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malpractice, overdose, injury
malpractice, overdose, injury
malpractice, overdose, injury
Inadequate differential proves fatal ... Death by fentanyl patch and methadone ... more
Culture results go undiscussed, man suffers stroke
TWO WEEKS AFTER PROSTATE SURGERY, a 76-year-old man went to the ED because he was having trouble urinating. The ED physician catheterized the patient, ordered a urine culture, and discharged him.
The culture results, showing methicillin-resistant Staphylococcus aureus, were sent to a printer in the ED twice, as was the usual practice, but evidently no one saw them.
The patient returned to the ED 2 weeks after his initial visit with the same complaint of difficult urination and was seen by the same physician. The physician again discharged him with a catheter but without mentioning the culture results. Two days later, the patient suffered a stroke, which paralyzed his left side.
PLAINTIFF’S CLAIM The bacteria had spread from the patient’s urine to his bloodstream, sparking a cascade of events that led to the stroke.
THE DEFENSE No information about the defense is available.
VERDICT $2.25 million New Jersey settlement.
COMMENT The repeated missed opportunities to diagnose and treat this patient’s infection were regrettable—and costly.
Inadequate differential proves fatal
SHORTNESS OF BREATH led a 52-year-old woman to visit her medical group, where she was a long-time patient. The family practitioner who saw her noted tachycardia and ordered an electrocardiogram, which was abnormal. The physician also ordered a chest x-ray and, because the woman had a history of anemia, a complete blood count and a number of other blood tests. He subsequently called the patient at home to tell her that the blood tests were normal and she didn’t have anemia.
Three days later, the patient went to an urgent care center complaining of shortness of breath and tightness in her chest. A pulmonary embolism was diagnosed, and she was transferred to a hospital ED. Later that evening, a code blue was called and the patient was resuscitated. She died the following day.
PLAINTIFF’S CLAIM The doctor assumed that the patient had anemia and failed to develop a differential diagnosis. The patient had risk factors for pulmonary embolism—obesity and the use of an ethinyl estradiol-etonogestrel vaginal contraceptive ring—which should have prompted the doctor to consider that possibility. If he had done so, the pulmonary embolism would have been diagnosed and the patient’s death prevented.
THE DEFENSE The patient’s presentation wasn’t typical for pulmonary embolism, and there wasn’t any way to know whether an earlier diagnosis would have resulted in survival.
VERDICT $1.9 million California verdict.
COMMENT Although pulmonary embolism can be a challenging diagnosis to make, it needs to be considered carefully in all patients with shortness of breath, chest pain, or poorly defined pulmonary or cardiac symptoms.
The correct diagnosis comes too late
FLU-LIKE SYMPTOMS AND AN IRREGULAR HEART RATE prompted a man to go to the ED, where the physician diagnosed a viral infection, prescribed pain medication, and discharged him. The following day, a laboratory report indicating a staph infection was sent to an ED secretary, but the patient wasn’t told the results.
The patient returned to the hospital 2 days later in a confused state. Tests revealed a staph infection and meningitis, for which the patient received antibiotics. A week later, the patient suffered a stroke, resulting in diminished cognitive ability, impaired vision, and right-sided motor deficits.
PLAINTIFF’S CLAIM The white blood cell count and C-reactive protein level measured at the patient’s first visit to the ED would have led to a diagnosis of bacterial infection. The patient should have been admitted to the hospital and given antibiotics at that time.
THE DEFENSE The original diagnosis was reasonable.
VERDICT Confidential settlement with the hospital. $900,000 net verdict against the physician in New Jersey.
COMMENT Lab reports gone awry and the lack of a fail-safe for abnormal tests result in a $900,000 judgment. Do you have adequate systems in place to avoid a communication failure like this one?
Slow response turns a bad situation into a disaster
A 66-YEAR-OLD MAN on warfarin therapy for chronic atrial fibrillation and a transient ischemic attack underwent lithotripsy for kidney stones. Three days after the lithotripsy, he went to the ED complaining of severe flank pain. A computed tomography (CT) scan of the abdomen showed a large retroperitoneal hematoma and prominent perinephric and pararenal hemorrhages.
The patient remained on a gurney in the hallway of the ED in deteriorating condition until he was admitted to the intensive care unit, by which time his condition was critical. He died the next day.
PLAINTIFF’S CLAIM The ED physician and admitting urologists failed to monitor and treat the patient’s active hemorrhage for 9 hours. They didn’t order coagulation studies or respond to signs of escalating hemorrhagic shock. They failed to seek timely consults from surgery and interventional radiology.
THE DEFENSE No information about the defense is available.
VERDICT $825,000 Virginia settlement.
COMMENT Preventing complications of anticoagulation is hard enough; the lack of a timely response in this case made a bad outcome disastrous.
Were steps taken quickly enough?
SEVERE LOWER ABDOMINAL PAIN prompted a 52-year-old woman to go to the ED. She said she hadn’t had a bowel movement in almost a week. The ED physician, in consultation with the attending physician, admitted her to the hospital and ordered intravenous fluids and a soap suds enema, which didn’t relieve the constipation. The patient’s vital signs deteriorated, and she was crying and restless.
When the attending physician saw the patient almost 3 hours after admission, she had a fever of 101.4°F. He ordered additional tests, a computed tomography (CT) scan, and antibiotics, but didn’t order them STAT.
About 1½ hours later, a house physician examined the patient, and, after speaking with the attending physician, transferred her to a step-down telemetry unit. About 1½ hours after the transfer, a nurse called the house physician to report that the patient’s condition was worsening. The house physician ordered pain relievers and a second enema but didn’t come to the hospital.
Because the patient wasn’t in the intensive care unit, no one checked on her again for 3½ hours. When the nurse did check, she found the patient pale, cold, and turning blue. The nurse called the house physician, who came to the hospital. The patient had a fever of 102.4°F and her blood pressure couldn’t be measured.
After speaking with the attending physician, the house physician had the patient admitted to the ICU and also ordered a STAT surgical consultation and CT scan. In the meantime, the patient went into cardiac arrest and couldn’t be revived. Death was caused by peritonitis with sepsis resulting from a large intestinal obstruction.
PLAINTIFF’S CLAIM The patient showed early signs of sepsis. She should have undergone testing sooner and been transferred to the ICU earlier.
THE DEFENSE The doctors claimed that all their actions were appropriate and that the actions suggested by the plaintiff wouldn’t have resulted in the patient’s survival.
VERDICT $3.8 million Pennsylvania verdict.
COMMENT Prompt evaluation and monitoring of this patient might have prevented death and a substantial verdict.
2 analgesic calamities: Death by fentanyl patch …
AFTER A WEEK OF INCREASING BACK PAIN, which had begun to shoot down his right leg, a 37-year-old man went to the ED. He was examined and given prescriptions for pain killers, including acetaminophen and hydrocodone, and muscle relaxants and discharged with instructions to return in 3 days for magnetic resonance imaging (MRI).
While he was at the hospital for the MRI, the patient returned to the ED because he was still in pain and his acetaminophen-hydrocodone prescription was running out. The ED physician prescribed a 0.75-mg fentanyl transdermal patch and instructed the patient to put it on his chest.
Three days later, the patient filled the prescription and applied the patch. The following day, his girlfriend found him dead in bed. Postmortem toxicology results showed a blood fentanyl level of 9.85 ng/mL, markedly higher than the therapeutic level. Respiratory failure caused by fentanyl toxicity was cited as the cause of death.
PLAINTIFF’S CLAIM The ED physician prescribed an excessive dose of fentanyl.
THE DEFENSE A defective patch or misuse of the patch caused the patient’s death.
VERDICT $1.2 million Indiana verdict.
… and methadone
A 36-YEAR-OLD MAN started treatment with a pain specialist for pain arising from a back problem, for which he had taken pain medication previously. The pain specialist prescribed methadone, 360 10-mg tablets. The prescription limited the patient to 2 tablets every 4 hours for a maximum dosage of 12 tablets (120 mg) per day.
Three days after the patient filled the prescription, he was found dead. An autopsy determined the cause of death to be drug toxicity from methadone. At the time the patient died, the bottle of methadone tablets contained 342 tablets, indicating that he had taken only 18 tablets, well within the maximum dosage authorized by the prescription.
PLAINTIFF’S CLAIM The prescribed methadone dosage was excessive for a patient just beginning to use the drug. A proper initial dosage is between 2.5 and 10 mg every 8 to 12 hours for a maximum of 30 mg per day.
THE DEFENSE No information about the defense is available.
VERDICT Confidential Utah settlement.
COMMENT These 2 cases have a common thread. The effects of opioids are often idiosyncratic. A plan for careful monitoring and follow-up should be prepared at initiation of treatment and when escalating the dosage.
Culture results go undiscussed, man suffers stroke
TWO WEEKS AFTER PROSTATE SURGERY, a 76-year-old man went to the ED because he was having trouble urinating. The ED physician catheterized the patient, ordered a urine culture, and discharged him.
The culture results, showing methicillin-resistant Staphylococcus aureus, were sent to a printer in the ED twice, as was the usual practice, but evidently no one saw them.
The patient returned to the ED 2 weeks after his initial visit with the same complaint of difficult urination and was seen by the same physician. The physician again discharged him with a catheter but without mentioning the culture results. Two days later, the patient suffered a stroke, which paralyzed his left side.
PLAINTIFF’S CLAIM The bacteria had spread from the patient’s urine to his bloodstream, sparking a cascade of events that led to the stroke.
THE DEFENSE No information about the defense is available.
VERDICT $2.25 million New Jersey settlement.
COMMENT The repeated missed opportunities to diagnose and treat this patient’s infection were regrettable—and costly.
Inadequate differential proves fatal
SHORTNESS OF BREATH led a 52-year-old woman to visit her medical group, where she was a long-time patient. The family practitioner who saw her noted tachycardia and ordered an electrocardiogram, which was abnormal. The physician also ordered a chest x-ray and, because the woman had a history of anemia, a complete blood count and a number of other blood tests. He subsequently called the patient at home to tell her that the blood tests were normal and she didn’t have anemia.
Three days later, the patient went to an urgent care center complaining of shortness of breath and tightness in her chest. A pulmonary embolism was diagnosed, and she was transferred to a hospital ED. Later that evening, a code blue was called and the patient was resuscitated. She died the following day.
PLAINTIFF’S CLAIM The doctor assumed that the patient had anemia and failed to develop a differential diagnosis. The patient had risk factors for pulmonary embolism—obesity and the use of an ethinyl estradiol-etonogestrel vaginal contraceptive ring—which should have prompted the doctor to consider that possibility. If he had done so, the pulmonary embolism would have been diagnosed and the patient’s death prevented.
THE DEFENSE The patient’s presentation wasn’t typical for pulmonary embolism, and there wasn’t any way to know whether an earlier diagnosis would have resulted in survival.
VERDICT $1.9 million California verdict.
COMMENT Although pulmonary embolism can be a challenging diagnosis to make, it needs to be considered carefully in all patients with shortness of breath, chest pain, or poorly defined pulmonary or cardiac symptoms.
The correct diagnosis comes too late
FLU-LIKE SYMPTOMS AND AN IRREGULAR HEART RATE prompted a man to go to the ED, where the physician diagnosed a viral infection, prescribed pain medication, and discharged him. The following day, a laboratory report indicating a staph infection was sent to an ED secretary, but the patient wasn’t told the results.
The patient returned to the hospital 2 days later in a confused state. Tests revealed a staph infection and meningitis, for which the patient received antibiotics. A week later, the patient suffered a stroke, resulting in diminished cognitive ability, impaired vision, and right-sided motor deficits.
PLAINTIFF’S CLAIM The white blood cell count and C-reactive protein level measured at the patient’s first visit to the ED would have led to a diagnosis of bacterial infection. The patient should have been admitted to the hospital and given antibiotics at that time.
THE DEFENSE The original diagnosis was reasonable.
VERDICT Confidential settlement with the hospital. $900,000 net verdict against the physician in New Jersey.
COMMENT Lab reports gone awry and the lack of a fail-safe for abnormal tests result in a $900,000 judgment. Do you have adequate systems in place to avoid a communication failure like this one?
Slow response turns a bad situation into a disaster
A 66-YEAR-OLD MAN on warfarin therapy for chronic atrial fibrillation and a transient ischemic attack underwent lithotripsy for kidney stones. Three days after the lithotripsy, he went to the ED complaining of severe flank pain. A computed tomography (CT) scan of the abdomen showed a large retroperitoneal hematoma and prominent perinephric and pararenal hemorrhages.
The patient remained on a gurney in the hallway of the ED in deteriorating condition until he was admitted to the intensive care unit, by which time his condition was critical. He died the next day.
PLAINTIFF’S CLAIM The ED physician and admitting urologists failed to monitor and treat the patient’s active hemorrhage for 9 hours. They didn’t order coagulation studies or respond to signs of escalating hemorrhagic shock. They failed to seek timely consults from surgery and interventional radiology.
THE DEFENSE No information about the defense is available.
VERDICT $825,000 Virginia settlement.
COMMENT Preventing complications of anticoagulation is hard enough; the lack of a timely response in this case made a bad outcome disastrous.
Were steps taken quickly enough?
SEVERE LOWER ABDOMINAL PAIN prompted a 52-year-old woman to go to the ED. She said she hadn’t had a bowel movement in almost a week. The ED physician, in consultation with the attending physician, admitted her to the hospital and ordered intravenous fluids and a soap suds enema, which didn’t relieve the constipation. The patient’s vital signs deteriorated, and she was crying and restless.
When the attending physician saw the patient almost 3 hours after admission, she had a fever of 101.4°F. He ordered additional tests, a computed tomography (CT) scan, and antibiotics, but didn’t order them STAT.
About 1½ hours later, a house physician examined the patient, and, after speaking with the attending physician, transferred her to a step-down telemetry unit. About 1½ hours after the transfer, a nurse called the house physician to report that the patient’s condition was worsening. The house physician ordered pain relievers and a second enema but didn’t come to the hospital.
Because the patient wasn’t in the intensive care unit, no one checked on her again for 3½ hours. When the nurse did check, she found the patient pale, cold, and turning blue. The nurse called the house physician, who came to the hospital. The patient had a fever of 102.4°F and her blood pressure couldn’t be measured.
After speaking with the attending physician, the house physician had the patient admitted to the ICU and also ordered a STAT surgical consultation and CT scan. In the meantime, the patient went into cardiac arrest and couldn’t be revived. Death was caused by peritonitis with sepsis resulting from a large intestinal obstruction.
PLAINTIFF’S CLAIM The patient showed early signs of sepsis. She should have undergone testing sooner and been transferred to the ICU earlier.
THE DEFENSE The doctors claimed that all their actions were appropriate and that the actions suggested by the plaintiff wouldn’t have resulted in the patient’s survival.
VERDICT $3.8 million Pennsylvania verdict.
COMMENT Prompt evaluation and monitoring of this patient might have prevented death and a substantial verdict.
2 analgesic calamities: Death by fentanyl patch …
AFTER A WEEK OF INCREASING BACK PAIN, which had begun to shoot down his right leg, a 37-year-old man went to the ED. He was examined and given prescriptions for pain killers, including acetaminophen and hydrocodone, and muscle relaxants and discharged with instructions to return in 3 days for magnetic resonance imaging (MRI).
While he was at the hospital for the MRI, the patient returned to the ED because he was still in pain and his acetaminophen-hydrocodone prescription was running out. The ED physician prescribed a 0.75-mg fentanyl transdermal patch and instructed the patient to put it on his chest.
Three days later, the patient filled the prescription and applied the patch. The following day, his girlfriend found him dead in bed. Postmortem toxicology results showed a blood fentanyl level of 9.85 ng/mL, markedly higher than the therapeutic level. Respiratory failure caused by fentanyl toxicity was cited as the cause of death.
PLAINTIFF’S CLAIM The ED physician prescribed an excessive dose of fentanyl.
THE DEFENSE A defective patch or misuse of the patch caused the patient’s death.
VERDICT $1.2 million Indiana verdict.
… and methadone
A 36-YEAR-OLD MAN started treatment with a pain specialist for pain arising from a back problem, for which he had taken pain medication previously. The pain specialist prescribed methadone, 360 10-mg tablets. The prescription limited the patient to 2 tablets every 4 hours for a maximum dosage of 12 tablets (120 mg) per day.
Three days after the patient filled the prescription, he was found dead. An autopsy determined the cause of death to be drug toxicity from methadone. At the time the patient died, the bottle of methadone tablets contained 342 tablets, indicating that he had taken only 18 tablets, well within the maximum dosage authorized by the prescription.
PLAINTIFF’S CLAIM The prescribed methadone dosage was excessive for a patient just beginning to use the drug. A proper initial dosage is between 2.5 and 10 mg every 8 to 12 hours for a maximum of 30 mg per day.
THE DEFENSE No information about the defense is available.
VERDICT Confidential Utah settlement.
COMMENT These 2 cases have a common thread. The effects of opioids are often idiosyncratic. A plan for careful monitoring and follow-up should be prepared at initiation of treatment and when escalating the dosage.
Culture results go undiscussed, man suffers stroke
TWO WEEKS AFTER PROSTATE SURGERY, a 76-year-old man went to the ED because he was having trouble urinating. The ED physician catheterized the patient, ordered a urine culture, and discharged him.
The culture results, showing methicillin-resistant Staphylococcus aureus, were sent to a printer in the ED twice, as was the usual practice, but evidently no one saw them.
The patient returned to the ED 2 weeks after his initial visit with the same complaint of difficult urination and was seen by the same physician. The physician again discharged him with a catheter but without mentioning the culture results. Two days later, the patient suffered a stroke, which paralyzed his left side.
PLAINTIFF’S CLAIM The bacteria had spread from the patient’s urine to his bloodstream, sparking a cascade of events that led to the stroke.
THE DEFENSE No information about the defense is available.
VERDICT $2.25 million New Jersey settlement.
COMMENT The repeated missed opportunities to diagnose and treat this patient’s infection were regrettable—and costly.
Inadequate differential proves fatal
SHORTNESS OF BREATH led a 52-year-old woman to visit her medical group, where she was a long-time patient. The family practitioner who saw her noted tachycardia and ordered an electrocardiogram, which was abnormal. The physician also ordered a chest x-ray and, because the woman had a history of anemia, a complete blood count and a number of other blood tests. He subsequently called the patient at home to tell her that the blood tests were normal and she didn’t have anemia.
Three days later, the patient went to an urgent care center complaining of shortness of breath and tightness in her chest. A pulmonary embolism was diagnosed, and she was transferred to a hospital ED. Later that evening, a code blue was called and the patient was resuscitated. She died the following day.
PLAINTIFF’S CLAIM The doctor assumed that the patient had anemia and failed to develop a differential diagnosis. The patient had risk factors for pulmonary embolism—obesity and the use of an ethinyl estradiol-etonogestrel vaginal contraceptive ring—which should have prompted the doctor to consider that possibility. If he had done so, the pulmonary embolism would have been diagnosed and the patient’s death prevented.
THE DEFENSE The patient’s presentation wasn’t typical for pulmonary embolism, and there wasn’t any way to know whether an earlier diagnosis would have resulted in survival.
VERDICT $1.9 million California verdict.
COMMENT Although pulmonary embolism can be a challenging diagnosis to make, it needs to be considered carefully in all patients with shortness of breath, chest pain, or poorly defined pulmonary or cardiac symptoms.
The correct diagnosis comes too late
FLU-LIKE SYMPTOMS AND AN IRREGULAR HEART RATE prompted a man to go to the ED, where the physician diagnosed a viral infection, prescribed pain medication, and discharged him. The following day, a laboratory report indicating a staph infection was sent to an ED secretary, but the patient wasn’t told the results.
The patient returned to the hospital 2 days later in a confused state. Tests revealed a staph infection and meningitis, for which the patient received antibiotics. A week later, the patient suffered a stroke, resulting in diminished cognitive ability, impaired vision, and right-sided motor deficits.
PLAINTIFF’S CLAIM The white blood cell count and C-reactive protein level measured at the patient’s first visit to the ED would have led to a diagnosis of bacterial infection. The patient should have been admitted to the hospital and given antibiotics at that time.
THE DEFENSE The original diagnosis was reasonable.
VERDICT Confidential settlement with the hospital. $900,000 net verdict against the physician in New Jersey.
COMMENT Lab reports gone awry and the lack of a fail-safe for abnormal tests result in a $900,000 judgment. Do you have adequate systems in place to avoid a communication failure like this one?
Slow response turns a bad situation into a disaster
A 66-YEAR-OLD MAN on warfarin therapy for chronic atrial fibrillation and a transient ischemic attack underwent lithotripsy for kidney stones. Three days after the lithotripsy, he went to the ED complaining of severe flank pain. A computed tomography (CT) scan of the abdomen showed a large retroperitoneal hematoma and prominent perinephric and pararenal hemorrhages.
The patient remained on a gurney in the hallway of the ED in deteriorating condition until he was admitted to the intensive care unit, by which time his condition was critical. He died the next day.
PLAINTIFF’S CLAIM The ED physician and admitting urologists failed to monitor and treat the patient’s active hemorrhage for 9 hours. They didn’t order coagulation studies or respond to signs of escalating hemorrhagic shock. They failed to seek timely consults from surgery and interventional radiology.
THE DEFENSE No information about the defense is available.
VERDICT $825,000 Virginia settlement.
COMMENT Preventing complications of anticoagulation is hard enough; the lack of a timely response in this case made a bad outcome disastrous.
Were steps taken quickly enough?
SEVERE LOWER ABDOMINAL PAIN prompted a 52-year-old woman to go to the ED. She said she hadn’t had a bowel movement in almost a week. The ED physician, in consultation with the attending physician, admitted her to the hospital and ordered intravenous fluids and a soap suds enema, which didn’t relieve the constipation. The patient’s vital signs deteriorated, and she was crying and restless.
When the attending physician saw the patient almost 3 hours after admission, she had a fever of 101.4°F. He ordered additional tests, a computed tomography (CT) scan, and antibiotics, but didn’t order them STAT.
About 1½ hours later, a house physician examined the patient, and, after speaking with the attending physician, transferred her to a step-down telemetry unit. About 1½ hours after the transfer, a nurse called the house physician to report that the patient’s condition was worsening. The house physician ordered pain relievers and a second enema but didn’t come to the hospital.
Because the patient wasn’t in the intensive care unit, no one checked on her again for 3½ hours. When the nurse did check, she found the patient pale, cold, and turning blue. The nurse called the house physician, who came to the hospital. The patient had a fever of 102.4°F and her blood pressure couldn’t be measured.
After speaking with the attending physician, the house physician had the patient admitted to the ICU and also ordered a STAT surgical consultation and CT scan. In the meantime, the patient went into cardiac arrest and couldn’t be revived. Death was caused by peritonitis with sepsis resulting from a large intestinal obstruction.
PLAINTIFF’S CLAIM The patient showed early signs of sepsis. She should have undergone testing sooner and been transferred to the ICU earlier.
THE DEFENSE The doctors claimed that all their actions were appropriate and that the actions suggested by the plaintiff wouldn’t have resulted in the patient’s survival.
VERDICT $3.8 million Pennsylvania verdict.
COMMENT Prompt evaluation and monitoring of this patient might have prevented death and a substantial verdict.
2 analgesic calamities: Death by fentanyl patch …
AFTER A WEEK OF INCREASING BACK PAIN, which had begun to shoot down his right leg, a 37-year-old man went to the ED. He was examined and given prescriptions for pain killers, including acetaminophen and hydrocodone, and muscle relaxants and discharged with instructions to return in 3 days for magnetic resonance imaging (MRI).
While he was at the hospital for the MRI, the patient returned to the ED because he was still in pain and his acetaminophen-hydrocodone prescription was running out. The ED physician prescribed a 0.75-mg fentanyl transdermal patch and instructed the patient to put it on his chest.
Three days later, the patient filled the prescription and applied the patch. The following day, his girlfriend found him dead in bed. Postmortem toxicology results showed a blood fentanyl level of 9.85 ng/mL, markedly higher than the therapeutic level. Respiratory failure caused by fentanyl toxicity was cited as the cause of death.
PLAINTIFF’S CLAIM The ED physician prescribed an excessive dose of fentanyl.
THE DEFENSE A defective patch or misuse of the patch caused the patient’s death.
VERDICT $1.2 million Indiana verdict.
… and methadone
A 36-YEAR-OLD MAN started treatment with a pain specialist for pain arising from a back problem, for which he had taken pain medication previously. The pain specialist prescribed methadone, 360 10-mg tablets. The prescription limited the patient to 2 tablets every 4 hours for a maximum dosage of 12 tablets (120 mg) per day.
Three days after the patient filled the prescription, he was found dead. An autopsy determined the cause of death to be drug toxicity from methadone. At the time the patient died, the bottle of methadone tablets contained 342 tablets, indicating that he had taken only 18 tablets, well within the maximum dosage authorized by the prescription.
PLAINTIFF’S CLAIM The prescribed methadone dosage was excessive for a patient just beginning to use the drug. A proper initial dosage is between 2.5 and 10 mg every 8 to 12 hours for a maximum of 30 mg per day.
THE DEFENSE No information about the defense is available.
VERDICT Confidential Utah settlement.
COMMENT These 2 cases have a common thread. The effects of opioids are often idiosyncratic. A plan for careful monitoring and follow-up should be prepared at initiation of treatment and when escalating the dosage.
Compensatory Damages
Question: A female patient who smokes suffered a cerebrovascular accident while taking an oral contraceptive. She successfully sued the doctor for failure to warn her about the risks associated with taking oral contraceptives and smoking. However, her neurological deficits would have been less disabling had she been compliant with intensive speech and physical therapy. In a claim for damages, which of the following is most accurate?
A. She is entitled to compensatory damages, that is, lost wages, medical expenses, pain and suffering, and hedonic damages.
B. By virtue of being a smoker, she is contributorily negligent, which can reduce or extinguish altogether any monetary award.
C. If the stroke had been fatal, her estate but not her dependants can claim damages on her behalf.
D. Compensatory damages will be unaffected, despite her noncompliance with rehabilitative care.
E. The twin reasons for compensatory damages are to make the victim "whole" and to punish the tortfeasor.
Answer: A. Since the plaintiff was not warned of the stroke risk of oral contraceptives or the heightened risk in smokers, it is unlikely she will be found to be contributorily negligent. A victim is required to mitigate his or her losses, and the medical noncompliance in this case will likely lead to a reduction in her award. In the case of a deceased patient, both the estate and the dependents can separately file a lawsuit, known as survival action and wrongful death action respectively. Choice A is best as it correctly describes compensatory damages, which are meant to return the victim to the preaccident status, but are not meant to be punitive.
In a tort action, "damages" refer to the money awarded to the injured plaintiff. It should be distinguished from the word "damage," which is a synonym for injury. Malpractice damages are of two sorts, compensatory damages and punitive damages (the latter will be discussed in a subsequent column). Compensatory damages can be further divided into two categories: Special, economic or pecuniary damages, including lost wages, medical expenses, out-of-pocket expenses, and other incidental expenses; and general, noneconomic, or nonpecuniary damages, which provide payments for pain and suffering, loss of consortium (loss of love, affection, society, sex, and household services), and lost or reduced enjoyment of life. This last item, called hedonic damages, is basically an expression of the dollar value of a life, determined by economists to be quantifiable at $1.5 million to $3.5 million, but as high as $8 million.
Damages for pain and suffering often contribute to "runaway" jury verdicts. One indignant observer has written: "In making arguments for pain and suffering awards, both sides attempt to win the jurors’ sympathies with highly emotional evidence. A blind plaintiff will receive careful instruction to come to court with his seeing-eye dog, and to dab at his eyes with a handkerchief." Tort reform proposals regularly aim to cap these awards in the $250,000 range, such as California’s Medical Injury Compensation Reform Act. Some of these state statutes, including California’s, have survived constitutional challenge, whereas others, such as the recent Illinois reform statute, have not (Lebron v. Gottlieb Memorial Hospital).
In the past, the death of either party extinguished all claims. This concept has since been reformed to recognize "survival of the causes of action." In other words, the lawsuit is now considered an inheritable property right, surviving the plaintiff’s death and now residing in the estate of the deceased. It should properly be called a surviving personal injury action, abbreviated to "survival action." Survival action should be distinguished from a wrongful death action, which is brought by family members and dependents seeking monetary compensation for losses that the negligent death had caused them.
Lost profits may sometimes be recoverable in tort action if evidence warrants recovery, such as in the case of a plaintiff who is prevented from operating a business due to negligent acts of a physician. Likewise, recovery for pure mental suffering is also allowed in some jurisdictions, even if it is not accompanied by physical injury or impact. Courts tend to inquire into whether the injuries were foreseeable rather than the type of injuries, and in some jurisdictions, negligent infliction of emotional distress constitutes a separate and actionable tort.
To recover full damages, the plaintiff must take reasonable steps to mitigate his or her injury. This is also known as the "rule of avoidable consequences." It may be anticipatory, such as wearing a seat belt or crash helmet, or postdamage such as seeking and abiding by continuing medical care. This rule is different from the "Eggshell Skull Rule," which refers to the negligent defendant’s responsibility for all aggravated injuries resulting from a preexisting condition.
While malpractice damages are widely feared to breach the million dollar mark, this is only true in serious injuries, and the typical quantum is substantially lower. According to The Wall Street Journal (Nov. 30, 2004, p. A-1), statistics from various governmental sources indicate that the median payment for damages on behalf of physicians was $150,000, and the amount of healthcare spending accounted for by malpractice costs was 2%. Still, awards in some cases can be shocking. In Warren v. Schecter, a California jury awarded $1.8 million plus periodic payments for future care, totaling $9.6 million over 34 years. The plaintiff, a young woman, had developed gastrointestinal complications and multiple osteoporotic fractures following gastric surgery, and had to be fed a special diet through a feeding tube. The case was against a surgeon who failed to warn of the remote risk of metabolic bone disease following gastric surgery.
Dr. Tan is an emeritus professor at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. It is adapted from the author’s book, "Medical Malpractice: Understanding the Law, Managing the Risk." For additional information, readers may contact the author at [email protected].
Question: A female patient who smokes suffered a cerebrovascular accident while taking an oral contraceptive. She successfully sued the doctor for failure to warn her about the risks associated with taking oral contraceptives and smoking. However, her neurological deficits would have been less disabling had she been compliant with intensive speech and physical therapy. In a claim for damages, which of the following is most accurate?
A. She is entitled to compensatory damages, that is, lost wages, medical expenses, pain and suffering, and hedonic damages.
B. By virtue of being a smoker, she is contributorily negligent, which can reduce or extinguish altogether any monetary award.
C. If the stroke had been fatal, her estate but not her dependants can claim damages on her behalf.
D. Compensatory damages will be unaffected, despite her noncompliance with rehabilitative care.
E. The twin reasons for compensatory damages are to make the victim "whole" and to punish the tortfeasor.
Answer: A. Since the plaintiff was not warned of the stroke risk of oral contraceptives or the heightened risk in smokers, it is unlikely she will be found to be contributorily negligent. A victim is required to mitigate his or her losses, and the medical noncompliance in this case will likely lead to a reduction in her award. In the case of a deceased patient, both the estate and the dependents can separately file a lawsuit, known as survival action and wrongful death action respectively. Choice A is best as it correctly describes compensatory damages, which are meant to return the victim to the preaccident status, but are not meant to be punitive.
In a tort action, "damages" refer to the money awarded to the injured plaintiff. It should be distinguished from the word "damage," which is a synonym for injury. Malpractice damages are of two sorts, compensatory damages and punitive damages (the latter will be discussed in a subsequent column). Compensatory damages can be further divided into two categories: Special, economic or pecuniary damages, including lost wages, medical expenses, out-of-pocket expenses, and other incidental expenses; and general, noneconomic, or nonpecuniary damages, which provide payments for pain and suffering, loss of consortium (loss of love, affection, society, sex, and household services), and lost or reduced enjoyment of life. This last item, called hedonic damages, is basically an expression of the dollar value of a life, determined by economists to be quantifiable at $1.5 million to $3.5 million, but as high as $8 million.
Damages for pain and suffering often contribute to "runaway" jury verdicts. One indignant observer has written: "In making arguments for pain and suffering awards, both sides attempt to win the jurors’ sympathies with highly emotional evidence. A blind plaintiff will receive careful instruction to come to court with his seeing-eye dog, and to dab at his eyes with a handkerchief." Tort reform proposals regularly aim to cap these awards in the $250,000 range, such as California’s Medical Injury Compensation Reform Act. Some of these state statutes, including California’s, have survived constitutional challenge, whereas others, such as the recent Illinois reform statute, have not (Lebron v. Gottlieb Memorial Hospital).
In the past, the death of either party extinguished all claims. This concept has since been reformed to recognize "survival of the causes of action." In other words, the lawsuit is now considered an inheritable property right, surviving the plaintiff’s death and now residing in the estate of the deceased. It should properly be called a surviving personal injury action, abbreviated to "survival action." Survival action should be distinguished from a wrongful death action, which is brought by family members and dependents seeking monetary compensation for losses that the negligent death had caused them.
Lost profits may sometimes be recoverable in tort action if evidence warrants recovery, such as in the case of a plaintiff who is prevented from operating a business due to negligent acts of a physician. Likewise, recovery for pure mental suffering is also allowed in some jurisdictions, even if it is not accompanied by physical injury or impact. Courts tend to inquire into whether the injuries were foreseeable rather than the type of injuries, and in some jurisdictions, negligent infliction of emotional distress constitutes a separate and actionable tort.
To recover full damages, the plaintiff must take reasonable steps to mitigate his or her injury. This is also known as the "rule of avoidable consequences." It may be anticipatory, such as wearing a seat belt or crash helmet, or postdamage such as seeking and abiding by continuing medical care. This rule is different from the "Eggshell Skull Rule," which refers to the negligent defendant’s responsibility for all aggravated injuries resulting from a preexisting condition.
While malpractice damages are widely feared to breach the million dollar mark, this is only true in serious injuries, and the typical quantum is substantially lower. According to The Wall Street Journal (Nov. 30, 2004, p. A-1), statistics from various governmental sources indicate that the median payment for damages on behalf of physicians was $150,000, and the amount of healthcare spending accounted for by malpractice costs was 2%. Still, awards in some cases can be shocking. In Warren v. Schecter, a California jury awarded $1.8 million plus periodic payments for future care, totaling $9.6 million over 34 years. The plaintiff, a young woman, had developed gastrointestinal complications and multiple osteoporotic fractures following gastric surgery, and had to be fed a special diet through a feeding tube. The case was against a surgeon who failed to warn of the remote risk of metabolic bone disease following gastric surgery.
Dr. Tan is an emeritus professor at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. It is adapted from the author’s book, "Medical Malpractice: Understanding the Law, Managing the Risk." For additional information, readers may contact the author at [email protected].
Question: A female patient who smokes suffered a cerebrovascular accident while taking an oral contraceptive. She successfully sued the doctor for failure to warn her about the risks associated with taking oral contraceptives and smoking. However, her neurological deficits would have been less disabling had she been compliant with intensive speech and physical therapy. In a claim for damages, which of the following is most accurate?
A. She is entitled to compensatory damages, that is, lost wages, medical expenses, pain and suffering, and hedonic damages.
B. By virtue of being a smoker, she is contributorily negligent, which can reduce or extinguish altogether any monetary award.
C. If the stroke had been fatal, her estate but not her dependants can claim damages on her behalf.
D. Compensatory damages will be unaffected, despite her noncompliance with rehabilitative care.
E. The twin reasons for compensatory damages are to make the victim "whole" and to punish the tortfeasor.
Answer: A. Since the plaintiff was not warned of the stroke risk of oral contraceptives or the heightened risk in smokers, it is unlikely she will be found to be contributorily negligent. A victim is required to mitigate his or her losses, and the medical noncompliance in this case will likely lead to a reduction in her award. In the case of a deceased patient, both the estate and the dependents can separately file a lawsuit, known as survival action and wrongful death action respectively. Choice A is best as it correctly describes compensatory damages, which are meant to return the victim to the preaccident status, but are not meant to be punitive.
In a tort action, "damages" refer to the money awarded to the injured plaintiff. It should be distinguished from the word "damage," which is a synonym for injury. Malpractice damages are of two sorts, compensatory damages and punitive damages (the latter will be discussed in a subsequent column). Compensatory damages can be further divided into two categories: Special, economic or pecuniary damages, including lost wages, medical expenses, out-of-pocket expenses, and other incidental expenses; and general, noneconomic, or nonpecuniary damages, which provide payments for pain and suffering, loss of consortium (loss of love, affection, society, sex, and household services), and lost or reduced enjoyment of life. This last item, called hedonic damages, is basically an expression of the dollar value of a life, determined by economists to be quantifiable at $1.5 million to $3.5 million, but as high as $8 million.
Damages for pain and suffering often contribute to "runaway" jury verdicts. One indignant observer has written: "In making arguments for pain and suffering awards, both sides attempt to win the jurors’ sympathies with highly emotional evidence. A blind plaintiff will receive careful instruction to come to court with his seeing-eye dog, and to dab at his eyes with a handkerchief." Tort reform proposals regularly aim to cap these awards in the $250,000 range, such as California’s Medical Injury Compensation Reform Act. Some of these state statutes, including California’s, have survived constitutional challenge, whereas others, such as the recent Illinois reform statute, have not (Lebron v. Gottlieb Memorial Hospital).
In the past, the death of either party extinguished all claims. This concept has since been reformed to recognize "survival of the causes of action." In other words, the lawsuit is now considered an inheritable property right, surviving the plaintiff’s death and now residing in the estate of the deceased. It should properly be called a surviving personal injury action, abbreviated to "survival action." Survival action should be distinguished from a wrongful death action, which is brought by family members and dependents seeking monetary compensation for losses that the negligent death had caused them.
Lost profits may sometimes be recoverable in tort action if evidence warrants recovery, such as in the case of a plaintiff who is prevented from operating a business due to negligent acts of a physician. Likewise, recovery for pure mental suffering is also allowed in some jurisdictions, even if it is not accompanied by physical injury or impact. Courts tend to inquire into whether the injuries were foreseeable rather than the type of injuries, and in some jurisdictions, negligent infliction of emotional distress constitutes a separate and actionable tort.
To recover full damages, the plaintiff must take reasonable steps to mitigate his or her injury. This is also known as the "rule of avoidable consequences." It may be anticipatory, such as wearing a seat belt or crash helmet, or postdamage such as seeking and abiding by continuing medical care. This rule is different from the "Eggshell Skull Rule," which refers to the negligent defendant’s responsibility for all aggravated injuries resulting from a preexisting condition.
While malpractice damages are widely feared to breach the million dollar mark, this is only true in serious injuries, and the typical quantum is substantially lower. According to The Wall Street Journal (Nov. 30, 2004, p. A-1), statistics from various governmental sources indicate that the median payment for damages on behalf of physicians was $150,000, and the amount of healthcare spending accounted for by malpractice costs was 2%. Still, awards in some cases can be shocking. In Warren v. Schecter, a California jury awarded $1.8 million plus periodic payments for future care, totaling $9.6 million over 34 years. The plaintiff, a young woman, had developed gastrointestinal complications and multiple osteoporotic fractures following gastric surgery, and had to be fed a special diet through a feeding tube. The case was against a surgeon who failed to warn of the remote risk of metabolic bone disease following gastric surgery.
Dr. Tan is an emeritus professor at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. It is adapted from the author’s book, "Medical Malpractice: Understanding the Law, Managing the Risk." For additional information, readers may contact the author at [email protected].
Compensatory Damages
Question: A female patient who smokes suffered a cerebrovascular accident while taking an oral contraceptive. She successfully sued the doctor for failure to warn her about the risks associated with taking oral contraceptives and smoking. However, her neurological deficits would have been less disabling had she been compliant with intensive speech and physical therapy. In a claim for damages, which of the following is most accurate?
A. She is entitled to compensatory damages, that is, lost wages, medical expenses, pain and suffering, and hedonic damages.
B. By virtue of being a smoker, she is contributorily negligent, which can reduce or extinguish altogether any monetary award.
C. If the stroke had been fatal, her estate but not her dependants can claim damages on her behalf.
D. Compensatory damages will be unaffected, despite her noncompliance with rehabilitative care.
E. The twin reasons for compensatory damages are to make the victim "whole" and to punish the tortfeasor.
Answer: A. Since the plaintiff was not warned of the stroke risk of oral contraceptives or the heightened risk in smokers, it is unlikely she will be found to be contributorily negligent. A victim is required to mitigate his or her losses, and the medical noncompliance in this case will likely lead to a reduction in her award. In the case of a deceased patient, both the estate and the dependents can separately file a lawsuit, known as survival action and wrongful death action respectively. Choice A is best as it correctly describes compensatory damages, which are meant to return the victim to the preaccident status, but are not meant to be punitive.
In a tort action, "damages" refer to the money awarded to the injured plaintiff. It should be distinguished from the word "damage," which is a synonym for injury. Malpractice damages are of two sorts, compensatory damages and punitive damages (the latter will be discussed in a subsequent column). Compensatory damages can be further divided into two categories: Special, economic or pecuniary damages, including lost wages, medical expenses, out-of-pocket expenses, and other incidental expenses; and general, noneconomic, or nonpecuniary damages, which provide payments for pain and suffering, loss of consortium (loss of love, affection, society, sex, and household services), and lost or reduced enjoyment of life. This last item, called hedonic damages, is basically an expression of the dollar value of a life, determined by economists to be quantifiable at $1.5 million to $3.5 million, but as high as $8 million.
Damages for pain and suffering often contribute to "runaway" jury verdicts. One indignant observer has written: "In making arguments for pain and suffering awards, both sides attempt to win the jurors’ sympathies with highly emotional evidence. A blind plaintiff will receive careful instruction to come to court with his seeing-eye dog, and to dab at his eyes with a handkerchief." Tort reform proposals regularly aim to cap these awards in the $250,000 range, such as California’s Medical Injury Compensation Reform Act. Some of these state statutes, including California’s, have survived constitutional challenge, whereas others, such as the recent Illinois reform statute, have not (Lebron v. Gottlieb Memorial Hospital).
In the past, the death of either party extinguished all claims. This concept has since been reformed to recognize "survival of the causes of action." In other words, the lawsuit is now considered an inheritable property right, surviving the plaintiff’s death and now residing in the estate of the deceased. It should properly be called a surviving personal injury action, abbreviated to "survival action." Survival action should be distinguished from a wrongful death action, which is brought by family members and dependents seeking monetary compensation for losses that the negligent death had caused them.
Lost profits may sometimes be recoverable in tort action if evidence warrants recovery, such as in the case of a plaintiff who is prevented from operating a business due to negligent acts of a physician. Likewise, recovery for pure mental suffering is also allowed in some jurisdictions, even if it is not accompanied by physical injury or impact. Courts tend to inquire into whether the injuries were foreseeable rather than the type of injuries, and in some jurisdictions, negligent infliction of emotional distress constitutes a separate and actionable tort.
To recover full damages, the plaintiff must take reasonable steps to mitigate his or her injury. This is also known as the "rule of avoidable consequences." It may be anticipatory, such as wearing a seat belt or crash helmet, or postdamage such as seeking and abiding by continuing medical care. This rule is different from the "Eggshell Skull Rule," which refers to the negligent defendant’s responsibility for all aggravated injuries resulting from a preexisting condition.
While malpractice damages are widely feared to breach the million dollar mark, this is only true in serious injuries, and the typical quantum is substantially lower. According to The Wall Street Journal (Nov. 30, 2004, p. A-1), statistics from various governmental sources indicate that the median payment for damages on behalf of physicians was $150,000, and the amount of healthcare spending accounted for by malpractice costs was 2%. Still, awards in some cases can be shocking. In Warren v. Schecter, a California jury awarded $1.8 million plus periodic payments for future care, totaling $9.6 million over 34 years. The plaintiff, a young woman, had developed gastrointestinal complications and multiple osteoporotic fractures following gastric surgery, and had to be fed a special diet through a feeding tube. The case was against a surgeon who failed to warn of the remote risk of metabolic bone disease following gastric surgery.
Question: A female patient who smokes suffered a cerebrovascular accident while taking an oral contraceptive. She successfully sued the doctor for failure to warn her about the risks associated with taking oral contraceptives and smoking. However, her neurological deficits would have been less disabling had she been compliant with intensive speech and physical therapy. In a claim for damages, which of the following is most accurate?
A. She is entitled to compensatory damages, that is, lost wages, medical expenses, pain and suffering, and hedonic damages.
B. By virtue of being a smoker, she is contributorily negligent, which can reduce or extinguish altogether any monetary award.
C. If the stroke had been fatal, her estate but not her dependants can claim damages on her behalf.
D. Compensatory damages will be unaffected, despite her noncompliance with rehabilitative care.
E. The twin reasons for compensatory damages are to make the victim "whole" and to punish the tortfeasor.
Answer: A. Since the plaintiff was not warned of the stroke risk of oral contraceptives or the heightened risk in smokers, it is unlikely she will be found to be contributorily negligent. A victim is required to mitigate his or her losses, and the medical noncompliance in this case will likely lead to a reduction in her award. In the case of a deceased patient, both the estate and the dependents can separately file a lawsuit, known as survival action and wrongful death action respectively. Choice A is best as it correctly describes compensatory damages, which are meant to return the victim to the preaccident status, but are not meant to be punitive.
In a tort action, "damages" refer to the money awarded to the injured plaintiff. It should be distinguished from the word "damage," which is a synonym for injury. Malpractice damages are of two sorts, compensatory damages and punitive damages (the latter will be discussed in a subsequent column). Compensatory damages can be further divided into two categories: Special, economic or pecuniary damages, including lost wages, medical expenses, out-of-pocket expenses, and other incidental expenses; and general, noneconomic, or nonpecuniary damages, which provide payments for pain and suffering, loss of consortium (loss of love, affection, society, sex, and household services), and lost or reduced enjoyment of life. This last item, called hedonic damages, is basically an expression of the dollar value of a life, determined by economists to be quantifiable at $1.5 million to $3.5 million, but as high as $8 million.
Damages for pain and suffering often contribute to "runaway" jury verdicts. One indignant observer has written: "In making arguments for pain and suffering awards, both sides attempt to win the jurors’ sympathies with highly emotional evidence. A blind plaintiff will receive careful instruction to come to court with his seeing-eye dog, and to dab at his eyes with a handkerchief." Tort reform proposals regularly aim to cap these awards in the $250,000 range, such as California’s Medical Injury Compensation Reform Act. Some of these state statutes, including California’s, have survived constitutional challenge, whereas others, such as the recent Illinois reform statute, have not (Lebron v. Gottlieb Memorial Hospital).
In the past, the death of either party extinguished all claims. This concept has since been reformed to recognize "survival of the causes of action." In other words, the lawsuit is now considered an inheritable property right, surviving the plaintiff’s death and now residing in the estate of the deceased. It should properly be called a surviving personal injury action, abbreviated to "survival action." Survival action should be distinguished from a wrongful death action, which is brought by family members and dependents seeking monetary compensation for losses that the negligent death had caused them.
Lost profits may sometimes be recoverable in tort action if evidence warrants recovery, such as in the case of a plaintiff who is prevented from operating a business due to negligent acts of a physician. Likewise, recovery for pure mental suffering is also allowed in some jurisdictions, even if it is not accompanied by physical injury or impact. Courts tend to inquire into whether the injuries were foreseeable rather than the type of injuries, and in some jurisdictions, negligent infliction of emotional distress constitutes a separate and actionable tort.
To recover full damages, the plaintiff must take reasonable steps to mitigate his or her injury. This is also known as the "rule of avoidable consequences." It may be anticipatory, such as wearing a seat belt or crash helmet, or postdamage such as seeking and abiding by continuing medical care. This rule is different from the "Eggshell Skull Rule," which refers to the negligent defendant’s responsibility for all aggravated injuries resulting from a preexisting condition.
While malpractice damages are widely feared to breach the million dollar mark, this is only true in serious injuries, and the typical quantum is substantially lower. According to The Wall Street Journal (Nov. 30, 2004, p. A-1), statistics from various governmental sources indicate that the median payment for damages on behalf of physicians was $150,000, and the amount of healthcare spending accounted for by malpractice costs was 2%. Still, awards in some cases can be shocking. In Warren v. Schecter, a California jury awarded $1.8 million plus periodic payments for future care, totaling $9.6 million over 34 years. The plaintiff, a young woman, had developed gastrointestinal complications and multiple osteoporotic fractures following gastric surgery, and had to be fed a special diet through a feeding tube. The case was against a surgeon who failed to warn of the remote risk of metabolic bone disease following gastric surgery.
Question: A female patient who smokes suffered a cerebrovascular accident while taking an oral contraceptive. She successfully sued the doctor for failure to warn her about the risks associated with taking oral contraceptives and smoking. However, her neurological deficits would have been less disabling had she been compliant with intensive speech and physical therapy. In a claim for damages, which of the following is most accurate?
A. She is entitled to compensatory damages, that is, lost wages, medical expenses, pain and suffering, and hedonic damages.
B. By virtue of being a smoker, she is contributorily negligent, which can reduce or extinguish altogether any monetary award.
C. If the stroke had been fatal, her estate but not her dependants can claim damages on her behalf.
D. Compensatory damages will be unaffected, despite her noncompliance with rehabilitative care.
E. The twin reasons for compensatory damages are to make the victim "whole" and to punish the tortfeasor.
Answer: A. Since the plaintiff was not warned of the stroke risk of oral contraceptives or the heightened risk in smokers, it is unlikely she will be found to be contributorily negligent. A victim is required to mitigate his or her losses, and the medical noncompliance in this case will likely lead to a reduction in her award. In the case of a deceased patient, both the estate and the dependents can separately file a lawsuit, known as survival action and wrongful death action respectively. Choice A is best as it correctly describes compensatory damages, which are meant to return the victim to the preaccident status, but are not meant to be punitive.
In a tort action, "damages" refer to the money awarded to the injured plaintiff. It should be distinguished from the word "damage," which is a synonym for injury. Malpractice damages are of two sorts, compensatory damages and punitive damages (the latter will be discussed in a subsequent column). Compensatory damages can be further divided into two categories: Special, economic or pecuniary damages, including lost wages, medical expenses, out-of-pocket expenses, and other incidental expenses; and general, noneconomic, or nonpecuniary damages, which provide payments for pain and suffering, loss of consortium (loss of love, affection, society, sex, and household services), and lost or reduced enjoyment of life. This last item, called hedonic damages, is basically an expression of the dollar value of a life, determined by economists to be quantifiable at $1.5 million to $3.5 million, but as high as $8 million.
Damages for pain and suffering often contribute to "runaway" jury verdicts. One indignant observer has written: "In making arguments for pain and suffering awards, both sides attempt to win the jurors’ sympathies with highly emotional evidence. A blind plaintiff will receive careful instruction to come to court with his seeing-eye dog, and to dab at his eyes with a handkerchief." Tort reform proposals regularly aim to cap these awards in the $250,000 range, such as California’s Medical Injury Compensation Reform Act. Some of these state statutes, including California’s, have survived constitutional challenge, whereas others, such as the recent Illinois reform statute, have not (Lebron v. Gottlieb Memorial Hospital).
In the past, the death of either party extinguished all claims. This concept has since been reformed to recognize "survival of the causes of action." In other words, the lawsuit is now considered an inheritable property right, surviving the plaintiff’s death and now residing in the estate of the deceased. It should properly be called a surviving personal injury action, abbreviated to "survival action." Survival action should be distinguished from a wrongful death action, which is brought by family members and dependents seeking monetary compensation for losses that the negligent death had caused them.
Lost profits may sometimes be recoverable in tort action if evidence warrants recovery, such as in the case of a plaintiff who is prevented from operating a business due to negligent acts of a physician. Likewise, recovery for pure mental suffering is also allowed in some jurisdictions, even if it is not accompanied by physical injury or impact. Courts tend to inquire into whether the injuries were foreseeable rather than the type of injuries, and in some jurisdictions, negligent infliction of emotional distress constitutes a separate and actionable tort.
To recover full damages, the plaintiff must take reasonable steps to mitigate his or her injury. This is also known as the "rule of avoidable consequences." It may be anticipatory, such as wearing a seat belt or crash helmet, or postdamage such as seeking and abiding by continuing medical care. This rule is different from the "Eggshell Skull Rule," which refers to the negligent defendant’s responsibility for all aggravated injuries resulting from a preexisting condition.
While malpractice damages are widely feared to breach the million dollar mark, this is only true in serious injuries, and the typical quantum is substantially lower. According to The Wall Street Journal (Nov. 30, 2004, p. A-1), statistics from various governmental sources indicate that the median payment for damages on behalf of physicians was $150,000, and the amount of healthcare spending accounted for by malpractice costs was 2%. Still, awards in some cases can be shocking. In Warren v. Schecter, a California jury awarded $1.8 million plus periodic payments for future care, totaling $9.6 million over 34 years. The plaintiff, a young woman, had developed gastrointestinal complications and multiple osteoporotic fractures following gastric surgery, and had to be fed a special diet through a feeding tube. The case was against a surgeon who failed to warn of the remote risk of metabolic bone disease following gastric surgery.
A Lowered Bedrail Results in Grave Consequences
Patient unaware of abnormal scans until it was too late ... For want of steroids, sight is lost ... more
Patient unaware of abnormal scans until it was too late
A COMPUTED TOMOGRAPHY (CT) SCAN of a patient’s chest ordered by his physician revealed a cancerous nodule on the right lung. The physician’s office received the report but didn’t notify the patient of the finding. Nor was the patient informed of the CT report during a visit to the physician 2 months later, or during several visits the following year.
A second CT scan a year after the first showed a larger cancerous area in the lung. The patient and his wife went to the physician several days after the scan to discuss the results. While reviewing the patient’s chart, the doctor asked how long the man had been his patient and said, “We should have been on this a year ago.” He then left the office, and the building, without speaking further to the patient or his wife or explaining his departure. The patient tried unsuccessfully to get a copy of his medical records from the practice.
Two months later, the patient went to the emergency department (ED) with abdominal pain, shortness of breath, and dizziness. He was diagnosed with stage 4 lung cancer. The patient died about 7 weeks later.
PLAINTIFF’S CLAIM No information about the plaintiff’s claim is available.
THE DEFENSE No information about the defense is available.
VERDICT $1 million South Carolina settlement.
COMMENT Fail-safes to assure the appropriate communication of abnormal test results are essential. I was pleased when my personal physician called recently concerning an abnormal lab test; too often timely communication doesn’t occur.
A cystic mass, then breast cancer
AFTER 6 MONTHS OF BREAST PAIN that became worse during menses, a 36-year-old woman, who had recently come to the United States from Iraq, consulted her family physician. The physician had been recommended because she was female, as the patient had requested, and, like the patient, was Iraqi.
The physician palpated the right breast and documented cystic fullness with no discrete masses or axillary nodes. She ordered a screening mammogram but was told by a radiologist that a 36-year-old woman could have screening mammography only if a mass was present. The physician changed the order to a diagnostic mammogram for a painful cystic mass. At the time of the mammogram, the patient told the technician that the lump came and went with her menstrual period. The results were reported as normal.
The physician continued to see the patient over the next 3 years for various health issues. At the patient’s final visit, the physician performed a clinical breast exam, which she documented as negative. The patient claimed that the physician hadn’t done any follow-up related to the right breast between her first visit and the final breast exam 3 years later.
Two years afterward, the now 41-year-old patient was diagnosed with cancer in her right breast after a mammogram, ultrasound, and biopsy. According to records at the hospital where she received the diagnosis, she’d discovered the lump 3 months earlier. The patient underwent a right mastectomy with chemotherapy and radiation and was cancer-free at the time of the trial.
PLAINTIFF’S CLAIM An ultrasound and biopsy should have been performed when the patient first consulted the family physician. The family physician didn’t perform any follow-up on the right breast until 3 years after she diagnosed the cystic fullness.
THE DEFENSE The family physician claimed that she tried twice to perform breast examinations during office visits in the 3 years she saw the patient, but the patient refused. The claim wasn’t documented. The patient’s cancer didn’t become palpable until after she left the doctor’s care. She had a fast-growing tumor, and the location of the cancerous mass differed from the area of cystic fullness the doctor originally discovered.
VERDICT $500,000 Illinois verdict.
COMMENT Failure to diagnose breast cancer continues to be a frequent and vexing allegation. Better documentation and follow-up could help obviate many of these claims.
For want of steroids, sight is lost
A 78-YEAR-OLD MAN was diagnosed with polymyalgia rheumatica (painful inflammation of the arteries, usually in the shoulders and hips) by his longtime primary care physician. The doctor treated the condition with low-dose steroids and monitored the patient’s erythrocyte sedimentation rate and C-reactive protein.
Two years after diagnosis, the patient complained to the physician of jaw pain and transient vision loss in the left eye. Three days later, he called the doctor to say that he had developed a headache. The physician lowered the steroid dosage but didn’t order blood tests or a biopsy. The following day the patient woke up and discovered he’d gone blind.
PLAINTIFF’S CLAIM The patient had giant cell arteritis and should have been treated with high-dose steroids. Starting treatment even one day earlier would have prevented blindness.
THE DEFENSE No information about the defense is available.
VERDICT $3 million Washington settlement.
COMMENT Timely diagnosis and appropriate treatment of temporal arteritis remain essential.
Sudden chest pain, sudden death, but not the usual suspects
SUDDEN ONSET OF CHEST PAIN brought a 41-year-old woman to the ED. Results of an electrocardiogram, chest radiograph, and lab tests were all normal. While in the ED, the patient developed diarrhea and was diagnosed with a gastrointestinal bleed.
She was admitted to the hospital, but no bed was available, so she remained in the ED, where she was found dead 7 hours later. Autopsy revealed a type A dissecting aorta to the level of the renal arteries.
PLAINTIFF’S CLAIM The ED physician failed to rule out all potential life-threatening causes of the chest pain and didn’t order a CT scan, which would have showed the aortic dissection.
DOCTOR’S DEFENSE Aortic dissection is a rare condition; the patient didn’t fit the profile of an individual at risk. A chest radiograph almost always reveals such abnormalities; no duty existed to rule out aortic dissection.
VERDICT $1.4 million Ohio verdict.
COMMENT Even though the details of this case are sketchy—and any death is a tragedy—I can’t help but sympathize with the defendant. While as physicians we should not chase zebras, we still have to consider the possibility of rare conditions.
Misdiagnosed cold foot leads to amputation
NUMBNESS IN HER RIGHT FOOT prompted 2 visits to the emergency department by a woman in her early 40s. The foot was cold and discolored. By the second visit, the patient was screaming with pain. A sprain was diagnosed without consulting a vascular surgeon, and the patient was sent home.
Ten days later, the patient had a computed tomography scan at another hospital, which found a blockage of the popliteal artery. Her right leg was amputated below the knee the following day and she was fitted with a prosthesis.
PLAINTIFF’S CLAIM No information about the plaintiff’s claim is available.
THE DEFENSE No information about the defense is available.
VERDICT $1.25 million New Jersey settlement.
COMMENT I have seen a rash of cases in which peripheral vascular disease was inappropriately diagnosed. One wonders how an alert clinician could miss vascular disease and diagnose a sprain when faced with pain and a cold discolored foot.
Patient unaware of abnormal scans until it was too late
A COMPUTED TOMOGRAPHY (CT) SCAN of a patient’s chest ordered by his physician revealed a cancerous nodule on the right lung. The physician’s office received the report but didn’t notify the patient of the finding. Nor was the patient informed of the CT report during a visit to the physician 2 months later, or during several visits the following year.
A second CT scan a year after the first showed a larger cancerous area in the lung. The patient and his wife went to the physician several days after the scan to discuss the results. While reviewing the patient’s chart, the doctor asked how long the man had been his patient and said, “We should have been on this a year ago.” He then left the office, and the building, without speaking further to the patient or his wife or explaining his departure. The patient tried unsuccessfully to get a copy of his medical records from the practice.
Two months later, the patient went to the emergency department (ED) with abdominal pain, shortness of breath, and dizziness. He was diagnosed with stage 4 lung cancer. The patient died about 7 weeks later.
PLAINTIFF’S CLAIM No information about the plaintiff’s claim is available.
THE DEFENSE No information about the defense is available.
VERDICT $1 million South Carolina settlement.
COMMENT Fail-safes to assure the appropriate communication of abnormal test results are essential. I was pleased when my personal physician called recently concerning an abnormal lab test; too often timely communication doesn’t occur.
A cystic mass, then breast cancer
AFTER 6 MONTHS OF BREAST PAIN that became worse during menses, a 36-year-old woman, who had recently come to the United States from Iraq, consulted her family physician. The physician had been recommended because she was female, as the patient had requested, and, like the patient, was Iraqi.
The physician palpated the right breast and documented cystic fullness with no discrete masses or axillary nodes. She ordered a screening mammogram but was told by a radiologist that a 36-year-old woman could have screening mammography only if a mass was present. The physician changed the order to a diagnostic mammogram for a painful cystic mass. At the time of the mammogram, the patient told the technician that the lump came and went with her menstrual period. The results were reported as normal.
The physician continued to see the patient over the next 3 years for various health issues. At the patient’s final visit, the physician performed a clinical breast exam, which she documented as negative. The patient claimed that the physician hadn’t done any follow-up related to the right breast between her first visit and the final breast exam 3 years later.
Two years afterward, the now 41-year-old patient was diagnosed with cancer in her right breast after a mammogram, ultrasound, and biopsy. According to records at the hospital where she received the diagnosis, she’d discovered the lump 3 months earlier. The patient underwent a right mastectomy with chemotherapy and radiation and was cancer-free at the time of the trial.
PLAINTIFF’S CLAIM An ultrasound and biopsy should have been performed when the patient first consulted the family physician. The family physician didn’t perform any follow-up on the right breast until 3 years after she diagnosed the cystic fullness.
THE DEFENSE The family physician claimed that she tried twice to perform breast examinations during office visits in the 3 years she saw the patient, but the patient refused. The claim wasn’t documented. The patient’s cancer didn’t become palpable until after she left the doctor’s care. She had a fast-growing tumor, and the location of the cancerous mass differed from the area of cystic fullness the doctor originally discovered.
VERDICT $500,000 Illinois verdict.
COMMENT Failure to diagnose breast cancer continues to be a frequent and vexing allegation. Better documentation and follow-up could help obviate many of these claims.
For want of steroids, sight is lost
A 78-YEAR-OLD MAN was diagnosed with polymyalgia rheumatica (painful inflammation of the arteries, usually in the shoulders and hips) by his longtime primary care physician. The doctor treated the condition with low-dose steroids and monitored the patient’s erythrocyte sedimentation rate and C-reactive protein.
Two years after diagnosis, the patient complained to the physician of jaw pain and transient vision loss in the left eye. Three days later, he called the doctor to say that he had developed a headache. The physician lowered the steroid dosage but didn’t order blood tests or a biopsy. The following day the patient woke up and discovered he’d gone blind.
PLAINTIFF’S CLAIM The patient had giant cell arteritis and should have been treated with high-dose steroids. Starting treatment even one day earlier would have prevented blindness.
THE DEFENSE No information about the defense is available.
VERDICT $3 million Washington settlement.
COMMENT Timely diagnosis and appropriate treatment of temporal arteritis remain essential.
Sudden chest pain, sudden death, but not the usual suspects
SUDDEN ONSET OF CHEST PAIN brought a 41-year-old woman to the ED. Results of an electrocardiogram, chest radiograph, and lab tests were all normal. While in the ED, the patient developed diarrhea and was diagnosed with a gastrointestinal bleed.
She was admitted to the hospital, but no bed was available, so she remained in the ED, where she was found dead 7 hours later. Autopsy revealed a type A dissecting aorta to the level of the renal arteries.
PLAINTIFF’S CLAIM The ED physician failed to rule out all potential life-threatening causes of the chest pain and didn’t order a CT scan, which would have showed the aortic dissection.
DOCTOR’S DEFENSE Aortic dissection is a rare condition; the patient didn’t fit the profile of an individual at risk. A chest radiograph almost always reveals such abnormalities; no duty existed to rule out aortic dissection.
VERDICT $1.4 million Ohio verdict.
COMMENT Even though the details of this case are sketchy—and any death is a tragedy—I can’t help but sympathize with the defendant. While as physicians we should not chase zebras, we still have to consider the possibility of rare conditions.
Misdiagnosed cold foot leads to amputation
NUMBNESS IN HER RIGHT FOOT prompted 2 visits to the emergency department by a woman in her early 40s. The foot was cold and discolored. By the second visit, the patient was screaming with pain. A sprain was diagnosed without consulting a vascular surgeon, and the patient was sent home.
Ten days later, the patient had a computed tomography scan at another hospital, which found a blockage of the popliteal artery. Her right leg was amputated below the knee the following day and she was fitted with a prosthesis.
PLAINTIFF’S CLAIM No information about the plaintiff’s claim is available.
THE DEFENSE No information about the defense is available.
VERDICT $1.25 million New Jersey settlement.
COMMENT I have seen a rash of cases in which peripheral vascular disease was inappropriately diagnosed. One wonders how an alert clinician could miss vascular disease and diagnose a sprain when faced with pain and a cold discolored foot.
Patient unaware of abnormal scans until it was too late
A COMPUTED TOMOGRAPHY (CT) SCAN of a patient’s chest ordered by his physician revealed a cancerous nodule on the right lung. The physician’s office received the report but didn’t notify the patient of the finding. Nor was the patient informed of the CT report during a visit to the physician 2 months later, or during several visits the following year.
A second CT scan a year after the first showed a larger cancerous area in the lung. The patient and his wife went to the physician several days after the scan to discuss the results. While reviewing the patient’s chart, the doctor asked how long the man had been his patient and said, “We should have been on this a year ago.” He then left the office, and the building, without speaking further to the patient or his wife or explaining his departure. The patient tried unsuccessfully to get a copy of his medical records from the practice.
Two months later, the patient went to the emergency department (ED) with abdominal pain, shortness of breath, and dizziness. He was diagnosed with stage 4 lung cancer. The patient died about 7 weeks later.
PLAINTIFF’S CLAIM No information about the plaintiff’s claim is available.
THE DEFENSE No information about the defense is available.
VERDICT $1 million South Carolina settlement.
COMMENT Fail-safes to assure the appropriate communication of abnormal test results are essential. I was pleased when my personal physician called recently concerning an abnormal lab test; too often timely communication doesn’t occur.
A cystic mass, then breast cancer
AFTER 6 MONTHS OF BREAST PAIN that became worse during menses, a 36-year-old woman, who had recently come to the United States from Iraq, consulted her family physician. The physician had been recommended because she was female, as the patient had requested, and, like the patient, was Iraqi.
The physician palpated the right breast and documented cystic fullness with no discrete masses or axillary nodes. She ordered a screening mammogram but was told by a radiologist that a 36-year-old woman could have screening mammography only if a mass was present. The physician changed the order to a diagnostic mammogram for a painful cystic mass. At the time of the mammogram, the patient told the technician that the lump came and went with her menstrual period. The results were reported as normal.
The physician continued to see the patient over the next 3 years for various health issues. At the patient’s final visit, the physician performed a clinical breast exam, which she documented as negative. The patient claimed that the physician hadn’t done any follow-up related to the right breast between her first visit and the final breast exam 3 years later.
Two years afterward, the now 41-year-old patient was diagnosed with cancer in her right breast after a mammogram, ultrasound, and biopsy. According to records at the hospital where she received the diagnosis, she’d discovered the lump 3 months earlier. The patient underwent a right mastectomy with chemotherapy and radiation and was cancer-free at the time of the trial.
PLAINTIFF’S CLAIM An ultrasound and biopsy should have been performed when the patient first consulted the family physician. The family physician didn’t perform any follow-up on the right breast until 3 years after she diagnosed the cystic fullness.
THE DEFENSE The family physician claimed that she tried twice to perform breast examinations during office visits in the 3 years she saw the patient, but the patient refused. The claim wasn’t documented. The patient’s cancer didn’t become palpable until after she left the doctor’s care. She had a fast-growing tumor, and the location of the cancerous mass differed from the area of cystic fullness the doctor originally discovered.
VERDICT $500,000 Illinois verdict.
COMMENT Failure to diagnose breast cancer continues to be a frequent and vexing allegation. Better documentation and follow-up could help obviate many of these claims.
For want of steroids, sight is lost
A 78-YEAR-OLD MAN was diagnosed with polymyalgia rheumatica (painful inflammation of the arteries, usually in the shoulders and hips) by his longtime primary care physician. The doctor treated the condition with low-dose steroids and monitored the patient’s erythrocyte sedimentation rate and C-reactive protein.
Two years after diagnosis, the patient complained to the physician of jaw pain and transient vision loss in the left eye. Three days later, he called the doctor to say that he had developed a headache. The physician lowered the steroid dosage but didn’t order blood tests or a biopsy. The following day the patient woke up and discovered he’d gone blind.
PLAINTIFF’S CLAIM The patient had giant cell arteritis and should have been treated with high-dose steroids. Starting treatment even one day earlier would have prevented blindness.
THE DEFENSE No information about the defense is available.
VERDICT $3 million Washington settlement.
COMMENT Timely diagnosis and appropriate treatment of temporal arteritis remain essential.
Sudden chest pain, sudden death, but not the usual suspects
SUDDEN ONSET OF CHEST PAIN brought a 41-year-old woman to the ED. Results of an electrocardiogram, chest radiograph, and lab tests were all normal. While in the ED, the patient developed diarrhea and was diagnosed with a gastrointestinal bleed.
She was admitted to the hospital, but no bed was available, so she remained in the ED, where she was found dead 7 hours later. Autopsy revealed a type A dissecting aorta to the level of the renal arteries.
PLAINTIFF’S CLAIM The ED physician failed to rule out all potential life-threatening causes of the chest pain and didn’t order a CT scan, which would have showed the aortic dissection.
DOCTOR’S DEFENSE Aortic dissection is a rare condition; the patient didn’t fit the profile of an individual at risk. A chest radiograph almost always reveals such abnormalities; no duty existed to rule out aortic dissection.
VERDICT $1.4 million Ohio verdict.
COMMENT Even though the details of this case are sketchy—and any death is a tragedy—I can’t help but sympathize with the defendant. While as physicians we should not chase zebras, we still have to consider the possibility of rare conditions.
Misdiagnosed cold foot leads to amputation
NUMBNESS IN HER RIGHT FOOT prompted 2 visits to the emergency department by a woman in her early 40s. The foot was cold and discolored. By the second visit, the patient was screaming with pain. A sprain was diagnosed without consulting a vascular surgeon, and the patient was sent home.
Ten days later, the patient had a computed tomography scan at another hospital, which found a blockage of the popliteal artery. Her right leg was amputated below the knee the following day and she was fitted with a prosthesis.
PLAINTIFF’S CLAIM No information about the plaintiff’s claim is available.
THE DEFENSE No information about the defense is available.
VERDICT $1.25 million New Jersey settlement.
COMMENT I have seen a rash of cases in which peripheral vascular disease was inappropriately diagnosed. One wonders how an alert clinician could miss vascular disease and diagnose a sprain when faced with pain and a cold discolored foot.
Clinical Innovation
Question: Intending to help an elderly patient suffering from dementia and Parkinsonism, a neurologist applied a series of therapeutic ultrasound treatments to her head. The patient had seen other neurologists previously, but their conventional measures were ineffective. The neurologist had used the novel method in the past, and claims it had been safe and effective. The medical literature contains only a few anecdotal reports on such use. Assuming the patient experienced no harm, but derived no benefit from the new treatment, which of the following statements is most accurate?
A. The treatment method is best characterized as clinical innovation.
B. Clinical innovation, like human experimentation, can help advance medical progress.
C. Intended patient benefit, clear safety, and informed consent are minimum requirements when the use of novel diagnostic or therapeutic modalities is considered.
D. The physician cannot be successfully sued because no harm came to patient.
E. All are correct.
Answer: E. This hypothetical is adapted from an actual case in Singapore in which the court ruled in favor of the treating neurologist. In striking the balance between inhibiting novel approaches that benefit patients vs. exposing patients to unwarranted risk, U.S. courts have occasionally allowed innovation, even though by definition it represents a departure from a customary or acceptable standard. However, clinical innovation can place a patient at risk for injuries, and can invite medical malpractice lawsuits and state medical board investigations into professional misconduct. It is definitely not something a clinician should indulge in casually or carelessly.
In medical experimentation, which typically takes the form of clinical trials, efficacy is still unproven, and any potential benefit is directed at future patients, not those being studied who may be on a standard drug or even a placebo. Accordingly, the courts tend to demand a higher standard of care, especially in regard to disclosure of risks. Investigators also are obligated to obtain prior approval from an institutional review board that is governed by the Food and Drug Administration and Department of Health and Human Services. Clinical innovation, on the other hand, is usually within the doctor-patient relationship, and refers to the use of a testing or treatment method that is not generally in use or accepted by peers, but whose intent is to benefit a particular patient based on published data or experience of efficacy and safety.
In Brook v. St .John’s Hickey Memorial Hospital (380 N.E. 2d 72 [Ind. 1978]), a radiologist injected contrast dye intramuscularly into the calves of a 23-month-old infant after he was unable to locate a vein for intravenous administration. He had successfully done this in the past because there were reports that use of the recommended sites (the buttocks or thighs) had met with occasional adverse results. The patient subsequently developed a shortening of the Achilles tendon that was arguably related to the injection. The court declined to characterize the technique as a medical experiment or find the defendant negligent in choosing an injection site that had not been specifically recommended by the medical community. The court wrote that "too often courts have confused judgmental decisions and experimentation. Therapeutic innovation has long been recognized as permissible to avoid serious consequences. The everyday practice of medicine involves constant judgmental decisions by physicians as they move from one patient to another in the conscious institution of procedures, special tests, trials and observations recognized generally by their profession as effective in treating the patient or providing a diagnosis of a diseased condition. Each patient presents a slightly different problem to the doctor. A physician is presumed to have the knowledge and skill necessary to use some innovation to fit the peculiar circumstances of each case."
When the patient’s condition is critical or terminal, or when usual measures have failed, an innovative or even experimental approach may be the only option. Such a case was Karp v. Cooley (493 F.2d 408 [5th Cir. 1974]), in which Dr. Denton Cooley, a well-known cardiac surgeon, transplanted a mechanical heart for the first time to save a patient who was dying from heart failure. There was no evidence that the patient’s treatment was other than therapeutic, and fully informed consent was obtained for all aspects of the novel surgery. The patient died within 3 days following transplant surgery. In the wrongful death suit that followed, the court, relying on conventional malpractice evidentiary standards, ruled in favor of Dr. Cooley on the issue of experimentation.
Sometimes a so-called "innovative" treatment stems from the doctor’s inexperience and poor judgment. In Felice v. Valleylab (520 So.2d 920 [La. 1987]), two medical trainees negligently used an electrosurgical unit to perform a circumcision on a child, burning and destroying his penis in the process. They had been trained in – but chose not to use – the time-tested surgical technique with a scalpel. The court ruled that the doctors were negligent, as they had used an unorthodox technique without reading the manual or the warning label on the device. In Edenfield v. Vahid (621 So.2d 1192 [La. 1993]), the court found a surgeon liable for his use of a polypropylene nonabsorbable suture during an anal fistulectomy operation. A medical review panel concluded that nonresorbable sutures were inappropriate in the anorectal area because they predisposed the wound to infection. The court held that it was more probable than not that the patient’s injuries were caused by the doctor’s improper choice of suture.
Physicians should tread cautiously when considering novel and unproven modalities. Depending on the facts and circumstances, a doctor’s unorthodox use of drugs, devices, or complementary and alternative medicine may be deemed to be below the standard of care and thus may invite state disciplinary investigation and/or civil action.
Question: Intending to help an elderly patient suffering from dementia and Parkinsonism, a neurologist applied a series of therapeutic ultrasound treatments to her head. The patient had seen other neurologists previously, but their conventional measures were ineffective. The neurologist had used the novel method in the past, and claims it had been safe and effective. The medical literature contains only a few anecdotal reports on such use. Assuming the patient experienced no harm, but derived no benefit from the new treatment, which of the following statements is most accurate?
A. The treatment method is best characterized as clinical innovation.
B. Clinical innovation, like human experimentation, can help advance medical progress.
C. Intended patient benefit, clear safety, and informed consent are minimum requirements when the use of novel diagnostic or therapeutic modalities is considered.
D. The physician cannot be successfully sued because no harm came to patient.
E. All are correct.
Answer: E. This hypothetical is adapted from an actual case in Singapore in which the court ruled in favor of the treating neurologist. In striking the balance between inhibiting novel approaches that benefit patients vs. exposing patients to unwarranted risk, U.S. courts have occasionally allowed innovation, even though by definition it represents a departure from a customary or acceptable standard. However, clinical innovation can place a patient at risk for injuries, and can invite medical malpractice lawsuits and state medical board investigations into professional misconduct. It is definitely not something a clinician should indulge in casually or carelessly.
In medical experimentation, which typically takes the form of clinical trials, efficacy is still unproven, and any potential benefit is directed at future patients, not those being studied who may be on a standard drug or even a placebo. Accordingly, the courts tend to demand a higher standard of care, especially in regard to disclosure of risks. Investigators also are obligated to obtain prior approval from an institutional review board that is governed by the Food and Drug Administration and Department of Health and Human Services. Clinical innovation, on the other hand, is usually within the doctor-patient relationship, and refers to the use of a testing or treatment method that is not generally in use or accepted by peers, but whose intent is to benefit a particular patient based on published data or experience of efficacy and safety.
In Brook v. St .John’s Hickey Memorial Hospital (380 N.E. 2d 72 [Ind. 1978]), a radiologist injected contrast dye intramuscularly into the calves of a 23-month-old infant after he was unable to locate a vein for intravenous administration. He had successfully done this in the past because there were reports that use of the recommended sites (the buttocks or thighs) had met with occasional adverse results. The patient subsequently developed a shortening of the Achilles tendon that was arguably related to the injection. The court declined to characterize the technique as a medical experiment or find the defendant negligent in choosing an injection site that had not been specifically recommended by the medical community. The court wrote that "too often courts have confused judgmental decisions and experimentation. Therapeutic innovation has long been recognized as permissible to avoid serious consequences. The everyday practice of medicine involves constant judgmental decisions by physicians as they move from one patient to another in the conscious institution of procedures, special tests, trials and observations recognized generally by their profession as effective in treating the patient or providing a diagnosis of a diseased condition. Each patient presents a slightly different problem to the doctor. A physician is presumed to have the knowledge and skill necessary to use some innovation to fit the peculiar circumstances of each case."
When the patient’s condition is critical or terminal, or when usual measures have failed, an innovative or even experimental approach may be the only option. Such a case was Karp v. Cooley (493 F.2d 408 [5th Cir. 1974]), in which Dr. Denton Cooley, a well-known cardiac surgeon, transplanted a mechanical heart for the first time to save a patient who was dying from heart failure. There was no evidence that the patient’s treatment was other than therapeutic, and fully informed consent was obtained for all aspects of the novel surgery. The patient died within 3 days following transplant surgery. In the wrongful death suit that followed, the court, relying on conventional malpractice evidentiary standards, ruled in favor of Dr. Cooley on the issue of experimentation.
Sometimes a so-called "innovative" treatment stems from the doctor’s inexperience and poor judgment. In Felice v. Valleylab (520 So.2d 920 [La. 1987]), two medical trainees negligently used an electrosurgical unit to perform a circumcision on a child, burning and destroying his penis in the process. They had been trained in – but chose not to use – the time-tested surgical technique with a scalpel. The court ruled that the doctors were negligent, as they had used an unorthodox technique without reading the manual or the warning label on the device. In Edenfield v. Vahid (621 So.2d 1192 [La. 1993]), the court found a surgeon liable for his use of a polypropylene nonabsorbable suture during an anal fistulectomy operation. A medical review panel concluded that nonresorbable sutures were inappropriate in the anorectal area because they predisposed the wound to infection. The court held that it was more probable than not that the patient’s injuries were caused by the doctor’s improper choice of suture.
Physicians should tread cautiously when considering novel and unproven modalities. Depending on the facts and circumstances, a doctor’s unorthodox use of drugs, devices, or complementary and alternative medicine may be deemed to be below the standard of care and thus may invite state disciplinary investigation and/or civil action.
Question: Intending to help an elderly patient suffering from dementia and Parkinsonism, a neurologist applied a series of therapeutic ultrasound treatments to her head. The patient had seen other neurologists previously, but their conventional measures were ineffective. The neurologist had used the novel method in the past, and claims it had been safe and effective. The medical literature contains only a few anecdotal reports on such use. Assuming the patient experienced no harm, but derived no benefit from the new treatment, which of the following statements is most accurate?
A. The treatment method is best characterized as clinical innovation.
B. Clinical innovation, like human experimentation, can help advance medical progress.
C. Intended patient benefit, clear safety, and informed consent are minimum requirements when the use of novel diagnostic or therapeutic modalities is considered.
D. The physician cannot be successfully sued because no harm came to patient.
E. All are correct.
Answer: E. This hypothetical is adapted from an actual case in Singapore in which the court ruled in favor of the treating neurologist. In striking the balance between inhibiting novel approaches that benefit patients vs. exposing patients to unwarranted risk, U.S. courts have occasionally allowed innovation, even though by definition it represents a departure from a customary or acceptable standard. However, clinical innovation can place a patient at risk for injuries, and can invite medical malpractice lawsuits and state medical board investigations into professional misconduct. It is definitely not something a clinician should indulge in casually or carelessly.
In medical experimentation, which typically takes the form of clinical trials, efficacy is still unproven, and any potential benefit is directed at future patients, not those being studied who may be on a standard drug or even a placebo. Accordingly, the courts tend to demand a higher standard of care, especially in regard to disclosure of risks. Investigators also are obligated to obtain prior approval from an institutional review board that is governed by the Food and Drug Administration and Department of Health and Human Services. Clinical innovation, on the other hand, is usually within the doctor-patient relationship, and refers to the use of a testing or treatment method that is not generally in use or accepted by peers, but whose intent is to benefit a particular patient based on published data or experience of efficacy and safety.
In Brook v. St .John’s Hickey Memorial Hospital (380 N.E. 2d 72 [Ind. 1978]), a radiologist injected contrast dye intramuscularly into the calves of a 23-month-old infant after he was unable to locate a vein for intravenous administration. He had successfully done this in the past because there were reports that use of the recommended sites (the buttocks or thighs) had met with occasional adverse results. The patient subsequently developed a shortening of the Achilles tendon that was arguably related to the injection. The court declined to characterize the technique as a medical experiment or find the defendant negligent in choosing an injection site that had not been specifically recommended by the medical community. The court wrote that "too often courts have confused judgmental decisions and experimentation. Therapeutic innovation has long been recognized as permissible to avoid serious consequences. The everyday practice of medicine involves constant judgmental decisions by physicians as they move from one patient to another in the conscious institution of procedures, special tests, trials and observations recognized generally by their profession as effective in treating the patient or providing a diagnosis of a diseased condition. Each patient presents a slightly different problem to the doctor. A physician is presumed to have the knowledge and skill necessary to use some innovation to fit the peculiar circumstances of each case."
When the patient’s condition is critical or terminal, or when usual measures have failed, an innovative or even experimental approach may be the only option. Such a case was Karp v. Cooley (493 F.2d 408 [5th Cir. 1974]), in which Dr. Denton Cooley, a well-known cardiac surgeon, transplanted a mechanical heart for the first time to save a patient who was dying from heart failure. There was no evidence that the patient’s treatment was other than therapeutic, and fully informed consent was obtained for all aspects of the novel surgery. The patient died within 3 days following transplant surgery. In the wrongful death suit that followed, the court, relying on conventional malpractice evidentiary standards, ruled in favor of Dr. Cooley on the issue of experimentation.
Sometimes a so-called "innovative" treatment stems from the doctor’s inexperience and poor judgment. In Felice v. Valleylab (520 So.2d 920 [La. 1987]), two medical trainees negligently used an electrosurgical unit to perform a circumcision on a child, burning and destroying his penis in the process. They had been trained in – but chose not to use – the time-tested surgical technique with a scalpel. The court ruled that the doctors were negligent, as they had used an unorthodox technique without reading the manual or the warning label on the device. In Edenfield v. Vahid (621 So.2d 1192 [La. 1993]), the court found a surgeon liable for his use of a polypropylene nonabsorbable suture during an anal fistulectomy operation. A medical review panel concluded that nonresorbable sutures were inappropriate in the anorectal area because they predisposed the wound to infection. The court held that it was more probable than not that the patient’s injuries were caused by the doctor’s improper choice of suture.
Physicians should tread cautiously when considering novel and unproven modalities. Depending on the facts and circumstances, a doctor’s unorthodox use of drugs, devices, or complementary and alternative medicine may be deemed to be below the standard of care and thus may invite state disciplinary investigation and/or civil action.
Clinical Innovation
Question: Intending to help an elderly patient suffering from dementia and Parkinsonism, a neurologist applied a series of therapeutic ultrasound treatments to her head. The patient had seen other neurologists previously, but their conventional measures were ineffective. The neurologist had used the novel method in the past, and claims it had been safe and effective. The medical literature contains only a few anecdotal reports on such use. Assuming the patient experienced no harm, but derived no benefit from the new treatment, which of the following statements is most accurate?
A. The treatment method is best characterized as clinical innovation.
B. Clinical innovation, like human experimentation, can help advance medical progress.
C. Intended patient benefit, clear safety, and informed consent are minimum requirements when the use of novel diagnostic or therapeutic modalities is considered.
D. The physician cannot be successfully sued because no harm came to patient.
E. All are correct.
Answer: E. This hypothetical is adapted from an actual case in Singapore in which the court ruled in favor of the treating neurologist. In striking the balance between inhibiting novel approaches that benefit patients vs. exposing patients to unwarranted risk, U.S. courts have occasionally allowed innovation, even though by definition it represents a departure from a customary or acceptable standard. However, clinical innovation can place a patient at risk for injuries, and can invite medical malpractice lawsuits and state medical board investigations into professional misconduct. It is definitely not something a clinician should indulge in casually or carelessly.
In medical experimentation, which typically takes the form of clinical trials, efficacy is still unproven, and any potential benefit is directed at future patients, not those being studied who may be on a standard drug or even a placebo. Accordingly, the courts tend to demand a higher standard of care, especially in regard to disclosure of risks. Investigators also are obligated to obtain prior approval from an institutional review board that is governed by the Food and Drug Administration and Department of Health and Human Services. Clinical innovation, on the other hand, is usually within the doctor-patient relationship, and refers to the use of a testing or treatment method that is not generally in use or accepted by peers, but whose intent is to benefit a particular patient based on published data or experience of efficacy and safety.
In Brook v. St .John’s Hickey Memorial Hospital (380 N.E. 2d 72 [Ind. 1978]), a radiologist injected contrast dye intramuscularly into the calves of a 23-month-old infant after he was unable to locate a vein for intravenous administration. He had successfully done this in the past because there were reports that use of the recommended sites (the buttocks or thighs) had met with occasional adverse results. The patient subsequently developed a shortening of the Achilles tendon that was arguably related to the injection. The court declined to characterize the technique as a medical experiment or find the defendant negligent in choosing an injection site that had not been specifically recommended by the medical community. The court wrote that "too often courts have confused judgmental decisions and experimentation. Therapeutic innovation has long been recognized as permissible to avoid serious consequences. The everyday practice of medicine involves constant judgmental decisions by physicians as they move from one patient to another in the conscious institution of procedures, special tests, trials and observations recognized generally by their profession as effective in treating the patient or providing a diagnosis of a diseased condition. Each patient presents a slightly different problem to the doctor. A physician is presumed to have the knowledge and skill necessary to use some innovation to fit the peculiar circumstances of each case."
When the patient’s condition is critical or terminal, or when usual measures have failed, an innovative or even experimental approach may be the only option. Such a case was Karp v. Cooley (493 F.2d 408 [5th Cir. 1974]), in which Dr. Denton Cooley, a well-known cardiac surgeon, transplanted a mechanical heart for the first time to save a patient who was dying from heart failure. There was no evidence that the patient’s treatment was other than therapeutic, and fully informed consent was obtained for all aspects of the novel surgery. The patient died within 3 days following transplant surgery. In the wrongful death suit that followed, the court, relying on conventional malpractice evidentiary standards, ruled in favor of Dr. Cooley on the issue of experimentation.
Sometimes a so-called "innovative" treatment stems from the doctor’s inexperience and poor judgment. In Felice v. Valleylab (520 So.2d 920 [La. 1987]), two medical trainees negligently used an electrosurgical unit to perform a circumcision on a child, burning and destroying his penis in the process. They had been trained in – but chose not to use – the time-tested surgical technique with a scalpel. The court ruled that the doctors were negligent, as they had used an unorthodox technique without reading the manual or the warning label on the device. In Edenfield v. Vahid (621 So.2d 1192 [La. 1993]), the court found a surgeon liable for his use of a polypropylene nonabsorbable suture during an anal fistulectomy operation. A medical review panel concluded that nonresorbable sutures were inappropriate in the anorectal area because they predisposed the wound to infection. The court held that it was more probable than not that the patient’s injuries were caused by the doctor’s improper choice of suture.
Physicians should tread cautiously when considering novel and unproven modalities. Depending on the facts and circumstances, a doctor’s unorthodox use of drugs, devices, or complementary and alternative medicine may be deemed to be below the standard of care and thus may invite state disciplinary investigation and/or civil action.
Question: Intending to help an elderly patient suffering from dementia and Parkinsonism, a neurologist applied a series of therapeutic ultrasound treatments to her head. The patient had seen other neurologists previously, but their conventional measures were ineffective. The neurologist had used the novel method in the past, and claims it had been safe and effective. The medical literature contains only a few anecdotal reports on such use. Assuming the patient experienced no harm, but derived no benefit from the new treatment, which of the following statements is most accurate?
A. The treatment method is best characterized as clinical innovation.
B. Clinical innovation, like human experimentation, can help advance medical progress.
C. Intended patient benefit, clear safety, and informed consent are minimum requirements when the use of novel diagnostic or therapeutic modalities is considered.
D. The physician cannot be successfully sued because no harm came to patient.
E. All are correct.
Answer: E. This hypothetical is adapted from an actual case in Singapore in which the court ruled in favor of the treating neurologist. In striking the balance between inhibiting novel approaches that benefit patients vs. exposing patients to unwarranted risk, U.S. courts have occasionally allowed innovation, even though by definition it represents a departure from a customary or acceptable standard. However, clinical innovation can place a patient at risk for injuries, and can invite medical malpractice lawsuits and state medical board investigations into professional misconduct. It is definitely not something a clinician should indulge in casually or carelessly.
In medical experimentation, which typically takes the form of clinical trials, efficacy is still unproven, and any potential benefit is directed at future patients, not those being studied who may be on a standard drug or even a placebo. Accordingly, the courts tend to demand a higher standard of care, especially in regard to disclosure of risks. Investigators also are obligated to obtain prior approval from an institutional review board that is governed by the Food and Drug Administration and Department of Health and Human Services. Clinical innovation, on the other hand, is usually within the doctor-patient relationship, and refers to the use of a testing or treatment method that is not generally in use or accepted by peers, but whose intent is to benefit a particular patient based on published data or experience of efficacy and safety.
In Brook v. St .John’s Hickey Memorial Hospital (380 N.E. 2d 72 [Ind. 1978]), a radiologist injected contrast dye intramuscularly into the calves of a 23-month-old infant after he was unable to locate a vein for intravenous administration. He had successfully done this in the past because there were reports that use of the recommended sites (the buttocks or thighs) had met with occasional adverse results. The patient subsequently developed a shortening of the Achilles tendon that was arguably related to the injection. The court declined to characterize the technique as a medical experiment or find the defendant negligent in choosing an injection site that had not been specifically recommended by the medical community. The court wrote that "too often courts have confused judgmental decisions and experimentation. Therapeutic innovation has long been recognized as permissible to avoid serious consequences. The everyday practice of medicine involves constant judgmental decisions by physicians as they move from one patient to another in the conscious institution of procedures, special tests, trials and observations recognized generally by their profession as effective in treating the patient or providing a diagnosis of a diseased condition. Each patient presents a slightly different problem to the doctor. A physician is presumed to have the knowledge and skill necessary to use some innovation to fit the peculiar circumstances of each case."
When the patient’s condition is critical or terminal, or when usual measures have failed, an innovative or even experimental approach may be the only option. Such a case was Karp v. Cooley (493 F.2d 408 [5th Cir. 1974]), in which Dr. Denton Cooley, a well-known cardiac surgeon, transplanted a mechanical heart for the first time to save a patient who was dying from heart failure. There was no evidence that the patient’s treatment was other than therapeutic, and fully informed consent was obtained for all aspects of the novel surgery. The patient died within 3 days following transplant surgery. In the wrongful death suit that followed, the court, relying on conventional malpractice evidentiary standards, ruled in favor of Dr. Cooley on the issue of experimentation.
Sometimes a so-called "innovative" treatment stems from the doctor’s inexperience and poor judgment. In Felice v. Valleylab (520 So.2d 920 [La. 1987]), two medical trainees negligently used an electrosurgical unit to perform a circumcision on a child, burning and destroying his penis in the process. They had been trained in – but chose not to use – the time-tested surgical technique with a scalpel. The court ruled that the doctors were negligent, as they had used an unorthodox technique without reading the manual or the warning label on the device. In Edenfield v. Vahid (621 So.2d 1192 [La. 1993]), the court found a surgeon liable for his use of a polypropylene nonabsorbable suture during an anal fistulectomy operation. A medical review panel concluded that nonresorbable sutures were inappropriate in the anorectal area because they predisposed the wound to infection. The court held that it was more probable than not that the patient’s injuries were caused by the doctor’s improper choice of suture.
Physicians should tread cautiously when considering novel and unproven modalities. Depending on the facts and circumstances, a doctor’s unorthodox use of drugs, devices, or complementary and alternative medicine may be deemed to be below the standard of care and thus may invite state disciplinary investigation and/or civil action.
Question: Intending to help an elderly patient suffering from dementia and Parkinsonism, a neurologist applied a series of therapeutic ultrasound treatments to her head. The patient had seen other neurologists previously, but their conventional measures were ineffective. The neurologist had used the novel method in the past, and claims it had been safe and effective. The medical literature contains only a few anecdotal reports on such use. Assuming the patient experienced no harm, but derived no benefit from the new treatment, which of the following statements is most accurate?
A. The treatment method is best characterized as clinical innovation.
B. Clinical innovation, like human experimentation, can help advance medical progress.
C. Intended patient benefit, clear safety, and informed consent are minimum requirements when the use of novel diagnostic or therapeutic modalities is considered.
D. The physician cannot be successfully sued because no harm came to patient.
E. All are correct.
Answer: E. This hypothetical is adapted from an actual case in Singapore in which the court ruled in favor of the treating neurologist. In striking the balance between inhibiting novel approaches that benefit patients vs. exposing patients to unwarranted risk, U.S. courts have occasionally allowed innovation, even though by definition it represents a departure from a customary or acceptable standard. However, clinical innovation can place a patient at risk for injuries, and can invite medical malpractice lawsuits and state medical board investigations into professional misconduct. It is definitely not something a clinician should indulge in casually or carelessly.
In medical experimentation, which typically takes the form of clinical trials, efficacy is still unproven, and any potential benefit is directed at future patients, not those being studied who may be on a standard drug or even a placebo. Accordingly, the courts tend to demand a higher standard of care, especially in regard to disclosure of risks. Investigators also are obligated to obtain prior approval from an institutional review board that is governed by the Food and Drug Administration and Department of Health and Human Services. Clinical innovation, on the other hand, is usually within the doctor-patient relationship, and refers to the use of a testing or treatment method that is not generally in use or accepted by peers, but whose intent is to benefit a particular patient based on published data or experience of efficacy and safety.
In Brook v. St .John’s Hickey Memorial Hospital (380 N.E. 2d 72 [Ind. 1978]), a radiologist injected contrast dye intramuscularly into the calves of a 23-month-old infant after he was unable to locate a vein for intravenous administration. He had successfully done this in the past because there were reports that use of the recommended sites (the buttocks or thighs) had met with occasional adverse results. The patient subsequently developed a shortening of the Achilles tendon that was arguably related to the injection. The court declined to characterize the technique as a medical experiment or find the defendant negligent in choosing an injection site that had not been specifically recommended by the medical community. The court wrote that "too often courts have confused judgmental decisions and experimentation. Therapeutic innovation has long been recognized as permissible to avoid serious consequences. The everyday practice of medicine involves constant judgmental decisions by physicians as they move from one patient to another in the conscious institution of procedures, special tests, trials and observations recognized generally by their profession as effective in treating the patient or providing a diagnosis of a diseased condition. Each patient presents a slightly different problem to the doctor. A physician is presumed to have the knowledge and skill necessary to use some innovation to fit the peculiar circumstances of each case."
When the patient’s condition is critical or terminal, or when usual measures have failed, an innovative or even experimental approach may be the only option. Such a case was Karp v. Cooley (493 F.2d 408 [5th Cir. 1974]), in which Dr. Denton Cooley, a well-known cardiac surgeon, transplanted a mechanical heart for the first time to save a patient who was dying from heart failure. There was no evidence that the patient’s treatment was other than therapeutic, and fully informed consent was obtained for all aspects of the novel surgery. The patient died within 3 days following transplant surgery. In the wrongful death suit that followed, the court, relying on conventional malpractice evidentiary standards, ruled in favor of Dr. Cooley on the issue of experimentation.
Sometimes a so-called "innovative" treatment stems from the doctor’s inexperience and poor judgment. In Felice v. Valleylab (520 So.2d 920 [La. 1987]), two medical trainees negligently used an electrosurgical unit to perform a circumcision on a child, burning and destroying his penis in the process. They had been trained in – but chose not to use – the time-tested surgical technique with a scalpel. The court ruled that the doctors were negligent, as they had used an unorthodox technique without reading the manual or the warning label on the device. In Edenfield v. Vahid (621 So.2d 1192 [La. 1993]), the court found a surgeon liable for his use of a polypropylene nonabsorbable suture during an anal fistulectomy operation. A medical review panel concluded that nonresorbable sutures were inappropriate in the anorectal area because they predisposed the wound to infection. The court held that it was more probable than not that the patient’s injuries were caused by the doctor’s improper choice of suture.
Physicians should tread cautiously when considering novel and unproven modalities. Depending on the facts and circumstances, a doctor’s unorthodox use of drugs, devices, or complementary and alternative medicine may be deemed to be below the standard of care and thus may invite state disciplinary investigation and/or civil action.
Clinical Innovation
Question: Intending to help an elderly patient suffering from dementia and Parkinsonism, a neurologist applied a series of therapeutic ultrasound treatments to her head. The patient had seen other neurologists previously, but their conventional measures were ineffective. The neurologist had used the novel method in the past, and claims it had been safe and effective. The medical literature contains only a few anecdotal reports on such use. Assuming the patient experienced no harm, but derived no benefit from the new treatment, which of the following statements is most accurate?
A. The treatment method is best characterized as clinical innovation.
B. Clinical innovation, like human experimentation, can help advance medical progress.
C. Intended patient benefit, clear safety, and informed consent are minimum requirements when the use of novel diagnostic or therapeutic modalities is considered.
D. The physician cannot be successfully sued because no harm came to patient.
E. All are correct.
Answer: E. This hypothetical is adapted from an actual case in Singapore in which the court ruled in favor of the treating neurologist. In striking the balance between inhibiting novel approaches that benefit patients vs. exposing patients to unwarranted risk, U.S. courts have occasionally allowed innovation, even though by definition it represents a departure from a customary or acceptable standard. However, clinical innovation can place a patient at risk for injuries, and can invite medical malpractice lawsuits and state medical board investigations into professional misconduct. It is definitely not something a clinician should indulge in casually or carelessly.
In medical experimentation, which typically takes the form of clinical trials, efficacy is still unproven, and any potential benefit is directed at future patients, not those being studied who may be on a standard drug or even a placebo. Accordingly, the courts tend to demand a higher standard of care, especially in regard to disclosure of risks. Investigators also are obligated to obtain prior approval from an institutional review board that is governed by the Food and Drug Administration and Department of Health and Human Services. Clinical innovation, on the other hand, is usually within the doctor-patient relationship, and refers to the use of a testing or treatment method that is not generally in use or accepted by peers, but whose intent is to benefit a particular patient based on published data or experience of efficacy and safety.
In Brook v. St .John’s Hickey Memorial Hospital (380 N.E. 2d 72 [Ind. 1978]), a radiologist injected contrast dye intramuscularly into the calves of a 23-month-old infant after he was unable to locate a vein for intravenous administration. He had successfully done this in the past because there were reports that use of the recommended sites (the buttocks or thighs) had met with occasional adverse results. The patient subsequently developed a shortening of the Achilles tendon that was arguably related to the injection. The court declined to characterize the technique as a medical experiment or find the defendant negligent in choosing an injection site that had not been specifically recommended by the medical community. The court wrote that "too often courts have confused judgmental decisions and experimentation. Therapeutic innovation has long been recognized as permissible to avoid serious consequences. The everyday practice of medicine involves constant judgmental decisions by physicians as they move from one patient to another in the conscious institution of procedures, special tests, trials and observations recognized generally by their profession as effective in treating the patient or providing a diagnosis of a diseased condition. Each patient presents a slightly different problem to the doctor. A physician is presumed to have the knowledge and skill necessary to use some innovation to fit the peculiar circumstances of each case."
When the patient’s condition is critical or terminal, or when usual measures have failed, an innovative or even experimental approach may be the only option. Such a case was Karp v. Cooley (493 F.2d 408 [5th Cir. 1974]), in which Dr. Denton Cooley, a well-known cardiac surgeon, transplanted a mechanical heart for the first time to save a patient who was dying from heart failure. There was no evidence that the patient’s treatment was other than therapeutic, and fully informed consent was obtained for all aspects of the novel surgery. The patient died within 3 days following transplant surgery. In the wrongful death suit that followed, the court, relying on conventional malpractice evidentiary standards, ruled in favor of Dr. Cooley on the issue of experimentation.
Sometimes a so-called "innovative" treatment stems from the doctor’s inexperience and poor judgment. In Felice v. Valleylab (520 So.2d 920 [La. 1987]), two medical trainees negligently used an electrosurgical unit to perform a circumcision on a child, burning and destroying his penis in the process. They had been trained in – but chose not to use – the time-tested surgical technique with a scalpel. The court ruled that the doctors were negligent, as they had used an unorthodox technique without reading the manual or the warning label on the device. In Edenfield v. Vahid (621 So.2d 1192 [La. 1993]), the court found a surgeon liable for his use of a polypropylene nonabsorbable suture during an anal fistulectomy operation. A medical review panel concluded that nonresorbable sutures were inappropriate in the anorectal area because they predisposed the wound to infection. The court held that it was more probable than not that the patient’s injuries were caused by the doctor’s improper choice of suture.
Physicians should tread cautiously when considering novel and unproven modalities. Depending on the facts and circumstances, a doctor’s unorthodox use of drugs, devices, or complementary and alternative medicine may be deemed to be below the standard of care and thus may invite state disciplinary investigation and/or civil action.
Dr. S. Y. Tan is an emeritus professor at the University of Hawaii. He reported no conflicts of interest related to this column. This article is meant to be educational and does not constitute medical, ethical, or legal advice. It is adapted from the author’s book, "Medical Malpractice: Understanding the Law, Managing the Risk" (2006). For additional information, readers may contact the author at [email protected].
Question: Intending to help an elderly patient suffering from dementia and Parkinsonism, a neurologist applied a series of therapeutic ultrasound treatments to her head. The patient had seen other neurologists previously, but their conventional measures were ineffective. The neurologist had used the novel method in the past, and claims it had been safe and effective. The medical literature contains only a few anecdotal reports on such use. Assuming the patient experienced no harm, but derived no benefit from the new treatment, which of the following statements is most accurate?
A. The treatment method is best characterized as clinical innovation.
B. Clinical innovation, like human experimentation, can help advance medical progress.
C. Intended patient benefit, clear safety, and informed consent are minimum requirements when the use of novel diagnostic or therapeutic modalities is considered.
D. The physician cannot be successfully sued because no harm came to patient.
E. All are correct.
Answer: E. This hypothetical is adapted from an actual case in Singapore in which the court ruled in favor of the treating neurologist. In striking the balance between inhibiting novel approaches that benefit patients vs. exposing patients to unwarranted risk, U.S. courts have occasionally allowed innovation, even though by definition it represents a departure from a customary or acceptable standard. However, clinical innovation can place a patient at risk for injuries, and can invite medical malpractice lawsuits and state medical board investigations into professional misconduct. It is definitely not something a clinician should indulge in casually or carelessly.
In medical experimentation, which typically takes the form of clinical trials, efficacy is still unproven, and any potential benefit is directed at future patients, not those being studied who may be on a standard drug or even a placebo. Accordingly, the courts tend to demand a higher standard of care, especially in regard to disclosure of risks. Investigators also are obligated to obtain prior approval from an institutional review board that is governed by the Food and Drug Administration and Department of Health and Human Services. Clinical innovation, on the other hand, is usually within the doctor-patient relationship, and refers to the use of a testing or treatment method that is not generally in use or accepted by peers, but whose intent is to benefit a particular patient based on published data or experience of efficacy and safety.
In Brook v. St .John’s Hickey Memorial Hospital (380 N.E. 2d 72 [Ind. 1978]), a radiologist injected contrast dye intramuscularly into the calves of a 23-month-old infant after he was unable to locate a vein for intravenous administration. He had successfully done this in the past because there were reports that use of the recommended sites (the buttocks or thighs) had met with occasional adverse results. The patient subsequently developed a shortening of the Achilles tendon that was arguably related to the injection. The court declined to characterize the technique as a medical experiment or find the defendant negligent in choosing an injection site that had not been specifically recommended by the medical community. The court wrote that "too often courts have confused judgmental decisions and experimentation. Therapeutic innovation has long been recognized as permissible to avoid serious consequences. The everyday practice of medicine involves constant judgmental decisions by physicians as they move from one patient to another in the conscious institution of procedures, special tests, trials and observations recognized generally by their profession as effective in treating the patient or providing a diagnosis of a diseased condition. Each patient presents a slightly different problem to the doctor. A physician is presumed to have the knowledge and skill necessary to use some innovation to fit the peculiar circumstances of each case."
When the patient’s condition is critical or terminal, or when usual measures have failed, an innovative or even experimental approach may be the only option. Such a case was Karp v. Cooley (493 F.2d 408 [5th Cir. 1974]), in which Dr. Denton Cooley, a well-known cardiac surgeon, transplanted a mechanical heart for the first time to save a patient who was dying from heart failure. There was no evidence that the patient’s treatment was other than therapeutic, and fully informed consent was obtained for all aspects of the novel surgery. The patient died within 3 days following transplant surgery. In the wrongful death suit that followed, the court, relying on conventional malpractice evidentiary standards, ruled in favor of Dr. Cooley on the issue of experimentation.
Sometimes a so-called "innovative" treatment stems from the doctor’s inexperience and poor judgment. In Felice v. Valleylab (520 So.2d 920 [La. 1987]), two medical trainees negligently used an electrosurgical unit to perform a circumcision on a child, burning and destroying his penis in the process. They had been trained in – but chose not to use – the time-tested surgical technique with a scalpel. The court ruled that the doctors were negligent, as they had used an unorthodox technique without reading the manual or the warning label on the device. In Edenfield v. Vahid (621 So.2d 1192 [La. 1993]), the court found a surgeon liable for his use of a polypropylene nonabsorbable suture during an anal fistulectomy operation. A medical review panel concluded that nonresorbable sutures were inappropriate in the anorectal area because they predisposed the wound to infection. The court held that it was more probable than not that the patient’s injuries were caused by the doctor’s improper choice of suture.
Physicians should tread cautiously when considering novel and unproven modalities. Depending on the facts and circumstances, a doctor’s unorthodox use of drugs, devices, or complementary and alternative medicine may be deemed to be below the standard of care and thus may invite state disciplinary investigation and/or civil action.
Dr. S. Y. Tan is an emeritus professor at the University of Hawaii. He reported no conflicts of interest related to this column. This article is meant to be educational and does not constitute medical, ethical, or legal advice. It is adapted from the author’s book, "Medical Malpractice: Understanding the Law, Managing the Risk" (2006). For additional information, readers may contact the author at [email protected].
Question: Intending to help an elderly patient suffering from dementia and Parkinsonism, a neurologist applied a series of therapeutic ultrasound treatments to her head. The patient had seen other neurologists previously, but their conventional measures were ineffective. The neurologist had used the novel method in the past, and claims it had been safe and effective. The medical literature contains only a few anecdotal reports on such use. Assuming the patient experienced no harm, but derived no benefit from the new treatment, which of the following statements is most accurate?
A. The treatment method is best characterized as clinical innovation.
B. Clinical innovation, like human experimentation, can help advance medical progress.
C. Intended patient benefit, clear safety, and informed consent are minimum requirements when the use of novel diagnostic or therapeutic modalities is considered.
D. The physician cannot be successfully sued because no harm came to patient.
E. All are correct.
Answer: E. This hypothetical is adapted from an actual case in Singapore in which the court ruled in favor of the treating neurologist. In striking the balance between inhibiting novel approaches that benefit patients vs. exposing patients to unwarranted risk, U.S. courts have occasionally allowed innovation, even though by definition it represents a departure from a customary or acceptable standard. However, clinical innovation can place a patient at risk for injuries, and can invite medical malpractice lawsuits and state medical board investigations into professional misconduct. It is definitely not something a clinician should indulge in casually or carelessly.
In medical experimentation, which typically takes the form of clinical trials, efficacy is still unproven, and any potential benefit is directed at future patients, not those being studied who may be on a standard drug or even a placebo. Accordingly, the courts tend to demand a higher standard of care, especially in regard to disclosure of risks. Investigators also are obligated to obtain prior approval from an institutional review board that is governed by the Food and Drug Administration and Department of Health and Human Services. Clinical innovation, on the other hand, is usually within the doctor-patient relationship, and refers to the use of a testing or treatment method that is not generally in use or accepted by peers, but whose intent is to benefit a particular patient based on published data or experience of efficacy and safety.
In Brook v. St .John’s Hickey Memorial Hospital (380 N.E. 2d 72 [Ind. 1978]), a radiologist injected contrast dye intramuscularly into the calves of a 23-month-old infant after he was unable to locate a vein for intravenous administration. He had successfully done this in the past because there were reports that use of the recommended sites (the buttocks or thighs) had met with occasional adverse results. The patient subsequently developed a shortening of the Achilles tendon that was arguably related to the injection. The court declined to characterize the technique as a medical experiment or find the defendant negligent in choosing an injection site that had not been specifically recommended by the medical community. The court wrote that "too often courts have confused judgmental decisions and experimentation. Therapeutic innovation has long been recognized as permissible to avoid serious consequences. The everyday practice of medicine involves constant judgmental decisions by physicians as they move from one patient to another in the conscious institution of procedures, special tests, trials and observations recognized generally by their profession as effective in treating the patient or providing a diagnosis of a diseased condition. Each patient presents a slightly different problem to the doctor. A physician is presumed to have the knowledge and skill necessary to use some innovation to fit the peculiar circumstances of each case."
When the patient’s condition is critical or terminal, or when usual measures have failed, an innovative or even experimental approach may be the only option. Such a case was Karp v. Cooley (493 F.2d 408 [5th Cir. 1974]), in which Dr. Denton Cooley, a well-known cardiac surgeon, transplanted a mechanical heart for the first time to save a patient who was dying from heart failure. There was no evidence that the patient’s treatment was other than therapeutic, and fully informed consent was obtained for all aspects of the novel surgery. The patient died within 3 days following transplant surgery. In the wrongful death suit that followed, the court, relying on conventional malpractice evidentiary standards, ruled in favor of Dr. Cooley on the issue of experimentation.
Sometimes a so-called "innovative" treatment stems from the doctor’s inexperience and poor judgment. In Felice v. Valleylab (520 So.2d 920 [La. 1987]), two medical trainees negligently used an electrosurgical unit to perform a circumcision on a child, burning and destroying his penis in the process. They had been trained in – but chose not to use – the time-tested surgical technique with a scalpel. The court ruled that the doctors were negligent, as they had used an unorthodox technique without reading the manual or the warning label on the device. In Edenfield v. Vahid (621 So.2d 1192 [La. 1993]), the court found a surgeon liable for his use of a polypropylene nonabsorbable suture during an anal fistulectomy operation. A medical review panel concluded that nonresorbable sutures were inappropriate in the anorectal area because they predisposed the wound to infection. The court held that it was more probable than not that the patient’s injuries were caused by the doctor’s improper choice of suture.
Physicians should tread cautiously when considering novel and unproven modalities. Depending on the facts and circumstances, a doctor’s unorthodox use of drugs, devices, or complementary and alternative medicine may be deemed to be below the standard of care and thus may invite state disciplinary investigation and/or civil action.
Dr. S. Y. Tan is an emeritus professor at the University of Hawaii. He reported no conflicts of interest related to this column. This article is meant to be educational and does not constitute medical, ethical, or legal advice. It is adapted from the author’s book, "Medical Malpractice: Understanding the Law, Managing the Risk" (2006). For additional information, readers may contact the author at [email protected].
ED Staff Negligence?
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malpractice, emergency medicine, negligence, diabetes, insulin, discharge,
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