternatively, the doctor may have a qualified privilege where there is a public health interest. For example, in Simonsen v. Swenson, a physician disclosed a positive syphilis test result that turned out to be an error. In the defamation suit that followed, the court declined to impose liability on the doctor, finding that he was protected in discharging his duty to disclose (Simonsen v. Swenson, 177 N.W. 831 [Neb. 1920]).

As a group, health care professionals ought to be far more circumspect in observing confidentiality. Loose talk, gossip, disclosure of patient identity, or indiscriminate release of medical records are all examples of confidentiality breach. We too often discuss cases, sometimes identifying the patient by name or room and bed number, in public places within earshot of strangers. In a 1995 study that observed 259 one-way elevator trips in five U.S. hospitals, the authors overheard a total of 39 inappropriate comments that took place on 36 rides (13.9% of the trips) (Am. J. Med. 1995;99:190-4). Many of the comments clearly breached patient confidentiality.

Contact the author at [email protected].

Question: Your patient tests positive for HIV and, despite repeated counseling, refuses to disclose this to his wife, who is also your patient. You assume husband and wife engage in unprotected sex. Select the single best answer:

A. You have both a moral and legal duty to inform your patient's wife.

B. The patient will successfully sue you if you breach confidentiality.

C. The patient's wife will successfully sue you if you do not warn her and she suffers harm.

D. You are legally obligated to disclose the information to health authorities.

E. All choices are incorrect.

Answer: E. Because a doctor must respect a patient's confidential information, medical information generally cannot be disclosed without consent. However, under some circumstances, a doctor is obligated by law or because of a higher competing interest to breach confidentiality. Examples include cases of suspected child abuse and certain public health hazards such as infectious diseases.

State law forbids the release of HIV records except in very special situations, and frequently permits but does not mandate reporting to state health authorities. Direct disclosure to third parties at risk is generally not provided by statute. However, California is an exception; the state allows the attending physician to disclose such information to “a person reasonably believed to be the spouse … a sexual partner or a person with whom the patient has shared the use of hypodermic needles, or to the local health officer” (California Health and Safety Code §121015[a]). This law is permissive, allowing but not requiring the physician to disclose.

In the hypothetical scenario described above, choice E is best. Although it could be argued that there may be a moral duty for the physician to directly inform the wife, especially since she is also a patient, legal duty is a different matter. Neither the wife nor the infected patient will necessarily be successful in a lawsuit against the doctor, depending in part on the jurisdiction and the prescribed manner of reporting/disclosure. Because statutes vary, physicians would do well to consult with state health authorities or a malpractice risk manager on the proper course of action in any given case.

Historically, patient confidentiality was part of an ethical code that all doctors abided in. The tradition dates back to the Hippocratic Oath, which states in part: “Whatever in connection with my professional practice, or not in connection with it, I see or hear, in the life of men, which ought not to be spoken of abroad, I will not divulge as reckoning that all should be kept secret.”

Notwithstanding Hippocrates (and HIPAA, its modern progeny, which protects personal health information), the professional duty to protect the secrets of a patient is not an absolute one, and in some situations limited disclosure is morally defensible and legally permissible or even obligatory. Most states require reporting in cases of suspected communicable diseases, impaired driving, child and elder abuse, domestic violence, or weapon injuries.

Even if there is no relevant state regulation, a doctor may have a legal duty to disclose sensitive information to named third parties if actual harm can be prevented through such disclosure. The well-known case of Tarasoff v. Regents of University of California established that where there is threatened harm to a named third party, the practitioner is required to reveal the information to the intended victim (this has been termed the Tarasoff rule). In Tarasoff, a patient confided in the university psychologist his intention to kill his ex-girlfriend. The information, though shared with campus security, was not released to the intended victim, and the patient stabbed her to death 2 months later. The court found the psychologist and the University of California (under respondeat superior) liable, reasoning that the protection of public safety was more important than the sanctity of doctor-patient confidentiality: “We recognize the public interest in supporting effective treatment of mental illness and in protecting the rights of patients to privacy and the consequent public importance of safeguarding the confidential character of psychotherapeutic communication. Against this interest, however, we must weigh the public interest in safety from violent assault…. In this risk-infested society, we can hardly tolerate the further exposure to danger that would result from a concealed knowledge of the therapist that his patient was lethal” (Tarasoff v. Regents of University of California, 551 P.2d 334 [S. Ct. Calif.1976]).

Disclosure to third parties of sensitive patient information may constitute defamation, which is defined as harming a person's reputation through communicating to others a verbal or written falsehood. However, truth is an absolute defense against a defamation claim; alternatively, the doctor may have a qualified privilege where there is a public health interest. For example, in Simonsen v. Swenson, a physician disclosed a positive syphilis test result that turned out to be an error. In the defamation suit that followed, the court declined to impose liability on the doctor, finding that he was protected in discharging his duty to disclose (Simonsen v. Swenson, 177 N.W. 831 [Neb. 1920]).

As a group, health care professionals ought to be far more circumspect in observing confidentiality. Loose talk, gossip, disclosure of patient identity, or indiscriminate release of medical records are all examples of confidentiality breach. We too often discuss cases, sometimes identifying the patient by name or room and bed number, in public places within earshot of strangers. In a 1995 study that observed 259 one-way elevator trips in five U.S. hospitals, the authors overheard a total of 39 inappropriate comments that took place on 36 rides (13.9% of the trips) (Am. J. Med. 1995;99:190-4). Many of the comments clearly breached patient confidentiality.

Contact the author at [email protected].

Question: As a general internist with a large practice, you own your own x-ray machine, and you regularly obtain and interpret your patients' x-rays instead of having a radiologist read them. Assume that the community standard is for radiologists rather than internists to read x-rays. What level of accuracy or standard of care will you be held to?

That of a general internist.

That of a reasonable doctor using his or her best judgment.

That of a radiologist.

A standard between that of a radiologist and a general internist.

That of an x-ray technician whose expertise in radiology is similar to yours.

Answer: C. A doctor is usually held to the objective standards of fellow doctors, given the circumstances of the case. Specialists will be held to a higher standard: that ordinarily expected of fellow doctors in that specialty. However, if you, a generalist, assume the duties normally performed by a specialist, the law will consider that you are representing yourself as capable of functioning at that level. In the above case, if internists do not regularly read their own x-rays and you, an internist, choose to do so, you will be held to the standard of a radiologist. Choice B is incorrect because “best judgment” is not a legal standard that governs malpractice matters.

The legal duty owed by doctors to their patients is that of reasonable care, defined as that level of care expected of the reasonably competent doctor—that is, a professional standard, not that of a reasonably prudent layperson, the latter being the standard used in negligence actions. Thus, Alabama has held that physicians must “exercise such reasonable care, diligence, and skill as reasonably competent physicians” would exercise in the same or similar circumstances (Keebler v. Winfield Carraway Hospital, 531 So.2d 841 [Ala. 1988]). An Illinois court used similar words: “[A] physician must possess and apply the knowledge, skill, and care of a reasonably well-qualified physician in the relevant medical community” (Purtill v. Hess, 489 N.E.2d 867 [Ill. 1986]). And in Hawaii, “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” (Craft v. Peebles, 893 P.2d 138 [Haw. 1995]).

While the professional standard applies to injuries arising out of medical care, the “reasonable person” standard continues to govern non–health care activities such as falls on slippery hospital floors. Unfortunately, the distinction may not always be clear. As one author put it, “Sometimes it is difficult to differentiate bad housekeeping and bad medical care, as where rats in a hospital repeatedly bit a comatose patient” (Dobbs, D.B. 2000. The Law of Torts. St. Paul, Minn.: West Group. Chapter 14, referring to Lejeunee v. Rayne Branch Hospital, 556 So.2d 559 [La. 1990]).

The doctor's specialty does matter in legal proceedings addressing the standard of care. The surgeon will be judged according to the community standard of the ordinarily skilled surgeon, and the internist according to that of other internists. But there is a separate duty to refer if the case is outside the doctor's field of expertise. If the standard is to refer to a specialist, the internist who undertakes to personally treat the patient within that specialty will be held to that higher standard. In Simpson v. Davis, for example, a general dentist performed root canal work and was therefore held to the standard of an endodontist (Simpson v. Davis, 549 P.2d 950 [Kan. 1976]).

The law expects doctors to provide reasonable care to their patients, even for conditions arguably outside their specialty. In a recent lawsuit, a gynecologist failed to consider appendicitis in a 32-year-old woman who presented with fever, chills, nausea, and lower abdominal pain. This delay in diagnosis led to rupture. The defendant-gynecologist argued that the diagnosis of a urinary tract infection or a pelvic condition was appropriate given the doctor's specialty. The gynecologist did not document the abdominal and pelvic examinations in detail, and did not obtain an ultrasound study. The trial court entered a verdict for the plaintiff; jury members later confided that the verdict would have been different had the doctor simply included appendicitis in the differential diagnosis (“Not My Specialty.” The Doctor's Advocate, Third Quarter, 2006).

In medicine, there is frequently a minority view as to how things ought to be done, so the standard of care need not necessarily be unanimous. So long as the minority view is held by a respectable group of doctors, the law will accept it as a legitimate alternative. However, this does not mean that any “on-the-fringe” publication on an issue will suffice. A minority view is reflective of a different approach to the same problem, but the care rendered must still comply with the standard of care espoused. In a Texas case, the court was not concerned with whether the practice was that of a respectable minority or a considerable number of physicians, but whether it met the standard. The case involved an augmentation mammoplasty procedure that resulted in silicone leakage. A number of qualified physicians had used that procedure, and this satisfied the court that the standard had been met (Henderson v. Heyer-Schulte Corp. of Santa Barbara, 600 S.W.2d 844 [Tex Civ. App. 1980]).

Finally, courts have in the past considered the locale where the tortious act took place, invoking the so-called “locality rule.” This was based on the belief that different standards of care were applicable in different areas of the country, for example, urban vs. rural. However, this rule has been largely abandoned in favor of a uniform standard, because current medical training and board certifications all adhere to a national standard. But geographic considerations are not entirely irrelevant. Where the local medical facilities lack state-of-the-art equipment or specialists, courts will give due consideration to such conditions. Still, there is always the duty to reasonably transfer to an available specialist or facility, and failure to do so may form the basis of liability.

Contact the author at [email protected].

Question: As a general internist with a large practice, you own your own x-ray machine, and you regularly obtain and interpret your patients' x-rays instead of having a radiologist read them. Assume that the community standard is for radiologists rather than internists to read x-rays. What level of accuracy or standard of care will you be held to?

That of a general internist.

That of a reasonable doctor using his or her best judgment.

That of a radiologist.

A standard between that of a radiologist and a general internist.

That of an x-ray technician whose expertise in radiology is similar to yours.

Answer: C. A doctor is usually held to the objective standards of fellow doctors, given the circumstances of the case. Specialists will be held to a higher standard: that ordinarily expected of fellow doctors in that specialty. However, if you, a generalist, assume the duties normally performed by a specialist, the law will consider that you are representing yourself as capable of functioning at that level. In the above case, if internists do not regularly read their own x-rays and you, an internist, choose to do so, you will be held to the standard of a radiologist. Choice B is incorrect because “best judgment” is not a legal standard that governs malpractice matters.

The legal duty owed by doctors to their patients is that of reasonable care, defined as that level of care expected of the reasonably competent doctor—that is, a professional standard, not that of a reasonably prudent layperson, the latter being the standard used in negligence actions. Thus, Alabama has held that physicians must “exercise such reasonable care, diligence, and skill as reasonably competent physicians” would exercise in the same or similar circumstances (Keebler v. Winfield Carraway Hospital, 531 So.2d 841 [Ala. 1988]). An Illinois court used similar words: “[A] physician must possess and apply the knowledge, skill, and care of a reasonably well-qualified physician in the relevant medical community” (Purtill v. Hess, 489 N.E.2d 867 [Ill. 1986]). And in Hawaii, “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” (Craft v. Peebles, 893 P.2d 138 [Haw. 1995]).

While the professional standard applies to injuries arising out of medical care, the “reasonable person” standard continues to govern non–health care activities such as falls on slippery hospital floors. Unfortunately, the distinction may not always be clear. As one author put it, “Sometimes it is difficult to differentiate bad housekeeping and bad medical care, as where rats in a hospital repeatedly bit a comatose patient” (Dobbs, D.B. 2000. The Law of Torts. St. Paul, Minn.: West Group. Chapter 14, referring to Lejeunee v. Rayne Branch Hospital, 556 So.2d 559 [La. 1990]).

The doctor's specialty does matter in legal proceedings addressing the standard of care. The surgeon will be judged according to the community standard of the ordinarily skilled surgeon, and the internist according to that of other internists. But there is a separate duty to refer if the case is outside the doctor's field of expertise. If the standard is to refer to a specialist, the internist who undertakes to personally treat the patient within that specialty will be held to that higher standard. In Simpson v. Davis, for example, a general dentist performed root canal work and was therefore held to the standard of an endodontist (Simpson v. Davis, 549 P.2d 950 [Kan. 1976]).

The law expects doctors to provide reasonable care to their patients, even for conditions arguably outside their specialty. In a recent lawsuit, a gynecologist failed to consider appendicitis in a 32-year-old woman who presented with fever, chills, nausea, and lower abdominal pain. This delay in diagnosis led to rupture. The defendant-gynecologist argued that the diagnosis of a urinary tract infection or a pelvic condition was appropriate given the doctor's specialty. The gynecologist did not document the abdominal and pelvic examinations in detail, and did not obtain an ultrasound study. The trial court entered a verdict for the plaintiff; jury members later confided that the verdict would have been different had the doctor simply included appendicitis in the differential diagnosis (“Not My Specialty.” The Doctor's Advocate, Third Quarter, 2006).

In medicine, there is frequently a minority view as to how things ought to be done, so the standard of care need not necessarily be unanimous. So long as the minority view is held by a respectable group of doctors, the law will accept it as a legitimate alternative. However, this does not mean that any “on-the-fringe” publication on an issue will suffice. A minority view is reflective of a different approach to the same problem, but the care rendered must still comply with the standard of care espoused. In a Texas case, the court was not concerned with whether the practice was that of a respectable minority or a considerable number of physicians, but whether it met the standard. The case involved an augmentation mammoplasty procedure that resulted in silicone leakage. A number of qualified physicians had used that procedure, and this satisfied the court that the standard had been met (Henderson v. Heyer-Schulte Corp. of Santa Barbara, 600 S.W.2d 844 [Tex Civ. App. 1980]).

Finally, courts have in the past considered the locale where the tortious act took place, invoking the so-called “locality rule.” This was based on the belief that different standards of care were applicable in different areas of the country, for example, urban vs. rural. However, this rule has been largely abandoned in favor of a uniform standard, because current medical training and board certifications all adhere to a national standard. But geographic considerations are not entirely irrelevant. Where the local medical facilities lack state-of-the-art equipment or specialists, courts will give due consideration to such conditions. Still, there is always the duty to reasonably transfer to an available specialist or facility, and failure to do so may form the basis of liability.

Contact the author at [email protected].

Question: As a general internist with a large practice, you own your own x-ray machine, and you regularly obtain and interpret your patients' x-rays instead of having a radiologist read them. Assume that the community standard is for radiologists rather than internists to read x-rays. What level of accuracy or standard of care will you be held to?

That of a general internist.

That of a reasonable doctor using his or her best judgment.

That of a radiologist.

A standard between that of a radiologist and a general internist.

That of an x-ray technician whose expertise in radiology is similar to yours.

Answer: C. A doctor is usually held to the objective standards of fellow doctors, given the circumstances of the case. Specialists will be held to a higher standard: that ordinarily expected of fellow doctors in that specialty. However, if you, a generalist, assume the duties normally performed by a specialist, the law will consider that you are representing yourself as capable of functioning at that level. In the above case, if internists do not regularly read their own x-rays and you, an internist, choose to do so, you will be held to the standard of a radiologist. Choice B is incorrect because “best judgment” is not a legal standard that governs malpractice matters.

The legal duty owed by doctors to their patients is that of reasonable care, defined as that level of care expected of the reasonably competent doctor—that is, a professional standard, not that of a reasonably prudent layperson, the latter being the standard used in negligence actions. Thus, Alabama has held that physicians must “exercise such reasonable care, diligence, and skill as reasonably competent physicians” would exercise in the same or similar circumstances (Keebler v. Winfield Carraway Hospital, 531 So.2d 841 [Ala. 1988]). An Illinois court used similar words: “[A] physician must possess and apply the knowledge, skill, and care of a reasonably well-qualified physician in the relevant medical community” (Purtill v. Hess, 489 N.E.2d 867 [Ill. 1986]). And in Hawaii, “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” (Craft v. Peebles, 893 P.2d 138 [Haw. 1995]).

While the professional standard applies to injuries arising out of medical care, the “reasonable person” standard continues to govern non–health care activities such as falls on slippery hospital floors. Unfortunately, the distinction may not always be clear. As one author put it, “Sometimes it is difficult to differentiate bad housekeeping and bad medical care, as where rats in a hospital repeatedly bit a comatose patient” (Dobbs, D.B. 2000. The Law of Torts. St. Paul, Minn.: West Group. Chapter 14, referring to Lejeunee v. Rayne Branch Hospital, 556 So.2d 559 [La. 1990]).

The doctor's specialty does matter in legal proceedings addressing the standard of care. The surgeon will be judged according to the community standard of the ordinarily skilled surgeon, and the internist according to that of other internists. But there is a separate duty to refer if the case is outside the doctor's field of expertise. If the standard is to refer to a specialist, the internist who undertakes to personally treat the patient within that specialty will be held to that higher standard. In Simpson v. Davis, for example, a general dentist performed root canal work and was therefore held to the standard of an endodontist (Simpson v. Davis, 549 P.2d 950 [Kan. 1976]).

The law expects doctors to provide reasonable care to their patients, even for conditions arguably outside their specialty. In a recent lawsuit, a gynecologist failed to consider appendicitis in a 32-year-old woman who presented with fever, chills, nausea, and lower abdominal pain. This delay in diagnosis led to rupture. The defendant-gynecologist argued that the diagnosis of a urinary tract infection or a pelvic condition was appropriate given the doctor's specialty. The gynecologist did not document the abdominal and pelvic examinations in detail, and did not obtain an ultrasound study. The trial court entered a verdict for the plaintiff; jury members later confided that the verdict would have been different had the doctor simply included appendicitis in the differential diagnosis (“Not My Specialty.” The Doctor's Advocate, Third Quarter, 2006).

In medicine, there is frequently a minority view as to how things ought to be done, so the standard of care need not necessarily be unanimous. So long as the minority view is held by a respectable group of doctors, the law will accept it as a legitimate alternative. However, this does not mean that any “on-the-fringe” publication on an issue will suffice. A minority view is reflective of a different approach to the same problem, but the care rendered must still comply with the standard of care espoused. In a Texas case, the court was not concerned with whether the practice was that of a respectable minority or a considerable number of physicians, but whether it met the standard. The case involved an augmentation mammoplasty procedure that resulted in silicone leakage. A number of qualified physicians had used that procedure, and this satisfied the court that the standard had been met (Henderson v. Heyer-Schulte Corp. of Santa Barbara, 600 S.W.2d 844 [Tex Civ. App. 1980]).

Finally, courts have in the past considered the locale where the tortious act took place, invoking the so-called “locality rule.” This was based on the belief that different standards of care were applicable in different areas of the country, for example, urban vs. rural. However, this rule has been largely abandoned in favor of a uniform standard, because current medical training and board certifications all adhere to a national standard. But geographic considerations are not entirely irrelevant. Where the local medical facilities lack state-of-the-art equipment or specialists, courts will give due consideration to such conditions. Still, there is always the duty to reasonably transfer to an available specialist or facility, and failure to do so may form the basis of liability.

Contact the author at [email protected].

Question: Dr. E, an endocrinologist, diagnosed a patient with multiple endocrine neoplasia type I, a rare disorder that is inherited in an autosomal dominant fashion. Dr. E did not inform or counsel the patient's three siblings and two children. Which of the following best describes this situation?

A. Confidentiality prevents Dr. E from discussing the diagnosis with others.

B. Without an established doctor-patient relationship between Dr. E and family members, no legal duty of care exists.

C. Were Dr. E a general practitioner, his conduct would have met the standard ordinarily expected of a doctor.

D. Dr. E should have provided family counseling after securing his patient's permission.

E. Unless physical injury results, there can be no malpractice action.

Answer: D. In this case, an endocrinologist would be expected to offer counseling to family members after securing patient consent. This is an example of a physician's duty to “third parties.” No doctor-patient relationship is required. Ideally, after obtaining the patient's permission, the doctor should contact family members and advise them to seek clinical and genetic screening.

The law requires that one act reasonably, and for a doctor this means adhering to the standards expected of fellow members of the profession. The requisite standard of care is different for the specialist than for the generalist, and it can be argued that a generalist may not be sufficiently familiar with this rare disorder to offer family counseling. However, the doctor still owes a duty to make a referral to a specialist.

For a malpractice suit to succeed, the plaintiff must prove, in addition to substandard conduct by the defendant, the elements of causation and damages. If no harm can be traced to the negligent act, no cause of action will ensue. However, for the purposes of tort damages, nonphysical injuries such as loss of consortium or emotional distress are every bit as relevant.

In a case such as the one involving Dr. E, a doctor can be found liable to someone other than his or her patient. Sometimes another person, referred to as a “third party,” may sue the doctor despite the absence of a doctor-patient relationship. For example, an obstetrician may fail to treat a pregnant woman known to have been exposed to German measles, who then delivers a child with birth defects. A Rhode Island court has ruled that a cause of action could be instituted by the child (Sylvia v. Gobeille, 220 A.2d 222 [R.I. 1966]).

In another example, a missed diagnosis of meningitis in a mother led to her son contracting and dying from the disease. The son's estate sued. The appellate court found liability and held that the physician-mother relationship resulted in a special situation for imposing a duty of care for her son (Shepard v. Redford Community Hospital, 390 N.W.2d 239 [Mich. App. 1986]).

Similarly, the Supreme Court of Tennessee held that a physician has a duty to warn members of the patient's immediate family of the risk of a disease such as Rocky Mountain spotted fever, even though it is not contagious (Bradshaw v. Daniel, 854 S.W.2d 865 [Tenn. 1993]).

A doctor may even have a duty to a total stranger. The best-known case occurred in California, where a court imposed a duty on a college psychologist to warn an intended victim of harm, even though that meant breaching patient-doctor confidentiality (Tarasoff v. Regents of University of California, 551 P.2d 334 [Cal. 1976]).

An emerging area of malpractice litigation affects patients who drive. If a patient injures another driver or a pedestrian while taking a prescribed medication, the doctor could be faced with potential liability to the injured party, a total stranger.

The Hawaii Supreme Court recently held that: “A physician owes a duty to nonpatient third parties injured in an automobile accident caused by an adverse reaction to the medication … where the physician has negligently failed to warn the patient that the medication may impair driving ability” (McKenzie v. Hawaii Permanente Medical Group, 47 P.3d 1209 [Haw. 2002]). The medication in this case was an antihypertensive drug that caused syncope and loss of vehicular control.

Contact the author at [email protected].

Question: Dr. E, an endocrinologist, diagnosed a patient with multiple endocrine neoplasia type I, a rare disorder that is inherited in an autosomal dominant fashion. Dr. E did not inform or counsel the patient's three siblings and two children. Which of the following best describes this situation?

A. Confidentiality prevents Dr. E from discussing the diagnosis with others.

B. Without an established doctor-patient relationship between Dr. E and family members, no legal duty of care exists.

C. Were Dr. E a general practitioner, his conduct would have met the standard ordinarily expected of a doctor.

D. Dr. E should have provided family counseling after securing his patient's permission.

E. Unless physical injury results, there can be no malpractice action.

Answer: D. In this case, an endocrinologist would be expected to offer counseling to family members after securing patient consent. This is an example of a physician's duty to “third parties.” No doctor-patient relationship is required. Ideally, after obtaining the patient's permission, the doctor should contact family members and advise them to seek clinical and genetic screening.

The law requires that one act reasonably, and for a doctor this means adhering to the standards expected of fellow members of the profession. The requisite standard of care is different for the specialist than for the generalist, and it can be argued that a generalist may not be sufficiently familiar with this rare disorder to offer family counseling. However, the doctor still owes a duty to make a referral to a specialist.

For a malpractice suit to succeed, the plaintiff must prove, in addition to substandard conduct by the defendant, the elements of causation and damages. If no harm can be traced to the negligent act, no cause of action will ensue. However, for the purposes of tort damages, nonphysical injuries such as loss of consortium or emotional distress are every bit as relevant.

In a case such as the one involving Dr. E, a doctor can be found liable to someone other than his or her patient. Sometimes another person, referred to as a “third party,” may sue the doctor despite the absence of a doctor-patient relationship. For example, an obstetrician may fail to treat a pregnant woman known to have been exposed to German measles, who then delivers a child with birth defects. A Rhode Island court has ruled that a cause of action could be instituted by the child (Sylvia v. Gobeille, 220 A.2d 222 [R.I. 1966]).

In another example, a missed diagnosis of meningitis in a mother led to her son contracting and dying from the disease. The son's estate sued. The appellate court found liability and held that the physician-mother relationship resulted in a special situation for imposing a duty of care for her son (Shepard v. Redford Community Hospital, 390 N.W.2d 239 [Mich. App. 1986]).

Similarly, the Supreme Court of Tennessee held that a physician has a duty to warn members of the patient's immediate family of the risk of a disease such as Rocky Mountain spotted fever, even though it is not contagious (Bradshaw v. Daniel, 854 S.W.2d 865 [Tenn. 1993]).

A doctor may even have a duty to a total stranger. The best-known case occurred in California, where a court imposed a duty on a college psychologist to warn an intended victim of harm, even though that meant breaching patient-doctor confidentiality (Tarasoff v. Regents of University of California, 551 P.2d 334 [Cal. 1976]).

An emerging area of malpractice litigation affects patients who drive. If a patient injures another driver or a pedestrian while taking a prescribed medication, the doctor could be faced with potential liability to the injured party, a total stranger.

The Hawaii Supreme Court recently held that: “A physician owes a duty to nonpatient third parties injured in an automobile accident caused by an adverse reaction to the medication … where the physician has negligently failed to warn the patient that the medication may impair driving ability” (McKenzie v. Hawaii Permanente Medical Group, 47 P.3d 1209 [Haw. 2002]). The medication in this case was an antihypertensive drug that caused syncope and loss of vehicular control.

Contact the author at [email protected].

Question: Dr. E, an endocrinologist, diagnosed a patient with multiple endocrine neoplasia type I, a rare disorder that is inherited in an autosomal dominant fashion. Dr. E did not inform or counsel the patient's three siblings and two children. Which of the following best describes this situation?

A. Confidentiality prevents Dr. E from discussing the diagnosis with others.

B. Without an established doctor-patient relationship between Dr. E and family members, no legal duty of care exists.

C. Were Dr. E a general practitioner, his conduct would have met the standard ordinarily expected of a doctor.

D. Dr. E should have provided family counseling after securing his patient's permission.

E. Unless physical injury results, there can be no malpractice action.

Answer: D. In this case, an endocrinologist would be expected to offer counseling to family members after securing patient consent. This is an example of a physician's duty to “third parties.” No doctor-patient relationship is required. Ideally, after obtaining the patient's permission, the doctor should contact family members and advise them to seek clinical and genetic screening.

The law requires that one act reasonably, and for a doctor this means adhering to the standards expected of fellow members of the profession. The requisite standard of care is different for the specialist than for the generalist, and it can be argued that a generalist may not be sufficiently familiar with this rare disorder to offer family counseling. However, the doctor still owes a duty to make a referral to a specialist.

For a malpractice suit to succeed, the plaintiff must prove, in addition to substandard conduct by the defendant, the elements of causation and damages. If no harm can be traced to the negligent act, no cause of action will ensue. However, for the purposes of tort damages, nonphysical injuries such as loss of consortium or emotional distress are every bit as relevant.

In a case such as the one involving Dr. E, a doctor can be found liable to someone other than his or her patient. Sometimes another person, referred to as a “third party,” may sue the doctor despite the absence of a doctor-patient relationship. For example, an obstetrician may fail to treat a pregnant woman known to have been exposed to German measles, who then delivers a child with birth defects. A Rhode Island court has ruled that a cause of action could be instituted by the child (Sylvia v. Gobeille, 220 A.2d 222 [R.I. 1966]).

In another example, a missed diagnosis of meningitis in a mother led to her son contracting and dying from the disease. The son's estate sued. The appellate court found liability and held that the physician-mother relationship resulted in a special situation for imposing a duty of care for her son (Shepard v. Redford Community Hospital, 390 N.W.2d 239 [Mich. App. 1986]).

Similarly, the Supreme Court of Tennessee held that a physician has a duty to warn members of the patient's immediate family of the risk of a disease such as Rocky Mountain spotted fever, even though it is not contagious (Bradshaw v. Daniel, 854 S.W.2d 865 [Tenn. 1993]).

A doctor may even have a duty to a total stranger. The best-known case occurred in California, where a court imposed a duty on a college psychologist to warn an intended victim of harm, even though that meant breaching patient-doctor confidentiality (Tarasoff v. Regents of University of California, 551 P.2d 334 [Cal. 1976]).

An emerging area of malpractice litigation affects patients who drive. If a patient injures another driver or a pedestrian while taking a prescribed medication, the doctor could be faced with potential liability to the injured party, a total stranger.

The Hawaii Supreme Court recently held that: “A physician owes a duty to nonpatient third parties injured in an automobile accident caused by an adverse reaction to the medication … where the physician has negligently failed to warn the patient that the medication may impair driving ability” (McKenzie v. Hawaii Permanente Medical Group, 47 P.3d 1209 [Haw. 2002]). The medication in this case was an antihypertensive drug that caused syncope and loss of vehicular control.

Contact the author at [email protected].

Question: To relieve intractable pain in a terminally ill patient, the physician administered increasing amounts of morphine. This led to respiratory arrest and hastened the patient's death. The physician's action is:

A. Medical malpractice.

B. Supported by a minority of physicians.

C. The intentional tort of assault and battery.

D. An example of “double effect.”

E. Homicide.

Answer: D. The “double effect” phenomenon describes situations in which a foreseeable adverse outcome supervenes, even though the intent was to confer a benefit. This doctrine of “secondary, unintended consequences” is commonly invoked to permit the proportionate, albeit aggressive, use of comfort measures such as narcotics in terminally ill patients. Among attending and house staff in a published survey, some 92%-94% agreed that “sometimes it is appropriate to give pain medication to relieve suffering, even if it may hasten a patient's death” (Am. J. Public Health 1993;83:14-23).

The doctor's action in this hypothetical case will therefore not amount to malpractice, as there is no breach of the standard of care and therefore no negligence. This is also not assault and battery, which is an intentional act that involves apprehension of or actual offensive touching without consent. In this clinical setting, consent usually has been explicitly given or implied by the patient or the surrogate decision maker.

The specter of a potential homicide charge may alarm, but no less an authority than the U.S. Supreme Court has reasoned otherwise. In Vacco v. Quill, the Court unanimously drew a distinction between aggressive palliation and physician-assisted suicide, clarifying that “in some cases, painkilling drugs may hasten a patient's death, but the physician's purpose and intent is, or may be, only to ease his patient's pain. A doctor who assists a suicide, however, must, necessarily and indubitably, intend primarily that the patient be made dead” (Vacco v. Quill, 117 S. Ct. 2293 [1997]).

Pain management and comfort care become primary treatment goals even if cure is impossible. Dying patients fear that their pain will not be aggressively treated, and studies have repeatedly shown that physicians do not adequately treat pain.

In addition to providing pain relief, physicians should communicate their plans regarding palliative care by using open-ended questions, screening for unaddressed spiritual concerns, and listening actively and with empathy (Ann. Int. Med. 1999;130:744-9).

In a California trial that received widespread media coverage, an Alameda County jury turned in a verdict against an internist charged with elder abuse and reckless negligence because he failed to give enough pain medication to a patient dying of cancer (Bergman v. Eden Medical Center, No. H205732-1 [Sup. Ct. Alameda Co., Cal., June 13, 2001]). Under California law, death of a plaintiff extinguishes a claim for pain and suffering. The case was therefore brought under the elder-abuse law, under which the burden of proof was higher, requiring a reckless rather than a simple negligence standard.

The case involved William Bergman, an 85-year-old retired railroad worker with lung cancer, who was admitted to Eden Medical Center in early 1998. The lawsuit alleged that the treating physician was reckless in not prescribing effective medication for Mr. Bergman, who complained of severe back pain. The patient stayed at the hospital for 6 days, and nurses consistently charted his pain in the 7-10 range. On the day of discharge, his pain was at level 10. He died at home shortly thereafter.

After 4 days of deliberation, the jury, in a 9-3 vote, entered a guilty verdict and awarded $1.5 million in general damages. This amount was subsequently reduced to $250,000 because of California's cap on noneconomic damages.

Eight jurors wanted to award punitive damages, as they believed that the doctor had acted with malice or had intentionally caused emotional distress. However, no punitive damages were assessed because nine votes were needed.

The hospital had settled privately with the family before trial. The guilty verdict came despite defense expert testimony that the treatment provided was reasonable and would be the same as that provided by 95% of all internists.

Mr. Bergman's family had earlier filed a complaint with the California Medical Board, which took no action despite a medical consultant's conclusion that the hospital's pain management was inadequate. The medical board felt that it lacked clear and convincing evidence to find a violation of the Medical Practice Act.

The Bergman case is notable for being the first of its kind, and squarely puts physicians on notice regarding their duty to provide adequate pain relief. The closest previous decision finding liability for failure to treat pain involved a nursing home's failure to administer pain medications that had been ordered by the doctor (Estate of Henry James v. Hillhaven Corp., Super Ct. Div. 89 CVS 64 [Hertford Cty, N.C., Jan. 15, 1991]).

Contact the author at [email protected].

Question: To relieve intractable pain in a terminally ill patient, the physician administered increasing amounts of morphine. This led to respiratory arrest and hastened the patient's death. The physician's action is:

A. Medical malpractice.

B. Supported by a minority of physicians.

C. The intentional tort of assault and battery.

D. An example of “double effect.”

E. Homicide.

Answer: D. The “double effect” phenomenon describes situations in which a foreseeable adverse outcome supervenes, even though the intent was to confer a benefit. This doctrine of “secondary, unintended consequences” is commonly invoked to permit the proportionate, albeit aggressive, use of comfort measures such as narcotics in terminally ill patients. Among attending and house staff in a published survey, some 92%-94% agreed that “sometimes it is appropriate to give pain medication to relieve suffering, even if it may hasten a patient's death” (Am. J. Public Health 1993;83:14-23).

The doctor's action in this hypothetical case will therefore not amount to malpractice, as there is no breach of the standard of care and therefore no negligence. This is also not assault and battery, which is an intentional act that involves apprehension of or actual offensive touching without consent. In this clinical setting, consent usually has been explicitly given or implied by the patient or the surrogate decision maker.

The specter of a potential homicide charge may alarm, but no less an authority than the U.S. Supreme Court has reasoned otherwise. In Vacco v. Quill, the Court unanimously drew a distinction between aggressive palliation and physician-assisted suicide, clarifying that “in some cases, painkilling drugs may hasten a patient's death, but the physician's purpose and intent is, or may be, only to ease his patient's pain. A doctor who assists a suicide, however, must, necessarily and indubitably, intend primarily that the patient be made dead” (Vacco v. Quill, 117 S. Ct. 2293 [1997]).

Pain management and comfort care become primary treatment goals even if cure is impossible. Dying patients fear that their pain will not be aggressively treated, and studies have repeatedly shown that physicians do not adequately treat pain.

In addition to providing pain relief, physicians should communicate their plans regarding palliative care by using open-ended questions, screening for unaddressed spiritual concerns, and listening actively and with empathy (Ann. Int. Med. 1999;130:744-9).

In a California trial that received widespread media coverage, an Alameda County jury turned in a verdict against an internist charged with elder abuse and reckless negligence because he failed to give enough pain medication to a patient dying of cancer (Bergman v. Eden Medical Center, No. H205732-1 [Sup. Ct. Alameda Co., Cal., June 13, 2001]). Under California law, death of a plaintiff extinguishes a claim for pain and suffering. The case was therefore brought under the elder-abuse law, under which the burden of proof was higher, requiring a reckless rather than a simple negligence standard.

The case involved William Bergman, an 85-year-old retired railroad worker with lung cancer, who was admitted to Eden Medical Center in early 1998. The lawsuit alleged that the treating physician was reckless in not prescribing effective medication for Mr. Bergman, who complained of severe back pain. The patient stayed at the hospital for 6 days, and nurses consistently charted his pain in the 7-10 range. On the day of discharge, his pain was at level 10. He died at home shortly thereafter.

After 4 days of deliberation, the jury, in a 9-3 vote, entered a guilty verdict and awarded $1.5 million in general damages. This amount was subsequently reduced to $250,000 because of California's cap on noneconomic damages.

Eight jurors wanted to award punitive damages, as they believed that the doctor had acted with malice or had intentionally caused emotional distress. However, no punitive damages were assessed because nine votes were needed.

The hospital had settled privately with the family before trial. The guilty verdict came despite defense expert testimony that the treatment provided was reasonable and would be the same as that provided by 95% of all internists.

Mr. Bergman's family had earlier filed a complaint with the California Medical Board, which took no action despite a medical consultant's conclusion that the hospital's pain management was inadequate. The medical board felt that it lacked clear and convincing evidence to find a violation of the Medical Practice Act.

The Bergman case is notable for being the first of its kind, and squarely puts physicians on notice regarding their duty to provide adequate pain relief. The closest previous decision finding liability for failure to treat pain involved a nursing home's failure to administer pain medications that had been ordered by the doctor (Estate of Henry James v. Hillhaven Corp., Super Ct. Div. 89 CVS 64 [Hertford Cty, N.C., Jan. 15, 1991]).

Contact the author at [email protected].

Question: To relieve intractable pain in a terminally ill patient, the physician administered increasing amounts of morphine. This led to respiratory arrest and hastened the patient's death. The physician's action is:

A. Medical malpractice.

B. Supported by a minority of physicians.

C. The intentional tort of assault and battery.

D. An example of “double effect.”

E. Homicide.

Answer: D. The “double effect” phenomenon describes situations in which a foreseeable adverse outcome supervenes, even though the intent was to confer a benefit. This doctrine of “secondary, unintended consequences” is commonly invoked to permit the proportionate, albeit aggressive, use of comfort measures such as narcotics in terminally ill patients. Among attending and house staff in a published survey, some 92%-94% agreed that “sometimes it is appropriate to give pain medication to relieve suffering, even if it may hasten a patient's death” (Am. J. Public Health 1993;83:14-23).

The doctor's action in this hypothetical case will therefore not amount to malpractice, as there is no breach of the standard of care and therefore no negligence. This is also not assault and battery, which is an intentional act that involves apprehension of or actual offensive touching without consent. In this clinical setting, consent usually has been explicitly given or implied by the patient or the surrogate decision maker.

The specter of a potential homicide charge may alarm, but no less an authority than the U.S. Supreme Court has reasoned otherwise. In Vacco v. Quill, the Court unanimously drew a distinction between aggressive palliation and physician-assisted suicide, clarifying that “in some cases, painkilling drugs may hasten a patient's death, but the physician's purpose and intent is, or may be, only to ease his patient's pain. A doctor who assists a suicide, however, must, necessarily and indubitably, intend primarily that the patient be made dead” (Vacco v. Quill, 117 S. Ct. 2293 [1997]).

Pain management and comfort care become primary treatment goals even if cure is impossible. Dying patients fear that their pain will not be aggressively treated, and studies have repeatedly shown that physicians do not adequately treat pain.

In addition to providing pain relief, physicians should communicate their plans regarding palliative care by using open-ended questions, screening for unaddressed spiritual concerns, and listening actively and with empathy (Ann. Int. Med. 1999;130:744-9).

In a California trial that received widespread media coverage, an Alameda County jury turned in a verdict against an internist charged with elder abuse and reckless negligence because he failed to give enough pain medication to a patient dying of cancer (Bergman v. Eden Medical Center, No. H205732-1 [Sup. Ct. Alameda Co., Cal., June 13, 2001]). Under California law, death of a plaintiff extinguishes a claim for pain and suffering. The case was therefore brought under the elder-abuse law, under which the burden of proof was higher, requiring a reckless rather than a simple negligence standard.

The case involved William Bergman, an 85-year-old retired railroad worker with lung cancer, who was admitted to Eden Medical Center in early 1998. The lawsuit alleged that the treating physician was reckless in not prescribing effective medication for Mr. Bergman, who complained of severe back pain. The patient stayed at the hospital for 6 days, and nurses consistently charted his pain in the 7-10 range. On the day of discharge, his pain was at level 10. He died at home shortly thereafter.

After 4 days of deliberation, the jury, in a 9-3 vote, entered a guilty verdict and awarded $1.5 million in general damages. This amount was subsequently reduced to $250,000 because of California's cap on noneconomic damages.

Eight jurors wanted to award punitive damages, as they believed that the doctor had acted with malice or had intentionally caused emotional distress. However, no punitive damages were assessed because nine votes were needed.

The hospital had settled privately with the family before trial. The guilty verdict came despite defense expert testimony that the treatment provided was reasonable and would be the same as that provided by 95% of all internists.

Mr. Bergman's family had earlier filed a complaint with the California Medical Board, which took no action despite a medical consultant's conclusion that the hospital's pain management was inadequate. The medical board felt that it lacked clear and convincing evidence to find a violation of the Medical Practice Act.

The Bergman case is notable for being the first of its kind, and squarely puts physicians on notice regarding their duty to provide adequate pain relief. The closest previous decision finding liability for failure to treat pain involved a nursing home's failure to administer pain medications that had been ordered by the doctor (Estate of Henry James v. Hillhaven Corp., Super Ct. Div. 89 CVS 64 [Hertford Cty, N.C., Jan. 15, 1991]).

Contact the author at [email protected].

Question: Which one of the following patient groups is least likely to file a malpractice lawsuit?

A. Patients who are critical of others.

B. Poor patients on welfare.

C. Educated patients who surf the Internet.

D. Doctor-shoppers.

E. Angry patients.

Answer: B. Most patients do not sue their health care providers, even when a negligent act or omission has taken place. Demanding and well-educated patients are more likely to sue, as are those who are already familiar with the legal system and with lawsuits. And watch out for the hypercritical patient. Low-income and poorly educated patients, on the other hand, are less likely to sue if only because they lack the medical sophistication to recognize substandard treatment and the know-how to seek legal redress.

Doctor-Patient Rapport

What do you call an angry patient? A plaintiff. (Some of the following materials have been adapted from “Seven Secrets of Avoiding Medmal Suits,” videotape, 1996, Frew Consulting Group Ltd.) This saying is a familiar refrain of malpractice attorneys and risk managers, and should serve as a warning to doctors. Financial gain is not the usual reason for a malpractice lawsuit, whereas anger lies at the root of all malpractice claims, either because of the adverse result itself or a perceived lack of caring.

The patient or family may consider the provider to be cold, indifferent, or arrogant. There may have been an offhand remark or a poor choice of words, or the doctor has not returned calls or is refusing to meet with the aggrieved. Patients view these actions as showing a lack of concern and compassion. After experiencing increasing dissatisfaction, exasperation, and anger, the injured party may then seek legal redress. And jurors who have had similar bad experiences are apt to return a runaway verdict.

Plaintiff attorneys tell us that the majority of their calls come from would-be litigants with poor doctor-patient rapport. 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.

Consider the following observations of an attorney: “In over 25 years of representing both physicians and patients, it became apparent that a large percentage of patient dissatisfaction was generated by physician attitude and denial, rather than the negligence itself. In fact, my experience has been that close to half of malpractice cases could have been avoided through disclosure or apology but instead were relegated to litigation. What the majority of 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” (Ann. Int. Med. 1999;131:970-2).

Poor Service

At Disney theme parks, everyone is a guest. Similarly, most hotels feature workers with smiling faces and a can-do, positive attitude. Guest comfort comes first, and customer service is everyone's job. Hospitals and clinics, on the other hand, sometimes hire relatively unskilled personnel with little or no training before being put on the job. Those on the front lines, such as the phone operators and information desk clerks, should be the most accommodating, but unfortunately some lack people skills and do not go the extra mile. Experts say there are two typical problems in a hospital or clinic setting: overworked employees who treat patients as burdens rather than as clients, and employees who are not empowered to promptly address patient complaints.

Disparaging Remarks or Attitudes

Some lawsuits are filed because of suspicion raised in the patient's mind by disparaging remarks made by one practitioner about another. An example (doctor or nurse pointing to a large abdominal surgical scar): “Who did that to you?” Without having all the facts, one should avoid making critical comments about a colleague's work. Seek clarification before passing judgment. Worse yet, unthinking health care providers sometimes enter disparaging remarks into the medical records. Statements like “physician refused to respond” should be replaced by “no response yet, will try again.” Disagreements between doctor and nurse clearly require proper channels for resolution, and the medical record is not one of them. In the event a staff member makes a mistake, the physician should be remain calm and professional and avoid voicing direct criticism in front of the patient or family.

The staff can also be the cause of a lawsuit. Staff members are typically the first people in contact with the patient and family. They must make a good impression, be active listeners, and strive to make others feel important. Staff should be as well trained in customer service as in quality care. A bad attitude is just as unacceptable as incompetence.

Money Disputes

Out-of-pocket costs for medical care are skyrocketing. With the increasingly impersonal nature of the medical encounter and the commercialization of health care, patients are more apt to become dissatisfied and be less tolerant of errors. Recall that medical school taught us to first elicit the patient's chief medical complaint. Nowadays, too often the first question is: “Do you have insurance?” Or “what kind of coverage do you have?” In such a practice environment, more injured patients can be expected to retaliate, especially if they feel unjustifiably overcharged.

Inform the patient at the outset regarding cost estimates for consultations, procedures, and so on. Such discussions may be relegated to an experienced and professional staff member, and the doctor himself or herself need not be directly involved. However, this should be done before the service is provided. Ambiguities, followed by an unpleasant surprise concerning money matters, will likely upset patients, especially those with an adverse medical outcome. Great tact and sensitivity is necessary to avoid turning such a situation into a malpractice claim. This is not to say that only good clinical results deserve to be paid for. However, a bill that is perceived as being unreasonably large may just get an injured patient angry enough to file suit.

In addition, when patients don't pay their bills, many of us resort to a debt collection agency without first speaking directly to the patient. If possible, physicians should first try to resolve the issue, for example, by offering a generous installment payment plan. The funds owed may not amount to much in an individual case, and aggressive pursuit may prove counterproductive. Consider adopting a policy of writing off unpaid bills in the name of public service, although this may be impractical for some institutions or when large sums are owed.

Contact the author at [email protected].

Question: Which one of the following patient groups is least likely to file a malpractice lawsuit?

A. Patients who are critical of others.

B. Poor patients on welfare.

C. Educated patients who surf the Internet.

D. Doctor-shoppers.

E. Angry patients.

Answer: B. Most patients do not sue their health care providers, even when a negligent act or omission has taken place. Demanding and well-educated patients are more likely to sue, as are those who are already familiar with the legal system and with lawsuits. And watch out for the hypercritical patient. Low-income and poorly educated patients, on the other hand, are less likely to sue if only because they lack the medical sophistication to recognize substandard treatment and the know-how to seek legal redress.

Doctor-Patient Rapport

What do you call an angry patient? A plaintiff. (Some of the following materials have been adapted from “Seven Secrets of Avoiding Medmal Suits,” videotape, 1996, Frew Consulting Group Ltd.) This saying is a familiar refrain of malpractice attorneys and risk managers, and should serve as a warning to doctors. Financial gain is not the usual reason for a malpractice lawsuit, whereas anger lies at the root of all malpractice claims, either because of the adverse result itself or a perceived lack of caring.

The patient or family may consider the provider to be cold, indifferent, or arrogant. There may have been an offhand remark or a poor choice of words, or the doctor has not returned calls or is refusing to meet with the aggrieved. Patients view these actions as showing a lack of concern and compassion. After experiencing increasing dissatisfaction, exasperation, and anger, the injured party may then seek legal redress. And jurors who have had similar bad experiences are apt to return a runaway verdict.

Plaintiff attorneys tell us that the majority of their calls come from would-be litigants with poor doctor-patient rapport. 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.

Consider the following observations of an attorney: “In over 25 years of representing both physicians and patients, it became apparent that a large percentage of patient dissatisfaction was generated by physician attitude and denial, rather than the negligence itself. In fact, my experience has been that close to half of malpractice cases could have been avoided through disclosure or apology but instead were relegated to litigation. What the majority of 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” (Ann. Int. Med. 1999;131:970-2).

Poor Service

At Disney theme parks, everyone is a guest. Similarly, most hotels feature workers with smiling faces and a can-do, positive attitude. Guest comfort comes first, and customer service is everyone's job. Hospitals and clinics, on the other hand, sometimes hire relatively unskilled personnel with little or no training before being put on the job. Those on the front lines, such as the phone operators and information desk clerks, should be the most accommodating, but unfortunately some lack people skills and do not go the extra mile. Experts say there are two typical problems in a hospital or clinic setting: overworked employees who treat patients as burdens rather than as clients, and employees who are not empowered to promptly address patient complaints.

Disparaging Remarks or Attitudes

Some lawsuits are filed because of suspicion raised in the patient's mind by disparaging remarks made by one practitioner about another. An example (doctor or nurse pointing to a large abdominal surgical scar): “Who did that to you?” Without having all the facts, one should avoid making critical comments about a colleague's work. Seek clarification before passing judgment. Worse yet, unthinking health care providers sometimes enter disparaging remarks into the medical records. Statements like “physician refused to respond” should be replaced by “no response yet, will try again.” Disagreements between doctor and nurse clearly require proper channels for resolution, and the medical record is not one of them. In the event a staff member makes a mistake, the physician should be remain calm and professional and avoid voicing direct criticism in front of the patient or family.

The staff can also be the cause of a lawsuit. Staff members are typically the first people in contact with the patient and family. They must make a good impression, be active listeners, and strive to make others feel important. Staff should be as well trained in customer service as in quality care. A bad attitude is just as unacceptable as incompetence.

Money Disputes

Out-of-pocket costs for medical care are skyrocketing. With the increasingly impersonal nature of the medical encounter and the commercialization of health care, patients are more apt to become dissatisfied and be less tolerant of errors. Recall that medical school taught us to first elicit the patient's chief medical complaint. Nowadays, too often the first question is: “Do you have insurance?” Or “what kind of coverage do you have?” In such a practice environment, more injured patients can be expected to retaliate, especially if they feel unjustifiably overcharged.

Inform the patient at the outset regarding cost estimates for consultations, procedures, and so on. Such discussions may be relegated to an experienced and professional staff member, and the doctor himself or herself need not be directly involved. However, this should be done before the service is provided. Ambiguities, followed by an unpleasant surprise concerning money matters, will likely upset patients, especially those with an adverse medical outcome. Great tact and sensitivity is necessary to avoid turning such a situation into a malpractice claim. This is not to say that only good clinical results deserve to be paid for. However, a bill that is perceived as being unreasonably large may just get an injured patient angry enough to file suit.

In addition, when patients don't pay their bills, many of us resort to a debt collection agency without first speaking directly to the patient. If possible, physicians should first try to resolve the issue, for example, by offering a generous installment payment plan. The funds owed may not amount to much in an individual case, and aggressive pursuit may prove counterproductive. Consider adopting a policy of writing off unpaid bills in the name of public service, although this may be impractical for some institutions or when large sums are owed.

Contact the author at [email protected].

Question: Which one of the following patient groups is least likely to file a malpractice lawsuit?

A. Patients who are critical of others.

B. Poor patients on welfare.

C. Educated patients who surf the Internet.

D. Doctor-shoppers.

E. Angry patients.

Answer: B. Most patients do not sue their health care providers, even when a negligent act or omission has taken place. Demanding and well-educated patients are more likely to sue, as are those who are already familiar with the legal system and with lawsuits. And watch out for the hypercritical patient. Low-income and poorly educated patients, on the other hand, are less likely to sue if only because they lack the medical sophistication to recognize substandard treatment and the know-how to seek legal redress.

Doctor-Patient Rapport

What do you call an angry patient? A plaintiff. (Some of the following materials have been adapted from “Seven Secrets of Avoiding Medmal Suits,” videotape, 1996, Frew Consulting Group Ltd.) This saying is a familiar refrain of malpractice attorneys and risk managers, and should serve as a warning to doctors. Financial gain is not the usual reason for a malpractice lawsuit, whereas anger lies at the root of all malpractice claims, either because of the adverse result itself or a perceived lack of caring.

The patient or family may consider the provider to be cold, indifferent, or arrogant. There may have been an offhand remark or a poor choice of words, or the doctor has not returned calls or is refusing to meet with the aggrieved. Patients view these actions as showing a lack of concern and compassion. After experiencing increasing dissatisfaction, exasperation, and anger, the injured party may then seek legal redress. And jurors who have had similar bad experiences are apt to return a runaway verdict.

Plaintiff attorneys tell us that the majority of their calls come from would-be litigants with poor doctor-patient rapport. 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.

Consider the following observations of an attorney: “In over 25 years of representing both physicians and patients, it became apparent that a large percentage of patient dissatisfaction was generated by physician attitude and denial, rather than the negligence itself. In fact, my experience has been that close to half of malpractice cases could have been avoided through disclosure or apology but instead were relegated to litigation. What the majority of 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” (Ann. Int. Med. 1999;131:970-2).

Poor Service

At Disney theme parks, everyone is a guest. Similarly, most hotels feature workers with smiling faces and a can-do, positive attitude. Guest comfort comes first, and customer service is everyone's job. Hospitals and clinics, on the other hand, sometimes hire relatively unskilled personnel with little or no training before being put on the job. Those on the front lines, such as the phone operators and information desk clerks, should be the most accommodating, but unfortunately some lack people skills and do not go the extra mile. Experts say there are two typical problems in a hospital or clinic setting: overworked employees who treat patients as burdens rather than as clients, and employees who are not empowered to promptly address patient complaints.

Disparaging Remarks or Attitudes

Some lawsuits are filed because of suspicion raised in the patient's mind by disparaging remarks made by one practitioner about another. An example (doctor or nurse pointing to a large abdominal surgical scar): “Who did that to you?” Without having all the facts, one should avoid making critical comments about a colleague's work. Seek clarification before passing judgment. Worse yet, unthinking health care providers sometimes enter disparaging remarks into the medical records. Statements like “physician refused to respond” should be replaced by “no response yet, will try again.” Disagreements between doctor and nurse clearly require proper channels for resolution, and the medical record is not one of them. In the event a staff member makes a mistake, the physician should be remain calm and professional and avoid voicing direct criticism in front of the patient or family.

The staff can also be the cause of a lawsuit. Staff members are typically the first people in contact with the patient and family. They must make a good impression, be active listeners, and strive to make others feel important. Staff should be as well trained in customer service as in quality care. A bad attitude is just as unacceptable as incompetence.

Money Disputes

Out-of-pocket costs for medical care are skyrocketing. With the increasingly impersonal nature of the medical encounter and the commercialization of health care, patients are more apt to become dissatisfied and be less tolerant of errors. Recall that medical school taught us to first elicit the patient's chief medical complaint. Nowadays, too often the first question is: “Do you have insurance?” Or “what kind of coverage do you have?” In such a practice environment, more injured patients can be expected to retaliate, especially if they feel unjustifiably overcharged.

Inform the patient at the outset regarding cost estimates for consultations, procedures, and so on. Such discussions may be relegated to an experienced and professional staff member, and the doctor himself or herself need not be directly involved. However, this should be done before the service is provided. Ambiguities, followed by an unpleasant surprise concerning money matters, will likely upset patients, especially those with an adverse medical outcome. Great tact and sensitivity is necessary to avoid turning such a situation into a malpractice claim. This is not to say that only good clinical results deserve to be paid for. However, a bill that is perceived as being unreasonably large may just get an injured patient angry enough to file suit.

In addition, when patients don't pay their bills, many of us resort to a debt collection agency without first speaking directly to the patient. If possible, physicians should first try to resolve the issue, for example, by offering a generous installment payment plan. The funds owed may not amount to much in an individual case, and aggressive pursuit may prove counterproductive. Consider adopting a policy of writing off unpaid bills in the name of public service, although this may be impractical for some institutions or when large sums are owed.

Contact the author at [email protected].

Question: A patient develops life-threatening angioedema after taking an angiotensin receptor blocker (ARB) prescribed by her doctor for diabetic nephropathy. The Physicians' Desk Reference (PDR) mentions this side effect, but the doctor did not warn the patient because it's uncommon. When promoting the drug, pharmaceutical sales representatives have regularly emphasized its benefits but not the risks. Which of the following is true in a malpractice action?

A. A good defense is to emphasize that the benefits of an ARB in diabetic nephropathy greatly outweigh any potential side effects.

B. The prescribing physician is justified in not informing the patient about the risk of angioedema, in accordance with the customary practice of doctors not to disclose this rare adverse effect.

C. The pharmaceutical manufacturer shares malpractice liability because its drug is “defective.”

D. The pharmaceutical manufacturer is liable because its sales reps are supposed to consistently emphasize this serious risk.

E. The learned-intermediary doctrine shields the pharmaceutical manufacturer, placing full liability instead on the prescribing doctor.

Answer: E. Choices A and B are incorrect. Benefits outweighing risks may indeed form the basis for Food and Drug Administration approval of a drug, but this does not constitute a defense against a malpractice lawsuit. And in cases alleging lack of informed consent, the “professional” standard (what physicians would ordinarily disclose) is no longer the law in some jurisdictions, being replaced by the more onerous “reasonable person” standard (what a reasonable person in the patient's position would want to know, even if it's a rare risk).

Choices C and D are also incorrect. Drug or device manufacturers can be sued for a “defective” product, a legal term of art used in products liability litigation, but not in malpractice lawsuits. And although pharmaceutical sales representatives have a responsibility to inform doctors of both benefits and risks, a process termed “fair balance,” they frequently defer to the drug's package insert, as featured in the PDR, to completely discharge this duty.

Generally speaking, if a doctor fails to warn the patient of a medication risk, and injury results, the patient may have a claim against the doctor but not against the drug manufacturer. This is termed the “learned-intermediary” doctrine, and it is also applicable to medical devices such as dialysis equipment, breast implants, blood products, penile prostheses, and even contact lenses, although the situation is less clear where an optometrist does the prescribing (Products Liability 63A Am. Jur.2d Products Liability §1214, updated Sept. 2008). The justification is that manufacturers can reasonably rely on the treating doctor to warn of adverse effects, which are disclosed to the profession through its sales reps, in the drug's package insert, and in the PDR. The treating doctor, in turn, is expected to use his or her professional judgment to adequately warn the patient. It is simply not feasible for the manufacturer to directly warn every patient without usurping the doctor-patient relationship.

In a litigated case where a woman developed a hypertensive crisis after being prescribed Deconamine, a sympathomimetic decongestant, the pharmaceutical company successfully relied on the learned-intermediary doctrine for its defense. The plaintiff happened to be taking Nardil, an MAO inhibitor antidepressant, which is a contraindication to the concurrent use of a sympathomimetic agent. She contended that drug manufacturers should directly provide a wallet-sized informational card to all patients taking an MAO inhibitor since the simultaneous consumption of various foods, beverages, and interacting drugs can raise the blood pressure to dangerous levels. The court, however, sided with the defense's position that its legal duty was to inform only the physician and not the patient (Ferrara v. Berlex Laboratories Inc., 732 F. Supp. 552 [E.D. Pa. 1990]).

Occasionally, a court sidesteps the doctrine. When a manufacturer knows that the drug will reach the consumer without the intervention of a physician (e.g., over-the-counter preparations), it must take reasonable action to directly warn the consumer. Another situation is where extensive advertising of a drug to the public has taken place. For example, the manufacturer of the oral contraceptive Norplant was successfully sued because the Supreme Court of New Jersey ruled that the company's nationwide direct-to-consumer advertising created a duty to directly warn all patients using its drug (Perez v. Wyeth Laboratories Inc., 734 A.2d 1245 [N.J. 1999]). Manufacturers may also be liable if they have not disclosed all known risks, as alleged in the recent litigation surrounding rofecoxib (Vioxx) and rosiglitazone (Avandia).

The latest development in drug products liability law comes from the landmark case Wyeth v. Levine (555 U.S. 2 [2009]), in which a plaintiff lost her arm after the drug Phenergan, given by intravenous push, extravasated into the surrounding tissues and entered an artery, resulting in gangrene. This serious drug risk was known to the company and to the FDA, which had approved a warning statement contained in the drug's package insert, but the lawsuit asserted that the warning was inadequate and should have been modified. A Vermont jury had earlier awarded damages of $6.7 million. On appeal, the defendant pharmaceutical company maintained that its warning was appropriate because it had been approved by the federal government through the FDA. It further argued that the drug's package insert could not be unilaterally altered or modified without running afoul of federal regulations. However, in a 6-3 decision, the U.S. Supreme Court held that the company was at liberty to issue a more rigorous warning, that FDA approval does not bar lawsuits, and that federal law was not pre-emptive of state law claims involving drug injuries.

Question: A patient develops life-threatening angioedema after taking an angiotensin receptor blocker (ARB) prescribed by her doctor for diabetic nephropathy. The Physicians' Desk Reference (PDR) mentions this side effect, but the doctor did not warn the patient because it's uncommon. When promoting the drug, pharmaceutical sales representatives have regularly emphasized its benefits but not the risks. Which of the following is true in a malpractice action?

A. A good defense is to emphasize that the benefits of an ARB in diabetic nephropathy greatly outweigh any potential side effects.

B. The prescribing physician is justified in not informing the patient about the risk of angioedema, in accordance with the customary practice of doctors not to disclose this rare adverse effect.

C. The pharmaceutical manufacturer shares malpractice liability because its drug is “defective.”

D. The pharmaceutical manufacturer is liable because its sales reps are supposed to consistently emphasize this serious risk.

E. The learned-intermediary doctrine shields the pharmaceutical manufacturer, placing full liability instead on the prescribing doctor.

Answer: E. Choices A and B are incorrect. Benefits outweighing risks may indeed form the basis for Food and Drug Administration approval of a drug, but this does not constitute a defense against a malpractice lawsuit. And in cases alleging lack of informed consent, the “professional” standard (what physicians would ordinarily disclose) is no longer the law in some jurisdictions, being replaced by the more onerous “reasonable person” standard (what a reasonable person in the patient's position would want to know, even if it's a rare risk).

Choices C and D are also incorrect. Drug or device manufacturers can be sued for a “defective” product, a legal term of art used in products liability litigation, but not in malpractice lawsuits. And although pharmaceutical sales representatives have a responsibility to inform doctors of both benefits and risks, a process termed “fair balance,” they frequently defer to the drug's package insert, as featured in the PDR, to completely discharge this duty.

Generally speaking, if a doctor fails to warn the patient of a medication risk, and injury results, the patient may have a claim against the doctor but not against the drug manufacturer. This is termed the “learned-intermediary” doctrine, and it is also applicable to medical devices such as dialysis equipment, breast implants, blood products, penile prostheses, and even contact lenses, although the situation is less clear where an optometrist does the prescribing (Products Liability 63A Am. Jur.2d Products Liability §1214, updated Sept. 2008). The justification is that manufacturers can reasonably rely on the treating doctor to warn of adverse effects, which are disclosed to the profession through its sales reps, in the drug's package insert, and in the PDR. The treating doctor, in turn, is expected to use his or her professional judgment to adequately warn the patient. It is simply not feasible for the manufacturer to directly warn every patient without usurping the doctor-patient relationship.

In a litigated case where a woman developed a hypertensive crisis after being prescribed Deconamine, a sympathomimetic decongestant, the pharmaceutical company successfully relied on the learned-intermediary doctrine for its defense. The plaintiff happened to be taking Nardil, an MAO inhibitor antidepressant, which is a contraindication to the concurrent use of a sympathomimetic agent. She contended that drug manufacturers should directly provide a wallet-sized informational card to all patients taking an MAO inhibitor since the simultaneous consumption of various foods, beverages, and interacting drugs can raise the blood pressure to dangerous levels. The court, however, sided with the defense's position that its legal duty was to inform only the physician and not the patient (Ferrara v. Berlex Laboratories Inc., 732 F. Supp. 552 [E.D. Pa. 1990]).

Occasionally, a court sidesteps the doctrine. When a manufacturer knows that the drug will reach the consumer without the intervention of a physician (e.g., over-the-counter preparations), it must take reasonable action to directly warn the consumer. Another situation is where extensive advertising of a drug to the public has taken place. For example, the manufacturer of the oral contraceptive Norplant was successfully sued because the Supreme Court of New Jersey ruled that the company's nationwide direct-to-consumer advertising created a duty to directly warn all patients using its drug (Perez v. Wyeth Laboratories Inc., 734 A.2d 1245 [N.J. 1999]). Manufacturers may also be liable if they have not disclosed all known risks, as alleged in the recent litigation surrounding rofecoxib (Vioxx) and rosiglitazone (Avandia).

The latest development in drug products liability law comes from the landmark case Wyeth v. Levine (555 U.S. 2 [2009]), in which a plaintiff lost her arm after the drug Phenergan, given by intravenous push, extravasated into the surrounding tissues and entered an artery, resulting in gangrene. This serious drug risk was known to the company and to the FDA, which had approved a warning statement contained in the drug's package insert, but the lawsuit asserted that the warning was inadequate and should have been modified. A Vermont jury had earlier awarded damages of $6.7 million. On appeal, the defendant pharmaceutical company maintained that its warning was appropriate because it had been approved by the federal government through the FDA. It further argued that the drug's package insert could not be unilaterally altered or modified without running afoul of federal regulations. However, in a 6-3 decision, the U.S. Supreme Court held that the company was at liberty to issue a more rigorous warning, that FDA approval does not bar lawsuits, and that federal law was not pre-emptive of state law claims involving drug injuries.

Question: A patient develops life-threatening angioedema after taking an angiotensin receptor blocker (ARB) prescribed by her doctor for diabetic nephropathy. The Physicians' Desk Reference (PDR) mentions this side effect, but the doctor did not warn the patient because it's uncommon. When promoting the drug, pharmaceutical sales representatives have regularly emphasized its benefits but not the risks. Which of the following is true in a malpractice action?

A. A good defense is to emphasize that the benefits of an ARB in diabetic nephropathy greatly outweigh any potential side effects.

B. The prescribing physician is justified in not informing the patient about the risk of angioedema, in accordance with the customary practice of doctors not to disclose this rare adverse effect.

C. The pharmaceutical manufacturer shares malpractice liability because its drug is “defective.”

D. The pharmaceutical manufacturer is liable because its sales reps are supposed to consistently emphasize this serious risk.

E. The learned-intermediary doctrine shields the pharmaceutical manufacturer, placing full liability instead on the prescribing doctor.

Answer: E. Choices A and B are incorrect. Benefits outweighing risks may indeed form the basis for Food and Drug Administration approval of a drug, but this does not constitute a defense against a malpractice lawsuit. And in cases alleging lack of informed consent, the “professional” standard (what physicians would ordinarily disclose) is no longer the law in some jurisdictions, being replaced by the more onerous “reasonable person” standard (what a reasonable person in the patient's position would want to know, even if it's a rare risk).

Choices C and D are also incorrect. Drug or device manufacturers can be sued for a “defective” product, a legal term of art used in products liability litigation, but not in malpractice lawsuits. And although pharmaceutical sales representatives have a responsibility to inform doctors of both benefits and risks, a process termed “fair balance,” they frequently defer to the drug's package insert, as featured in the PDR, to completely discharge this duty.

Generally speaking, if a doctor fails to warn the patient of a medication risk, and injury results, the patient may have a claim against the doctor but not against the drug manufacturer. This is termed the “learned-intermediary” doctrine, and it is also applicable to medical devices such as dialysis equipment, breast implants, blood products, penile prostheses, and even contact lenses, although the situation is less clear where an optometrist does the prescribing (Products Liability 63A Am. Jur.2d Products Liability §1214, updated Sept. 2008). The justification is that manufacturers can reasonably rely on the treating doctor to warn of adverse effects, which are disclosed to the profession through its sales reps, in the drug's package insert, and in the PDR. The treating doctor, in turn, is expected to use his or her professional judgment to adequately warn the patient. It is simply not feasible for the manufacturer to directly warn every patient without usurping the doctor-patient relationship.

In a litigated case where a woman developed a hypertensive crisis after being prescribed Deconamine, a sympathomimetic decongestant, the pharmaceutical company successfully relied on the learned-intermediary doctrine for its defense. The plaintiff happened to be taking Nardil, an MAO inhibitor antidepressant, which is a contraindication to the concurrent use of a sympathomimetic agent. She contended that drug manufacturers should directly provide a wallet-sized informational card to all patients taking an MAO inhibitor since the simultaneous consumption of various foods, beverages, and interacting drugs can raise the blood pressure to dangerous levels. The court, however, sided with the defense's position that its legal duty was to inform only the physician and not the patient (Ferrara v. Berlex Laboratories Inc., 732 F. Supp. 552 [E.D. Pa. 1990]).

Occasionally, a court sidesteps the doctrine. When a manufacturer knows that the drug will reach the consumer without the intervention of a physician (e.g., over-the-counter preparations), it must take reasonable action to directly warn the consumer. Another situation is where extensive advertising of a drug to the public has taken place. For example, the manufacturer of the oral contraceptive Norplant was successfully sued because the Supreme Court of New Jersey ruled that the company's nationwide direct-to-consumer advertising created a duty to directly warn all patients using its drug (Perez v. Wyeth Laboratories Inc., 734 A.2d 1245 [N.J. 1999]). Manufacturers may also be liable if they have not disclosed all known risks, as alleged in the recent litigation surrounding rofecoxib (Vioxx) and rosiglitazone (Avandia).

The latest development in drug products liability law comes from the landmark case Wyeth v. Levine (555 U.S. 2 [2009]), in which a plaintiff lost her arm after the drug Phenergan, given by intravenous push, extravasated into the surrounding tissues and entered an artery, resulting in gangrene. This serious drug risk was known to the company and to the FDA, which had approved a warning statement contained in the drug's package insert, but the lawsuit asserted that the warning was inadequate and should have been modified. A Vermont jury had earlier awarded damages of $6.7 million. On appeal, the defendant pharmaceutical company maintained that its warning was appropriate because it had been approved by the federal government through the FDA. It further argued that the drug's package insert could not be unilaterally altered or modified without running afoul of federal regulations. However, in a 6-3 decision, the U.S. Supreme Court held that the company was at liberty to issue a more rigorous warning, that FDA approval does not bar lawsuits, and that federal law was not pre-emptive of state law claims involving drug injuries.

Question: A patient consults her physician for a painful wrist, which is treated with indomethacin. The patient has developed skin rashes caused by various medications in the past, but she does not inform the doctor about this. Shortly after starting indomethacin, she develops Stevens-Johnson syndrome. In regard to an assumption of risk defense, which of the following is true?

A. A patient has a legal duty to reveal to the physician all relevant medical history.

B. Assumption of risk is no longer a valid rule of law.

C. Assumption of risk is an affirmative defense in a tort action and constitutes a complete bar to recovery.

D. Assumption of risk is synonymous with contributory negligence.

E. Giving informed consent is tantamount to assumption of risk.

Answer: C. If a plaintiff is fully aware of the risk to which he or she is exposed, and voluntarily accepts that risk, there will be no recovery of damages if harm results. Known as assumption of risk, it constitutes a valid and complete bar to recovery. This defense has two main elements: a patient's full awareness of the risks, and his or her consent to waive all claims for damages.

In contrast, contributory negligence, which usually serves as a partial rather than complete bar to recovery, arises when negligence by the plaintiff played a part in the resulting injury.

Informed consent is when, after being apprised of the risks and alternatives, a patient gives the physician permission to proceed with diagnosis and treatment. However, this principle says nothing about a patient bearing the risk of harm arising out of negligence or incomplete disclosure by the physician.

The Restatement of Torts defines assumption of risk to mean that the plaintiff fully understands the risk and nonetheless chooses voluntarily to take it (Restatement of Torts, §496-C). One court put it this way: “The doctrine of assumption of the risk of danger applies only where the plaintiff, with a full appreciation of the danger involved and without restriction from his freedom of choice, either by circumstances or coercion, deliberately chooses an obviously perilous course of conduct so that it can be said as a matter of law he has assumed all risk of injury” (Myers v. Boleman, 260 S.E. 2d 359, Ga., 1979).

The assumption of risk defense has been asserted most prominently in sports activities such as boxing, where serious injuries are an integral known risk. Other examples include foolhardy actions, such as “where one tries to beat a rapidly approaching train across the track, to engage in drag racing or to walk upon a frozen pond where the ice is thin” (Myers case, supra).

A physician is expected to obtain a complete medical history, but although the patient is expected to be cooperative, he or she does not have to affirmatively volunteer medical information. A doctor cannot readily invoke this doctrine as a defense simply because the patient has not provided a complete medical history. Thus, in the question above (modified from Hayes v. Hoffman, 296 S.E.2d 216, Ga., 1982), the doctor's assumption of risk defense will likely fail. In the scenario described at the beginning of this column, the patient cannot be assumed to have understood fully the risk of not disclosing her drug allergies. She certainly did not anticipate developing something as serious as Stevens-Johnson syndrome. In a similar case where a patient developed anaphylaxis from using a sulfa-containing drug, an appeals court held that the trial judge erred by instructing the jury that a patient who fails to disclose relevant medical history to a physician has assumed risk of harm (Hawkins v. Greenberg, 283 S.E. 2d 301, Ga., 1981).

In other situations, however, an assumption of risk defense may be used successfully. For example, a patient in California voluntarily and actively sought unorthodox natural herbal treatment for breast cancer after she had refused all conventional therapy. She received full disclosure of the nature of the experimental treatment protocol, and the court therefore rejected her subsequent claim for damages. By giving informed consent to nonconventional experimental therapy in this case, the patient was in effect assuming the risk of harm (Schneider v. Revici, 817 F.2d 987, 2nd Cir., 1987).

In English law, the assumption of risk defense is called volenti non fit injuri (Latin for “to a willing person, no injury is done”). However, mere knowledge of risk does not necessarily imply consent. For example, a plaintiff once accepted a ride from a drunk driver and sustained injuries in a subsequent accident. The court ruled that volenti did not apply in such cases unless the drunkenness was so extreme and so obvious that accepting the ride was equivalent to walking on the edge of an unfenced cliff.

Question: A patient consults her physician for a painful wrist, which is treated with indomethacin. The patient has developed skin rashes caused by various medications in the past, but she does not inform the doctor about this. Shortly after starting indomethacin, she develops Stevens-Johnson syndrome. In regard to an assumption of risk defense, which of the following is true?

A. A patient has a legal duty to reveal to the physician all relevant medical history.

B. Assumption of risk is no longer a valid rule of law.

C. Assumption of risk is an affirmative defense in a tort action and constitutes a complete bar to recovery.

D. Assumption of risk is synonymous with contributory negligence.

E. Giving informed consent is tantamount to assumption of risk.

Answer: C. If a plaintiff is fully aware of the risk to which he or she is exposed, and voluntarily accepts that risk, there will be no recovery of damages if harm results. Known as assumption of risk, it constitutes a valid and complete bar to recovery. This defense has two main elements: a patient's full awareness of the risks, and his or her consent to waive all claims for damages.

In contrast, contributory negligence, which usually serves as a partial rather than complete bar to recovery, arises when negligence by the plaintiff played a part in the resulting injury.

Informed consent is when, after being apprised of the risks and alternatives, a patient gives the physician permission to proceed with diagnosis and treatment. However, this principle says nothing about a patient bearing the risk of harm arising out of negligence or incomplete disclosure by the physician.

The Restatement of Torts defines assumption of risk to mean that the plaintiff fully understands the risk and nonetheless chooses voluntarily to take it (Restatement of Torts, §496-C). One court put it this way: “The doctrine of assumption of the risk of danger applies only where the plaintiff, with a full appreciation of the danger involved and without restriction from his freedom of choice, either by circumstances or coercion, deliberately chooses an obviously perilous course of conduct so that it can be said as a matter of law he has assumed all risk of injury” (Myers v. Boleman, 260 S.E. 2d 359, Ga., 1979).

The assumption of risk defense has been asserted most prominently in sports activities such as boxing, where serious injuries are an integral known risk. Other examples include foolhardy actions, such as “where one tries to beat a rapidly approaching train across the track, to engage in drag racing or to walk upon a frozen pond where the ice is thin” (Myers case, supra).

A physician is expected to obtain a complete medical history, but although the patient is expected to be cooperative, he or she does not have to affirmatively volunteer medical information. A doctor cannot readily invoke this doctrine as a defense simply because the patient has not provided a complete medical history. Thus, in the question above (modified from Hayes v. Hoffman, 296 S.E.2d 216, Ga., 1982), the doctor's assumption of risk defense will likely fail. In the scenario described at the beginning of this column, the patient cannot be assumed to have understood fully the risk of not disclosing her drug allergies. She certainly did not anticipate developing something as serious as Stevens-Johnson syndrome. In a similar case where a patient developed anaphylaxis from using a sulfa-containing drug, an appeals court held that the trial judge erred by instructing the jury that a patient who fails to disclose relevant medical history to a physician has assumed risk of harm (Hawkins v. Greenberg, 283 S.E. 2d 301, Ga., 1981).

In other situations, however, an assumption of risk defense may be used successfully. For example, a patient in California voluntarily and actively sought unorthodox natural herbal treatment for breast cancer after she had refused all conventional therapy. She received full disclosure of the nature of the experimental treatment protocol, and the court therefore rejected her subsequent claim for damages. By giving informed consent to nonconventional experimental therapy in this case, the patient was in effect assuming the risk of harm (Schneider v. Revici, 817 F.2d 987, 2nd Cir., 1987).

In English law, the assumption of risk defense is called volenti non fit injuri (Latin for “to a willing person, no injury is done”). However, mere knowledge of risk does not necessarily imply consent. For example, a plaintiff once accepted a ride from a drunk driver and sustained injuries in a subsequent accident. The court ruled that volenti did not apply in such cases unless the drunkenness was so extreme and so obvious that accepting the ride was equivalent to walking on the edge of an unfenced cliff.

Question: A patient consults her physician for a painful wrist, which is treated with indomethacin. The patient has developed skin rashes caused by various medications in the past, but she does not inform the doctor about this. Shortly after starting indomethacin, she develops Stevens-Johnson syndrome. In regard to an assumption of risk defense, which of the following is true?

A. A patient has a legal duty to reveal to the physician all relevant medical history.

B. Assumption of risk is no longer a valid rule of law.

C. Assumption of risk is an affirmative defense in a tort action and constitutes a complete bar to recovery.

D. Assumption of risk is synonymous with contributory negligence.

E. Giving informed consent is tantamount to assumption of risk.

Answer: C. If a plaintiff is fully aware of the risk to which he or she is exposed, and voluntarily accepts that risk, there will be no recovery of damages if harm results. Known as assumption of risk, it constitutes a valid and complete bar to recovery. This defense has two main elements: a patient's full awareness of the risks, and his or her consent to waive all claims for damages.

In contrast, contributory negligence, which usually serves as a partial rather than complete bar to recovery, arises when negligence by the plaintiff played a part in the resulting injury.

Informed consent is when, after being apprised of the risks and alternatives, a patient gives the physician permission to proceed with diagnosis and treatment. However, this principle says nothing about a patient bearing the risk of harm arising out of negligence or incomplete disclosure by the physician.

The Restatement of Torts defines assumption of risk to mean that the plaintiff fully understands the risk and nonetheless chooses voluntarily to take it (Restatement of Torts, §496-C). One court put it this way: “The doctrine of assumption of the risk of danger applies only where the plaintiff, with a full appreciation of the danger involved and without restriction from his freedom of choice, either by circumstances or coercion, deliberately chooses an obviously perilous course of conduct so that it can be said as a matter of law he has assumed all risk of injury” (Myers v. Boleman, 260 S.E. 2d 359, Ga., 1979).

The assumption of risk defense has been asserted most prominently in sports activities such as boxing, where serious injuries are an integral known risk. Other examples include foolhardy actions, such as “where one tries to beat a rapidly approaching train across the track, to engage in drag racing or to walk upon a frozen pond where the ice is thin” (Myers case, supra).

A physician is expected to obtain a complete medical history, but although the patient is expected to be cooperative, he or she does not have to affirmatively volunteer medical information. A doctor cannot readily invoke this doctrine as a defense simply because the patient has not provided a complete medical history. Thus, in the question above (modified from Hayes v. Hoffman, 296 S.E.2d 216, Ga., 1982), the doctor's assumption of risk defense will likely fail. In the scenario described at the beginning of this column, the patient cannot be assumed to have understood fully the risk of not disclosing her drug allergies. She certainly did not anticipate developing something as serious as Stevens-Johnson syndrome. In a similar case where a patient developed anaphylaxis from using a sulfa-containing drug, an appeals court held that the trial judge erred by instructing the jury that a patient who fails to disclose relevant medical history to a physician has assumed risk of harm (Hawkins v. Greenberg, 283 S.E. 2d 301, Ga., 1981).

In other situations, however, an assumption of risk defense may be used successfully. For example, a patient in California voluntarily and actively sought unorthodox natural herbal treatment for breast cancer after she had refused all conventional therapy. She received full disclosure of the nature of the experimental treatment protocol, and the court therefore rejected her subsequent claim for damages. By giving informed consent to nonconventional experimental therapy in this case, the patient was in effect assuming the risk of harm (Schneider v. Revici, 817 F.2d 987, 2nd Cir., 1987).

In English law, the assumption of risk defense is called volenti non fit injuri (Latin for “to a willing person, no injury is done”). However, mere knowledge of risk does not necessarily imply consent. For example, a plaintiff once accepted a ride from a drunk driver and sustained injuries in a subsequent accident. The court ruled that volenti did not apply in such cases unless the drunkenness was so extreme and so obvious that accepting the ride was equivalent to walking on the edge of an unfenced cliff.

Question: A patient develops life-threatening angioedema after taking an angiotensin receptor blocker (ARB) prescribed by her doctor for diabetic nephropathy. The Physicians' Desk Reference (PDR) mentions this side effect, but the doctor did not warn the patient because it's uncommon. When promoting the drug, pharmaceutical sales representatives have regularly emphasized its benefits but not the risks. Which of the following is true in a malpractice action?

A. A good defense is to emphasize that the benefits of an ARB in diabetic nephropathy greatly outweigh any potential side effects.

B. The prescribing physician is justified in not informing the patient about the risk of angioedema, in accordance with the customary practice of doctors not to disclose this rare adverse effect.

C. The pharmaceutical manufacturer shares malpractice liability because its drug is “defective.”

D. The pharmaceutical manufacturer is liable because its sales reps are supposed to consistently emphasize this serious risk.

E. The learned-intermediary doctrine shields the pharmaceutical manufacturer, placing full liability instead on the prescribing doctor.

Answer: E. Choices A and B are incorrect. Benefits outweighing risks may indeed form the basis for Food and Drug Administration approval of a drug, but this does not constitute a defense against a malpractice lawsuit. And in cases alleging lack of informed consent, the “professional” standard (what physicians would ordinarily disclose) is no longer the law in some jurisdictions, being replaced by the more onerous “reasonable person” standard (what a reasonable person in the patient's position would want to know, even if it's a rare risk).

Choices C and D are also incorrect. Drug or device manufacturers can be sued for a “defective” product, a legal term of art used in products liability litigation, but not in malpractice lawsuits. And although pharmaceutical sales representatives have a responsibility to inform doctors of both benefits and risks, a process termed “fair balance,” they frequently defer to the drug's package insert, as featured in the PDR, to completely discharge this duty.

Generally speaking, if a doctor fails to warn the patient of a medication risk, and injury results, the patient may have a claim against the doctor but not against the drug manufacturer. This is termed the “learned-intermediary” doctrine, and it is also applicable to medical devices such as dialysis equipment, breast implants, blood products, penile prostheses, and even contact lenses, although the situation is less clear where an optometrist does the prescribing (Products Liability 63A Am. Jur.2d Products Liability §1214, updated Sept. 2008). The justification is that manufacturers can reasonably rely on the treating doctor to warn of adverse effects, which are disclosed to the profession through its sales reps, in the drug's package insert, and in the PDR. The treating doctor, in turn, is expected to use his or her professional judgment to adequately warn the patient. It is simply not feasible for the manufacturer to directly warn every patient without usurping the doctor-patient relationship.

In a litigated case where a woman developed a hypertensive crisis after being prescribed Deconamine, a sympathomimetic decongestant, the pharmaceutical company successfully relied on the learned-intermediary doctrine for its defense. The plaintiff happened to be taking Nardil, an MAO inhibitor antidepressant, which is a contraindication to the concurrent use of a sympathomimetic agent. She contended that drug manufacturers should directly provide a wallet-sized informational card to all patients taking an MAO inhibitor since the simultaneous consumption of various foods, beverages, and interacting drugs can raise the blood pressure to dangerous levels. The court, however, sided with the defense's position that its legal duty was to inform only the physician and not the patient (Ferrara v. Berlex Laboratories Inc., 732 F. Supp. 552 [E.D. Pa. 1990]).

Occasionally, a court sidesteps the doctrine. When a manufacturer knows that the drug will reach the consumer without the intervention of a physician (e.g., over-the-counter preparations), it must take reasonable action to directly warn the consumer. Another situation is where there has been extensive advertising of a drug to the public. For example, the manufacturer of the oral contraceptive Norplant was successfully sued because the Supreme Court of New Jersey ruled that the company's nationwide direct-to-consumer advertising created a duty to directly warn all patients using its drug (Perez v. Wyeth Laboratories Inc., 734 A.2d 1245 [N.J. 1999]). Manufacturers may also be liable if they have not disclosed all known risks, as alleged in the recent litigation surrounding rofecoxib (Vioxx) and rosiglitazone (Avandia).

The latest development in drug products liability law comes from the landmark case Wyeth v. Levine (555 U.S. 2 [2009]), in which a plaintiff lost her arm after the drug Phenergan, given by intravenous push, extravasated into the surrounding tissues and entered an artery, resulting in gangrene. This serious drug risk was known to the company and to the FDA, which had approved a warning statement contained in the drug's package insert, but the lawsuit asserted that the warning was inadequate and should have been modified. A Vermont jury had earlier awarded damages of $6.7 million. On appeal, the defendant pharmaceutical company maintained that its warning was appropriate because it had been approved by the federal government through the FDA. It further argued that the drug's package insert could not be unilaterally altered or modified without running afoul of federal regulations. However, in a 6-3 decision, the U.S. Supreme Court held that the company was at liberty to issue a more rigorous warning, that FDA approval does not bar lawsuits, and that federal law was not pre-emptive of state law claims involving drug injuries.

Contact the author at [email protected].

Question: A patient develops life-threatening angioedema after taking an angiotensin receptor blocker (ARB) prescribed by her doctor for diabetic nephropathy. The Physicians' Desk Reference (PDR) mentions this side effect, but the doctor did not warn the patient because it's uncommon. When promoting the drug, pharmaceutical sales representatives have regularly emphasized its benefits but not the risks. Which of the following is true in a malpractice action?

A. A good defense is to emphasize that the benefits of an ARB in diabetic nephropathy greatly outweigh any potential side effects.

B. The prescribing physician is justified in not informing the patient about the risk of angioedema, in accordance with the customary practice of doctors not to disclose this rare adverse effect.

C. The pharmaceutical manufacturer shares malpractice liability because its drug is “defective.”

D. The pharmaceutical manufacturer is liable because its sales reps are supposed to consistently emphasize this serious risk.

E. The learned-intermediary doctrine shields the pharmaceutical manufacturer, placing full liability instead on the prescribing doctor.

Answer: E. Choices A and B are incorrect. Benefits outweighing risks may indeed form the basis for Food and Drug Administration approval of a drug, but this does not constitute a defense against a malpractice lawsuit. And in cases alleging lack of informed consent, the “professional” standard (what physicians would ordinarily disclose) is no longer the law in some jurisdictions, being replaced by the more onerous “reasonable person” standard (what a reasonable person in the patient's position would want to know, even if it's a rare risk).

Choices C and D are also incorrect. Drug or device manufacturers can be sued for a “defective” product, a legal term of art used in products liability litigation, but not in malpractice lawsuits. And although pharmaceutical sales representatives have a responsibility to inform doctors of both benefits and risks, a process termed “fair balance,” they frequently defer to the drug's package insert, as featured in the PDR, to completely discharge this duty.

Generally speaking, if a doctor fails to warn the patient of a medication risk, and injury results, the patient may have a claim against the doctor but not against the drug manufacturer. This is termed the “learned-intermediary” doctrine, and it is also applicable to medical devices such as dialysis equipment, breast implants, blood products, penile prostheses, and even contact lenses, although the situation is less clear where an optometrist does the prescribing (Products Liability 63A Am. Jur.2d Products Liability §1214, updated Sept. 2008). The justification is that manufacturers can reasonably rely on the treating doctor to warn of adverse effects, which are disclosed to the profession through its sales reps, in the drug's package insert, and in the PDR. The treating doctor, in turn, is expected to use his or her professional judgment to adequately warn the patient. It is simply not feasible for the manufacturer to directly warn every patient without usurping the doctor-patient relationship.

In a litigated case where a woman developed a hypertensive crisis after being prescribed Deconamine, a sympathomimetic decongestant, the pharmaceutical company successfully relied on the learned-intermediary doctrine for its defense. The plaintiff happened to be taking Nardil, an MAO inhibitor antidepressant, which is a contraindication to the concurrent use of a sympathomimetic agent. She contended that drug manufacturers should directly provide a wallet-sized informational card to all patients taking an MAO inhibitor since the simultaneous consumption of various foods, beverages, and interacting drugs can raise the blood pressure to dangerous levels. The court, however, sided with the defense's position that its legal duty was to inform only the physician and not the patient (Ferrara v. Berlex Laboratories Inc., 732 F. Supp. 552 [E.D. Pa. 1990]).

Occasionally, a court sidesteps the doctrine. When a manufacturer knows that the drug will reach the consumer without the intervention of a physician (e.g., over-the-counter preparations), it must take reasonable action to directly warn the consumer. Another situation is where there has been extensive advertising of a drug to the public. For example, the manufacturer of the oral contraceptive Norplant was successfully sued because the Supreme Court of New Jersey ruled that the company's nationwide direct-to-consumer advertising created a duty to directly warn all patients using its drug (Perez v. Wyeth Laboratories Inc., 734 A.2d 1245 [N.J. 1999]). Manufacturers may also be liable if they have not disclosed all known risks, as alleged in the recent litigation surrounding rofecoxib (Vioxx) and rosiglitazone (Avandia).

The latest development in drug products liability law comes from the landmark case Wyeth v. Levine (555 U.S. 2 [2009]), in which a plaintiff lost her arm after the drug Phenergan, given by intravenous push, extravasated into the surrounding tissues and entered an artery, resulting in gangrene. This serious drug risk was known to the company and to the FDA, which had approved a warning statement contained in the drug's package insert, but the lawsuit asserted that the warning was inadequate and should have been modified. A Vermont jury had earlier awarded damages of $6.7 million. On appeal, the defendant pharmaceutical company maintained that its warning was appropriate because it had been approved by the federal government through the FDA. It further argued that the drug's package insert could not be unilaterally altered or modified without running afoul of federal regulations. However, in a 6-3 decision, the U.S. Supreme Court held that the company was at liberty to issue a more rigorous warning, that FDA approval does not bar lawsuits, and that federal law was not pre-emptive of state law claims involving drug injuries.

Contact the author at [email protected].

Question: A patient develops life-threatening angioedema after taking an angiotensin receptor blocker (ARB) prescribed by her doctor for diabetic nephropathy. The Physicians' Desk Reference (PDR) mentions this side effect, but the doctor did not warn the patient because it's uncommon. When promoting the drug, pharmaceutical sales representatives have regularly emphasized its benefits but not the risks. Which of the following is true in a malpractice action?

A. A good defense is to emphasize that the benefits of an ARB in diabetic nephropathy greatly outweigh any potential side effects.

B. The prescribing physician is justified in not informing the patient about the risk of angioedema, in accordance with the customary practice of doctors not to disclose this rare adverse effect.

C. The pharmaceutical manufacturer shares malpractice liability because its drug is “defective.”

D. The pharmaceutical manufacturer is liable because its sales reps are supposed to consistently emphasize this serious risk.

E. The learned-intermediary doctrine shields the pharmaceutical manufacturer, placing full liability instead on the prescribing doctor.

Answer: E. Choices A and B are incorrect. Benefits outweighing risks may indeed form the basis for Food and Drug Administration approval of a drug, but this does not constitute a defense against a malpractice lawsuit. And in cases alleging lack of informed consent, the “professional” standard (what physicians would ordinarily disclose) is no longer the law in some jurisdictions, being replaced by the more onerous “reasonable person” standard (what a reasonable person in the patient's position would want to know, even if it's a rare risk).

Choices C and D are also incorrect. Drug or device manufacturers can be sued for a “defective” product, a legal term of art used in products liability litigation, but not in malpractice lawsuits. And although pharmaceutical sales representatives have a responsibility to inform doctors of both benefits and risks, a process termed “fair balance,” they frequently defer to the drug's package insert, as featured in the PDR, to completely discharge this duty.

Generally speaking, if a doctor fails to warn the patient of a medication risk, and injury results, the patient may have a claim against the doctor but not against the drug manufacturer. This is termed the “learned-intermediary” doctrine, and it is also applicable to medical devices such as dialysis equipment, breast implants, blood products, penile prostheses, and even contact lenses, although the situation is less clear where an optometrist does the prescribing (Products Liability 63A Am. Jur.2d Products Liability §1214, updated Sept. 2008). The justification is that manufacturers can reasonably rely on the treating doctor to warn of adverse effects, which are disclosed to the profession through its sales reps, in the drug's package insert, and in the PDR. The treating doctor, in turn, is expected to use his or her professional judgment to adequately warn the patient. It is simply not feasible for the manufacturer to directly warn every patient without usurping the doctor-patient relationship.

In a litigated case where a woman developed a hypertensive crisis after being prescribed Deconamine, a sympathomimetic decongestant, the pharmaceutical company successfully relied on the learned-intermediary doctrine for its defense. The plaintiff happened to be taking Nardil, an MAO inhibitor antidepressant, which is a contraindication to the concurrent use of a sympathomimetic agent. She contended that drug manufacturers should directly provide a wallet-sized informational card to all patients taking an MAO inhibitor since the simultaneous consumption of various foods, beverages, and interacting drugs can raise the blood pressure to dangerous levels. The court, however, sided with the defense's position that its legal duty was to inform only the physician and not the patient (Ferrara v. Berlex Laboratories Inc., 732 F. Supp. 552 [E.D. Pa. 1990]).

Occasionally, a court sidesteps the doctrine. When a manufacturer knows that the drug will reach the consumer without the intervention of a physician (e.g., over-the-counter preparations), it must take reasonable action to directly warn the consumer. Another situation is where there has been extensive advertising of a drug to the public. For example, the manufacturer of the oral contraceptive Norplant was successfully sued because the Supreme Court of New Jersey ruled that the company's nationwide direct-to-consumer advertising created a duty to directly warn all patients using its drug (Perez v. Wyeth Laboratories Inc., 734 A.2d 1245 [N.J. 1999]). Manufacturers may also be liable if they have not disclosed all known risks, as alleged in the recent litigation surrounding rofecoxib (Vioxx) and rosiglitazone (Avandia).

The latest development in drug products liability law comes from the landmark case Wyeth v. Levine (555 U.S. 2 [2009]), in which a plaintiff lost her arm after the drug Phenergan, given by intravenous push, extravasated into the surrounding tissues and entered an artery, resulting in gangrene. This serious drug risk was known to the company and to the FDA, which had approved a warning statement contained in the drug's package insert, but the lawsuit asserted that the warning was inadequate and should have been modified. A Vermont jury had earlier awarded damages of $6.7 million. On appeal, the defendant pharmaceutical company maintained that its warning was appropriate because it had been approved by the federal government through the FDA. It further argued that the drug's package insert could not be unilaterally altered or modified without running afoul of federal regulations. However, in a 6-3 decision, the U.S. Supreme Court held that the company was at liberty to issue a more rigorous warning, that FDA approval does not bar lawsuits, and that federal law was not pre-emptive of state law claims involving drug injuries.

Contact the author at [email protected].