Law & Medicine

Should these complaints have prompted a colonoscopy?

A 45-YEAR-OLD WOMAN went to her primary care physician due to cramping abdominal pain after eating. She hadn’t seen her physician in 5 years and noted that her bowel movements were somewhat smaller than usual. Her physician suspected an ulcer and treated her with acid-reducing medication.

A month later, the patient returned with similar symptoms and said that her bowel movements were somewhat loose. The physician increased the dosage of the acid-reducing medication. The patient returned again a month later and reported constipation. The stomach issues continued and she was referred to a gynecologist. Ultimately, she went to a gastroenterologist and underwent a colonoscopy 8 months after her first visit. She was diagnosed with stage IV colon cancer with metastasis to the ovaries. The patient passed away 8 years later.

PLAINTIFF’S CLAIM The physician was negligent in failing to suspect colon cancer and perform a colonoscopy, digital rectal exam, or fecal occult blood test.

THE DEFENSE The decedent’s symptoms were inconsistent with cancer and did not indicate the need for a colonoscopy. The cancer was already advanced and the outcome would not have changed.

VERDICT $2.16 million Massachusetts verdict.

COMMENT Wow, this is a tough one! I am not at all sure I would have diagnosed this correctly. Is there a lesson here? Perhaps the history was not sufficiently thorough? Perhaps these were totally new symptoms that should have demanded a more thorough investigation? Or perhaps it would have taken 4 to 6 months for any of us to make this diagnosis in a 45-year-old woman.

Complication of pregnancy goes undetected after delivery 

A 31-YEAR-OLD WOMAN went to the emergency department (ED) complaining of tightness in her chest, difficulty breathing, and swelling in her lower legs 4 days after she delivered a child. The ED physician ruled out a pulmonary embolism and discharged her. Three days later, she returned with the same symptoms, but her legs were more swollen and her systolic blood pressure was above 160 mm Hg. She was sent home again. The woman had a seizure 4 days later. In the ambulance on the way to the hospital and following her arrival, she suffered more seizures. A few days later, she was transferred to a different facility and died soon after.

PLAINTIFF’S CLAIM The hospital and 2 ED physicians were negligent in failing to diagnose and treat postpartum preeclampsia during the ED visits. This led to the seizures, brain damage, and death. Antihypertensive and anti-seizure medications would have prevented her death.

THE DEFENSE The actions taken were reasonable, especially because the decedent had no symptoms of preeclampsia during pregnancy or delivery.

VERDICT $6.9 million Illinois settlement.

COMMENT This case speaks for itself. The physicians involved appear to have had a knowledge gap since they apparently did not consider preeclampsia in the differential. Primary care physicians and emergency physicians must be trained to recognize complications of pregnancy.

Should these complaints have prompted a colonoscopy?

A 45-YEAR-OLD WOMAN went to her primary care physician due to cramping abdominal pain after eating. She hadn’t seen her physician in 5 years and noted that her bowel movements were somewhat smaller than usual. Her physician suspected an ulcer and treated her with acid-reducing medication.

A month later, the patient returned with similar symptoms and said that her bowel movements were somewhat loose. The physician increased the dosage of the acid-reducing medication. The patient returned again a month later and reported constipation. The stomach issues continued and she was referred to a gynecologist. Ultimately, she went to a gastroenterologist and underwent a colonoscopy 8 months after her first visit. She was diagnosed with stage IV colon cancer with metastasis to the ovaries. The patient passed away 8 years later.

PLAINTIFF’S CLAIM The physician was negligent in failing to suspect colon cancer and perform a colonoscopy, digital rectal exam, or fecal occult blood test.

THE DEFENSE The decedent’s symptoms were inconsistent with cancer and did not indicate the need for a colonoscopy. The cancer was already advanced and the outcome would not have changed.

VERDICT $2.16 million Massachusetts verdict.

COMMENT Wow, this is a tough one! I am not at all sure I would have diagnosed this correctly. Is there a lesson here? Perhaps the history was not sufficiently thorough? Perhaps these were totally new symptoms that should have demanded a more thorough investigation? Or perhaps it would have taken 4 to 6 months for any of us to make this diagnosis in a 45-year-old woman.

Complication of pregnancy goes undetected after delivery 

A 31-YEAR-OLD WOMAN went to the emergency department (ED) complaining of tightness in her chest, difficulty breathing, and swelling in her lower legs 4 days after she delivered a child. The ED physician ruled out a pulmonary embolism and discharged her. Three days later, she returned with the same symptoms, but her legs were more swollen and her systolic blood pressure was above 160 mm Hg. She was sent home again. The woman had a seizure 4 days later. In the ambulance on the way to the hospital and following her arrival, she suffered more seizures. A few days later, she was transferred to a different facility and died soon after.

PLAINTIFF’S CLAIM The hospital and 2 ED physicians were negligent in failing to diagnose and treat postpartum preeclampsia during the ED visits. This led to the seizures, brain damage, and death. Antihypertensive and anti-seizure medications would have prevented her death.

THE DEFENSE The actions taken were reasonable, especially because the decedent had no symptoms of preeclampsia during pregnancy or delivery.

VERDICT $6.9 million Illinois settlement.

COMMENT This case speaks for itself. The physicians involved appear to have had a knowledge gap since they apparently did not consider preeclampsia in the differential. Primary care physicians and emergency physicians must be trained to recognize complications of pregnancy.

Should these complaints have prompted a colonoscopy?

A 45-YEAR-OLD WOMAN went to her primary care physician due to cramping abdominal pain after eating. She hadn’t seen her physician in 5 years and noted that her bowel movements were somewhat smaller than usual. Her physician suspected an ulcer and treated her with acid-reducing medication.

A month later, the patient returned with similar symptoms and said that her bowel movements were somewhat loose. The physician increased the dosage of the acid-reducing medication. The patient returned again a month later and reported constipation. The stomach issues continued and she was referred to a gynecologist. Ultimately, she went to a gastroenterologist and underwent a colonoscopy 8 months after her first visit. She was diagnosed with stage IV colon cancer with metastasis to the ovaries. The patient passed away 8 years later.

PLAINTIFF’S CLAIM The physician was negligent in failing to suspect colon cancer and perform a colonoscopy, digital rectal exam, or fecal occult blood test.

THE DEFENSE The decedent’s symptoms were inconsistent with cancer and did not indicate the need for a colonoscopy. The cancer was already advanced and the outcome would not have changed.

VERDICT $2.16 million Massachusetts verdict.

COMMENT Wow, this is a tough one! I am not at all sure I would have diagnosed this correctly. Is there a lesson here? Perhaps the history was not sufficiently thorough? Perhaps these were totally new symptoms that should have demanded a more thorough investigation? Or perhaps it would have taken 4 to 6 months for any of us to make this diagnosis in a 45-year-old woman.

Complication of pregnancy goes undetected after delivery 

A 31-YEAR-OLD WOMAN went to the emergency department (ED) complaining of tightness in her chest, difficulty breathing, and swelling in her lower legs 4 days after she delivered a child. The ED physician ruled out a pulmonary embolism and discharged her. Three days later, she returned with the same symptoms, but her legs were more swollen and her systolic blood pressure was above 160 mm Hg. She was sent home again. The woman had a seizure 4 days later. In the ambulance on the way to the hospital and following her arrival, she suffered more seizures. A few days later, she was transferred to a different facility and died soon after.

PLAINTIFF’S CLAIM The hospital and 2 ED physicians were negligent in failing to diagnose and treat postpartum preeclampsia during the ED visits. This led to the seizures, brain damage, and death. Antihypertensive and anti-seizure medications would have prevented her death.

THE DEFENSE The actions taken were reasonable, especially because the decedent had no symptoms of preeclampsia during pregnancy or delivery.

VERDICT $6.9 million Illinois settlement.

COMMENT This case speaks for itself. The physicians involved appear to have had a knowledge gap since they apparently did not consider preeclampsia in the differential. Primary care physicians and emergency physicians must be trained to recognize complications of pregnancy.

Missed Preeclampsia

On physical examination, the patient’s vital signs were remarkable for the following: heart rate (HR), 86 beats/minute; blood pressure (BP), 164/94 mm Hg; respiratory rate, 18 breaths/minute; temperature, 98.6^oF. Oxygen saturation was 96% on room air. The head, eye, ear, nose and throat examination was unremarkable. The lungs were clear to auscultation bilaterally, and HR and heart rhythm were normal. The abdomen was soft and nontender without guarding or rebound. The lower extremities were remarkable for 1+ pedal and pretibial edema bilaterally.

The patient presented to the same ED 2 days later, again with the chief complaint of shortness of breath. On examination, her BP was noted to be elevated and she had 1+ dependent edema bilaterally. Again, the EP was concerned for a PE and ordered a repeat CTA scan of the chest. This study, similar to the first, was read as normal, and showed no evidence of PE. The patient was diagnosed again with “shortness of breath of unknown etiology” and discharged home. The patient’s obstetrician-gynecologist (Ob/Gyn) was not consulted; however, the patient was encouraged to follow up with him.

The next day, the patient presented to the same ED via emergency medical services, this time with seizures; she had no prior history of a seizure disorder. On presentation to the ED, she was noted to be postictal, with an elevated BP and tachycardic with an HR of 104 beats/minute. On examination, the lungs were clear to auscultation and the lower extremities exhibited 1+ pedal and pretibial edema. A urinalysis revealed proteinuria. The patient was given 4 g of magnesium sulfate intravenously (IV) and her Ob/Gyn was consulted.

The patient was admitted to the hospital with a diagnosis of eclampsia. She was given an IV drip of magnesium and labetalol for the high BP. Unfortunately, the patient apparently had suffered an anoxic brain injury from the previous seizures and died on hospital day 3.

The family sued the treating EPs and the hospital for failure to diagnose preeclampsia on two separate ED presentations. They noted the patient’s Ob/Gyn was never consulted; no action was taken to treat the hypertension; and no urinalysis was ordered on either visit. The EPs and hospital settled the case prior to trial for several million dollars.

Discussion

This is an incredibly sad case, and the EPs and hospital were right to settle and not go to trial. While PE was a reasonable diagnosis to consider in this patient on her first ED visit, it should not have been the only one in the differential diagnosis. The EP became anchored to this single diagnosis and refused to consider other alternative diagnoses—even after the CTA scan of the chest ruled out PE. Moreover, it appears the EP either never considered the significance of the elevated BP and dependent edema or just ignored these findings. To repeat essentially the same exact workup on the second visit does not make sense—one should “cast a wider net, not the same net.”

The diagnosis of “shortness of breath of unknown etiology” is similarly unacceptable. While this is a common and accepted diagnosis when it pertains to abdominal pain, the same is not true for dyspnea.

Preeclampsia is characterized by hypertension (BP >140/90 mm Hg) and proteinuria; associated symptoms include edema and hyperreflexia. Postpartum preeclampsia occurs infrequently and can develop up to 4 weeks after delivery.¹ In one 10-year retrospective case series, the incidence of preeclampsia in the postpartum period was 5.7%, and nearly 16% went on to develop eclampsia.² In a retrospective study of 22 postpartum preeclamptic patients, the median time to presentation was 5 days postpartum.¹ In a similar retrospective study of 152 patients, 90% of such patients presented within 7 days.³ The patient in this case initially presented on postpartum day 4.

Interestingly, in a study by Al-Safi et al,³ 63% of postpartum preeclamptic patients had no antecedent diagnosis of hypertensive disease during pregnancy. These findings are consistent with the findings of others that 33% to 69% of such patients show no evidence of preeclampsia in the ante- or peripartum period.

The clinical presentation of postpartum preeclampsia is similar to preeclampsia complicating pregnancy after gestation week 20. In the study by Al-Safi et al,³ headache was the most common presenting symptom (69%), followed by shortness of breath (30%), blurry vision (21%), nausea (12.5%), and epigastric abdominal pain (5%). Similarly, Yancey et al¹ found headache (82%) to be the most common presenting symptom in their series. Unfortunately, it is not known whether the patient in this case complained of headache or blurred vision as the published records note neither their presence nor absence.

The management of patients with preeclampsia includes IV magnesium to prevent seizures (ie, eclampsia) and BP control.¹ A bolus of 4 to 6 g IV magnesium sulfate over 15 to 30 minutes is recommended, followed by an infusion of 2 g/h IV. Historically, IV hydralazine has been used to manage preeclamptic patients with a BP greater than 160/110 mm Hg. More recently, however, IV labetalol has become popular.⁵ All such patients require admission to the hospital with Ob/Gyn involvement.

Missed Subdural Hematoma

A 59-year-old man presented to the ED with a chief complaint of headache, the onset of which he stated started gradually 2 days prior. He noted the headache was worse than normal but without associated nausea, vomiting, fever, chills, or change in vision. His past medical history was significant for a lower extremity deep vein thrombosis 3 months prior, for which he was taking warfarin.

The patient’s vital signs were all normal. The physical examination, including a thorough neurological examination, was also normal. The EP ordered a prothrombin time (PT), an international normalized ratio (INR), and a noncontrast CT scan of the head. The PT/INR results were therapeutic at 22 seconds and 2.3. The CT scan was interpreted by radiology services as normal. The patient’s headache was treated with IV prochlorperazine and diphenhydramine. After treatment, the patient reported feeling better and was discharged home with instructions to follow up with his primary care physician.

Over the next several months, the patient presented to the same ED on seven different occasions, each time with the chief complaint of headache. At each of these presentations, the history and physical examination were documented as unremarkable, with no history of trauma. The thoroughness, however, of the documentation varied considerably for each ED encounter. No head CT scan was ordered on the subsequent seven visits, and at each presentation, the patient was treated symptomatically and discharged home.

Two days after his eighth visit to the same hospital ED, the patient presented to a different ED, again with a chief complaint of headache. The EP at this ED ordered a noncontrast CT of the head, which demonstrated a left subdural hematoma. The patient was admitted to the hospital, given IV vitamin K and fresh frozen plasma, and underwent evacuation of the hematoma by neurosurgery. The patient’s hospital course was unremarkable, and he was discharged home without any focal weakness.

The patient, however, claimed that he suffered cognitive impairment as a result of the missed diagnosis. He sued treating EPs at the first ED as well as the hospital for failure to timely diagnose the subdural hematoma, stating that a CT scan should have been performed at each of his ED visits since he was on warfarin. The defense claimed that a CT scan was not warranted for each visit, and that the timing of when and how the brain bleed started was uncertain. At trial, a defense verdict was returned.

Discussion

It is well known that patients receiving warfarin are at an increased risk for intracranial hemorrhage (ICH) following blunt head trauma.¹ The recommendation is that all such patients have a noncontrast CT scan of the head to rule out intracranial bleeding. This is due to the fact that 60% of patients presenting with an immediate traumatic intracranial hemorrhage will have a normal mental status on examination; and 11% will have no history of loss of consciousness, a normal mental status examination, and no physical evidence of trauma above the clavicles.¹ In a study by Hart et al,² subdural hematoma accounted for 44% of all ICH in these types of patients.

More controversial is how to manage patients on warfarin who experience blunt head trauma and have a normal CT scan of the head. Because of the fear for delayed traumatic ICH, many clinicians recommend admitting such patients for neurological observation and repeat head CT scan the next morning.³ Additionally, some clinicians even recommend reversing the warfarin anticoagulation in such patients. ⁴ These recommendations, though, are based on expert consensus rather than on rigorous, prospective multicenter studies.¹  These strategies are also problematic, since such multiple repeat CT scans would not only be incredibly expensive but also would expose the patient to high doses of radiation to the brain. Moreover, the Centers for Medicare and Medicaid Services has now made CT brain scan imaging of patients presenting to the ED with complaint of nontraumatic headache a quality measure they follow. Their goal is to decrease the number of “unnecessary” head CT scans.

The patient in this case denied any history of trauma on the subsequent seven ED visits. Unfortunately, as pointed out, even minor trauma can result in ICH, and patients may not recall the occurrence of the event.

For patients on warfarin who present with headache, a very careful history must be taken—including inquiring about minor traumatic events. Even then, as has been shown, patients may have not experienced a loss of consciousness, have a normal mental status examination, and exhibit no external evidence of head trauma. The clinician is forced to use her or his own best judgment when evaluating such patients in the ED.

Interestingly, the risk of ICH secondary to blunt head trauma in patients on warfarin is increased if they are on concomitant aspirin therapy.² Similarly, the risk of ICH following head trauma in patients on clopidogrel is greater than for those patients taking warfarin,¹ and the risk of ICH in patients taking dabigatran is less than if taking warfarin.²

Missed Preeclampsia

On physical examination, the patient’s vital signs were remarkable for the following: heart rate (HR), 86 beats/minute; blood pressure (BP), 164/94 mm Hg; respiratory rate, 18 breaths/minute; temperature, 98.6^oF. Oxygen saturation was 96% on room air. The head, eye, ear, nose and throat examination was unremarkable. The lungs were clear to auscultation bilaterally, and HR and heart rhythm were normal. The abdomen was soft and nontender without guarding or rebound. The lower extremities were remarkable for 1+ pedal and pretibial edema bilaterally.

The patient presented to the same ED 2 days later, again with the chief complaint of shortness of breath. On examination, her BP was noted to be elevated and she had 1+ dependent edema bilaterally. Again, the EP was concerned for a PE and ordered a repeat CTA scan of the chest. This study, similar to the first, was read as normal, and showed no evidence of PE. The patient was diagnosed again with “shortness of breath of unknown etiology” and discharged home. The patient’s obstetrician-gynecologist (Ob/Gyn) was not consulted; however, the patient was encouraged to follow up with him.

The next day, the patient presented to the same ED via emergency medical services, this time with seizures; she had no prior history of a seizure disorder. On presentation to the ED, she was noted to be postictal, with an elevated BP and tachycardic with an HR of 104 beats/minute. On examination, the lungs were clear to auscultation and the lower extremities exhibited 1+ pedal and pretibial edema. A urinalysis revealed proteinuria. The patient was given 4 g of magnesium sulfate intravenously (IV) and her Ob/Gyn was consulted.

The patient was admitted to the hospital with a diagnosis of eclampsia. She was given an IV drip of magnesium and labetalol for the high BP. Unfortunately, the patient apparently had suffered an anoxic brain injury from the previous seizures and died on hospital day 3.

The family sued the treating EPs and the hospital for failure to diagnose preeclampsia on two separate ED presentations. They noted the patient’s Ob/Gyn was never consulted; no action was taken to treat the hypertension; and no urinalysis was ordered on either visit. The EPs and hospital settled the case prior to trial for several million dollars.

Discussion

This is an incredibly sad case, and the EPs and hospital were right to settle and not go to trial. While PE was a reasonable diagnosis to consider in this patient on her first ED visit, it should not have been the only one in the differential diagnosis. The EP became anchored to this single diagnosis and refused to consider other alternative diagnoses—even after the CTA scan of the chest ruled out PE. Moreover, it appears the EP either never considered the significance of the elevated BP and dependent edema or just ignored these findings. To repeat essentially the same exact workup on the second visit does not make sense—one should “cast a wider net, not the same net.”

The diagnosis of “shortness of breath of unknown etiology” is similarly unacceptable. While this is a common and accepted diagnosis when it pertains to abdominal pain, the same is not true for dyspnea.

Preeclampsia is characterized by hypertension (BP >140/90 mm Hg) and proteinuria; associated symptoms include edema and hyperreflexia. Postpartum preeclampsia occurs infrequently and can develop up to 4 weeks after delivery.¹ In one 10-year retrospective case series, the incidence of preeclampsia in the postpartum period was 5.7%, and nearly 16% went on to develop eclampsia.² In a retrospective study of 22 postpartum preeclamptic patients, the median time to presentation was 5 days postpartum.¹ In a similar retrospective study of 152 patients, 90% of such patients presented within 7 days.³ The patient in this case initially presented on postpartum day 4.

Interestingly, in a study by Al-Safi et al,³ 63% of postpartum preeclamptic patients had no antecedent diagnosis of hypertensive disease during pregnancy. These findings are consistent with the findings of others that 33% to 69% of such patients show no evidence of preeclampsia in the ante- or peripartum period.

The clinical presentation of postpartum preeclampsia is similar to preeclampsia complicating pregnancy after gestation week 20. In the study by Al-Safi et al,³ headache was the most common presenting symptom (69%), followed by shortness of breath (30%), blurry vision (21%), nausea (12.5%), and epigastric abdominal pain (5%). Similarly, Yancey et al¹ found headache (82%) to be the most common presenting symptom in their series. Unfortunately, it is not known whether the patient in this case complained of headache or blurred vision as the published records note neither their presence nor absence.

The management of patients with preeclampsia includes IV magnesium to prevent seizures (ie, eclampsia) and BP control.¹ A bolus of 4 to 6 g IV magnesium sulfate over 15 to 30 minutes is recommended, followed by an infusion of 2 g/h IV. Historically, IV hydralazine has been used to manage preeclamptic patients with a BP greater than 160/110 mm Hg. More recently, however, IV labetalol has become popular.⁵ All such patients require admission to the hospital with Ob/Gyn involvement.

Missed Subdural Hematoma

A 59-year-old man presented to the ED with a chief complaint of headache, the onset of which he stated started gradually 2 days prior. He noted the headache was worse than normal but without associated nausea, vomiting, fever, chills, or change in vision. His past medical history was significant for a lower extremity deep vein thrombosis 3 months prior, for which he was taking warfarin.

The patient’s vital signs were all normal. The physical examination, including a thorough neurological examination, was also normal. The EP ordered a prothrombin time (PT), an international normalized ratio (INR), and a noncontrast CT scan of the head. The PT/INR results were therapeutic at 22 seconds and 2.3. The CT scan was interpreted by radiology services as normal. The patient’s headache was treated with IV prochlorperazine and diphenhydramine. After treatment, the patient reported feeling better and was discharged home with instructions to follow up with his primary care physician.

Over the next several months, the patient presented to the same ED on seven different occasions, each time with the chief complaint of headache. At each of these presentations, the history and physical examination were documented as unremarkable, with no history of trauma. The thoroughness, however, of the documentation varied considerably for each ED encounter. No head CT scan was ordered on the subsequent seven visits, and at each presentation, the patient was treated symptomatically and discharged home.

Two days after his eighth visit to the same hospital ED, the patient presented to a different ED, again with a chief complaint of headache. The EP at this ED ordered a noncontrast CT of the head, which demonstrated a left subdural hematoma. The patient was admitted to the hospital, given IV vitamin K and fresh frozen plasma, and underwent evacuation of the hematoma by neurosurgery. The patient’s hospital course was unremarkable, and he was discharged home without any focal weakness.

The patient, however, claimed that he suffered cognitive impairment as a result of the missed diagnosis. He sued treating EPs at the first ED as well as the hospital for failure to timely diagnose the subdural hematoma, stating that a CT scan should have been performed at each of his ED visits since he was on warfarin. The defense claimed that a CT scan was not warranted for each visit, and that the timing of when and how the brain bleed started was uncertain. At trial, a defense verdict was returned.

Discussion

It is well known that patients receiving warfarin are at an increased risk for intracranial hemorrhage (ICH) following blunt head trauma.¹ The recommendation is that all such patients have a noncontrast CT scan of the head to rule out intracranial bleeding. This is due to the fact that 60% of patients presenting with an immediate traumatic intracranial hemorrhage will have a normal mental status on examination; and 11% will have no history of loss of consciousness, a normal mental status examination, and no physical evidence of trauma above the clavicles.¹ In a study by Hart et al,² subdural hematoma accounted for 44% of all ICH in these types of patients.

More controversial is how to manage patients on warfarin who experience blunt head trauma and have a normal CT scan of the head. Because of the fear for delayed traumatic ICH, many clinicians recommend admitting such patients for neurological observation and repeat head CT scan the next morning.³ Additionally, some clinicians even recommend reversing the warfarin anticoagulation in such patients. ⁴ These recommendations, though, are based on expert consensus rather than on rigorous, prospective multicenter studies.¹  These strategies are also problematic, since such multiple repeat CT scans would not only be incredibly expensive but also would expose the patient to high doses of radiation to the brain. Moreover, the Centers for Medicare and Medicaid Services has now made CT brain scan imaging of patients presenting to the ED with complaint of nontraumatic headache a quality measure they follow. Their goal is to decrease the number of “unnecessary” head CT scans.

The patient in this case denied any history of trauma on the subsequent seven ED visits. Unfortunately, as pointed out, even minor trauma can result in ICH, and patients may not recall the occurrence of the event.

For patients on warfarin who present with headache, a very careful history must be taken—including inquiring about minor traumatic events. Even then, as has been shown, patients may have not experienced a loss of consciousness, have a normal mental status examination, and exhibit no external evidence of head trauma. The clinician is forced to use her or his own best judgment when evaluating such patients in the ED.

Interestingly, the risk of ICH secondary to blunt head trauma in patients on warfarin is increased if they are on concomitant aspirin therapy.² Similarly, the risk of ICH following head trauma in patients on clopidogrel is greater than for those patients taking warfarin,¹ and the risk of ICH in patients taking dabigatran is less than if taking warfarin.²

Missed Preeclampsia

On physical examination, the patient’s vital signs were remarkable for the following: heart rate (HR), 86 beats/minute; blood pressure (BP), 164/94 mm Hg; respiratory rate, 18 breaths/minute; temperature, 98.6^oF. Oxygen saturation was 96% on room air. The head, eye, ear, nose and throat examination was unremarkable. The lungs were clear to auscultation bilaterally, and HR and heart rhythm were normal. The abdomen was soft and nontender without guarding or rebound. The lower extremities were remarkable for 1+ pedal and pretibial edema bilaterally.

The patient presented to the same ED 2 days later, again with the chief complaint of shortness of breath. On examination, her BP was noted to be elevated and she had 1+ dependent edema bilaterally. Again, the EP was concerned for a PE and ordered a repeat CTA scan of the chest. This study, similar to the first, was read as normal, and showed no evidence of PE. The patient was diagnosed again with “shortness of breath of unknown etiology” and discharged home. The patient’s obstetrician-gynecologist (Ob/Gyn) was not consulted; however, the patient was encouraged to follow up with him.

The next day, the patient presented to the same ED via emergency medical services, this time with seizures; she had no prior history of a seizure disorder. On presentation to the ED, she was noted to be postictal, with an elevated BP and tachycardic with an HR of 104 beats/minute. On examination, the lungs were clear to auscultation and the lower extremities exhibited 1+ pedal and pretibial edema. A urinalysis revealed proteinuria. The patient was given 4 g of magnesium sulfate intravenously (IV) and her Ob/Gyn was consulted.

The patient was admitted to the hospital with a diagnosis of eclampsia. She was given an IV drip of magnesium and labetalol for the high BP. Unfortunately, the patient apparently had suffered an anoxic brain injury from the previous seizures and died on hospital day 3.

The family sued the treating EPs and the hospital for failure to diagnose preeclampsia on two separate ED presentations. They noted the patient’s Ob/Gyn was never consulted; no action was taken to treat the hypertension; and no urinalysis was ordered on either visit. The EPs and hospital settled the case prior to trial for several million dollars.

Discussion

This is an incredibly sad case, and the EPs and hospital were right to settle and not go to trial. While PE was a reasonable diagnosis to consider in this patient on her first ED visit, it should not have been the only one in the differential diagnosis. The EP became anchored to this single diagnosis and refused to consider other alternative diagnoses—even after the CTA scan of the chest ruled out PE. Moreover, it appears the EP either never considered the significance of the elevated BP and dependent edema or just ignored these findings. To repeat essentially the same exact workup on the second visit does not make sense—one should “cast a wider net, not the same net.”

The diagnosis of “shortness of breath of unknown etiology” is similarly unacceptable. While this is a common and accepted diagnosis when it pertains to abdominal pain, the same is not true for dyspnea.

Preeclampsia is characterized by hypertension (BP >140/90 mm Hg) and proteinuria; associated symptoms include edema and hyperreflexia. Postpartum preeclampsia occurs infrequently and can develop up to 4 weeks after delivery.¹ In one 10-year retrospective case series, the incidence of preeclampsia in the postpartum period was 5.7%, and nearly 16% went on to develop eclampsia.² In a retrospective study of 22 postpartum preeclamptic patients, the median time to presentation was 5 days postpartum.¹ In a similar retrospective study of 152 patients, 90% of such patients presented within 7 days.³ The patient in this case initially presented on postpartum day 4.

Interestingly, in a study by Al-Safi et al,³ 63% of postpartum preeclamptic patients had no antecedent diagnosis of hypertensive disease during pregnancy. These findings are consistent with the findings of others that 33% to 69% of such patients show no evidence of preeclampsia in the ante- or peripartum period.

The clinical presentation of postpartum preeclampsia is similar to preeclampsia complicating pregnancy after gestation week 20. In the study by Al-Safi et al,³ headache was the most common presenting symptom (69%), followed by shortness of breath (30%), blurry vision (21%), nausea (12.5%), and epigastric abdominal pain (5%). Similarly, Yancey et al¹ found headache (82%) to be the most common presenting symptom in their series. Unfortunately, it is not known whether the patient in this case complained of headache or blurred vision as the published records note neither their presence nor absence.

The management of patients with preeclampsia includes IV magnesium to prevent seizures (ie, eclampsia) and BP control.¹ A bolus of 4 to 6 g IV magnesium sulfate over 15 to 30 minutes is recommended, followed by an infusion of 2 g/h IV. Historically, IV hydralazine has been used to manage preeclamptic patients with a BP greater than 160/110 mm Hg. More recently, however, IV labetalol has become popular.⁵ All such patients require admission to the hospital with Ob/Gyn involvement.

Missed Subdural Hematoma

A 59-year-old man presented to the ED with a chief complaint of headache, the onset of which he stated started gradually 2 days prior. He noted the headache was worse than normal but without associated nausea, vomiting, fever, chills, or change in vision. His past medical history was significant for a lower extremity deep vein thrombosis 3 months prior, for which he was taking warfarin.

The patient’s vital signs were all normal. The physical examination, including a thorough neurological examination, was also normal. The EP ordered a prothrombin time (PT), an international normalized ratio (INR), and a noncontrast CT scan of the head. The PT/INR results were therapeutic at 22 seconds and 2.3. The CT scan was interpreted by radiology services as normal. The patient’s headache was treated with IV prochlorperazine and diphenhydramine. After treatment, the patient reported feeling better and was discharged home with instructions to follow up with his primary care physician.

Over the next several months, the patient presented to the same ED on seven different occasions, each time with the chief complaint of headache. At each of these presentations, the history and physical examination were documented as unremarkable, with no history of trauma. The thoroughness, however, of the documentation varied considerably for each ED encounter. No head CT scan was ordered on the subsequent seven visits, and at each presentation, the patient was treated symptomatically and discharged home.

Two days after his eighth visit to the same hospital ED, the patient presented to a different ED, again with a chief complaint of headache. The EP at this ED ordered a noncontrast CT of the head, which demonstrated a left subdural hematoma. The patient was admitted to the hospital, given IV vitamin K and fresh frozen plasma, and underwent evacuation of the hematoma by neurosurgery. The patient’s hospital course was unremarkable, and he was discharged home without any focal weakness.

The patient, however, claimed that he suffered cognitive impairment as a result of the missed diagnosis. He sued treating EPs at the first ED as well as the hospital for failure to timely diagnose the subdural hematoma, stating that a CT scan should have been performed at each of his ED visits since he was on warfarin. The defense claimed that a CT scan was not warranted for each visit, and that the timing of when and how the brain bleed started was uncertain. At trial, a defense verdict was returned.

Discussion

It is well known that patients receiving warfarin are at an increased risk for intracranial hemorrhage (ICH) following blunt head trauma.¹ The recommendation is that all such patients have a noncontrast CT scan of the head to rule out intracranial bleeding. This is due to the fact that 60% of patients presenting with an immediate traumatic intracranial hemorrhage will have a normal mental status on examination; and 11% will have no history of loss of consciousness, a normal mental status examination, and no physical evidence of trauma above the clavicles.¹ In a study by Hart et al,² subdural hematoma accounted for 44% of all ICH in these types of patients.

More controversial is how to manage patients on warfarin who experience blunt head trauma and have a normal CT scan of the head. Because of the fear for delayed traumatic ICH, many clinicians recommend admitting such patients for neurological observation and repeat head CT scan the next morning.³ Additionally, some clinicians even recommend reversing the warfarin anticoagulation in such patients. ⁴ These recommendations, though, are based on expert consensus rather than on rigorous, prospective multicenter studies.¹  These strategies are also problematic, since such multiple repeat CT scans would not only be incredibly expensive but also would expose the patient to high doses of radiation to the brain. Moreover, the Centers for Medicare and Medicaid Services has now made CT brain scan imaging of patients presenting to the ED with complaint of nontraumatic headache a quality measure they follow. Their goal is to decrease the number of “unnecessary” head CT scans.

The patient in this case denied any history of trauma on the subsequent seven ED visits. Unfortunately, as pointed out, even minor trauma can result in ICH, and patients may not recall the occurrence of the event.

For patients on warfarin who present with headache, a very careful history must be taken—including inquiring about minor traumatic events. Even then, as has been shown, patients may have not experienced a loss of consciousness, have a normal mental status examination, and exhibit no external evidence of head trauma. The clinician is forced to use her or his own best judgment when evaluating such patients in the ED.

Interestingly, the risk of ICH secondary to blunt head trauma in patients on warfarin is increased if they are on concomitant aspirin therapy.² Similarly, the risk of ICH following head trauma in patients on clopidogrel is greater than for those patients taking warfarin,¹ and the risk of ICH in patients taking dabigatran is less than if taking warfarin.²

Question: Which of the following statements regarding statutory caps on malpractice damages is best?

A. All states have such a statutory provision.

B. The provision limits the recovery of both economic and noneconomic losses.

C. It’s constitutional.

D. It’s not constitutional.

E. Whether it’s constitutional depends on the jurisdiction.

Answer: E. In 1975, California enacted its historic Medical Injury Compensation Reform Act (MICRA),¹ the state legislature declaring that there was “a major health care crisis in the State of California attributable to skyrocketing malpractice premium costs and resulting in a potential breakdown of the health delivery system.”

The rationale was to provide some predictability, because noneconomic damages are difficult to quantify, and jury sympathy may result in unrealistically high payments. It was believed that damages for pain and suffering, for example, often contributed to runaway jury verdicts, prompting one indignant observer to write: “In making arguments for pain and suffering awards, both sides attempt to win the jurors’ sympathies with highly emotional evidence. A blind plaintiff will receive careful instruction to come to court with his [guide] dog, and to dab at his eyes with a handkerchief.”²

One of the main provisions of MICRA is to limit noneconomic recovery for injuries arising out of medical negligence. It caps noneconomic damages – for example, pain and suffering, disfigurement, emotional distress, loss of consortium, and other nonpecuniary losses – at $250,000. The law does not restrict recovery of economic damages such as wage loss, medical expenses, and future lost income.

California is the pioneer state to institute this tort reform measure, and about a dozen other states have followed suit, such as Proposition 12 in Texas, which limits noneconomic damages to $750,000 – $250,000 from the defendant doctor and $500,000 from the hospital.

Many tort reformists hail MICRA as the prototype success story, crediting it for bringing California’s malpractice insurance premiums from one of the highest levels in the nation to one of its lowest. A 2004 study reported that states with caps have a loss ratio (losses plus costs over premiums) that is 12% lower than in those without damage caps.³ Lower premiums in turn are linked to greater physician entry into the locality, especially for high-risk specialists.

In addition, caps may have a salutary effect on the wasteful practice of defensive medicine. A 2007 report by the American Medical Association confirms and extends an earlier study that reached such conclusions.

However, recent medical malpractice rates are generally no longer rising or even falling – both in states that had enacted tort reform and in states that had not. This may mean that other interventions such as medical error recognition and reduction are also effective.

Unsurprisingly, caps on damages have been challenged on constitutional grounds, as a violation of the equal rights amendment and the patient’s right to a jury trial. Two recent cases with divergent results – one on California, and the other in Florida – illustrate the state of flux over this controversy.

In Chan v. Curran, the plaintiff sought to relitigate the constitutionality of the California damage cap, but the appellate court ruled for the doctor defendant.⁴ The case alleged a wrongful death when the patient died from hemorrhage related to warfarin (Coumadin) use during open heart surgery.

The plaintiff argued that MICRA’s rationale was irrelevant, because there was no longer a malpractice insurance crisis in California – thus, restrictions placed on the quantum of damages are not rationally related to any legitimate state interest.

Furthermore, by limiting the amount of noneconomic damages to $250,000, MICRA violated equal protection and discouraged or inhibited attorneys from taking up malpractice cases on a contingency fee basis. Finally, the plaintiff argued that under the statute, a litigant is deprived of the right to a jury trial.

The court rejected all of these arguments, and reaffirmed the constitutionality of MICRA in line with earlier decisions that began with California’s Supreme Court decision in the Fein v. Permanente Medical Group case.⁵

On the other hand, the recent case of Estate of Michelle Evette McCall v. U.S. found the Florida Supreme Court ruling for the plaintiff.⁶ There, the court deemed unconstitutional Florida’s statute limiting wrongful death damages in medical malpractice to $1 million.

The case involved a young mother who died of massive hemorrhage following a cesarean section. In a 5-2 decision, the court held that the statute was arbitrary, reasoning that “the statutory cap on wrongful death noneconomic damages fails because it imposes unfair and illogical burdens on injured parties.”

Unlike California, the Florida court found that the cap bears no rational relationship to any perceived malpractice insurance crisis. And, while saving a modest amount for many, the statute imposed devastating costs on those who are most grievously injured, as well as on cases affecting multiple claimants.

The court commented that “the finding by the Legislature and the Task Force that Florida was in the midst of a bona fide medical malpractice crisis, threatening the access of Floridians to health care, is dubious and questionable at the very best.” The court also noted that four malpractice carriers actually increased their net income by more than 4,300% between 2003 and 2010.

In 2010, the Illinois Supreme Court also held in Lebron v. Gottlieb Memorial Hospital that the state’s $500,000 cap for noneconomic damages was unconstitutional, being in violation of the separation of powers doctrine.⁷ Only judges are empowered to reduce excessive verdicts, termed a remittitur. Thus, a statutory damage cap amounted to a “legislative remittitur” that invaded the power of the judiciary and violated the constitutional requirement of separation of powers.

The battle over caps continues unabated, with the trend appearing to favor the plaintiff bar. Florida’s ruling was the eighth state supreme court decision that held damage caps unconstitutional, joining Alabama, Georgia, Illinois, Missouri, New Hampshire, Oregon, and Washington. Five other states – Arizona, Arkansas, Kentucky, Pennsylvania, and Wyoming – already have state constitutional prohibitions on damage caps.

References

1. Medical Injury Compensation Reform Act of 1975, Cal. Civ. Proc. Code § 3333.2 (West 1982).

2. O’Connell, J. Offers That Can’t Be Refused: Foreclosure of Personal Injury Claims by Defendants’ Prompt Tender of Claimants’ Net Economic Losses. 77 N.W.U.L. Rev. 589, 591 (1982).

3. Thorpe, K. The Medical Malpractice Crisis: Recent Trends and the Impact of State Tort Reforms, Health Affairs 2004, Jan 21 [doi:10.1377/hlthaff.w4.20].

4. Chan v. Curran, 237 Cal. App. 4th 601 (Cal.Ct.App. 2015).

5. Fein v. Permanente Medical Group, 695 P.2d 665 (Cal. 1985).

6. Estate of Michelle Evette McCall v. U.S., 2014 Fla. LEXIS 933 (Fla. Mar. 13, 2014).

7. Lebron v. Gottlieb Memorial Hospital, 930 N.E.2d 895 (Ill. 2010).

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].

Question: Which of the following statements regarding statutory caps on malpractice damages is best?

A. All states have such a statutory provision.

B. The provision limits the recovery of both economic and noneconomic losses.

C. It’s constitutional.

D. It’s not constitutional.

E. Whether it’s constitutional depends on the jurisdiction.

Answer: E. In 1975, California enacted its historic Medical Injury Compensation Reform Act (MICRA),¹ the state legislature declaring that there was “a major health care crisis in the State of California attributable to skyrocketing malpractice premium costs and resulting in a potential breakdown of the health delivery system.”

The rationale was to provide some predictability, because noneconomic damages are difficult to quantify, and jury sympathy may result in unrealistically high payments. It was believed that damages for pain and suffering, for example, often contributed to runaway jury verdicts, prompting one indignant observer to write: “In making arguments for pain and suffering awards, both sides attempt to win the jurors’ sympathies with highly emotional evidence. A blind plaintiff will receive careful instruction to come to court with his [guide] dog, and to dab at his eyes with a handkerchief.”²

One of the main provisions of MICRA is to limit noneconomic recovery for injuries arising out of medical negligence. It caps noneconomic damages – for example, pain and suffering, disfigurement, emotional distress, loss of consortium, and other nonpecuniary losses – at $250,000. The law does not restrict recovery of economic damages such as wage loss, medical expenses, and future lost income.

California is the pioneer state to institute this tort reform measure, and about a dozen other states have followed suit, such as Proposition 12 in Texas, which limits noneconomic damages to $750,000 – $250,000 from the defendant doctor and $500,000 from the hospital.

Many tort reformists hail MICRA as the prototype success story, crediting it for bringing California’s malpractice insurance premiums from one of the highest levels in the nation to one of its lowest. A 2004 study reported that states with caps have a loss ratio (losses plus costs over premiums) that is 12% lower than in those without damage caps.³ Lower premiums in turn are linked to greater physician entry into the locality, especially for high-risk specialists.

In addition, caps may have a salutary effect on the wasteful practice of defensive medicine. A 2007 report by the American Medical Association confirms and extends an earlier study that reached such conclusions.

However, recent medical malpractice rates are generally no longer rising or even falling – both in states that had enacted tort reform and in states that had not. This may mean that other interventions such as medical error recognition and reduction are also effective.

Unsurprisingly, caps on damages have been challenged on constitutional grounds, as a violation of the equal rights amendment and the patient’s right to a jury trial. Two recent cases with divergent results – one on California, and the other in Florida – illustrate the state of flux over this controversy.

In Chan v. Curran, the plaintiff sought to relitigate the constitutionality of the California damage cap, but the appellate court ruled for the doctor defendant.⁴ The case alleged a wrongful death when the patient died from hemorrhage related to warfarin (Coumadin) use during open heart surgery.

The plaintiff argued that MICRA’s rationale was irrelevant, because there was no longer a malpractice insurance crisis in California – thus, restrictions placed on the quantum of damages are not rationally related to any legitimate state interest.

Furthermore, by limiting the amount of noneconomic damages to $250,000, MICRA violated equal protection and discouraged or inhibited attorneys from taking up malpractice cases on a contingency fee basis. Finally, the plaintiff argued that under the statute, a litigant is deprived of the right to a jury trial.

The court rejected all of these arguments, and reaffirmed the constitutionality of MICRA in line with earlier decisions that began with California’s Supreme Court decision in the Fein v. Permanente Medical Group case.⁵

On the other hand, the recent case of Estate of Michelle Evette McCall v. U.S. found the Florida Supreme Court ruling for the plaintiff.⁶ There, the court deemed unconstitutional Florida’s statute limiting wrongful death damages in medical malpractice to $1 million.

The case involved a young mother who died of massive hemorrhage following a cesarean section. In a 5-2 decision, the court held that the statute was arbitrary, reasoning that “the statutory cap on wrongful death noneconomic damages fails because it imposes unfair and illogical burdens on injured parties.”

Unlike California, the Florida court found that the cap bears no rational relationship to any perceived malpractice insurance crisis. And, while saving a modest amount for many, the statute imposed devastating costs on those who are most grievously injured, as well as on cases affecting multiple claimants.

The court commented that “the finding by the Legislature and the Task Force that Florida was in the midst of a bona fide medical malpractice crisis, threatening the access of Floridians to health care, is dubious and questionable at the very best.” The court also noted that four malpractice carriers actually increased their net income by more than 4,300% between 2003 and 2010.

In 2010, the Illinois Supreme Court also held in Lebron v. Gottlieb Memorial Hospital that the state’s $500,000 cap for noneconomic damages was unconstitutional, being in violation of the separation of powers doctrine.⁷ Only judges are empowered to reduce excessive verdicts, termed a remittitur. Thus, a statutory damage cap amounted to a “legislative remittitur” that invaded the power of the judiciary and violated the constitutional requirement of separation of powers.

The battle over caps continues unabated, with the trend appearing to favor the plaintiff bar. Florida’s ruling was the eighth state supreme court decision that held damage caps unconstitutional, joining Alabama, Georgia, Illinois, Missouri, New Hampshire, Oregon, and Washington. Five other states – Arizona, Arkansas, Kentucky, Pennsylvania, and Wyoming – already have state constitutional prohibitions on damage caps.

References

1. Medical Injury Compensation Reform Act of 1975, Cal. Civ. Proc. Code § 3333.2 (West 1982).

2. O’Connell, J. Offers That Can’t Be Refused: Foreclosure of Personal Injury Claims by Defendants’ Prompt Tender of Claimants’ Net Economic Losses. 77 N.W.U.L. Rev. 589, 591 (1982).

3. Thorpe, K. The Medical Malpractice Crisis: Recent Trends and the Impact of State Tort Reforms, Health Affairs 2004, Jan 21 [doi:10.1377/hlthaff.w4.20].

4. Chan v. Curran, 237 Cal. App. 4th 601 (Cal.Ct.App. 2015).

5. Fein v. Permanente Medical Group, 695 P.2d 665 (Cal. 1985).

6. Estate of Michelle Evette McCall v. U.S., 2014 Fla. LEXIS 933 (Fla. Mar. 13, 2014).

7. Lebron v. Gottlieb Memorial Hospital, 930 N.E.2d 895 (Ill. 2010).

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].

Question: Which of the following statements regarding statutory caps on malpractice damages is best?

A. All states have such a statutory provision.

B. The provision limits the recovery of both economic and noneconomic losses.

C. It’s constitutional.

D. It’s not constitutional.

E. Whether it’s constitutional depends on the jurisdiction.

Answer: E. In 1975, California enacted its historic Medical Injury Compensation Reform Act (MICRA),¹ the state legislature declaring that there was “a major health care crisis in the State of California attributable to skyrocketing malpractice premium costs and resulting in a potential breakdown of the health delivery system.”

The rationale was to provide some predictability, because noneconomic damages are difficult to quantify, and jury sympathy may result in unrealistically high payments. It was believed that damages for pain and suffering, for example, often contributed to runaway jury verdicts, prompting one indignant observer to write: “In making arguments for pain and suffering awards, both sides attempt to win the jurors’ sympathies with highly emotional evidence. A blind plaintiff will receive careful instruction to come to court with his [guide] dog, and to dab at his eyes with a handkerchief.”²

One of the main provisions of MICRA is to limit noneconomic recovery for injuries arising out of medical negligence. It caps noneconomic damages – for example, pain and suffering, disfigurement, emotional distress, loss of consortium, and other nonpecuniary losses – at $250,000. The law does not restrict recovery of economic damages such as wage loss, medical expenses, and future lost income.

California is the pioneer state to institute this tort reform measure, and about a dozen other states have followed suit, such as Proposition 12 in Texas, which limits noneconomic damages to $750,000 – $250,000 from the defendant doctor and $500,000 from the hospital.

Many tort reformists hail MICRA as the prototype success story, crediting it for bringing California’s malpractice insurance premiums from one of the highest levels in the nation to one of its lowest. A 2004 study reported that states with caps have a loss ratio (losses plus costs over premiums) that is 12% lower than in those without damage caps.³ Lower premiums in turn are linked to greater physician entry into the locality, especially for high-risk specialists.

In addition, caps may have a salutary effect on the wasteful practice of defensive medicine. A 2007 report by the American Medical Association confirms and extends an earlier study that reached such conclusions.

However, recent medical malpractice rates are generally no longer rising or even falling – both in states that had enacted tort reform and in states that had not. This may mean that other interventions such as medical error recognition and reduction are also effective.

Unsurprisingly, caps on damages have been challenged on constitutional grounds, as a violation of the equal rights amendment and the patient’s right to a jury trial. Two recent cases with divergent results – one on California, and the other in Florida – illustrate the state of flux over this controversy.

In Chan v. Curran, the plaintiff sought to relitigate the constitutionality of the California damage cap, but the appellate court ruled for the doctor defendant.⁴ The case alleged a wrongful death when the patient died from hemorrhage related to warfarin (Coumadin) use during open heart surgery.

The plaintiff argued that MICRA’s rationale was irrelevant, because there was no longer a malpractice insurance crisis in California – thus, restrictions placed on the quantum of damages are not rationally related to any legitimate state interest.

Furthermore, by limiting the amount of noneconomic damages to $250,000, MICRA violated equal protection and discouraged or inhibited attorneys from taking up malpractice cases on a contingency fee basis. Finally, the plaintiff argued that under the statute, a litigant is deprived of the right to a jury trial.

The court rejected all of these arguments, and reaffirmed the constitutionality of MICRA in line with earlier decisions that began with California’s Supreme Court decision in the Fein v. Permanente Medical Group case.⁵

On the other hand, the recent case of Estate of Michelle Evette McCall v. U.S. found the Florida Supreme Court ruling for the plaintiff.⁶ There, the court deemed unconstitutional Florida’s statute limiting wrongful death damages in medical malpractice to $1 million.

The case involved a young mother who died of massive hemorrhage following a cesarean section. In a 5-2 decision, the court held that the statute was arbitrary, reasoning that “the statutory cap on wrongful death noneconomic damages fails because it imposes unfair and illogical burdens on injured parties.”

Unlike California, the Florida court found that the cap bears no rational relationship to any perceived malpractice insurance crisis. And, while saving a modest amount for many, the statute imposed devastating costs on those who are most grievously injured, as well as on cases affecting multiple claimants.

The court commented that “the finding by the Legislature and the Task Force that Florida was in the midst of a bona fide medical malpractice crisis, threatening the access of Floridians to health care, is dubious and questionable at the very best.” The court also noted that four malpractice carriers actually increased their net income by more than 4,300% between 2003 and 2010.

In 2010, the Illinois Supreme Court also held in Lebron v. Gottlieb Memorial Hospital that the state’s $500,000 cap for noneconomic damages was unconstitutional, being in violation of the separation of powers doctrine.⁷ Only judges are empowered to reduce excessive verdicts, termed a remittitur. Thus, a statutory damage cap amounted to a “legislative remittitur” that invaded the power of the judiciary and violated the constitutional requirement of separation of powers.

The battle over caps continues unabated, with the trend appearing to favor the plaintiff bar. Florida’s ruling was the eighth state supreme court decision that held damage caps unconstitutional, joining Alabama, Georgia, Illinois, Missouri, New Hampshire, Oregon, and Washington. Five other states – Arizona, Arkansas, Kentucky, Pennsylvania, and Wyoming – already have state constitutional prohibitions on damage caps.

References

1. Medical Injury Compensation Reform Act of 1975, Cal. Civ. Proc. Code § 3333.2 (West 1982).

2. O’Connell, J. Offers That Can’t Be Refused: Foreclosure of Personal Injury Claims by Defendants’ Prompt Tender of Claimants’ Net Economic Losses. 77 N.W.U.L. Rev. 589, 591 (1982).

3. Thorpe, K. The Medical Malpractice Crisis: Recent Trends and the Impact of State Tort Reforms, Health Affairs 2004, Jan 21 [doi:10.1377/hlthaff.w4.20].

4. Chan v. Curran, 237 Cal. App. 4th 601 (Cal.Ct.App. 2015).

5. Fein v. Permanente Medical Group, 695 P.2d 665 (Cal. 1985).

6. Estate of Michelle Evette McCall v. U.S., 2014 Fla. LEXIS 933 (Fla. Mar. 13, 2014).

7. Lebron v. Gottlieb Memorial Hospital, 930 N.E.2d 895 (Ill. 2010).

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].

Question: Which of the following statements regarding the doctrine of informed consent is best?

A. All jurisdictions now require disclosure geared toward the reasonable patient rather than the reasonable doctor.

B. Disclosures are less important and sometimes unnecessary in global clinical research protocols.

C. The trend is toward the use of simplified and personalized consent forms.

D. A and C.

Answer: C. An important development in the doctrine of informed consent deals with the typical consent form, which is lengthy (going on 14 pages in one report), largely incomprehensible, and densely legalistic. Worse, the physician may misconstrue the form as a proxy for risk disclosure, whereas in fact the duly signed form merely purports to indicate that meaningful discussion of risks, benefits, and alternatives had taken place – if indeed that has been the case.

A review of more than 500 separate informed consent forms revealed these documents have limited educational value, go mostly unread, and are frequently misunderstood by patients (Arch. Surg. 2000;135:26-33).Thus, there is much to recommend the recent move toward shorter forms that use simpler language, bigger type fonts, and even graphics to improve patient and family understanding.

For example, a novel personalized approach currently being tested offers evidence-based benefits and risks to patients undergoing elective percutaneous coronary intervention. The consent document draws on the American College of Cardiology’s National Cardiovascular Data Registry to offer individualized risk estimates, and lists the experience of the health care team and the anticipated financial costs (JAMA 2010;303:1190-1).

Such approaches are consonant with the notion of patient-centered care, which the Institute of Medicine has identified as a core attribute of high-quality health care systems.

One of the continuing controversies in informed consent is the requisite standard of disclosure.

Historically, what needed to be disclosed was judged by what was ordinarily expected of the reasonable physician in the community. However, in 1972, Canterbury v. Spence (464 F.2d 772 [D.C. Cir. 1972]) persuasively argued for replacing such a professional standard (what doctors customarily would disclose) with a patient-oriented standard, i.e., what a reasonable patient would want to know.

California quickly followed, and an increasing number of jurisdictions such as Alaska, Hawaii, Massachusetts, Minnesota, Texas, West Virginia, and Wisconsin have since embraced this patient-centered standard. However, a number of other jurisdictions, including Arkansas, Indiana, Michigan, Montana, Nebraska, Nevada, and Wyoming, continue to adhere to the professional or physician-centered standard.

The momentum toward patient-centered disclosure appears to be growing, and has spread to other common-law jurisdictions abroad such as Canada and Australia. The United Kingdom was a steadfast opponent of patient-centric consent since Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital ([1985] AC 871), its seminal House of Lords decision in the 1980s.

However, it finally abandoned its opposition on March 11, 2015, when its Supreme Court decided the case of a baby boy who sustained brain injury and arm paralysis at birth as a result of shoulder dystocia (Montgomery v. Lanarkshire Health Board [2015] UKSC 11).

The plaintiff alleged that being a diabetic mother, she should have been warned of the risks of shoulder dystocia and offered the alternative of a cesarean section. The obstetrician said she did not warn because the risks of a serious problem were very small. The court sided with the plaintiff, overturned Sidaway’s professional standard, and adopted the patient standard of disclosure as the new law.

What needs to be disclosed continues to plague the practitioner. The term “material risks” merely begs the question of the definition of “material.” It has been said that the crucial factor is the patient’s need.

The vexing issue surrounding the scope of risk disclosure is compounded by court decisions allowing inquiry outside the medical condition itself, such as a physician’s alcoholism or HIV status, and financial incentives amounting to a breach of fiduciary responsibility. However, courts have tended to reject requiring disclosure of practitioner experience or patient prognosis.

Novel issues continue to surface. For example, a recent Wisconsin Supreme Court case dealt with whether it was necessary for a physician to disclose the availability of a collateral test not directly linked to a patient’s diagnosis.

In Jandre v. Wis. Injured Patients & Families Comp. Fund (813 N.W.2d 627 [Wis. 2012]), a doctor diagnosed Bell’s palsy as the cause of a patient’s neurologic symptoms, because she heard no carotid bruits and the head CT scan was normal. Shortly thereafter, the patient developed a stroke. Although the doctor was found not negligent for the misdiagnosis, the plaintiff then proceeded on a lack of informed consent theory, asserting that the doctor should have advised him of the availability of a carotid ultrasound test to rule out a TIA.

In a momentous decision, the Wisconsin Supreme Court affirmed the lower court’s judgment in finding the physician liable for failing to disclose the availability of the ultrasound procedure.

Another area where informed consent is under renewed scrutiny is in research. Doctors in practice are increasingly participating as coinvestigators in industry-sponsored drug trials, and should be familiar with what is expected in the research context.

Augmented rules regarding informed consent govern all clinical research, with patient safety and free meaningful choice being paramount considerations. Federal and state regulations, implemented and monitored by institutional review boards, serve to enforce compliance and safeguard the safety of experimental subjects.

Still, as predicted nearly 50 years ago by Dr. Henry K. Beecher, “In any precise sense, statements regarding consent are meaningless unless one knows how fully the patient was informed of all risks, and if these are not known, that fact should also be made clear. A far more dependable safeguard than consent is the presence of a truly responsible investigator” (N. Engl. J. Med. 1966;274:1354-60).

Scandals in human research led by or in collaboration with U.S. investigators in foreign countries have been in the news. Global clinical trials are supposed to be carried out in compliance with the Nuremberg Code and the Declaration of Helsinki, but there may be occasional lapses or disregard for such international laws. A recent example is the trial using the antibiotic trovafloxacin, administered orally, versus FDA-approved parenteral ceftriaxone, during a meningitis outbreak in Nigeria (N. Engl. J. Med. 2009;360:2050-3).

Finally, the politics of abortion and first amendment rights have managed to insinuate themselves into the informed consent debate. Can states mandate disclosure in the name of securing meaningful informed consent, e.g., requiring physicians to provide information that might encourage a woman to reconsider her decision to have an abortion?

In 1992, the U.S. Supreme Court decided that this passes constitutional muster, because it did not place an undue burden on the woman. However, the Fourth Circuit Appellate Court recently ruled unconstitutional a North Carolina statute called Display of Real-Time View Requirement. The statute requires physicians to display ultrasound images of the unborn child to a mother contemplating an abortion, which the court ruled violated the First Amendment’s prohibition on state-compelled speech (N. Engl. J. Med. 2015;372:1285-7).

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].

Question: Which of the following statements regarding the doctrine of informed consent is best?

A. All jurisdictions now require disclosure geared toward the reasonable patient rather than the reasonable doctor.

B. Disclosures are less important and sometimes unnecessary in global clinical research protocols.

C. The trend is toward the use of simplified and personalized consent forms.

D. A and C.

Answer: C. An important development in the doctrine of informed consent deals with the typical consent form, which is lengthy (going on 14 pages in one report), largely incomprehensible, and densely legalistic. Worse, the physician may misconstrue the form as a proxy for risk disclosure, whereas in fact the duly signed form merely purports to indicate that meaningful discussion of risks, benefits, and alternatives had taken place – if indeed that has been the case.

A review of more than 500 separate informed consent forms revealed these documents have limited educational value, go mostly unread, and are frequently misunderstood by patients (Arch. Surg. 2000;135:26-33).Thus, there is much to recommend the recent move toward shorter forms that use simpler language, bigger type fonts, and even graphics to improve patient and family understanding.

For example, a novel personalized approach currently being tested offers evidence-based benefits and risks to patients undergoing elective percutaneous coronary intervention. The consent document draws on the American College of Cardiology’s National Cardiovascular Data Registry to offer individualized risk estimates, and lists the experience of the health care team and the anticipated financial costs (JAMA 2010;303:1190-1).

Such approaches are consonant with the notion of patient-centered care, which the Institute of Medicine has identified as a core attribute of high-quality health care systems.

One of the continuing controversies in informed consent is the requisite standard of disclosure.

Historically, what needed to be disclosed was judged by what was ordinarily expected of the reasonable physician in the community. However, in 1972, Canterbury v. Spence (464 F.2d 772 [D.C. Cir. 1972]) persuasively argued for replacing such a professional standard (what doctors customarily would disclose) with a patient-oriented standard, i.e., what a reasonable patient would want to know.

California quickly followed, and an increasing number of jurisdictions such as Alaska, Hawaii, Massachusetts, Minnesota, Texas, West Virginia, and Wisconsin have since embraced this patient-centered standard. However, a number of other jurisdictions, including Arkansas, Indiana, Michigan, Montana, Nebraska, Nevada, and Wyoming, continue to adhere to the professional or physician-centered standard.

The momentum toward patient-centered disclosure appears to be growing, and has spread to other common-law jurisdictions abroad such as Canada and Australia. The United Kingdom was a steadfast opponent of patient-centric consent since Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital ([1985] AC 871), its seminal House of Lords decision in the 1980s.

However, it finally abandoned its opposition on March 11, 2015, when its Supreme Court decided the case of a baby boy who sustained brain injury and arm paralysis at birth as a result of shoulder dystocia (Montgomery v. Lanarkshire Health Board [2015] UKSC 11).

The plaintiff alleged that being a diabetic mother, she should have been warned of the risks of shoulder dystocia and offered the alternative of a cesarean section. The obstetrician said she did not warn because the risks of a serious problem were very small. The court sided with the plaintiff, overturned Sidaway’s professional standard, and adopted the patient standard of disclosure as the new law.

What needs to be disclosed continues to plague the practitioner. The term “material risks” merely begs the question of the definition of “material.” It has been said that the crucial factor is the patient’s need.

The vexing issue surrounding the scope of risk disclosure is compounded by court decisions allowing inquiry outside the medical condition itself, such as a physician’s alcoholism or HIV status, and financial incentives amounting to a breach of fiduciary responsibility. However, courts have tended to reject requiring disclosure of practitioner experience or patient prognosis.

Novel issues continue to surface. For example, a recent Wisconsin Supreme Court case dealt with whether it was necessary for a physician to disclose the availability of a collateral test not directly linked to a patient’s diagnosis.

In Jandre v. Wis. Injured Patients & Families Comp. Fund (813 N.W.2d 627 [Wis. 2012]), a doctor diagnosed Bell’s palsy as the cause of a patient’s neurologic symptoms, because she heard no carotid bruits and the head CT scan was normal. Shortly thereafter, the patient developed a stroke. Although the doctor was found not negligent for the misdiagnosis, the plaintiff then proceeded on a lack of informed consent theory, asserting that the doctor should have advised him of the availability of a carotid ultrasound test to rule out a TIA.

In a momentous decision, the Wisconsin Supreme Court affirmed the lower court’s judgment in finding the physician liable for failing to disclose the availability of the ultrasound procedure.

Another area where informed consent is under renewed scrutiny is in research. Doctors in practice are increasingly participating as coinvestigators in industry-sponsored drug trials, and should be familiar with what is expected in the research context.

Augmented rules regarding informed consent govern all clinical research, with patient safety and free meaningful choice being paramount considerations. Federal and state regulations, implemented and monitored by institutional review boards, serve to enforce compliance and safeguard the safety of experimental subjects.

Still, as predicted nearly 50 years ago by Dr. Henry K. Beecher, “In any precise sense, statements regarding consent are meaningless unless one knows how fully the patient was informed of all risks, and if these are not known, that fact should also be made clear. A far more dependable safeguard than consent is the presence of a truly responsible investigator” (N. Engl. J. Med. 1966;274:1354-60).

Scandals in human research led by or in collaboration with U.S. investigators in foreign countries have been in the news. Global clinical trials are supposed to be carried out in compliance with the Nuremberg Code and the Declaration of Helsinki, but there may be occasional lapses or disregard for such international laws. A recent example is the trial using the antibiotic trovafloxacin, administered orally, versus FDA-approved parenteral ceftriaxone, during a meningitis outbreak in Nigeria (N. Engl. J. Med. 2009;360:2050-3).

Finally, the politics of abortion and first amendment rights have managed to insinuate themselves into the informed consent debate. Can states mandate disclosure in the name of securing meaningful informed consent, e.g., requiring physicians to provide information that might encourage a woman to reconsider her decision to have an abortion?

In 1992, the U.S. Supreme Court decided that this passes constitutional muster, because it did not place an undue burden on the woman. However, the Fourth Circuit Appellate Court recently ruled unconstitutional a North Carolina statute called Display of Real-Time View Requirement. The statute requires physicians to display ultrasound images of the unborn child to a mother contemplating an abortion, which the court ruled violated the First Amendment’s prohibition on state-compelled speech (N. Engl. J. Med. 2015;372:1285-7).

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].

Question: Which of the following statements regarding the doctrine of informed consent is best?

A. All jurisdictions now require disclosure geared toward the reasonable patient rather than the reasonable doctor.

B. Disclosures are less important and sometimes unnecessary in global clinical research protocols.

C. The trend is toward the use of simplified and personalized consent forms.

D. A and C.

Answer: C. An important development in the doctrine of informed consent deals with the typical consent form, which is lengthy (going on 14 pages in one report), largely incomprehensible, and densely legalistic. Worse, the physician may misconstrue the form as a proxy for risk disclosure, whereas in fact the duly signed form merely purports to indicate that meaningful discussion of risks, benefits, and alternatives had taken place – if indeed that has been the case.

A review of more than 500 separate informed consent forms revealed these documents have limited educational value, go mostly unread, and are frequently misunderstood by patients (Arch. Surg. 2000;135:26-33).Thus, there is much to recommend the recent move toward shorter forms that use simpler language, bigger type fonts, and even graphics to improve patient and family understanding.

For example, a novel personalized approach currently being tested offers evidence-based benefits and risks to patients undergoing elective percutaneous coronary intervention. The consent document draws on the American College of Cardiology’s National Cardiovascular Data Registry to offer individualized risk estimates, and lists the experience of the health care team and the anticipated financial costs (JAMA 2010;303:1190-1).

Such approaches are consonant with the notion of patient-centered care, which the Institute of Medicine has identified as a core attribute of high-quality health care systems.

One of the continuing controversies in informed consent is the requisite standard of disclosure.

Historically, what needed to be disclosed was judged by what was ordinarily expected of the reasonable physician in the community. However, in 1972, Canterbury v. Spence (464 F.2d 772 [D.C. Cir. 1972]) persuasively argued for replacing such a professional standard (what doctors customarily would disclose) with a patient-oriented standard, i.e., what a reasonable patient would want to know.

California quickly followed, and an increasing number of jurisdictions such as Alaska, Hawaii, Massachusetts, Minnesota, Texas, West Virginia, and Wisconsin have since embraced this patient-centered standard. However, a number of other jurisdictions, including Arkansas, Indiana, Michigan, Montana, Nebraska, Nevada, and Wyoming, continue to adhere to the professional or physician-centered standard.

The momentum toward patient-centered disclosure appears to be growing, and has spread to other common-law jurisdictions abroad such as Canada and Australia. The United Kingdom was a steadfast opponent of patient-centric consent since Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital ([1985] AC 871), its seminal House of Lords decision in the 1980s.

However, it finally abandoned its opposition on March 11, 2015, when its Supreme Court decided the case of a baby boy who sustained brain injury and arm paralysis at birth as a result of shoulder dystocia (Montgomery v. Lanarkshire Health Board [2015] UKSC 11).

The plaintiff alleged that being a diabetic mother, she should have been warned of the risks of shoulder dystocia and offered the alternative of a cesarean section. The obstetrician said she did not warn because the risks of a serious problem were very small. The court sided with the plaintiff, overturned Sidaway’s professional standard, and adopted the patient standard of disclosure as the new law.

What needs to be disclosed continues to plague the practitioner. The term “material risks” merely begs the question of the definition of “material.” It has been said that the crucial factor is the patient’s need.

The vexing issue surrounding the scope of risk disclosure is compounded by court decisions allowing inquiry outside the medical condition itself, such as a physician’s alcoholism or HIV status, and financial incentives amounting to a breach of fiduciary responsibility. However, courts have tended to reject requiring disclosure of practitioner experience or patient prognosis.

Novel issues continue to surface. For example, a recent Wisconsin Supreme Court case dealt with whether it was necessary for a physician to disclose the availability of a collateral test not directly linked to a patient’s diagnosis.

In Jandre v. Wis. Injured Patients & Families Comp. Fund (813 N.W.2d 627 [Wis. 2012]), a doctor diagnosed Bell’s palsy as the cause of a patient’s neurologic symptoms, because she heard no carotid bruits and the head CT scan was normal. Shortly thereafter, the patient developed a stroke. Although the doctor was found not negligent for the misdiagnosis, the plaintiff then proceeded on a lack of informed consent theory, asserting that the doctor should have advised him of the availability of a carotid ultrasound test to rule out a TIA.

In a momentous decision, the Wisconsin Supreme Court affirmed the lower court’s judgment in finding the physician liable for failing to disclose the availability of the ultrasound procedure.

Another area where informed consent is under renewed scrutiny is in research. Doctors in practice are increasingly participating as coinvestigators in industry-sponsored drug trials, and should be familiar with what is expected in the research context.

Augmented rules regarding informed consent govern all clinical research, with patient safety and free meaningful choice being paramount considerations. Federal and state regulations, implemented and monitored by institutional review boards, serve to enforce compliance and safeguard the safety of experimental subjects.

Still, as predicted nearly 50 years ago by Dr. Henry K. Beecher, “In any precise sense, statements regarding consent are meaningless unless one knows how fully the patient was informed of all risks, and if these are not known, that fact should also be made clear. A far more dependable safeguard than consent is the presence of a truly responsible investigator” (N. Engl. J. Med. 1966;274:1354-60).

Scandals in human research led by or in collaboration with U.S. investigators in foreign countries have been in the news. Global clinical trials are supposed to be carried out in compliance with the Nuremberg Code and the Declaration of Helsinki, but there may be occasional lapses or disregard for such international laws. A recent example is the trial using the antibiotic trovafloxacin, administered orally, versus FDA-approved parenteral ceftriaxone, during a meningitis outbreak in Nigeria (N. Engl. J. Med. 2009;360:2050-3).

Finally, the politics of abortion and first amendment rights have managed to insinuate themselves into the informed consent debate. Can states mandate disclosure in the name of securing meaningful informed consent, e.g., requiring physicians to provide information that might encourage a woman to reconsider her decision to have an abortion?

In 1992, the U.S. Supreme Court decided that this passes constitutional muster, because it did not place an undue burden on the woman. However, the Fourth Circuit Appellate Court recently ruled unconstitutional a North Carolina statute called Display of Real-Time View Requirement. The statute requires physicians to display ultrasound images of the unborn child to a mother contemplating an abortion, which the court ruled violated the First Amendment’s prohibition on state-compelled speech (N. Engl. J. Med. 2015;372:1285-7).

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].

Acute Coronary Syndromes

A 53-year-old obese man presented to the ED complaining of pain in his chest, bilateral jaw, and back. He stated that his symptoms had started the previous evening and had increased in severity the morning of presentation. He denied any change in breathing, or any nausea or vomiting. The patient’s medical history was significant for hypertension and chronic back pain. Regarding his social history, the patient noted that he smoked one pack of cigarettes per day; he denied alcohol use.

On physical examination, the patient’s weight was 350 lb, and he was profusely diaphoretic. Vital signs were remarkable for an elevated blood pressure (BP) of 214/106 mm Hg; respiratory rate (RR), heart rate (HR), temperature (T), and oxygen saturation were normal. The head, eyes, ears, nose, and throat examination was normal, and there was no jugular venous distention. The lung and heart examinations were also normal, and the abdominal examination was unremarkable. The patient had 2+ pitting edema in his lower extremities, which he said had been present for the past few weeks. The back examination was unremarkable, and the neurological examination was completely normal, including deep tendon reflexes.

Because of the presence of chest and back pain and history of hypertension, the EP ordered a computed tomography (CT) scan of the chest with intravenous (IV) contrast to rule out aortic dissection. He also administered 0.2 mg of clonidine orally for the elevated BP. Approximately 20 minutes later, the patient was given 2 mg morphine IV for the back pain and another 0.2 mg of clonidine orally. The elevated BP responded to the clonidine, and the patient stated he was feeling better.

The CT scan of the chest was interpreted by radiology services as normal. The patient was then administered 325 mg of aspirin by mouth. Since the EP’s hospital did not have facilities for cardiac catheterization, the EP consulted with a physician at another facility regarding a possible transfer. The consulted physician did not accept the patient for transfer, but instead recommended keeping the patient at the EP’s institution for observation and continuing treatment for the elevated BP and pain. The EP agreed, and diagnosed the patient with a hypertensive emergency and a flare-up of his chronic back pain.

In the ED, the patient’s BP decreased to near normal levels, and he was feeling much improved. Approximately 5.5 hours after his arrival to the ED, he was admitted to a monitored bed under the care of a hospitalist.

A few hours later, the patient began to complain of burning in the epigastric area; analgesics and nitroglycerin were administered and a repeat ECG was ordered. A second troponin level, drawn approximately 6 hours after the original, was found to be significantly elevated. The repeat ECG demonstrated sinus tachycardia with ST-segment depression.

The hospitalist was concerned about an acute coronary syndrome (ACS) and attempted to make contact with the other facility to transfer the patient for an emergent cardiac catheterization. The consulted physician agreed to accept the patient and recommended starting an IV heparin drip and giving clopidogrel bisulfate (Plavix). While arranging for the transfer, the patient suffered a cardiac arrest; resuscitation attempts were unsuccessful. 

The family of the patient sued the hospital, the EP, and the hospitalist, alleging the EP failed to recognize that the initial ECG and elevated troponin level were suggestive of an ACS. They also complained that the morphine, oxygen, nitroglycerin, and aspirin were not started in a timely manner. In addition, the family claimed the decedent should have been immediately transferred to another facility because the defendant’s hospital could not perform cardiac catheterization. They further alleged that the hospitalist failed to perform an independent evaluation of the patient and also failed to obtain a repeat 12-lead ECG sooner. Lastly, the plaintiffs claimed that the hospital’s nursing staff was negligent in failing to provide nursing care for 3 hours prior to the patient being found unresponsive.

The defendant EP asserted that the initial ECG was nondiagnostic and that the initial troponin level, while elevated, was nonspecific. He argued the ED evaluation and care provided was appropriate. Following trial, a defense verdict was returned.

Discussion

Fortunately, the jury ruled correctly in this case. Acute coronary sydromes can be some of the most challenging medical conditions to evaluate and manage in the ED. The EP’s initial cardiac workup and evaluation for a possible acute thoracic aortic dissection were appropriate—an acute thoracic aortic dissection is a true cardiovascular emergency. After interpreting the initial ECG as nondiagnostic (specifically, to rule out evidence of ST-segment elevation, myocardial infarction [MI], or STEMI), obtaining the contrast CT scan of the chest emergently was critically important. This patient had multiple risk factors for aortic dissection: he was a male between the ages of 50 and 55 years old (the mean age for proximal thoracic aortic dissection); he had a history of hypertension; and he was experiencing chest and back pain.¹

Once an acute aortic dissection was excluded, focusing on a cardiac etiology, as the EP did, was appropriate. The only criticism is that this patient probably should have been managed with an IV antihypertensive agent to allow for a more controlled BP reduction; this, however, does not seem to have played any role in the patient’s ultimate outcome.

Acute coronary syndromes are a dynamic process and progress over time. The EP was clearly concerned about an ACS very early in the case, as evidenced by his attempt to transfer the patient to a facility with specialized cardiac capabilities. After not being able to do so, the most appropriate next step was his admission of the patient to a monitored bed with serial cardiac enzymes and ECGs. It is well known that initial evaluation of both ECG and cardiac enzymes can be normal early on in an ACS. Patients with a normal or nonspecific ECG have a 1% to 5% incidence of MI and a 4% to 23% incidence of unstable angina.²

This patient ultimately experienced a non-ST-segment elevation myocardial infarction (NSTEMI). However, this diagnosis did not become evident until several hours after the patient’s admission to the hospital. It is unfortunate the physician consulted by the EP at the onset did not agree to accept this patient. This patient’s best chance for survival was at a facility capable of percutaneous coronary intervention.

Serotonin Syndrome

Acute Coronary Syndromes

A 53-year-old obese man presented to the ED complaining of pain in his chest, bilateral jaw, and back. He stated that his symptoms had started the previous evening and had increased in severity the morning of presentation. He denied any change in breathing, or any nausea or vomiting. The patient’s medical history was significant for hypertension and chronic back pain. Regarding his social history, the patient noted that he smoked one pack of cigarettes per day; he denied alcohol use.

On physical examination, the patient’s weight was 350 lb, and he was profusely diaphoretic. Vital signs were remarkable for an elevated blood pressure (BP) of 214/106 mm Hg; respiratory rate (RR), heart rate (HR), temperature (T), and oxygen saturation were normal. The head, eyes, ears, nose, and throat examination was normal, and there was no jugular venous distention. The lung and heart examinations were also normal, and the abdominal examination was unremarkable. The patient had 2+ pitting edema in his lower extremities, which he said had been present for the past few weeks. The back examination was unremarkable, and the neurological examination was completely normal, including deep tendon reflexes.

Because of the presence of chest and back pain and history of hypertension, the EP ordered a computed tomography (CT) scan of the chest with intravenous (IV) contrast to rule out aortic dissection. He also administered 0.2 mg of clonidine orally for the elevated BP. Approximately 20 minutes later, the patient was given 2 mg morphine IV for the back pain and another 0.2 mg of clonidine orally. The elevated BP responded to the clonidine, and the patient stated he was feeling better.

The CT scan of the chest was interpreted by radiology services as normal. The patient was then administered 325 mg of aspirin by mouth. Since the EP’s hospital did not have facilities for cardiac catheterization, the EP consulted with a physician at another facility regarding a possible transfer. The consulted physician did not accept the patient for transfer, but instead recommended keeping the patient at the EP’s institution for observation and continuing treatment for the elevated BP and pain. The EP agreed, and diagnosed the patient with a hypertensive emergency and a flare-up of his chronic back pain.

In the ED, the patient’s BP decreased to near normal levels, and he was feeling much improved. Approximately 5.5 hours after his arrival to the ED, he was admitted to a monitored bed under the care of a hospitalist.

A few hours later, the patient began to complain of burning in the epigastric area; analgesics and nitroglycerin were administered and a repeat ECG was ordered. A second troponin level, drawn approximately 6 hours after the original, was found to be significantly elevated. The repeat ECG demonstrated sinus tachycardia with ST-segment depression.

The hospitalist was concerned about an acute coronary syndrome (ACS) and attempted to make contact with the other facility to transfer the patient for an emergent cardiac catheterization. The consulted physician agreed to accept the patient and recommended starting an IV heparin drip and giving clopidogrel bisulfate (Plavix). While arranging for the transfer, the patient suffered a cardiac arrest; resuscitation attempts were unsuccessful. 

The family of the patient sued the hospital, the EP, and the hospitalist, alleging the EP failed to recognize that the initial ECG and elevated troponin level were suggestive of an ACS. They also complained that the morphine, oxygen, nitroglycerin, and aspirin were not started in a timely manner. In addition, the family claimed the decedent should have been immediately transferred to another facility because the defendant’s hospital could not perform cardiac catheterization. They further alleged that the hospitalist failed to perform an independent evaluation of the patient and also failed to obtain a repeat 12-lead ECG sooner. Lastly, the plaintiffs claimed that the hospital’s nursing staff was negligent in failing to provide nursing care for 3 hours prior to the patient being found unresponsive.

The defendant EP asserted that the initial ECG was nondiagnostic and that the initial troponin level, while elevated, was nonspecific. He argued the ED evaluation and care provided was appropriate. Following trial, a defense verdict was returned.

Discussion

Fortunately, the jury ruled correctly in this case. Acute coronary sydromes can be some of the most challenging medical conditions to evaluate and manage in the ED. The EP’s initial cardiac workup and evaluation for a possible acute thoracic aortic dissection were appropriate—an acute thoracic aortic dissection is a true cardiovascular emergency. After interpreting the initial ECG as nondiagnostic (specifically, to rule out evidence of ST-segment elevation, myocardial infarction [MI], or STEMI), obtaining the contrast CT scan of the chest emergently was critically important. This patient had multiple risk factors for aortic dissection: he was a male between the ages of 50 and 55 years old (the mean age for proximal thoracic aortic dissection); he had a history of hypertension; and he was experiencing chest and back pain.¹

Once an acute aortic dissection was excluded, focusing on a cardiac etiology, as the EP did, was appropriate. The only criticism is that this patient probably should have been managed with an IV antihypertensive agent to allow for a more controlled BP reduction; this, however, does not seem to have played any role in the patient’s ultimate outcome.

Acute coronary syndromes are a dynamic process and progress over time. The EP was clearly concerned about an ACS very early in the case, as evidenced by his attempt to transfer the patient to a facility with specialized cardiac capabilities. After not being able to do so, the most appropriate next step was his admission of the patient to a monitored bed with serial cardiac enzymes and ECGs. It is well known that initial evaluation of both ECG and cardiac enzymes can be normal early on in an ACS. Patients with a normal or nonspecific ECG have a 1% to 5% incidence of MI and a 4% to 23% incidence of unstable angina.²

This patient ultimately experienced a non-ST-segment elevation myocardial infarction (NSTEMI). However, this diagnosis did not become evident until several hours after the patient’s admission to the hospital. It is unfortunate the physician consulted by the EP at the onset did not agree to accept this patient. This patient’s best chance for survival was at a facility capable of percutaneous coronary intervention.

Serotonin Syndrome

Acute Coronary Syndromes

A 53-year-old obese man presented to the ED complaining of pain in his chest, bilateral jaw, and back. He stated that his symptoms had started the previous evening and had increased in severity the morning of presentation. He denied any change in breathing, or any nausea or vomiting. The patient’s medical history was significant for hypertension and chronic back pain. Regarding his social history, the patient noted that he smoked one pack of cigarettes per day; he denied alcohol use.

On physical examination, the patient’s weight was 350 lb, and he was profusely diaphoretic. Vital signs were remarkable for an elevated blood pressure (BP) of 214/106 mm Hg; respiratory rate (RR), heart rate (HR), temperature (T), and oxygen saturation were normal. The head, eyes, ears, nose, and throat examination was normal, and there was no jugular venous distention. The lung and heart examinations were also normal, and the abdominal examination was unremarkable. The patient had 2+ pitting edema in his lower extremities, which he said had been present for the past few weeks. The back examination was unremarkable, and the neurological examination was completely normal, including deep tendon reflexes.

Because of the presence of chest and back pain and history of hypertension, the EP ordered a computed tomography (CT) scan of the chest with intravenous (IV) contrast to rule out aortic dissection. He also administered 0.2 mg of clonidine orally for the elevated BP. Approximately 20 minutes later, the patient was given 2 mg morphine IV for the back pain and another 0.2 mg of clonidine orally. The elevated BP responded to the clonidine, and the patient stated he was feeling better.

The CT scan of the chest was interpreted by radiology services as normal. The patient was then administered 325 mg of aspirin by mouth. Since the EP’s hospital did not have facilities for cardiac catheterization, the EP consulted with a physician at another facility regarding a possible transfer. The consulted physician did not accept the patient for transfer, but instead recommended keeping the patient at the EP’s institution for observation and continuing treatment for the elevated BP and pain. The EP agreed, and diagnosed the patient with a hypertensive emergency and a flare-up of his chronic back pain.

In the ED, the patient’s BP decreased to near normal levels, and he was feeling much improved. Approximately 5.5 hours after his arrival to the ED, he was admitted to a monitored bed under the care of a hospitalist.

A few hours later, the patient began to complain of burning in the epigastric area; analgesics and nitroglycerin were administered and a repeat ECG was ordered. A second troponin level, drawn approximately 6 hours after the original, was found to be significantly elevated. The repeat ECG demonstrated sinus tachycardia with ST-segment depression.

The hospitalist was concerned about an acute coronary syndrome (ACS) and attempted to make contact with the other facility to transfer the patient for an emergent cardiac catheterization. The consulted physician agreed to accept the patient and recommended starting an IV heparin drip and giving clopidogrel bisulfate (Plavix). While arranging for the transfer, the patient suffered a cardiac arrest; resuscitation attempts were unsuccessful. 

The family of the patient sued the hospital, the EP, and the hospitalist, alleging the EP failed to recognize that the initial ECG and elevated troponin level were suggestive of an ACS. They also complained that the morphine, oxygen, nitroglycerin, and aspirin were not started in a timely manner. In addition, the family claimed the decedent should have been immediately transferred to another facility because the defendant’s hospital could not perform cardiac catheterization. They further alleged that the hospitalist failed to perform an independent evaluation of the patient and also failed to obtain a repeat 12-lead ECG sooner. Lastly, the plaintiffs claimed that the hospital’s nursing staff was negligent in failing to provide nursing care for 3 hours prior to the patient being found unresponsive.

The defendant EP asserted that the initial ECG was nondiagnostic and that the initial troponin level, while elevated, was nonspecific. He argued the ED evaluation and care provided was appropriate. Following trial, a defense verdict was returned.

Discussion

Fortunately, the jury ruled correctly in this case. Acute coronary sydromes can be some of the most challenging medical conditions to evaluate and manage in the ED. The EP’s initial cardiac workup and evaluation for a possible acute thoracic aortic dissection were appropriate—an acute thoracic aortic dissection is a true cardiovascular emergency. After interpreting the initial ECG as nondiagnostic (specifically, to rule out evidence of ST-segment elevation, myocardial infarction [MI], or STEMI), obtaining the contrast CT scan of the chest emergently was critically important. This patient had multiple risk factors for aortic dissection: he was a male between the ages of 50 and 55 years old (the mean age for proximal thoracic aortic dissection); he had a history of hypertension; and he was experiencing chest and back pain.¹

Once an acute aortic dissection was excluded, focusing on a cardiac etiology, as the EP did, was appropriate. The only criticism is that this patient probably should have been managed with an IV antihypertensive agent to allow for a more controlled BP reduction; this, however, does not seem to have played any role in the patient’s ultimate outcome.

Acute coronary syndromes are a dynamic process and progress over time. The EP was clearly concerned about an ACS very early in the case, as evidenced by his attempt to transfer the patient to a facility with specialized cardiac capabilities. After not being able to do so, the most appropriate next step was his admission of the patient to a monitored bed with serial cardiac enzymes and ECGs. It is well known that initial evaluation of both ECG and cardiac enzymes can be normal early on in an ACS. Patients with a normal or nonspecific ECG have a 1% to 5% incidence of MI and a 4% to 23% incidence of unstable angina.²

This patient ultimately experienced a non-ST-segment elevation myocardial infarction (NSTEMI). However, this diagnosis did not become evident until several hours after the patient’s admission to the hospital. It is unfortunate the physician consulted by the EP at the onset did not agree to accept this patient. This patient’s best chance for survival was at a facility capable of percutaneous coronary intervention.

Serotonin Syndrome

Question: Driving home after a demanding 24 hours on call, the sleepy and fatigued first-year medical resident momentarily dozed off at the wheel, ran a stop sign, and struck an oncoming car, injuring its driver. In a lawsuit by the injured victim, which of the following answers is best?

A. The residency program is definitely liable, being in violation of Accreditation Council for Graduate Medical Education rules on consecutive work hours.

B. The resident is solely liable, because he’s the one who owed the duty of due care.

C. The hospital may be a named codefendant, because it knew or should have known that sleep deprivation can impair a person’s driving ability.

D. A and C are correct.

E. Only B and C are correct.

Answer: E. Residency training programs face many potential liabilities, such as those arising from disciplinary actions, employer-employee disputes, sexual harassment, and so on. But one issue deserving attention is auto accidents in overfatigued trainees. The incidence of falling asleep at the wheel is very high – in some surveys, close to 50% – and accidents are more likely to occur in the immediate post-call period.

The two main research papers documenting a relationship between extended work duty and auto accidents are from Laura K. Barger, Ph.D., and Dr. Colin P. West.

In the Barger study, the authors conducted a nationwide Web-based survey of 2,737 interns (N. Engl. J. Med. 2005;352:125-34). They found that an extended work shift (greater than 24 hours) was 2.3 times as likely for a motor vehicle crash, and 5.9 times for a near-miss accident. The researchers calculated that every extended shift in the month increased the crash risk by 9.1% and near-miss risk by 16.2%.

In the West study, the authors performed a prospective, 5-year longitudinal study of a cohort of 340 first-year Mayo Clinic residents in internal medicine (Mayo Clin. Proc. 2012;87:1138-44). In self-generated quarterly filings, 11.3% reported a motor vehicle crash and 43.3% a near-miss accident. Sleepiness (as well as other variables such as depression, burnout, diminished quality of life, and fatigue) significantly increased the odds of a motor vehicle incident in the subsequent 3-month period. Each 1-point increase in fatigue or Epworth Sleepiness Scale score was associated with a 52% and 12% respective increase in a motor vehicle crash.

The Accreditation Council for Graduate Medical Education (ACGME) has formulated rules, which have undergone recent changes, regarding consecutive work-duty hours. Its latest edict in June 2014 can be found on its website and stipulates that “Duty periods of PGY-1 residents must not exceed 16 hours in duration,” and “Duty periods of PGY-2 residents and above may be scheduled to a maximum of 24 hours of continuous duty in the hospital.”

Furthermore, programs must encourage residents to use alertness management strategies in the context of patient care responsibilities. Strategic napping, especially after 16 hours of continuous duty and between the hours of 10:00 p.m. and 8:00 a.m., was a strong suggestion.

In a 2005 lawsuit naming Chicago’s Rush Presbyterian-St. Luke’s Medical Center as a defendant, an Illinois court faced the issue of whether a hospital owed a duty to a plaintiff injured by an off-duty resident doctor allegedly suffering from sleep deprivation as a result of a hospital’s policy on working hours (Brewster v. Rush Presbyterian-St. Luke’s Medical Center (836 N.E.2d 635 (Il. App. 2005)). The doctor was an intern who had worked 34 hours of a 36-hour work shift, and fell asleep behind the wheel of her car, striking and seriously injuring the driver of an oncoming car.

In its decision, the court noted the plaintiff’s argument that it was reasonably foreseeable and likely that drivers who were sleep deprived would cause traffic accidents resulting in injuries. For public policy reasons, the plaintiff also maintained that such injuries could be prevented if hospitals either changed work schedules of their residents or provided them with additional rest periods.

However, the court held that there was no liability imputed to health care providers for injuries to nonpatient third parties absent the existence of a “special relationship” between the parties.

Thus, training programs or hospitals may or may not be found liable in future such cases or in other jurisdictions – but the new, stricter ACGME rules suggest that they will, at a minimum, be a named defendant.

Note that in some jurisdictions, injured nonpatient third parties have successfully sued doctors for failing to warn their patients that certain medications can adversely affect their driving ability, and for failing to warn about medical conditions, e.g., syncope, that can adversely impact driving.

Court decisions in analogous factual circumstances have sometimes favored the accident victim.

In Robertson v. LeMaster (301 S.E.2d 563 (W. Va. 1983)), the West Virginia Supreme Court of Appeals noted that the defendant’s employer, Norfolk & Western Railway Company, “could have reasonably foreseen that its exhausted employee, who had been required to work 27 hours without rest, would pose a risk of harm to other motorists^.”

In Faverty v. McDonald’s Restaurants of Oregon (892 P.2d 703 (Ore. Ct. App.1995)), an Oregon appeals court held that the defendant corporation (McDonald’s Restaurants of Oregon) knew or should have known that its employee was a hazard to himself and others when he drove home from the workplace after working multiple shifts in a 24-hour period.

On the other hand, in Barclay v. Briscoe (47 A.3d 560 (Md. 2012)), a longshoreman employed by Ports America Baltimore fell asleep at the wheel while traveling home after working a 22-hour shift and caused a head-on collision resulting in catastrophic injuries. Ports America Baltimore contended that it could not be held primarily liable, because it owed no duty to the public to ensure that an employee was fit to drive his personal vehicle home. The trial court agreed, and the Maryland Court of Appeals affirmed.

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].

Question: Driving home after a demanding 24 hours on call, the sleepy and fatigued first-year medical resident momentarily dozed off at the wheel, ran a stop sign, and struck an oncoming car, injuring its driver. In a lawsuit by the injured victim, which of the following answers is best?

A. The residency program is definitely liable, being in violation of Accreditation Council for Graduate Medical Education rules on consecutive work hours.

B. The resident is solely liable, because he’s the one who owed the duty of due care.

C. The hospital may be a named codefendant, because it knew or should have known that sleep deprivation can impair a person’s driving ability.

D. A and C are correct.

E. Only B and C are correct.

Answer: E. Residency training programs face many potential liabilities, such as those arising from disciplinary actions, employer-employee disputes, sexual harassment, and so on. But one issue deserving attention is auto accidents in overfatigued trainees. The incidence of falling asleep at the wheel is very high – in some surveys, close to 50% – and accidents are more likely to occur in the immediate post-call period.

The two main research papers documenting a relationship between extended work duty and auto accidents are from Laura K. Barger, Ph.D., and Dr. Colin P. West.

In the Barger study, the authors conducted a nationwide Web-based survey of 2,737 interns (N. Engl. J. Med. 2005;352:125-34). They found that an extended work shift (greater than 24 hours) was 2.3 times as likely for a motor vehicle crash, and 5.9 times for a near-miss accident. The researchers calculated that every extended shift in the month increased the crash risk by 9.1% and near-miss risk by 16.2%.

In the West study, the authors performed a prospective, 5-year longitudinal study of a cohort of 340 first-year Mayo Clinic residents in internal medicine (Mayo Clin. Proc. 2012;87:1138-44). In self-generated quarterly filings, 11.3% reported a motor vehicle crash and 43.3% a near-miss accident. Sleepiness (as well as other variables such as depression, burnout, diminished quality of life, and fatigue) significantly increased the odds of a motor vehicle incident in the subsequent 3-month period. Each 1-point increase in fatigue or Epworth Sleepiness Scale score was associated with a 52% and 12% respective increase in a motor vehicle crash.

The Accreditation Council for Graduate Medical Education (ACGME) has formulated rules, which have undergone recent changes, regarding consecutive work-duty hours. Its latest edict in June 2014 can be found on its website and stipulates that “Duty periods of PGY-1 residents must not exceed 16 hours in duration,” and “Duty periods of PGY-2 residents and above may be scheduled to a maximum of 24 hours of continuous duty in the hospital.”

Furthermore, programs must encourage residents to use alertness management strategies in the context of patient care responsibilities. Strategic napping, especially after 16 hours of continuous duty and between the hours of 10:00 p.m. and 8:00 a.m., was a strong suggestion.

In a 2005 lawsuit naming Chicago’s Rush Presbyterian-St. Luke’s Medical Center as a defendant, an Illinois court faced the issue of whether a hospital owed a duty to a plaintiff injured by an off-duty resident doctor allegedly suffering from sleep deprivation as a result of a hospital’s policy on working hours (Brewster v. Rush Presbyterian-St. Luke’s Medical Center (836 N.E.2d 635 (Il. App. 2005)). The doctor was an intern who had worked 34 hours of a 36-hour work shift, and fell asleep behind the wheel of her car, striking and seriously injuring the driver of an oncoming car.

In its decision, the court noted the plaintiff’s argument that it was reasonably foreseeable and likely that drivers who were sleep deprived would cause traffic accidents resulting in injuries. For public policy reasons, the plaintiff also maintained that such injuries could be prevented if hospitals either changed work schedules of their residents or provided them with additional rest periods.

However, the court held that there was no liability imputed to health care providers for injuries to nonpatient third parties absent the existence of a “special relationship” between the parties.

Thus, training programs or hospitals may or may not be found liable in future such cases or in other jurisdictions – but the new, stricter ACGME rules suggest that they will, at a minimum, be a named defendant.

Note that in some jurisdictions, injured nonpatient third parties have successfully sued doctors for failing to warn their patients that certain medications can adversely affect their driving ability, and for failing to warn about medical conditions, e.g., syncope, that can adversely impact driving.

Court decisions in analogous factual circumstances have sometimes favored the accident victim.

In Robertson v. LeMaster (301 S.E.2d 563 (W. Va. 1983)), the West Virginia Supreme Court of Appeals noted that the defendant’s employer, Norfolk & Western Railway Company, “could have reasonably foreseen that its exhausted employee, who had been required to work 27 hours without rest, would pose a risk of harm to other motorists^.”

In Faverty v. McDonald’s Restaurants of Oregon (892 P.2d 703 (Ore. Ct. App.1995)), an Oregon appeals court held that the defendant corporation (McDonald’s Restaurants of Oregon) knew or should have known that its employee was a hazard to himself and others when he drove home from the workplace after working multiple shifts in a 24-hour period.

On the other hand, in Barclay v. Briscoe (47 A.3d 560 (Md. 2012)), a longshoreman employed by Ports America Baltimore fell asleep at the wheel while traveling home after working a 22-hour shift and caused a head-on collision resulting in catastrophic injuries. Ports America Baltimore contended that it could not be held primarily liable, because it owed no duty to the public to ensure that an employee was fit to drive his personal vehicle home. The trial court agreed, and the Maryland Court of Appeals affirmed.

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].

Question: Driving home after a demanding 24 hours on call, the sleepy and fatigued first-year medical resident momentarily dozed off at the wheel, ran a stop sign, and struck an oncoming car, injuring its driver. In a lawsuit by the injured victim, which of the following answers is best?

A. The residency program is definitely liable, being in violation of Accreditation Council for Graduate Medical Education rules on consecutive work hours.

B. The resident is solely liable, because he’s the one who owed the duty of due care.

C. The hospital may be a named codefendant, because it knew or should have known that sleep deprivation can impair a person’s driving ability.

D. A and C are correct.

E. Only B and C are correct.

Answer: E. Residency training programs face many potential liabilities, such as those arising from disciplinary actions, employer-employee disputes, sexual harassment, and so on. But one issue deserving attention is auto accidents in overfatigued trainees. The incidence of falling asleep at the wheel is very high – in some surveys, close to 50% – and accidents are more likely to occur in the immediate post-call period.

The two main research papers documenting a relationship between extended work duty and auto accidents are from Laura K. Barger, Ph.D., and Dr. Colin P. West.

In the Barger study, the authors conducted a nationwide Web-based survey of 2,737 interns (N. Engl. J. Med. 2005;352:125-34). They found that an extended work shift (greater than 24 hours) was 2.3 times as likely for a motor vehicle crash, and 5.9 times for a near-miss accident. The researchers calculated that every extended shift in the month increased the crash risk by 9.1% and near-miss risk by 16.2%.

In the West study, the authors performed a prospective, 5-year longitudinal study of a cohort of 340 first-year Mayo Clinic residents in internal medicine (Mayo Clin. Proc. 2012;87:1138-44). In self-generated quarterly filings, 11.3% reported a motor vehicle crash and 43.3% a near-miss accident. Sleepiness (as well as other variables such as depression, burnout, diminished quality of life, and fatigue) significantly increased the odds of a motor vehicle incident in the subsequent 3-month period. Each 1-point increase in fatigue or Epworth Sleepiness Scale score was associated with a 52% and 12% respective increase in a motor vehicle crash.

The Accreditation Council for Graduate Medical Education (ACGME) has formulated rules, which have undergone recent changes, regarding consecutive work-duty hours. Its latest edict in June 2014 can be found on its website and stipulates that “Duty periods of PGY-1 residents must not exceed 16 hours in duration,” and “Duty periods of PGY-2 residents and above may be scheduled to a maximum of 24 hours of continuous duty in the hospital.”

Furthermore, programs must encourage residents to use alertness management strategies in the context of patient care responsibilities. Strategic napping, especially after 16 hours of continuous duty and between the hours of 10:00 p.m. and 8:00 a.m., was a strong suggestion.

In a 2005 lawsuit naming Chicago’s Rush Presbyterian-St. Luke’s Medical Center as a defendant, an Illinois court faced the issue of whether a hospital owed a duty to a plaintiff injured by an off-duty resident doctor allegedly suffering from sleep deprivation as a result of a hospital’s policy on working hours (Brewster v. Rush Presbyterian-St. Luke’s Medical Center (836 N.E.2d 635 (Il. App. 2005)). The doctor was an intern who had worked 34 hours of a 36-hour work shift, and fell asleep behind the wheel of her car, striking and seriously injuring the driver of an oncoming car.

In its decision, the court noted the plaintiff’s argument that it was reasonably foreseeable and likely that drivers who were sleep deprived would cause traffic accidents resulting in injuries. For public policy reasons, the plaintiff also maintained that such injuries could be prevented if hospitals either changed work schedules of their residents or provided them with additional rest periods.

However, the court held that there was no liability imputed to health care providers for injuries to nonpatient third parties absent the existence of a “special relationship” between the parties.

Thus, training programs or hospitals may or may not be found liable in future such cases or in other jurisdictions – but the new, stricter ACGME rules suggest that they will, at a minimum, be a named defendant.

Note that in some jurisdictions, injured nonpatient third parties have successfully sued doctors for failing to warn their patients that certain medications can adversely affect their driving ability, and for failing to warn about medical conditions, e.g., syncope, that can adversely impact driving.

Court decisions in analogous factual circumstances have sometimes favored the accident victim.

In Robertson v. LeMaster (301 S.E.2d 563 (W. Va. 1983)), the West Virginia Supreme Court of Appeals noted that the defendant’s employer, Norfolk & Western Railway Company, “could have reasonably foreseen that its exhausted employee, who had been required to work 27 hours without rest, would pose a risk of harm to other motorists^.”

In Faverty v. McDonald’s Restaurants of Oregon (892 P.2d 703 (Ore. Ct. App.1995)), an Oregon appeals court held that the defendant corporation (McDonald’s Restaurants of Oregon) knew or should have known that its employee was a hazard to himself and others when he drove home from the workplace after working multiple shifts in a 24-hour period.

On the other hand, in Barclay v. Briscoe (47 A.3d 560 (Md. 2012)), a longshoreman employed by Ports America Baltimore fell asleep at the wheel while traveling home after working a 22-hour shift and caused a head-on collision resulting in catastrophic injuries. Ports America Baltimore contended that it could not be held primarily liable, because it owed no duty to the public to ensure that an employee was fit to drive his personal vehicle home. The trial court agreed, and the Maryland Court of Appeals affirmed.

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii, and currently directs the St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. Some of the articles in this series are adapted from the author’s 2006 book, “Medical Malpractice: Understanding the Law, Managing the Risk,” and his 2012 Halsbury treatise, “Medical Negligence and Professional Misconduct.” For additional information, readers may contact the author at [email protected].

Missed case of group A strep results in amputation of limbs

A 53-YEAR-OLD WOMAN went to the emergency department (ED) with severe abdominal pain, a rapid heartbeat, and a 101.3° F fever. After 9 hours, the ED physician discharged her around midnight with instructions to contact her gynecologist in the morning for “fibroid issues.” Later that day, the patient collapsed at home and was transported back to the hospital. She was treated for septic shock from a group A Streptococcus infection and had all 4 of her limbs amputated.

Older patients with a fever and no definite source of infection must be handled with great caution.

PLAINTIFF’S CLAIM The ED physician, who discharged the patient with a 102.9° F fever, should have spotted the infection and should have spent more time with her—given the complexity of her case. The physician should have given the patient alternative diagnoses, which would have prompted her to pursue other treatment.

THE DEFENSE The defendants denied any negligence.

VERDICT $25.3 million Wisconsin verdict.

COMMENT Although we are not given many details of this case, I suspect there was a fairly thorough work-up with no specific source of infection discovered. While this was an emergency medicine case, it is a strong reminder that older patients with a fever and no definite source of infection must be handled with great caution.

Patient dies following "routine" warfarin change

AN 80-YEAR-OLD WOMAN was taking warfarin for chronic pulmonary emboli. She saw her physician for a follow-up visit after being hospitalized for heart failure and shortness of breath. He ordered lab work, which revealed an elevated international normalized ratio (INR) of 3.7. The physician e-mailed a nurse to contact the patient and tell her to reduce her warfarin dosage. The nurse documented that she told the patient and called in a new prescription. Five days later, the patient was admitted to the hospital with a significantly elevated INR and a spinal bleed that caused paralysis. The patient was transferred to a nursing home, where she died 6 months after her initial follow-up visit.

PLANTIFF’S CLAIM The physician’s instructions were ambiguous, and a repeat INR should have been performed in 2 or 3 days. The nurse did not properly instruct the decedent and should have notified the family and the visiting nurse of the medication change.

THE DEFENSE The instructions the physician gave were correct and the appropriate plan was to repeat the INR in 13 days. The decedent had managed her warfarin through 11 previous dose changes, so there was no reason to notify the family or visiting nurse.

VERDICT $40,000 settlement.

COMMENT This case is a reminder of the difficulties one can encounter with warfarin dose adjustments. In view of the small settlement, it does not appear there was much physician liability. Most patients do not bleed with an INR of 3.7. It certainly would have been prudent to recheck in 2 to 3 days, however.

Severe headache, but no CT scan results in death

A HOSPITALIZED 57-YEAR-OLD MAN complained of a severe headache that he described as a 10 on a scale of 1 to 10. At the time, he was taking warfarin. After 6 days, he died from a brain herniation and hemorrhage.

PLAINTIFF’S CLAIM Despite the patient’s complaint of severe headache, the physician failed to order a computed tomography scan of the head.

THE DEFENSE The patient’s headaches had waxed and waned and were associated with a fever of recent onset. There were no focal neurologic deficits to suggest that there was any problem with the brain. The brain hemorrhage was a sudden and acute event.

VERDICT $250,000 Illinois verdict.

COMMENT Have a high index of suspicion for intracranial hemorrhage in patients taking warfarin with severe headache. What more needs to be said?

Missed case of group A strep results in amputation of limbs

A 53-YEAR-OLD WOMAN went to the emergency department (ED) with severe abdominal pain, a rapid heartbeat, and a 101.3° F fever. After 9 hours, the ED physician discharged her around midnight with instructions to contact her gynecologist in the morning for “fibroid issues.” Later that day, the patient collapsed at home and was transported back to the hospital. She was treated for septic shock from a group A Streptococcus infection and had all 4 of her limbs amputated.

Older patients with a fever and no definite source of infection must be handled with great caution.

PLAINTIFF’S CLAIM The ED physician, who discharged the patient with a 102.9° F fever, should have spotted the infection and should have spent more time with her—given the complexity of her case. The physician should have given the patient alternative diagnoses, which would have prompted her to pursue other treatment.

THE DEFENSE The defendants denied any negligence.

VERDICT $25.3 million Wisconsin verdict.

COMMENT Although we are not given many details of this case, I suspect there was a fairly thorough work-up with no specific source of infection discovered. While this was an emergency medicine case, it is a strong reminder that older patients with a fever and no definite source of infection must be handled with great caution.

Patient dies following "routine" warfarin change

AN 80-YEAR-OLD WOMAN was taking warfarin for chronic pulmonary emboli. She saw her physician for a follow-up visit after being hospitalized for heart failure and shortness of breath. He ordered lab work, which revealed an elevated international normalized ratio (INR) of 3.7. The physician e-mailed a nurse to contact the patient and tell her to reduce her warfarin dosage. The nurse documented that she told the patient and called in a new prescription. Five days later, the patient was admitted to the hospital with a significantly elevated INR and a spinal bleed that caused paralysis. The patient was transferred to a nursing home, where she died 6 months after her initial follow-up visit.

PLANTIFF’S CLAIM The physician’s instructions were ambiguous, and a repeat INR should have been performed in 2 or 3 days. The nurse did not properly instruct the decedent and should have notified the family and the visiting nurse of the medication change.

THE DEFENSE The instructions the physician gave were correct and the appropriate plan was to repeat the INR in 13 days. The decedent had managed her warfarin through 11 previous dose changes, so there was no reason to notify the family or visiting nurse.

VERDICT $40,000 settlement.

COMMENT This case is a reminder of the difficulties one can encounter with warfarin dose adjustments. In view of the small settlement, it does not appear there was much physician liability. Most patients do not bleed with an INR of 3.7. It certainly would have been prudent to recheck in 2 to 3 days, however.

Severe headache, but no CT scan results in death

A HOSPITALIZED 57-YEAR-OLD MAN complained of a severe headache that he described as a 10 on a scale of 1 to 10. At the time, he was taking warfarin. After 6 days, he died from a brain herniation and hemorrhage.

PLAINTIFF’S CLAIM Despite the patient’s complaint of severe headache, the physician failed to order a computed tomography scan of the head.

THE DEFENSE The patient’s headaches had waxed and waned and were associated with a fever of recent onset. There were no focal neurologic deficits to suggest that there was any problem with the brain. The brain hemorrhage was a sudden and acute event.

VERDICT $250,000 Illinois verdict.

COMMENT Have a high index of suspicion for intracranial hemorrhage in patients taking warfarin with severe headache. What more needs to be said?

Missed case of group A strep results in amputation of limbs

A 53-YEAR-OLD WOMAN went to the emergency department (ED) with severe abdominal pain, a rapid heartbeat, and a 101.3° F fever. After 9 hours, the ED physician discharged her around midnight with instructions to contact her gynecologist in the morning for “fibroid issues.” Later that day, the patient collapsed at home and was transported back to the hospital. She was treated for septic shock from a group A Streptococcus infection and had all 4 of her limbs amputated.

Older patients with a fever and no definite source of infection must be handled with great caution.

PLAINTIFF’S CLAIM The ED physician, who discharged the patient with a 102.9° F fever, should have spotted the infection and should have spent more time with her—given the complexity of her case. The physician should have given the patient alternative diagnoses, which would have prompted her to pursue other treatment.

THE DEFENSE The defendants denied any negligence.

VERDICT $25.3 million Wisconsin verdict.

COMMENT Although we are not given many details of this case, I suspect there was a fairly thorough work-up with no specific source of infection discovered. While this was an emergency medicine case, it is a strong reminder that older patients with a fever and no definite source of infection must be handled with great caution.

Patient dies following "routine" warfarin change

AN 80-YEAR-OLD WOMAN was taking warfarin for chronic pulmonary emboli. She saw her physician for a follow-up visit after being hospitalized for heart failure and shortness of breath. He ordered lab work, which revealed an elevated international normalized ratio (INR) of 3.7. The physician e-mailed a nurse to contact the patient and tell her to reduce her warfarin dosage. The nurse documented that she told the patient and called in a new prescription. Five days later, the patient was admitted to the hospital with a significantly elevated INR and a spinal bleed that caused paralysis. The patient was transferred to a nursing home, where she died 6 months after her initial follow-up visit.

PLANTIFF’S CLAIM The physician’s instructions were ambiguous, and a repeat INR should have been performed in 2 or 3 days. The nurse did not properly instruct the decedent and should have notified the family and the visiting nurse of the medication change.

THE DEFENSE The instructions the physician gave were correct and the appropriate plan was to repeat the INR in 13 days. The decedent had managed her warfarin through 11 previous dose changes, so there was no reason to notify the family or visiting nurse.

VERDICT $40,000 settlement.

COMMENT This case is a reminder of the difficulties one can encounter with warfarin dose adjustments. In view of the small settlement, it does not appear there was much physician liability. Most patients do not bleed with an INR of 3.7. It certainly would have been prudent to recheck in 2 to 3 days, however.

Severe headache, but no CT scan results in death

A HOSPITALIZED 57-YEAR-OLD MAN complained of a severe headache that he described as a 10 on a scale of 1 to 10. At the time, he was taking warfarin. After 6 days, he died from a brain herniation and hemorrhage.

PLAINTIFF’S CLAIM Despite the patient’s complaint of severe headache, the physician failed to order a computed tomography scan of the head.

THE DEFENSE The patient’s headaches had waxed and waned and were associated with a fever of recent onset. There were no focal neurologic deficits to suggest that there was any problem with the brain. The brain hemorrhage was a sudden and acute event.

VERDICT $250,000 Illinois verdict.

COMMENT Have a high index of suspicion for intracranial hemorrhage in patients taking warfarin with severe headache. What more needs to be said?

Hypoglycemia

mrfiza/ Shutterstock

A 44-year-old-man with type 1 diabetes mellitus (DM) was transported to the ED via emergency medical services (EMS) with a chief complaint of hypoglycemia. His wife stated the patient had been acting strangely prior to presentation. She further noted that after checking his blood sugar, which was 19 mg/dL, she gave her husband an oral glucose tablet with some water before calling EMS.

Upon arrival to the ED, the patient was triaged and designated as an urgent level III. At that time, he was alert and oriented, with a blood glucose level of 66 mg/dL. The patient was examined by a physician assistant (PA) within 15 minutes of his arrival. When interviewed by the PA, the patient described feelings of weakness, dizziness, and lightheadedness. The PA attributed these symptoms to the patient’s hypoglycemic state and ordered him a food tray. The patient was then observed for approximately 2 hours, during which time repeat blood-glucose testing revealed a level of 438 mg/dL. Approximately 20 minutes later, another blood-glucose test showed a level of 400 mg/dL. The patient felt well, appeared back to baseline, and expressed the desire to go home. At discharge, the PA instructed the patient to reduce his insulin by 20% and to follow up with his primary care physician (PCP) that same week.

Approximately 3 hours after discharge, the patient was found unresponsive by his wife, and EMS was again called. When EMS arrived at the patient’s house, his blood glucose level was 85 mg/dL. At presentation to the ED, the patient was unresponsive and without a pulse. Despite approximately 30 minutes of intensive resuscitative efforts, the code was called and the patient was pronounced dead.

The family sued the hospital, the emergency physician (EP), and the PA. They claimed the triage nurse failed to obtain an adequate history of the patient’s recent glucometer checks, previous hypoglycemic episodes, the amount and time of his last dose of insulin, and when and how much food he had recently ingested. The plaintiff further argued that that PA failed to obtain an electrocardiogram (ECG) to determine if the patient’s heart rhythm had been affected by his hypoglycemic state. The plaintiff also claimed the PA should have notified the patient’s PCP that the patient was in the ED, so that he could be admitted.

The defendants denied any negligence and argued the patient’s death was due to a sudden cardiac event, which was unrelated to the low-blood sugar levels. The defense contended that the patient’s enlarged heart and preexisting cardiovascular disease, hypertension, hypercholesterolemia, poorly controlled type 1 DM, history of alcohol abuse, and documented evidence of medication noncompliance were the cause of death. According to published accounts, a defense verdict was returned.

Discussion

It seems that rarely a shift goes by without a patient presenting with diabetes-associated complications such as hyperglycemia or hypoglycemia. While the jury reached the correct conclusion in this case, it does serve as a reminder that cases of hypoglycemia should not be treated lightly, and the EP must attempt to determine its cause.

The most commonly accepted definition of hypoglycemia is a blood-glucose level <50 mg/dL with associated symptoms. The causes of hypoglycemia in patients treated with insulin typically involves inadequate or no food intake, or accidental administration of too much insulin or the wrong type of insulin.¹

The differential diagnosis, however, needs to be more than just these two conditions. Since insulin is cleared by the kidneys, and patients with DM are at increased risk for kidney disease, acute renal failure should be considered in the differential. Other conditions to consider include infection, acute coronary syndromes, or unusual physical or mental stress.²

As with every patient presenting to the ED, patients with DM require a good history taking and physical examination. Additional testing, such as an ECG, troponin level, and kidney function test, should be performed based on the history and physical examination. Once the cause is determined, the majority of these patients can be treated with either intravenous (IV) or oral medications, observed, and discharged home with follow-up instructions.

Diabetic patients presenting with hypoglycemia due to a sulfonylurea agent or a long-acting insulin are in a completely different category. Because of the longer half-life of these agents, such patients will usually require admission to the hospital for serial glucose monitoring and treatment.² On occasion, patients with diabetic hypoglycemia and who are on a regular form of insulin will also require hospital admission. Those at highest risk are patients with DM aged 80 years and older.¹

Hyperkalemia

A 59-year-old man presented to the ED complaining of generalized weakness, the onset of which he stated had developed gradually over the previous 3 days. He denied chest pain, shortness of breath, or nausea and vomiting. His medical history was significant only for renal insufficiency. The patient was on no medications and denied alcohol or tobacco use.

Monkey Business Images/ Shutterstock

On physical examination, the patient had normal vital signs, including normal pulse oximetry. Similarly, the heart, lung, and abdominal examinations were all normal. On neurological examination, the patient had 5/5 motor strength in all four extremities and exhibited a normal gait.

The EP ordered an ECG, complete blood count (CBC), basic metabolic panel, urinalysis, and a chest X-ray (CXR). Laboratory evaluation showed an elevated potassium level of 6 mEq/L. The results of the CBC, urinalysis, and CXR were all reported as normal. (Unfortunately, there was no published information on the results of the BUN, creatinine, serum bicarbonate, or ECG findings.)

Based on the patient’s elevated potassium level, the EP ordered sodium polystyrene (Kayexalate) orally and arranged for admission to the hospital. The sodium polystyrene was administered to the patient approximately 1 hour after it was ordered.  While waiting for an inpatient bed, the patient experienced a cardiac arrest and died in the ED.

The family sued the EP and hospital for failure to properly respond to the patient’s elevated potassium level. The hospital denied any negligence, and the defense argued that the death was not related to any electrolyte abnormality, but was due to a respiratory arrest that led to the cardiac arrest. The defendants also maintained the sodium polystyrene had been administered in a timely manner. At trial, a defense verdict was returned.

Discussion

Hyperkalemia has been variably defined as serum potassium concentrations >5 mEq/L, >5.5 mEq/L, or >6 mEq/L.¹ Symptoms of hyperkalemia include generalized muscle weakness (as seen in this patient), muscle cramps, paresthesias, nausea, vomiting, and/or diarrhea. However, it is the cardiac manifestations (eg, ventricular arrhythmias, complete heart block, asystole) associated with hyperkalemia that are most concerning.

There are numerous causes of hyperkalemia, including medications, renal failure, digitalis toxicity, and metabolic acidosis. Therefore, it is important for the EP to identify the etiology in order to definitively treat the hyperkalemia.

Traditionally, it has been taught that hyperkalemia only requires treatment if abnormalities on the ECG are noted. Classic findings seen on ECG include prolonged PR interval, peaked T waves,² shortened QT interval, QRS widening, and a sinusoidal wave pattern. Once fictitious or hemolysis has been ruled out as the etiology, most EPs will initiate treatment above a specific threshold value (frequently 6 mEq/L),

Since it is the cardiac effects of hyperkalemia that can result in death, the initial treatment must be directed toward cardiac membrane stabilization. This is best accomplished by the administration of calcium gluconate 10% IV. This medication has a rapid onset of action (typically 1-3 minutes) and helps prevent the development of cardiac arrhythmias. Additional measures, which involve moving potassium intracellullarly, include sodium bicarbonate IV and insulin with glucose IV.

Actual removal of potassium from the body involves either the administration sodium polystyrene sulfonate or hemodialysis. Sodium polystyrene sulfonate, which is an ion-exchange resin designed to exchange sodium for potassium in the colon, can be given either orally or as an enema. Even though sodium polystyrene sulfonate has been approved for the treatment of hyperkalemia since 1958, it does not take effect for 1 to 2 hours after administration; there is also growing evidence questioning its efficacy and safety.³ In addition, sodium polystyrene sulfonate can exacerbate volume overload due to the associated increase in serum sodium. Therefore, hemodialysis is the most effective treatment for hyperkalemia, and is the treatment of choice for unstable patients with hyperkalemia and acute or chronic renal failure.

Hypoglycemia

mrfiza/ Shutterstock

A 44-year-old-man with type 1 diabetes mellitus (DM) was transported to the ED via emergency medical services (EMS) with a chief complaint of hypoglycemia. His wife stated the patient had been acting strangely prior to presentation. She further noted that after checking his blood sugar, which was 19 mg/dL, she gave her husband an oral glucose tablet with some water before calling EMS.

Upon arrival to the ED, the patient was triaged and designated as an urgent level III. At that time, he was alert and oriented, with a blood glucose level of 66 mg/dL. The patient was examined by a physician assistant (PA) within 15 minutes of his arrival. When interviewed by the PA, the patient described feelings of weakness, dizziness, and lightheadedness. The PA attributed these symptoms to the patient’s hypoglycemic state and ordered him a food tray. The patient was then observed for approximately 2 hours, during which time repeat blood-glucose testing revealed a level of 438 mg/dL. Approximately 20 minutes later, another blood-glucose test showed a level of 400 mg/dL. The patient felt well, appeared back to baseline, and expressed the desire to go home. At discharge, the PA instructed the patient to reduce his insulin by 20% and to follow up with his primary care physician (PCP) that same week.

Approximately 3 hours after discharge, the patient was found unresponsive by his wife, and EMS was again called. When EMS arrived at the patient’s house, his blood glucose level was 85 mg/dL. At presentation to the ED, the patient was unresponsive and without a pulse. Despite approximately 30 minutes of intensive resuscitative efforts, the code was called and the patient was pronounced dead.

The family sued the hospital, the emergency physician (EP), and the PA. They claimed the triage nurse failed to obtain an adequate history of the patient’s recent glucometer checks, previous hypoglycemic episodes, the amount and time of his last dose of insulin, and when and how much food he had recently ingested. The plaintiff further argued that that PA failed to obtain an electrocardiogram (ECG) to determine if the patient’s heart rhythm had been affected by his hypoglycemic state. The plaintiff also claimed the PA should have notified the patient’s PCP that the patient was in the ED, so that he could be admitted.

The defendants denied any negligence and argued the patient’s death was due to a sudden cardiac event, which was unrelated to the low-blood sugar levels. The defense contended that the patient’s enlarged heart and preexisting cardiovascular disease, hypertension, hypercholesterolemia, poorly controlled type 1 DM, history of alcohol abuse, and documented evidence of medication noncompliance were the cause of death. According to published accounts, a defense verdict was returned.

Discussion

It seems that rarely a shift goes by without a patient presenting with diabetes-associated complications such as hyperglycemia or hypoglycemia. While the jury reached the correct conclusion in this case, it does serve as a reminder that cases of hypoglycemia should not be treated lightly, and the EP must attempt to determine its cause.

The most commonly accepted definition of hypoglycemia is a blood-glucose level <50 mg/dL with associated symptoms. The causes of hypoglycemia in patients treated with insulin typically involves inadequate or no food intake, or accidental administration of too much insulin or the wrong type of insulin.¹

The differential diagnosis, however, needs to be more than just these two conditions. Since insulin is cleared by the kidneys, and patients with DM are at increased risk for kidney disease, acute renal failure should be considered in the differential. Other conditions to consider include infection, acute coronary syndromes, or unusual physical or mental stress.²

As with every patient presenting to the ED, patients with DM require a good history taking and physical examination. Additional testing, such as an ECG, troponin level, and kidney function test, should be performed based on the history and physical examination. Once the cause is determined, the majority of these patients can be treated with either intravenous (IV) or oral medications, observed, and discharged home with follow-up instructions.

Diabetic patients presenting with hypoglycemia due to a sulfonylurea agent or a long-acting insulin are in a completely different category. Because of the longer half-life of these agents, such patients will usually require admission to the hospital for serial glucose monitoring and treatment.² On occasion, patients with diabetic hypoglycemia and who are on a regular form of insulin will also require hospital admission. Those at highest risk are patients with DM aged 80 years and older.¹

Hyperkalemia

A 59-year-old man presented to the ED complaining of generalized weakness, the onset of which he stated had developed gradually over the previous 3 days. He denied chest pain, shortness of breath, or nausea and vomiting. His medical history was significant only for renal insufficiency. The patient was on no medications and denied alcohol or tobacco use.

Monkey Business Images/ Shutterstock

On physical examination, the patient had normal vital signs, including normal pulse oximetry. Similarly, the heart, lung, and abdominal examinations were all normal. On neurological examination, the patient had 5/5 motor strength in all four extremities and exhibited a normal gait.

The EP ordered an ECG, complete blood count (CBC), basic metabolic panel, urinalysis, and a chest X-ray (CXR). Laboratory evaluation showed an elevated potassium level of 6 mEq/L. The results of the CBC, urinalysis, and CXR were all reported as normal. (Unfortunately, there was no published information on the results of the BUN, creatinine, serum bicarbonate, or ECG findings.)

Based on the patient’s elevated potassium level, the EP ordered sodium polystyrene (Kayexalate) orally and arranged for admission to the hospital. The sodium polystyrene was administered to the patient approximately 1 hour after it was ordered.  While waiting for an inpatient bed, the patient experienced a cardiac arrest and died in the ED.

The family sued the EP and hospital for failure to properly respond to the patient’s elevated potassium level. The hospital denied any negligence, and the defense argued that the death was not related to any electrolyte abnormality, but was due to a respiratory arrest that led to the cardiac arrest. The defendants also maintained the sodium polystyrene had been administered in a timely manner. At trial, a defense verdict was returned.

Discussion

Hyperkalemia has been variably defined as serum potassium concentrations >5 mEq/L, >5.5 mEq/L, or >6 mEq/L.¹ Symptoms of hyperkalemia include generalized muscle weakness (as seen in this patient), muscle cramps, paresthesias, nausea, vomiting, and/or diarrhea. However, it is the cardiac manifestations (eg, ventricular arrhythmias, complete heart block, asystole) associated with hyperkalemia that are most concerning.

There are numerous causes of hyperkalemia, including medications, renal failure, digitalis toxicity, and metabolic acidosis. Therefore, it is important for the EP to identify the etiology in order to definitively treat the hyperkalemia.

Traditionally, it has been taught that hyperkalemia only requires treatment if abnormalities on the ECG are noted. Classic findings seen on ECG include prolonged PR interval, peaked T waves,² shortened QT interval, QRS widening, and a sinusoidal wave pattern. Once fictitious or hemolysis has been ruled out as the etiology, most EPs will initiate treatment above a specific threshold value (frequently 6 mEq/L),

Since it is the cardiac effects of hyperkalemia that can result in death, the initial treatment must be directed toward cardiac membrane stabilization. This is best accomplished by the administration of calcium gluconate 10% IV. This medication has a rapid onset of action (typically 1-3 minutes) and helps prevent the development of cardiac arrhythmias. Additional measures, which involve moving potassium intracellullarly, include sodium bicarbonate IV and insulin with glucose IV.

Actual removal of potassium from the body involves either the administration sodium polystyrene sulfonate or hemodialysis. Sodium polystyrene sulfonate, which is an ion-exchange resin designed to exchange sodium for potassium in the colon, can be given either orally or as an enema. Even though sodium polystyrene sulfonate has been approved for the treatment of hyperkalemia since 1958, it does not take effect for 1 to 2 hours after administration; there is also growing evidence questioning its efficacy and safety.³ In addition, sodium polystyrene sulfonate can exacerbate volume overload due to the associated increase in serum sodium. Therefore, hemodialysis is the most effective treatment for hyperkalemia, and is the treatment of choice for unstable patients with hyperkalemia and acute or chronic renal failure.

Hypoglycemia

mrfiza/ Shutterstock

A 44-year-old-man with type 1 diabetes mellitus (DM) was transported to the ED via emergency medical services (EMS) with a chief complaint of hypoglycemia. His wife stated the patient had been acting strangely prior to presentation. She further noted that after checking his blood sugar, which was 19 mg/dL, she gave her husband an oral glucose tablet with some water before calling EMS.

Upon arrival to the ED, the patient was triaged and designated as an urgent level III. At that time, he was alert and oriented, with a blood glucose level of 66 mg/dL. The patient was examined by a physician assistant (PA) within 15 minutes of his arrival. When interviewed by the PA, the patient described feelings of weakness, dizziness, and lightheadedness. The PA attributed these symptoms to the patient’s hypoglycemic state and ordered him a food tray. The patient was then observed for approximately 2 hours, during which time repeat blood-glucose testing revealed a level of 438 mg/dL. Approximately 20 minutes later, another blood-glucose test showed a level of 400 mg/dL. The patient felt well, appeared back to baseline, and expressed the desire to go home. At discharge, the PA instructed the patient to reduce his insulin by 20% and to follow up with his primary care physician (PCP) that same week.

Approximately 3 hours after discharge, the patient was found unresponsive by his wife, and EMS was again called. When EMS arrived at the patient’s house, his blood glucose level was 85 mg/dL. At presentation to the ED, the patient was unresponsive and without a pulse. Despite approximately 30 minutes of intensive resuscitative efforts, the code was called and the patient was pronounced dead.

The family sued the hospital, the emergency physician (EP), and the PA. They claimed the triage nurse failed to obtain an adequate history of the patient’s recent glucometer checks, previous hypoglycemic episodes, the amount and time of his last dose of insulin, and when and how much food he had recently ingested. The plaintiff further argued that that PA failed to obtain an electrocardiogram (ECG) to determine if the patient’s heart rhythm had been affected by his hypoglycemic state. The plaintiff also claimed the PA should have notified the patient’s PCP that the patient was in the ED, so that he could be admitted.

The defendants denied any negligence and argued the patient’s death was due to a sudden cardiac event, which was unrelated to the low-blood sugar levels. The defense contended that the patient’s enlarged heart and preexisting cardiovascular disease, hypertension, hypercholesterolemia, poorly controlled type 1 DM, history of alcohol abuse, and documented evidence of medication noncompliance were the cause of death. According to published accounts, a defense verdict was returned.

Discussion

It seems that rarely a shift goes by without a patient presenting with diabetes-associated complications such as hyperglycemia or hypoglycemia. While the jury reached the correct conclusion in this case, it does serve as a reminder that cases of hypoglycemia should not be treated lightly, and the EP must attempt to determine its cause.

The most commonly accepted definition of hypoglycemia is a blood-glucose level <50 mg/dL with associated symptoms. The causes of hypoglycemia in patients treated with insulin typically involves inadequate or no food intake, or accidental administration of too much insulin or the wrong type of insulin.¹

The differential diagnosis, however, needs to be more than just these two conditions. Since insulin is cleared by the kidneys, and patients with DM are at increased risk for kidney disease, acute renal failure should be considered in the differential. Other conditions to consider include infection, acute coronary syndromes, or unusual physical or mental stress.²

As with every patient presenting to the ED, patients with DM require a good history taking and physical examination. Additional testing, such as an ECG, troponin level, and kidney function test, should be performed based on the history and physical examination. Once the cause is determined, the majority of these patients can be treated with either intravenous (IV) or oral medications, observed, and discharged home with follow-up instructions.

Diabetic patients presenting with hypoglycemia due to a sulfonylurea agent or a long-acting insulin are in a completely different category. Because of the longer half-life of these agents, such patients will usually require admission to the hospital for serial glucose monitoring and treatment.² On occasion, patients with diabetic hypoglycemia and who are on a regular form of insulin will also require hospital admission. Those at highest risk are patients with DM aged 80 years and older.¹

Hyperkalemia

A 59-year-old man presented to the ED complaining of generalized weakness, the onset of which he stated had developed gradually over the previous 3 days. He denied chest pain, shortness of breath, or nausea and vomiting. His medical history was significant only for renal insufficiency. The patient was on no medications and denied alcohol or tobacco use.

Monkey Business Images/ Shutterstock

On physical examination, the patient had normal vital signs, including normal pulse oximetry. Similarly, the heart, lung, and abdominal examinations were all normal. On neurological examination, the patient had 5/5 motor strength in all four extremities and exhibited a normal gait.

The EP ordered an ECG, complete blood count (CBC), basic metabolic panel, urinalysis, and a chest X-ray (CXR). Laboratory evaluation showed an elevated potassium level of 6 mEq/L. The results of the CBC, urinalysis, and CXR were all reported as normal. (Unfortunately, there was no published information on the results of the BUN, creatinine, serum bicarbonate, or ECG findings.)

Based on the patient’s elevated potassium level, the EP ordered sodium polystyrene (Kayexalate) orally and arranged for admission to the hospital. The sodium polystyrene was administered to the patient approximately 1 hour after it was ordered.  While waiting for an inpatient bed, the patient experienced a cardiac arrest and died in the ED.

The family sued the EP and hospital for failure to properly respond to the patient’s elevated potassium level. The hospital denied any negligence, and the defense argued that the death was not related to any electrolyte abnormality, but was due to a respiratory arrest that led to the cardiac arrest. The defendants also maintained the sodium polystyrene had been administered in a timely manner. At trial, a defense verdict was returned.

Discussion

Hyperkalemia has been variably defined as serum potassium concentrations >5 mEq/L, >5.5 mEq/L, or >6 mEq/L.¹ Symptoms of hyperkalemia include generalized muscle weakness (as seen in this patient), muscle cramps, paresthesias, nausea, vomiting, and/or diarrhea. However, it is the cardiac manifestations (eg, ventricular arrhythmias, complete heart block, asystole) associated with hyperkalemia that are most concerning.

There are numerous causes of hyperkalemia, including medications, renal failure, digitalis toxicity, and metabolic acidosis. Therefore, it is important for the EP to identify the etiology in order to definitively treat the hyperkalemia.

Traditionally, it has been taught that hyperkalemia only requires treatment if abnormalities on the ECG are noted. Classic findings seen on ECG include prolonged PR interval, peaked T waves,² shortened QT interval, QRS widening, and a sinusoidal wave pattern. Once fictitious or hemolysis has been ruled out as the etiology, most EPs will initiate treatment above a specific threshold value (frequently 6 mEq/L),

Since it is the cardiac effects of hyperkalemia that can result in death, the initial treatment must be directed toward cardiac membrane stabilization. This is best accomplished by the administration of calcium gluconate 10% IV. This medication has a rapid onset of action (typically 1-3 minutes) and helps prevent the development of cardiac arrhythmias. Additional measures, which involve moving potassium intracellullarly, include sodium bicarbonate IV and insulin with glucose IV.

Actual removal of potassium from the body involves either the administration sodium polystyrene sulfonate or hemodialysis. Sodium polystyrene sulfonate, which is an ion-exchange resin designed to exchange sodium for potassium in the colon, can be given either orally or as an enema. Even though sodium polystyrene sulfonate has been approved for the treatment of hyperkalemia since 1958, it does not take effect for 1 to 2 hours after administration; there is also growing evidence questioning its efficacy and safety.³ In addition, sodium polystyrene sulfonate can exacerbate volume overload due to the associated increase in serum sodium. Therefore, hemodialysis is the most effective treatment for hyperkalemia, and is the treatment of choice for unstable patients with hyperkalemia and acute or chronic renal failure.

Question: Grandma finally checked into a skilled nursing facility (SNF), a member of a national chain of for-profit SNFs, after her progressive dementia prevented her from performing the basic activities of daily living. Unfortunately, the staffing was inadequate, and there were lapses in attention toward her nutrition, medications, and body hygiene. She even fell from her bed on a couple of occasions. Other residents have registered similar complaints. Which of the following legal recourses is available?

A. A lawsuit against the SNF, alleging neglect and abuse.
B. A class action suit against the SNF and its corporate owners.
C. A lawsuit against the attending physician and/or the medical director.
D. A, B, and C.
E. Only A and B.

Answer: D. According to the Wall Street Journal, more than 1.4 million people live in U.S. nursing homes, 69% of which are run by for-profit entities.¹ In contrast to a malpractice complaint, lawsuits against nursing homes and SNFs typically involve allegations of a pattern of neglect and abuse rather than any single incident of negligence. The terms nursing home and SNF are often used interchangeably, but do differ somewhat in that the former deals with non-Medicare regulated custodial care, whereas Medicare regulates and certifies all SNFs, which provide both custodial and medical care. Federal and state statutes, e.g., 42 CFR §483 and Centers for Medicare and Medicaid Services guidelines in the State Operations Manual, prescribe the requisite standards. Collectively referred to as the OBRA standards, their violations are frequently at the heart of a plaintiff’s allegations. These may include short staffing, inattention to body hygiene, skin infections, pressure ulcers, improper use of restraints, poor nutrition and hydration, and failure to monitor or supervise, including failure to administer prescription medications and prevention of falls and violent acts from other residents.

In the past 2 decades, nursing homes and SNFs have experienced soaring numbers of lawsuits, with Texas and Florida being especially vulnerable.² Runaway jury verdicts can result even where the elderly victim has incurred little or no economic loss. Noneconomic losses such as pain and suffering as well as punitive damages explain these huge awards. A recent widely publicized case is illustrative: On Sept. 4, 2009, 87-year-old Dorothy Douglas, an Alzheimer’s patient, was admitted to Heartland Nursing Home in Charleston, W.Va. Still cognitive, she was able to ambulate with an assistive device and was well nourished. However, within 19 days of admission, she became barely responsive, dehydrated, and bedridden, and had fallen numerous times, injuring her head. She died shortly thereafter. Her son sued the owner of Heartland and those responsible for its operations, claiming, among other things, medical and corporate negligence. A jury found in his favor, awarding $11.5 million in compensatory damages and $80 million in punitive damages. On appeal, the West Virginia Supreme Court affirmed in part the trial court’s order, although it reduced the punitive damages from $80 million to $32 million (termed a remittitur).³

There are other sizable verdicts, such as a $29 million lawsuit against a Rocklin, Calif., facility in 2010. Another, possibly the largest on record, was a 2013 Florida jury award of $110 million in compensatory damages and $1.0 billion in punitive damages against Auburndale Oaks Healthcare Center. However, this may not have been the final negotiated amount. Increasingly popular is the use of class action lawsuits, where representative plaintiffs assert claims on behalf of a large class of similarly injured members. Typically, they allege grossly substandard care and understaffing in violation of Medicare and/or other statutory rules. New York’s first nursing home class action suit,⁴ which dragged on for some 9 years, ended up with a settlement sum of only $950,000 for its 22 class members. The suit alleged, among other things, inedible food, inadequate heat, and squalid conditions. A more recent example: In 2010, a Humboldt County, Calif., jury returned a $677 million verdict (Lavender v. Skilled Healthcare Group Inc.) against one of the nation’s largest nursing home chains for violating California’s Health and Safety Code in its 22 statewide facilities. The case later settled for $62.8 million on behalf of the 32,000 residents.

What about physician liability? Many doctors attend to SNF patients and a number act as medical directors. Liability exists in both roles. The first is governed by the usual tort action of malpractice. The latter is infinitely trickier. Medicare mandates all SNFs to have a medical director, and federal law [42 CFR 483.75 (i)] requires the medical director to be responsible for implementation of resident care policies and the coordination of medical care in the facility. Although their duties are administrative in nature, medical directors are not infrequently named as codefendants in SNF lawsuits. Allegations against the medical director may include negligent supervision of staff, and/or the failure to set standards, policies, and procedures, especially if they have been made aware of citations by auditing agencies. Because a doctor’s professional liability policy typically excludes coverage for such work, it behooves all medical directors to insist on being a named insured in the institution’s general liability policy (to include tail coverage), and to be informed in a timely fashion should there be a relevant change or cancellation of coverage. Their contract should stipulate that the facility would indemnify them for all lawsuits arising out of their work. More and more nursing homes are dropping their insurance to bypass legal exposure, leaving the attending physician and/or medical director at increased risk. To avoid a serious gap in coverage, medical directors should consider purchasing a specific medical director policy.⁵ Medical directors should also be aware of potential Stark Law violations, such as treating private patients without paying fair rent or receiving compensation in exchange for referrals.

Importantly, elder abuse judgments, as opposed to malpractice awards, may negate restrictions on attorney fees and noneconomic damages such as California’s $250,000 cap. The jury may also levy punitive damages, which are not covered by professional insurance. The plaintiff will need to prove, by clear and convincing evidence, something more than simple or gross negligence such as malice, fraud, oppression, or recklessness.⁶ Under California’s elder abuse and dependent Adult Civil Protection Act, an appellate court has held that a plaintiff may mount an elder abuse claim directed at physicians and not just facilities with “custodial” duties.⁷This important issue is currently under appeal before the California Supreme Court.

References

1. The Wall Street Journal, Oct. 3, 2014.

2. Stevenson, DG and DM Studdert, The Rise Of Nursing Home Litigation: Findings From A National Survey Of Attorneys. Health Affairs 2003; 22:219-29.

3. Manor Care Inc. v. Douglas, 763 N.E.2d 73 (W. Va. 2014).

4. Fleming v. Barnwell Nursing Hone and Health Facilities Inc., 309 A.D.2d 1132 (N.Y. App. Div. 2003).

5. See the American Medical Directors Association’s (AMDA) offering at http://locktonmedicalliabilityinsurance.com/amda/.

6. Delaney v. Baker, 20 Cal. 4th 23 (1999).

7. Winn v. Pioneer Medical Group Inc., 216 Cal. App. 4th 875 (2013).

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii. He currently directs The St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at [email protected].

Question: Grandma finally checked into a skilled nursing facility (SNF), a member of a national chain of for-profit SNFs, after her progressive dementia prevented her from performing the basic activities of daily living. Unfortunately, the staffing was inadequate, and there were lapses in attention toward her nutrition, medications, and body hygiene. She even fell from her bed on a couple of occasions. Other residents have registered similar complaints. Which of the following legal recourses is available?

A. A lawsuit against the SNF, alleging neglect and abuse.
B. A class action suit against the SNF and its corporate owners.
C. A lawsuit against the attending physician and/or the medical director.
D. A, B, and C.
E. Only A and B.

Answer: D. According to the Wall Street Journal, more than 1.4 million people live in U.S. nursing homes, 69% of which are run by for-profit entities.¹ In contrast to a malpractice complaint, lawsuits against nursing homes and SNFs typically involve allegations of a pattern of neglect and abuse rather than any single incident of negligence. The terms nursing home and SNF are often used interchangeably, but do differ somewhat in that the former deals with non-Medicare regulated custodial care, whereas Medicare regulates and certifies all SNFs, which provide both custodial and medical care. Federal and state statutes, e.g., 42 CFR §483 and Centers for Medicare and Medicaid Services guidelines in the State Operations Manual, prescribe the requisite standards. Collectively referred to as the OBRA standards, their violations are frequently at the heart of a plaintiff’s allegations. These may include short staffing, inattention to body hygiene, skin infections, pressure ulcers, improper use of restraints, poor nutrition and hydration, and failure to monitor or supervise, including failure to administer prescription medications and prevention of falls and violent acts from other residents.

In the past 2 decades, nursing homes and SNFs have experienced soaring numbers of lawsuits, with Texas and Florida being especially vulnerable.² Runaway jury verdicts can result even where the elderly victim has incurred little or no economic loss. Noneconomic losses such as pain and suffering as well as punitive damages explain these huge awards. A recent widely publicized case is illustrative: On Sept. 4, 2009, 87-year-old Dorothy Douglas, an Alzheimer’s patient, was admitted to Heartland Nursing Home in Charleston, W.Va. Still cognitive, she was able to ambulate with an assistive device and was well nourished. However, within 19 days of admission, she became barely responsive, dehydrated, and bedridden, and had fallen numerous times, injuring her head. She died shortly thereafter. Her son sued the owner of Heartland and those responsible for its operations, claiming, among other things, medical and corporate negligence. A jury found in his favor, awarding $11.5 million in compensatory damages and $80 million in punitive damages. On appeal, the West Virginia Supreme Court affirmed in part the trial court’s order, although it reduced the punitive damages from $80 million to $32 million (termed a remittitur).³

There are other sizable verdicts, such as a $29 million lawsuit against a Rocklin, Calif., facility in 2010. Another, possibly the largest on record, was a 2013 Florida jury award of $110 million in compensatory damages and $1.0 billion in punitive damages against Auburndale Oaks Healthcare Center. However, this may not have been the final negotiated amount. Increasingly popular is the use of class action lawsuits, where representative plaintiffs assert claims on behalf of a large class of similarly injured members. Typically, they allege grossly substandard care and understaffing in violation of Medicare and/or other statutory rules. New York’s first nursing home class action suit,⁴ which dragged on for some 9 years, ended up with a settlement sum of only $950,000 for its 22 class members. The suit alleged, among other things, inedible food, inadequate heat, and squalid conditions. A more recent example: In 2010, a Humboldt County, Calif., jury returned a $677 million verdict (Lavender v. Skilled Healthcare Group Inc.) against one of the nation’s largest nursing home chains for violating California’s Health and Safety Code in its 22 statewide facilities. The case later settled for $62.8 million on behalf of the 32,000 residents.

What about physician liability? Many doctors attend to SNF patients and a number act as medical directors. Liability exists in both roles. The first is governed by the usual tort action of malpractice. The latter is infinitely trickier. Medicare mandates all SNFs to have a medical director, and federal law [42 CFR 483.75 (i)] requires the medical director to be responsible for implementation of resident care policies and the coordination of medical care in the facility. Although their duties are administrative in nature, medical directors are not infrequently named as codefendants in SNF lawsuits. Allegations against the medical director may include negligent supervision of staff, and/or the failure to set standards, policies, and procedures, especially if they have been made aware of citations by auditing agencies. Because a doctor’s professional liability policy typically excludes coverage for such work, it behooves all medical directors to insist on being a named insured in the institution’s general liability policy (to include tail coverage), and to be informed in a timely fashion should there be a relevant change or cancellation of coverage. Their contract should stipulate that the facility would indemnify them for all lawsuits arising out of their work. More and more nursing homes are dropping their insurance to bypass legal exposure, leaving the attending physician and/or medical director at increased risk. To avoid a serious gap in coverage, medical directors should consider purchasing a specific medical director policy.⁵ Medical directors should also be aware of potential Stark Law violations, such as treating private patients without paying fair rent or receiving compensation in exchange for referrals.

Importantly, elder abuse judgments, as opposed to malpractice awards, may negate restrictions on attorney fees and noneconomic damages such as California’s $250,000 cap. The jury may also levy punitive damages, which are not covered by professional insurance. The plaintiff will need to prove, by clear and convincing evidence, something more than simple or gross negligence such as malice, fraud, oppression, or recklessness.⁶ Under California’s elder abuse and dependent Adult Civil Protection Act, an appellate court has held that a plaintiff may mount an elder abuse claim directed at physicians and not just facilities with “custodial” duties.⁷This important issue is currently under appeal before the California Supreme Court.

References

1. The Wall Street Journal, Oct. 3, 2014.

2. Stevenson, DG and DM Studdert, The Rise Of Nursing Home Litigation: Findings From A National Survey Of Attorneys. Health Affairs 2003; 22:219-29.

3. Manor Care Inc. v. Douglas, 763 N.E.2d 73 (W. Va. 2014).

4. Fleming v. Barnwell Nursing Hone and Health Facilities Inc., 309 A.D.2d 1132 (N.Y. App. Div. 2003).

5. See the American Medical Directors Association’s (AMDA) offering at http://locktonmedicalliabilityinsurance.com/amda/.

6. Delaney v. Baker, 20 Cal. 4th 23 (1999).

7. Winn v. Pioneer Medical Group Inc., 216 Cal. App. 4th 875 (2013).

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii. He currently directs The St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at [email protected].

Question: Grandma finally checked into a skilled nursing facility (SNF), a member of a national chain of for-profit SNFs, after her progressive dementia prevented her from performing the basic activities of daily living. Unfortunately, the staffing was inadequate, and there were lapses in attention toward her nutrition, medications, and body hygiene. She even fell from her bed on a couple of occasions. Other residents have registered similar complaints. Which of the following legal recourses is available?

A. A lawsuit against the SNF, alleging neglect and abuse.
B. A class action suit against the SNF and its corporate owners.
C. A lawsuit against the attending physician and/or the medical director.
D. A, B, and C.
E. Only A and B.

Answer: D. According to the Wall Street Journal, more than 1.4 million people live in U.S. nursing homes, 69% of which are run by for-profit entities.¹ In contrast to a malpractice complaint, lawsuits against nursing homes and SNFs typically involve allegations of a pattern of neglect and abuse rather than any single incident of negligence. The terms nursing home and SNF are often used interchangeably, but do differ somewhat in that the former deals with non-Medicare regulated custodial care, whereas Medicare regulates and certifies all SNFs, which provide both custodial and medical care. Federal and state statutes, e.g., 42 CFR §483 and Centers for Medicare and Medicaid Services guidelines in the State Operations Manual, prescribe the requisite standards. Collectively referred to as the OBRA standards, their violations are frequently at the heart of a plaintiff’s allegations. These may include short staffing, inattention to body hygiene, skin infections, pressure ulcers, improper use of restraints, poor nutrition and hydration, and failure to monitor or supervise, including failure to administer prescription medications and prevention of falls and violent acts from other residents.

In the past 2 decades, nursing homes and SNFs have experienced soaring numbers of lawsuits, with Texas and Florida being especially vulnerable.² Runaway jury verdicts can result even where the elderly victim has incurred little or no economic loss. Noneconomic losses such as pain and suffering as well as punitive damages explain these huge awards. A recent widely publicized case is illustrative: On Sept. 4, 2009, 87-year-old Dorothy Douglas, an Alzheimer’s patient, was admitted to Heartland Nursing Home in Charleston, W.Va. Still cognitive, she was able to ambulate with an assistive device and was well nourished. However, within 19 days of admission, she became barely responsive, dehydrated, and bedridden, and had fallen numerous times, injuring her head. She died shortly thereafter. Her son sued the owner of Heartland and those responsible for its operations, claiming, among other things, medical and corporate negligence. A jury found in his favor, awarding $11.5 million in compensatory damages and $80 million in punitive damages. On appeal, the West Virginia Supreme Court affirmed in part the trial court’s order, although it reduced the punitive damages from $80 million to $32 million (termed a remittitur).³

There are other sizable verdicts, such as a $29 million lawsuit against a Rocklin, Calif., facility in 2010. Another, possibly the largest on record, was a 2013 Florida jury award of $110 million in compensatory damages and $1.0 billion in punitive damages against Auburndale Oaks Healthcare Center. However, this may not have been the final negotiated amount. Increasingly popular is the use of class action lawsuits, where representative plaintiffs assert claims on behalf of a large class of similarly injured members. Typically, they allege grossly substandard care and understaffing in violation of Medicare and/or other statutory rules. New York’s first nursing home class action suit,⁴ which dragged on for some 9 years, ended up with a settlement sum of only $950,000 for its 22 class members. The suit alleged, among other things, inedible food, inadequate heat, and squalid conditions. A more recent example: In 2010, a Humboldt County, Calif., jury returned a $677 million verdict (Lavender v. Skilled Healthcare Group Inc.) against one of the nation’s largest nursing home chains for violating California’s Health and Safety Code in its 22 statewide facilities. The case later settled for $62.8 million on behalf of the 32,000 residents.

What about physician liability? Many doctors attend to SNF patients and a number act as medical directors. Liability exists in both roles. The first is governed by the usual tort action of malpractice. The latter is infinitely trickier. Medicare mandates all SNFs to have a medical director, and federal law [42 CFR 483.75 (i)] requires the medical director to be responsible for implementation of resident care policies and the coordination of medical care in the facility. Although their duties are administrative in nature, medical directors are not infrequently named as codefendants in SNF lawsuits. Allegations against the medical director may include negligent supervision of staff, and/or the failure to set standards, policies, and procedures, especially if they have been made aware of citations by auditing agencies. Because a doctor’s professional liability policy typically excludes coverage for such work, it behooves all medical directors to insist on being a named insured in the institution’s general liability policy (to include tail coverage), and to be informed in a timely fashion should there be a relevant change or cancellation of coverage. Their contract should stipulate that the facility would indemnify them for all lawsuits arising out of their work. More and more nursing homes are dropping their insurance to bypass legal exposure, leaving the attending physician and/or medical director at increased risk. To avoid a serious gap in coverage, medical directors should consider purchasing a specific medical director policy.⁵ Medical directors should also be aware of potential Stark Law violations, such as treating private patients without paying fair rent or receiving compensation in exchange for referrals.

Importantly, elder abuse judgments, as opposed to malpractice awards, may negate restrictions on attorney fees and noneconomic damages such as California’s $250,000 cap. The jury may also levy punitive damages, which are not covered by professional insurance. The plaintiff will need to prove, by clear and convincing evidence, something more than simple or gross negligence such as malice, fraud, oppression, or recklessness.⁶ Under California’s elder abuse and dependent Adult Civil Protection Act, an appellate court has held that a plaintiff may mount an elder abuse claim directed at physicians and not just facilities with “custodial” duties.⁷This important issue is currently under appeal before the California Supreme Court.

References

1. The Wall Street Journal, Oct. 3, 2014.

2. Stevenson, DG and DM Studdert, The Rise Of Nursing Home Litigation: Findings From A National Survey Of Attorneys. Health Affairs 2003; 22:219-29.

3. Manor Care Inc. v. Douglas, 763 N.E.2d 73 (W. Va. 2014).

4. Fleming v. Barnwell Nursing Hone and Health Facilities Inc., 309 A.D.2d 1132 (N.Y. App. Div. 2003).

5. See the American Medical Directors Association’s (AMDA) offering at http://locktonmedicalliabilityinsurance.com/amda/.

6. Delaney v. Baker, 20 Cal. 4th 23 (1999).

7. Winn v. Pioneer Medical Group Inc., 216 Cal. App. 4th 875 (2013).

Dr. Tan is emeritus professor of medicine and former adjunct professor of law at the University of Hawaii. He currently directs The St. Francis International Center for Healthcare Ethics in Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. For additional information, readers may contact the author at [email protected].

Stomach pain chalked up to flu; patient suffers fatal cardiac event

A 40-YEAR-OLD MAN went to the emergency department (ED) after 2 days of stomach discomfort. The ED physician who evaluated him released him after 4 or 5 hours without testing for levels of troponin or other cardiac enzymes. The patient’s discomfort continued, and about 3 days later, he told his wife to call 911. He was transported to the ED but did not survive.

PLAINTIFF’S CLAIM The decedent had been suffering from an acute cardiac event during the first ED visit. Testing to rule out cardiac problems should have been performed.

THE DEFENSE The patient had been suffering from a stomach flu during his initial ED visit. Any testing performed at that time would have been normal. The patient’s death was unrelated to the symptoms he was experiencing when he was first seen.

VERDICT $4 million Alabama verdict.

COMMENT Many questions come to mind with this case: How careful was the history? Did the patient’s discomfort get worse with activity? What were the characteristics of his pain? What were the patient’s cardiac risk factors? A colleague of mine missed a very similar case several years ago in a 67-year-old. The patient even had vomiting and diarrhea, but clearly had a myocardial infarction when diagnosed a few days later.

Follow-up failure on PSA results costs patient valuable Tx time

A PATIENT AT A GROUP PRACTICE underwent prostate specific antigen (PSA) screening, which revealed an abnormal result (4.1 ng/mL). The physician circled this value on the lab report, wrote, “Discuss next visit,” and placed the report in the patient’s chart. However, the patient switched to another physician in the group and was not told of the abnormal result for more than 2 years. When the patient went to a medical center for back pain, magnetic resonance imaging of his spine revealed the presence of cancer in his spine, shoulder blades, pelvis, and ribs. A PSA test performed at that time came back at 100 ng/mL. Two days later, a biopsy confirmed the diagnosis of prostate cancer (Gleason score, 9).

PLAINTIFF’S CLAIM In addition to failing to inform the patient of his abnormal PSA test result, the physician did not perform digital rectal exams.

THE DEFENSE Earlier treatment would not have made a difference in the outcome.

VERDICT $934,000 Florida verdict.

COMMENT If you order a PSA, you must follow up on it. When a patient transfers to your care, be sure to obtain and review past testing and provide follow-up on abnormal results. We now send all test results directly to patients so they can serve as a safety check for their own care. Despite fears of being inundated with calls, most organizations that have instituted such a policy have not turned back.

Stomach pain chalked up to flu; patient suffers fatal cardiac event

A 40-YEAR-OLD MAN went to the emergency department (ED) after 2 days of stomach discomfort. The ED physician who evaluated him released him after 4 or 5 hours without testing for levels of troponin or other cardiac enzymes. The patient’s discomfort continued, and about 3 days later, he told his wife to call 911. He was transported to the ED but did not survive.

PLAINTIFF’S CLAIM The decedent had been suffering from an acute cardiac event during the first ED visit. Testing to rule out cardiac problems should have been performed.

THE DEFENSE The patient had been suffering from a stomach flu during his initial ED visit. Any testing performed at that time would have been normal. The patient’s death was unrelated to the symptoms he was experiencing when he was first seen.

VERDICT $4 million Alabama verdict.

COMMENT Many questions come to mind with this case: How careful was the history? Did the patient’s discomfort get worse with activity? What were the characteristics of his pain? What were the patient’s cardiac risk factors? A colleague of mine missed a very similar case several years ago in a 67-year-old. The patient even had vomiting and diarrhea, but clearly had a myocardial infarction when diagnosed a few days later.

Follow-up failure on PSA results costs patient valuable Tx time

A PATIENT AT A GROUP PRACTICE underwent prostate specific antigen (PSA) screening, which revealed an abnormal result (4.1 ng/mL). The physician circled this value on the lab report, wrote, “Discuss next visit,” and placed the report in the patient’s chart. However, the patient switched to another physician in the group and was not told of the abnormal result for more than 2 years. When the patient went to a medical center for back pain, magnetic resonance imaging of his spine revealed the presence of cancer in his spine, shoulder blades, pelvis, and ribs. A PSA test performed at that time came back at 100 ng/mL. Two days later, a biopsy confirmed the diagnosis of prostate cancer (Gleason score, 9).

PLAINTIFF’S CLAIM In addition to failing to inform the patient of his abnormal PSA test result, the physician did not perform digital rectal exams.

THE DEFENSE Earlier treatment would not have made a difference in the outcome.

VERDICT $934,000 Florida verdict.

COMMENT If you order a PSA, you must follow up on it. When a patient transfers to your care, be sure to obtain and review past testing and provide follow-up on abnormal results. We now send all test results directly to patients so they can serve as a safety check for their own care. Despite fears of being inundated with calls, most organizations that have instituted such a policy have not turned back.

Stomach pain chalked up to flu; patient suffers fatal cardiac event

A 40-YEAR-OLD MAN went to the emergency department (ED) after 2 days of stomach discomfort. The ED physician who evaluated him released him after 4 or 5 hours without testing for levels of troponin or other cardiac enzymes. The patient’s discomfort continued, and about 3 days later, he told his wife to call 911. He was transported to the ED but did not survive.

PLAINTIFF’S CLAIM The decedent had been suffering from an acute cardiac event during the first ED visit. Testing to rule out cardiac problems should have been performed.

THE DEFENSE The patient had been suffering from a stomach flu during his initial ED visit. Any testing performed at that time would have been normal. The patient’s death was unrelated to the symptoms he was experiencing when he was first seen.

VERDICT $4 million Alabama verdict.

COMMENT Many questions come to mind with this case: How careful was the history? Did the patient’s discomfort get worse with activity? What were the characteristics of his pain? What were the patient’s cardiac risk factors? A colleague of mine missed a very similar case several years ago in a 67-year-old. The patient even had vomiting and diarrhea, but clearly had a myocardial infarction when diagnosed a few days later.

Follow-up failure on PSA results costs patient valuable Tx time

A PATIENT AT A GROUP PRACTICE underwent prostate specific antigen (PSA) screening, which revealed an abnormal result (4.1 ng/mL). The physician circled this value on the lab report, wrote, “Discuss next visit,” and placed the report in the patient’s chart. However, the patient switched to another physician in the group and was not told of the abnormal result for more than 2 years. When the patient went to a medical center for back pain, magnetic resonance imaging of his spine revealed the presence of cancer in his spine, shoulder blades, pelvis, and ribs. A PSA test performed at that time came back at 100 ng/mL. Two days later, a biopsy confirmed the diagnosis of prostate cancer (Gleason score, 9).

PLAINTIFF’S CLAIM In addition to failing to inform the patient of his abnormal PSA test result, the physician did not perform digital rectal exams.

THE DEFENSE Earlier treatment would not have made a difference in the outcome.

VERDICT $934,000 Florida verdict.

COMMENT If you order a PSA, you must follow up on it. When a patient transfers to your care, be sure to obtain and review past testing and provide follow-up on abnormal results. We now send all test results directly to patients so they can serve as a safety check for their own care. Despite fears of being inundated with calls, most organizations that have instituted such a policy have not turned back.