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Wrong Tx for 4 years...Negligence case hinges on penicillin allergy...more
4 years of Tx, but diagnosis was wrong
FOR 4 YEARS, STARTING AT AGE 50, A WOMAN COMPLAINED TO HER INTERNIST of a persistent cough, nasal congestion, muscle and joint pain, and respiratory difficulty on exertion. The doctor treated her with allergy shots, massage therapy, vitamins, and a combination of drugs.
A little more than 4 years after the woman’s first visit to the internist, another physician diagnosed metastatic bone cancer. By then, the disease had spread from the primary mass in the lungs to the brain, legs, liver, and spine. The patient died 2 months later.
PLAINTIFF’S CLAIM The diagnosis should have been made when the patient first visited the internist; prompt treatment could have saved her life.
DOCTOR’S DEFENSE The patient’s respiratory difficulty wasn’t persistent and was judged to arise from seasonal allergies. In addition, the respiratory problems resulted from deconditioning caused by chronic fatigue syndrome.
VERDICT $1.2 million New York verdict.
COMMENT Persistent symptoms should always prompt a reevaluation of the diagnosis.
Negligence case hinges on penicillin allergy
AN 18-MONTH-OLD GIRL WITH AN EAR INFECTION was seen by a pediatrician, who prescribed amoxicillin clavulanate. The next day she developed puffy eyes and a runny nose. Her parents took her to the emergency room, where the physician diagnosed an allergic reaction to amoxicillin clavulanate and changed her medication to azithromycin. The doctor also prescribed diphenhydramine for the allergic reaction and told the parents to bring the child back the next day for follow-up. After the child took azithromycin, the puffiness and redness around her eyes began to go away. It was more prominent on one side than the other.
When the parents and child returned to the ER the following day, the girl was seen by another doctor, who diagnosed orbital cellulitis without reviewing the chart from the previous visit. He ordered intravenous ceftriaxone, a third-generation cephalosporin with a “known” cross-reactivity with penicillin-based drugs.
Despite the note in the chart about the child’s penicillin allergy, the nursing staff administered the drug while the child’s father held her in his arms. Within several minutes, the girl’s eyes were fixed and she wasn’t moving. The mother ran to get the nurses, by which time the child’s face was turning blue and she was limp. Resuscitation efforts failed.
PLAINTIFFS’ CLAIM The ER physician who saw the child on the second day was negligent in failing to note her history of penicillin allergy. Orbital cellulitis was the wrong diagnosis, unsupported by the symptoms. It should have been confirmed with a computed tomography or magnetic resonance imaging scan. The doctor was negligent in prescribing ceftriaxone, which caused an anaphylactic reaction, acute circulatory collapse, and death. The nurse should have asked the doctor to explain the ceftriaxone order before giving the drug to make sure the doctor was aware of the penicillin allergy. Ceftriaxone should have been administered by IV drip rather than gravity. The child should have been given a green allergy ID wrist band when her parents brought her to the ER the second time.
THE DEFENSE No information about the defense is available.
VERDICT $3 million Illinois settlement.
COMMENT A poorly managed handoff with resulting discontinuity of care, alleged misdiagnosis, and a dubious assertion of cross-reactivity between penicillin and ceftriaxone (see www.jfponline.com/Pages.asp?AID=3850&issue=February%202006 for details) make for a $3 million settlement!
Poor follow-up hinders stage 3 cancer Dx
A LUMP IN HER LEFT BREAST prompted a 42-year-old woman to contact her primary care physician. Office staff returned her phone call, advised her to apply warm compresses to the site, and told her that she’d be scheduled for a mammogram and ultrasound examination. The mammogram revealed bilateral asymmetry. An ultrasound wasn’t done. The woman’s primary care physician didn’t perform a physical examination or refer her for surgical consultation.
Eight months after her initial call to her doctor, the woman began to see another physician, who didn’t follow-up on her complaints of a lump and tenderness in her breast or refer her to a surgeon. Six months later, she was diagnosed with stage 3 breast cancer. Her prognosis was poor.
PLAINTIFF’S CLAIM No information about the plaintiff’s claim is available.
THE DEFENSE No information about the defense is available.
VERDICT $1 million Massachusetts settlement.
COMMENT Yet another example of inadequate follow-up of a breast mass that turned out to be cancer. It’s critical that physicians establish a tickler file to assure appropriate follow-up of all women with breast masses.
Was lack of regular PSA testing to blame?
A 49-YEAR-OLD MAN HAD A PARTIAL PHYSICAL EXAM and a prostate-specific antigen test. He complained of urinary problems, including frequent urination and a weak stream. The patient didn’t complete the second part of the exam.
Five months later, he scheduled a follow-up and acute care visit, at which time he complained of rectal bleeding. The doctor performed a digital rectal exam, which revealed an enlarged prostate. He didn’t discuss further PSA testing or follow-up on the previous urinary complaints. He referred the patient to a gastroenterologist.
Six months after the second visit, the patient called to ask about some blood work, including a test for diabetes. The physician ordered a fasting blood sugar test. About a year after that, the patient saw his doctor for a sore throat. The doctor ordered lipid panels, thyroid-stimulating hormone tests, and liver enzyme tests. He didn’t order or discuss PSA testing.
Seventeen months later, the patient was diagnosed with stage 4 prostate cancer, which had metastasized to the brain, lungs, spine, and bony extremities. Various treatment protocols failed to help. By the time of arbitration, the patient had been given fewer than 2 weeks to live.
PLAINTIFF’S CLAIM The plaintiff should have had more regular PSA testing.
THE DEFENSE The PSA test done at the time of the initial physical examination was sufficient; even if the patient had been diagnosed at the second doctor visit 5 months later, his chance of survival would have been less than 50%.
VERDICT $3.5 million California arbitration award.
COMMENT Evidence? What evidence? Here is an arbitration award of $3.5 million for failure to perform PSA testing regularly in a 49-year-old. Although this account is incomplete, remember that the courts are sometimes impervious to evidence-based medicine.
4 years of Tx, but diagnosis was wrong
FOR 4 YEARS, STARTING AT AGE 50, A WOMAN COMPLAINED TO HER INTERNIST of a persistent cough, nasal congestion, muscle and joint pain, and respiratory difficulty on exertion. The doctor treated her with allergy shots, massage therapy, vitamins, and a combination of drugs.
A little more than 4 years after the woman’s first visit to the internist, another physician diagnosed metastatic bone cancer. By then, the disease had spread from the primary mass in the lungs to the brain, legs, liver, and spine. The patient died 2 months later.
PLAINTIFF’S CLAIM The diagnosis should have been made when the patient first visited the internist; prompt treatment could have saved her life.
DOCTOR’S DEFENSE The patient’s respiratory difficulty wasn’t persistent and was judged to arise from seasonal allergies. In addition, the respiratory problems resulted from deconditioning caused by chronic fatigue syndrome.
VERDICT $1.2 million New York verdict.
COMMENT Persistent symptoms should always prompt a reevaluation of the diagnosis.
Negligence case hinges on penicillin allergy
AN 18-MONTH-OLD GIRL WITH AN EAR INFECTION was seen by a pediatrician, who prescribed amoxicillin clavulanate. The next day she developed puffy eyes and a runny nose. Her parents took her to the emergency room, where the physician diagnosed an allergic reaction to amoxicillin clavulanate and changed her medication to azithromycin. The doctor also prescribed diphenhydramine for the allergic reaction and told the parents to bring the child back the next day for follow-up. After the child took azithromycin, the puffiness and redness around her eyes began to go away. It was more prominent on one side than the other.
When the parents and child returned to the ER the following day, the girl was seen by another doctor, who diagnosed orbital cellulitis without reviewing the chart from the previous visit. He ordered intravenous ceftriaxone, a third-generation cephalosporin with a “known” cross-reactivity with penicillin-based drugs.
Despite the note in the chart about the child’s penicillin allergy, the nursing staff administered the drug while the child’s father held her in his arms. Within several minutes, the girl’s eyes were fixed and she wasn’t moving. The mother ran to get the nurses, by which time the child’s face was turning blue and she was limp. Resuscitation efforts failed.
PLAINTIFFS’ CLAIM The ER physician who saw the child on the second day was negligent in failing to note her history of penicillin allergy. Orbital cellulitis was the wrong diagnosis, unsupported by the symptoms. It should have been confirmed with a computed tomography or magnetic resonance imaging scan. The doctor was negligent in prescribing ceftriaxone, which caused an anaphylactic reaction, acute circulatory collapse, and death. The nurse should have asked the doctor to explain the ceftriaxone order before giving the drug to make sure the doctor was aware of the penicillin allergy. Ceftriaxone should have been administered by IV drip rather than gravity. The child should have been given a green allergy ID wrist band when her parents brought her to the ER the second time.
THE DEFENSE No information about the defense is available.
VERDICT $3 million Illinois settlement.
COMMENT A poorly managed handoff with resulting discontinuity of care, alleged misdiagnosis, and a dubious assertion of cross-reactivity between penicillin and ceftriaxone (see www.jfponline.com/Pages.asp?AID=3850&issue=February%202006 for details) make for a $3 million settlement!
Poor follow-up hinders stage 3 cancer Dx
A LUMP IN HER LEFT BREAST prompted a 42-year-old woman to contact her primary care physician. Office staff returned her phone call, advised her to apply warm compresses to the site, and told her that she’d be scheduled for a mammogram and ultrasound examination. The mammogram revealed bilateral asymmetry. An ultrasound wasn’t done. The woman’s primary care physician didn’t perform a physical examination or refer her for surgical consultation.
Eight months after her initial call to her doctor, the woman began to see another physician, who didn’t follow-up on her complaints of a lump and tenderness in her breast or refer her to a surgeon. Six months later, she was diagnosed with stage 3 breast cancer. Her prognosis was poor.
PLAINTIFF’S CLAIM No information about the plaintiff’s claim is available.
THE DEFENSE No information about the defense is available.
VERDICT $1 million Massachusetts settlement.
COMMENT Yet another example of inadequate follow-up of a breast mass that turned out to be cancer. It’s critical that physicians establish a tickler file to assure appropriate follow-up of all women with breast masses.
Was lack of regular PSA testing to blame?
A 49-YEAR-OLD MAN HAD A PARTIAL PHYSICAL EXAM and a prostate-specific antigen test. He complained of urinary problems, including frequent urination and a weak stream. The patient didn’t complete the second part of the exam.
Five months later, he scheduled a follow-up and acute care visit, at which time he complained of rectal bleeding. The doctor performed a digital rectal exam, which revealed an enlarged prostate. He didn’t discuss further PSA testing or follow-up on the previous urinary complaints. He referred the patient to a gastroenterologist.
Six months after the second visit, the patient called to ask about some blood work, including a test for diabetes. The physician ordered a fasting blood sugar test. About a year after that, the patient saw his doctor for a sore throat. The doctor ordered lipid panels, thyroid-stimulating hormone tests, and liver enzyme tests. He didn’t order or discuss PSA testing.
Seventeen months later, the patient was diagnosed with stage 4 prostate cancer, which had metastasized to the brain, lungs, spine, and bony extremities. Various treatment protocols failed to help. By the time of arbitration, the patient had been given fewer than 2 weeks to live.
PLAINTIFF’S CLAIM The plaintiff should have had more regular PSA testing.
THE DEFENSE The PSA test done at the time of the initial physical examination was sufficient; even if the patient had been diagnosed at the second doctor visit 5 months later, his chance of survival would have been less than 50%.
VERDICT $3.5 million California arbitration award.
COMMENT Evidence? What evidence? Here is an arbitration award of $3.5 million for failure to perform PSA testing regularly in a 49-year-old. Although this account is incomplete, remember that the courts are sometimes impervious to evidence-based medicine.
4 years of Tx, but diagnosis was wrong
FOR 4 YEARS, STARTING AT AGE 50, A WOMAN COMPLAINED TO HER INTERNIST of a persistent cough, nasal congestion, muscle and joint pain, and respiratory difficulty on exertion. The doctor treated her with allergy shots, massage therapy, vitamins, and a combination of drugs.
A little more than 4 years after the woman’s first visit to the internist, another physician diagnosed metastatic bone cancer. By then, the disease had spread from the primary mass in the lungs to the brain, legs, liver, and spine. The patient died 2 months later.
PLAINTIFF’S CLAIM The diagnosis should have been made when the patient first visited the internist; prompt treatment could have saved her life.
DOCTOR’S DEFENSE The patient’s respiratory difficulty wasn’t persistent and was judged to arise from seasonal allergies. In addition, the respiratory problems resulted from deconditioning caused by chronic fatigue syndrome.
VERDICT $1.2 million New York verdict.
COMMENT Persistent symptoms should always prompt a reevaluation of the diagnosis.
Negligence case hinges on penicillin allergy
AN 18-MONTH-OLD GIRL WITH AN EAR INFECTION was seen by a pediatrician, who prescribed amoxicillin clavulanate. The next day she developed puffy eyes and a runny nose. Her parents took her to the emergency room, where the physician diagnosed an allergic reaction to amoxicillin clavulanate and changed her medication to azithromycin. The doctor also prescribed diphenhydramine for the allergic reaction and told the parents to bring the child back the next day for follow-up. After the child took azithromycin, the puffiness and redness around her eyes began to go away. It was more prominent on one side than the other.
When the parents and child returned to the ER the following day, the girl was seen by another doctor, who diagnosed orbital cellulitis without reviewing the chart from the previous visit. He ordered intravenous ceftriaxone, a third-generation cephalosporin with a “known” cross-reactivity with penicillin-based drugs.
Despite the note in the chart about the child’s penicillin allergy, the nursing staff administered the drug while the child’s father held her in his arms. Within several minutes, the girl’s eyes were fixed and she wasn’t moving. The mother ran to get the nurses, by which time the child’s face was turning blue and she was limp. Resuscitation efforts failed.
PLAINTIFFS’ CLAIM The ER physician who saw the child on the second day was negligent in failing to note her history of penicillin allergy. Orbital cellulitis was the wrong diagnosis, unsupported by the symptoms. It should have been confirmed with a computed tomography or magnetic resonance imaging scan. The doctor was negligent in prescribing ceftriaxone, which caused an anaphylactic reaction, acute circulatory collapse, and death. The nurse should have asked the doctor to explain the ceftriaxone order before giving the drug to make sure the doctor was aware of the penicillin allergy. Ceftriaxone should have been administered by IV drip rather than gravity. The child should have been given a green allergy ID wrist band when her parents brought her to the ER the second time.
THE DEFENSE No information about the defense is available.
VERDICT $3 million Illinois settlement.
COMMENT A poorly managed handoff with resulting discontinuity of care, alleged misdiagnosis, and a dubious assertion of cross-reactivity between penicillin and ceftriaxone (see www.jfponline.com/Pages.asp?AID=3850&issue=February%202006 for details) make for a $3 million settlement!
Poor follow-up hinders stage 3 cancer Dx
A LUMP IN HER LEFT BREAST prompted a 42-year-old woman to contact her primary care physician. Office staff returned her phone call, advised her to apply warm compresses to the site, and told her that she’d be scheduled for a mammogram and ultrasound examination. The mammogram revealed bilateral asymmetry. An ultrasound wasn’t done. The woman’s primary care physician didn’t perform a physical examination or refer her for surgical consultation.
Eight months after her initial call to her doctor, the woman began to see another physician, who didn’t follow-up on her complaints of a lump and tenderness in her breast or refer her to a surgeon. Six months later, she was diagnosed with stage 3 breast cancer. Her prognosis was poor.
PLAINTIFF’S CLAIM No information about the plaintiff’s claim is available.
THE DEFENSE No information about the defense is available.
VERDICT $1 million Massachusetts settlement.
COMMENT Yet another example of inadequate follow-up of a breast mass that turned out to be cancer. It’s critical that physicians establish a tickler file to assure appropriate follow-up of all women with breast masses.
Was lack of regular PSA testing to blame?
A 49-YEAR-OLD MAN HAD A PARTIAL PHYSICAL EXAM and a prostate-specific antigen test. He complained of urinary problems, including frequent urination and a weak stream. The patient didn’t complete the second part of the exam.
Five months later, he scheduled a follow-up and acute care visit, at which time he complained of rectal bleeding. The doctor performed a digital rectal exam, which revealed an enlarged prostate. He didn’t discuss further PSA testing or follow-up on the previous urinary complaints. He referred the patient to a gastroenterologist.
Six months after the second visit, the patient called to ask about some blood work, including a test for diabetes. The physician ordered a fasting blood sugar test. About a year after that, the patient saw his doctor for a sore throat. The doctor ordered lipid panels, thyroid-stimulating hormone tests, and liver enzyme tests. He didn’t order or discuss PSA testing.
Seventeen months later, the patient was diagnosed with stage 4 prostate cancer, which had metastasized to the brain, lungs, spine, and bony extremities. Various treatment protocols failed to help. By the time of arbitration, the patient had been given fewer than 2 weeks to live.
PLAINTIFF’S CLAIM The plaintiff should have had more regular PSA testing.
THE DEFENSE The PSA test done at the time of the initial physical examination was sufficient; even if the patient had been diagnosed at the second doctor visit 5 months later, his chance of survival would have been less than 50%.
VERDICT $3.5 million California arbitration award.
COMMENT Evidence? What evidence? Here is an arbitration award of $3.5 million for failure to perform PSA testing regularly in a 49-year-old. Although this account is incomplete, remember that the courts are sometimes impervious to evidence-based medicine.
Filing misstep leads to missed diagnosis...Too much amiodarone led to respiratory failure...more...
Discontinued anticoagulant blamed for stroke
A MAN ON WARFARIN 3 YEARS AFTER A MASSIVE PULMONARY EMBOLISM visited a doctor, who reviewed the 37-year-old patient’s records and noted that test results showed he no longer had hypercoagulation. The doctor discontinued the warfarin.
About 5 months later, the patient suffered an embolic stroke that caused brain damage. He has impaired cognitive function and executive decision-making skills, as well as residual emotional and psychiatric problems.
PLAINTIFF’S CLAIM The patient had a hereditary disposition to clots and had suffered a previous embolism, necessitating lifelong use of warfarin.
DOCTOR’S DEFENSE Hypercoagulation is treated with 6 to 12 months of warfarin; the patient hadn’t showed a recurrence of hypercoagulation. The doctor denied conclusive evidence of a hereditary predisposition to developing clots.
VERDICT $3.1 million New York verdict.
COMMENT Whatever the underlying factors in this case, documenting a careful discussion of benefits and harms and consulting with experts can sometimes avoid a date in court.
Filing misstep leads to missed diagnosis
A 76-YEAR-OLD MAN HAD A CHEST RADIOGRAPH before undergoing cardiac catheterization. The radiograph showed a 4-cm mass in the left lung, which the radiologist reported as bronchogenic carcinoma. A staff member in the office of the physician who ordered the radiograph filed the radiologist’s report in the patient’s chart in the mistaken belief that the physician had seen it. No one saw the report again until 6 months later, after the patient had been diagnosed with lung cancer that had metastasized to the liver, pelvis, hip, femur, spine, and shoulder. The patient died 18 days after the diagnosis.
PLAINTIFF’S CLAIM If the cancer had been diagnosed earlier, the patient could have been made comfortable while undergoing treatment and would have survived longer.
DOCTORS’ DEFENSE The physician admitted liability, but claimed that the reduction in the patient’s life expectancy was minimal because his cancer was advanced at the time of the radiograph. The net increase in pain and suffering also was minimal because the patient would have undergone chemotherapy and radiation if the cancer had been diagnosed earlier.
VERDICT $1 million Illinois verdict.
COMMENT Coordination of care is key. Never assume that another clinician on the team has taken responsibility for a high-stakes finding such as a mass on a chest X-ray.
Too much amiodarone led to respiratory failure
AMIODARONE WAS PRESCRIBED TO REGULATE THE HEARTBEAT of a patient who underwent surgery at a Veteran’s Administration medical center to replace a defective heart defibrillator. The plan was to decrease the dosage gradually from 600 to 200 mg a day. A second doctor subsequently saw the patient and prescribed amiodarone but with no reduction in dosage. Each of the 7 authorized refills directed the patient to take 3 pills a day. The patient refilled the prescription 6 times at the VA hospital.
A year after the surgery, the patient was admitted to another hospital with respiratory problems, which were attributed to the amiodarone. The patient died a few weeks later after several relapses. The cause of death was listed as pulmonary fibrosis and respiratory failure caused by the medication.
PLAINTIFF’S CLAIM No information about the plaintiff’s claim is available.
DOCTOR’S DEFENSE No information about the doctor’s defense is available.
VERDICT $400,000 Utah settlement.
COMMENT Prescribing limited refills of medications that can cause substantial harm will help assure appropriate monitoring and evaluation for side effects.
Rising PSA, but no follow-up
CHEST PAIN PROMPTED A 48-YEAR-OLD MAN to visit his primary care physician. Blood work, including a prostate-specific antigen (PSA) test, revealed a slightly elevated PSA of 5.08. Five months later, the patient returned to the doctor complaining of a burning sensation on urination. Urinalysis and a digital rectal examination were normal. Laboratory test results included a PSA of 8.29. Nine months later the patient visited the physician for nonurologic complaints. Six months after that, when the patient had a complete physical because of a change in his insurance, his PSA was 17.11.
Subsequent testing revealed prostate cancer, and the patient underwent a non-nerve-sparing prostatectomy. A positron emission tomography scan done after the surgery showed an enlarged internal iliac lymph node, which indicated metastatic disease.
PLAINTIFF’S CLAIM The primary care physician was negligent in failing to follow up on the rising PSA values. The patient wasn’t informed of the PSA results.
THE DEFENSE The patient was informed of the abnormal test results (though it wasn’t charted). The patient would have had the same treatment, even with an earlier diagnosis, because he had a high Gleason score.
VERDICT $750,000 California settlement.
COMMENT Not charted = never happened. So many cases could be avoided if documentation was timely and complete!
Discontinued anticoagulant blamed for stroke
A MAN ON WARFARIN 3 YEARS AFTER A MASSIVE PULMONARY EMBOLISM visited a doctor, who reviewed the 37-year-old patient’s records and noted that test results showed he no longer had hypercoagulation. The doctor discontinued the warfarin.
About 5 months later, the patient suffered an embolic stroke that caused brain damage. He has impaired cognitive function and executive decision-making skills, as well as residual emotional and psychiatric problems.
PLAINTIFF’S CLAIM The patient had a hereditary disposition to clots and had suffered a previous embolism, necessitating lifelong use of warfarin.
DOCTOR’S DEFENSE Hypercoagulation is treated with 6 to 12 months of warfarin; the patient hadn’t showed a recurrence of hypercoagulation. The doctor denied conclusive evidence of a hereditary predisposition to developing clots.
VERDICT $3.1 million New York verdict.
COMMENT Whatever the underlying factors in this case, documenting a careful discussion of benefits and harms and consulting with experts can sometimes avoid a date in court.
Filing misstep leads to missed diagnosis
A 76-YEAR-OLD MAN HAD A CHEST RADIOGRAPH before undergoing cardiac catheterization. The radiograph showed a 4-cm mass in the left lung, which the radiologist reported as bronchogenic carcinoma. A staff member in the office of the physician who ordered the radiograph filed the radiologist’s report in the patient’s chart in the mistaken belief that the physician had seen it. No one saw the report again until 6 months later, after the patient had been diagnosed with lung cancer that had metastasized to the liver, pelvis, hip, femur, spine, and shoulder. The patient died 18 days after the diagnosis.
PLAINTIFF’S CLAIM If the cancer had been diagnosed earlier, the patient could have been made comfortable while undergoing treatment and would have survived longer.
DOCTORS’ DEFENSE The physician admitted liability, but claimed that the reduction in the patient’s life expectancy was minimal because his cancer was advanced at the time of the radiograph. The net increase in pain and suffering also was minimal because the patient would have undergone chemotherapy and radiation if the cancer had been diagnosed earlier.
VERDICT $1 million Illinois verdict.
COMMENT Coordination of care is key. Never assume that another clinician on the team has taken responsibility for a high-stakes finding such as a mass on a chest X-ray.
Too much amiodarone led to respiratory failure
AMIODARONE WAS PRESCRIBED TO REGULATE THE HEARTBEAT of a patient who underwent surgery at a Veteran’s Administration medical center to replace a defective heart defibrillator. The plan was to decrease the dosage gradually from 600 to 200 mg a day. A second doctor subsequently saw the patient and prescribed amiodarone but with no reduction in dosage. Each of the 7 authorized refills directed the patient to take 3 pills a day. The patient refilled the prescription 6 times at the VA hospital.
A year after the surgery, the patient was admitted to another hospital with respiratory problems, which were attributed to the amiodarone. The patient died a few weeks later after several relapses. The cause of death was listed as pulmonary fibrosis and respiratory failure caused by the medication.
PLAINTIFF’S CLAIM No information about the plaintiff’s claim is available.
DOCTOR’S DEFENSE No information about the doctor’s defense is available.
VERDICT $400,000 Utah settlement.
COMMENT Prescribing limited refills of medications that can cause substantial harm will help assure appropriate monitoring and evaluation for side effects.
Rising PSA, but no follow-up
CHEST PAIN PROMPTED A 48-YEAR-OLD MAN to visit his primary care physician. Blood work, including a prostate-specific antigen (PSA) test, revealed a slightly elevated PSA of 5.08. Five months later, the patient returned to the doctor complaining of a burning sensation on urination. Urinalysis and a digital rectal examination were normal. Laboratory test results included a PSA of 8.29. Nine months later the patient visited the physician for nonurologic complaints. Six months after that, when the patient had a complete physical because of a change in his insurance, his PSA was 17.11.
Subsequent testing revealed prostate cancer, and the patient underwent a non-nerve-sparing prostatectomy. A positron emission tomography scan done after the surgery showed an enlarged internal iliac lymph node, which indicated metastatic disease.
PLAINTIFF’S CLAIM The primary care physician was negligent in failing to follow up on the rising PSA values. The patient wasn’t informed of the PSA results.
THE DEFENSE The patient was informed of the abnormal test results (though it wasn’t charted). The patient would have had the same treatment, even with an earlier diagnosis, because he had a high Gleason score.
VERDICT $750,000 California settlement.
COMMENT Not charted = never happened. So many cases could be avoided if documentation was timely and complete!
Discontinued anticoagulant blamed for stroke
A MAN ON WARFARIN 3 YEARS AFTER A MASSIVE PULMONARY EMBOLISM visited a doctor, who reviewed the 37-year-old patient’s records and noted that test results showed he no longer had hypercoagulation. The doctor discontinued the warfarin.
About 5 months later, the patient suffered an embolic stroke that caused brain damage. He has impaired cognitive function and executive decision-making skills, as well as residual emotional and psychiatric problems.
PLAINTIFF’S CLAIM The patient had a hereditary disposition to clots and had suffered a previous embolism, necessitating lifelong use of warfarin.
DOCTOR’S DEFENSE Hypercoagulation is treated with 6 to 12 months of warfarin; the patient hadn’t showed a recurrence of hypercoagulation. The doctor denied conclusive evidence of a hereditary predisposition to developing clots.
VERDICT $3.1 million New York verdict.
COMMENT Whatever the underlying factors in this case, documenting a careful discussion of benefits and harms and consulting with experts can sometimes avoid a date in court.
Filing misstep leads to missed diagnosis
A 76-YEAR-OLD MAN HAD A CHEST RADIOGRAPH before undergoing cardiac catheterization. The radiograph showed a 4-cm mass in the left lung, which the radiologist reported as bronchogenic carcinoma. A staff member in the office of the physician who ordered the radiograph filed the radiologist’s report in the patient’s chart in the mistaken belief that the physician had seen it. No one saw the report again until 6 months later, after the patient had been diagnosed with lung cancer that had metastasized to the liver, pelvis, hip, femur, spine, and shoulder. The patient died 18 days after the diagnosis.
PLAINTIFF’S CLAIM If the cancer had been diagnosed earlier, the patient could have been made comfortable while undergoing treatment and would have survived longer.
DOCTORS’ DEFENSE The physician admitted liability, but claimed that the reduction in the patient’s life expectancy was minimal because his cancer was advanced at the time of the radiograph. The net increase in pain and suffering also was minimal because the patient would have undergone chemotherapy and radiation if the cancer had been diagnosed earlier.
VERDICT $1 million Illinois verdict.
COMMENT Coordination of care is key. Never assume that another clinician on the team has taken responsibility for a high-stakes finding such as a mass on a chest X-ray.
Too much amiodarone led to respiratory failure
AMIODARONE WAS PRESCRIBED TO REGULATE THE HEARTBEAT of a patient who underwent surgery at a Veteran’s Administration medical center to replace a defective heart defibrillator. The plan was to decrease the dosage gradually from 600 to 200 mg a day. A second doctor subsequently saw the patient and prescribed amiodarone but with no reduction in dosage. Each of the 7 authorized refills directed the patient to take 3 pills a day. The patient refilled the prescription 6 times at the VA hospital.
A year after the surgery, the patient was admitted to another hospital with respiratory problems, which were attributed to the amiodarone. The patient died a few weeks later after several relapses. The cause of death was listed as pulmonary fibrosis and respiratory failure caused by the medication.
PLAINTIFF’S CLAIM No information about the plaintiff’s claim is available.
DOCTOR’S DEFENSE No information about the doctor’s defense is available.
VERDICT $400,000 Utah settlement.
COMMENT Prescribing limited refills of medications that can cause substantial harm will help assure appropriate monitoring and evaluation for side effects.
Rising PSA, but no follow-up
CHEST PAIN PROMPTED A 48-YEAR-OLD MAN to visit his primary care physician. Blood work, including a prostate-specific antigen (PSA) test, revealed a slightly elevated PSA of 5.08. Five months later, the patient returned to the doctor complaining of a burning sensation on urination. Urinalysis and a digital rectal examination were normal. Laboratory test results included a PSA of 8.29. Nine months later the patient visited the physician for nonurologic complaints. Six months after that, when the patient had a complete physical because of a change in his insurance, his PSA was 17.11.
Subsequent testing revealed prostate cancer, and the patient underwent a non-nerve-sparing prostatectomy. A positron emission tomography scan done after the surgery showed an enlarged internal iliac lymph node, which indicated metastatic disease.
PLAINTIFF’S CLAIM The primary care physician was negligent in failing to follow up on the rising PSA values. The patient wasn’t informed of the PSA results.
THE DEFENSE The patient was informed of the abnormal test results (though it wasn’t charted). The patient would have had the same treatment, even with an earlier diagnosis, because he had a high Gleason score.
VERDICT $750,000 California settlement.
COMMENT Not charted = never happened. So many cases could be avoided if documentation was timely and complete!
Assumption of Risk
Question: A patient consults her physician for a painful wrist, which is treated with indomethacin. The patient has developed skin rashes caused by various medications in the past, but she does not inform the doctor about this. Shortly after starting indomethacin, she develops Stevens-Johnson syndrome. In regard to an assumption of risk defense, which of the following is true?
A. A patient has a legal duty to reveal to the physician all relevant medical history.
B. Assumption of risk is no longer a valid rule of law.
C. Assumption of risk is an affirmative defense in a tort action and constitutes a complete bar to recovery.
D. Assumption of risk is synonymous with contributory negligence.
E. Giving informed consent is tantamount to assumption of risk.
Answer: C. If a plaintiff is fully aware of the risk to which he or she is exposed, and voluntarily accepts that risk, there will be no recovery of damages if harm results. Known as assumption of risk, it constitutes a valid and complete bar to recovery. This defense has two main elements: a patient's full awareness of the risks, and his or her consent to waive all claims for damages.
In contrast, contributory negligence, which usually serves as a partial rather than complete bar to recovery, arises when negligence by the plaintiff played a part in the resulting injury.
Informed consent is when, after being apprised of the risks and alternatives, a patient gives the physician permission to proceed with diagnosis and treatment. However, this principle says nothing about a patient bearing the risk of harm arising out of negligence or incomplete disclosure by the physician.
The Restatement of Torts defines assumption of risk to mean that the plaintiff fully understands the risk and nonetheless chooses voluntarily to take it (Restatement of Torts, §496-C). One court put it this way: “The doctrine of assumption of the risk of danger applies only where the plaintiff, with a full appreciation of the danger involved and without restriction from his freedom of choice, either by circumstances or coercion, deliberately chooses an obviously perilous course of conduct so that it can be said as a matter of law he has assumed all risk of injury” (Myers v. Boleman, 260 S.E. 2d 359, Ga., 1979).
The assumption of risk defense has been asserted most prominently in sports activities such as boxing, where serious injuries are an integral known risk. Other examples include foolhardy actions, such as “where one tries to beat a rapidly approaching train across the track, to engage in drag racing or to walk upon a frozen pond where the ice is thin” (Myers case, supra).
A physician is expected to obtain a complete medical history, but although the patient is expected to be cooperative, he or she does not have to affirmatively volunteer medical information. A doctor cannot readily invoke this doctrine as a defense simply because the patient has not provided a complete medical history. Thus, in the question above (modified from Hayes v. Hoffman, 296 S.E.2d 216, Ga., 1982), the doctor's assumption of risk defense will likely fail. In the scenario described at the beginning of this column, the patient cannot be assumed to have understood fully the risk of not disclosing her drug allergies. She certainly did not anticipate developing something as serious as Stevens-Johnson syndrome. In a similar case where a patient developed anaphylaxis from using a sulfa-containing drug, an appeals court held that the trial judge erred by instructing the jury that a patient who fails to disclose relevant medical history to a physician has assumed risk of harm (Hawkins v. Greenberg, 283 S.E. 2d 301, Ga., 1981).
In other situations, however, an assumption of risk defense may be used successfully. For example, a patient in California voluntarily and actively sought unorthodox natural herbal treatment for breast cancer after she had refused all conventional therapy. She received full disclosure of the nature of the experimental treatment protocol, and the court therefore rejected her subsequent claim for damages. By giving informed consent to nonconventional experimental therapy in this case, the patient was in effect assuming the risk of harm (Schneider v. Revici, 817 F.2d 987, 2nd Cir., 1987).
In English law, the assumption of risk defense is called volenti non fit injuri (Latin for “to a willing person, no injury is done”). However, mere knowledge of risk does not necessarily imply consent. For example, a plaintiff once accepted a ride from a drunk driver and sustained injuries in a subsequent accident. The court ruled that volenti did not apply in such cases unless the drunkenness was so extreme and so obvious that accepting the ride was equivalent to walking on the edge of an unfenced cliff.
Question: A patient consults her physician for a painful wrist, which is treated with indomethacin. The patient has developed skin rashes caused by various medications in the past, but she does not inform the doctor about this. Shortly after starting indomethacin, she develops Stevens-Johnson syndrome. In regard to an assumption of risk defense, which of the following is true?
A. A patient has a legal duty to reveal to the physician all relevant medical history.
B. Assumption of risk is no longer a valid rule of law.
C. Assumption of risk is an affirmative defense in a tort action and constitutes a complete bar to recovery.
D. Assumption of risk is synonymous with contributory negligence.
E. Giving informed consent is tantamount to assumption of risk.
Answer: C. If a plaintiff is fully aware of the risk to which he or she is exposed, and voluntarily accepts that risk, there will be no recovery of damages if harm results. Known as assumption of risk, it constitutes a valid and complete bar to recovery. This defense has two main elements: a patient's full awareness of the risks, and his or her consent to waive all claims for damages.
In contrast, contributory negligence, which usually serves as a partial rather than complete bar to recovery, arises when negligence by the plaintiff played a part in the resulting injury.
Informed consent is when, after being apprised of the risks and alternatives, a patient gives the physician permission to proceed with diagnosis and treatment. However, this principle says nothing about a patient bearing the risk of harm arising out of negligence or incomplete disclosure by the physician.
The Restatement of Torts defines assumption of risk to mean that the plaintiff fully understands the risk and nonetheless chooses voluntarily to take it (Restatement of Torts, §496-C). One court put it this way: “The doctrine of assumption of the risk of danger applies only where the plaintiff, with a full appreciation of the danger involved and without restriction from his freedom of choice, either by circumstances or coercion, deliberately chooses an obviously perilous course of conduct so that it can be said as a matter of law he has assumed all risk of injury” (Myers v. Boleman, 260 S.E. 2d 359, Ga., 1979).
The assumption of risk defense has been asserted most prominently in sports activities such as boxing, where serious injuries are an integral known risk. Other examples include foolhardy actions, such as “where one tries to beat a rapidly approaching train across the track, to engage in drag racing or to walk upon a frozen pond where the ice is thin” (Myers case, supra).
A physician is expected to obtain a complete medical history, but although the patient is expected to be cooperative, he or she does not have to affirmatively volunteer medical information. A doctor cannot readily invoke this doctrine as a defense simply because the patient has not provided a complete medical history. Thus, in the question above (modified from Hayes v. Hoffman, 296 S.E.2d 216, Ga., 1982), the doctor's assumption of risk defense will likely fail. In the scenario described at the beginning of this column, the patient cannot be assumed to have understood fully the risk of not disclosing her drug allergies. She certainly did not anticipate developing something as serious as Stevens-Johnson syndrome. In a similar case where a patient developed anaphylaxis from using a sulfa-containing drug, an appeals court held that the trial judge erred by instructing the jury that a patient who fails to disclose relevant medical history to a physician has assumed risk of harm (Hawkins v. Greenberg, 283 S.E. 2d 301, Ga., 1981).
In other situations, however, an assumption of risk defense may be used successfully. For example, a patient in California voluntarily and actively sought unorthodox natural herbal treatment for breast cancer after she had refused all conventional therapy. She received full disclosure of the nature of the experimental treatment protocol, and the court therefore rejected her subsequent claim for damages. By giving informed consent to nonconventional experimental therapy in this case, the patient was in effect assuming the risk of harm (Schneider v. Revici, 817 F.2d 987, 2nd Cir., 1987).
In English law, the assumption of risk defense is called volenti non fit injuri (Latin for “to a willing person, no injury is done”). However, mere knowledge of risk does not necessarily imply consent. For example, a plaintiff once accepted a ride from a drunk driver and sustained injuries in a subsequent accident. The court ruled that volenti did not apply in such cases unless the drunkenness was so extreme and so obvious that accepting the ride was equivalent to walking on the edge of an unfenced cliff.
Question: A patient consults her physician for a painful wrist, which is treated with indomethacin. The patient has developed skin rashes caused by various medications in the past, but she does not inform the doctor about this. Shortly after starting indomethacin, she develops Stevens-Johnson syndrome. In regard to an assumption of risk defense, which of the following is true?
A. A patient has a legal duty to reveal to the physician all relevant medical history.
B. Assumption of risk is no longer a valid rule of law.
C. Assumption of risk is an affirmative defense in a tort action and constitutes a complete bar to recovery.
D. Assumption of risk is synonymous with contributory negligence.
E. Giving informed consent is tantamount to assumption of risk.
Answer: C. If a plaintiff is fully aware of the risk to which he or she is exposed, and voluntarily accepts that risk, there will be no recovery of damages if harm results. Known as assumption of risk, it constitutes a valid and complete bar to recovery. This defense has two main elements: a patient's full awareness of the risks, and his or her consent to waive all claims for damages.
In contrast, contributory negligence, which usually serves as a partial rather than complete bar to recovery, arises when negligence by the plaintiff played a part in the resulting injury.
Informed consent is when, after being apprised of the risks and alternatives, a patient gives the physician permission to proceed with diagnosis and treatment. However, this principle says nothing about a patient bearing the risk of harm arising out of negligence or incomplete disclosure by the physician.
The Restatement of Torts defines assumption of risk to mean that the plaintiff fully understands the risk and nonetheless chooses voluntarily to take it (Restatement of Torts, §496-C). One court put it this way: “The doctrine of assumption of the risk of danger applies only where the plaintiff, with a full appreciation of the danger involved and without restriction from his freedom of choice, either by circumstances or coercion, deliberately chooses an obviously perilous course of conduct so that it can be said as a matter of law he has assumed all risk of injury” (Myers v. Boleman, 260 S.E. 2d 359, Ga., 1979).
The assumption of risk defense has been asserted most prominently in sports activities such as boxing, where serious injuries are an integral known risk. Other examples include foolhardy actions, such as “where one tries to beat a rapidly approaching train across the track, to engage in drag racing or to walk upon a frozen pond where the ice is thin” (Myers case, supra).
A physician is expected to obtain a complete medical history, but although the patient is expected to be cooperative, he or she does not have to affirmatively volunteer medical information. A doctor cannot readily invoke this doctrine as a defense simply because the patient has not provided a complete medical history. Thus, in the question above (modified from Hayes v. Hoffman, 296 S.E.2d 216, Ga., 1982), the doctor's assumption of risk defense will likely fail. In the scenario described at the beginning of this column, the patient cannot be assumed to have understood fully the risk of not disclosing her drug allergies. She certainly did not anticipate developing something as serious as Stevens-Johnson syndrome. In a similar case where a patient developed anaphylaxis from using a sulfa-containing drug, an appeals court held that the trial judge erred by instructing the jury that a patient who fails to disclose relevant medical history to a physician has assumed risk of harm (Hawkins v. Greenberg, 283 S.E. 2d 301, Ga., 1981).
In other situations, however, an assumption of risk defense may be used successfully. For example, a patient in California voluntarily and actively sought unorthodox natural herbal treatment for breast cancer after she had refused all conventional therapy. She received full disclosure of the nature of the experimental treatment protocol, and the court therefore rejected her subsequent claim for damages. By giving informed consent to nonconventional experimental therapy in this case, the patient was in effect assuming the risk of harm (Schneider v. Revici, 817 F.2d 987, 2nd Cir., 1987).
In English law, the assumption of risk defense is called volenti non fit injuri (Latin for “to a willing person, no injury is done”). However, mere knowledge of risk does not necessarily imply consent. For example, a plaintiff once accepted a ride from a drunk driver and sustained injuries in a subsequent accident. The court ruled that volenti did not apply in such cases unless the drunkenness was so extreme and so obvious that accepting the ride was equivalent to walking on the edge of an unfenced cliff.
Learned-Intermediary Doctrine
Question: A patient develops life-threatening angioedema after taking an angiotensin receptor blocker (ARB) prescribed by her doctor for diabetic nephropathy. The Physicians' Desk Reference (PDR) mentions this side effect, but the doctor did not warn the patient because it's uncommon. When promoting the drug, pharmaceutical sales representatives have regularly emphasized its benefits but not the risks. Which of the following is true in a malpractice action?
A. A good defense is to emphasize that the benefits of an ARB in diabetic nephropathy greatly outweigh any potential side effects.
B. The prescribing physician is justified in not informing the patient about the risk of angioedema, in accordance with the customary practice of doctors not to disclose this rare adverse effect.
C. The pharmaceutical manufacturer shares malpractice liability because its drug is “defective.”
D. The pharmaceutical manufacturer is liable because its sales reps are supposed to consistently emphasize this serious risk.
E. The learned-intermediary doctrine shields the pharmaceutical manufacturer, placing full liability instead on the prescribing doctor.
Answer: E. Choices A and B are incorrect. Benefits outweighing risks may indeed form the basis for Food and Drug Administration approval of a drug, but this does not constitute a defense against a malpractice lawsuit. And in cases alleging lack of informed consent, the “professional” standard (what physicians would ordinarily disclose) is no longer the law in some jurisdictions, being replaced by the more onerous “reasonable person” standard (what a reasonable person in the patient's position would want to know, even if it's a rare risk).
Choices C and D are also incorrect. Drug or device manufacturers can be sued for a “defective” product, a legal term of art used in products liability litigation, but not in malpractice lawsuits. And although pharmaceutical sales representatives have a responsibility to inform doctors of both benefits and risks, a process termed “fair balance,” they frequently defer to the drug's package insert, as featured in the PDR, to completely discharge this duty.
Generally speaking, if a doctor fails to warn the patient of a medication risk, and injury results, the patient may have a claim against the doctor but not against the drug manufacturer. This is termed the “learned-intermediary” doctrine, and it is also applicable to medical devices such as dialysis equipment, breast implants, blood products, penile prostheses, and even contact lenses, although the situation is less clear where an optometrist does the prescribing (Products Liability 63A Am. Jur.2d Products Liability §1214, updated Sept. 2008). The justification is that manufacturers can reasonably rely on the treating doctor to warn of adverse effects, which are disclosed to the profession through its sales reps, in the drug's package insert, and in the PDR. The treating doctor, in turn, is expected to use his or her professional judgment to adequately warn the patient. It is simply not feasible for the manufacturer to directly warn every patient without usurping the doctor-patient relationship.
In a litigated case where a woman developed a hypertensive crisis after being prescribed Deconamine, a sympathomimetic decongestant, the pharmaceutical company successfully relied on the learned-intermediary doctrine for its defense. The plaintiff happened to be taking Nardil, an MAO inhibitor antidepressant, which is a contraindication to the concurrent use of a sympathomimetic agent. She contended that drug manufacturers should directly provide a wallet-sized informational card to all patients taking an MAO inhibitor since the simultaneous consumption of various foods, beverages, and interacting drugs can raise the blood pressure to dangerous levels. The court, however, sided with the defense's position that its legal duty was to inform only the physician and not the patient (Ferrara v. Berlex Laboratories Inc., 732 F. Supp. 552 [E.D. Pa. 1990]).
Occasionally, a court sidesteps the doctrine. When a manufacturer knows that the drug will reach the consumer without the intervention of a physician (e.g., over-the-counter preparations), it must take reasonable action to directly warn the consumer. Another situation is where there has been extensive advertising of a drug to the public. For example, the manufacturer of the oral contraceptive Norplant was successfully sued because the Supreme Court of New Jersey ruled that the company's nationwide direct-to-consumer advertising created a duty to directly warn all patients using its drug (Perez v. Wyeth Laboratories Inc., 734 A.2d 1245 [N.J. 1999]). Manufacturers may also be liable if they have not disclosed all known risks, as alleged in the recent litigation surrounding rofecoxib (Vioxx) and rosiglitazone (Avandia).
The latest development in drug products liability law comes from the landmark case Wyeth v. Levine (555 U.S. 2 [2009]), in which a plaintiff lost her arm after the drug Phenergan, given by intravenous push, extravasated into the surrounding tissues and entered an artery, resulting in gangrene. This serious drug risk was known to the company and to the FDA, which had approved a warning statement contained in the drug's package insert, but the lawsuit asserted that the warning was inadequate and should have been modified. A Vermont jury had earlier awarded damages of $6.7 million. On appeal, the defendant pharmaceutical company maintained that its warning was appropriate because it had been approved by the federal government through the FDA. It further argued that the drug's package insert could not be unilaterally altered or modified without running afoul of federal regulations. However, in a 6-3 decision, the U.S. Supreme Court held that the company was at liberty to issue a more rigorous warning, that FDA approval does not bar lawsuits, and that federal law was not pre-emptive of state law claims involving drug injuries.
Contact the author at [email protected].
Question: A patient develops life-threatening angioedema after taking an angiotensin receptor blocker (ARB) prescribed by her doctor for diabetic nephropathy. The Physicians' Desk Reference (PDR) mentions this side effect, but the doctor did not warn the patient because it's uncommon. When promoting the drug, pharmaceutical sales representatives have regularly emphasized its benefits but not the risks. Which of the following is true in a malpractice action?
A. A good defense is to emphasize that the benefits of an ARB in diabetic nephropathy greatly outweigh any potential side effects.
B. The prescribing physician is justified in not informing the patient about the risk of angioedema, in accordance with the customary practice of doctors not to disclose this rare adverse effect.
C. The pharmaceutical manufacturer shares malpractice liability because its drug is “defective.”
D. The pharmaceutical manufacturer is liable because its sales reps are supposed to consistently emphasize this serious risk.
E. The learned-intermediary doctrine shields the pharmaceutical manufacturer, placing full liability instead on the prescribing doctor.
Answer: E. Choices A and B are incorrect. Benefits outweighing risks may indeed form the basis for Food and Drug Administration approval of a drug, but this does not constitute a defense against a malpractice lawsuit. And in cases alleging lack of informed consent, the “professional” standard (what physicians would ordinarily disclose) is no longer the law in some jurisdictions, being replaced by the more onerous “reasonable person” standard (what a reasonable person in the patient's position would want to know, even if it's a rare risk).
Choices C and D are also incorrect. Drug or device manufacturers can be sued for a “defective” product, a legal term of art used in products liability litigation, but not in malpractice lawsuits. And although pharmaceutical sales representatives have a responsibility to inform doctors of both benefits and risks, a process termed “fair balance,” they frequently defer to the drug's package insert, as featured in the PDR, to completely discharge this duty.
Generally speaking, if a doctor fails to warn the patient of a medication risk, and injury results, the patient may have a claim against the doctor but not against the drug manufacturer. This is termed the “learned-intermediary” doctrine, and it is also applicable to medical devices such as dialysis equipment, breast implants, blood products, penile prostheses, and even contact lenses, although the situation is less clear where an optometrist does the prescribing (Products Liability 63A Am. Jur.2d Products Liability §1214, updated Sept. 2008). The justification is that manufacturers can reasonably rely on the treating doctor to warn of adverse effects, which are disclosed to the profession through its sales reps, in the drug's package insert, and in the PDR. The treating doctor, in turn, is expected to use his or her professional judgment to adequately warn the patient. It is simply not feasible for the manufacturer to directly warn every patient without usurping the doctor-patient relationship.
In a litigated case where a woman developed a hypertensive crisis after being prescribed Deconamine, a sympathomimetic decongestant, the pharmaceutical company successfully relied on the learned-intermediary doctrine for its defense. The plaintiff happened to be taking Nardil, an MAO inhibitor antidepressant, which is a contraindication to the concurrent use of a sympathomimetic agent. She contended that drug manufacturers should directly provide a wallet-sized informational card to all patients taking an MAO inhibitor since the simultaneous consumption of various foods, beverages, and interacting drugs can raise the blood pressure to dangerous levels. The court, however, sided with the defense's position that its legal duty was to inform only the physician and not the patient (Ferrara v. Berlex Laboratories Inc., 732 F. Supp. 552 [E.D. Pa. 1990]).
Occasionally, a court sidesteps the doctrine. When a manufacturer knows that the drug will reach the consumer without the intervention of a physician (e.g., over-the-counter preparations), it must take reasonable action to directly warn the consumer. Another situation is where there has been extensive advertising of a drug to the public. For example, the manufacturer of the oral contraceptive Norplant was successfully sued because the Supreme Court of New Jersey ruled that the company's nationwide direct-to-consumer advertising created a duty to directly warn all patients using its drug (Perez v. Wyeth Laboratories Inc., 734 A.2d 1245 [N.J. 1999]). Manufacturers may also be liable if they have not disclosed all known risks, as alleged in the recent litigation surrounding rofecoxib (Vioxx) and rosiglitazone (Avandia).
The latest development in drug products liability law comes from the landmark case Wyeth v. Levine (555 U.S. 2 [2009]), in which a plaintiff lost her arm after the drug Phenergan, given by intravenous push, extravasated into the surrounding tissues and entered an artery, resulting in gangrene. This serious drug risk was known to the company and to the FDA, which had approved a warning statement contained in the drug's package insert, but the lawsuit asserted that the warning was inadequate and should have been modified. A Vermont jury had earlier awarded damages of $6.7 million. On appeal, the defendant pharmaceutical company maintained that its warning was appropriate because it had been approved by the federal government through the FDA. It further argued that the drug's package insert could not be unilaterally altered or modified without running afoul of federal regulations. However, in a 6-3 decision, the U.S. Supreme Court held that the company was at liberty to issue a more rigorous warning, that FDA approval does not bar lawsuits, and that federal law was not pre-emptive of state law claims involving drug injuries.
Contact the author at [email protected].
Question: A patient develops life-threatening angioedema after taking an angiotensin receptor blocker (ARB) prescribed by her doctor for diabetic nephropathy. The Physicians' Desk Reference (PDR) mentions this side effect, but the doctor did not warn the patient because it's uncommon. When promoting the drug, pharmaceutical sales representatives have regularly emphasized its benefits but not the risks. Which of the following is true in a malpractice action?
A. A good defense is to emphasize that the benefits of an ARB in diabetic nephropathy greatly outweigh any potential side effects.
B. The prescribing physician is justified in not informing the patient about the risk of angioedema, in accordance with the customary practice of doctors not to disclose this rare adverse effect.
C. The pharmaceutical manufacturer shares malpractice liability because its drug is “defective.”
D. The pharmaceutical manufacturer is liable because its sales reps are supposed to consistently emphasize this serious risk.
E. The learned-intermediary doctrine shields the pharmaceutical manufacturer, placing full liability instead on the prescribing doctor.
Answer: E. Choices A and B are incorrect. Benefits outweighing risks may indeed form the basis for Food and Drug Administration approval of a drug, but this does not constitute a defense against a malpractice lawsuit. And in cases alleging lack of informed consent, the “professional” standard (what physicians would ordinarily disclose) is no longer the law in some jurisdictions, being replaced by the more onerous “reasonable person” standard (what a reasonable person in the patient's position would want to know, even if it's a rare risk).
Choices C and D are also incorrect. Drug or device manufacturers can be sued for a “defective” product, a legal term of art used in products liability litigation, but not in malpractice lawsuits. And although pharmaceutical sales representatives have a responsibility to inform doctors of both benefits and risks, a process termed “fair balance,” they frequently defer to the drug's package insert, as featured in the PDR, to completely discharge this duty.
Generally speaking, if a doctor fails to warn the patient of a medication risk, and injury results, the patient may have a claim against the doctor but not against the drug manufacturer. This is termed the “learned-intermediary” doctrine, and it is also applicable to medical devices such as dialysis equipment, breast implants, blood products, penile prostheses, and even contact lenses, although the situation is less clear where an optometrist does the prescribing (Products Liability 63A Am. Jur.2d Products Liability §1214, updated Sept. 2008). The justification is that manufacturers can reasonably rely on the treating doctor to warn of adverse effects, which are disclosed to the profession through its sales reps, in the drug's package insert, and in the PDR. The treating doctor, in turn, is expected to use his or her professional judgment to adequately warn the patient. It is simply not feasible for the manufacturer to directly warn every patient without usurping the doctor-patient relationship.
In a litigated case where a woman developed a hypertensive crisis after being prescribed Deconamine, a sympathomimetic decongestant, the pharmaceutical company successfully relied on the learned-intermediary doctrine for its defense. The plaintiff happened to be taking Nardil, an MAO inhibitor antidepressant, which is a contraindication to the concurrent use of a sympathomimetic agent. She contended that drug manufacturers should directly provide a wallet-sized informational card to all patients taking an MAO inhibitor since the simultaneous consumption of various foods, beverages, and interacting drugs can raise the blood pressure to dangerous levels. The court, however, sided with the defense's position that its legal duty was to inform only the physician and not the patient (Ferrara v. Berlex Laboratories Inc., 732 F. Supp. 552 [E.D. Pa. 1990]).
Occasionally, a court sidesteps the doctrine. When a manufacturer knows that the drug will reach the consumer without the intervention of a physician (e.g., over-the-counter preparations), it must take reasonable action to directly warn the consumer. Another situation is where there has been extensive advertising of a drug to the public. For example, the manufacturer of the oral contraceptive Norplant was successfully sued because the Supreme Court of New Jersey ruled that the company's nationwide direct-to-consumer advertising created a duty to directly warn all patients using its drug (Perez v. Wyeth Laboratories Inc., 734 A.2d 1245 [N.J. 1999]). Manufacturers may also be liable if they have not disclosed all known risks, as alleged in the recent litigation surrounding rofecoxib (Vioxx) and rosiglitazone (Avandia).
The latest development in drug products liability law comes from the landmark case Wyeth v. Levine (555 U.S. 2 [2009]), in which a plaintiff lost her arm after the drug Phenergan, given by intravenous push, extravasated into the surrounding tissues and entered an artery, resulting in gangrene. This serious drug risk was known to the company and to the FDA, which had approved a warning statement contained in the drug's package insert, but the lawsuit asserted that the warning was inadequate and should have been modified. A Vermont jury had earlier awarded damages of $6.7 million. On appeal, the defendant pharmaceutical company maintained that its warning was appropriate because it had been approved by the federal government through the FDA. It further argued that the drug's package insert could not be unilaterally altered or modified without running afoul of federal regulations. However, in a 6-3 decision, the U.S. Supreme Court held that the company was at liberty to issue a more rigorous warning, that FDA approval does not bar lawsuits, and that federal law was not pre-emptive of state law claims involving drug injuries.
Contact the author at [email protected].
SJS is diagnosed, but not quickly...Lithium unmonitored, kidney failure followed...more...
SJS is diagnosed, but not quickly
AFTER MULTIPLE HOSPITAL VISITS FOR A RASH, a 34-year-old man was sent to a regional medical center for treatment. The rash was eventually diagnosed as a reaction to allopurinol, a potential side effect that was prominently noted in the drug warnings.
The patient developed Stevens-Johnson syndrome. He recovered after several days in the intensive care unit and was discharged with mild scarring over 80% of his body.
PLAINTIFF’S CLAIM The defendants negligently failed to diagnose a drug reaction after multiple reports of a known side effect.
DOCTORS’ DEFENSE Rashes are a common complaint in an emergency room; delayed withdrawal of the drug caused no additional harm.
VERDICT $72,500 South Carolina settlement.
COMMENT Although instances are rare, failure to diagnose and treat a dermatologic problem promptly can have catastrophic results. Stevens-Johnson syndrome needs to be included in the differential diagnosis of drug reactions and must be handled promptly. (See “Derm diagnoses you can’t afford to miss”.)
Lithium unmonitored, kidney failure followed
A WOMAN WAS STARTED ON LITHIUM, but the doctor who wrote the prescription never ordered follow-up blood tests for creatinine levels. When her blood was tested 7 years later by another physician for another medical problem, her creatinine levels were high.
The physician sent the woman to a nephrologist, who discontinued the lithium. Three years later the patient went into renal failure. She received a kidney transplant from her sister. The patient, 39 years of age, will have to take antirejection medication for the rest of her life. The plaintiff sued the doctor who wrote the original prescription as well as 2 other physicians who treated her.
PLAINTIFF’S CLAIM The 2 physicians who treated her saw blood test results showing a rise in creatinine, which should have prompted them to act.
DOCTORS’ DEFENSE No information about the doctors’ defense is available.
VERDICT $2 million New Jersey settlement.
COMMENT Certain medications, such as lithium, require careful and frequent monitoring. Although such surveillance is seldom evidence-based, this is probably one of those times when covering yourself is a guiding precept.
One more drug leads to one big problem
A 56-YEAR-OLD MAN WAS HOSPITALIZED WITH PNEUMONIA, for which his physician prescribed fluconazole (supplied by the hospital pharmacy). The patient was taking cyclosporine, prescribed after a kidney transplant 20 years earlier, and atorvastatin. Lab work performed a week later revealed renal function problems. The patient’s medications weren’t adjusted.
The patient’s wife had him transferred to another facility, where he was diagnosed with rhabdomyolysis resulting from the multiple medications. After extensive hospitalization and rehabilitation, the patient was left with debilitating muscle weakness, especially in his legs.
PLAINTIFF’S CLAIM The hospital and doctor were negligent in failing to recognize the potential for adverse interaction among atorvastatin, cyclosporine, and fluconazole, and in failing to discontinue the atorvastatin.
THE DEFENSE No information about the nature of the defense is available.
VERDICT $1.63 million gross verdict in West Virginia.
COMMENT Can you remember all those CYP450 drug-drug interactions? Neither can I. So when a patient is on an unfamiliar medication (cyclosporine isn’t a regular in my practice), it’s worth looking up the drug and exploring potential problems.
Necrotizing fasciitis leads to lost use of arm
REDNESS AND SWELLING OF THE RIGHT ARM, vomiting, and dehydration brought a 30-year-old woman to the family practice clinic at an Air Force base. The patient’s medical history included endometriosis, hypothyroidism, insomnia, headaches, anxiety, and diffuse cellulitis. She took many drugs for pain associated with the endometriosis and cellulitis, including opioids such as hydromorphone. She also took lorazepam for anxiety.
About 2 weeks later she was seen by an endocrinologist at a hospital for testing related to hypothyroidism. She had a fever and skin lesions, which prompted the endocrinologist to refer her to the Air Force base emergency room for treatment of an infection.
A month later, the patient returned to the endocrinologist, who placed a peripherally inserted catheter on the inside of her right arm near the elbow to facilitate blood drawing for endocrine tests. After 10 days, the patient experienced redness, pain, and swelling in her right arm. A few days later, she saw a family practitioner at the Air Force family practice clinic, who told her to go home, take ibuprofen, and come back if the symptoms didn’t improve.
Four days later, the patient was brought to the Air Force base emergency room and diagnosed with necrotizing fasciitis. After immediate aggressive debridement, she was transferred to another hospital, where she underwent 5 surgeries, including skin grafts. As a result, her right arm is withered and scarred and lacks the muscles and tendons necessary to sustain meaningful activity. The patient has to wear a prosthetic device over her forearm and wrist to provide support and compression, and she suffers continuous, debilitating pain, for which she wears a fentanyl transdermal patch. She is unable to work.
PLAINTIFF’S CLAIM Her arm was not properly examined when the redness and swelling developed; cellulitis should have been diagnosed during that first visit.
DOCTOR’S DEFENSE The patient didn’t complain about her right arm during the initial visit to the family practice clinic, and neither the doctor nor his assistant noted any problems, as evidenced by the lack of mention of the arm in the chart notes. The chart recorded complaints of vomiting, dehydration, and “the same symptoms I always have” and noted that the patient had come to the clinic to refill a lorazepam/hydromorphone prescription to replace a lost bottle of pills. The infection occurred after the visit; once the process began, nothing could be done to alter the outcome.
VERDICT $8.6 million Illinois bench verdict.
COMMENT It is crucial to recognize aggressive skin infections, including necrotizing fasciitis, and to initiate prompt treatment.
SJS is diagnosed, but not quickly
AFTER MULTIPLE HOSPITAL VISITS FOR A RASH, a 34-year-old man was sent to a regional medical center for treatment. The rash was eventually diagnosed as a reaction to allopurinol, a potential side effect that was prominently noted in the drug warnings.
The patient developed Stevens-Johnson syndrome. He recovered after several days in the intensive care unit and was discharged with mild scarring over 80% of his body.
PLAINTIFF’S CLAIM The defendants negligently failed to diagnose a drug reaction after multiple reports of a known side effect.
DOCTORS’ DEFENSE Rashes are a common complaint in an emergency room; delayed withdrawal of the drug caused no additional harm.
VERDICT $72,500 South Carolina settlement.
COMMENT Although instances are rare, failure to diagnose and treat a dermatologic problem promptly can have catastrophic results. Stevens-Johnson syndrome needs to be included in the differential diagnosis of drug reactions and must be handled promptly. (See “Derm diagnoses you can’t afford to miss”.)
Lithium unmonitored, kidney failure followed
A WOMAN WAS STARTED ON LITHIUM, but the doctor who wrote the prescription never ordered follow-up blood tests for creatinine levels. When her blood was tested 7 years later by another physician for another medical problem, her creatinine levels were high.
The physician sent the woman to a nephrologist, who discontinued the lithium. Three years later the patient went into renal failure. She received a kidney transplant from her sister. The patient, 39 years of age, will have to take antirejection medication for the rest of her life. The plaintiff sued the doctor who wrote the original prescription as well as 2 other physicians who treated her.
PLAINTIFF’S CLAIM The 2 physicians who treated her saw blood test results showing a rise in creatinine, which should have prompted them to act.
DOCTORS’ DEFENSE No information about the doctors’ defense is available.
VERDICT $2 million New Jersey settlement.
COMMENT Certain medications, such as lithium, require careful and frequent monitoring. Although such surveillance is seldom evidence-based, this is probably one of those times when covering yourself is a guiding precept.
One more drug leads to one big problem
A 56-YEAR-OLD MAN WAS HOSPITALIZED WITH PNEUMONIA, for which his physician prescribed fluconazole (supplied by the hospital pharmacy). The patient was taking cyclosporine, prescribed after a kidney transplant 20 years earlier, and atorvastatin. Lab work performed a week later revealed renal function problems. The patient’s medications weren’t adjusted.
The patient’s wife had him transferred to another facility, where he was diagnosed with rhabdomyolysis resulting from the multiple medications. After extensive hospitalization and rehabilitation, the patient was left with debilitating muscle weakness, especially in his legs.
PLAINTIFF’S CLAIM The hospital and doctor were negligent in failing to recognize the potential for adverse interaction among atorvastatin, cyclosporine, and fluconazole, and in failing to discontinue the atorvastatin.
THE DEFENSE No information about the nature of the defense is available.
VERDICT $1.63 million gross verdict in West Virginia.
COMMENT Can you remember all those CYP450 drug-drug interactions? Neither can I. So when a patient is on an unfamiliar medication (cyclosporine isn’t a regular in my practice), it’s worth looking up the drug and exploring potential problems.
Necrotizing fasciitis leads to lost use of arm
REDNESS AND SWELLING OF THE RIGHT ARM, vomiting, and dehydration brought a 30-year-old woman to the family practice clinic at an Air Force base. The patient’s medical history included endometriosis, hypothyroidism, insomnia, headaches, anxiety, and diffuse cellulitis. She took many drugs for pain associated with the endometriosis and cellulitis, including opioids such as hydromorphone. She also took lorazepam for anxiety.
About 2 weeks later she was seen by an endocrinologist at a hospital for testing related to hypothyroidism. She had a fever and skin lesions, which prompted the endocrinologist to refer her to the Air Force base emergency room for treatment of an infection.
A month later, the patient returned to the endocrinologist, who placed a peripherally inserted catheter on the inside of her right arm near the elbow to facilitate blood drawing for endocrine tests. After 10 days, the patient experienced redness, pain, and swelling in her right arm. A few days later, she saw a family practitioner at the Air Force family practice clinic, who told her to go home, take ibuprofen, and come back if the symptoms didn’t improve.
Four days later, the patient was brought to the Air Force base emergency room and diagnosed with necrotizing fasciitis. After immediate aggressive debridement, she was transferred to another hospital, where she underwent 5 surgeries, including skin grafts. As a result, her right arm is withered and scarred and lacks the muscles and tendons necessary to sustain meaningful activity. The patient has to wear a prosthetic device over her forearm and wrist to provide support and compression, and she suffers continuous, debilitating pain, for which she wears a fentanyl transdermal patch. She is unable to work.
PLAINTIFF’S CLAIM Her arm was not properly examined when the redness and swelling developed; cellulitis should have been diagnosed during that first visit.
DOCTOR’S DEFENSE The patient didn’t complain about her right arm during the initial visit to the family practice clinic, and neither the doctor nor his assistant noted any problems, as evidenced by the lack of mention of the arm in the chart notes. The chart recorded complaints of vomiting, dehydration, and “the same symptoms I always have” and noted that the patient had come to the clinic to refill a lorazepam/hydromorphone prescription to replace a lost bottle of pills. The infection occurred after the visit; once the process began, nothing could be done to alter the outcome.
VERDICT $8.6 million Illinois bench verdict.
COMMENT It is crucial to recognize aggressive skin infections, including necrotizing fasciitis, and to initiate prompt treatment.
SJS is diagnosed, but not quickly
AFTER MULTIPLE HOSPITAL VISITS FOR A RASH, a 34-year-old man was sent to a regional medical center for treatment. The rash was eventually diagnosed as a reaction to allopurinol, a potential side effect that was prominently noted in the drug warnings.
The patient developed Stevens-Johnson syndrome. He recovered after several days in the intensive care unit and was discharged with mild scarring over 80% of his body.
PLAINTIFF’S CLAIM The defendants negligently failed to diagnose a drug reaction after multiple reports of a known side effect.
DOCTORS’ DEFENSE Rashes are a common complaint in an emergency room; delayed withdrawal of the drug caused no additional harm.
VERDICT $72,500 South Carolina settlement.
COMMENT Although instances are rare, failure to diagnose and treat a dermatologic problem promptly can have catastrophic results. Stevens-Johnson syndrome needs to be included in the differential diagnosis of drug reactions and must be handled promptly. (See “Derm diagnoses you can’t afford to miss”.)
Lithium unmonitored, kidney failure followed
A WOMAN WAS STARTED ON LITHIUM, but the doctor who wrote the prescription never ordered follow-up blood tests for creatinine levels. When her blood was tested 7 years later by another physician for another medical problem, her creatinine levels were high.
The physician sent the woman to a nephrologist, who discontinued the lithium. Three years later the patient went into renal failure. She received a kidney transplant from her sister. The patient, 39 years of age, will have to take antirejection medication for the rest of her life. The plaintiff sued the doctor who wrote the original prescription as well as 2 other physicians who treated her.
PLAINTIFF’S CLAIM The 2 physicians who treated her saw blood test results showing a rise in creatinine, which should have prompted them to act.
DOCTORS’ DEFENSE No information about the doctors’ defense is available.
VERDICT $2 million New Jersey settlement.
COMMENT Certain medications, such as lithium, require careful and frequent monitoring. Although such surveillance is seldom evidence-based, this is probably one of those times when covering yourself is a guiding precept.
One more drug leads to one big problem
A 56-YEAR-OLD MAN WAS HOSPITALIZED WITH PNEUMONIA, for which his physician prescribed fluconazole (supplied by the hospital pharmacy). The patient was taking cyclosporine, prescribed after a kidney transplant 20 years earlier, and atorvastatin. Lab work performed a week later revealed renal function problems. The patient’s medications weren’t adjusted.
The patient’s wife had him transferred to another facility, where he was diagnosed with rhabdomyolysis resulting from the multiple medications. After extensive hospitalization and rehabilitation, the patient was left with debilitating muscle weakness, especially in his legs.
PLAINTIFF’S CLAIM The hospital and doctor were negligent in failing to recognize the potential for adverse interaction among atorvastatin, cyclosporine, and fluconazole, and in failing to discontinue the atorvastatin.
THE DEFENSE No information about the nature of the defense is available.
VERDICT $1.63 million gross verdict in West Virginia.
COMMENT Can you remember all those CYP450 drug-drug interactions? Neither can I. So when a patient is on an unfamiliar medication (cyclosporine isn’t a regular in my practice), it’s worth looking up the drug and exploring potential problems.
Necrotizing fasciitis leads to lost use of arm
REDNESS AND SWELLING OF THE RIGHT ARM, vomiting, and dehydration brought a 30-year-old woman to the family practice clinic at an Air Force base. The patient’s medical history included endometriosis, hypothyroidism, insomnia, headaches, anxiety, and diffuse cellulitis. She took many drugs for pain associated with the endometriosis and cellulitis, including opioids such as hydromorphone. She also took lorazepam for anxiety.
About 2 weeks later she was seen by an endocrinologist at a hospital for testing related to hypothyroidism. She had a fever and skin lesions, which prompted the endocrinologist to refer her to the Air Force base emergency room for treatment of an infection.
A month later, the patient returned to the endocrinologist, who placed a peripherally inserted catheter on the inside of her right arm near the elbow to facilitate blood drawing for endocrine tests. After 10 days, the patient experienced redness, pain, and swelling in her right arm. A few days later, she saw a family practitioner at the Air Force family practice clinic, who told her to go home, take ibuprofen, and come back if the symptoms didn’t improve.
Four days later, the patient was brought to the Air Force base emergency room and diagnosed with necrotizing fasciitis. After immediate aggressive debridement, she was transferred to another hospital, where she underwent 5 surgeries, including skin grafts. As a result, her right arm is withered and scarred and lacks the muscles and tendons necessary to sustain meaningful activity. The patient has to wear a prosthetic device over her forearm and wrist to provide support and compression, and she suffers continuous, debilitating pain, for which she wears a fentanyl transdermal patch. She is unable to work.
PLAINTIFF’S CLAIM Her arm was not properly examined when the redness and swelling developed; cellulitis should have been diagnosed during that first visit.
DOCTOR’S DEFENSE The patient didn’t complain about her right arm during the initial visit to the family practice clinic, and neither the doctor nor his assistant noted any problems, as evidenced by the lack of mention of the arm in the chart notes. The chart recorded complaints of vomiting, dehydration, and “the same symptoms I always have” and noted that the patient had come to the clinic to refill a lorazepam/hydromorphone prescription to replace a lost bottle of pills. The infection occurred after the visit; once the process began, nothing could be done to alter the outcome.
VERDICT $8.6 million Illinois bench verdict.
COMMENT It is crucial to recognize aggressive skin infections, including necrotizing fasciitis, and to initiate prompt treatment.
Gross Negligence
Question: A patient developed postoperative paralytic ileus with intractable vomiting. The attending doctor inserted a nasogastric tube and administered intravenous fluids in the form of 5% dextrose in water. The patient died 6 days later from hypovolemic shock and cardiac arrhythmias. Serum electrolytes were not measured until the last day, when severe hyponatremia and hypokalemia became evident. A lawsuit for wrongful death alleged gross negligence and sought punitive damages, but no expert witness was called to testify. Which of the following best describes the situation?
A. This is a clear case of gross negligence, a standard of care so low as to shock the conscience.
B. The plaintiff will win; expert testimony is unnecessary because a reasonable layperson would conclude that there was substandard care.
C. Punitive damages are commonly awarded in medical malpractice cases, especially when negligence has caused death or severe neurologic injury.
D. Gross negligence is something more than ordinary negligence, but less than reckless or wanton misconduct.
E. Good Samaritan laws encourage aid to strangers by providing immunity for a defendant who would otherwise be liable for ordinary or gross negligence.
Answer: D. This hypothetical scenario introduces the notion of gross negligence as being different from ordinary negligence, and the legal implications of that distinction. The vast majority of medical malpractice cases allege ordinary rather than gross negligence. While it is agreed that gross negligence denotes something more “substandard” than ordinary negligence, there is no precise legal definition. In some jurisdictions, such as Connecticut, gross negligence may constitute an exception to the need for expert testimony, which is otherwise a requirement to establish medical negligence. In the above scenario, the jury may be allowed to determine liability without expert testimony only if the doctor's misconduct was so obvious as to constitute gross negligence—by no means a foregone conclusion.
Compensatory damages are the norm for medical plaintiffs who prevail. Punitive damages may occasionally be awarded when gross negligence is proved, but courts in several states have discouraged such awards, absent a malicious intent, so choice C is incorrect. Choice E is also incorrect. To encourage aid to strangers, “Good Samaritan” statutes immunize aid-givers from liability should ordinary negligence result in harm, but such immunity is typically forfeited if there is a finding of gross negligence.
In the medical context, the operational definition of negligence is best referenced in Prosser's Textbook on Torts: “The formula under which this usually is put to the jury is that the doctor must have and use the knowledge, skill and care ordinarily possessed and employed by members of the profession in good standing.” Gross negligence denotes a higher degree of culpability than ordinary negligence, signifying “more than ordinary inadvertence or inattention, but less perhaps than conscious indifference to the consequences.” The California Supreme Court approved the definition of gross negligence as “the want of even scant care or an extreme departure from the ordinary standard of conduct” (Van Meter v. Bent Construction Co., 297 P.2d 644, 1956). Likewise, the law in Texas stipulates: “Gross negligence means more than momentary thoughtlessness, inadvertence or error of judgment. It means an entire want of care as to establish that the act or omission was the result of actual, conscious indifference to the rights, safety and welfare of the person affected” (Texas Civil Practice & Remedies Code § 41.001[7]).
Gross negligence does not have to amount to willful, wanton, or malicious misconduct. It does not even have to reach the level of “reckless disregard.” Thus, in the Restatement (First) of Torts, an authoritative source of law, the authors differentiate reckless disregard from gross negligence by stating that the former creates a degree of risk “so marked as to amount substantially to a difference (from gross negligence) in kind.”
Court decisions on the issue of gross negligence, predicated on inconsistent standards, can cut both ways, some favoring the plaintiff and others the defendant. In Jackson v. Taylor, Dr. James Taylor prescribed birth control pills for plaintiff Lois Jackson, who subsequently developed bleeding liver tumors allegedly caused by the birth control pills. The plaintiff's expert testified that Dr. Taylor's acts and omissions demonstrated his conscious indifference to the welfare of his patient (Jackson v. Taylor, 912 F.2d 795, 1990). In another case, the Oklahoma Supreme Court ruled that a 61/2-inch clamp left in a surgical incision “might be construed to support a willful, wanton conduct amounting to gross negligence” (Fox v. Oklahoma Memorial Hospital, 774 P.2d 459, 1989).
A recent decision favoring the defendant involved a penicillin-allergic patient who died from massive hemolysis after receiving ceftriaxone (Rocephin). Relying on the gross negligence exception, the plaintiff failed to call an expert witness and lost the case. The Connecticut Supreme Court decided that “the defendant's conduct in administering Rocephin to the decedent and subsequently refusing to treat or to readmit the decedent does not meet the high threshold of egregiousness necessary to fall within the gross negligence exception” (Boone v. William W. Backus Hospital, 864 A.2d 1, 2005).
Contact the author at [email protected].
Question: A patient developed postoperative paralytic ileus with intractable vomiting. The attending doctor inserted a nasogastric tube and administered intravenous fluids in the form of 5% dextrose in water. The patient died 6 days later from hypovolemic shock and cardiac arrhythmias. Serum electrolytes were not measured until the last day, when severe hyponatremia and hypokalemia became evident. A lawsuit for wrongful death alleged gross negligence and sought punitive damages, but no expert witness was called to testify. Which of the following best describes the situation?
A. This is a clear case of gross negligence, a standard of care so low as to shock the conscience.
B. The plaintiff will win; expert testimony is unnecessary because a reasonable layperson would conclude that there was substandard care.
C. Punitive damages are commonly awarded in medical malpractice cases, especially when negligence has caused death or severe neurologic injury.
D. Gross negligence is something more than ordinary negligence, but less than reckless or wanton misconduct.
E. Good Samaritan laws encourage aid to strangers by providing immunity for a defendant who would otherwise be liable for ordinary or gross negligence.
Answer: D. This hypothetical scenario introduces the notion of gross negligence as being different from ordinary negligence, and the legal implications of that distinction. The vast majority of medical malpractice cases allege ordinary rather than gross negligence. While it is agreed that gross negligence denotes something more “substandard” than ordinary negligence, there is no precise legal definition. In some jurisdictions, such as Connecticut, gross negligence may constitute an exception to the need for expert testimony, which is otherwise a requirement to establish medical negligence. In the above scenario, the jury may be allowed to determine liability without expert testimony only if the doctor's misconduct was so obvious as to constitute gross negligence—by no means a foregone conclusion.
Compensatory damages are the norm for medical plaintiffs who prevail. Punitive damages may occasionally be awarded when gross negligence is proved, but courts in several states have discouraged such awards, absent a malicious intent, so choice C is incorrect. Choice E is also incorrect. To encourage aid to strangers, “Good Samaritan” statutes immunize aid-givers from liability should ordinary negligence result in harm, but such immunity is typically forfeited if there is a finding of gross negligence.
In the medical context, the operational definition of negligence is best referenced in Prosser's Textbook on Torts: “The formula under which this usually is put to the jury is that the doctor must have and use the knowledge, skill and care ordinarily possessed and employed by members of the profession in good standing.” Gross negligence denotes a higher degree of culpability than ordinary negligence, signifying “more than ordinary inadvertence or inattention, but less perhaps than conscious indifference to the consequences.” The California Supreme Court approved the definition of gross negligence as “the want of even scant care or an extreme departure from the ordinary standard of conduct” (Van Meter v. Bent Construction Co., 297 P.2d 644, 1956). Likewise, the law in Texas stipulates: “Gross negligence means more than momentary thoughtlessness, inadvertence or error of judgment. It means an entire want of care as to establish that the act or omission was the result of actual, conscious indifference to the rights, safety and welfare of the person affected” (Texas Civil Practice & Remedies Code § 41.001[7]).
Gross negligence does not have to amount to willful, wanton, or malicious misconduct. It does not even have to reach the level of “reckless disregard.” Thus, in the Restatement (First) of Torts, an authoritative source of law, the authors differentiate reckless disregard from gross negligence by stating that the former creates a degree of risk “so marked as to amount substantially to a difference (from gross negligence) in kind.”
Court decisions on the issue of gross negligence, predicated on inconsistent standards, can cut both ways, some favoring the plaintiff and others the defendant. In Jackson v. Taylor, Dr. James Taylor prescribed birth control pills for plaintiff Lois Jackson, who subsequently developed bleeding liver tumors allegedly caused by the birth control pills. The plaintiff's expert testified that Dr. Taylor's acts and omissions demonstrated his conscious indifference to the welfare of his patient (Jackson v. Taylor, 912 F.2d 795, 1990). In another case, the Oklahoma Supreme Court ruled that a 61/2-inch clamp left in a surgical incision “might be construed to support a willful, wanton conduct amounting to gross negligence” (Fox v. Oklahoma Memorial Hospital, 774 P.2d 459, 1989).
A recent decision favoring the defendant involved a penicillin-allergic patient who died from massive hemolysis after receiving ceftriaxone (Rocephin). Relying on the gross negligence exception, the plaintiff failed to call an expert witness and lost the case. The Connecticut Supreme Court decided that “the defendant's conduct in administering Rocephin to the decedent and subsequently refusing to treat or to readmit the decedent does not meet the high threshold of egregiousness necessary to fall within the gross negligence exception” (Boone v. William W. Backus Hospital, 864 A.2d 1, 2005).
Contact the author at [email protected].
Question: A patient developed postoperative paralytic ileus with intractable vomiting. The attending doctor inserted a nasogastric tube and administered intravenous fluids in the form of 5% dextrose in water. The patient died 6 days later from hypovolemic shock and cardiac arrhythmias. Serum electrolytes were not measured until the last day, when severe hyponatremia and hypokalemia became evident. A lawsuit for wrongful death alleged gross negligence and sought punitive damages, but no expert witness was called to testify. Which of the following best describes the situation?
A. This is a clear case of gross negligence, a standard of care so low as to shock the conscience.
B. The plaintiff will win; expert testimony is unnecessary because a reasonable layperson would conclude that there was substandard care.
C. Punitive damages are commonly awarded in medical malpractice cases, especially when negligence has caused death or severe neurologic injury.
D. Gross negligence is something more than ordinary negligence, but less than reckless or wanton misconduct.
E. Good Samaritan laws encourage aid to strangers by providing immunity for a defendant who would otherwise be liable for ordinary or gross negligence.
Answer: D. This hypothetical scenario introduces the notion of gross negligence as being different from ordinary negligence, and the legal implications of that distinction. The vast majority of medical malpractice cases allege ordinary rather than gross negligence. While it is agreed that gross negligence denotes something more “substandard” than ordinary negligence, there is no precise legal definition. In some jurisdictions, such as Connecticut, gross negligence may constitute an exception to the need for expert testimony, which is otherwise a requirement to establish medical negligence. In the above scenario, the jury may be allowed to determine liability without expert testimony only if the doctor's misconduct was so obvious as to constitute gross negligence—by no means a foregone conclusion.
Compensatory damages are the norm for medical plaintiffs who prevail. Punitive damages may occasionally be awarded when gross negligence is proved, but courts in several states have discouraged such awards, absent a malicious intent, so choice C is incorrect. Choice E is also incorrect. To encourage aid to strangers, “Good Samaritan” statutes immunize aid-givers from liability should ordinary negligence result in harm, but such immunity is typically forfeited if there is a finding of gross negligence.
In the medical context, the operational definition of negligence is best referenced in Prosser's Textbook on Torts: “The formula under which this usually is put to the jury is that the doctor must have and use the knowledge, skill and care ordinarily possessed and employed by members of the profession in good standing.” Gross negligence denotes a higher degree of culpability than ordinary negligence, signifying “more than ordinary inadvertence or inattention, but less perhaps than conscious indifference to the consequences.” The California Supreme Court approved the definition of gross negligence as “the want of even scant care or an extreme departure from the ordinary standard of conduct” (Van Meter v. Bent Construction Co., 297 P.2d 644, 1956). Likewise, the law in Texas stipulates: “Gross negligence means more than momentary thoughtlessness, inadvertence or error of judgment. It means an entire want of care as to establish that the act or omission was the result of actual, conscious indifference to the rights, safety and welfare of the person affected” (Texas Civil Practice & Remedies Code § 41.001[7]).
Gross negligence does not have to amount to willful, wanton, or malicious misconduct. It does not even have to reach the level of “reckless disregard.” Thus, in the Restatement (First) of Torts, an authoritative source of law, the authors differentiate reckless disregard from gross negligence by stating that the former creates a degree of risk “so marked as to amount substantially to a difference (from gross negligence) in kind.”
Court decisions on the issue of gross negligence, predicated on inconsistent standards, can cut both ways, some favoring the plaintiff and others the defendant. In Jackson v. Taylor, Dr. James Taylor prescribed birth control pills for plaintiff Lois Jackson, who subsequently developed bleeding liver tumors allegedly caused by the birth control pills. The plaintiff's expert testified that Dr. Taylor's acts and omissions demonstrated his conscious indifference to the welfare of his patient (Jackson v. Taylor, 912 F.2d 795, 1990). In another case, the Oklahoma Supreme Court ruled that a 61/2-inch clamp left in a surgical incision “might be construed to support a willful, wanton conduct amounting to gross negligence” (Fox v. Oklahoma Memorial Hospital, 774 P.2d 459, 1989).
A recent decision favoring the defendant involved a penicillin-allergic patient who died from massive hemolysis after receiving ceftriaxone (Rocephin). Relying on the gross negligence exception, the plaintiff failed to call an expert witness and lost the case. The Connecticut Supreme Court decided that “the defendant's conduct in administering Rocephin to the decedent and subsequently refusing to treat or to readmit the decedent does not meet the high threshold of egregiousness necessary to fall within the gross negligence exception” (Boone v. William W. Backus Hospital, 864 A.2d 1, 2005).
Contact the author at [email protected].
Lack of CT follow-up delays cancer diagnosis...PE recognized too late...more...
Lack of CT follow-up delays cancer diagnosis
SEVERAL WEEKS OF ABDOMINAL PAIN in the lower left quadrant prompted a 58-year-old woman to visit her doctor in March. A colonoscopy performed in July showed 2 small polyps, which were removed. The woman returned in August complaining of feeling weak and again in early September with pain and rectal bleeding. An abdominal computed tomography (CT) scan performed 11 days later revealed a 4 × 3-inch left pelvic mass.
Believing that the CT results suggested an inflammatory process, the doctor prescribed antibiotics. The patient subsequently developed anemia, but didn’t undergo small bowel follow through and barium enema because of equipment failure and scheduling difficulties. She was told to diet and exercise and follow up in 3 months. She returned in a few days with the same complaints and was started on Levaquin and Flagyl.
The patient was seen again the following May, 8 months after the CT scan. A barium enema and small bowel follow through performed in July were negative.
In November, the patient went to a hospital complaining of abdominal pain. A CT scan showed a diffuse abdominal and pelvic mass; a needle biopsy diagnosed a gastrointestinal stromal tumor. Disease was widespread; the patient’s chance of survival was estimated at <50%.
PLAINTIFF’S CLAIM A diagnosis should have been made at the time of the first abdominal CT scan.
DOCTOR’S DEFENSE No information about the doctor’s defense is available.
VERDICT $700,000 Virginia settlement.
COMMENT Whenever a mass—potentially cancer—is involved, effective follow-up is key. Even when the risk is deemed small, repeat imaging is usually the prudent path.
PE recognized too late
TWO MONTHS AFTER UNDERGOING KNEE SURGERY, a 35-year-old man was hospitalized for diverticulitis. A week and a half later, he went to an emergency room complaining of chest pain, shortness of breath, and heart palpitations. The ER physician performed an electrocardiogram (EKG), which he read as normal. He diagnosed a panic attack, prescribed lorazepam, and discharged the patient.
Two days later, the patient visited a psychiatrist complaining of panic attacks. Believing that the man had a medical condition, the psychiatrist told him to see his personal doctor or go to an ER. The patient went to his primary care physician, who suspected angina and admitted him to a local medical center.
In the 12 hours before he was seen, the patient’s pain and breathing problems increased and his calf swelled. By the time his doctor and a cardiologist noted the swelling and diagnosed pulmonary embolism (PE), a clot had traveled to his heart. He was airlifted to another hospital, where he died within 8 hours.
PLAINTIFF’S CLAIM The doctors were negligent in failing to promptly diagnose and treat PE. The ER physician failed to read the EKG correctly and take a detailed history; he diagnosed a panic attack without ruling out PE. The patient’s increased heart rate, shortness of breath, and abnormal EKG should have raised suspicion of an embolism.
DOCTORS’ DEFENSE The diagnosis was reasonable.
VERDICT $1.26 million Pennsylvania verdict.
COMMENT PE should be in the differential diagnosis of any patient with chest pain or shortness of breath.
“GERD” turns out to be heart disease
INDIGESTION AND PAIN IN HIS ARMS FOR 2 MONTHS led a 38-year-old man to consult his primary care physician, who diagnosed gastroesophageal reflux disease (GERD) and prescribed medication. The patient called the doctor to express satisfaction with the reflux medication and symptom relief, but the doctor doubled the dosage and told the patient he would refer him to a gastroenterologist. (The plaintiff later claimed that the medication never worked, and other medical records appeared to support that claim.)
About 6 weeks after the initial visit, the primary care physician referred the patient to a gastroenterologist, who also diagnosed GERD and scheduled an endoscopy. The gastroenterologist noted that a cardiac stress test should be considered if the symptoms worsened or the endoscopy was negative.
Six days later, before the endoscopy, the patient died after complaining of chest pain and temporary loss of vision. An autopsy attributed death to a fatal arrhythmia caused by idiopathic cardiomyopathy. The pathologist who performed the autopsy testified that the patient had dilated cardiomyopathy with a noncontributing component of ischemic change.
PLAINTIFF’S CLAIM The doctors failed to diagnose and treat the patient’s cardiac condition. The patient should have been referred for an EKG or other cardiac evaluation when he was first seen; doing so would have revealed the cardiomyopathy, which could then have been treated.
DOCTORS’ DEFENSE The patient’s symptoms were consistent with GERD and didn’t require cardiac testing. The autopsy report and evidence from the tissue slides were inconsistent with heart disease.
Additionally, the gastroenterologist claimed that cardiac disease could not have been diagnosed and treated in 6 days even if he’d referred the patient for evaluation. He also claimed that the patient died of a stroke.
VERDICT $2.3 million Virginia verdict against the primary care physician only.
COMMENT The misdiagnosis of cardiac disease is common; remember coronary artery disease when confronted with unresponsive GERD.
Lack of CT follow-up delays cancer diagnosis
SEVERAL WEEKS OF ABDOMINAL PAIN in the lower left quadrant prompted a 58-year-old woman to visit her doctor in March. A colonoscopy performed in July showed 2 small polyps, which were removed. The woman returned in August complaining of feeling weak and again in early September with pain and rectal bleeding. An abdominal computed tomography (CT) scan performed 11 days later revealed a 4 × 3-inch left pelvic mass.
Believing that the CT results suggested an inflammatory process, the doctor prescribed antibiotics. The patient subsequently developed anemia, but didn’t undergo small bowel follow through and barium enema because of equipment failure and scheduling difficulties. She was told to diet and exercise and follow up in 3 months. She returned in a few days with the same complaints and was started on Levaquin and Flagyl.
The patient was seen again the following May, 8 months after the CT scan. A barium enema and small bowel follow through performed in July were negative.
In November, the patient went to a hospital complaining of abdominal pain. A CT scan showed a diffuse abdominal and pelvic mass; a needle biopsy diagnosed a gastrointestinal stromal tumor. Disease was widespread; the patient’s chance of survival was estimated at <50%.
PLAINTIFF’S CLAIM A diagnosis should have been made at the time of the first abdominal CT scan.
DOCTOR’S DEFENSE No information about the doctor’s defense is available.
VERDICT $700,000 Virginia settlement.
COMMENT Whenever a mass—potentially cancer—is involved, effective follow-up is key. Even when the risk is deemed small, repeat imaging is usually the prudent path.
PE recognized too late
TWO MONTHS AFTER UNDERGOING KNEE SURGERY, a 35-year-old man was hospitalized for diverticulitis. A week and a half later, he went to an emergency room complaining of chest pain, shortness of breath, and heart palpitations. The ER physician performed an electrocardiogram (EKG), which he read as normal. He diagnosed a panic attack, prescribed lorazepam, and discharged the patient.
Two days later, the patient visited a psychiatrist complaining of panic attacks. Believing that the man had a medical condition, the psychiatrist told him to see his personal doctor or go to an ER. The patient went to his primary care physician, who suspected angina and admitted him to a local medical center.
In the 12 hours before he was seen, the patient’s pain and breathing problems increased and his calf swelled. By the time his doctor and a cardiologist noted the swelling and diagnosed pulmonary embolism (PE), a clot had traveled to his heart. He was airlifted to another hospital, where he died within 8 hours.
PLAINTIFF’S CLAIM The doctors were negligent in failing to promptly diagnose and treat PE. The ER physician failed to read the EKG correctly and take a detailed history; he diagnosed a panic attack without ruling out PE. The patient’s increased heart rate, shortness of breath, and abnormal EKG should have raised suspicion of an embolism.
DOCTORS’ DEFENSE The diagnosis was reasonable.
VERDICT $1.26 million Pennsylvania verdict.
COMMENT PE should be in the differential diagnosis of any patient with chest pain or shortness of breath.
“GERD” turns out to be heart disease
INDIGESTION AND PAIN IN HIS ARMS FOR 2 MONTHS led a 38-year-old man to consult his primary care physician, who diagnosed gastroesophageal reflux disease (GERD) and prescribed medication. The patient called the doctor to express satisfaction with the reflux medication and symptom relief, but the doctor doubled the dosage and told the patient he would refer him to a gastroenterologist. (The plaintiff later claimed that the medication never worked, and other medical records appeared to support that claim.)
About 6 weeks after the initial visit, the primary care physician referred the patient to a gastroenterologist, who also diagnosed GERD and scheduled an endoscopy. The gastroenterologist noted that a cardiac stress test should be considered if the symptoms worsened or the endoscopy was negative.
Six days later, before the endoscopy, the patient died after complaining of chest pain and temporary loss of vision. An autopsy attributed death to a fatal arrhythmia caused by idiopathic cardiomyopathy. The pathologist who performed the autopsy testified that the patient had dilated cardiomyopathy with a noncontributing component of ischemic change.
PLAINTIFF’S CLAIM The doctors failed to diagnose and treat the patient’s cardiac condition. The patient should have been referred for an EKG or other cardiac evaluation when he was first seen; doing so would have revealed the cardiomyopathy, which could then have been treated.
DOCTORS’ DEFENSE The patient’s symptoms were consistent with GERD and didn’t require cardiac testing. The autopsy report and evidence from the tissue slides were inconsistent with heart disease.
Additionally, the gastroenterologist claimed that cardiac disease could not have been diagnosed and treated in 6 days even if he’d referred the patient for evaluation. He also claimed that the patient died of a stroke.
VERDICT $2.3 million Virginia verdict against the primary care physician only.
COMMENT The misdiagnosis of cardiac disease is common; remember coronary artery disease when confronted with unresponsive GERD.
Lack of CT follow-up delays cancer diagnosis
SEVERAL WEEKS OF ABDOMINAL PAIN in the lower left quadrant prompted a 58-year-old woman to visit her doctor in March. A colonoscopy performed in July showed 2 small polyps, which were removed. The woman returned in August complaining of feeling weak and again in early September with pain and rectal bleeding. An abdominal computed tomography (CT) scan performed 11 days later revealed a 4 × 3-inch left pelvic mass.
Believing that the CT results suggested an inflammatory process, the doctor prescribed antibiotics. The patient subsequently developed anemia, but didn’t undergo small bowel follow through and barium enema because of equipment failure and scheduling difficulties. She was told to diet and exercise and follow up in 3 months. She returned in a few days with the same complaints and was started on Levaquin and Flagyl.
The patient was seen again the following May, 8 months after the CT scan. A barium enema and small bowel follow through performed in July were negative.
In November, the patient went to a hospital complaining of abdominal pain. A CT scan showed a diffuse abdominal and pelvic mass; a needle biopsy diagnosed a gastrointestinal stromal tumor. Disease was widespread; the patient’s chance of survival was estimated at <50%.
PLAINTIFF’S CLAIM A diagnosis should have been made at the time of the first abdominal CT scan.
DOCTOR’S DEFENSE No information about the doctor’s defense is available.
VERDICT $700,000 Virginia settlement.
COMMENT Whenever a mass—potentially cancer—is involved, effective follow-up is key. Even when the risk is deemed small, repeat imaging is usually the prudent path.
PE recognized too late
TWO MONTHS AFTER UNDERGOING KNEE SURGERY, a 35-year-old man was hospitalized for diverticulitis. A week and a half later, he went to an emergency room complaining of chest pain, shortness of breath, and heart palpitations. The ER physician performed an electrocardiogram (EKG), which he read as normal. He diagnosed a panic attack, prescribed lorazepam, and discharged the patient.
Two days later, the patient visited a psychiatrist complaining of panic attacks. Believing that the man had a medical condition, the psychiatrist told him to see his personal doctor or go to an ER. The patient went to his primary care physician, who suspected angina and admitted him to a local medical center.
In the 12 hours before he was seen, the patient’s pain and breathing problems increased and his calf swelled. By the time his doctor and a cardiologist noted the swelling and diagnosed pulmonary embolism (PE), a clot had traveled to his heart. He was airlifted to another hospital, where he died within 8 hours.
PLAINTIFF’S CLAIM The doctors were negligent in failing to promptly diagnose and treat PE. The ER physician failed to read the EKG correctly and take a detailed history; he diagnosed a panic attack without ruling out PE. The patient’s increased heart rate, shortness of breath, and abnormal EKG should have raised suspicion of an embolism.
DOCTORS’ DEFENSE The diagnosis was reasonable.
VERDICT $1.26 million Pennsylvania verdict.
COMMENT PE should be in the differential diagnosis of any patient with chest pain or shortness of breath.
“GERD” turns out to be heart disease
INDIGESTION AND PAIN IN HIS ARMS FOR 2 MONTHS led a 38-year-old man to consult his primary care physician, who diagnosed gastroesophageal reflux disease (GERD) and prescribed medication. The patient called the doctor to express satisfaction with the reflux medication and symptom relief, but the doctor doubled the dosage and told the patient he would refer him to a gastroenterologist. (The plaintiff later claimed that the medication never worked, and other medical records appeared to support that claim.)
About 6 weeks after the initial visit, the primary care physician referred the patient to a gastroenterologist, who also diagnosed GERD and scheduled an endoscopy. The gastroenterologist noted that a cardiac stress test should be considered if the symptoms worsened or the endoscopy was negative.
Six days later, before the endoscopy, the patient died after complaining of chest pain and temporary loss of vision. An autopsy attributed death to a fatal arrhythmia caused by idiopathic cardiomyopathy. The pathologist who performed the autopsy testified that the patient had dilated cardiomyopathy with a noncontributing component of ischemic change.
PLAINTIFF’S CLAIM The doctors failed to diagnose and treat the patient’s cardiac condition. The patient should have been referred for an EKG or other cardiac evaluation when he was first seen; doing so would have revealed the cardiomyopathy, which could then have been treated.
DOCTORS’ DEFENSE The patient’s symptoms were consistent with GERD and didn’t require cardiac testing. The autopsy report and evidence from the tissue slides were inconsistent with heart disease.
Additionally, the gastroenterologist claimed that cardiac disease could not have been diagnosed and treated in 6 days even if he’d referred the patient for evaluation. He also claimed that the patient died of a stroke.
VERDICT $2.3 million Virginia verdict against the primary care physician only.
COMMENT The misdiagnosis of cardiac disease is common; remember coronary artery disease when confronted with unresponsive GERD.
Causation
Question: An internist prescribed increasing doses of cholestyramine for a patient with hypercholesterolemia with resulting constipation. The constipation worsened after codeine was used to relieve abdominal pain. A month later, the patient experienced severe abdominal distress, and a barium enema revealed a perforated sigmoid colon. She underwent emergency surgery, and the colon was found to be distended, with impacted feces the size of tennis balls. She sued the internist, alleging that his negligence in prescribing the various medications led to the intestinal perforation. Which of the following statements best fits the situation?
A. The internist will lose the case because he should have chosen a statin over a bile acid sequestrant.
B. The internist was negligent when he prescribed codeine in combination with cholestyramine.
C. The patient was fully aware that constipation is a side effect of these medications, and so assumed the risk of injury.
D. The patient has not proved that the bowel perforation was caused by the internist's negligence.
E. The barium enema could have caused the perforation, and the proper party to sue is the radiologist.
Answer: D. Choices A and B may reflect the general medical view, but the use of these approved drugs is determined by the individual clinical situation and may not constitute substandard care. Choice C is incorrect, as the patient can hardly be said to have accepted the risk of a bowel perforation. This hypothetical case is adapted from Roskin v. Rosow (#301356, San Mateo Cty Super. Ct. [Cal. 1987]), which illustrates the importance of the causation factor in tort litigation. The defendant contended that the plaintiff reported only mild constipation, and that the bowel was perforated during the barium enema. The plaintiff demanded $500,000, which was then reduced to $300,000; the defendant offered $100,000. The jury found for the defendant because the plaintiff did not satisfy the causation element. The radiologist was apparently not sued, perhaps because the statute of limitations had lapsed.
To prevail in a medical negligence lawsuit, a plaintiff must prove causation even after establishing that the doctor owes a duty of care and that there has been a breach of the standard of care. There are two types of causation, factual cause and proximate cause, and both must be proved. Factual cause is also known as cause-in-fact, actual cause, or physical cause. It is established with the “but-for” test: “The defendant's conduct is a factual cause of plaintiff's injuries if plaintiff's harm would not have occurred but for defendant's conduct,” or “the defendant's conduct is a factual cause of plaintiff's injuries if plaintiff's harm would not have occurred without defendant's conduct” (Steven Finz, 1998, “Sum & Substance Audio on Torts”).
Whereas factual cause is relatively easy to ascertain, proximate cause is not. One Court of Appeals has stated: “A plaintiff proves proximate cause, also referred to as legal cause, by demonstrating a natural and continuous sequence of events stemming from the defendant's act or omission, unbroken by any efficient intervening cause, that produces an injury, in whole or in part, and without which the injury would not have occurred” (Barrett v. Harris, 86 P.3d 954 [Ariz. 2004]).
The key inquiry in proximate cause analysis is whether the injury was foreseeable rather than remote. If the defendant could not reasonably have foreseen the resulting harm, the defendant escapes liability. Suppose Mr. A negligently broke the leg of a pedestrian as the result of careless driving. Unfortunately, the injury was worsened by a surgeon's intervening negligence. Because surgical malpractice is foreseeable, the surgeon's negligence is said to be a concurring cause, and Mr. A, the original tortfeasor, becomes liable for both the original and the aggravated injury (the surgeon is, of course, also liable).
To analyze causation issues systematically, one has to identify factual cause issues separately from proximate cause issues. To make matters worse, the term “legal cause” is sometimes used interchangeably with “proximate cause.” Reflecting this complexity, the California Supreme Court now disallows confusing jury instructions regarding proximate cause, requiring instead that the jury be simply directed to determine whether the defendant's conduct was a contributory factor in the plaintiff's injury (Mitchell v. Gonzales, 819 P.2d 872 [Cal. 1991]).
Question: An internist prescribed increasing doses of cholestyramine for a patient with hypercholesterolemia with resulting constipation. The constipation worsened after codeine was used to relieve abdominal pain. A month later, the patient experienced severe abdominal distress, and a barium enema revealed a perforated sigmoid colon. She underwent emergency surgery, and the colon was found to be distended, with impacted feces the size of tennis balls. She sued the internist, alleging that his negligence in prescribing the various medications led to the intestinal perforation. Which of the following statements best fits the situation?
A. The internist will lose the case because he should have chosen a statin over a bile acid sequestrant.
B. The internist was negligent when he prescribed codeine in combination with cholestyramine.
C. The patient was fully aware that constipation is a side effect of these medications, and so assumed the risk of injury.
D. The patient has not proved that the bowel perforation was caused by the internist's negligence.
E. The barium enema could have caused the perforation, and the proper party to sue is the radiologist.
Answer: D. Choices A and B may reflect the general medical view, but the use of these approved drugs is determined by the individual clinical situation and may not constitute substandard care. Choice C is incorrect, as the patient can hardly be said to have accepted the risk of a bowel perforation. This hypothetical case is adapted from Roskin v. Rosow (#301356, San Mateo Cty Super. Ct. [Cal. 1987]), which illustrates the importance of the causation factor in tort litigation. The defendant contended that the plaintiff reported only mild constipation, and that the bowel was perforated during the barium enema. The plaintiff demanded $500,000, which was then reduced to $300,000; the defendant offered $100,000. The jury found for the defendant because the plaintiff did not satisfy the causation element. The radiologist was apparently not sued, perhaps because the statute of limitations had lapsed.
To prevail in a medical negligence lawsuit, a plaintiff must prove causation even after establishing that the doctor owes a duty of care and that there has been a breach of the standard of care. There are two types of causation, factual cause and proximate cause, and both must be proved. Factual cause is also known as cause-in-fact, actual cause, or physical cause. It is established with the “but-for” test: “The defendant's conduct is a factual cause of plaintiff's injuries if plaintiff's harm would not have occurred but for defendant's conduct,” or “the defendant's conduct is a factual cause of plaintiff's injuries if plaintiff's harm would not have occurred without defendant's conduct” (Steven Finz, 1998, “Sum & Substance Audio on Torts”).
Whereas factual cause is relatively easy to ascertain, proximate cause is not. One Court of Appeals has stated: “A plaintiff proves proximate cause, also referred to as legal cause, by demonstrating a natural and continuous sequence of events stemming from the defendant's act or omission, unbroken by any efficient intervening cause, that produces an injury, in whole or in part, and without which the injury would not have occurred” (Barrett v. Harris, 86 P.3d 954 [Ariz. 2004]).
The key inquiry in proximate cause analysis is whether the injury was foreseeable rather than remote. If the defendant could not reasonably have foreseen the resulting harm, the defendant escapes liability. Suppose Mr. A negligently broke the leg of a pedestrian as the result of careless driving. Unfortunately, the injury was worsened by a surgeon's intervening negligence. Because surgical malpractice is foreseeable, the surgeon's negligence is said to be a concurring cause, and Mr. A, the original tortfeasor, becomes liable for both the original and the aggravated injury (the surgeon is, of course, also liable).
To analyze causation issues systematically, one has to identify factual cause issues separately from proximate cause issues. To make matters worse, the term “legal cause” is sometimes used interchangeably with “proximate cause.” Reflecting this complexity, the California Supreme Court now disallows confusing jury instructions regarding proximate cause, requiring instead that the jury be simply directed to determine whether the defendant's conduct was a contributory factor in the plaintiff's injury (Mitchell v. Gonzales, 819 P.2d 872 [Cal. 1991]).
Question: An internist prescribed increasing doses of cholestyramine for a patient with hypercholesterolemia with resulting constipation. The constipation worsened after codeine was used to relieve abdominal pain. A month later, the patient experienced severe abdominal distress, and a barium enema revealed a perforated sigmoid colon. She underwent emergency surgery, and the colon was found to be distended, with impacted feces the size of tennis balls. She sued the internist, alleging that his negligence in prescribing the various medications led to the intestinal perforation. Which of the following statements best fits the situation?
A. The internist will lose the case because he should have chosen a statin over a bile acid sequestrant.
B. The internist was negligent when he prescribed codeine in combination with cholestyramine.
C. The patient was fully aware that constipation is a side effect of these medications, and so assumed the risk of injury.
D. The patient has not proved that the bowel perforation was caused by the internist's negligence.
E. The barium enema could have caused the perforation, and the proper party to sue is the radiologist.
Answer: D. Choices A and B may reflect the general medical view, but the use of these approved drugs is determined by the individual clinical situation and may not constitute substandard care. Choice C is incorrect, as the patient can hardly be said to have accepted the risk of a bowel perforation. This hypothetical case is adapted from Roskin v. Rosow (#301356, San Mateo Cty Super. Ct. [Cal. 1987]), which illustrates the importance of the causation factor in tort litigation. The defendant contended that the plaintiff reported only mild constipation, and that the bowel was perforated during the barium enema. The plaintiff demanded $500,000, which was then reduced to $300,000; the defendant offered $100,000. The jury found for the defendant because the plaintiff did not satisfy the causation element. The radiologist was apparently not sued, perhaps because the statute of limitations had lapsed.
To prevail in a medical negligence lawsuit, a plaintiff must prove causation even after establishing that the doctor owes a duty of care and that there has been a breach of the standard of care. There are two types of causation, factual cause and proximate cause, and both must be proved. Factual cause is also known as cause-in-fact, actual cause, or physical cause. It is established with the “but-for” test: “The defendant's conduct is a factual cause of plaintiff's injuries if plaintiff's harm would not have occurred but for defendant's conduct,” or “the defendant's conduct is a factual cause of plaintiff's injuries if plaintiff's harm would not have occurred without defendant's conduct” (Steven Finz, 1998, “Sum & Substance Audio on Torts”).
Whereas factual cause is relatively easy to ascertain, proximate cause is not. One Court of Appeals has stated: “A plaintiff proves proximate cause, also referred to as legal cause, by demonstrating a natural and continuous sequence of events stemming from the defendant's act or omission, unbroken by any efficient intervening cause, that produces an injury, in whole or in part, and without which the injury would not have occurred” (Barrett v. Harris, 86 P.3d 954 [Ariz. 2004]).
The key inquiry in proximate cause analysis is whether the injury was foreseeable rather than remote. If the defendant could not reasonably have foreseen the resulting harm, the defendant escapes liability. Suppose Mr. A negligently broke the leg of a pedestrian as the result of careless driving. Unfortunately, the injury was worsened by a surgeon's intervening negligence. Because surgical malpractice is foreseeable, the surgeon's negligence is said to be a concurring cause, and Mr. A, the original tortfeasor, becomes liable for both the original and the aggravated injury (the surgeon is, of course, also liable).
To analyze causation issues systematically, one has to identify factual cause issues separately from proximate cause issues. To make matters worse, the term “legal cause” is sometimes used interchangeably with “proximate cause.” Reflecting this complexity, the California Supreme Court now disallows confusing jury instructions regarding proximate cause, requiring instead that the jury be simply directed to determine whether the defendant's conduct was a contributory factor in the plaintiff's injury (Mitchell v. Gonzales, 819 P.2d 872 [Cal. 1991]).
Communication and Malpractice
Question: Doctors who are most subject to lawsuits:
A. Are ultrabusy practitioners.
B. Have poor interpersonal skills.
C. Talk down to patients.
D. Are often in high-risk specialties such as neurosurgery and obstetrics.
E. All of the above.
Answer: E. All choices are correct. The first three speak to hasty evaluations, poor communication, and arrogance. These behaviors predictably get doctors into trouble. Option D describes doctors who must inevitably deal with catastrophic and tragic injuries, with potentially huge awards for the plaintiff who successfully alleges negligence.
What prompts a lawsuit are poor communication and the perception that the physician is uncaring and at fault for an unfavorable outcome. Yet quality of medical care correlates poorly with malpractice lawsuits. In one study, the quality of treatment as judged by peer review was not different in frequently sued versus never-sued doctors (JAMA 1994;272:1588–91). In another study on the relationship between malpractice and patient satisfaction, patients of doctors with prior malpractice claims reported feeling rushed, feeling ignored, receiving inadequate explanations or advice, and spending less time during routine visits, compared with patients of doctors without prior claims (JAMA 1994;272:1583–7). Communication problems exist in more than 70% of malpractice cases (Arch. Intern. Med. 1994;154:1365–70).
In another study, the authors asked 160 adults to view a videotape of a clinical encounter that resulted in complications. In one scenario, the doctor used positive communication behaviors such as eye contact and a friendly tone of voice, and in another scenario, negative communication behaviors such as not smiling (West J. Med. 1993;158:268–72). The videotape viewers were then asked whether they would be inclined to sue the doctor.
The viewers expressed increased litigious intentions when the physician used negative communication behaviors. These results prompted the authors to state: “Positive communications would result in less litigiousness because the physician is viewed as having cared about the patient and thus having acted in good faith. … Long before there is any medical outcome to be concerned about, the patient may believe that the physician has already done something 'wrong' simply by relating in what is perceived to be an uncaring manner. This may set the stage for later retaliation if something does go wrong.”
The authors offered this advice: “To lower litigation risk by using extra medical procedures and tests, consultation, and extensive documentation, often known as 'defensive medicine,' may miss the point. Defensive medicine is not so much a tool to prevent lawsuits as it is to win them if they do occur. But if the intention is to prevent a lawsuit in the first place, forging a physician-patient bond that can effectively resist the pressure of our litigation-crazed and socially antagonistic society seems indispensable.”
Good advice, indeed. Every effort should be made to communicate effectively, with empathy and tact. Communicating well begins with active listening. Patients want their doctors to listen to them and to explain their conditions and treatment plans in simple, understandable language. The physician should give patients ample opportunity to tell their story and to ask questions. In one well-publicized study, only 23% of patients were able to complete their opening statement before the doctor interrupted, which occurred an average of 18 seconds after the patient began to speak (Ann. Intern. Med. 1984;101:692–6).
Do not hesitate to call the patient or family members at home to remind, reassure, or clarify. This is especially important if the treatment or test procedure had lasted longer than usual, was traumatic, was complicated, or may result in posttreatment complications. Answer or return all patient phone calls in a timely fashion. It is usually best to make the call yourself rather than relegate it to an assistant. Patients appreciate a doctor who has taken the time to personally return a phone call, and appreciative patients usually do not sue. Regarding phone conversations, note the four basic rules: listen and instruct carefully; insist on seeing the patient or have the patient go to the emergency department if there is any doubt; ask the patient (or pharmacist) to repeat your instructions or orders to minimize miscommunication; and document everything in writing. Risk managers warn in particular of calls concerning abdominal or chest pain, high fever, seizures, bleeding, head injury, dyspnea, tight orthopedic casts, visual complaints, and onset of labor.
Contact the author at [email protected].
Question: Doctors who are most subject to lawsuits:
A. Are ultrabusy practitioners.
B. Have poor interpersonal skills.
C. Talk down to patients.
D. Are often in high-risk specialties such as neurosurgery and obstetrics.
E. All of the above.
Answer: E. All choices are correct. The first three speak to hasty evaluations, poor communication, and arrogance. These behaviors predictably get doctors into trouble. Option D describes doctors who must inevitably deal with catastrophic and tragic injuries, with potentially huge awards for the plaintiff who successfully alleges negligence.
What prompts a lawsuit are poor communication and the perception that the physician is uncaring and at fault for an unfavorable outcome. Yet quality of medical care correlates poorly with malpractice lawsuits. In one study, the quality of treatment as judged by peer review was not different in frequently sued versus never-sued doctors (JAMA 1994;272:1588–91). In another study on the relationship between malpractice and patient satisfaction, patients of doctors with prior malpractice claims reported feeling rushed, feeling ignored, receiving inadequate explanations or advice, and spending less time during routine visits, compared with patients of doctors without prior claims (JAMA 1994;272:1583–7). Communication problems exist in more than 70% of malpractice cases (Arch. Intern. Med. 1994;154:1365–70).
In another study, the authors asked 160 adults to view a videotape of a clinical encounter that resulted in complications. In one scenario, the doctor used positive communication behaviors such as eye contact and a friendly tone of voice, and in another scenario, negative communication behaviors such as not smiling (West J. Med. 1993;158:268–72). The videotape viewers were then asked whether they would be inclined to sue the doctor.
The viewers expressed increased litigious intentions when the physician used negative communication behaviors. These results prompted the authors to state: “Positive communications would result in less litigiousness because the physician is viewed as having cared about the patient and thus having acted in good faith. … Long before there is any medical outcome to be concerned about, the patient may believe that the physician has already done something 'wrong' simply by relating in what is perceived to be an uncaring manner. This may set the stage for later retaliation if something does go wrong.”
The authors offered this advice: “To lower litigation risk by using extra medical procedures and tests, consultation, and extensive documentation, often known as 'defensive medicine,' may miss the point. Defensive medicine is not so much a tool to prevent lawsuits as it is to win them if they do occur. But if the intention is to prevent a lawsuit in the first place, forging a physician-patient bond that can effectively resist the pressure of our litigation-crazed and socially antagonistic society seems indispensable.”
Good advice, indeed. Every effort should be made to communicate effectively, with empathy and tact. Communicating well begins with active listening. Patients want their doctors to listen to them and to explain their conditions and treatment plans in simple, understandable language. The physician should give patients ample opportunity to tell their story and to ask questions. In one well-publicized study, only 23% of patients were able to complete their opening statement before the doctor interrupted, which occurred an average of 18 seconds after the patient began to speak (Ann. Intern. Med. 1984;101:692–6).
Do not hesitate to call the patient or family members at home to remind, reassure, or clarify. This is especially important if the treatment or test procedure had lasted longer than usual, was traumatic, was complicated, or may result in posttreatment complications. Answer or return all patient phone calls in a timely fashion. It is usually best to make the call yourself rather than relegate it to an assistant. Patients appreciate a doctor who has taken the time to personally return a phone call, and appreciative patients usually do not sue. Regarding phone conversations, note the four basic rules: listen and instruct carefully; insist on seeing the patient or have the patient go to the emergency department if there is any doubt; ask the patient (or pharmacist) to repeat your instructions or orders to minimize miscommunication; and document everything in writing. Risk managers warn in particular of calls concerning abdominal or chest pain, high fever, seizures, bleeding, head injury, dyspnea, tight orthopedic casts, visual complaints, and onset of labor.
Contact the author at [email protected].
Question: Doctors who are most subject to lawsuits:
A. Are ultrabusy practitioners.
B. Have poor interpersonal skills.
C. Talk down to patients.
D. Are often in high-risk specialties such as neurosurgery and obstetrics.
E. All of the above.
Answer: E. All choices are correct. The first three speak to hasty evaluations, poor communication, and arrogance. These behaviors predictably get doctors into trouble. Option D describes doctors who must inevitably deal with catastrophic and tragic injuries, with potentially huge awards for the plaintiff who successfully alleges negligence.
What prompts a lawsuit are poor communication and the perception that the physician is uncaring and at fault for an unfavorable outcome. Yet quality of medical care correlates poorly with malpractice lawsuits. In one study, the quality of treatment as judged by peer review was not different in frequently sued versus never-sued doctors (JAMA 1994;272:1588–91). In another study on the relationship between malpractice and patient satisfaction, patients of doctors with prior malpractice claims reported feeling rushed, feeling ignored, receiving inadequate explanations or advice, and spending less time during routine visits, compared with patients of doctors without prior claims (JAMA 1994;272:1583–7). Communication problems exist in more than 70% of malpractice cases (Arch. Intern. Med. 1994;154:1365–70).
In another study, the authors asked 160 adults to view a videotape of a clinical encounter that resulted in complications. In one scenario, the doctor used positive communication behaviors such as eye contact and a friendly tone of voice, and in another scenario, negative communication behaviors such as not smiling (West J. Med. 1993;158:268–72). The videotape viewers were then asked whether they would be inclined to sue the doctor.
The viewers expressed increased litigious intentions when the physician used negative communication behaviors. These results prompted the authors to state: “Positive communications would result in less litigiousness because the physician is viewed as having cared about the patient and thus having acted in good faith. … Long before there is any medical outcome to be concerned about, the patient may believe that the physician has already done something 'wrong' simply by relating in what is perceived to be an uncaring manner. This may set the stage for later retaliation if something does go wrong.”
The authors offered this advice: “To lower litigation risk by using extra medical procedures and tests, consultation, and extensive documentation, often known as 'defensive medicine,' may miss the point. Defensive medicine is not so much a tool to prevent lawsuits as it is to win them if they do occur. But if the intention is to prevent a lawsuit in the first place, forging a physician-patient bond that can effectively resist the pressure of our litigation-crazed and socially antagonistic society seems indispensable.”
Good advice, indeed. Every effort should be made to communicate effectively, with empathy and tact. Communicating well begins with active listening. Patients want their doctors to listen to them and to explain their conditions and treatment plans in simple, understandable language. The physician should give patients ample opportunity to tell their story and to ask questions. In one well-publicized study, only 23% of patients were able to complete their opening statement before the doctor interrupted, which occurred an average of 18 seconds after the patient began to speak (Ann. Intern. Med. 1984;101:692–6).
Do not hesitate to call the patient or family members at home to remind, reassure, or clarify. This is especially important if the treatment or test procedure had lasted longer than usual, was traumatic, was complicated, or may result in posttreatment complications. Answer or return all patient phone calls in a timely fashion. It is usually best to make the call yourself rather than relegate it to an assistant. Patients appreciate a doctor who has taken the time to personally return a phone call, and appreciative patients usually do not sue. Regarding phone conversations, note the four basic rules: listen and instruct carefully; insist on seeing the patient or have the patient go to the emergency department if there is any doubt; ask the patient (or pharmacist) to repeat your instructions or orders to minimize miscommunication; and document everything in writing. Risk managers warn in particular of calls concerning abdominal or chest pain, high fever, seizures, bleeding, head injury, dyspnea, tight orthopedic casts, visual complaints, and onset of labor.
Contact the author at [email protected].
Disabling stroke follows failure to treat stenosis...Child’s hearing loss blamed on missed meningitis Dx...more...
Disabling stroke follows failure to treat stenosis
NUMBNESS AND WEAKNESS IN HIS LEFT ARM brought a 52-year-old man to his internist. A magnetic resonance imaging scan revealed that the patient had suffered a minor, nondisabling stroke within the previous few weeks caused by an embolism arising from stenosis of the right internal carotid artery. The internist referred the patient to a neurologist but didn’t inform the neurologist that the man’s symptoms were becoming worse.
The neurologist saw the patient about a week later. She was unaware of the unstable symptoms and didn’t communicate with the internist, whose office was 1 floor below hers. The neurologist put the patient on low-dose aspirin and sent him for a nonurgent ultrasound to determine the extent of the stenosis.
The ultrasound report, which the neurologist read 8 days after the patient visit, indicated an 80% to 90% stenosis of the right internal carotid artery. The neurologist claimed she tried to reach the patient 4 times over 2 days. She left one message, but did not reach him.
Two days after the neurologist obtained the ultrasound report, the patient had a major stroke caused by a clot that had broken off from his right internal carotid artery. The stroke left him mostly paralyzed on his left side, confined to a wheelchair, and unable to work or drive.
PLAINTIFF’S CLAIM The internist failed to convey all medically significant information to the neurologist; he had a duty to intervene when he received worrisome clinical information. The neurologist should have ordered an urgent carotid endarterectomy, which would have prevented a major stroke. She also should have contacted the internist; communication would have brought to light the need for urgent treatment.
DOCTORS’ DEFENSE The internist claimed that the neurology referral was all that was required of him. The neurologist maintained that the risk of another embolic stroke within 90 days of the minor stroke was low and that nonurgent evaluation was appropriate. Both doctors claimed that the major stroke was an unfortunate and unpredictable occurrence and that, in any event, vascular surgery wouldn’t have been performed for at least 4 to 6 weeks after the small stroke because of concern over severe cerebral hemorrhage.
VERDICT $1.75 million Massachusetts settlement.
COMMENT Communicate, communicate, communicate. Without appropriate coordination of care, such unfortunate stories are likely to be repeated. Never assume that another colleague is going to follow up on that markedly abnormal finding—take matters into your own hands!
Child’s hearing loss blamed on missed meningitis Dx
A 1-YEAR-OLD GIRL WITH A PERSISTENT FEVER was seen by her pediatrician, who diagnosed tonsillitis. During the hours after her visit to the pediatrician, the child’s fever reached 104°F and she began to vomit. She was brought to an emergency room, where a radiograph revealed a potentially abnormal density of the lungs. Developing pneumonia was suspected, and she was admitted to the hospital. Doctors also suspected meningitis, but didn’t detect any abnormalities of the meninges. An antibiotic was given.
On the third day of hospitalization, a nurse observed nuchal rigidity. The child remained in the hospital for 2 weeks, during which time her body temperature remained at 100°F or higher. Two days after discharge, the girl experienced a total loss of hearing. A computed tomography scan revealed damage to the cochleae.
PLAINTIFF’S CLAIM The damage to the patient’s cochleae was caused by untreated meningitis. Nuchal rigidity should have prompted an immediate spinal tap or other test for meningitis.
DOCTOR’S DEFENSE Proper care was given; the child’s symptoms didn’t warrant additional treatment. The cochlear damage was congenital.
VERDICT $3 million New York settlement.
COMMENT Meningitis may occur less often nowadays, but it should never be forgotten. When in doubt, order (or perform) a lumbar puncture, which can lead to a life-saving diagnosis. Early initiation of presumptive antibiotic treatment is critical.
Untreated high blood sugar ends in coma and disability
A 65-YEAR-OLD MAN sought treatment from an endocrinologist for previously diagnosed diabetes. An in-office pin prick test showed a blood sugar level exceeding the instrument’s limit. The endocrinologist ordered blood work at an outside lab. The tests indicated dangerous blood sugar levels, which were reported to the endocrinologist and his staff. The doctor allegedly didn’t act on the results.
About a week after seeing the endocrinologist, the patient collapsed; he was rushed to a hospital and placed in a protective coma. He emerged from the coma with significant injuries, including blindness in 1 eye and bilateral foot drop.
PLAINTIFF’S CLAIM The in-office test results should have alerted the doctor to a serious problem. The doctor should have sent the patient to the hospital for an immediate blood test.
DOCTOR’S DEFENSE The doctor denied any negligence.
VERDICT $1.5 million Connecticut settlement.
COMMENT Delayed or inappropriate follow up of in-office lab work remains a preventable cause of liability. If you order a test, make sure you have a protocol in place to assure timely adjudication of test results.
Disabling stroke follows failure to treat stenosis
NUMBNESS AND WEAKNESS IN HIS LEFT ARM brought a 52-year-old man to his internist. A magnetic resonance imaging scan revealed that the patient had suffered a minor, nondisabling stroke within the previous few weeks caused by an embolism arising from stenosis of the right internal carotid artery. The internist referred the patient to a neurologist but didn’t inform the neurologist that the man’s symptoms were becoming worse.
The neurologist saw the patient about a week later. She was unaware of the unstable symptoms and didn’t communicate with the internist, whose office was 1 floor below hers. The neurologist put the patient on low-dose aspirin and sent him for a nonurgent ultrasound to determine the extent of the stenosis.
The ultrasound report, which the neurologist read 8 days after the patient visit, indicated an 80% to 90% stenosis of the right internal carotid artery. The neurologist claimed she tried to reach the patient 4 times over 2 days. She left one message, but did not reach him.
Two days after the neurologist obtained the ultrasound report, the patient had a major stroke caused by a clot that had broken off from his right internal carotid artery. The stroke left him mostly paralyzed on his left side, confined to a wheelchair, and unable to work or drive.
PLAINTIFF’S CLAIM The internist failed to convey all medically significant information to the neurologist; he had a duty to intervene when he received worrisome clinical information. The neurologist should have ordered an urgent carotid endarterectomy, which would have prevented a major stroke. She also should have contacted the internist; communication would have brought to light the need for urgent treatment.
DOCTORS’ DEFENSE The internist claimed that the neurology referral was all that was required of him. The neurologist maintained that the risk of another embolic stroke within 90 days of the minor stroke was low and that nonurgent evaluation was appropriate. Both doctors claimed that the major stroke was an unfortunate and unpredictable occurrence and that, in any event, vascular surgery wouldn’t have been performed for at least 4 to 6 weeks after the small stroke because of concern over severe cerebral hemorrhage.
VERDICT $1.75 million Massachusetts settlement.
COMMENT Communicate, communicate, communicate. Without appropriate coordination of care, such unfortunate stories are likely to be repeated. Never assume that another colleague is going to follow up on that markedly abnormal finding—take matters into your own hands!
Child’s hearing loss blamed on missed meningitis Dx
A 1-YEAR-OLD GIRL WITH A PERSISTENT FEVER was seen by her pediatrician, who diagnosed tonsillitis. During the hours after her visit to the pediatrician, the child’s fever reached 104°F and she began to vomit. She was brought to an emergency room, where a radiograph revealed a potentially abnormal density of the lungs. Developing pneumonia was suspected, and she was admitted to the hospital. Doctors also suspected meningitis, but didn’t detect any abnormalities of the meninges. An antibiotic was given.
On the third day of hospitalization, a nurse observed nuchal rigidity. The child remained in the hospital for 2 weeks, during which time her body temperature remained at 100°F or higher. Two days after discharge, the girl experienced a total loss of hearing. A computed tomography scan revealed damage to the cochleae.
PLAINTIFF’S CLAIM The damage to the patient’s cochleae was caused by untreated meningitis. Nuchal rigidity should have prompted an immediate spinal tap or other test for meningitis.
DOCTOR’S DEFENSE Proper care was given; the child’s symptoms didn’t warrant additional treatment. The cochlear damage was congenital.
VERDICT $3 million New York settlement.
COMMENT Meningitis may occur less often nowadays, but it should never be forgotten. When in doubt, order (or perform) a lumbar puncture, which can lead to a life-saving diagnosis. Early initiation of presumptive antibiotic treatment is critical.
Untreated high blood sugar ends in coma and disability
A 65-YEAR-OLD MAN sought treatment from an endocrinologist for previously diagnosed diabetes. An in-office pin prick test showed a blood sugar level exceeding the instrument’s limit. The endocrinologist ordered blood work at an outside lab. The tests indicated dangerous blood sugar levels, which were reported to the endocrinologist and his staff. The doctor allegedly didn’t act on the results.
About a week after seeing the endocrinologist, the patient collapsed; he was rushed to a hospital and placed in a protective coma. He emerged from the coma with significant injuries, including blindness in 1 eye and bilateral foot drop.
PLAINTIFF’S CLAIM The in-office test results should have alerted the doctor to a serious problem. The doctor should have sent the patient to the hospital for an immediate blood test.
DOCTOR’S DEFENSE The doctor denied any negligence.
VERDICT $1.5 million Connecticut settlement.
COMMENT Delayed or inappropriate follow up of in-office lab work remains a preventable cause of liability. If you order a test, make sure you have a protocol in place to assure timely adjudication of test results.
Disabling stroke follows failure to treat stenosis
NUMBNESS AND WEAKNESS IN HIS LEFT ARM brought a 52-year-old man to his internist. A magnetic resonance imaging scan revealed that the patient had suffered a minor, nondisabling stroke within the previous few weeks caused by an embolism arising from stenosis of the right internal carotid artery. The internist referred the patient to a neurologist but didn’t inform the neurologist that the man’s symptoms were becoming worse.
The neurologist saw the patient about a week later. She was unaware of the unstable symptoms and didn’t communicate with the internist, whose office was 1 floor below hers. The neurologist put the patient on low-dose aspirin and sent him for a nonurgent ultrasound to determine the extent of the stenosis.
The ultrasound report, which the neurologist read 8 days after the patient visit, indicated an 80% to 90% stenosis of the right internal carotid artery. The neurologist claimed she tried to reach the patient 4 times over 2 days. She left one message, but did not reach him.
Two days after the neurologist obtained the ultrasound report, the patient had a major stroke caused by a clot that had broken off from his right internal carotid artery. The stroke left him mostly paralyzed on his left side, confined to a wheelchair, and unable to work or drive.
PLAINTIFF’S CLAIM The internist failed to convey all medically significant information to the neurologist; he had a duty to intervene when he received worrisome clinical information. The neurologist should have ordered an urgent carotid endarterectomy, which would have prevented a major stroke. She also should have contacted the internist; communication would have brought to light the need for urgent treatment.
DOCTORS’ DEFENSE The internist claimed that the neurology referral was all that was required of him. The neurologist maintained that the risk of another embolic stroke within 90 days of the minor stroke was low and that nonurgent evaluation was appropriate. Both doctors claimed that the major stroke was an unfortunate and unpredictable occurrence and that, in any event, vascular surgery wouldn’t have been performed for at least 4 to 6 weeks after the small stroke because of concern over severe cerebral hemorrhage.
VERDICT $1.75 million Massachusetts settlement.
COMMENT Communicate, communicate, communicate. Without appropriate coordination of care, such unfortunate stories are likely to be repeated. Never assume that another colleague is going to follow up on that markedly abnormal finding—take matters into your own hands!
Child’s hearing loss blamed on missed meningitis Dx
A 1-YEAR-OLD GIRL WITH A PERSISTENT FEVER was seen by her pediatrician, who diagnosed tonsillitis. During the hours after her visit to the pediatrician, the child’s fever reached 104°F and she began to vomit. She was brought to an emergency room, where a radiograph revealed a potentially abnormal density of the lungs. Developing pneumonia was suspected, and she was admitted to the hospital. Doctors also suspected meningitis, but didn’t detect any abnormalities of the meninges. An antibiotic was given.
On the third day of hospitalization, a nurse observed nuchal rigidity. The child remained in the hospital for 2 weeks, during which time her body temperature remained at 100°F or higher. Two days after discharge, the girl experienced a total loss of hearing. A computed tomography scan revealed damage to the cochleae.
PLAINTIFF’S CLAIM The damage to the patient’s cochleae was caused by untreated meningitis. Nuchal rigidity should have prompted an immediate spinal tap or other test for meningitis.
DOCTOR’S DEFENSE Proper care was given; the child’s symptoms didn’t warrant additional treatment. The cochlear damage was congenital.
VERDICT $3 million New York settlement.
COMMENT Meningitis may occur less often nowadays, but it should never be forgotten. When in doubt, order (or perform) a lumbar puncture, which can lead to a life-saving diagnosis. Early initiation of presumptive antibiotic treatment is critical.
Untreated high blood sugar ends in coma and disability
A 65-YEAR-OLD MAN sought treatment from an endocrinologist for previously diagnosed diabetes. An in-office pin prick test showed a blood sugar level exceeding the instrument’s limit. The endocrinologist ordered blood work at an outside lab. The tests indicated dangerous blood sugar levels, which were reported to the endocrinologist and his staff. The doctor allegedly didn’t act on the results.
About a week after seeing the endocrinologist, the patient collapsed; he was rushed to a hospital and placed in a protective coma. He emerged from the coma with significant injuries, including blindness in 1 eye and bilateral foot drop.
PLAINTIFF’S CLAIM The in-office test results should have alerted the doctor to a serious problem. The doctor should have sent the patient to the hospital for an immediate blood test.
DOCTOR’S DEFENSE The doctor denied any negligence.
VERDICT $1.5 million Connecticut settlement.
COMMENT Delayed or inappropriate follow up of in-office lab work remains a preventable cause of liability. If you order a test, make sure you have a protocol in place to assure timely adjudication of test results.