Law & Medicine

An overlooked finding and missed opportunity

A WOMAN IN HER LATE 70s had an abdominal and pelvic computed tomography (CT) scan, which was reported as normal. Four years later she had a second abdominal and pelvic scan because of blood in her urine. A comparison with the previous scan noted that “the endometrium is thickened, measuring approximately 22 mm, compared to 17 mm” on the first scan.

Endometrial cancer was diagnosed, and the woman underwent a radical hysterectomy and other procedures before being discharged from the hospital. She died about 4 months later of complications from the cancer.

PLAINTIFF’S CLAIM The thickness of the endometrium on the first CT scan should have prompted follow-up because a thickness >10 mm almost always suggests possible endometrial cancer in postmenopausal women. Diagnosing and treating the cancer at the time of the first scan would have prevented metastasis.

THE DEFENSE No information about the defense is available.

VERDICT $600,000 Massachusetts settlement.

COMMENT Incidental findings can be the bane of one’s existence; make sure you read those imaging reports carefully.

A headache, then death, for a 13-year-old

A COMPLAINT OF HEADACHE prompted a 13-year-old girl to seek treatment at a health center. She subsequently developed bacterial meningitis, attributed to sinusitis, and died.

PLAINTIFF’S CLAIM The physician who saw the girl at the health center failed to review records of a previous trip to an emergency room, ask the patient about the severity of her headache, or prescribe antibiotics.

THE DEFENSE No information about the defense is available.

VERDICT $3.75M Illinois verdict.

COMMENT The old lesson of considering not only the most common but also the “have-to-make” diagnoses remains timeless.

Did a failure to communicate cost this patient his life?

A MAN WITH A DRY, NONPRODUCTIVE COUGH and a long history of sinus problems and upper respiratory issues was seen several times by his family care group. One physician ordered a chest radiograph, which a technician performed in house and a radiologist read at another location of the practice. The radiologist compared the radiograph with a chest film done several years earlier and reported a new finding: a 1-cm lung nodule. He recommended further evaluation with a computed tomography (CT) scan.

On the same day as the chest radiograph, the patient was referred to an ear, nose, and throat specialist, who examined him the following day and ordered a CT scan of the sinus. The patient was never notified of the abnormality on the chest radiograph or the need for a follow-up CT scan.

Almost 2 years later, the patient began losing weight and experiencing shortness of breath and chest pain. He went to another medical group and was referred for radiologic evaluation. He was subsequently diagnosed with stage IV terminal lung cancer and died about 9 months later.

PLAINTIFFS’ CLAIM The family care group was negligent for failing to communicate the results of the chest radiograph to the patient. Treatment at the time of the chest x-ray would likely have been curative.

THE DEFENSE No information about the defense is available.

VERDICT $900,000 Virginia settlement.

COMMENT Another abnormal radiograph, another example of inadequate communication leads to a $900,000 settlement.

An overlooked finding and missed opportunity

A WOMAN IN HER LATE 70s had an abdominal and pelvic computed tomography (CT) scan, which was reported as normal. Four years later she had a second abdominal and pelvic scan because of blood in her urine. A comparison with the previous scan noted that “the endometrium is thickened, measuring approximately 22 mm, compared to 17 mm” on the first scan.

Endometrial cancer was diagnosed, and the woman underwent a radical hysterectomy and other procedures before being discharged from the hospital. She died about 4 months later of complications from the cancer.

PLAINTIFF’S CLAIM The thickness of the endometrium on the first CT scan should have prompted follow-up because a thickness >10 mm almost always suggests possible endometrial cancer in postmenopausal women. Diagnosing and treating the cancer at the time of the first scan would have prevented metastasis.

THE DEFENSE No information about the defense is available.

VERDICT $600,000 Massachusetts settlement.

COMMENT Incidental findings can be the bane of one’s existence; make sure you read those imaging reports carefully.

A headache, then death, for a 13-year-old

A COMPLAINT OF HEADACHE prompted a 13-year-old girl to seek treatment at a health center. She subsequently developed bacterial meningitis, attributed to sinusitis, and died.

PLAINTIFF’S CLAIM The physician who saw the girl at the health center failed to review records of a previous trip to an emergency room, ask the patient about the severity of her headache, or prescribe antibiotics.

THE DEFENSE No information about the defense is available.

VERDICT $3.75M Illinois verdict.

COMMENT The old lesson of considering not only the most common but also the “have-to-make” diagnoses remains timeless.

Did a failure to communicate cost this patient his life?

A MAN WITH A DRY, NONPRODUCTIVE COUGH and a long history of sinus problems and upper respiratory issues was seen several times by his family care group. One physician ordered a chest radiograph, which a technician performed in house and a radiologist read at another location of the practice. The radiologist compared the radiograph with a chest film done several years earlier and reported a new finding: a 1-cm lung nodule. He recommended further evaluation with a computed tomography (CT) scan.

On the same day as the chest radiograph, the patient was referred to an ear, nose, and throat specialist, who examined him the following day and ordered a CT scan of the sinus. The patient was never notified of the abnormality on the chest radiograph or the need for a follow-up CT scan.

Almost 2 years later, the patient began losing weight and experiencing shortness of breath and chest pain. He went to another medical group and was referred for radiologic evaluation. He was subsequently diagnosed with stage IV terminal lung cancer and died about 9 months later.

PLAINTIFFS’ CLAIM The family care group was negligent for failing to communicate the results of the chest radiograph to the patient. Treatment at the time of the chest x-ray would likely have been curative.

THE DEFENSE No information about the defense is available.

VERDICT $900,000 Virginia settlement.

COMMENT Another abnormal radiograph, another example of inadequate communication leads to a $900,000 settlement.

An overlooked finding and missed opportunity

A WOMAN IN HER LATE 70s had an abdominal and pelvic computed tomography (CT) scan, which was reported as normal. Four years later she had a second abdominal and pelvic scan because of blood in her urine. A comparison with the previous scan noted that “the endometrium is thickened, measuring approximately 22 mm, compared to 17 mm” on the first scan.

Endometrial cancer was diagnosed, and the woman underwent a radical hysterectomy and other procedures before being discharged from the hospital. She died about 4 months later of complications from the cancer.

PLAINTIFF’S CLAIM The thickness of the endometrium on the first CT scan should have prompted follow-up because a thickness >10 mm almost always suggests possible endometrial cancer in postmenopausal women. Diagnosing and treating the cancer at the time of the first scan would have prevented metastasis.

THE DEFENSE No information about the defense is available.

VERDICT $600,000 Massachusetts settlement.

COMMENT Incidental findings can be the bane of one’s existence; make sure you read those imaging reports carefully.

A headache, then death, for a 13-year-old

A COMPLAINT OF HEADACHE prompted a 13-year-old girl to seek treatment at a health center. She subsequently developed bacterial meningitis, attributed to sinusitis, and died.

PLAINTIFF’S CLAIM The physician who saw the girl at the health center failed to review records of a previous trip to an emergency room, ask the patient about the severity of her headache, or prescribe antibiotics.

THE DEFENSE No information about the defense is available.

VERDICT $3.75M Illinois verdict.

COMMENT The old lesson of considering not only the most common but also the “have-to-make” diagnoses remains timeless.

Did a failure to communicate cost this patient his life?

A MAN WITH A DRY, NONPRODUCTIVE COUGH and a long history of sinus problems and upper respiratory issues was seen several times by his family care group. One physician ordered a chest radiograph, which a technician performed in house and a radiologist read at another location of the practice. The radiologist compared the radiograph with a chest film done several years earlier and reported a new finding: a 1-cm lung nodule. He recommended further evaluation with a computed tomography (CT) scan.

On the same day as the chest radiograph, the patient was referred to an ear, nose, and throat specialist, who examined him the following day and ordered a CT scan of the sinus. The patient was never notified of the abnormality on the chest radiograph or the need for a follow-up CT scan.

Almost 2 years later, the patient began losing weight and experiencing shortness of breath and chest pain. He went to another medical group and was referred for radiologic evaluation. He was subsequently diagnosed with stage IV terminal lung cancer and died about 9 months later.

PLAINTIFFS’ CLAIM The family care group was negligent for failing to communicate the results of the chest radiograph to the patient. Treatment at the time of the chest x-ray would likely have been curative.

THE DEFENSE No information about the defense is available.

VERDICT $900,000 Virginia settlement.

COMMENT Another abnormal radiograph, another example of inadequate communication leads to a $900,000 settlement.

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].

Bladder and bowel function lost to cauda equina syndrome

LOWER BACK PAIN developed in a 34-year-old woman around the time she had fibroids removed by her obstetrician-gynecologist. The woman reported the pain at her first postoperative visit. The OB/GYN offered treatment, but the patient traveled to the Dominican Republic for 2 months instead.

The month after the patient’s return, she experienced sharp pain in her legs and temporarily lost control of her bladder and bowels. Eight days later, she returned to the OB/GYN complaining of pain and occasional urinary incontinence. The doctor diagnosed neurogenic bladder, prescribed medication, and told the patient to follow up in a week. At some point over the next few days, the patient could not urinate, but didn’t return to the doctor for a week. The doctor catheterized her and drained about 3000 mL of urine. He then sent her to a hospital.

The hospital staff suspected cauda equina syndrome and consulted a neurologist, who concluded that the patient didn’t have the condition. The patient refused a magnetic resonance imaging (MRI) scan at that time because she didn’t think she could assume the required position. The patient ultimately underwent an MRI scan a week later. Another neurologist reviewed the scan and diagnosed cauda equina syndrome. Despite surgery, the patient has permanent bowel and bladder dysfunction.

PLAINTIFF’S CLAIM The defendants were negligent in failing to diagnose cauda equina syndrome earlier.

DOCTORS’ DEFENSE The OB/GYN claimed that the patient didn’t undergo the recommended follow-up treatment after surgery. The neurologist claimed that his examination didn’t reveal any objective indications of cauda equina syndrome.

VERDICT $1.5 million New York settlement.

COMMENT Suspicion of cauda equina demands prompt imaging and neurologic consultation. Failure to do so can lead to devastating consequences.

Failure to suspect stroke results in brain damage

A 37-YEAR-OLD WOMAN went to a gastroenterologist for a postoperative consult. Her blood pressure was 180/100. Her medical history included recent symptoms of blurred vision, dizziness, nosebleeds, and tingling in the face and right arm. She was taking medications that increased her risk of stroke, had preexisting Crohn’s disease, and smoked.

The day after the doctor visit, the woman went to a hospital, where she was diagnosed with a stroke from a left cerebral artery infarction and dissection with clot formation in the left internal carotid artery. She suffered brain damage with aphasia and right hemiparalysis.

PLAINTIFF’S CLAIM The doctor was negligent for failing to diagnose the patient’s condition and provide treatment.

DOCTOR’S DEFENSE The doctor denied any negligence.

VERDICT Indiana defense verdict.

COMMENT In this age of thrombolysis and aggressive stroke management, rapid diagnosis and intervention has gone from an academic exercise to a standard of care.

Suspicious finding + no follow-up = lawsuit

CONGESTIVE HEART FAILURE and atrial fibrillation prompted the hospitalization of a 79-year-old woman. A radiograph showed a density in the upper left lobe of her lung, and another x-ray was ordered. The same radiologist reviewed both films and recommended that the patient undergo a third radiograph after discharge from the hospital. Although informed of the radiologist’s findings and recommendations, the patient’s physician didn’t order a radiograph or computed tomography (CT) scan. The patient wasn’t notified of the findings.

The density was still visible on radiographs taken about 19 months after the original films. Seventeen months later, the patient complained of left chest wall discomfort and had another radiograph, which showed the density and a collection of pleural fluid. A CT scan suggested cancer. The patient was ultimately diagnosed with stage-III, poorly differentiated adenocarcinoma—which has a very low survival rate—in her left pleura. Because of the prognosis, a biopsy wasn’t performed.

PLAINTIFF’S CLAIM The defendant was negligent in failing to follow up on the radiologist’s report. Proper diagnosis and treatment at the time of the original radiographs would have meant targeting the cancer at stage I, when the survival rate would have been much higher.

THE DEFENSE The primary lung cancer wasn’t in the upper left lobe, and the density was probably only a scar. The cancer was likely somewhere else, possibly the gastrointestinal tract.

VERDICT $500,000 Massachusetts arbitration award.

COMMENT Poor handoffs in care, especially follow-up of abnormal imaging tests, such as a lung or breast mass, remain an all too common cause of malpractice claims.

Doctor crosses line, pays the price

A WOMAN BECAME SEXUALLY INVOLVED with her family practitioner, an affair she claimed the doctor initiated while he was treating her for anxiety and depression. She said the physician-patient relationship had begun more than a year before the sexual involvement when she learned that her infant daughter had cerebral palsy; the doctor prescribed paroxetine and bupropion.

The affair ended about 10 months after it began. The patient said it caused her marriage to deteriorate.

PLAINTIFF’S CLAIM The patient couldn’t exercise independent judgment because she was experiencing eroticized transference; the doctor mishandled the transference phenomenon.

THE DEFENSE The sexual relationship was brief and ended 6 months before the doctor treated the patient.

VERDICT $416,500 net verdict in New York.

COMMENT It’s never prudent to become involved sexually with a patient.

Bladder and bowel function lost to cauda equina syndrome

LOWER BACK PAIN developed in a 34-year-old woman around the time she had fibroids removed by her obstetrician-gynecologist. The woman reported the pain at her first postoperative visit. The OB/GYN offered treatment, but the patient traveled to the Dominican Republic for 2 months instead.

The month after the patient’s return, she experienced sharp pain in her legs and temporarily lost control of her bladder and bowels. Eight days later, she returned to the OB/GYN complaining of pain and occasional urinary incontinence. The doctor diagnosed neurogenic bladder, prescribed medication, and told the patient to follow up in a week. At some point over the next few days, the patient could not urinate, but didn’t return to the doctor for a week. The doctor catheterized her and drained about 3000 mL of urine. He then sent her to a hospital.

The hospital staff suspected cauda equina syndrome and consulted a neurologist, who concluded that the patient didn’t have the condition. The patient refused a magnetic resonance imaging (MRI) scan at that time because she didn’t think she could assume the required position. The patient ultimately underwent an MRI scan a week later. Another neurologist reviewed the scan and diagnosed cauda equina syndrome. Despite surgery, the patient has permanent bowel and bladder dysfunction.

PLAINTIFF’S CLAIM The defendants were negligent in failing to diagnose cauda equina syndrome earlier.

DOCTORS’ DEFENSE The OB/GYN claimed that the patient didn’t undergo the recommended follow-up treatment after surgery. The neurologist claimed that his examination didn’t reveal any objective indications of cauda equina syndrome.

VERDICT $1.5 million New York settlement.

COMMENT Suspicion of cauda equina demands prompt imaging and neurologic consultation. Failure to do so can lead to devastating consequences.

Failure to suspect stroke results in brain damage

A 37-YEAR-OLD WOMAN went to a gastroenterologist for a postoperative consult. Her blood pressure was 180/100. Her medical history included recent symptoms of blurred vision, dizziness, nosebleeds, and tingling in the face and right arm. She was taking medications that increased her risk of stroke, had preexisting Crohn’s disease, and smoked.

The day after the doctor visit, the woman went to a hospital, where she was diagnosed with a stroke from a left cerebral artery infarction and dissection with clot formation in the left internal carotid artery. She suffered brain damage with aphasia and right hemiparalysis.

PLAINTIFF’S CLAIM The doctor was negligent for failing to diagnose the patient’s condition and provide treatment.

DOCTOR’S DEFENSE The doctor denied any negligence.

VERDICT Indiana defense verdict.

COMMENT In this age of thrombolysis and aggressive stroke management, rapid diagnosis and intervention has gone from an academic exercise to a standard of care.

Suspicious finding + no follow-up = lawsuit

CONGESTIVE HEART FAILURE and atrial fibrillation prompted the hospitalization of a 79-year-old woman. A radiograph showed a density in the upper left lobe of her lung, and another x-ray was ordered. The same radiologist reviewed both films and recommended that the patient undergo a third radiograph after discharge from the hospital. Although informed of the radiologist’s findings and recommendations, the patient’s physician didn’t order a radiograph or computed tomography (CT) scan. The patient wasn’t notified of the findings.

The density was still visible on radiographs taken about 19 months after the original films. Seventeen months later, the patient complained of left chest wall discomfort and had another radiograph, which showed the density and a collection of pleural fluid. A CT scan suggested cancer. The patient was ultimately diagnosed with stage-III, poorly differentiated adenocarcinoma—which has a very low survival rate—in her left pleura. Because of the prognosis, a biopsy wasn’t performed.

PLAINTIFF’S CLAIM The defendant was negligent in failing to follow up on the radiologist’s report. Proper diagnosis and treatment at the time of the original radiographs would have meant targeting the cancer at stage I, when the survival rate would have been much higher.

THE DEFENSE The primary lung cancer wasn’t in the upper left lobe, and the density was probably only a scar. The cancer was likely somewhere else, possibly the gastrointestinal tract.

VERDICT $500,000 Massachusetts arbitration award.

COMMENT Poor handoffs in care, especially follow-up of abnormal imaging tests, such as a lung or breast mass, remain an all too common cause of malpractice claims.

Doctor crosses line, pays the price

A WOMAN BECAME SEXUALLY INVOLVED with her family practitioner, an affair she claimed the doctor initiated while he was treating her for anxiety and depression. She said the physician-patient relationship had begun more than a year before the sexual involvement when she learned that her infant daughter had cerebral palsy; the doctor prescribed paroxetine and bupropion.

The affair ended about 10 months after it began. The patient said it caused her marriage to deteriorate.

PLAINTIFF’S CLAIM The patient couldn’t exercise independent judgment because she was experiencing eroticized transference; the doctor mishandled the transference phenomenon.

THE DEFENSE The sexual relationship was brief and ended 6 months before the doctor treated the patient.

VERDICT $416,500 net verdict in New York.

COMMENT It’s never prudent to become involved sexually with a patient.

Bladder and bowel function lost to cauda equina syndrome

LOWER BACK PAIN developed in a 34-year-old woman around the time she had fibroids removed by her obstetrician-gynecologist. The woman reported the pain at her first postoperative visit. The OB/GYN offered treatment, but the patient traveled to the Dominican Republic for 2 months instead.

The month after the patient’s return, she experienced sharp pain in her legs and temporarily lost control of her bladder and bowels. Eight days later, she returned to the OB/GYN complaining of pain and occasional urinary incontinence. The doctor diagnosed neurogenic bladder, prescribed medication, and told the patient to follow up in a week. At some point over the next few days, the patient could not urinate, but didn’t return to the doctor for a week. The doctor catheterized her and drained about 3000 mL of urine. He then sent her to a hospital.

The hospital staff suspected cauda equina syndrome and consulted a neurologist, who concluded that the patient didn’t have the condition. The patient refused a magnetic resonance imaging (MRI) scan at that time because she didn’t think she could assume the required position. The patient ultimately underwent an MRI scan a week later. Another neurologist reviewed the scan and diagnosed cauda equina syndrome. Despite surgery, the patient has permanent bowel and bladder dysfunction.

PLAINTIFF’S CLAIM The defendants were negligent in failing to diagnose cauda equina syndrome earlier.

DOCTORS’ DEFENSE The OB/GYN claimed that the patient didn’t undergo the recommended follow-up treatment after surgery. The neurologist claimed that his examination didn’t reveal any objective indications of cauda equina syndrome.

VERDICT $1.5 million New York settlement.

COMMENT Suspicion of cauda equina demands prompt imaging and neurologic consultation. Failure to do so can lead to devastating consequences.

Failure to suspect stroke results in brain damage

A 37-YEAR-OLD WOMAN went to a gastroenterologist for a postoperative consult. Her blood pressure was 180/100. Her medical history included recent symptoms of blurred vision, dizziness, nosebleeds, and tingling in the face and right arm. She was taking medications that increased her risk of stroke, had preexisting Crohn’s disease, and smoked.

The day after the doctor visit, the woman went to a hospital, where she was diagnosed with a stroke from a left cerebral artery infarction and dissection with clot formation in the left internal carotid artery. She suffered brain damage with aphasia and right hemiparalysis.

PLAINTIFF’S CLAIM The doctor was negligent for failing to diagnose the patient’s condition and provide treatment.

DOCTOR’S DEFENSE The doctor denied any negligence.

VERDICT Indiana defense verdict.

COMMENT In this age of thrombolysis and aggressive stroke management, rapid diagnosis and intervention has gone from an academic exercise to a standard of care.

Suspicious finding + no follow-up = lawsuit

CONGESTIVE HEART FAILURE and atrial fibrillation prompted the hospitalization of a 79-year-old woman. A radiograph showed a density in the upper left lobe of her lung, and another x-ray was ordered. The same radiologist reviewed both films and recommended that the patient undergo a third radiograph after discharge from the hospital. Although informed of the radiologist’s findings and recommendations, the patient’s physician didn’t order a radiograph or computed tomography (CT) scan. The patient wasn’t notified of the findings.

The density was still visible on radiographs taken about 19 months after the original films. Seventeen months later, the patient complained of left chest wall discomfort and had another radiograph, which showed the density and a collection of pleural fluid. A CT scan suggested cancer. The patient was ultimately diagnosed with stage-III, poorly differentiated adenocarcinoma—which has a very low survival rate—in her left pleura. Because of the prognosis, a biopsy wasn’t performed.

PLAINTIFF’S CLAIM The defendant was negligent in failing to follow up on the radiologist’s report. Proper diagnosis and treatment at the time of the original radiographs would have meant targeting the cancer at stage I, when the survival rate would have been much higher.

THE DEFENSE The primary lung cancer wasn’t in the upper left lobe, and the density was probably only a scar. The cancer was likely somewhere else, possibly the gastrointestinal tract.

VERDICT $500,000 Massachusetts arbitration award.

COMMENT Poor handoffs in care, especially follow-up of abnormal imaging tests, such as a lung or breast mass, remain an all too common cause of malpractice claims.

Doctor crosses line, pays the price

A WOMAN BECAME SEXUALLY INVOLVED with her family practitioner, an affair she claimed the doctor initiated while he was treating her for anxiety and depression. She said the physician-patient relationship had begun more than a year before the sexual involvement when she learned that her infant daughter had cerebral palsy; the doctor prescribed paroxetine and bupropion.

The affair ended about 10 months after it began. The patient said it caused her marriage to deteriorate.

PLAINTIFF’S CLAIM The patient couldn’t exercise independent judgment because she was experiencing eroticized transference; the doctor mishandled the transference phenomenon.

THE DEFENSE The sexual relationship was brief and ended 6 months before the doctor treated the patient.

VERDICT $416,500 net verdict in New York.

COMMENT It’s never prudent to become involved sexually with a patient.

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].

Car accident blamed on lack of post-test monitoring

AN IN-OFFICE FASTING BLOOD TEST was performed at a medical clinic on a 53-year-old man with diabetes. The man had been hospitalized recently with life-threatening complications arising from poor management of his diabetes. He hadn’t eaten or taken any medication, including insulin, in the 12 hours before the test.

After his blood was taken, the patient was told that he could leave the clinic. Shortly afterwards, another patient reported that a man in the parking lot was acting confused and disoriented.

Office personnel read the blood test results—which showed a blood sugar level <50 mg/dL—and called the man’s wife.

Almost immediately afterward, the wife received a call from the police informing her that her husband had been in a single-car rollover accident. He suffered a stable T12 compression fracture. His blood sugar, taken by paramedics, was 24. The patient said he was unaware of his hypoglycemia and impaired cognitive function.

PLAINTIFF’S CLAIM The clinic didn’t have policies and procedures for testing fasting blood sugar in patients with diabetes, who have a known risk of hypoglycemia. The clinic shouldn’t have allowed a fasting patient with diabetes to leave before his blood tests were complete and he had eaten a snack.

THE DEFENSE The only explanation for the drop in the patient’s blood sugar was that he had taken his morning insulin in disregard of his doctor’s orders. Patients who are unaware of their hypoglycemia often show no outward signs of impairment. The patient failed to take responsibility for educating himself about his disease and managing it properly.

VERDICT $400,000 Missouri settlement.

COMMENT Clear office policies and procedures can reduce the risk of lawsuits.

Car accident blamed on lack of post-test monitoring

AN IN-OFFICE FASTING BLOOD TEST was performed at a medical clinic on a 53-year-old man with diabetes. The man had been hospitalized recently with life-threatening complications arising from poor management of his diabetes. He hadn’t eaten or taken any medication, including insulin, in the 12 hours before the test.

After his blood was taken, the patient was told that he could leave the clinic. Shortly afterwards, another patient reported that a man in the parking lot was acting confused and disoriented.

Office personnel read the blood test results—which showed a blood sugar level <50 mg/dL—and called the man’s wife.

Almost immediately afterward, the wife received a call from the police informing her that her husband had been in a single-car rollover accident. He suffered a stable T12 compression fracture. His blood sugar, taken by paramedics, was 24. The patient said he was unaware of his hypoglycemia and impaired cognitive function.

PLAINTIFF’S CLAIM The clinic didn’t have policies and procedures for testing fasting blood sugar in patients with diabetes, who have a known risk of hypoglycemia. The clinic shouldn’t have allowed a fasting patient with diabetes to leave before his blood tests were complete and he had eaten a snack.

THE DEFENSE The only explanation for the drop in the patient’s blood sugar was that he had taken his morning insulin in disregard of his doctor’s orders. Patients who are unaware of their hypoglycemia often show no outward signs of impairment. The patient failed to take responsibility for educating himself about his disease and managing it properly.

VERDICT $400,000 Missouri settlement.

COMMENT Clear office policies and procedures can reduce the risk of lawsuits.

Car accident blamed on lack of post-test monitoring

AN IN-OFFICE FASTING BLOOD TEST was performed at a medical clinic on a 53-year-old man with diabetes. The man had been hospitalized recently with life-threatening complications arising from poor management of his diabetes. He hadn’t eaten or taken any medication, including insulin, in the 12 hours before the test.

After his blood was taken, the patient was told that he could leave the clinic. Shortly afterwards, another patient reported that a man in the parking lot was acting confused and disoriented.

Office personnel read the blood test results—which showed a blood sugar level <50 mg/dL—and called the man’s wife.

Almost immediately afterward, the wife received a call from the police informing her that her husband had been in a single-car rollover accident. He suffered a stable T12 compression fracture. His blood sugar, taken by paramedics, was 24. The patient said he was unaware of his hypoglycemia and impaired cognitive function.

PLAINTIFF’S CLAIM The clinic didn’t have policies and procedures for testing fasting blood sugar in patients with diabetes, who have a known risk of hypoglycemia. The clinic shouldn’t have allowed a fasting patient with diabetes to leave before his blood tests were complete and he had eaten a snack.

THE DEFENSE The only explanation for the drop in the patient’s blood sugar was that he had taken his morning insulin in disregard of his doctor’s orders. Patients who are unaware of their hypoglycemia often show no outward signs of impairment. The patient failed to take responsibility for educating himself about his disease and managing it properly.

VERDICT $400,000 Missouri settlement.

COMMENT Clear office policies and procedures can reduce the risk of lawsuits.

A Web site designed to encourage consumers to ask appropriate questions of their doctor or other clinicians has been launched by the Agency for Healthcare Research and Quality, with the Advertising Council and actress Fran Drescher.

The site features tips for patients and has a Question Builder tool that allows patients to create a list of questions they can take with them to medical appointments. Visit the Web site at www.ahrq.gov/questionsaretheanswer

A Web site designed to encourage consumers to ask appropriate questions of their doctor or other clinicians has been launched by the Agency for Healthcare Research and Quality, with the Advertising Council and actress Fran Drescher.

The site features tips for patients and has a Question Builder tool that allows patients to create a list of questions they can take with them to medical appointments. Visit the Web site at www.ahrq.gov/questionsaretheanswer

A Web site designed to encourage consumers to ask appropriate questions of their doctor or other clinicians has been launched by the Agency for Healthcare Research and Quality, with the Advertising Council and actress Fran Drescher.

The site features tips for patients and has a Question Builder tool that allows patients to create a list of questions they can take with them to medical appointments. Visit the Web site at www.ahrq.gov/questionsaretheanswer

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].

A 64-YEAR-OLD MAN WAS REFERRED TO A PULMONARY SPECIALIST in January by his primary care physician after a computed tomography (CT) scan showed a spiculated density adjacent to the right main-stem bronchus, a prominent right hilar lymph node, and a noncalcified nodule in the right middle lobe.

Before examining the patient, the pulmonary specialist ordered a positron emission tomography (PET) scan, which he interpreted as showing no significant uptake. He attributed the prominent lymph node to bronchitis and ordered surveillance at 3-month intervals.

A CT scan ordered by the pulmonary specialist in May showed no change, but the radiologist noted that “the possibility of malignancy cannot be excluded.” When the patient saw the specialist in early June, the doctor recommended another CT scan in 3 months.

The patient didn’t return to the specialist until September of the following year. By that time, a CT scan taken a couple of months before (June) as part of preoperative clearance for knee surgery showed that the irregular mass had grown significantly since the CT scan in May of the previous year. A bronchoscopy done in September to evaluate the mass was negative. In November, a lymph node biopsy revealed that the patient had metastatic lung cancer. He died about a month later.

PLAINTIFF’S CLAIM Because the patient was a smoker and the CT scan showed a density, the suspicion for cancer should have been high. A specimen should have been obtained to rule out cancer.

DOCTORS’ DEFENSE The pulmonary specialist followed the correct protocol; failure to diagnose cancer at the September visit didn’t affect the outcome because the cancer was already metastatic and incurable. The patient didn’t quit smoking or follow up regularly with his primary care physician. Moreover, the cancer was at least stage IIA when the primary care physician referred the patient to the specialist.

VERDICT Pennsylvania defense verdict.

COMMENT Although a defense verdict was ultimately returned, wouldn’t a “tickler file” or a reminder to the patient (and documentation if the patient failed to follow-up as recommended) have been easier?

A 64-YEAR-OLD MAN WAS REFERRED TO A PULMONARY SPECIALIST in January by his primary care physician after a computed tomography (CT) scan showed a spiculated density adjacent to the right main-stem bronchus, a prominent right hilar lymph node, and a noncalcified nodule in the right middle lobe.

Before examining the patient, the pulmonary specialist ordered a positron emission tomography (PET) scan, which he interpreted as showing no significant uptake. He attributed the prominent lymph node to bronchitis and ordered surveillance at 3-month intervals.

A CT scan ordered by the pulmonary specialist in May showed no change, but the radiologist noted that “the possibility of malignancy cannot be excluded.” When the patient saw the specialist in early June, the doctor recommended another CT scan in 3 months.

The patient didn’t return to the specialist until September of the following year. By that time, a CT scan taken a couple of months before (June) as part of preoperative clearance for knee surgery showed that the irregular mass had grown significantly since the CT scan in May of the previous year. A bronchoscopy done in September to evaluate the mass was negative. In November, a lymph node biopsy revealed that the patient had metastatic lung cancer. He died about a month later.

PLAINTIFF’S CLAIM Because the patient was a smoker and the CT scan showed a density, the suspicion for cancer should have been high. A specimen should have been obtained to rule out cancer.

DOCTORS’ DEFENSE The pulmonary specialist followed the correct protocol; failure to diagnose cancer at the September visit didn’t affect the outcome because the cancer was already metastatic and incurable. The patient didn’t quit smoking or follow up regularly with his primary care physician. Moreover, the cancer was at least stage IIA when the primary care physician referred the patient to the specialist.

VERDICT Pennsylvania defense verdict.

COMMENT Although a defense verdict was ultimately returned, wouldn’t a “tickler file” or a reminder to the patient (and documentation if the patient failed to follow-up as recommended) have been easier?

A 64-YEAR-OLD MAN WAS REFERRED TO A PULMONARY SPECIALIST in January by his primary care physician after a computed tomography (CT) scan showed a spiculated density adjacent to the right main-stem bronchus, a prominent right hilar lymph node, and a noncalcified nodule in the right middle lobe.

Before examining the patient, the pulmonary specialist ordered a positron emission tomography (PET) scan, which he interpreted as showing no significant uptake. He attributed the prominent lymph node to bronchitis and ordered surveillance at 3-month intervals.

A CT scan ordered by the pulmonary specialist in May showed no change, but the radiologist noted that “the possibility of malignancy cannot be excluded.” When the patient saw the specialist in early June, the doctor recommended another CT scan in 3 months.

The patient didn’t return to the specialist until September of the following year. By that time, a CT scan taken a couple of months before (June) as part of preoperative clearance for knee surgery showed that the irregular mass had grown significantly since the CT scan in May of the previous year. A bronchoscopy done in September to evaluate the mass was negative. In November, a lymph node biopsy revealed that the patient had metastatic lung cancer. He died about a month later.

PLAINTIFF’S CLAIM Because the patient was a smoker and the CT scan showed a density, the suspicion for cancer should have been high. A specimen should have been obtained to rule out cancer.

DOCTORS’ DEFENSE The pulmonary specialist followed the correct protocol; failure to diagnose cancer at the September visit didn’t affect the outcome because the cancer was already metastatic and incurable. The patient didn’t quit smoking or follow up regularly with his primary care physician. Moreover, the cancer was at least stage IIA when the primary care physician referred the patient to the specialist.

VERDICT Pennsylvania defense verdict.

COMMENT Although a defense verdict was ultimately returned, wouldn’t a “tickler file” or a reminder to the patient (and documentation if the patient failed to follow-up as recommended) have been easier?

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 &dollar;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 &dollar;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 &dollar;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.