Medicolegal Issues

Sued If You Do, Sued If You Don’t

A 52-year-old woman presented to the ED with complaints of abdominal pain, vaginal bleeding, and left leg pain. The patient stated that the symptoms, which she had been experiencing over the past few days, were becoming progressively worse. She denied fevers, chills, nausea, vomiting, diarrhea, or constipation. Her surgical history was
remarkable for an appendectomy 30 years prior. The patient was not currently on any medications. Regarding social history, she denied alcohol or tobacco use. She also denied any allergies to medications.

On physical examination, all of the patient’s vital signs were normal. The head, eyes, ears, nose, and throat, and lung and heart examinations were also normal; however, on abdominal examination, she exhibited tenderness throughout the lower abdomen, but without guarding or rebound. There was no costovertebral angle tenderness of the back. The pelvic examination was remarkable for a small amount of blood from the cervical os and a slightly enlarged uterus. The adnexa were normal and without tenderness.

The patient sued both the EP and the hospital, claiming that the CT scan was unnecessary and had it not been performed, she would not have experienced the stroke. The defense asserted that the CT scan with contrast was appropriate given the patient’s symptoms and physical findings, and that the contrast dye used was not the cause of the stroke. The jury awarded the plaintiff $3.6 million.

Discussion

This case is unique in that the EP was sued for ordering a CT scan. In the overwhelming majority of malpractice cases, EPs are sued for not obtaining a certain test—frequently a CT scan. It does not appear the jury in this case was correct in their judgment as there was no conceivable way the EP could have anticipated this type of unusual reaction, especially in a patient with no history of medication allergies.

This jury ruling places EPs in an untenable situation: If they order a test and anything bad happens, they will be sued. If they do not order a test and something bad happens, they will be sued. In legal theory, there must be proximal cause between what the physician did (ie, order the CT scan) and the bad outcome, or negligence (ie, SAH). For this case, the two events seem true-true and unrelated. The contrast dye clearly did not cause the cerebral aneurysm, which was a preexisting condition.

Nonidiosyncratic reactions are due to direct toxic or osmolar effects. Symptoms include bradycardia, hypotension, vasovagal reactions, sensation of warmth, metallic taste in the mouth, and nausea and vomiting.¹

Ironically, the majority of adverse reactions to ICM involve hypotension, not hypertension. This includes cardiovascular reactions to ICM, which typically involve bradycardia, peripheral vasodilation, and hypotension.¹ The incidence and severity of an adverse reaction to ICM also depends on whether ionic or nonionic ICM was used. (Unfortunately, the type of ICM administered to the patient in this case was not disclosed.)

The incidence and severity of adverse reactions to ICM are less with nonionic compared to ionic ICM. More than 90% of adverse reactions to nonionic ICM are anaphlyactoid.² In general, adverse reactions occur in 4% to 12% of patients receiving ionic ICM compared to 1% to 3% of those receiving nonionic ICM.² In a study of more than 300,000 contrast administrations, Katayama et al,³ found the overall risk for severe adverse reaction to be 0.2% for ionic ICM compared to 0.04% for nonionic ICM.

The bottom line in this case is that the patient’s event was a very rare and completely unforeseen result temporally related to the contrast CT scan ordered to evaluate the etiology of this patient’s abdominal pain.

Falls

A 67-year-old woman with a chief complaint of lightheadedness and dizziness was transferred from a dialysis center to the ED by emergency medical services (EMS). She stated that her symptoms came on suddenly right after she had completed her scheduled dialysis.

As the patient was being rolled on a stretcher from the ambulance to the ED entrance, the stretcher collapsed and tipped over, causing the patient to fall and strike her head on the pavement. The patient suffered a severe intraparenchymal brain hemorrhage, requiring intubation, ventilation, and admission to the intensive care unit. On the second day of admission, the patient’s family signed “do not resuscitate” orders and, in accordance with their wishes, life support was withdrawn and the patient died.

The family sued the ambulance company, stating the patient’s death was a direct result of negligent training and supervision of EMS personnel. The plaintiff further claimed the incident was caused by the failure to properly secure a locking mechanism on the stretcher, which caused it to tip. The ambulance company disputed the liability, asserting that what occurred was a tragic accident, not negligence. The jury found in favor of the plaintiff and awarded $1.5 million.

Discussion

While this is not a true ED case since the patient’s fall occurred just outside the ED, it does emphasize the importance of falls and the challenges of fall prevention within the hospital—including the ED. The incidence of falls within hospitals ranges from 1.3 to 9 falls per 1,000 occupied bed days (OBD).¹ This incidence, however, is not evenly distributed across hospital departments. Not surprisingly, the highest rates are reported in areas such as geriatric, neurology, and rehabilitation units.¹ The highest rates, 17 to 67 per 1,000 OBDs, appear to occur in geropsychiatric units,^2,3 and a significant number of such patient falls are serious, with some type of injury resulting from the fall in 30% to 51% of cases.¹ The percentage of falls resulting in a fracture ranges from 1% to 3%.¹

As previously noted, the ED is not immune to patient falls. A review of one academic medical center ED with 75,000 annual visits found an incidence of 1.3 falls per month, 31% of which resulted in patient injury.⁴

Some relatively simple steps can be taken to reduce the incidence of falls. For example, identifying patients at high risk of falling (eg, patients who are elderly, confused, dizzy) and ensuring other care-team workers are aware of the risk, can be very helpful.^4,5 In addition, brightly colored signs on the stretcher or colored wrist bands indicating the patient is at high-risk for falls helps to engage the entire healthcare team in fall-prevention measures.⁴ Sitters with high-risk patients can also help minimize fall risk.

Although side rails on hospital beds are intended to increase patient safety, their use is not without controversy. Most hospitals require staff to have side rails up for obvious reasons. Some hospitals, however, are concerned that the use of side rails can cause a fall from a higher position and increase the risk of injury when a patient attempts to get out of bed. Additional important steps include ensuring that all wet surfaces are quickly identified and cleaned, and making sure everyone is aware of the importance of fall-prevention measures.

 The employment of the abovementioned fall-prevention measures is especially important in relation to the aging US population. As the number of elderly patients in the United States continues to grow, the risk of patient falls is expected to increase. Therefore, hospitals should be proactive in implementing preventive measures to reduce the risk of patient falls and injury.  

Sued If You Do, Sued If You Don’t

A 52-year-old woman presented to the ED with complaints of abdominal pain, vaginal bleeding, and left leg pain. The patient stated that the symptoms, which she had been experiencing over the past few days, were becoming progressively worse. She denied fevers, chills, nausea, vomiting, diarrhea, or constipation. Her surgical history was
remarkable for an appendectomy 30 years prior. The patient was not currently on any medications. Regarding social history, she denied alcohol or tobacco use. She also denied any allergies to medications.

On physical examination, all of the patient’s vital signs were normal. The head, eyes, ears, nose, and throat, and lung and heart examinations were also normal; however, on abdominal examination, she exhibited tenderness throughout the lower abdomen, but without guarding or rebound. There was no costovertebral angle tenderness of the back. The pelvic examination was remarkable for a small amount of blood from the cervical os and a slightly enlarged uterus. The adnexa were normal and without tenderness.

The patient sued both the EP and the hospital, claiming that the CT scan was unnecessary and had it not been performed, she would not have experienced the stroke. The defense asserted that the CT scan with contrast was appropriate given the patient’s symptoms and physical findings, and that the contrast dye used was not the cause of the stroke. The jury awarded the plaintiff $3.6 million.

Discussion

This case is unique in that the EP was sued for ordering a CT scan. In the overwhelming majority of malpractice cases, EPs are sued for not obtaining a certain test—frequently a CT scan. It does not appear the jury in this case was correct in their judgment as there was no conceivable way the EP could have anticipated this type of unusual reaction, especially in a patient with no history of medication allergies.

This jury ruling places EPs in an untenable situation: If they order a test and anything bad happens, they will be sued. If they do not order a test and something bad happens, they will be sued. In legal theory, there must be proximal cause between what the physician did (ie, order the CT scan) and the bad outcome, or negligence (ie, SAH). For this case, the two events seem true-true and unrelated. The contrast dye clearly did not cause the cerebral aneurysm, which was a preexisting condition.

Nonidiosyncratic reactions are due to direct toxic or osmolar effects. Symptoms include bradycardia, hypotension, vasovagal reactions, sensation of warmth, metallic taste in the mouth, and nausea and vomiting.¹

Ironically, the majority of adverse reactions to ICM involve hypotension, not hypertension. This includes cardiovascular reactions to ICM, which typically involve bradycardia, peripheral vasodilation, and hypotension.¹ The incidence and severity of an adverse reaction to ICM also depends on whether ionic or nonionic ICM was used. (Unfortunately, the type of ICM administered to the patient in this case was not disclosed.)

The incidence and severity of adverse reactions to ICM are less with nonionic compared to ionic ICM. More than 90% of adverse reactions to nonionic ICM are anaphlyactoid.² In general, adverse reactions occur in 4% to 12% of patients receiving ionic ICM compared to 1% to 3% of those receiving nonionic ICM.² In a study of more than 300,000 contrast administrations, Katayama et al,³ found the overall risk for severe adverse reaction to be 0.2% for ionic ICM compared to 0.04% for nonionic ICM.

The bottom line in this case is that the patient’s event was a very rare and completely unforeseen result temporally related to the contrast CT scan ordered to evaluate the etiology of this patient’s abdominal pain.

Falls

A 67-year-old woman with a chief complaint of lightheadedness and dizziness was transferred from a dialysis center to the ED by emergency medical services (EMS). She stated that her symptoms came on suddenly right after she had completed her scheduled dialysis.

As the patient was being rolled on a stretcher from the ambulance to the ED entrance, the stretcher collapsed and tipped over, causing the patient to fall and strike her head on the pavement. The patient suffered a severe intraparenchymal brain hemorrhage, requiring intubation, ventilation, and admission to the intensive care unit. On the second day of admission, the patient’s family signed “do not resuscitate” orders and, in accordance with their wishes, life support was withdrawn and the patient died.

The family sued the ambulance company, stating the patient’s death was a direct result of negligent training and supervision of EMS personnel. The plaintiff further claimed the incident was caused by the failure to properly secure a locking mechanism on the stretcher, which caused it to tip. The ambulance company disputed the liability, asserting that what occurred was a tragic accident, not negligence. The jury found in favor of the plaintiff and awarded $1.5 million.

Discussion

While this is not a true ED case since the patient’s fall occurred just outside the ED, it does emphasize the importance of falls and the challenges of fall prevention within the hospital—including the ED. The incidence of falls within hospitals ranges from 1.3 to 9 falls per 1,000 occupied bed days (OBD).¹ This incidence, however, is not evenly distributed across hospital departments. Not surprisingly, the highest rates are reported in areas such as geriatric, neurology, and rehabilitation units.¹ The highest rates, 17 to 67 per 1,000 OBDs, appear to occur in geropsychiatric units,^2,3 and a significant number of such patient falls are serious, with some type of injury resulting from the fall in 30% to 51% of cases.¹ The percentage of falls resulting in a fracture ranges from 1% to 3%.¹

As previously noted, the ED is not immune to patient falls. A review of one academic medical center ED with 75,000 annual visits found an incidence of 1.3 falls per month, 31% of which resulted in patient injury.⁴

Some relatively simple steps can be taken to reduce the incidence of falls. For example, identifying patients at high risk of falling (eg, patients who are elderly, confused, dizzy) and ensuring other care-team workers are aware of the risk, can be very helpful.^4,5 In addition, brightly colored signs on the stretcher or colored wrist bands indicating the patient is at high-risk for falls helps to engage the entire healthcare team in fall-prevention measures.⁴ Sitters with high-risk patients can also help minimize fall risk.

Although side rails on hospital beds are intended to increase patient safety, their use is not without controversy. Most hospitals require staff to have side rails up for obvious reasons. Some hospitals, however, are concerned that the use of side rails can cause a fall from a higher position and increase the risk of injury when a patient attempts to get out of bed. Additional important steps include ensuring that all wet surfaces are quickly identified and cleaned, and making sure everyone is aware of the importance of fall-prevention measures.

 The employment of the abovementioned fall-prevention measures is especially important in relation to the aging US population. As the number of elderly patients in the United States continues to grow, the risk of patient falls is expected to increase. Therefore, hospitals should be proactive in implementing preventive measures to reduce the risk of patient falls and injury.  

Sued If You Do, Sued If You Don’t

A 52-year-old woman presented to the ED with complaints of abdominal pain, vaginal bleeding, and left leg pain. The patient stated that the symptoms, which she had been experiencing over the past few days, were becoming progressively worse. She denied fevers, chills, nausea, vomiting, diarrhea, or constipation. Her surgical history was
remarkable for an appendectomy 30 years prior. The patient was not currently on any medications. Regarding social history, she denied alcohol or tobacco use. She also denied any allergies to medications.

On physical examination, all of the patient’s vital signs were normal. The head, eyes, ears, nose, and throat, and lung and heart examinations were also normal; however, on abdominal examination, she exhibited tenderness throughout the lower abdomen, but without guarding or rebound. There was no costovertebral angle tenderness of the back. The pelvic examination was remarkable for a small amount of blood from the cervical os and a slightly enlarged uterus. The adnexa were normal and without tenderness.

The patient sued both the EP and the hospital, claiming that the CT scan was unnecessary and had it not been performed, she would not have experienced the stroke. The defense asserted that the CT scan with contrast was appropriate given the patient’s symptoms and physical findings, and that the contrast dye used was not the cause of the stroke. The jury awarded the plaintiff $3.6 million.

Discussion

This case is unique in that the EP was sued for ordering a CT scan. In the overwhelming majority of malpractice cases, EPs are sued for not obtaining a certain test—frequently a CT scan. It does not appear the jury in this case was correct in their judgment as there was no conceivable way the EP could have anticipated this type of unusual reaction, especially in a patient with no history of medication allergies.

This jury ruling places EPs in an untenable situation: If they order a test and anything bad happens, they will be sued. If they do not order a test and something bad happens, they will be sued. In legal theory, there must be proximal cause between what the physician did (ie, order the CT scan) and the bad outcome, or negligence (ie, SAH). For this case, the two events seem true-true and unrelated. The contrast dye clearly did not cause the cerebral aneurysm, which was a preexisting condition.

Nonidiosyncratic reactions are due to direct toxic or osmolar effects. Symptoms include bradycardia, hypotension, vasovagal reactions, sensation of warmth, metallic taste in the mouth, and nausea and vomiting.¹

Ironically, the majority of adverse reactions to ICM involve hypotension, not hypertension. This includes cardiovascular reactions to ICM, which typically involve bradycardia, peripheral vasodilation, and hypotension.¹ The incidence and severity of an adverse reaction to ICM also depends on whether ionic or nonionic ICM was used. (Unfortunately, the type of ICM administered to the patient in this case was not disclosed.)

The incidence and severity of adverse reactions to ICM are less with nonionic compared to ionic ICM. More than 90% of adverse reactions to nonionic ICM are anaphlyactoid.² In general, adverse reactions occur in 4% to 12% of patients receiving ionic ICM compared to 1% to 3% of those receiving nonionic ICM.² In a study of more than 300,000 contrast administrations, Katayama et al,³ found the overall risk for severe adverse reaction to be 0.2% for ionic ICM compared to 0.04% for nonionic ICM.

The bottom line in this case is that the patient’s event was a very rare and completely unforeseen result temporally related to the contrast CT scan ordered to evaluate the etiology of this patient’s abdominal pain.

Falls

A 67-year-old woman with a chief complaint of lightheadedness and dizziness was transferred from a dialysis center to the ED by emergency medical services (EMS). She stated that her symptoms came on suddenly right after she had completed her scheduled dialysis.

As the patient was being rolled on a stretcher from the ambulance to the ED entrance, the stretcher collapsed and tipped over, causing the patient to fall and strike her head on the pavement. The patient suffered a severe intraparenchymal brain hemorrhage, requiring intubation, ventilation, and admission to the intensive care unit. On the second day of admission, the patient’s family signed “do not resuscitate” orders and, in accordance with their wishes, life support was withdrawn and the patient died.

The family sued the ambulance company, stating the patient’s death was a direct result of negligent training and supervision of EMS personnel. The plaintiff further claimed the incident was caused by the failure to properly secure a locking mechanism on the stretcher, which caused it to tip. The ambulance company disputed the liability, asserting that what occurred was a tragic accident, not negligence. The jury found in favor of the plaintiff and awarded $1.5 million.

Discussion

While this is not a true ED case since the patient’s fall occurred just outside the ED, it does emphasize the importance of falls and the challenges of fall prevention within the hospital—including the ED. The incidence of falls within hospitals ranges from 1.3 to 9 falls per 1,000 occupied bed days (OBD).¹ This incidence, however, is not evenly distributed across hospital departments. Not surprisingly, the highest rates are reported in areas such as geriatric, neurology, and rehabilitation units.¹ The highest rates, 17 to 67 per 1,000 OBDs, appear to occur in geropsychiatric units,^2,3 and a significant number of such patient falls are serious, with some type of injury resulting from the fall in 30% to 51% of cases.¹ The percentage of falls resulting in a fracture ranges from 1% to 3%.¹

As previously noted, the ED is not immune to patient falls. A review of one academic medical center ED with 75,000 annual visits found an incidence of 1.3 falls per month, 31% of which resulted in patient injury.⁴

Some relatively simple steps can be taken to reduce the incidence of falls. For example, identifying patients at high risk of falling (eg, patients who are elderly, confused, dizzy) and ensuring other care-team workers are aware of the risk, can be very helpful.^4,5 In addition, brightly colored signs on the stretcher or colored wrist bands indicating the patient is at high-risk for falls helps to engage the entire healthcare team in fall-prevention measures.⁴ Sitters with high-risk patients can also help minimize fall risk.

Although side rails on hospital beds are intended to increase patient safety, their use is not without controversy. Most hospitals require staff to have side rails up for obvious reasons. Some hospitals, however, are concerned that the use of side rails can cause a fall from a higher position and increase the risk of injury when a patient attempts to get out of bed. Additional important steps include ensuring that all wet surfaces are quickly identified and cleaned, and making sure everyone is aware of the importance of fall-prevention measures.

 The employment of the abovementioned fall-prevention measures is especially important in relation to the aging US population. As the number of elderly patients in the United States continues to grow, the risk of patient falls is expected to increase. Therefore, hospitals should be proactive in implementing preventive measures to reduce the risk of patient falls and injury.  

Signs of chorioamnionitis ignored? $3.5M settlement
At 31 weeks’ gestation, a mother at risk for preterm labor was admitted to the hospital for 2 days. Examination and test results showed evidence of infection. She was given antenatal corticosteroids for fetal lung development in case of premature delivery. At discharge, bed rest was ordered and she complied. At 32 weeks’ gestation, she returned to the hospital with worsening symptoms, was prescribed antibiotics to treat a urinary tract infection, and was discharged. She went to the hospital a third time at almost 33 weeks’ gestation, experiencing contractions and leaking fluid. She was admitted with a plan to deliver the baby if any signs or symptoms of intra-amniotic infection (clinical chorioamnionitis) were present. Four days later, a cesarean delivery was ordered due to fetal tachycardia and decreased fetal heart rate. Imaging results performed in the neonatal intensive care unit showed that the baby received a brain injury. The child has physical and mental impairments including cerebral palsy, cortical blindness, and epilepsy.

Parents’ claim Hospital health care providers failed to communicate with each other or to obtain records from prior admissions, although the mother told them that she had been to the hospital twice within the past 2 weeks. Medical records from all 3 admissions showed clear signs and symptoms of a vaginal/cervical infection that had progressed to clinical chorioamnionitis 2 days before delivery. Examination of the placenta by a pathologist confirmed that the infection had spread to the umbilical cord, injuring the child.

Defendant’s defense The standard of care was met. There was no indication that an earlier delivery was needed.

Verdict A $3.5 million Michigan settlement was reached by the hospital during the trial.

Surgical approach questioned
A woman went to her ObGyn for tubal ligation and ventral hernia repair. The patient was concerned about infection and scarring. She agreed to a laparoscopic procedure, knowing that the procedure might have to be altered to laparotomy.

Patient’s claim The patient consented to laparoscopic surgery. However, surgery did not begin as laparoscopy but as an open procedure. The patient has a 6-inch scar on her abdomen. She accused both the ObGyn and the hospital of lack of informed consent for laparotomy.

Defendant’s defense The hospital claimed that their nurses’ role was to read the consent form signed by the patient in the ObGyn’s office. The ObGyn claimed that the patient signed a general consent form that permitted him to do what was reasonable. He had determined after surgery began that a laparoscopic procedure would have been more dangerous.

Verdict A $150,000 Louisiana verdict was returned against the ObGyn; the hospital was acquitted.

Macrosomic baby and mother both injured during delivery
Delivery of a mother’s fourth child was managed by a hospital-employed family physician (FP). Shoulder dystocia was encountered, and the FP made a 4th-degree extension of the episiotomy. The baby weighed 10 lb 14 oz at birth. The mother has fecal and urinary incontinence and pain as a result of the large episiotomy. The child has a right-sided brachial plexus injury.

Parents’ claim Failure to perform cesarean delivery caused injury to the mother and child. The FP should have recognized from the mother’s history of delivering 3 macrosomic babies and the progress of this pregnancy, that the baby was large.

Defendant’s defense The case was settled during trial.

Verdict A $1.5 million Minnesota settlement was reached that included $1.2 million for the child and $300,000 for the mother.

Surgical table folds during hysterectomy: $5.3M verdict
While a woman was undergoing a hysterectomy, the surgical table she was lying on folded up into a “U” position, causing the inserted speculum to tear the patient from vagina to rectum. The fall also caused a back injury usually attributed to falls from great distances. The patient has permanent pain, recurring diarrhea, and depression as a result of the injuries.

Patient’s claim The injuries occurred because of the defendants’ failure to read, understand, and follow the warning labels on the surgical table.

Defendant’s defense The case was settled before trial.

Verdict A $5.3 million settlement was reached with the hospital.

Signs of chorioamnionitis ignored? $3.5M settlement
At 31 weeks’ gestation, a mother at risk for preterm labor was admitted to the hospital for 2 days. Examination and test results showed evidence of infection. She was given antenatal corticosteroids for fetal lung development in case of premature delivery. At discharge, bed rest was ordered and she complied. At 32 weeks’ gestation, she returned to the hospital with worsening symptoms, was prescribed antibiotics to treat a urinary tract infection, and was discharged. She went to the hospital a third time at almost 33 weeks’ gestation, experiencing contractions and leaking fluid. She was admitted with a plan to deliver the baby if any signs or symptoms of intra-amniotic infection (clinical chorioamnionitis) were present. Four days later, a cesarean delivery was ordered due to fetal tachycardia and decreased fetal heart rate. Imaging results performed in the neonatal intensive care unit showed that the baby received a brain injury. The child has physical and mental impairments including cerebral palsy, cortical blindness, and epilepsy.

Parents’ claim Hospital health care providers failed to communicate with each other or to obtain records from prior admissions, although the mother told them that she had been to the hospital twice within the past 2 weeks. Medical records from all 3 admissions showed clear signs and symptoms of a vaginal/cervical infection that had progressed to clinical chorioamnionitis 2 days before delivery. Examination of the placenta by a pathologist confirmed that the infection had spread to the umbilical cord, injuring the child.

Defendant’s defense The standard of care was met. There was no indication that an earlier delivery was needed.

Verdict A $3.5 million Michigan settlement was reached by the hospital during the trial.

Surgical approach questioned
A woman went to her ObGyn for tubal ligation and ventral hernia repair. The patient was concerned about infection and scarring. She agreed to a laparoscopic procedure, knowing that the procedure might have to be altered to laparotomy.

Patient’s claim The patient consented to laparoscopic surgery. However, surgery did not begin as laparoscopy but as an open procedure. The patient has a 6-inch scar on her abdomen. She accused both the ObGyn and the hospital of lack of informed consent for laparotomy.

Defendant’s defense The hospital claimed that their nurses’ role was to read the consent form signed by the patient in the ObGyn’s office. The ObGyn claimed that the patient signed a general consent form that permitted him to do what was reasonable. He had determined after surgery began that a laparoscopic procedure would have been more dangerous.

Verdict A $150,000 Louisiana verdict was returned against the ObGyn; the hospital was acquitted.

Macrosomic baby and mother both injured during delivery
Delivery of a mother’s fourth child was managed by a hospital-employed family physician (FP). Shoulder dystocia was encountered, and the FP made a 4th-degree extension of the episiotomy. The baby weighed 10 lb 14 oz at birth. The mother has fecal and urinary incontinence and pain as a result of the large episiotomy. The child has a right-sided brachial plexus injury.

Parents’ claim Failure to perform cesarean delivery caused injury to the mother and child. The FP should have recognized from the mother’s history of delivering 3 macrosomic babies and the progress of this pregnancy, that the baby was large.

Defendant’s defense The case was settled during trial.

Verdict A $1.5 million Minnesota settlement was reached that included $1.2 million for the child and $300,000 for the mother.

Surgical table folds during hysterectomy: $5.3M verdict
While a woman was undergoing a hysterectomy, the surgical table she was lying on folded up into a “U” position, causing the inserted speculum to tear the patient from vagina to rectum. The fall also caused a back injury usually attributed to falls from great distances. The patient has permanent pain, recurring diarrhea, and depression as a result of the injuries.

Patient’s claim The injuries occurred because of the defendants’ failure to read, understand, and follow the warning labels on the surgical table.

Defendant’s defense The case was settled before trial.

Verdict A $5.3 million settlement was reached with the hospital.

Signs of chorioamnionitis ignored? $3.5M settlement
At 31 weeks’ gestation, a mother at risk for preterm labor was admitted to the hospital for 2 days. Examination and test results showed evidence of infection. She was given antenatal corticosteroids for fetal lung development in case of premature delivery. At discharge, bed rest was ordered and she complied. At 32 weeks’ gestation, she returned to the hospital with worsening symptoms, was prescribed antibiotics to treat a urinary tract infection, and was discharged. She went to the hospital a third time at almost 33 weeks’ gestation, experiencing contractions and leaking fluid. She was admitted with a plan to deliver the baby if any signs or symptoms of intra-amniotic infection (clinical chorioamnionitis) were present. Four days later, a cesarean delivery was ordered due to fetal tachycardia and decreased fetal heart rate. Imaging results performed in the neonatal intensive care unit showed that the baby received a brain injury. The child has physical and mental impairments including cerebral palsy, cortical blindness, and epilepsy.

Parents’ claim Hospital health care providers failed to communicate with each other or to obtain records from prior admissions, although the mother told them that she had been to the hospital twice within the past 2 weeks. Medical records from all 3 admissions showed clear signs and symptoms of a vaginal/cervical infection that had progressed to clinical chorioamnionitis 2 days before delivery. Examination of the placenta by a pathologist confirmed that the infection had spread to the umbilical cord, injuring the child.

Defendant’s defense The standard of care was met. There was no indication that an earlier delivery was needed.

Verdict A $3.5 million Michigan settlement was reached by the hospital during the trial.

Surgical approach questioned
A woman went to her ObGyn for tubal ligation and ventral hernia repair. The patient was concerned about infection and scarring. She agreed to a laparoscopic procedure, knowing that the procedure might have to be altered to laparotomy.

Patient’s claim The patient consented to laparoscopic surgery. However, surgery did not begin as laparoscopy but as an open procedure. The patient has a 6-inch scar on her abdomen. She accused both the ObGyn and the hospital of lack of informed consent for laparotomy.

Defendant’s defense The hospital claimed that their nurses’ role was to read the consent form signed by the patient in the ObGyn’s office. The ObGyn claimed that the patient signed a general consent form that permitted him to do what was reasonable. He had determined after surgery began that a laparoscopic procedure would have been more dangerous.

Verdict A $150,000 Louisiana verdict was returned against the ObGyn; the hospital was acquitted.

Macrosomic baby and mother both injured during delivery
Delivery of a mother’s fourth child was managed by a hospital-employed family physician (FP). Shoulder dystocia was encountered, and the FP made a 4th-degree extension of the episiotomy. The baby weighed 10 lb 14 oz at birth. The mother has fecal and urinary incontinence and pain as a result of the large episiotomy. The child has a right-sided brachial plexus injury.

Parents’ claim Failure to perform cesarean delivery caused injury to the mother and child. The FP should have recognized from the mother’s history of delivering 3 macrosomic babies and the progress of this pregnancy, that the baby was large.

Defendant’s defense The case was settled during trial.

Verdict A $1.5 million Minnesota settlement was reached that included $1.2 million for the child and $300,000 for the mother.

Surgical table folds during hysterectomy: $5.3M verdict
While a woman was undergoing a hysterectomy, the surgical table she was lying on folded up into a “U” position, causing the inserted speculum to tear the patient from vagina to rectum. The fall also caused a back injury usually attributed to falls from great distances. The patient has permanent pain, recurring diarrhea, and depression as a result of the injuries.

Patient’s claim The injuries occurred because of the defendants’ failure to read, understand, and follow the warning labels on the surgical table.

Defendant’s defense The case was settled before trial.

Verdict A $5.3 million settlement was reached with the hospital.

Physicians paid about the same in liability insurance premiums in 2015 as in 2014, and analysts don’t see costs changing anytime soon. A nationwide survey of insurers by the Medical Liability Monitor shows that 71% of insurance premiums did not change this year, while 17% of rates rose and 12% fell.

Internists experienced an average premium increase of 0.6% in 2015, while general surgeons saw a 0.2% average rate decrease, and ob.gyns experienced an average 0.5% rate increase.

The static premium market is being largely driven by the low number of lawsuits filed by patients and family members in recent years, said survey coauthor Paul Greve Jr., executive vice president/senior consultant for the Willis Health Care Practice, a global risk management consultant firm.

“It’s amazing to see the continuing stability in claim frequency,” Mr. Greve said in an interview. “The claims counts are just not rising. Its great for the industry, and it’s great for physicians, but it is puzzling because you wonder what has caused what amounts to a sea change in the attitudes of the general public toward malpractice litigation such that the claim counts were drop off.”

Premiums continue to vary geographically. Southern Florida internists for example, will pay $47,707 for malpractice insurance this year, while their counterparts in Minnesota will pay $3,375. For ob.gyns., premiums range from $214,999 in southern New York to $16,240 in central California. General surgeons in Southern Florida will pay $190,829 this year, while Wisconsin surgeons will pay $10,868.

Various factors influence premium amounts, including the overall legal climate and the rate of insurer competition in each state, said Susan J. Forray, principal and consulting actuary with the Milwaukee office of Milliman, a global provider of actuarial services.

“The dollar amounts themselves are a function of the litigation environment [and] the cost level of medicine or living within the state,” Ms. Forray said in an interview. “In terms of rate changes, we are seeing certain environments where there is more competition. Obviously, those more competitive markets are more likely to have rate decreases or perhaps, stable rates, where perhaps markets with less competition are more likely to see increased rates.”

On a regional basis, Southern physicians experienced the largest rate increases, while doctors in the Northeast, West, and Midwest continued to see decreases. The Midwest’s 0.8% rate decrease was the largest decline, while Western states experienced a 0.2% average rate decrease. On average, the South showed a rate increase of 0.9% and the Northeast experienced a 0.1% average decrease. Doctors in Georgia, North Carolina, and Texas saw rate increases in excess of 5%, while Iowa physicians experienced an 11% rate decrease. Only three western states experienced rate increases: New Mexico at 2.5%, Oregon at 2%, and Idaho at 1%. Premium changes for Northeastern doctors fluctuated from Rhode Island’s 7% increase to Pennsylvania’s 8% decrease. Additionally, for the first time in 8 years, the premium market experienced an average overall increase of 0.3% in 2015, compared with an average overall decrease of 1.5% last year.

The jury is still out on how the Affordable Care Act and other health reforms will impact the malpractice premium market, according to Mr. Greve. He said that he believes the majority of upcoming health reforms will improve patient safety, thus reducing liability for doctors. However, as more physicians become part of larger networks to deliver new models of care, their contractual liability spreads, he said. However, as value-based care becomes the law of the land, new claims could arise.

“We’re just beginning to see the tip of the iceberg here,” Mr. Greve said. “In the past, it was overutilization, [the claim] that you did something in order to put money in your pocket. With putting providers at financial risk with capitated or bundled payments or global payments, then the argument is going to be, ‘You didn’t deliver enough care,’ or ‘You [used that device] because it was less expensive.’ ”

The MLM survey, published yearly in October, gathered July 1 premium data from the major malpractice insurers and examines rates for mature, claims-made policies with $1 million/$3 million limits for internists, general surgeons, and ob.gyns.

[email protected]

On Twitter @legal_med

Physicians paid about the same in liability insurance premiums in 2015 as in 2014, and analysts don’t see costs changing anytime soon. A nationwide survey of insurers by the Medical Liability Monitor shows that 71% of insurance premiums did not change this year, while 17% of rates rose and 12% fell.

Internists experienced an average premium increase of 0.6% in 2015, while general surgeons saw a 0.2% average rate decrease, and ob.gyns experienced an average 0.5% rate increase.

The static premium market is being largely driven by the low number of lawsuits filed by patients and family members in recent years, said survey coauthor Paul Greve Jr., executive vice president/senior consultant for the Willis Health Care Practice, a global risk management consultant firm.

“It’s amazing to see the continuing stability in claim frequency,” Mr. Greve said in an interview. “The claims counts are just not rising. Its great for the industry, and it’s great for physicians, but it is puzzling because you wonder what has caused what amounts to a sea change in the attitudes of the general public toward malpractice litigation such that the claim counts were drop off.”

Premiums continue to vary geographically. Southern Florida internists for example, will pay $47,707 for malpractice insurance this year, while their counterparts in Minnesota will pay $3,375. For ob.gyns., premiums range from $214,999 in southern New York to $16,240 in central California. General surgeons in Southern Florida will pay $190,829 this year, while Wisconsin surgeons will pay $10,868.

Various factors influence premium amounts, including the overall legal climate and the rate of insurer competition in each state, said Susan J. Forray, principal and consulting actuary with the Milwaukee office of Milliman, a global provider of actuarial services.

“The dollar amounts themselves are a function of the litigation environment [and] the cost level of medicine or living within the state,” Ms. Forray said in an interview. “In terms of rate changes, we are seeing certain environments where there is more competition. Obviously, those more competitive markets are more likely to have rate decreases or perhaps, stable rates, where perhaps markets with less competition are more likely to see increased rates.”

On a regional basis, Southern physicians experienced the largest rate increases, while doctors in the Northeast, West, and Midwest continued to see decreases. The Midwest’s 0.8% rate decrease was the largest decline, while Western states experienced a 0.2% average rate decrease. On average, the South showed a rate increase of 0.9% and the Northeast experienced a 0.1% average decrease. Doctors in Georgia, North Carolina, and Texas saw rate increases in excess of 5%, while Iowa physicians experienced an 11% rate decrease. Only three western states experienced rate increases: New Mexico at 2.5%, Oregon at 2%, and Idaho at 1%. Premium changes for Northeastern doctors fluctuated from Rhode Island’s 7% increase to Pennsylvania’s 8% decrease. Additionally, for the first time in 8 years, the premium market experienced an average overall increase of 0.3% in 2015, compared with an average overall decrease of 1.5% last year.

The jury is still out on how the Affordable Care Act and other health reforms will impact the malpractice premium market, according to Mr. Greve. He said that he believes the majority of upcoming health reforms will improve patient safety, thus reducing liability for doctors. However, as more physicians become part of larger networks to deliver new models of care, their contractual liability spreads, he said. However, as value-based care becomes the law of the land, new claims could arise.

“We’re just beginning to see the tip of the iceberg here,” Mr. Greve said. “In the past, it was overutilization, [the claim] that you did something in order to put money in your pocket. With putting providers at financial risk with capitated or bundled payments or global payments, then the argument is going to be, ‘You didn’t deliver enough care,’ or ‘You [used that device] because it was less expensive.’ ”

The MLM survey, published yearly in October, gathered July 1 premium data from the major malpractice insurers and examines rates for mature, claims-made policies with $1 million/$3 million limits for internists, general surgeons, and ob.gyns.

[email protected]

On Twitter @legal_med

Physicians paid about the same in liability insurance premiums in 2015 as in 2014, and analysts don’t see costs changing anytime soon. A nationwide survey of insurers by the Medical Liability Monitor shows that 71% of insurance premiums did not change this year, while 17% of rates rose and 12% fell.

Internists experienced an average premium increase of 0.6% in 2015, while general surgeons saw a 0.2% average rate decrease, and ob.gyns experienced an average 0.5% rate increase.

The static premium market is being largely driven by the low number of lawsuits filed by patients and family members in recent years, said survey coauthor Paul Greve Jr., executive vice president/senior consultant for the Willis Health Care Practice, a global risk management consultant firm.

“It’s amazing to see the continuing stability in claim frequency,” Mr. Greve said in an interview. “The claims counts are just not rising. Its great for the industry, and it’s great for physicians, but it is puzzling because you wonder what has caused what amounts to a sea change in the attitudes of the general public toward malpractice litigation such that the claim counts were drop off.”

Premiums continue to vary geographically. Southern Florida internists for example, will pay $47,707 for malpractice insurance this year, while their counterparts in Minnesota will pay $3,375. For ob.gyns., premiums range from $214,999 in southern New York to $16,240 in central California. General surgeons in Southern Florida will pay $190,829 this year, while Wisconsin surgeons will pay $10,868.

Various factors influence premium amounts, including the overall legal climate and the rate of insurer competition in each state, said Susan J. Forray, principal and consulting actuary with the Milwaukee office of Milliman, a global provider of actuarial services.

“The dollar amounts themselves are a function of the litigation environment [and] the cost level of medicine or living within the state,” Ms. Forray said in an interview. “In terms of rate changes, we are seeing certain environments where there is more competition. Obviously, those more competitive markets are more likely to have rate decreases or perhaps, stable rates, where perhaps markets with less competition are more likely to see increased rates.”

On a regional basis, Southern physicians experienced the largest rate increases, while doctors in the Northeast, West, and Midwest continued to see decreases. The Midwest’s 0.8% rate decrease was the largest decline, while Western states experienced a 0.2% average rate decrease. On average, the South showed a rate increase of 0.9% and the Northeast experienced a 0.1% average decrease. Doctors in Georgia, North Carolina, and Texas saw rate increases in excess of 5%, while Iowa physicians experienced an 11% rate decrease. Only three western states experienced rate increases: New Mexico at 2.5%, Oregon at 2%, and Idaho at 1%. Premium changes for Northeastern doctors fluctuated from Rhode Island’s 7% increase to Pennsylvania’s 8% decrease. Additionally, for the first time in 8 years, the premium market experienced an average overall increase of 0.3% in 2015, compared with an average overall decrease of 1.5% last year.

The jury is still out on how the Affordable Care Act and other health reforms will impact the malpractice premium market, according to Mr. Greve. He said that he believes the majority of upcoming health reforms will improve patient safety, thus reducing liability for doctors. However, as more physicians become part of larger networks to deliver new models of care, their contractual liability spreads, he said. However, as value-based care becomes the law of the land, new claims could arise.

“We’re just beginning to see the tip of the iceberg here,” Mr. Greve said. “In the past, it was overutilization, [the claim] that you did something in order to put money in your pocket. With putting providers at financial risk with capitated or bundled payments or global payments, then the argument is going to be, ‘You didn’t deliver enough care,’ or ‘You [used that device] because it was less expensive.’ ”

The MLM survey, published yearly in October, gathered July 1 premium data from the major malpractice insurers and examines rates for mature, claims-made policies with $1 million/$3 million limits for internists, general surgeons, and ob.gyns.

[email protected]

On Twitter @legal_med

A 54-year-old woman with chronic renal disease was diagnosed with gout and prescribed allopurinol. Two days later, she was evaluated by her nephrologist, whom she informed about her new medication.

Subsequently, the patient developed fever and rash. Laboratory analysis indicated elevated transaminase levels and eosinophilia. She was admitted to the hospital.

During her stay, an infectious disease consultation was obtained, and the allopurinol was discontinued. When the patient’s condition improved, she was discharged.

Following discharge, the patient resumed taking allopurinol, and her rash returned. Eleven days later, she returned to the hospital, where she was diagnosed with toxic epidermal necrolysis. She was found to have a desquamating rash covering 62% of her body. The patient was transferred to a burn center but eventually succumbed to multi-organ failure.

The patient’s estate filed a medical malpractice lawsuit against the nephrologist alleging negligence—specifically, failure to diagnose toxic epidermal necrolysis and failure to review her medications more carefully.

Continue for the outcome >>

OUTCOME
A $5.1 million verdict was returned against the nephrologist.

COMMENT
Many medications cause rash and are subsequently withdrawn; in a few cases, the effects are life threatening. Toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS) are relatively uncommon but potentially fatal examples.

From the limited facts presented, we know that a 54-year-old woman with established renal disease of unknown magnitude was prescribed allopurinol for gout and consulted the nephrologist two days later. It is unclear if the patient had the rash during the first visit with her nephrologist. But we do know that she was eventually admitted and maintained on allopurinol while she had the rash, pending infectious disease consultation. At some point, the allopurinol was apparently stopped and the rash improved. After discharge, the patient resumed taking allopurinol. The rash not only returned but also worsened, necessitating her readmission to a burn center.

TEN, like SJS, is often induced by certain medications, including sulfonamides, macrolides, penicillins, and quinolones. Allopur­inol, phenobarbital, phenytoin, carbamazepine, valproic acid, and lamotrigine are frequently implicated as well.

TEN is rare but serious. The initial presentation may be subtle, with influenza-like symptoms such as malaise, fever, cough, rhinitis, headache, and arthralgia—and the most discriminating sign: rash.

The rash begins as a poorly defined, erythematous macular rash with purpuric centers. The lesions predominate on the torso and face, sparing the scalp. Mucosal membranes are involved in more than 90% of cases.¹ Pain at the site of the skin lesions is often the predominate symptom and is often out of proportion to physical findings. Over a period of hours to days, the rash coalesces to form flaccid blisters and sheetlike epidermal detachment.² In established cases, patients will nearly universally demonstrate Nikolsky’s sign: Mild frictional contact with the skin results in epithelial desquamation and immediate blistering.

Management involves immediate withdrawal of the offending agent and hospitalization for aggressive management. The mortality rate is high (30% to 60%³) and generally attributed to sepsis or multi-organ failure.

As clinicians, we are sometimes hesitant to label a rash allergic—thereby forever disqualifying an entire class of useful agents from that patient. However, in this case, the fact that the rash occurred simultaneously with a constellation of signs and symptoms perhaps made the rash appear to be part of an infectious process and not a drug-induced reaction. That is the challenge with TEN and SJS: The symptoms are subtle, flu-like, and confounding.

Here, the nephrologist apparently did not take action to stop the allopurinol after the patient first developed the rash. The jury was persuaded that a reasonably prudent clinician would have recognized the clinical presentation and stopped the allopurinol—and certainly not restarted it following discharge (especially after the allopurinol was stopped in the hospital and the rash began to improve).

This case brings to mind two physicians from my training who made an impression. The first was a second-year internal medicine resident. I remember quietly remarking to another student during rounds, “He is really good.” Overhearing, an attending physician answered, “He is really good because in his workup he always considers a presentation as a function of an underlying process, and walks through each of those processes in formulating his differential.”

“Walking through” various disease categories forces the clinician to consider them all: infectious, autoimmune, neoplastic, environmental/toxic, vascular, traumatic, metabolic, inflammatory. In challenging cases, I’ve found it helpful to step backward into those broad basic categories of disease and reconsider the clinical picture.

Here, doing so may have allowed the clinician to reconsider inflammatory and autoimmune processes and revisit the possibility of iatrogenic toxic/environmental causes (ie, the allopurinol). Perhaps the outcome of this case would have been different.

The second physician was a nephrology fellow, who left me with this piece of wisdom: “When in doubt, blame the drug.” Since nephrologists are expert drug-blamers, I suspect the early stages of this unfortunate case presented a clinical challenge.

IN SUM 
Before you “missile lock” onto a diagnosis, take a mental step back to consider broad categories of disease. —DML

REFERENCES
1. Letko E, Papaliodis DN, Papaliodis GN, et al. Stevens-Johnson syndrome and toxic epidermal necrolysis: a review of the literature. Ann Allergy Asthma Immunol. 2005;94(4):419-436.
2. Cohen V, Jellinek SP, Schwartz RA, et al. Toxic epidermal necrolysis.  Medscape; 2013. emedicine.medscape.com/article/229698-overview. Accessed September 16, 2015.
3. Schulz JT, Sheridan RL, Ryan CM, et al. A 10-year experience with toxic epidermal necrolysis. J Burn Care Rehabil. 2000;21(3): 199-204.

A 54-year-old woman with chronic renal disease was diagnosed with gout and prescribed allopurinol. Two days later, she was evaluated by her nephrologist, whom she informed about her new medication.

Subsequently, the patient developed fever and rash. Laboratory analysis indicated elevated transaminase levels and eosinophilia. She was admitted to the hospital.

During her stay, an infectious disease consultation was obtained, and the allopurinol was discontinued. When the patient’s condition improved, she was discharged.

Following discharge, the patient resumed taking allopurinol, and her rash returned. Eleven days later, she returned to the hospital, where she was diagnosed with toxic epidermal necrolysis. She was found to have a desquamating rash covering 62% of her body. The patient was transferred to a burn center but eventually succumbed to multi-organ failure.

The patient’s estate filed a medical malpractice lawsuit against the nephrologist alleging negligence—specifically, failure to diagnose toxic epidermal necrolysis and failure to review her medications more carefully.

Continue for the outcome >>

OUTCOME
A $5.1 million verdict was returned against the nephrologist.

COMMENT
Many medications cause rash and are subsequently withdrawn; in a few cases, the effects are life threatening. Toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS) are relatively uncommon but potentially fatal examples.

From the limited facts presented, we know that a 54-year-old woman with established renal disease of unknown magnitude was prescribed allopurinol for gout and consulted the nephrologist two days later. It is unclear if the patient had the rash during the first visit with her nephrologist. But we do know that she was eventually admitted and maintained on allopurinol while she had the rash, pending infectious disease consultation. At some point, the allopurinol was apparently stopped and the rash improved. After discharge, the patient resumed taking allopurinol. The rash not only returned but also worsened, necessitating her readmission to a burn center.

TEN, like SJS, is often induced by certain medications, including sulfonamides, macrolides, penicillins, and quinolones. Allopur­inol, phenobarbital, phenytoin, carbamazepine, valproic acid, and lamotrigine are frequently implicated as well.

TEN is rare but serious. The initial presentation may be subtle, with influenza-like symptoms such as malaise, fever, cough, rhinitis, headache, and arthralgia—and the most discriminating sign: rash.

The rash begins as a poorly defined, erythematous macular rash with purpuric centers. The lesions predominate on the torso and face, sparing the scalp. Mucosal membranes are involved in more than 90% of cases.¹ Pain at the site of the skin lesions is often the predominate symptom and is often out of proportion to physical findings. Over a period of hours to days, the rash coalesces to form flaccid blisters and sheetlike epidermal detachment.² In established cases, patients will nearly universally demonstrate Nikolsky’s sign: Mild frictional contact with the skin results in epithelial desquamation and immediate blistering.

Management involves immediate withdrawal of the offending agent and hospitalization for aggressive management. The mortality rate is high (30% to 60%³) and generally attributed to sepsis or multi-organ failure.

As clinicians, we are sometimes hesitant to label a rash allergic—thereby forever disqualifying an entire class of useful agents from that patient. However, in this case, the fact that the rash occurred simultaneously with a constellation of signs and symptoms perhaps made the rash appear to be part of an infectious process and not a drug-induced reaction. That is the challenge with TEN and SJS: The symptoms are subtle, flu-like, and confounding.

Here, the nephrologist apparently did not take action to stop the allopurinol after the patient first developed the rash. The jury was persuaded that a reasonably prudent clinician would have recognized the clinical presentation and stopped the allopurinol—and certainly not restarted it following discharge (especially after the allopurinol was stopped in the hospital and the rash began to improve).

This case brings to mind two physicians from my training who made an impression. The first was a second-year internal medicine resident. I remember quietly remarking to another student during rounds, “He is really good.” Overhearing, an attending physician answered, “He is really good because in his workup he always considers a presentation as a function of an underlying process, and walks through each of those processes in formulating his differential.”

“Walking through” various disease categories forces the clinician to consider them all: infectious, autoimmune, neoplastic, environmental/toxic, vascular, traumatic, metabolic, inflammatory. In challenging cases, I’ve found it helpful to step backward into those broad basic categories of disease and reconsider the clinical picture.

Here, doing so may have allowed the clinician to reconsider inflammatory and autoimmune processes and revisit the possibility of iatrogenic toxic/environmental causes (ie, the allopurinol). Perhaps the outcome of this case would have been different.

The second physician was a nephrology fellow, who left me with this piece of wisdom: “When in doubt, blame the drug.” Since nephrologists are expert drug-blamers, I suspect the early stages of this unfortunate case presented a clinical challenge.

IN SUM 
Before you “missile lock” onto a diagnosis, take a mental step back to consider broad categories of disease. —DML

REFERENCES
1. Letko E, Papaliodis DN, Papaliodis GN, et al. Stevens-Johnson syndrome and toxic epidermal necrolysis: a review of the literature. Ann Allergy Asthma Immunol. 2005;94(4):419-436.
2. Cohen V, Jellinek SP, Schwartz RA, et al. Toxic epidermal necrolysis.  Medscape; 2013. emedicine.medscape.com/article/229698-overview. Accessed September 16, 2015.
3. Schulz JT, Sheridan RL, Ryan CM, et al. A 10-year experience with toxic epidermal necrolysis. J Burn Care Rehabil. 2000;21(3): 199-204.

A 54-year-old woman with chronic renal disease was diagnosed with gout and prescribed allopurinol. Two days later, she was evaluated by her nephrologist, whom she informed about her new medication.

Subsequently, the patient developed fever and rash. Laboratory analysis indicated elevated transaminase levels and eosinophilia. She was admitted to the hospital.

During her stay, an infectious disease consultation was obtained, and the allopurinol was discontinued. When the patient’s condition improved, she was discharged.

Following discharge, the patient resumed taking allopurinol, and her rash returned. Eleven days later, she returned to the hospital, where she was diagnosed with toxic epidermal necrolysis. She was found to have a desquamating rash covering 62% of her body. The patient was transferred to a burn center but eventually succumbed to multi-organ failure.

The patient’s estate filed a medical malpractice lawsuit against the nephrologist alleging negligence—specifically, failure to diagnose toxic epidermal necrolysis and failure to review her medications more carefully.

Continue for the outcome >>

OUTCOME
A $5.1 million verdict was returned against the nephrologist.

COMMENT
Many medications cause rash and are subsequently withdrawn; in a few cases, the effects are life threatening. Toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS) are relatively uncommon but potentially fatal examples.

From the limited facts presented, we know that a 54-year-old woman with established renal disease of unknown magnitude was prescribed allopurinol for gout and consulted the nephrologist two days later. It is unclear if the patient had the rash during the first visit with her nephrologist. But we do know that she was eventually admitted and maintained on allopurinol while she had the rash, pending infectious disease consultation. At some point, the allopurinol was apparently stopped and the rash improved. After discharge, the patient resumed taking allopurinol. The rash not only returned but also worsened, necessitating her readmission to a burn center.

TEN, like SJS, is often induced by certain medications, including sulfonamides, macrolides, penicillins, and quinolones. Allopur­inol, phenobarbital, phenytoin, carbamazepine, valproic acid, and lamotrigine are frequently implicated as well.

TEN is rare but serious. The initial presentation may be subtle, with influenza-like symptoms such as malaise, fever, cough, rhinitis, headache, and arthralgia—and the most discriminating sign: rash.

The rash begins as a poorly defined, erythematous macular rash with purpuric centers. The lesions predominate on the torso and face, sparing the scalp. Mucosal membranes are involved in more than 90% of cases.¹ Pain at the site of the skin lesions is often the predominate symptom and is often out of proportion to physical findings. Over a period of hours to days, the rash coalesces to form flaccid blisters and sheetlike epidermal detachment.² In established cases, patients will nearly universally demonstrate Nikolsky’s sign: Mild frictional contact with the skin results in epithelial desquamation and immediate blistering.

Management involves immediate withdrawal of the offending agent and hospitalization for aggressive management. The mortality rate is high (30% to 60%³) and generally attributed to sepsis or multi-organ failure.

As clinicians, we are sometimes hesitant to label a rash allergic—thereby forever disqualifying an entire class of useful agents from that patient. However, in this case, the fact that the rash occurred simultaneously with a constellation of signs and symptoms perhaps made the rash appear to be part of an infectious process and not a drug-induced reaction. That is the challenge with TEN and SJS: The symptoms are subtle, flu-like, and confounding.

Here, the nephrologist apparently did not take action to stop the allopurinol after the patient first developed the rash. The jury was persuaded that a reasonably prudent clinician would have recognized the clinical presentation and stopped the allopurinol—and certainly not restarted it following discharge (especially after the allopurinol was stopped in the hospital and the rash began to improve).

This case brings to mind two physicians from my training who made an impression. The first was a second-year internal medicine resident. I remember quietly remarking to another student during rounds, “He is really good.” Overhearing, an attending physician answered, “He is really good because in his workup he always considers a presentation as a function of an underlying process, and walks through each of those processes in formulating his differential.”

“Walking through” various disease categories forces the clinician to consider them all: infectious, autoimmune, neoplastic, environmental/toxic, vascular, traumatic, metabolic, inflammatory. In challenging cases, I’ve found it helpful to step backward into those broad basic categories of disease and reconsider the clinical picture.

Here, doing so may have allowed the clinician to reconsider inflammatory and autoimmune processes and revisit the possibility of iatrogenic toxic/environmental causes (ie, the allopurinol). Perhaps the outcome of this case would have been different.

The second physician was a nephrology fellow, who left me with this piece of wisdom: “When in doubt, blame the drug.” Since nephrologists are expert drug-blamers, I suspect the early stages of this unfortunate case presented a clinical challenge.

IN SUM 
Before you “missile lock” onto a diagnosis, take a mental step back to consider broad categories of disease. —DML

REFERENCES
1. Letko E, Papaliodis DN, Papaliodis GN, et al. Stevens-Johnson syndrome and toxic epidermal necrolysis: a review of the literature. Ann Allergy Asthma Immunol. 2005;94(4):419-436.
2. Cohen V, Jellinek SP, Schwartz RA, et al. Toxic epidermal necrolysis.  Medscape; 2013. emedicine.medscape.com/article/229698-overview. Accessed September 16, 2015.
3. Schulz JT, Sheridan RL, Ryan CM, et al. A 10-year experience with toxic epidermal necrolysis. J Burn Care Rehabil. 2000;21(3): 199-204.

Postpartum preeclampsia, mother dies: $6.9M settlement
Four days after delivery of a healthy child, a 31-year-old mother went to the emergency department (ED) reporting tightness in her chest, difficulty breathing, and swelling in her lower extremities. Pulmonary embolism was ruled out and she was discharged. When she returned 3 days later, her legs were more swollen than before and her systolic blood pressure was 160 mm Hg. She was sent home again. Four days later, she suffered a seizure at home, in the ambulance during transport, and at the hospital. She was transferred to another facility a few days later where she died a week after transfer.

Estate’s Claim The ED physicians and hospital staff were negligent in not diagnosing and treating postpartum preeclampsia. This led to seizures, brain damage, and death. Antihypertensive and antiseizure medications would have prevented her death.

Defendant’s defense The actions taken were reasonable because she had no symptoms of preeclampsia during pregnancy or delivery.

Verdict A $6.9 million Illinois settlement was reached.

Ovary not removed; cyst develops
A 38-year-old woman underwent what was planned as total hysterectomy with bilateral salpingo-oophorectomy. The procedure was prophylactic: she had been treated for stage 3 breast cancer and her family history put her at high risk for developing ovarian cancer. Two days after surgery, the pathology report noted only 1 ovary.

Two months later, the patient went to the ED with right lower quadrant pain. It was determined that she had an ovarian cyst. She underwent additional surgery to remove the right ovary.

Patient’s claim The gynecologist was negligent in failing to remove the patient’s right ovary.

Physician’s defense Failure to remove the ovary was due to the patient’s abnormal anatomy.

Verdict A $250,000 Missouri verdict was returned.

Microcephaly not detected before birth
At 19 weeks’ gestation, an ultrasonographic anatomy scan showed that both hands of the fetus were clenched tightly. Amniocentesis results were reported as normal. No further fetal testing was ordered.

At birth, the baby was found to have Dandy Walker Variant, a severe brain malformation. The child has difficulty moving, is cognitively impaired, and requires a feeding tube and 24-hour care.

Parents’ claim Seen on ultrasonography, the fetus’ clenched fists were a sign of possible fetal abnormality. The maternal-fetal medicine (MFM) specialist who evaluated the ultrasound and amniocentesis and the ObGyn should have recommended fetal magnetic resonance imaging, which would have shown the microcephaly. If the parents had known of the abnormality, they would have terminated the pregnancy.

Defendant’s defense The case was settled during trial.

Verdict A $6 million New Jersey settlement was reached, including 
$5 million from the MFM and 
$1 million from the ObGyn.

Injury during hydrothermal ablation
When a 41-year-old woman underwent hydrothermal ablation to treat menorrhagia, her uterus was perforated and hot saline solution injured her intestines. During repair surgery, 21 inches of bowel were resected and a colostomy was created, which was reversed 8 months later.

Patient’s claim The gynecologist was negligent in performing the ablation. The manufacturer produced a poorly designed device.

Defendant’s defense The rupture was spontaneous. The procedure was properly performed. The device is safe.

Verdict A $2 million Kansas verdict was returned. The gynecologist was found 60% at fault and the manufacturer was 40% at fault. The patient’s net recovery was $322,300 due to the state cap.
 

Postpartum preeclampsia, mother dies: $6.9M settlement
Four days after delivery of a healthy child, a 31-year-old mother went to the emergency department (ED) reporting tightness in her chest, difficulty breathing, and swelling in her lower extremities. Pulmonary embolism was ruled out and she was discharged. When she returned 3 days later, her legs were more swollen than before and her systolic blood pressure was 160 mm Hg. She was sent home again. Four days later, she suffered a seizure at home, in the ambulance during transport, and at the hospital. She was transferred to another facility a few days later where she died a week after transfer.

Estate’s Claim The ED physicians and hospital staff were negligent in not diagnosing and treating postpartum preeclampsia. This led to seizures, brain damage, and death. Antihypertensive and antiseizure medications would have prevented her death.

Defendant’s defense The actions taken were reasonable because she had no symptoms of preeclampsia during pregnancy or delivery.

Verdict A $6.9 million Illinois settlement was reached.

Ovary not removed; cyst develops
A 38-year-old woman underwent what was planned as total hysterectomy with bilateral salpingo-oophorectomy. The procedure was prophylactic: she had been treated for stage 3 breast cancer and her family history put her at high risk for developing ovarian cancer. Two days after surgery, the pathology report noted only 1 ovary.

Two months later, the patient went to the ED with right lower quadrant pain. It was determined that she had an ovarian cyst. She underwent additional surgery to remove the right ovary.

Patient’s claim The gynecologist was negligent in failing to remove the patient’s right ovary.

Physician’s defense Failure to remove the ovary was due to the patient’s abnormal anatomy.

Verdict A $250,000 Missouri verdict was returned.

Microcephaly not detected before birth
At 19 weeks’ gestation, an ultrasonographic anatomy scan showed that both hands of the fetus were clenched tightly. Amniocentesis results were reported as normal. No further fetal testing was ordered.

At birth, the baby was found to have Dandy Walker Variant, a severe brain malformation. The child has difficulty moving, is cognitively impaired, and requires a feeding tube and 24-hour care.

Parents’ claim Seen on ultrasonography, the fetus’ clenched fists were a sign of possible fetal abnormality. The maternal-fetal medicine (MFM) specialist who evaluated the ultrasound and amniocentesis and the ObGyn should have recommended fetal magnetic resonance imaging, which would have shown the microcephaly. If the parents had known of the abnormality, they would have terminated the pregnancy.

Defendant’s defense The case was settled during trial.

Verdict A $6 million New Jersey settlement was reached, including 
$5 million from the MFM and 
$1 million from the ObGyn.

Injury during hydrothermal ablation
When a 41-year-old woman underwent hydrothermal ablation to treat menorrhagia, her uterus was perforated and hot saline solution injured her intestines. During repair surgery, 21 inches of bowel were resected and a colostomy was created, which was reversed 8 months later.

Patient’s claim The gynecologist was negligent in performing the ablation. The manufacturer produced a poorly designed device.

Defendant’s defense The rupture was spontaneous. The procedure was properly performed. The device is safe.

Verdict A $2 million Kansas verdict was returned. The gynecologist was found 60% at fault and the manufacturer was 40% at fault. The patient’s net recovery was $322,300 due to the state cap.
 

Postpartum preeclampsia, mother dies: $6.9M settlement
Four days after delivery of a healthy child, a 31-year-old mother went to the emergency department (ED) reporting tightness in her chest, difficulty breathing, and swelling in her lower extremities. Pulmonary embolism was ruled out and she was discharged. When she returned 3 days later, her legs were more swollen than before and her systolic blood pressure was 160 mm Hg. She was sent home again. Four days later, she suffered a seizure at home, in the ambulance during transport, and at the hospital. She was transferred to another facility a few days later where she died a week after transfer.

Estate’s Claim The ED physicians and hospital staff were negligent in not diagnosing and treating postpartum preeclampsia. This led to seizures, brain damage, and death. Antihypertensive and antiseizure medications would have prevented her death.

Defendant’s defense The actions taken were reasonable because she had no symptoms of preeclampsia during pregnancy or delivery.

Verdict A $6.9 million Illinois settlement was reached.

Ovary not removed; cyst develops
A 38-year-old woman underwent what was planned as total hysterectomy with bilateral salpingo-oophorectomy. The procedure was prophylactic: she had been treated for stage 3 breast cancer and her family history put her at high risk for developing ovarian cancer. Two days after surgery, the pathology report noted only 1 ovary.

Two months later, the patient went to the ED with right lower quadrant pain. It was determined that she had an ovarian cyst. She underwent additional surgery to remove the right ovary.

Patient’s claim The gynecologist was negligent in failing to remove the patient’s right ovary.

Physician’s defense Failure to remove the ovary was due to the patient’s abnormal anatomy.

Verdict A $250,000 Missouri verdict was returned.

Microcephaly not detected before birth
At 19 weeks’ gestation, an ultrasonographic anatomy scan showed that both hands of the fetus were clenched tightly. Amniocentesis results were reported as normal. No further fetal testing was ordered.

At birth, the baby was found to have Dandy Walker Variant, a severe brain malformation. The child has difficulty moving, is cognitively impaired, and requires a feeding tube and 24-hour care.

Parents’ claim Seen on ultrasonography, the fetus’ clenched fists were a sign of possible fetal abnormality. The maternal-fetal medicine (MFM) specialist who evaluated the ultrasound and amniocentesis and the ObGyn should have recommended fetal magnetic resonance imaging, which would have shown the microcephaly. If the parents had known of the abnormality, they would have terminated the pregnancy.

Defendant’s defense The case was settled during trial.

Verdict A $6 million New Jersey settlement was reached, including 
$5 million from the MFM and 
$1 million from the ObGyn.

Injury during hydrothermal ablation
When a 41-year-old woman underwent hydrothermal ablation to treat menorrhagia, her uterus was perforated and hot saline solution injured her intestines. During repair surgery, 21 inches of bowel were resected and a colostomy was created, which was reversed 8 months later.

Patient’s claim The gynecologist was negligent in performing the ablation. The manufacturer produced a poorly designed device.

Defendant’s defense The rupture was spontaneous. The procedure was properly performed. The device is safe.

Verdict A $2 million Kansas verdict was returned. The gynecologist was found 60% at fault and the manufacturer was 40% at fault. The patient’s net recovery was $322,300 due to the state cap.
 

The problem is enormous: Heart disease is the lead­ing cause of death in the United States, and coronary artery disease (CAD) is the most common form of heart disease—responsible for 385,000 deaths in the United States in 2009 (http://www.cdc.gov/heartdisease/facts. htm). Patients with psychiatric illness have higher rates of morbidity and mortality from CAD than the general popu­lation, and warrant consideration as a special population. You should be familiar with routine cardiac medications; your patients’ medical problems; potential cardiac-related interactions among their psychotropic medications; and interactions among illnesses in their mental health and medical health domains (Box).

CASE Type 2 diabetes mellitus plus a long history of heavy smoking
Ms. S, age 57, is an African American woman with chronic para­noid schizophrenia who has been seeing a psychiatrist for the past 10 years. Ms. S’s psychiatric symptoms have been well con­trolled on risperidone, 3 mg/d.

Ms. S has a family history of diabetes, hypertension, and early CAD (a brother died of a myocardial infarction [MI] in his late 40s). She continues to smoke 2 packs of unfiltered ciga­rettes daily, as she has done for the past 40 years.

The psychiatrist has been following American Diabetes Association/American Psychiatric Association guidelines for monitoring; he has noticed that Ms. S’s body mass index (BMI) has increased from 27 to 31 kg/m² over the past year. She has devel­oped type 2 diabetes mellitus (T2DM).

At today’s visit, Ms. S arrives a few minutes late and appears flustered and out of breath. She explains that she had to climb a flight of stairs to get to office because the elevator is broken.

During the visit, the psychiatrist notes that Ms. S occasionally winces and massages her left shoulder.

Questions to ponder
   • What else could the psychiatrist do to modify Ms. S’s cardiac risk factors?
   • What is Ms. S’s 10-year risk of an acute coronary event?
   • What should her physician do now?
 

Overview: Cardiac risk in patients with mental illness
Modifiable risks for CAD include hyperten­sion, hypercholesterolemia, T2DM, obesity (all of which, taken together, constitute the metabolic syndrome), smoking, and a sed­entary lifestyle. Some risk factors, including sex, age, and family history, are not modifi­able. Whether or not this modification leads to better outcomes, psychiatric comorbid­ity is associated with higher morbidity and mortality from CAD.

Whether a common underlying patho­logical process manifesting in both CAD and mental illness exists, or whether the association is causal, are not well understood. Symptoms characteristic of depression (apathy, amotivation) and schizophrenia (disorganization, paranoia) could lead to poor self-care or impaired adherence to programs designed to lower CAD risk factors.^1,2

People with mental illness smoke at a higher rate than those who do not have mental illness.³ This finding is of particu­lar relevance because smoking contributes to worse outcomes with respect to CAD, even when medications are prescribed to address metabolic risks.⁴

Lower socioeconomic status is associ­ated with poorer prognosis from CAD⁵ and is a risk factor for depression.⁶ Depression is a strong independent pre­dictor of worse survival in acute coro­nary syndromes.⁵ Some experts consider depression to be a stronger risk factor for MI than traditional medical risk factors such as obesity, hypertension, and second-hand smoke.⁷

Interventions used to treat certain men­tal illnesses can exacerbate, or predispose to, metabolic syndrome (which, in turn, increases the risk of CAD). Although some studies have demonstrated meta­bolic derangements in medication-naïve patients who have a new diagnosis of schizophrenia,⁸ there is a clearly established association between second-generation antipsychotic use and obesity, hyperten­sion, hyperlipidemia, and T2DM. This asso­ciation prompted development in 2004 of consensus recommendations for cardiovas­cular monitoring of patients who are taking an atypical antipsychotic.⁹ 

Some studies suggest that the stress of mental illness contributes to the pathogen­ esis of CAD.⁸ Hypothesized mechanisms include:
   • sympathetic activation
   • vagal deactivation
   • platelet activation
   • hypothalamic-pituitary-adrenocorti­cal pathways
   • anticholinergic mechanisms
   • inflammatory mediators, including cytokines.

Mental stress itself has the capacity to induce coronary ischemia.¹⁰ The mental stress of psychiatric illness could have an important pathophysiologic role in CAD. It can be tempting to disregard chest pain in a patient who is known to have panic disorder, but that patient might in fact be experiencing stress-induced myocardial ischemia.¹¹

As many as 30% to 40% of patients with CAD suffer from clinically signifi­cant symptoms of depression; as many as 20% of patients with CAD meet criteria for major depressive disorder, compared with 5% to 10% of people who do not have CAD.2 Depression post-MI has been asso­ciated with a higher rate of sudden cardiac death and worse outcomes.¹²

Anxiety also can portend worse outcomes from CAD,¹³ including higher all-cause mor­tality.¹⁴ There is some hope, but limited evi­dence, that treating depression and anxiety, whether with antidepressant medication or behavioral therapy, can improve CAD outcomes.^10,15

Making a diagnosis of CAD
CAD can present in a variety of ways, ranging from unrecog­nized or so-called silent CAD (there is an association between T2DM and unrecognized CAD and between hypertension and unrecognized CAD) to stable angina, unstable angina, acute coronary syndrome, MI, and sudden cardiac death. A vari­ety of abnormalities on resting and exercise electrocardiogram (ECG), including ST segment depression, ST elevation, Q waves, and other morphological changes are indicative of CAD.

Other modalities, including coronary calcification score on computed tomogra­phy and coronary angiography can con­firm the presence of CAD. Some clinicians recommend periodic ECG treadmill test­ing in patients who have:
   • a total cholesterol level is >240 mg/dL
   • systolic blood pressure >140 mm Hg, diastolic blood pressure >90 mm Hg, or both
   • a family history of MI or sudden car­diac death in young (age <60) first-degree relatives
   • a history of smoking
   • diabetes.

Preventive guidelines
Risk stratification. A low (<10%), mod­erate (10% to 20%), or high (>20%) 10-year risk of CAD can be ascertained using a risk calculator, such as one that is available through the Framingham Heart Study (Figure) and the National Heart, Lung, and Blood Institute (http://cvdrisk.nhlbi. nih.gov). Because patients with risk factors for CAD should be offered interventions— including smoking cessation therapy, diet and exercise, aspirin, lipid-lowering ther­apy, and blood pressure modification strate­gies—whether or not they have evidence of CAD, the United States Preventive Services Task Force does not recommend for or against diagnostic screening in patients at moderate or elevated risk of CAD.¹⁶

There are guidelines in the literature rec­ommending specific screening strategies for patients with mental illness, although the vetting and update process has been ill defined. Among patients with schizophre­nia, though, regardless of antipsychotic pre­scription status, baseline and then regular monitoring of metabolic risk parameters is recommended.¹⁷

Primary prevention. Lifestyle modification and attention to modifiable coronary risk factors are important primary prevention strategies. Dietary modifications, exercise, not smoking, and maintenance of a nor­mal BMI (<25 kg/m2) are associated with a lower risk of CAD.^18,19

Lifestyle modifications can be challeng­ing for patients with persistent mental illness, however: For example, patients with schizophrenia smoke more, eat less healthfully, and participate less in behavioral modification that targets risk factors than patients who do not have schizophrenia.^20,21

According to 2012 evidence-based prac­tice guidelines established by a collabora­tion that included the American College of Physicians and several cardiology and thoracic medicine societies, persons age >50 who do not have symptomatic CAD should take low-dose (75 to 100 mg/d) aspirin; the benefit of low-dose aspirin in persons at moderate or high risk of CAD is even greater. Other medications, includ­ing statins and fixed-dose combinations of antihypertensive medications in combina­tion with a statin are not clearly beneficial as primary prevention strategies across the board, although selected high-risk popula­tions might benefit.

Regrettably, the high-risk population of persons with mental illness and whose pri­mary care is suboptimal has not been stud­ied. It stands to reason that these patients would especially benefit from more atten­tive monitoring and intervention.

Collaborative care? Although many psy­chiatrists do not practice in such a model, a comprehensive approach to the care of their patients, using a collaborative care strategy that includes attention to the mental health diagnosis along with medical health, can result in improved health in both domains.²² However, enlisting patients with paranoia or an inherent distrust of medications and health care providers to adhere to either a medication regimen or lifestyle modification can be challenging.

Common-sense strategies, such as creat­ing a multidisciplinary team with the psy­chiatrist coordinating care and optimizing antipsychotic treatment, might provide ben­efit.¹ Data demonstrate that patients with severe mental illness who experience acute coronary events undergo revascularization at a lower rate than their mentally heathy counterparts, despite the fact that patients with severe mental illness die at a higher rate from their CAD than patients who do not have mental illness. An important role for the psychiatrist, even in the absence of a collaborative care program, is to be an advo­cate for appropriate guideline-based care.²³

Secondary prevention. Once a patient develops CAD, ongoing risk factor modifi­cation is important. Adherence to a thera­peutic regimen that variously combines a platelet inhibitor, beta blocker, statin, and angiotensin-converting enzyme (ACE) inhibitor is associated with improved out­comes in patients with CAD.²⁴ Specific antiplatelet recommendations and a rec­ommendation for single vs combination antiplatelet therapy depends on chronicity and type of revascularization in a setting of CAD.²⁵

Summary of guideline-based recommendations
Treatment guidelines published in the National Guidelines Clearinghouse address depression, CAD screening, and specific cardiac therapies, including ACE inhibitors, angiotensin-receptor blockers, oral anticoag­ulants, platelet inhibitors, beta blockers, and lifestyle modification.

Primary prevention. Recommendations for treatment to prevent CAD are listed in Table 1.

Secondary prevention. Recommendations for treatment after a diagnosis of CAD are listed in Table 2.

Special considerations for psychiatric providers
You should be comfortable with patients’ use of antihypertensive therapies and familiar with the potential these agents have to interact with psychotropics; in addition, you can take a more active role in prescribing, and monitoring patients’ responses to, these medications. Provide appropriate monitoring of ACE inhibitors, statins, and beta blockers; also, provide appropriate monitoring of psychotropics in patients who take recommended cardio­protective medications.

In situations that prompt referral (such as recent MI, new symptoms of heart fail­ure, any history of syncope or new iden­tification of T2DM), ideally you should collaborate with the patient’s primary care provider to help enhance adherence to rec­ommended treatment strategies. You also should employ motivational interviewing techniques and offer strategies by which patients can engage in meaningful lifestyle modification.

There are official recommendations for depression screening strategies²⁶ and psy­chosocial risk screening for patients in whom CAD has been identified.²⁷ Official screening strategies for CAD in patients with psychiatric illness have not, however, been spelled out.

Primary CAD prevention with medica­tion is not routinely recommended for the general population, but the increased risk of CAD associated with psychiatric diagno­ses (particularly schizophrenia, as well as the medications used to treat it) might war­rant consideration of aggressive primary prevention strategies.²⁸ For example, some experts recommend starting metformin to reduce the risk of T2DM in patients who have been started on olanzapine or clozap­ine, regardless of the baseline fasting blood glucose level.²⁹

You should be fully informed and aware of patients’ underlying medical condi­tions and the medications that are recom­mended to treat their conditions. Ideally, an integrated care strategy or, at the least, clear communication between you and the patient’s primary care providers should be in place to avoid foreseeable problems.

Stimulants. Systematic reviews suggest an association between prescription stimulants and at least the 2 cardiovascular risk factors of elevated heart rate and blood pressure. Stimulants are not recommended, therefore, for routine use in patients who have known hypertension or CAD.³⁰

Second-generation antipsychotics are associated with significant weight gain and development of metabolic syndrome.

Selective serotonin reuptake inhibitors are associated with an increased risk of gas­trointestinal bleeding risk related to platelet inhibition and gastric effects. Risk increases with additional platelet inhibitors, such as aspirin or clopidogrel.³¹

Lithium is excreted solely by the kid­ney. Guidelines recommend ACE inhibi­tors and angiotensin receptor-blockers for patients with CAD or T2DM, and many patients with symptomatic congestive heart failure are prescribed a diuretic; all of these classes of medications impair excretion of lithium. In a nested case-control study, 3% of observed cases of lith­ium toxicity were attributable to a newly initiated ACE inhibitor or angiotensin receptor-blocker.³² It is essential that you, and your patients taking lithium, be aware of the need to monitor the drug level fre­quently and be vigilant for symptoms of mild toxicity.

Beta blockers. No prospectively collected data support a association between beta blockers and depression.³³ Patients with CAD should be given a trial of a beta blocker to achieve optimal medical man­agement; because they are at increased risk of depression in the first place, all patients with CAD should undergo monitoring for depressive symptoms.

Clopidogrel is activated through the cyto­chrome P450 2C19 isoenzyme; medica­tions such as fluoxetine and fluvoxamine that inhibit the function of CYP2C19 can impair the effectiveness of clopidogrel.³¹

Other considerations. Patients taking a second-generation antipsychotic should have baseline and periodic (monthly for the first quarter, then quarterly) assess­ments of BMI and, after monitoring at 3 months after baseline, annual monitor­ing of blood pressure, the fasting glucose level, and abdominal waist circumference. Lipid levels should be monitored every 5 years⁹ (Table 3).

Baseline and periodic monitoring of hepatic enzymes is recommended for patients taking a statin. You, and the patient, should be alert to the possible development of muscle weakness or pain; establish a low threshold for screening for an elevated creatine kinase level, which signals rhabdomyolysis.
 

Case concluded
Ms. S’s psychiatrist measures her blood pres­sure and finds that it is 147/92 mm Hg. He uses the Pooled Cohort Equations to deter­mine that her lifetime risk of cardiovascular event is 50% (compared with a 8% lifetime risk among a cohort in whom risk factors are optimized) and that her 10-year risk is 41% (compared with a 2.2% risk among optimized controls).

At this point, the psychiatrist starts met­formin to prevent T2DM. He also starts Ms. S on a statin to prevent CAD in a setting of diagnosed T2DM.

Ms. S’s exertional dyspnea and shoulder discomfort could be associated with angina, and the physician wisely refers her for urgent evaluation. Because he is aware of the litera­ture demonstrating decreased revasculariza­tion among patients with mental illness, he urges her other health care providers to pro­vide her with guideline-based strategies to treat her cardiovascular disease.

Bottom Line
Patients with psychiatric illness have higher rates of morbidity and mortality from coronary artery disease (CAD) than the general population. Symptoms characteristic of depression and schizophrenia could lead to poor self-care or impaired adherence to programs designed to lower CAD risk factors. Institute strategies for primary and secondary prevention of CAD among your patients, based on published guidelines, and be aware of, and alert for, adverse cardiac effects and an increase in risk factors for CAD from the use of psychotropics.

Related Resources
• Elderon L, Whooley MA. Depression and cardiovascular dis­ease. Prog Cardiovasc Dis. 2013;55(6):511-523.
• Interactive cardiovascular risk calculator developed from the Framingham Heart Study. https://www.framingham heartstudy.org/risk-functions/cardiovascular-disease/ 10-year-risk.php.
• Pooled Cohort Equations calculator. To determine estimat­ed cardiovascular risk in comparison with peers with opti­mized risk factors. http://clincalc.com/cardiology/ascvd/ pooledcohort.aspx.
• To learn more about traditional cardiovascular risk factors from the Framingham Heart Study. http://www.framinghamheart study.org/risk-functions/.

Drug Brand Names
Amlodipine • Norvasc              
Clozapine • Clozaril            
Clopidogrel • Plavix                   
Felodipine • Plendil
Fluoxetine • Prozac      
Fluvoxamine • Luvox
Lithium • Eskalith, Lithobid
Metformin • Glucophage
Olanzapine • Zyprexa
Risperidone • Risperdal

Disclosure
The author reports no financial relationships with any company whose products are mentioned in this article or with manufacturers of competing products.

The problem is enormous: Heart disease is the lead­ing cause of death in the United States, and coronary artery disease (CAD) is the most common form of heart disease—responsible for 385,000 deaths in the United States in 2009 (http://www.cdc.gov/heartdisease/facts. htm). Patients with psychiatric illness have higher rates of morbidity and mortality from CAD than the general popu­lation, and warrant consideration as a special population. You should be familiar with routine cardiac medications; your patients’ medical problems; potential cardiac-related interactions among their psychotropic medications; and interactions among illnesses in their mental health and medical health domains (Box).

CASE Type 2 diabetes mellitus plus a long history of heavy smoking
Ms. S, age 57, is an African American woman with chronic para­noid schizophrenia who has been seeing a psychiatrist for the past 10 years. Ms. S’s psychiatric symptoms have been well con­trolled on risperidone, 3 mg/d.

Ms. S has a family history of diabetes, hypertension, and early CAD (a brother died of a myocardial infarction [MI] in his late 40s). She continues to smoke 2 packs of unfiltered ciga­rettes daily, as she has done for the past 40 years.

The psychiatrist has been following American Diabetes Association/American Psychiatric Association guidelines for monitoring; he has noticed that Ms. S’s body mass index (BMI) has increased from 27 to 31 kg/m² over the past year. She has devel­oped type 2 diabetes mellitus (T2DM).

At today’s visit, Ms. S arrives a few minutes late and appears flustered and out of breath. She explains that she had to climb a flight of stairs to get to office because the elevator is broken.

During the visit, the psychiatrist notes that Ms. S occasionally winces and massages her left shoulder.

Questions to ponder
   • What else could the psychiatrist do to modify Ms. S’s cardiac risk factors?
   • What is Ms. S’s 10-year risk of an acute coronary event?
   • What should her physician do now?
 

Overview: Cardiac risk in patients with mental illness
Modifiable risks for CAD include hyperten­sion, hypercholesterolemia, T2DM, obesity (all of which, taken together, constitute the metabolic syndrome), smoking, and a sed­entary lifestyle. Some risk factors, including sex, age, and family history, are not modifi­able. Whether or not this modification leads to better outcomes, psychiatric comorbid­ity is associated with higher morbidity and mortality from CAD.

Whether a common underlying patho­logical process manifesting in both CAD and mental illness exists, or whether the association is causal, are not well understood. Symptoms characteristic of depression (apathy, amotivation) and schizophrenia (disorganization, paranoia) could lead to poor self-care or impaired adherence to programs designed to lower CAD risk factors.^1,2

People with mental illness smoke at a higher rate than those who do not have mental illness.³ This finding is of particu­lar relevance because smoking contributes to worse outcomes with respect to CAD, even when medications are prescribed to address metabolic risks.⁴

Lower socioeconomic status is associ­ated with poorer prognosis from CAD⁵ and is a risk factor for depression.⁶ Depression is a strong independent pre­dictor of worse survival in acute coro­nary syndromes.⁵ Some experts consider depression to be a stronger risk factor for MI than traditional medical risk factors such as obesity, hypertension, and second-hand smoke.⁷

Interventions used to treat certain men­tal illnesses can exacerbate, or predispose to, metabolic syndrome (which, in turn, increases the risk of CAD). Although some studies have demonstrated meta­bolic derangements in medication-naïve patients who have a new diagnosis of schizophrenia,⁸ there is a clearly established association between second-generation antipsychotic use and obesity, hyperten­sion, hyperlipidemia, and T2DM. This asso­ciation prompted development in 2004 of consensus recommendations for cardiovas­cular monitoring of patients who are taking an atypical antipsychotic.⁹ 

Some studies suggest that the stress of mental illness contributes to the pathogen­ esis of CAD.⁸ Hypothesized mechanisms include:
   • sympathetic activation
   • vagal deactivation
   • platelet activation
   • hypothalamic-pituitary-adrenocorti­cal pathways
   • anticholinergic mechanisms
   • inflammatory mediators, including cytokines.

Mental stress itself has the capacity to induce coronary ischemia.¹⁰ The mental stress of psychiatric illness could have an important pathophysiologic role in CAD. It can be tempting to disregard chest pain in a patient who is known to have panic disorder, but that patient might in fact be experiencing stress-induced myocardial ischemia.¹¹

As many as 30% to 40% of patients with CAD suffer from clinically signifi­cant symptoms of depression; as many as 20% of patients with CAD meet criteria for major depressive disorder, compared with 5% to 10% of people who do not have CAD.2 Depression post-MI has been asso­ciated with a higher rate of sudden cardiac death and worse outcomes.¹²

Anxiety also can portend worse outcomes from CAD,¹³ including higher all-cause mor­tality.¹⁴ There is some hope, but limited evi­dence, that treating depression and anxiety, whether with antidepressant medication or behavioral therapy, can improve CAD outcomes.^10,15

Making a diagnosis of CAD
CAD can present in a variety of ways, ranging from unrecog­nized or so-called silent CAD (there is an association between T2DM and unrecognized CAD and between hypertension and unrecognized CAD) to stable angina, unstable angina, acute coronary syndrome, MI, and sudden cardiac death. A vari­ety of abnormalities on resting and exercise electrocardiogram (ECG), including ST segment depression, ST elevation, Q waves, and other morphological changes are indicative of CAD.

Other modalities, including coronary calcification score on computed tomogra­phy and coronary angiography can con­firm the presence of CAD. Some clinicians recommend periodic ECG treadmill test­ing in patients who have:
   • a total cholesterol level is >240 mg/dL
   • systolic blood pressure >140 mm Hg, diastolic blood pressure >90 mm Hg, or both
   • a family history of MI or sudden car­diac death in young (age <60) first-degree relatives
   • a history of smoking
   • diabetes.

Preventive guidelines
Risk stratification. A low (<10%), mod­erate (10% to 20%), or high (>20%) 10-year risk of CAD can be ascertained using a risk calculator, such as one that is available through the Framingham Heart Study (Figure) and the National Heart, Lung, and Blood Institute (http://cvdrisk.nhlbi. nih.gov). Because patients with risk factors for CAD should be offered interventions— including smoking cessation therapy, diet and exercise, aspirin, lipid-lowering ther­apy, and blood pressure modification strate­gies—whether or not they have evidence of CAD, the United States Preventive Services Task Force does not recommend for or against diagnostic screening in patients at moderate or elevated risk of CAD.¹⁶

There are guidelines in the literature rec­ommending specific screening strategies for patients with mental illness, although the vetting and update process has been ill defined. Among patients with schizophre­nia, though, regardless of antipsychotic pre­scription status, baseline and then regular monitoring of metabolic risk parameters is recommended.¹⁷

Primary prevention. Lifestyle modification and attention to modifiable coronary risk factors are important primary prevention strategies. Dietary modifications, exercise, not smoking, and maintenance of a nor­mal BMI (<25 kg/m2) are associated with a lower risk of CAD.^18,19

Lifestyle modifications can be challeng­ing for patients with persistent mental illness, however: For example, patients with schizophrenia smoke more, eat less healthfully, and participate less in behavioral modification that targets risk factors than patients who do not have schizophrenia.^20,21

According to 2012 evidence-based prac­tice guidelines established by a collabora­tion that included the American College of Physicians and several cardiology and thoracic medicine societies, persons age >50 who do not have symptomatic CAD should take low-dose (75 to 100 mg/d) aspirin; the benefit of low-dose aspirin in persons at moderate or high risk of CAD is even greater. Other medications, includ­ing statins and fixed-dose combinations of antihypertensive medications in combina­tion with a statin are not clearly beneficial as primary prevention strategies across the board, although selected high-risk popula­tions might benefit.

Regrettably, the high-risk population of persons with mental illness and whose pri­mary care is suboptimal has not been stud­ied. It stands to reason that these patients would especially benefit from more atten­tive monitoring and intervention.

Collaborative care? Although many psy­chiatrists do not practice in such a model, a comprehensive approach to the care of their patients, using a collaborative care strategy that includes attention to the mental health diagnosis along with medical health, can result in improved health in both domains.²² However, enlisting patients with paranoia or an inherent distrust of medications and health care providers to adhere to either a medication regimen or lifestyle modification can be challenging.

Common-sense strategies, such as creat­ing a multidisciplinary team with the psy­chiatrist coordinating care and optimizing antipsychotic treatment, might provide ben­efit.¹ Data demonstrate that patients with severe mental illness who experience acute coronary events undergo revascularization at a lower rate than their mentally heathy counterparts, despite the fact that patients with severe mental illness die at a higher rate from their CAD than patients who do not have mental illness. An important role for the psychiatrist, even in the absence of a collaborative care program, is to be an advo­cate for appropriate guideline-based care.²³

Secondary prevention. Once a patient develops CAD, ongoing risk factor modifi­cation is important. Adherence to a thera­peutic regimen that variously combines a platelet inhibitor, beta blocker, statin, and angiotensin-converting enzyme (ACE) inhibitor is associated with improved out­comes in patients with CAD.²⁴ Specific antiplatelet recommendations and a rec­ommendation for single vs combination antiplatelet therapy depends on chronicity and type of revascularization in a setting of CAD.²⁵

Summary of guideline-based recommendations
Treatment guidelines published in the National Guidelines Clearinghouse address depression, CAD screening, and specific cardiac therapies, including ACE inhibitors, angiotensin-receptor blockers, oral anticoag­ulants, platelet inhibitors, beta blockers, and lifestyle modification.

Primary prevention. Recommendations for treatment to prevent CAD are listed in Table 1.

Secondary prevention. Recommendations for treatment after a diagnosis of CAD are listed in Table 2.

Special considerations for psychiatric providers
You should be comfortable with patients’ use of antihypertensive therapies and familiar with the potential these agents have to interact with psychotropics; in addition, you can take a more active role in prescribing, and monitoring patients’ responses to, these medications. Provide appropriate monitoring of ACE inhibitors, statins, and beta blockers; also, provide appropriate monitoring of psychotropics in patients who take recommended cardio­protective medications.

In situations that prompt referral (such as recent MI, new symptoms of heart fail­ure, any history of syncope or new iden­tification of T2DM), ideally you should collaborate with the patient’s primary care provider to help enhance adherence to rec­ommended treatment strategies. You also should employ motivational interviewing techniques and offer strategies by which patients can engage in meaningful lifestyle modification.

There are official recommendations for depression screening strategies²⁶ and psy­chosocial risk screening for patients in whom CAD has been identified.²⁷ Official screening strategies for CAD in patients with psychiatric illness have not, however, been spelled out.

Primary CAD prevention with medica­tion is not routinely recommended for the general population, but the increased risk of CAD associated with psychiatric diagno­ses (particularly schizophrenia, as well as the medications used to treat it) might war­rant consideration of aggressive primary prevention strategies.²⁸ For example, some experts recommend starting metformin to reduce the risk of T2DM in patients who have been started on olanzapine or clozap­ine, regardless of the baseline fasting blood glucose level.²⁹

You should be fully informed and aware of patients’ underlying medical condi­tions and the medications that are recom­mended to treat their conditions. Ideally, an integrated care strategy or, at the least, clear communication between you and the patient’s primary care providers should be in place to avoid foreseeable problems.

Stimulants. Systematic reviews suggest an association between prescription stimulants and at least the 2 cardiovascular risk factors of elevated heart rate and blood pressure. Stimulants are not recommended, therefore, for routine use in patients who have known hypertension or CAD.³⁰

Second-generation antipsychotics are associated with significant weight gain and development of metabolic syndrome.

Selective serotonin reuptake inhibitors are associated with an increased risk of gas­trointestinal bleeding risk related to platelet inhibition and gastric effects. Risk increases with additional platelet inhibitors, such as aspirin or clopidogrel.³¹

Lithium is excreted solely by the kid­ney. Guidelines recommend ACE inhibi­tors and angiotensin receptor-blockers for patients with CAD or T2DM, and many patients with symptomatic congestive heart failure are prescribed a diuretic; all of these classes of medications impair excretion of lithium. In a nested case-control study, 3% of observed cases of lith­ium toxicity were attributable to a newly initiated ACE inhibitor or angiotensin receptor-blocker.³² It is essential that you, and your patients taking lithium, be aware of the need to monitor the drug level fre­quently and be vigilant for symptoms of mild toxicity.

Beta blockers. No prospectively collected data support a association between beta blockers and depression.³³ Patients with CAD should be given a trial of a beta blocker to achieve optimal medical man­agement; because they are at increased risk of depression in the first place, all patients with CAD should undergo monitoring for depressive symptoms.

Clopidogrel is activated through the cyto­chrome P450 2C19 isoenzyme; medica­tions such as fluoxetine and fluvoxamine that inhibit the function of CYP2C19 can impair the effectiveness of clopidogrel.³¹

Other considerations. Patients taking a second-generation antipsychotic should have baseline and periodic (monthly for the first quarter, then quarterly) assess­ments of BMI and, after monitoring at 3 months after baseline, annual monitor­ing of blood pressure, the fasting glucose level, and abdominal waist circumference. Lipid levels should be monitored every 5 years⁹ (Table 3).

Baseline and periodic monitoring of hepatic enzymes is recommended for patients taking a statin. You, and the patient, should be alert to the possible development of muscle weakness or pain; establish a low threshold for screening for an elevated creatine kinase level, which signals rhabdomyolysis.
 

Case concluded
Ms. S’s psychiatrist measures her blood pres­sure and finds that it is 147/92 mm Hg. He uses the Pooled Cohort Equations to deter­mine that her lifetime risk of cardiovascular event is 50% (compared with a 8% lifetime risk among a cohort in whom risk factors are optimized) and that her 10-year risk is 41% (compared with a 2.2% risk among optimized controls).

At this point, the psychiatrist starts met­formin to prevent T2DM. He also starts Ms. S on a statin to prevent CAD in a setting of diagnosed T2DM.

Ms. S’s exertional dyspnea and shoulder discomfort could be associated with angina, and the physician wisely refers her for urgent evaluation. Because he is aware of the litera­ture demonstrating decreased revasculariza­tion among patients with mental illness, he urges her other health care providers to pro­vide her with guideline-based strategies to treat her cardiovascular disease.

Bottom Line
Patients with psychiatric illness have higher rates of morbidity and mortality from coronary artery disease (CAD) than the general population. Symptoms characteristic of depression and schizophrenia could lead to poor self-care or impaired adherence to programs designed to lower CAD risk factors. Institute strategies for primary and secondary prevention of CAD among your patients, based on published guidelines, and be aware of, and alert for, adverse cardiac effects and an increase in risk factors for CAD from the use of psychotropics.

Related Resources
• Elderon L, Whooley MA. Depression and cardiovascular dis­ease. Prog Cardiovasc Dis. 2013;55(6):511-523.
• Interactive cardiovascular risk calculator developed from the Framingham Heart Study. https://www.framingham heartstudy.org/risk-functions/cardiovascular-disease/ 10-year-risk.php.
• Pooled Cohort Equations calculator. To determine estimat­ed cardiovascular risk in comparison with peers with opti­mized risk factors. http://clincalc.com/cardiology/ascvd/ pooledcohort.aspx.
• To learn more about traditional cardiovascular risk factors from the Framingham Heart Study. http://www.framinghamheart study.org/risk-functions/.

Drug Brand Names
Amlodipine • Norvasc              
Clozapine • Clozaril            
Clopidogrel • Plavix                   
Felodipine • Plendil
Fluoxetine • Prozac      
Fluvoxamine • Luvox
Lithium • Eskalith, Lithobid
Metformin • Glucophage
Olanzapine • Zyprexa
Risperidone • Risperdal

Disclosure
The author reports no financial relationships with any company whose products are mentioned in this article or with manufacturers of competing products.

The problem is enormous: Heart disease is the lead­ing cause of death in the United States, and coronary artery disease (CAD) is the most common form of heart disease—responsible for 385,000 deaths in the United States in 2009 (http://www.cdc.gov/heartdisease/facts. htm). Patients with psychiatric illness have higher rates of morbidity and mortality from CAD than the general popu­lation, and warrant consideration as a special population. You should be familiar with routine cardiac medications; your patients’ medical problems; potential cardiac-related interactions among their psychotropic medications; and interactions among illnesses in their mental health and medical health domains (Box).

CASE Type 2 diabetes mellitus plus a long history of heavy smoking
Ms. S, age 57, is an African American woman with chronic para­noid schizophrenia who has been seeing a psychiatrist for the past 10 years. Ms. S’s psychiatric symptoms have been well con­trolled on risperidone, 3 mg/d.

Ms. S has a family history of diabetes, hypertension, and early CAD (a brother died of a myocardial infarction [MI] in his late 40s). She continues to smoke 2 packs of unfiltered ciga­rettes daily, as she has done for the past 40 years.

The psychiatrist has been following American Diabetes Association/American Psychiatric Association guidelines for monitoring; he has noticed that Ms. S’s body mass index (BMI) has increased from 27 to 31 kg/m² over the past year. She has devel­oped type 2 diabetes mellitus (T2DM).

At today’s visit, Ms. S arrives a few minutes late and appears flustered and out of breath. She explains that she had to climb a flight of stairs to get to office because the elevator is broken.

During the visit, the psychiatrist notes that Ms. S occasionally winces and massages her left shoulder.

Questions to ponder
   • What else could the psychiatrist do to modify Ms. S’s cardiac risk factors?
   • What is Ms. S’s 10-year risk of an acute coronary event?
   • What should her physician do now?
 

Overview: Cardiac risk in patients with mental illness
Modifiable risks for CAD include hyperten­sion, hypercholesterolemia, T2DM, obesity (all of which, taken together, constitute the metabolic syndrome), smoking, and a sed­entary lifestyle. Some risk factors, including sex, age, and family history, are not modifi­able. Whether or not this modification leads to better outcomes, psychiatric comorbid­ity is associated with higher morbidity and mortality from CAD.

Whether a common underlying patho­logical process manifesting in both CAD and mental illness exists, or whether the association is causal, are not well understood. Symptoms characteristic of depression (apathy, amotivation) and schizophrenia (disorganization, paranoia) could lead to poor self-care or impaired adherence to programs designed to lower CAD risk factors.^1,2

People with mental illness smoke at a higher rate than those who do not have mental illness.³ This finding is of particu­lar relevance because smoking contributes to worse outcomes with respect to CAD, even when medications are prescribed to address metabolic risks.⁴

Lower socioeconomic status is associ­ated with poorer prognosis from CAD⁵ and is a risk factor for depression.⁶ Depression is a strong independent pre­dictor of worse survival in acute coro­nary syndromes.⁵ Some experts consider depression to be a stronger risk factor for MI than traditional medical risk factors such as obesity, hypertension, and second-hand smoke.⁷

Interventions used to treat certain men­tal illnesses can exacerbate, or predispose to, metabolic syndrome (which, in turn, increases the risk of CAD). Although some studies have demonstrated meta­bolic derangements in medication-naïve patients who have a new diagnosis of schizophrenia,⁸ there is a clearly established association between second-generation antipsychotic use and obesity, hyperten­sion, hyperlipidemia, and T2DM. This asso­ciation prompted development in 2004 of consensus recommendations for cardiovas­cular monitoring of patients who are taking an atypical antipsychotic.⁹ 

Some studies suggest that the stress of mental illness contributes to the pathogen­ esis of CAD.⁸ Hypothesized mechanisms include:
   • sympathetic activation
   • vagal deactivation
   • platelet activation
   • hypothalamic-pituitary-adrenocorti­cal pathways
   • anticholinergic mechanisms
   • inflammatory mediators, including cytokines.

Mental stress itself has the capacity to induce coronary ischemia.¹⁰ The mental stress of psychiatric illness could have an important pathophysiologic role in CAD. It can be tempting to disregard chest pain in a patient who is known to have panic disorder, but that patient might in fact be experiencing stress-induced myocardial ischemia.¹¹

As many as 30% to 40% of patients with CAD suffer from clinically signifi­cant symptoms of depression; as many as 20% of patients with CAD meet criteria for major depressive disorder, compared with 5% to 10% of people who do not have CAD.2 Depression post-MI has been asso­ciated with a higher rate of sudden cardiac death and worse outcomes.¹²

Anxiety also can portend worse outcomes from CAD,¹³ including higher all-cause mor­tality.¹⁴ There is some hope, but limited evi­dence, that treating depression and anxiety, whether with antidepressant medication or behavioral therapy, can improve CAD outcomes.^10,15

Making a diagnosis of CAD
CAD can present in a variety of ways, ranging from unrecog­nized or so-called silent CAD (there is an association between T2DM and unrecognized CAD and between hypertension and unrecognized CAD) to stable angina, unstable angina, acute coronary syndrome, MI, and sudden cardiac death. A vari­ety of abnormalities on resting and exercise electrocardiogram (ECG), including ST segment depression, ST elevation, Q waves, and other morphological changes are indicative of CAD.

Other modalities, including coronary calcification score on computed tomogra­phy and coronary angiography can con­firm the presence of CAD. Some clinicians recommend periodic ECG treadmill test­ing in patients who have:
   • a total cholesterol level is >240 mg/dL
   • systolic blood pressure >140 mm Hg, diastolic blood pressure >90 mm Hg, or both
   • a family history of MI or sudden car­diac death in young (age <60) first-degree relatives
   • a history of smoking
   • diabetes.

Preventive guidelines
Risk stratification. A low (<10%), mod­erate (10% to 20%), or high (>20%) 10-year risk of CAD can be ascertained using a risk calculator, such as one that is available through the Framingham Heart Study (Figure) and the National Heart, Lung, and Blood Institute (http://cvdrisk.nhlbi. nih.gov). Because patients with risk factors for CAD should be offered interventions— including smoking cessation therapy, diet and exercise, aspirin, lipid-lowering ther­apy, and blood pressure modification strate­gies—whether or not they have evidence of CAD, the United States Preventive Services Task Force does not recommend for or against diagnostic screening in patients at moderate or elevated risk of CAD.¹⁶

There are guidelines in the literature rec­ommending specific screening strategies for patients with mental illness, although the vetting and update process has been ill defined. Among patients with schizophre­nia, though, regardless of antipsychotic pre­scription status, baseline and then regular monitoring of metabolic risk parameters is recommended.¹⁷

Primary prevention. Lifestyle modification and attention to modifiable coronary risk factors are important primary prevention strategies. Dietary modifications, exercise, not smoking, and maintenance of a nor­mal BMI (<25 kg/m2) are associated with a lower risk of CAD.^18,19

Lifestyle modifications can be challeng­ing for patients with persistent mental illness, however: For example, patients with schizophrenia smoke more, eat less healthfully, and participate less in behavioral modification that targets risk factors than patients who do not have schizophrenia.^20,21

According to 2012 evidence-based prac­tice guidelines established by a collabora­tion that included the American College of Physicians and several cardiology and thoracic medicine societies, persons age >50 who do not have symptomatic CAD should take low-dose (75 to 100 mg/d) aspirin; the benefit of low-dose aspirin in persons at moderate or high risk of CAD is even greater. Other medications, includ­ing statins and fixed-dose combinations of antihypertensive medications in combina­tion with a statin are not clearly beneficial as primary prevention strategies across the board, although selected high-risk popula­tions might benefit.

Regrettably, the high-risk population of persons with mental illness and whose pri­mary care is suboptimal has not been stud­ied. It stands to reason that these patients would especially benefit from more atten­tive monitoring and intervention.

Collaborative care? Although many psy­chiatrists do not practice in such a model, a comprehensive approach to the care of their patients, using a collaborative care strategy that includes attention to the mental health diagnosis along with medical health, can result in improved health in both domains.²² However, enlisting patients with paranoia or an inherent distrust of medications and health care providers to adhere to either a medication regimen or lifestyle modification can be challenging.

Common-sense strategies, such as creat­ing a multidisciplinary team with the psy­chiatrist coordinating care and optimizing antipsychotic treatment, might provide ben­efit.¹ Data demonstrate that patients with severe mental illness who experience acute coronary events undergo revascularization at a lower rate than their mentally heathy counterparts, despite the fact that patients with severe mental illness die at a higher rate from their CAD than patients who do not have mental illness. An important role for the psychiatrist, even in the absence of a collaborative care program, is to be an advo­cate for appropriate guideline-based care.²³

Secondary prevention. Once a patient develops CAD, ongoing risk factor modifi­cation is important. Adherence to a thera­peutic regimen that variously combines a platelet inhibitor, beta blocker, statin, and angiotensin-converting enzyme (ACE) inhibitor is associated with improved out­comes in patients with CAD.²⁴ Specific antiplatelet recommendations and a rec­ommendation for single vs combination antiplatelet therapy depends on chronicity and type of revascularization in a setting of CAD.²⁵

Summary of guideline-based recommendations
Treatment guidelines published in the National Guidelines Clearinghouse address depression, CAD screening, and specific cardiac therapies, including ACE inhibitors, angiotensin-receptor blockers, oral anticoag­ulants, platelet inhibitors, beta blockers, and lifestyle modification.

Primary prevention. Recommendations for treatment to prevent CAD are listed in Table 1.

Secondary prevention. Recommendations for treatment after a diagnosis of CAD are listed in Table 2.

Special considerations for psychiatric providers
You should be comfortable with patients’ use of antihypertensive therapies and familiar with the potential these agents have to interact with psychotropics; in addition, you can take a more active role in prescribing, and monitoring patients’ responses to, these medications. Provide appropriate monitoring of ACE inhibitors, statins, and beta blockers; also, provide appropriate monitoring of psychotropics in patients who take recommended cardio­protective medications.

In situations that prompt referral (such as recent MI, new symptoms of heart fail­ure, any history of syncope or new iden­tification of T2DM), ideally you should collaborate with the patient’s primary care provider to help enhance adherence to rec­ommended treatment strategies. You also should employ motivational interviewing techniques and offer strategies by which patients can engage in meaningful lifestyle modification.

There are official recommendations for depression screening strategies²⁶ and psy­chosocial risk screening for patients in whom CAD has been identified.²⁷ Official screening strategies for CAD in patients with psychiatric illness have not, however, been spelled out.

Primary CAD prevention with medica­tion is not routinely recommended for the general population, but the increased risk of CAD associated with psychiatric diagno­ses (particularly schizophrenia, as well as the medications used to treat it) might war­rant consideration of aggressive primary prevention strategies.²⁸ For example, some experts recommend starting metformin to reduce the risk of T2DM in patients who have been started on olanzapine or clozap­ine, regardless of the baseline fasting blood glucose level.²⁹

You should be fully informed and aware of patients’ underlying medical condi­tions and the medications that are recom­mended to treat their conditions. Ideally, an integrated care strategy or, at the least, clear communication between you and the patient’s primary care providers should be in place to avoid foreseeable problems.

Stimulants. Systematic reviews suggest an association between prescription stimulants and at least the 2 cardiovascular risk factors of elevated heart rate and blood pressure. Stimulants are not recommended, therefore, for routine use in patients who have known hypertension or CAD.³⁰

Second-generation antipsychotics are associated with significant weight gain and development of metabolic syndrome.

Selective serotonin reuptake inhibitors are associated with an increased risk of gas­trointestinal bleeding risk related to platelet inhibition and gastric effects. Risk increases with additional platelet inhibitors, such as aspirin or clopidogrel.³¹

Lithium is excreted solely by the kid­ney. Guidelines recommend ACE inhibi­tors and angiotensin receptor-blockers for patients with CAD or T2DM, and many patients with symptomatic congestive heart failure are prescribed a diuretic; all of these classes of medications impair excretion of lithium. In a nested case-control study, 3% of observed cases of lith­ium toxicity were attributable to a newly initiated ACE inhibitor or angiotensin receptor-blocker.³² It is essential that you, and your patients taking lithium, be aware of the need to monitor the drug level fre­quently and be vigilant for symptoms of mild toxicity.

Beta blockers. No prospectively collected data support a association between beta blockers and depression.³³ Patients with CAD should be given a trial of a beta blocker to achieve optimal medical man­agement; because they are at increased risk of depression in the first place, all patients with CAD should undergo monitoring for depressive symptoms.

Clopidogrel is activated through the cyto­chrome P450 2C19 isoenzyme; medica­tions such as fluoxetine and fluvoxamine that inhibit the function of CYP2C19 can impair the effectiveness of clopidogrel.³¹

Other considerations. Patients taking a second-generation antipsychotic should have baseline and periodic (monthly for the first quarter, then quarterly) assess­ments of BMI and, after monitoring at 3 months after baseline, annual monitor­ing of blood pressure, the fasting glucose level, and abdominal waist circumference. Lipid levels should be monitored every 5 years⁹ (Table 3).

Baseline and periodic monitoring of hepatic enzymes is recommended for patients taking a statin. You, and the patient, should be alert to the possible development of muscle weakness or pain; establish a low threshold for screening for an elevated creatine kinase level, which signals rhabdomyolysis.
 

Case concluded
Ms. S’s psychiatrist measures her blood pres­sure and finds that it is 147/92 mm Hg. He uses the Pooled Cohort Equations to deter­mine that her lifetime risk of cardiovascular event is 50% (compared with a 8% lifetime risk among a cohort in whom risk factors are optimized) and that her 10-year risk is 41% (compared with a 2.2% risk among optimized controls).

At this point, the psychiatrist starts met­formin to prevent T2DM. He also starts Ms. S on a statin to prevent CAD in a setting of diagnosed T2DM.

Ms. S’s exertional dyspnea and shoulder discomfort could be associated with angina, and the physician wisely refers her for urgent evaluation. Because he is aware of the litera­ture demonstrating decreased revasculariza­tion among patients with mental illness, he urges her other health care providers to pro­vide her with guideline-based strategies to treat her cardiovascular disease.

Bottom Line
Patients with psychiatric illness have higher rates of morbidity and mortality from coronary artery disease (CAD) than the general population. Symptoms characteristic of depression and schizophrenia could lead to poor self-care or impaired adherence to programs designed to lower CAD risk factors. Institute strategies for primary and secondary prevention of CAD among your patients, based on published guidelines, and be aware of, and alert for, adverse cardiac effects and an increase in risk factors for CAD from the use of psychotropics.

Related Resources
• Elderon L, Whooley MA. Depression and cardiovascular dis­ease. Prog Cardiovasc Dis. 2013;55(6):511-523.
• Interactive cardiovascular risk calculator developed from the Framingham Heart Study. https://www.framingham heartstudy.org/risk-functions/cardiovascular-disease/ 10-year-risk.php.
• Pooled Cohort Equations calculator. To determine estimat­ed cardiovascular risk in comparison with peers with opti­mized risk factors. http://clincalc.com/cardiology/ascvd/ pooledcohort.aspx.
• To learn more about traditional cardiovascular risk factors from the Framingham Heart Study. http://www.framinghamheart study.org/risk-functions/.

Drug Brand Names
Amlodipine • Norvasc              
Clozapine • Clozaril            
Clopidogrel • Plavix                   
Felodipine • Plendil
Fluoxetine • Prozac      
Fluvoxamine • Luvox
Lithium • Eskalith, Lithobid
Metformin • Glucophage
Olanzapine • Zyprexa
Risperidone • Risperdal

Disclosure
The author reports no financial relationships with any company whose products are mentioned in this article or with manufacturers of competing products.

Transgender patients who receive health care via government programs or funding must receive equal access to treatments and insurance coverage, according to a proposed rule issued Sept. 3 by the Health and Human Services department. The rule would extend antidiscrimination policies under the Affordable Care Act to include gender identity.

The rule would apply to health providers who accept patients covered by Medicare and Medicaid as well as insurance purchased via the health insurance marketplaces.

chris2766/Thinkstock.com

“The proposed rule clarifies and harmonizes existing well-established federal civil rights laws and clarifies the standards that HHS and in particular, the Office of Civil Rights, will apply in implementing [ACA] Section 1557,” Jocelyn Samuels, OCR director, said in a press conference. “Prior laws enforced by the Office of Civil Rights barred discrimination based only on race, color, national origin, age, or disability. All of the protections against sex discrimination that will be incorporated into the rule are new in this space.”

Section 1557 of the ACA extends civil rights protections to ban sex discrimination in federal health care programs and activities. The new proposed rule establishes that the prohibition on sex discrimination includes discrimination based on gender identity. The rule also includes requirements for effective communication for patients with disabilities and enhanced language assistance for patients with limited English proficiency.

Specifics of the proposed rule include:

• Patients must be treated equally and consistent with their gender identity by health providers. Insurers must provide fair access to coverage regardless of gender identity. For example, some insurers have historically excluded coverage of all care related to gender transition. Such categorical exclusions are prohibited under the proposed rule.

• Women must be treated equally with men in the health care they receive, not only in the health coverage they obtain but in the services they seek from providers.

• For patients with disabilities, the rule contains requirements for the provision of auxiliary aids and services, including alternative formats and sign language interpreters and the accessibility of programs offered through electronic and information technology.

• The rule bolsters language assistance for people with limited English proficiency so that patients are able to more effectively communicate with their providers to describe their symptoms and understand treatment.

During the press conference, Ms. Samuels clarified that the rule does not mean that health insurers must cover any specific treatments or procedures, rather they must apply nondiscriminatory criteria when assessing coverage requests.

The proposed extension of protections is, in part, driven by ongoing cases of sex and identity discrimination by some health providers. In one case, a hospital denied a transgender patient a room assignment consistent with her gender identity. In another, a male domestic violence victim was denied services at a hospital because he did not fit the traditional profile of a domestic violence victim, Ms. Samuels said. In another case, a health provider required that a husband be the guarantor for his wife’s medical bills but did not require the same for male patients and their spouses.

“There continue to be serious problems of discrimination in the health care arena,” she said. “This proposed rule provides very valuable tools for us to be able to appropriately address them.”

HHS is requesting comments on whether Section 1557 should include exemptions for religious organizations and, if so, to what extent. The administration notes that nothing in the proposed rule would affect the application of existing protections for religious beliefs and practices, such as provider conscience laws and regulations under the ACA involving preventive health services.

Comments on the rule will be accepted at www.regulations.gov until Nov. 6.

[email protected]

On Twitter @legal_med

Transgender patients who receive health care via government programs or funding must receive equal access to treatments and insurance coverage, according to a proposed rule issued Sept. 3 by the Health and Human Services department. The rule would extend antidiscrimination policies under the Affordable Care Act to include gender identity.

The rule would apply to health providers who accept patients covered by Medicare and Medicaid as well as insurance purchased via the health insurance marketplaces.

chris2766/Thinkstock.com

“The proposed rule clarifies and harmonizes existing well-established federal civil rights laws and clarifies the standards that HHS and in particular, the Office of Civil Rights, will apply in implementing [ACA] Section 1557,” Jocelyn Samuels, OCR director, said in a press conference. “Prior laws enforced by the Office of Civil Rights barred discrimination based only on race, color, national origin, age, or disability. All of the protections against sex discrimination that will be incorporated into the rule are new in this space.”

Section 1557 of the ACA extends civil rights protections to ban sex discrimination in federal health care programs and activities. The new proposed rule establishes that the prohibition on sex discrimination includes discrimination based on gender identity. The rule also includes requirements for effective communication for patients with disabilities and enhanced language assistance for patients with limited English proficiency.

Specifics of the proposed rule include:

• Patients must be treated equally and consistent with their gender identity by health providers. Insurers must provide fair access to coverage regardless of gender identity. For example, some insurers have historically excluded coverage of all care related to gender transition. Such categorical exclusions are prohibited under the proposed rule.

• Women must be treated equally with men in the health care they receive, not only in the health coverage they obtain but in the services they seek from providers.

• For patients with disabilities, the rule contains requirements for the provision of auxiliary aids and services, including alternative formats and sign language interpreters and the accessibility of programs offered through electronic and information technology.

• The rule bolsters language assistance for people with limited English proficiency so that patients are able to more effectively communicate with their providers to describe their symptoms and understand treatment.

During the press conference, Ms. Samuels clarified that the rule does not mean that health insurers must cover any specific treatments or procedures, rather they must apply nondiscriminatory criteria when assessing coverage requests.

The proposed extension of protections is, in part, driven by ongoing cases of sex and identity discrimination by some health providers. In one case, a hospital denied a transgender patient a room assignment consistent with her gender identity. In another, a male domestic violence victim was denied services at a hospital because he did not fit the traditional profile of a domestic violence victim, Ms. Samuels said. In another case, a health provider required that a husband be the guarantor for his wife’s medical bills but did not require the same for male patients and their spouses.

“There continue to be serious problems of discrimination in the health care arena,” she said. “This proposed rule provides very valuable tools for us to be able to appropriately address them.”

HHS is requesting comments on whether Section 1557 should include exemptions for religious organizations and, if so, to what extent. The administration notes that nothing in the proposed rule would affect the application of existing protections for religious beliefs and practices, such as provider conscience laws and regulations under the ACA involving preventive health services.

Comments on the rule will be accepted at www.regulations.gov until Nov. 6.

[email protected]

On Twitter @legal_med

Transgender patients who receive health care via government programs or funding must receive equal access to treatments and insurance coverage, according to a proposed rule issued Sept. 3 by the Health and Human Services department. The rule would extend antidiscrimination policies under the Affordable Care Act to include gender identity.

The rule would apply to health providers who accept patients covered by Medicare and Medicaid as well as insurance purchased via the health insurance marketplaces.

chris2766/Thinkstock.com

“The proposed rule clarifies and harmonizes existing well-established federal civil rights laws and clarifies the standards that HHS and in particular, the Office of Civil Rights, will apply in implementing [ACA] Section 1557,” Jocelyn Samuels, OCR director, said in a press conference. “Prior laws enforced by the Office of Civil Rights barred discrimination based only on race, color, national origin, age, or disability. All of the protections against sex discrimination that will be incorporated into the rule are new in this space.”

Section 1557 of the ACA extends civil rights protections to ban sex discrimination in federal health care programs and activities. The new proposed rule establishes that the prohibition on sex discrimination includes discrimination based on gender identity. The rule also includes requirements for effective communication for patients with disabilities and enhanced language assistance for patients with limited English proficiency.

Specifics of the proposed rule include:

• Patients must be treated equally and consistent with their gender identity by health providers. Insurers must provide fair access to coverage regardless of gender identity. For example, some insurers have historically excluded coverage of all care related to gender transition. Such categorical exclusions are prohibited under the proposed rule.

• Women must be treated equally with men in the health care they receive, not only in the health coverage they obtain but in the services they seek from providers.

• For patients with disabilities, the rule contains requirements for the provision of auxiliary aids and services, including alternative formats and sign language interpreters and the accessibility of programs offered through electronic and information technology.

• The rule bolsters language assistance for people with limited English proficiency so that patients are able to more effectively communicate with their providers to describe their symptoms and understand treatment.

During the press conference, Ms. Samuels clarified that the rule does not mean that health insurers must cover any specific treatments or procedures, rather they must apply nondiscriminatory criteria when assessing coverage requests.

The proposed extension of protections is, in part, driven by ongoing cases of sex and identity discrimination by some health providers. In one case, a hospital denied a transgender patient a room assignment consistent with her gender identity. In another, a male domestic violence victim was denied services at a hospital because he did not fit the traditional profile of a domestic violence victim, Ms. Samuels said. In another case, a health provider required that a husband be the guarantor for his wife’s medical bills but did not require the same for male patients and their spouses.

“There continue to be serious problems of discrimination in the health care arena,” she said. “This proposed rule provides very valuable tools for us to be able to appropriately address them.”

HHS is requesting comments on whether Section 1557 should include exemptions for religious organizations and, if so, to what extent. The administration notes that nothing in the proposed rule would affect the application of existing protections for religious beliefs and practices, such as provider conscience laws and regulations under the ACA involving preventive health services.

Comments on the rule will be accepted at www.regulations.gov until Nov. 6.

[email protected]

On Twitter @legal_med

A 3-month-old boy was diagnosed with severe respiratory syncytial virus infection at a North Carolina hospital in 2009. The infant was intubated, and a transfer to another hospital that had a pediatric ICU was ordered. The second hospital’s emergency transport service facilitated the transfer.

The ambulance was staffed by an EMT-paramedic and a transport registered nurse, both certified in Pediatric Advanced Life Support (PALS). During transport, the infant was intubated and medically paralyzed with vecuronium. About 10 minutes prior to arrival, the infant’s condition worsened, and he experienced cardiac arrest. Chest compressions and heart medications were provided.

Upon arrival at the second hospital, the infant was resuscitated. An emergency department physician, Dr S., ordered reintubation, and the infant again experienced cardiac arrest. For the next 10 minutes, Dr S. ordered chest compressions and heart medication; he eventually reintubated the infant, at which point cardiac arrest ceased with a spontaneous heartbeat.

After transfer to the pediatric ICU, the infant was diagnosed with permanent hypoxic ischemic brain injury caused by the cardiac episodes and low oxygen intake. At the time of trial, the child could not walk, talk, or hear very well and was fed via feeding tube. His vision and cognitive function were also impaired.

The plaintiff claimed that the intubation tube should have been adjusted or removed and re-inserted in the ambulance, but that did not happen. At trial, they called as an adverse witness the EMT-paramedic who had been in the ambulance with the plaintiff.

Continue for the outcome >>

OUTCOME  
During the plaintiff’s presentation of evidence, the hospital agreed to a settlement of $13 million. The trial against Dr S. continued but ended in a mistrial. The plaintiffs were expected to re-try the claims against him.

COMMENT  
This is a bad-airway case. Many medical malpractice cases are bad-airways cases: They are easy to bring and easy for jurors to understand, since hypoxic/anoxic injury is evident and plainly correlated with the airway missteps. These cases are also easy to prove, since the plaintiff can always hire an expert to testify that a reasonably prudent clinician would have been able to properly secure and monitor the airway—and the patient “would be standing here today,” unscathed.

Of course, securing an airway is not a “given” and can be challenging. Factor in variables such as anatomy, age, body habitus, intoxication, combativeness, medical comorbidities, and a full stomach, and the risk swells. If your employment requires that you manage airways, you are practicing in a high-legal-risk environment.

Make sure your skills are up to par. Practice often. Have a plan, a backup plan, and rescue backup plan. Have working suction ready. Check your equipment regularly. Run practice codes—particularly if your practice does not manage cardiorespiratory emergencies often. Does your staff know how to open the crash cart? Are the meds expired? Is the oxygen cylinder empty? Are roles clearly defined? As clinicians, we sit through our share of useless meetings (discussing things like who left what in the break room fridge). We should find time to drill on cardiorespiratory emergencies, because there is no time to “reacquaint oneself” on the fly.

In the case report, we are told that the patient was monitored by O₂ saturation (SaO₂) and end tidal CO₂ (ETCO₂). The plaintiff alleges that the transport team (EMT-paramedic and RN) failed to address tube placement and rather focused their efforts on chest compressions and medications. As we know, most cases of pediatric cardiac arrest are not primarily cardiac but instead follow primary progressive respiratory failure. Despite the emphasis on “airway, breathing, circulation” covered by PALS, the airway appears to have been missed and tube placement unquestioned after the child began to decompensate. Tube placement wasn’t reconsidered until 10 minutes after arrival at the second hospital, when the patient was reintubated and ventilatory status improved.

Airway cases—this one included—are “high damages” cases. A high damages case is one in which the injury is clear and expenses and costs to care for the patient are clear and immense. Such cases can be difficult to defend, because the enormity of the plaintiff’s plight (the limitations, years of required rehabilitation, hospitalization, PT, OT, nutritional care, etc) can overwhelm the jury, who may infer negligence based on the plaintiff’s condition. While jurors are required to consider damages only after negligence has been proven, lay jurors are human and many find it difficult to parse liability from damages. This is particularly true in airway cases involving a young, now-debilitated patient and an expert witness claiming an error that was preventable.

In this case, the plaintiff’s attorney made an unusual move, by calling as a “hostile witness” the paramedic who treated the 3-month-old boy. The paramedic would generally be called by the defense and later cross-examined by the plaintiff. Instead, the plaintiff chose to examine him first. Under evidence rules in most states (including North Carolina,¹ where this case was heard), an adverse (or hostile) witness can be called by the opposing party.

Why is this important? Because during direct examination, you cannot lead the witness; during cross-examination, you can. Leading questions (if done correctly) generally produce the most effective and damaging moments during a trial. In this case, the plaintiffs were able to immediately examine one of the defendant’s principal actors using leading questions. Shortly thereafter, when the plaintiff was directly examining his own paramedic expert witnesses, the defense relented and settled for $13 million, with further recovery against the emergency physician still available.

Interestingly, the attorney suing the medical personnel in this case was none other than John Edwards. Yes, that John Edwards—the former vice presidential candidate famous for his $500 haircuts, campaign finance tribulations, and ethical lapses. He originally became famous (and rich) suing clinicians. After his political fall from grace, he is back in business suing clinicians—and for him, business is good.

IN SUM
This case was unfortunate. Always use care in securing the airway, particularly during patient movement. Once it is established, monitor the airway using SaO₂, ETCO₂, and keen observation. Airways are not in the “set it and forget it” camp. An airway must be maintained, safeguarded, and protected. Be prepared to act quickly should the airway become dislodged, migrate, or otherwise fail. —DML

REFERENCE
1. North Carolina Rules of Evidence Rule 611 (1983, c. 701, s. 1.).

A 3-month-old boy was diagnosed with severe respiratory syncytial virus infection at a North Carolina hospital in 2009. The infant was intubated, and a transfer to another hospital that had a pediatric ICU was ordered. The second hospital’s emergency transport service facilitated the transfer.

The ambulance was staffed by an EMT-paramedic and a transport registered nurse, both certified in Pediatric Advanced Life Support (PALS). During transport, the infant was intubated and medically paralyzed with vecuronium. About 10 minutes prior to arrival, the infant’s condition worsened, and he experienced cardiac arrest. Chest compressions and heart medications were provided.

Upon arrival at the second hospital, the infant was resuscitated. An emergency department physician, Dr S., ordered reintubation, and the infant again experienced cardiac arrest. For the next 10 minutes, Dr S. ordered chest compressions and heart medication; he eventually reintubated the infant, at which point cardiac arrest ceased with a spontaneous heartbeat.

After transfer to the pediatric ICU, the infant was diagnosed with permanent hypoxic ischemic brain injury caused by the cardiac episodes and low oxygen intake. At the time of trial, the child could not walk, talk, or hear very well and was fed via feeding tube. His vision and cognitive function were also impaired.

The plaintiff claimed that the intubation tube should have been adjusted or removed and re-inserted in the ambulance, but that did not happen. At trial, they called as an adverse witness the EMT-paramedic who had been in the ambulance with the plaintiff.

Continue for the outcome >>

OUTCOME  
During the plaintiff’s presentation of evidence, the hospital agreed to a settlement of $13 million. The trial against Dr S. continued but ended in a mistrial. The plaintiffs were expected to re-try the claims against him.

COMMENT  
This is a bad-airway case. Many medical malpractice cases are bad-airways cases: They are easy to bring and easy for jurors to understand, since hypoxic/anoxic injury is evident and plainly correlated with the airway missteps. These cases are also easy to prove, since the plaintiff can always hire an expert to testify that a reasonably prudent clinician would have been able to properly secure and monitor the airway—and the patient “would be standing here today,” unscathed.

Of course, securing an airway is not a “given” and can be challenging. Factor in variables such as anatomy, age, body habitus, intoxication, combativeness, medical comorbidities, and a full stomach, and the risk swells. If your employment requires that you manage airways, you are practicing in a high-legal-risk environment.

Make sure your skills are up to par. Practice often. Have a plan, a backup plan, and rescue backup plan. Have working suction ready. Check your equipment regularly. Run practice codes—particularly if your practice does not manage cardiorespiratory emergencies often. Does your staff know how to open the crash cart? Are the meds expired? Is the oxygen cylinder empty? Are roles clearly defined? As clinicians, we sit through our share of useless meetings (discussing things like who left what in the break room fridge). We should find time to drill on cardiorespiratory emergencies, because there is no time to “reacquaint oneself” on the fly.

In the case report, we are told that the patient was monitored by O₂ saturation (SaO₂) and end tidal CO₂ (ETCO₂). The plaintiff alleges that the transport team (EMT-paramedic and RN) failed to address tube placement and rather focused their efforts on chest compressions and medications. As we know, most cases of pediatric cardiac arrest are not primarily cardiac but instead follow primary progressive respiratory failure. Despite the emphasis on “airway, breathing, circulation” covered by PALS, the airway appears to have been missed and tube placement unquestioned after the child began to decompensate. Tube placement wasn’t reconsidered until 10 minutes after arrival at the second hospital, when the patient was reintubated and ventilatory status improved.

Airway cases—this one included—are “high damages” cases. A high damages case is one in which the injury is clear and expenses and costs to care for the patient are clear and immense. Such cases can be difficult to defend, because the enormity of the plaintiff’s plight (the limitations, years of required rehabilitation, hospitalization, PT, OT, nutritional care, etc) can overwhelm the jury, who may infer negligence based on the plaintiff’s condition. While jurors are required to consider damages only after negligence has been proven, lay jurors are human and many find it difficult to parse liability from damages. This is particularly true in airway cases involving a young, now-debilitated patient and an expert witness claiming an error that was preventable.

In this case, the plaintiff’s attorney made an unusual move, by calling as a “hostile witness” the paramedic who treated the 3-month-old boy. The paramedic would generally be called by the defense and later cross-examined by the plaintiff. Instead, the plaintiff chose to examine him first. Under evidence rules in most states (including North Carolina,¹ where this case was heard), an adverse (or hostile) witness can be called by the opposing party.

Why is this important? Because during direct examination, you cannot lead the witness; during cross-examination, you can. Leading questions (if done correctly) generally produce the most effective and damaging moments during a trial. In this case, the plaintiffs were able to immediately examine one of the defendant’s principal actors using leading questions. Shortly thereafter, when the plaintiff was directly examining his own paramedic expert witnesses, the defense relented and settled for $13 million, with further recovery against the emergency physician still available.

Interestingly, the attorney suing the medical personnel in this case was none other than John Edwards. Yes, that John Edwards—the former vice presidential candidate famous for his $500 haircuts, campaign finance tribulations, and ethical lapses. He originally became famous (and rich) suing clinicians. After his political fall from grace, he is back in business suing clinicians—and for him, business is good.

IN SUM
This case was unfortunate. Always use care in securing the airway, particularly during patient movement. Once it is established, monitor the airway using SaO₂, ETCO₂, and keen observation. Airways are not in the “set it and forget it” camp. An airway must be maintained, safeguarded, and protected. Be prepared to act quickly should the airway become dislodged, migrate, or otherwise fail. —DML

REFERENCE
1. North Carolina Rules of Evidence Rule 611 (1983, c. 701, s. 1.).

A 3-month-old boy was diagnosed with severe respiratory syncytial virus infection at a North Carolina hospital in 2009. The infant was intubated, and a transfer to another hospital that had a pediatric ICU was ordered. The second hospital’s emergency transport service facilitated the transfer.

The ambulance was staffed by an EMT-paramedic and a transport registered nurse, both certified in Pediatric Advanced Life Support (PALS). During transport, the infant was intubated and medically paralyzed with vecuronium. About 10 minutes prior to arrival, the infant’s condition worsened, and he experienced cardiac arrest. Chest compressions and heart medications were provided.

Upon arrival at the second hospital, the infant was resuscitated. An emergency department physician, Dr S., ordered reintubation, and the infant again experienced cardiac arrest. For the next 10 minutes, Dr S. ordered chest compressions and heart medication; he eventually reintubated the infant, at which point cardiac arrest ceased with a spontaneous heartbeat.

After transfer to the pediatric ICU, the infant was diagnosed with permanent hypoxic ischemic brain injury caused by the cardiac episodes and low oxygen intake. At the time of trial, the child could not walk, talk, or hear very well and was fed via feeding tube. His vision and cognitive function were also impaired.

The plaintiff claimed that the intubation tube should have been adjusted or removed and re-inserted in the ambulance, but that did not happen. At trial, they called as an adverse witness the EMT-paramedic who had been in the ambulance with the plaintiff.

Continue for the outcome >>

OUTCOME  
During the plaintiff’s presentation of evidence, the hospital agreed to a settlement of $13 million. The trial against Dr S. continued but ended in a mistrial. The plaintiffs were expected to re-try the claims against him.

COMMENT  
This is a bad-airway case. Many medical malpractice cases are bad-airways cases: They are easy to bring and easy for jurors to understand, since hypoxic/anoxic injury is evident and plainly correlated with the airway missteps. These cases are also easy to prove, since the plaintiff can always hire an expert to testify that a reasonably prudent clinician would have been able to properly secure and monitor the airway—and the patient “would be standing here today,” unscathed.

Of course, securing an airway is not a “given” and can be challenging. Factor in variables such as anatomy, age, body habitus, intoxication, combativeness, medical comorbidities, and a full stomach, and the risk swells. If your employment requires that you manage airways, you are practicing in a high-legal-risk environment.

Make sure your skills are up to par. Practice often. Have a plan, a backup plan, and rescue backup plan. Have working suction ready. Check your equipment regularly. Run practice codes—particularly if your practice does not manage cardiorespiratory emergencies often. Does your staff know how to open the crash cart? Are the meds expired? Is the oxygen cylinder empty? Are roles clearly defined? As clinicians, we sit through our share of useless meetings (discussing things like who left what in the break room fridge). We should find time to drill on cardiorespiratory emergencies, because there is no time to “reacquaint oneself” on the fly.

In the case report, we are told that the patient was monitored by O₂ saturation (SaO₂) and end tidal CO₂ (ETCO₂). The plaintiff alleges that the transport team (EMT-paramedic and RN) failed to address tube placement and rather focused their efforts on chest compressions and medications. As we know, most cases of pediatric cardiac arrest are not primarily cardiac but instead follow primary progressive respiratory failure. Despite the emphasis on “airway, breathing, circulation” covered by PALS, the airway appears to have been missed and tube placement unquestioned after the child began to decompensate. Tube placement wasn’t reconsidered until 10 minutes after arrival at the second hospital, when the patient was reintubated and ventilatory status improved.

Airway cases—this one included—are “high damages” cases. A high damages case is one in which the injury is clear and expenses and costs to care for the patient are clear and immense. Such cases can be difficult to defend, because the enormity of the plaintiff’s plight (the limitations, years of required rehabilitation, hospitalization, PT, OT, nutritional care, etc) can overwhelm the jury, who may infer negligence based on the plaintiff’s condition. While jurors are required to consider damages only after negligence has been proven, lay jurors are human and many find it difficult to parse liability from damages. This is particularly true in airway cases involving a young, now-debilitated patient and an expert witness claiming an error that was preventable.

In this case, the plaintiff’s attorney made an unusual move, by calling as a “hostile witness” the paramedic who treated the 3-month-old boy. The paramedic would generally be called by the defense and later cross-examined by the plaintiff. Instead, the plaintiff chose to examine him first. Under evidence rules in most states (including North Carolina,¹ where this case was heard), an adverse (or hostile) witness can be called by the opposing party.

Why is this important? Because during direct examination, you cannot lead the witness; during cross-examination, you can. Leading questions (if done correctly) generally produce the most effective and damaging moments during a trial. In this case, the plaintiffs were able to immediately examine one of the defendant’s principal actors using leading questions. Shortly thereafter, when the plaintiff was directly examining his own paramedic expert witnesses, the defense relented and settled for $13 million, with further recovery against the emergency physician still available.

Interestingly, the attorney suing the medical personnel in this case was none other than John Edwards. Yes, that John Edwards—the former vice presidential candidate famous for his $500 haircuts, campaign finance tribulations, and ethical lapses. He originally became famous (and rich) suing clinicians. After his political fall from grace, he is back in business suing clinicians—and for him, business is good.

IN SUM
This case was unfortunate. Always use care in securing the airway, particularly during patient movement. Once it is established, monitor the airway using SaO₂, ETCO₂, and keen observation. Airways are not in the “set it and forget it” camp. An airway must be maintained, safeguarded, and protected. Be prepared to act quickly should the airway become dislodged, migrate, or otherwise fail. —DML

REFERENCE
1. North Carolina Rules of Evidence Rule 611 (1983, c. 701, s. 1.).

CASE: Physician defames sedated patient

Our case takes us to the Commonwealth of Virginia. A male patient preparing to undergo a colonoscopy was concerned that, because of grogginess brought on by anesthesia, he might misunderstand postprocedure instructions or advice. He, therefore, turned his cell phone’s record function “on” and put it with his clothes. His clothes were put in a plastic bag, which ended up under the table with him in the operating room.

Following the procedure, as his wife drove him home, the patient replayed the instructions on the cell phone and realized that it had recorded the entire procedure. It quickly became apparent that the medical personnel had engaged in a series of inappropriate and insulting comments at the patient’s expense.

The anesthesiologist, talking to the now-unconscious patient, said, “after five minutes of talking to you in pre-op, I wanted to punch you in the face.” The patient had reported he was taking medication for a mild penile rash. The anesthesiologist warned an assistant not to touch it or “you might get syphilis on your arm or something,” but then noted, “it’s probably tuberculosis of the penis, so you’ll be all right.” There was further mocking of the patient, including a question of whether he was homosexual.

The anesthesiologist and gastroenterologist wanted to avoid talking to the patient after the procedure, and the gastroenterologist instructed an assistant to lie to the patient and convince the patient that the gastroenterologist had already spoken to him following the colonoscopy but, “you just don’t remember it.” In addition, the anesthesiologist announced that she was going to mark “hemorrhoids” on the patient’s chart, which she knew was a 
false diagnosis.

The patient, who is identified only by 
initials, is an attorney.¹ Of course, the smartphone was “good documentation” of what came out of what the health care team said.

The lawsuit

The patient (now plaintiff) claimed that he was verbally brutalized and suffered anxiety, embarrassment, and loss of sleep for 
several months.

On the first day of trial, the gastroenterologist was dismissed from the case. The trial went on against the anesthesiologist and the anesthesia practice.

What’s the verdict?

The patient was awarded $500,000, as follows:

• $100,000 for defamation, ($50,000 each for the syphilis and tuberculosis comments),
• $200,000 for medical malpractice
• $200,000 in punitive damages (including $50,000 the jury found that the anesthesia practice should pay).

Caveat. The above facts about this case come from the plaintiff’s complaint¹ and various professional commentaries and news sources.^2–5 Such sources are not always reliable, so they may not describe accurately all of the relevant events and statements.

Neither of the authors of this column attended the trial or heard the testimony presented. For the purposes of discussing the issues below, however, we treat as true the facts stated above. In addition, some of the legal claims in this case are uncertain. It is entirely possible that an appeal will be made and accepted, and some or all of the damages could be reduced by the trial court or an appellate court. The jury award, therefore, is not necessarily the last word.

Medicolegal takeaways 
from this case

This case raises a number of professional, ethical, and legal issues. Most fundamentally, the health care team is always expected to prioritize the patient’s best interest. Respect for the patient is an essential element of that.

Behaviors such as those reported about these physicians are “absolutely not to engage in any time,” stated President of the American Society of Anesthesiologists 
John Absentein, MD.⁶ A former president of the Academy of Anesthesiology, 
Kathryn McGoldrick, MD, added some common sense advice that such discussions are “not only offensive but frankly stupid.” As she notes, “we can never be certain that our patients are asleep and wouldn’t have recall.”⁷

The actions of the physicians also may violate ethical obligations. The very first principle of medical ethics is that the physician shall provide care “with compassion and respect for human dignity and rights.”⁸

The legal claims included defamation, infliction of emotional distress, privacy (related to medical records), and malpractice. We will take a very brief look at each of those causes of action and then say a word about punitive damages (which the jury awarded in this case).

It is important to remember that state law, rather than federal, is providing the legal principles on which these claims were decided. Federal law might provide some relevant principles in such cases (for example, the First Amendment freedom of speech limits the state defamation rules), but that is the exception. State law is the rule.

Defamation—award of damages

At its core, defamation is publishing (that is, telling someone other than the plaintiff) something untrue that may be harmful to another person. Generally the harm is reputational and the plaintiff may be affected by loss of business, mental suffering, or loss of esteem in the community.⁹

Defamation claims are not typical in health care cases. However, these claims are not rare: instances of health care professionals defaming other health care professionals, patients giving negative “reviews,” or health care professionals releasing false information to employers certainly do exist.

In this case, in addition to saying that the patient had syphilis and tuberculosis (both untrue), the physicians said he was a “wimp.” One interesting concept of 
defamation law that has developed over the centuries is “negligence per se.” This means a falsehood has been published about someone and the falsehood is likely to cause serious reputational harm. Claims that someone has a contagious disease traditionally have been considered negligence per se. Syphilis and tuberculosis fall in that category. On the other hand, saying someone needs to “man up” is usually a matter of opinion, so defamation for such comments is unlikely without special circumstances.

From the anesthesiologist’s perspective, the question is whether anyone who heard the publication really believed that the patient had either of the diseases. A joke that nobody believes to be based on fact generally is not defamatory because it has not harmed the plaintiff.¹⁰ It is apparent that the jury felt the patient had been defamed, however, given the $100,000 award for defamation.

In the United States there is special sensitivity to defamation awards because they may implicate the First Amendment’s protection of free speech. That being the case, this award may be particularly open to review by the judge and appellate courts.

Emotional distress—no award 
of damages

There are 2 kinds of “emotional distress” claimed in this case:

• intentional infliction
• negligent infliction.

Intentional infliction usually requires outrageous conduct by the defendant who acts intentionally or recklessly to inflict severe mental pain on the plaintiff.¹¹ In this case, the element of “intentional” or “reckless” is interesting. While the conduct was outrageous, it is doubtful that there was any way the anesthesiologist could have imagined that these outrageous statements would have been transmitted to the patient/plaintiff.

As for negligent infliction of emotional distress, most states have been wary of opening a Pandora’s Box of litigation. Therefore, they generally require significant physical manifestations of great stress to allow recovery.¹² It appears that the jury did not find the elements of either intentional or negligent infliction of emotional distress in this case.

As a side-note, this kind of emotional distress is viewed by the law as different from emotional distress that is incidental to a physical injury (pain and suffering). All states recognize that form of emotional distress.

Privacy—no award of damages

The privacy of medical records has, of course, become a major concern in the last few years. Both federal and state law provides significant penalties for the unauthorized release of medical information. However, in this case, it does not appear ­that medical information was improp-
erly revealed.¹³

The patient’s complaint suggested that the anesthesiologist’s discussion during the colonoscopy of the medication for the penile rash was unnecessary for health care purposes.¹ Therefore, it claims, the discussion violated the state health records privacy law. At the same time there was no indication in the public reports that this caused any harm 
to the patient.

Medical malpractice—award 
of damages

Malpractice usually involves professional practice that is unacceptable to the profession itself. It most commonly is negligence, or carelessness, that causes injury to the patient. The gross disregard for professional medical standards here was certainly negligence.¹⁴ The plaintiff claimed that discussing the medication for the penile rash and falsification of the medical records 
constituted malpractice.¹

Presumably the jury award for medical malpractice means the jury found that the misconduct of the medical staff caused the emotional harm that the plaintiff experienced (described as embarrassment, loss of sleep, mental anguish, and anxiety), and that those injuries warranted a 
$200,000 award.

Punitive damage—award of damages

The jury also awarded $200,000 in “punitive” or “exemplary” damages. These are unusual damages, given not so much to compensate the victim but rather as a deterrent for the future. Generally the defendant’s conduct must have been egregious and completely unacceptable.¹⁵ Those elements were apparent to the jury from the facts of this case.

What about loss of practice privileges?

It is not unlikely that one or more of the medical professionals might, beyond civil liability, be subject to licensure discipline by the Virginia board. In addition, there are other secondary consequences of this lawsuit. The employment of those involved may be interrupted. (The anesthesiologist is said to have moved to another state, for example.) Hospital privileges also may be affected, as may insurance rates. The results of this award likely will have to be reported to the National Practitioner Data Bank.

As physicians, what’s 
our takeaway?

Conduct unbecoming a physician remains front and center with a recent essay published in the internal medicine literature.¹⁶ The anonymous author attests to witnessing a male gynecologist making sexual comments regarding the patient at the time of vaginal surgery preparation and an obstetrician singing and dancing to a Mexican song while treating his Hispanic patient for postpartum bleeding.

The unusual case of the anesthesiologist that we address was made even more unusual by the fact that it was recorded. Recordings, however, are likely to become ever more common. The advice of everyone’s grandmother is well taken: “Always act as though what you do will be published on the front page of the newspaper.” The ubiquitous presence of video and audio cameras and untold other devices means that someone may well be watching.

Aside from the risk of getting caught, respect for patients and clients is the very foundation of respect and professional care. It is distressing that the anesthesiologist was so disrespectful of a patient. It is equally disappointing that nobody put a stop to it.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

CASE: Physician defames sedated patient

Our case takes us to the Commonwealth of Virginia. A male patient preparing to undergo a colonoscopy was concerned that, because of grogginess brought on by anesthesia, he might misunderstand postprocedure instructions or advice. He, therefore, turned his cell phone’s record function “on” and put it with his clothes. His clothes were put in a plastic bag, which ended up under the table with him in the operating room.

Following the procedure, as his wife drove him home, the patient replayed the instructions on the cell phone and realized that it had recorded the entire procedure. It quickly became apparent that the medical personnel had engaged in a series of inappropriate and insulting comments at the patient’s expense.

The anesthesiologist, talking to the now-unconscious patient, said, “after five minutes of talking to you in pre-op, I wanted to punch you in the face.” The patient had reported he was taking medication for a mild penile rash. The anesthesiologist warned an assistant not to touch it or “you might get syphilis on your arm or something,” but then noted, “it’s probably tuberculosis of the penis, so you’ll be all right.” There was further mocking of the patient, including a question of whether he was homosexual.

The anesthesiologist and gastroenterologist wanted to avoid talking to the patient after the procedure, and the gastroenterologist instructed an assistant to lie to the patient and convince the patient that the gastroenterologist had already spoken to him following the colonoscopy but, “you just don’t remember it.” In addition, the anesthesiologist announced that she was going to mark “hemorrhoids” on the patient’s chart, which she knew was a 
false diagnosis.

The patient, who is identified only by 
initials, is an attorney.¹ Of course, the smartphone was “good documentation” of what came out of what the health care team said.

The lawsuit

The patient (now plaintiff) claimed that he was verbally brutalized and suffered anxiety, embarrassment, and loss of sleep for 
several months.

On the first day of trial, the gastroenterologist was dismissed from the case. The trial went on against the anesthesiologist and the anesthesia practice.

What’s the verdict?

The patient was awarded $500,000, as follows:

• $100,000 for defamation, ($50,000 each for the syphilis and tuberculosis comments),
• $200,000 for medical malpractice
• $200,000 in punitive damages (including $50,000 the jury found that the anesthesia practice should pay).

Caveat. The above facts about this case come from the plaintiff’s complaint¹ and various professional commentaries and news sources.^2–5 Such sources are not always reliable, so they may not describe accurately all of the relevant events and statements.

Neither of the authors of this column attended the trial or heard the testimony presented. For the purposes of discussing the issues below, however, we treat as true the facts stated above. In addition, some of the legal claims in this case are uncertain. It is entirely possible that an appeal will be made and accepted, and some or all of the damages could be reduced by the trial court or an appellate court. The jury award, therefore, is not necessarily the last word.

Medicolegal takeaways 
from this case

This case raises a number of professional, ethical, and legal issues. Most fundamentally, the health care team is always expected to prioritize the patient’s best interest. Respect for the patient is an essential element of that.

Behaviors such as those reported about these physicians are “absolutely not to engage in any time,” stated President of the American Society of Anesthesiologists 
John Absentein, MD.⁶ A former president of the Academy of Anesthesiology, 
Kathryn McGoldrick, MD, added some common sense advice that such discussions are “not only offensive but frankly stupid.” As she notes, “we can never be certain that our patients are asleep and wouldn’t have recall.”⁷

The actions of the physicians also may violate ethical obligations. The very first principle of medical ethics is that the physician shall provide care “with compassion and respect for human dignity and rights.”⁸

The legal claims included defamation, infliction of emotional distress, privacy (related to medical records), and malpractice. We will take a very brief look at each of those causes of action and then say a word about punitive damages (which the jury awarded in this case).

It is important to remember that state law, rather than federal, is providing the legal principles on which these claims were decided. Federal law might provide some relevant principles in such cases (for example, the First Amendment freedom of speech limits the state defamation rules), but that is the exception. State law is the rule.

Defamation—award of damages

At its core, defamation is publishing (that is, telling someone other than the plaintiff) something untrue that may be harmful to another person. Generally the harm is reputational and the plaintiff may be affected by loss of business, mental suffering, or loss of esteem in the community.⁹

Defamation claims are not typical in health care cases. However, these claims are not rare: instances of health care professionals defaming other health care professionals, patients giving negative “reviews,” or health care professionals releasing false information to employers certainly do exist.

In this case, in addition to saying that the patient had syphilis and tuberculosis (both untrue), the physicians said he was a “wimp.” One interesting concept of 
defamation law that has developed over the centuries is “negligence per se.” This means a falsehood has been published about someone and the falsehood is likely to cause serious reputational harm. Claims that someone has a contagious disease traditionally have been considered negligence per se. Syphilis and tuberculosis fall in that category. On the other hand, saying someone needs to “man up” is usually a matter of opinion, so defamation for such comments is unlikely without special circumstances.

From the anesthesiologist’s perspective, the question is whether anyone who heard the publication really believed that the patient had either of the diseases. A joke that nobody believes to be based on fact generally is not defamatory because it has not harmed the plaintiff.¹⁰ It is apparent that the jury felt the patient had been defamed, however, given the $100,000 award for defamation.

In the United States there is special sensitivity to defamation awards because they may implicate the First Amendment’s protection of free speech. That being the case, this award may be particularly open to review by the judge and appellate courts.

Emotional distress—no award 
of damages

There are 2 kinds of “emotional distress” claimed in this case:

• intentional infliction
• negligent infliction.

Intentional infliction usually requires outrageous conduct by the defendant who acts intentionally or recklessly to inflict severe mental pain on the plaintiff.¹¹ In this case, the element of “intentional” or “reckless” is interesting. While the conduct was outrageous, it is doubtful that there was any way the anesthesiologist could have imagined that these outrageous statements would have been transmitted to the patient/plaintiff.

As for negligent infliction of emotional distress, most states have been wary of opening a Pandora’s Box of litigation. Therefore, they generally require significant physical manifestations of great stress to allow recovery.¹² It appears that the jury did not find the elements of either intentional or negligent infliction of emotional distress in this case.

As a side-note, this kind of emotional distress is viewed by the law as different from emotional distress that is incidental to a physical injury (pain and suffering). All states recognize that form of emotional distress.

Privacy—no award of damages

The privacy of medical records has, of course, become a major concern in the last few years. Both federal and state law provides significant penalties for the unauthorized release of medical information. However, in this case, it does not appear ­that medical information was improp-
erly revealed.¹³

The patient’s complaint suggested that the anesthesiologist’s discussion during the colonoscopy of the medication for the penile rash was unnecessary for health care purposes.¹ Therefore, it claims, the discussion violated the state health records privacy law. At the same time there was no indication in the public reports that this caused any harm 
to the patient.

Medical malpractice—award 
of damages

Malpractice usually involves professional practice that is unacceptable to the profession itself. It most commonly is negligence, or carelessness, that causes injury to the patient. The gross disregard for professional medical standards here was certainly negligence.¹⁴ The plaintiff claimed that discussing the medication for the penile rash and falsification of the medical records 
constituted malpractice.¹

Presumably the jury award for medical malpractice means the jury found that the misconduct of the medical staff caused the emotional harm that the plaintiff experienced (described as embarrassment, loss of sleep, mental anguish, and anxiety), and that those injuries warranted a 
$200,000 award.

Punitive damage—award of damages

The jury also awarded $200,000 in “punitive” or “exemplary” damages. These are unusual damages, given not so much to compensate the victim but rather as a deterrent for the future. Generally the defendant’s conduct must have been egregious and completely unacceptable.¹⁵ Those elements were apparent to the jury from the facts of this case.

What about loss of practice privileges?

It is not unlikely that one or more of the medical professionals might, beyond civil liability, be subject to licensure discipline by the Virginia board. In addition, there are other secondary consequences of this lawsuit. The employment of those involved may be interrupted. (The anesthesiologist is said to have moved to another state, for example.) Hospital privileges also may be affected, as may insurance rates. The results of this award likely will have to be reported to the National Practitioner Data Bank.

As physicians, what’s 
our takeaway?

Conduct unbecoming a physician remains front and center with a recent essay published in the internal medicine literature.¹⁶ The anonymous author attests to witnessing a male gynecologist making sexual comments regarding the patient at the time of vaginal surgery preparation and an obstetrician singing and dancing to a Mexican song while treating his Hispanic patient for postpartum bleeding.

The unusual case of the anesthesiologist that we address was made even more unusual by the fact that it was recorded. Recordings, however, are likely to become ever more common. The advice of everyone’s grandmother is well taken: “Always act as though what you do will be published on the front page of the newspaper.” The ubiquitous presence of video and audio cameras and untold other devices means that someone may well be watching.

Aside from the risk of getting caught, respect for patients and clients is the very foundation of respect and professional care. It is distressing that the anesthesiologist was so disrespectful of a patient. It is equally disappointing that nobody put a stop to it.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

CASE: Physician defames sedated patient

Our case takes us to the Commonwealth of Virginia. A male patient preparing to undergo a colonoscopy was concerned that, because of grogginess brought on by anesthesia, he might misunderstand postprocedure instructions or advice. He, therefore, turned his cell phone’s record function “on” and put it with his clothes. His clothes were put in a plastic bag, which ended up under the table with him in the operating room.

Following the procedure, as his wife drove him home, the patient replayed the instructions on the cell phone and realized that it had recorded the entire procedure. It quickly became apparent that the medical personnel had engaged in a series of inappropriate and insulting comments at the patient’s expense.

The anesthesiologist, talking to the now-unconscious patient, said, “after five minutes of talking to you in pre-op, I wanted to punch you in the face.” The patient had reported he was taking medication for a mild penile rash. The anesthesiologist warned an assistant not to touch it or “you might get syphilis on your arm or something,” but then noted, “it’s probably tuberculosis of the penis, so you’ll be all right.” There was further mocking of the patient, including a question of whether he was homosexual.

The anesthesiologist and gastroenterologist wanted to avoid talking to the patient after the procedure, and the gastroenterologist instructed an assistant to lie to the patient and convince the patient that the gastroenterologist had already spoken to him following the colonoscopy but, “you just don’t remember it.” In addition, the anesthesiologist announced that she was going to mark “hemorrhoids” on the patient’s chart, which she knew was a 
false diagnosis.

The patient, who is identified only by 
initials, is an attorney.¹ Of course, the smartphone was “good documentation” of what came out of what the health care team said.

The lawsuit

The patient (now plaintiff) claimed that he was verbally brutalized and suffered anxiety, embarrassment, and loss of sleep for 
several months.

On the first day of trial, the gastroenterologist was dismissed from the case. The trial went on against the anesthesiologist and the anesthesia practice.

What’s the verdict?

The patient was awarded $500,000, as follows:

• $100,000 for defamation, ($50,000 each for the syphilis and tuberculosis comments),
• $200,000 for medical malpractice
• $200,000 in punitive damages (including $50,000 the jury found that the anesthesia practice should pay).

Caveat. The above facts about this case come from the plaintiff’s complaint¹ and various professional commentaries and news sources.^2–5 Such sources are not always reliable, so they may not describe accurately all of the relevant events and statements.

Neither of the authors of this column attended the trial or heard the testimony presented. For the purposes of discussing the issues below, however, we treat as true the facts stated above. In addition, some of the legal claims in this case are uncertain. It is entirely possible that an appeal will be made and accepted, and some or all of the damages could be reduced by the trial court or an appellate court. The jury award, therefore, is not necessarily the last word.

Medicolegal takeaways 
from this case

This case raises a number of professional, ethical, and legal issues. Most fundamentally, the health care team is always expected to prioritize the patient’s best interest. Respect for the patient is an essential element of that.

Behaviors such as those reported about these physicians are “absolutely not to engage in any time,” stated President of the American Society of Anesthesiologists 
John Absentein, MD.⁶ A former president of the Academy of Anesthesiology, 
Kathryn McGoldrick, MD, added some common sense advice that such discussions are “not only offensive but frankly stupid.” As she notes, “we can never be certain that our patients are asleep and wouldn’t have recall.”⁷

The actions of the physicians also may violate ethical obligations. The very first principle of medical ethics is that the physician shall provide care “with compassion and respect for human dignity and rights.”⁸

The legal claims included defamation, infliction of emotional distress, privacy (related to medical records), and malpractice. We will take a very brief look at each of those causes of action and then say a word about punitive damages (which the jury awarded in this case).

It is important to remember that state law, rather than federal, is providing the legal principles on which these claims were decided. Federal law might provide some relevant principles in such cases (for example, the First Amendment freedom of speech limits the state defamation rules), but that is the exception. State law is the rule.

Defamation—award of damages

At its core, defamation is publishing (that is, telling someone other than the plaintiff) something untrue that may be harmful to another person. Generally the harm is reputational and the plaintiff may be affected by loss of business, mental suffering, or loss of esteem in the community.⁹

Defamation claims are not typical in health care cases. However, these claims are not rare: instances of health care professionals defaming other health care professionals, patients giving negative “reviews,” or health care professionals releasing false information to employers certainly do exist.

In this case, in addition to saying that the patient had syphilis and tuberculosis (both untrue), the physicians said he was a “wimp.” One interesting concept of 
defamation law that has developed over the centuries is “negligence per se.” This means a falsehood has been published about someone and the falsehood is likely to cause serious reputational harm. Claims that someone has a contagious disease traditionally have been considered negligence per se. Syphilis and tuberculosis fall in that category. On the other hand, saying someone needs to “man up” is usually a matter of opinion, so defamation for such comments is unlikely without special circumstances.

From the anesthesiologist’s perspective, the question is whether anyone who heard the publication really believed that the patient had either of the diseases. A joke that nobody believes to be based on fact generally is not defamatory because it has not harmed the plaintiff.¹⁰ It is apparent that the jury felt the patient had been defamed, however, given the $100,000 award for defamation.

In the United States there is special sensitivity to defamation awards because they may implicate the First Amendment’s protection of free speech. That being the case, this award may be particularly open to review by the judge and appellate courts.

Emotional distress—no award 
of damages

There are 2 kinds of “emotional distress” claimed in this case:

• intentional infliction
• negligent infliction.

Intentional infliction usually requires outrageous conduct by the defendant who acts intentionally or recklessly to inflict severe mental pain on the plaintiff.¹¹ In this case, the element of “intentional” or “reckless” is interesting. While the conduct was outrageous, it is doubtful that there was any way the anesthesiologist could have imagined that these outrageous statements would have been transmitted to the patient/plaintiff.

As for negligent infliction of emotional distress, most states have been wary of opening a Pandora’s Box of litigation. Therefore, they generally require significant physical manifestations of great stress to allow recovery.¹² It appears that the jury did not find the elements of either intentional or negligent infliction of emotional distress in this case.

As a side-note, this kind of emotional distress is viewed by the law as different from emotional distress that is incidental to a physical injury (pain and suffering). All states recognize that form of emotional distress.

Privacy—no award of damages

The privacy of medical records has, of course, become a major concern in the last few years. Both federal and state law provides significant penalties for the unauthorized release of medical information. However, in this case, it does not appear ­that medical information was improp-
erly revealed.¹³

The patient’s complaint suggested that the anesthesiologist’s discussion during the colonoscopy of the medication for the penile rash was unnecessary for health care purposes.¹ Therefore, it claims, the discussion violated the state health records privacy law. At the same time there was no indication in the public reports that this caused any harm 
to the patient.

Medical malpractice—award 
of damages

Malpractice usually involves professional practice that is unacceptable to the profession itself. It most commonly is negligence, or carelessness, that causes injury to the patient. The gross disregard for professional medical standards here was certainly negligence.¹⁴ The plaintiff claimed that discussing the medication for the penile rash and falsification of the medical records 
constituted malpractice.¹

Presumably the jury award for medical malpractice means the jury found that the misconduct of the medical staff caused the emotional harm that the plaintiff experienced (described as embarrassment, loss of sleep, mental anguish, and anxiety), and that those injuries warranted a 
$200,000 award.

Punitive damage—award of damages

The jury also awarded $200,000 in “punitive” or “exemplary” damages. These are unusual damages, given not so much to compensate the victim but rather as a deterrent for the future. Generally the defendant’s conduct must have been egregious and completely unacceptable.¹⁵ Those elements were apparent to the jury from the facts of this case.

What about loss of practice privileges?

It is not unlikely that one or more of the medical professionals might, beyond civil liability, be subject to licensure discipline by the Virginia board. In addition, there are other secondary consequences of this lawsuit. The employment of those involved may be interrupted. (The anesthesiologist is said to have moved to another state, for example.) Hospital privileges also may be affected, as may insurance rates. The results of this award likely will have to be reported to the National Practitioner Data Bank.

As physicians, what’s 
our takeaway?

Conduct unbecoming a physician remains front and center with a recent essay published in the internal medicine literature.¹⁶ The anonymous author attests to witnessing a male gynecologist making sexual comments regarding the patient at the time of vaginal surgery preparation and an obstetrician singing and dancing to a Mexican song while treating his Hispanic patient for postpartum bleeding.

The unusual case of the anesthesiologist that we address was made even more unusual by the fact that it was recorded. Recordings, however, are likely to become ever more common. The advice of everyone’s grandmother is well taken: “Always act as though what you do will be published on the front page of the newspaper.” The ubiquitous presence of video and audio cameras and untold other devices means that someone may well be watching.

Aside from the risk of getting caught, respect for patients and clients is the very foundation of respect and professional care. It is distressing that the anesthesiologist was so disrespectful of a patient. It is equally disappointing that nobody put a stop to it.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Dear Dr. Mossman,

I practice in a state that allows medical mari­juana use. A few of my patients have asked me to help them obtain marijuana for their conditions. How risky would it be to oblige?

Submitted by “Dr. J”

In recent years, public debate about mar­ijuana has acquired 2 new dimensions: (1) the wishes and medical needs of peo­ple who seek marijuana for its purported health benefits, and (2) the role of physi­cians who practice where “medical mari­juana” is legal. This article, the authors’ joint effort to address Dr. J’s concerns, hits 3 topics:
   • the intersection of marijuana policy and health care in the United States
   • the risks and possible benefits of mari­juana use
   • the medicolegal problems faced by physicians who might advise patients to use marijuana.

Legal haze
Two cannabinoids—dronabinol and nabi­lone—have received FDA approval as appetite enhancers and anti-nausea agents. Third-party payors usually cover these types of medications, but no insurer pays for medical marijuana.¹ The Controlled Substances Act of 1970² classified mari­juana as a Schedule I drug because of its abuse potential, lack of accepted medical applications, and uncertain safety. The FDA has not approved marijuana use for any medical condition.

Although people commonly speak of “prescribing” marijuana, physicians cannot legally do this in the United States. What physicians may do, in the 23 states that allow medical marijuana, is recommend or certify a patient’s marijuana use—an action that has constitutional protection under the First Amendment’s freedom of speech clause.^3,4

A physician may complete documenta­tion that a patient has one of the qualifying medical conditions for which the jurisdic­tion has legalized medical marijuana. Either the patient or the physician then submits that documentation to the appropriate gov­ernment agency (eg, the state’s department of health).

If the documentation receives approval, the agency will issue the patient a registra­tion card that allows possession of medi­cal marijuana, with which the patient can obtain or grow a small amount of mari­juana. The cannabinoid content of mari­juana products varies considerably,⁵ and physicians who certify marijuana typi­cally defer dosage recommendations to the patient or the dispensary.¹

In states that allow medical marijuana, users may assert an affirmative defense of medical necessity if they face criminal pros­ecution.^3,6 Possession of marijuana remains illegal under federal law, however, regard­less of one’s reason for having it.^7,8 Since October 2009, the Attorney General’s office has discouraged federal prosecutions of per­sons “whose actions are in clear and unam­biguous compliance with existing state laws providing for the medical use of mari­juana.”⁹ But given the remaining conflicts between state and federal laws, “the legal implications of certifying patients for medi­cal marijuana remain unclear.”¹⁰

Physicians have few resources to instruct them on the legal risks of certifying medical marijuana. When Canada legalized medical marijuana, the organization that provides malpractice insurance to Canadian physi­cians told its members that “prescribing medical marijuana cannot be compared to prescribing prescription drugs” and rec­ommended that physicians obtain signed release forms documenting that they have discussed the risks of medical marijuana with patients.¹¹ For some risky approved drugs, the FDA has established a risk evalu­ation and mitigation strategy, but no such guidance is available for marijuana.

Highlighting the benefits and risks
Proponents of medical marijuana claim that Cannabis can help patients, and dispas­sionate experts acknowledge that at least modest evidence supports the benefits of using “marijuana for nausea and vomit­ing related to chemotherapy, specific pain syndromes, and spasticity from multiple sclerosis.”¹⁰ For several other conditions— HIV/AIDS, depression, anxiety disor­ders, sleep disorders, psychosis, Tourette syndrome—evidence of benefit is poor.¹² Rigorous evaluation of medical marijuana is difficult because the plant contains hun­dreds of active chemical compounds. The chemical content of marijuana is highly variable, depending on its preparation and administration,^10,13—one reason why only a few good randomized controlled trials of marijuana have been conducted.

Marijuana has several side effects and carries many health risks (Table 1).^4,14-20

On the highway: Marijuana and driving
Marijuana use impairs driving ability.¹⁴ Following enactment of more lenient mari­juana laws, several states have reported higher numbers of fatally injured drivers who tested positive for Cannabis^21-23 and had a positive screen of tetrahydrocannabi­nol (THC) in driving under the influence cases.^24,25 One study showed that a blood THC concentration >5 ng/mL (comparable to a blood alcohol concentration of 0.15%) increased the crash odds ratio to 6.^6.25,26

Marijuana impairs reaction time, informa­tion processing, motor performance, atten­tion, and visual processing.^14,16,27,28 Drivers who are under the influence of marijuana make more driving errors, despite being cautious about how they react to traffic.²⁹ Even after weeks of abstinence, previ­ous daily users of marijuana display some cognitive processing and driving-related impairments.^30,31

Courts have found physicians negligent if their patients’ treatment-induced driving impairments injured others when the risk of driving-related injury was foreseeable.³² The Massachusetts case of Coombes v Florio³³ lik­ened the physician’s duty to that of a liquor store that sells alcohol to a minor who sub­sequently crashes, or to a father who did not lock his firearms away from his violent adult son.

Three variables influence a court’s judgment about whether risk is “foresee­able”: “the relative knowledge of the risk as between lay persons and physicians, whether the patient has previously used the medication and/or experienced the adverse effect, and whether a warning would other­wise have been futile.”³⁴ A physician who certified a patient to use marijuana without adequately explaining the risks of driv­ing might be vulnerable to a lawsuit if the patient’s driving accident occurred while the patient was under the influence of the drug. Recommending marijuana as a treat­ment also could lead to a malpractice action if a patient experienced and was harmed by the drug’s adverse effects.

Other drags
Another malpractice risk stems from mari­juana’s addiction potential. Although many people think Cannabis isn’t addictive, nearly 10% of all marijuana users develop depen­dence.^10,17 Regular Cannabis users are more likely to use alcohol, tobacco, and “recre­ational” drugs,^17,35 and using alcohol and marijuana together greatly heightens the risk of driving accidents.^14,15 Although we know of no case that relates directly to mari­juana, physicians have faced lawsuits for injuries stemming from a patient’s addiction to prescription drugs,36 particularly when the patient’s behavior should have led the physician to suspect abuse or overuse.³⁷

When certifying marijuana use, physi­cians have the same obligations that apply to more conventional medical treatment:
   • establishing a proper physician–patient relationship
   • taking an appropriate history
   • conducting a proper examination
   • reviewing records
   • developing a comprehensive treatment plan
   • weighing risks and alternatives
   • providing follow-up care.

Neglecting these steps could lead to medical board sanctions and suspension or revocation of a medical license.¹³

The blunt reality
We advise against recommending mari­juana for your patients. But if you have exhausted the alternatives, see marijuana as the last resort, and believe that taking the risk is worth the potential benefit, you can take some steps to reduce your legal risk (Table 2,^1,32,37,38 and Table 3¹³).

Bottom LinE
Medical marijuana is a controversial topic that demands more rigorous research and regulatory consideration. In the present climate, cautious physicians will avoid recommending marijuana to their patients. If you think that a patient has a medical indication, with no treatment option better than medical marijuana, be sure to understand the medical and legal ramifications before you authorize its use.

Disclosures
The authors report no financial relationship with any company whose products are mentioned in this article or with manufacturers of competing products.

Dear Dr. Mossman,

I practice in a state that allows medical mari­juana use. A few of my patients have asked me to help them obtain marijuana for their conditions. How risky would it be to oblige?

Submitted by “Dr. J”

In recent years, public debate about mar­ijuana has acquired 2 new dimensions: (1) the wishes and medical needs of peo­ple who seek marijuana for its purported health benefits, and (2) the role of physi­cians who practice where “medical mari­juana” is legal. This article, the authors’ joint effort to address Dr. J’s concerns, hits 3 topics:
   • the intersection of marijuana policy and health care in the United States
   • the risks and possible benefits of mari­juana use
   • the medicolegal problems faced by physicians who might advise patients to use marijuana.

Legal haze
Two cannabinoids—dronabinol and nabi­lone—have received FDA approval as appetite enhancers and anti-nausea agents. Third-party payors usually cover these types of medications, but no insurer pays for medical marijuana.¹ The Controlled Substances Act of 1970² classified mari­juana as a Schedule I drug because of its abuse potential, lack of accepted medical applications, and uncertain safety. The FDA has not approved marijuana use for any medical condition.

Although people commonly speak of “prescribing” marijuana, physicians cannot legally do this in the United States. What physicians may do, in the 23 states that allow medical marijuana, is recommend or certify a patient’s marijuana use—an action that has constitutional protection under the First Amendment’s freedom of speech clause.^3,4

A physician may complete documenta­tion that a patient has one of the qualifying medical conditions for which the jurisdic­tion has legalized medical marijuana. Either the patient or the physician then submits that documentation to the appropriate gov­ernment agency (eg, the state’s department of health).

If the documentation receives approval, the agency will issue the patient a registra­tion card that allows possession of medi­cal marijuana, with which the patient can obtain or grow a small amount of mari­juana. The cannabinoid content of mari­juana products varies considerably,⁵ and physicians who certify marijuana typi­cally defer dosage recommendations to the patient or the dispensary.¹

In states that allow medical marijuana, users may assert an affirmative defense of medical necessity if they face criminal pros­ecution.^3,6 Possession of marijuana remains illegal under federal law, however, regard­less of one’s reason for having it.^7,8 Since October 2009, the Attorney General’s office has discouraged federal prosecutions of per­sons “whose actions are in clear and unam­biguous compliance with existing state laws providing for the medical use of mari­juana.”⁹ But given the remaining conflicts between state and federal laws, “the legal implications of certifying patients for medi­cal marijuana remain unclear.”¹⁰

Physicians have few resources to instruct them on the legal risks of certifying medical marijuana. When Canada legalized medical marijuana, the organization that provides malpractice insurance to Canadian physi­cians told its members that “prescribing medical marijuana cannot be compared to prescribing prescription drugs” and rec­ommended that physicians obtain signed release forms documenting that they have discussed the risks of medical marijuana with patients.¹¹ For some risky approved drugs, the FDA has established a risk evalu­ation and mitigation strategy, but no such guidance is available for marijuana.

Highlighting the benefits and risks
Proponents of medical marijuana claim that Cannabis can help patients, and dispas­sionate experts acknowledge that at least modest evidence supports the benefits of using “marijuana for nausea and vomit­ing related to chemotherapy, specific pain syndromes, and spasticity from multiple sclerosis.”¹⁰ For several other conditions— HIV/AIDS, depression, anxiety disor­ders, sleep disorders, psychosis, Tourette syndrome—evidence of benefit is poor.¹² Rigorous evaluation of medical marijuana is difficult because the plant contains hun­dreds of active chemical compounds. The chemical content of marijuana is highly variable, depending on its preparation and administration,^10,13—one reason why only a few good randomized controlled trials of marijuana have been conducted.

Marijuana has several side effects and carries many health risks (Table 1).^4,14-20

On the highway: Marijuana and driving
Marijuana use impairs driving ability.¹⁴ Following enactment of more lenient mari­juana laws, several states have reported higher numbers of fatally injured drivers who tested positive for Cannabis^21-23 and had a positive screen of tetrahydrocannabi­nol (THC) in driving under the influence cases.^24,25 One study showed that a blood THC concentration >5 ng/mL (comparable to a blood alcohol concentration of 0.15%) increased the crash odds ratio to 6.^6.25,26

Marijuana impairs reaction time, informa­tion processing, motor performance, atten­tion, and visual processing.^14,16,27,28 Drivers who are under the influence of marijuana make more driving errors, despite being cautious about how they react to traffic.²⁹ Even after weeks of abstinence, previ­ous daily users of marijuana display some cognitive processing and driving-related impairments.^30,31

Courts have found physicians negligent if their patients’ treatment-induced driving impairments injured others when the risk of driving-related injury was foreseeable.³² The Massachusetts case of Coombes v Florio³³ lik­ened the physician’s duty to that of a liquor store that sells alcohol to a minor who sub­sequently crashes, or to a father who did not lock his firearms away from his violent adult son.

Three variables influence a court’s judgment about whether risk is “foresee­able”: “the relative knowledge of the risk as between lay persons and physicians, whether the patient has previously used the medication and/or experienced the adverse effect, and whether a warning would other­wise have been futile.”³⁴ A physician who certified a patient to use marijuana without adequately explaining the risks of driv­ing might be vulnerable to a lawsuit if the patient’s driving accident occurred while the patient was under the influence of the drug. Recommending marijuana as a treat­ment also could lead to a malpractice action if a patient experienced and was harmed by the drug’s adverse effects.

Other drags
Another malpractice risk stems from mari­juana’s addiction potential. Although many people think Cannabis isn’t addictive, nearly 10% of all marijuana users develop depen­dence.^10,17 Regular Cannabis users are more likely to use alcohol, tobacco, and “recre­ational” drugs,^17,35 and using alcohol and marijuana together greatly heightens the risk of driving accidents.^14,15 Although we know of no case that relates directly to mari­juana, physicians have faced lawsuits for injuries stemming from a patient’s addiction to prescription drugs,36 particularly when the patient’s behavior should have led the physician to suspect abuse or overuse.³⁷

When certifying marijuana use, physi­cians have the same obligations that apply to more conventional medical treatment:
   • establishing a proper physician–patient relationship
   • taking an appropriate history
   • conducting a proper examination
   • reviewing records
   • developing a comprehensive treatment plan
   • weighing risks and alternatives
   • providing follow-up care.

Neglecting these steps could lead to medical board sanctions and suspension or revocation of a medical license.¹³

The blunt reality
We advise against recommending mari­juana for your patients. But if you have exhausted the alternatives, see marijuana as the last resort, and believe that taking the risk is worth the potential benefit, you can take some steps to reduce your legal risk (Table 2,^1,32,37,38 and Table 3¹³).

Bottom LinE
Medical marijuana is a controversial topic that demands more rigorous research and regulatory consideration. In the present climate, cautious physicians will avoid recommending marijuana to their patients. If you think that a patient has a medical indication, with no treatment option better than medical marijuana, be sure to understand the medical and legal ramifications before you authorize its use.

Disclosures
The authors report no financial relationship with any company whose products are mentioned in this article or with manufacturers of competing products.

Dear Dr. Mossman,

I practice in a state that allows medical mari­juana use. A few of my patients have asked me to help them obtain marijuana for their conditions. How risky would it be to oblige?

Submitted by “Dr. J”

In recent years, public debate about mar­ijuana has acquired 2 new dimensions: (1) the wishes and medical needs of peo­ple who seek marijuana for its purported health benefits, and (2) the role of physi­cians who practice where “medical mari­juana” is legal. This article, the authors’ joint effort to address Dr. J’s concerns, hits 3 topics:
   • the intersection of marijuana policy and health care in the United States
   • the risks and possible benefits of mari­juana use
   • the medicolegal problems faced by physicians who might advise patients to use marijuana.

Legal haze
Two cannabinoids—dronabinol and nabi­lone—have received FDA approval as appetite enhancers and anti-nausea agents. Third-party payors usually cover these types of medications, but no insurer pays for medical marijuana.¹ The Controlled Substances Act of 1970² classified mari­juana as a Schedule I drug because of its abuse potential, lack of accepted medical applications, and uncertain safety. The FDA has not approved marijuana use for any medical condition.

Although people commonly speak of “prescribing” marijuana, physicians cannot legally do this in the United States. What physicians may do, in the 23 states that allow medical marijuana, is recommend or certify a patient’s marijuana use—an action that has constitutional protection under the First Amendment’s freedom of speech clause.^3,4

A physician may complete documenta­tion that a patient has one of the qualifying medical conditions for which the jurisdic­tion has legalized medical marijuana. Either the patient or the physician then submits that documentation to the appropriate gov­ernment agency (eg, the state’s department of health).

If the documentation receives approval, the agency will issue the patient a registra­tion card that allows possession of medi­cal marijuana, with which the patient can obtain or grow a small amount of mari­juana. The cannabinoid content of mari­juana products varies considerably,⁵ and physicians who certify marijuana typi­cally defer dosage recommendations to the patient or the dispensary.¹

In states that allow medical marijuana, users may assert an affirmative defense of medical necessity if they face criminal pros­ecution.^3,6 Possession of marijuana remains illegal under federal law, however, regard­less of one’s reason for having it.^7,8 Since October 2009, the Attorney General’s office has discouraged federal prosecutions of per­sons “whose actions are in clear and unam­biguous compliance with existing state laws providing for the medical use of mari­juana.”⁹ But given the remaining conflicts between state and federal laws, “the legal implications of certifying patients for medi­cal marijuana remain unclear.”¹⁰

Physicians have few resources to instruct them on the legal risks of certifying medical marijuana. When Canada legalized medical marijuana, the organization that provides malpractice insurance to Canadian physi­cians told its members that “prescribing medical marijuana cannot be compared to prescribing prescription drugs” and rec­ommended that physicians obtain signed release forms documenting that they have discussed the risks of medical marijuana with patients.¹¹ For some risky approved drugs, the FDA has established a risk evalu­ation and mitigation strategy, but no such guidance is available for marijuana.

Highlighting the benefits and risks
Proponents of medical marijuana claim that Cannabis can help patients, and dispas­sionate experts acknowledge that at least modest evidence supports the benefits of using “marijuana for nausea and vomit­ing related to chemotherapy, specific pain syndromes, and spasticity from multiple sclerosis.”¹⁰ For several other conditions— HIV/AIDS, depression, anxiety disor­ders, sleep disorders, psychosis, Tourette syndrome—evidence of benefit is poor.¹² Rigorous evaluation of medical marijuana is difficult because the plant contains hun­dreds of active chemical compounds. The chemical content of marijuana is highly variable, depending on its preparation and administration,^10,13—one reason why only a few good randomized controlled trials of marijuana have been conducted.

Marijuana has several side effects and carries many health risks (Table 1).^4,14-20

On the highway: Marijuana and driving
Marijuana use impairs driving ability.¹⁴ Following enactment of more lenient mari­juana laws, several states have reported higher numbers of fatally injured drivers who tested positive for Cannabis^21-23 and had a positive screen of tetrahydrocannabi­nol (THC) in driving under the influence cases.^24,25 One study showed that a blood THC concentration >5 ng/mL (comparable to a blood alcohol concentration of 0.15%) increased the crash odds ratio to 6.^6.25,26

Marijuana impairs reaction time, informa­tion processing, motor performance, atten­tion, and visual processing.^14,16,27,28 Drivers who are under the influence of marijuana make more driving errors, despite being cautious about how they react to traffic.²⁹ Even after weeks of abstinence, previ­ous daily users of marijuana display some cognitive processing and driving-related impairments.^30,31

Courts have found physicians negligent if their patients’ treatment-induced driving impairments injured others when the risk of driving-related injury was foreseeable.³² The Massachusetts case of Coombes v Florio³³ lik­ened the physician’s duty to that of a liquor store that sells alcohol to a minor who sub­sequently crashes, or to a father who did not lock his firearms away from his violent adult son.

Three variables influence a court’s judgment about whether risk is “foresee­able”: “the relative knowledge of the risk as between lay persons and physicians, whether the patient has previously used the medication and/or experienced the adverse effect, and whether a warning would other­wise have been futile.”³⁴ A physician who certified a patient to use marijuana without adequately explaining the risks of driv­ing might be vulnerable to a lawsuit if the patient’s driving accident occurred while the patient was under the influence of the drug. Recommending marijuana as a treat­ment also could lead to a malpractice action if a patient experienced and was harmed by the drug’s adverse effects.

Other drags
Another malpractice risk stems from mari­juana’s addiction potential. Although many people think Cannabis isn’t addictive, nearly 10% of all marijuana users develop depen­dence.^10,17 Regular Cannabis users are more likely to use alcohol, tobacco, and “recre­ational” drugs,^17,35 and using alcohol and marijuana together greatly heightens the risk of driving accidents.^14,15 Although we know of no case that relates directly to mari­juana, physicians have faced lawsuits for injuries stemming from a patient’s addiction to prescription drugs,36 particularly when the patient’s behavior should have led the physician to suspect abuse or overuse.³⁷

When certifying marijuana use, physi­cians have the same obligations that apply to more conventional medical treatment:
   • establishing a proper physician–patient relationship
   • taking an appropriate history
   • conducting a proper examination
   • reviewing records
   • developing a comprehensive treatment plan
   • weighing risks and alternatives
   • providing follow-up care.

Neglecting these steps could lead to medical board sanctions and suspension or revocation of a medical license.¹³

The blunt reality
We advise against recommending mari­juana for your patients. But if you have exhausted the alternatives, see marijuana as the last resort, and believe that taking the risk is worth the potential benefit, you can take some steps to reduce your legal risk (Table 2,^1,32,37,38 and Table 3¹³).

Bottom LinE
Medical marijuana is a controversial topic that demands more rigorous research and regulatory consideration. In the present climate, cautious physicians will avoid recommending marijuana to their patients. If you think that a patient has a medical indication, with no treatment option better than medical marijuana, be sure to understand the medical and legal ramifications before you authorize its use.

Disclosures
The authors report no financial relationship with any company whose products are mentioned in this article or with manufacturers of competing products.