Law & Medicine

No tests ordered, despite baby’s yellowing skin

Many studies suggest that our ability to judge bilirubin levels on the basis of skin color is rather limited.

A 5-DAY-OLD INFANT’S YELLOW COMPLEXION led his worried mother to take him to a family practice. The physician assistant (PA) who examined the child noted yellowing of his face and chest. When the baby’s doctor arrived at the office unexpectedly, the PA consulted with her. The mother was given standard infant care instructions; no orders for diagnostic testing were issued.

Two days later the baby’s skin became yellower and he appeared lethargic. His mother brought him to a clinic, where she was told to take him to the hospital immediately. Testing at the hospital revealed an elevated bilirubin level. The infant developed kernicterus and suffered brain damage, resulting in developmental delays and cerebral palsy.

PLAINTIFF’S CLAIM The physician was negligent in failing to test and treat the infant promptly. The mother claimed that the physician had treated her older son for jaundice, as well. The mother also claimed that the physician noted the infant’s skin color but did nothing.

THE DEFENSE The infant’s sclera were white and he was alert and active when examined. The mother didn’t follow the instructions given to her.

VERDICT $6.25 million Delaware verdict.

COMMENT Many studies suggest that our ability to judge bilirubin levels on the basis of skin color is rather limited. It’s hard to imagine not doing a simple test in this situation.

Amputation blamed on tardy Dx of compartment syndrome

PAIN IN HER RIGHT LEG AND KNEE prompted a woman in her 60s to go to the emergency department (ED). She couldn’t remember any specific event or trauma that might have triggered the pain. Her history included deep vein thrombosis, pulmonary embolism, diabetes, hypertension, placement of a Green-field filter, and right knee replacement. She was taking warfarin; her international normalized ratio (INR) in the ED was 5.0. A physician diagnosed joint effusion and sent the patient home on pain killers.

Two days later, the patient returned to the ED complaining of numbness in her leg and excruciating pain in her right calf. She was seen by a different physician, who ordered a surgical consultation. Evaluation revealed a lack of sensation in her right foot, a dorsalis pedis pulse undetectable by Doppler ultrasound, and inability to dorsiflex or plantarflex the right foot.

Compartment syndrome was diagnosed and an emergent fasciotomy performed. The patient suffered extensive muscle and tissue death and became septic, necessitating an above-knee amputation. While recuperating and waiting for a prosthesis, the patient fell from her wheelchair, fracturing her dominant arm and shoulder in several places.

PLAINTIFF’S CLAIM No information about the plaintiff‘s claim is available.

THE DEFENSE No information about the defense is available.

VERDICT $890,000 Virginia settlement.

COMMENT When the diagnosis is ambiguous, close follow-up and reevaluation is key to avoiding a hefty settlement.

Abnormal labs go unnoted, patient goes into septic shock

A 52-YEAR-OLD WOMAN went to the ED because of vomiting and weakness. Her fingers and toes were blue; she was tachycardic and hypotensive. A pacemaker/defibrillator had been implanted 3 weeks earlier. The woman’s history included cardiomyopathy, eczema, renal failure, and lumbar fusion requiring maintenance narcotic medication. When initial blood tests showed hypokalemia, she was given potassium and general fluid resuscitation.

The ED physician also ordered a complete blood count, which automatically included differential and band counts. The patient’s bands were high and her platelets low, but these results weren’t noted.

The patient improved after receiving fluids; her longtime physician admitted her to the hospital with a diagnosis of hypokalemia and narcotic withdrawal. He ordered repeat blood work for the following morning.

That evening, another doctor, who was covering for the patient’s physician, received calls from nurses reporting that the patient was complaining of increased pain in her extremities. He diagnosed Raynaud’s syndrome and ordered medication. The patient’s physician also diagnosed Raynaud’s syndrome when he saw her the next morning; he noted that she was improving and ordered her diet to resume. The results from the second CBC, performed that morning, weren’t noted in the patient’s chart.

The covering doctor was on duty again in the evening and again received calls reporting that the patient was in pain. The following morning the patient went into septic shock. She was diagnosed with a staph infection and transferred to the ICU, where she died of sepsis and multi-organ failure a few days later.

PLAINTIFF’S CLAIM The doctors and nurses were negligent in failing to note the abnormal band and platelet counts for 44 hours. The physicians should have recognized signs and symptoms of infection and administered antibiotics. The hospital should have reported the laboratory results and findings of infection to the physicians.

THE DEFENSE The patient’s physician maintained that the patient’s signs and symptoms weren’t consistent with infection. He didn’t order a differential blood test and wasn’t aware that the hospital performed it automatically. He claimed that the results weren’t available to him on the first 2 days; the hospital and nurses claimed that the results were available.

The covering doctor argued that he was only the on-call physician, never actually saw the patient, and had no duty to follow up on the blood tests. The hospital maintained that the nurses had no duty to look at the laboratory results unless requested to do so and that the physicians hadn’t asked them to do so.

VERDICT $500,000 Illinois verdict against the patient’s physician; high/low agreement of $3 million/$150,000 between plaintiff and hospital ($150,000 to be set off from the verdict against the physician).

COMMENT If a test is ordered, review it promptly. Ignorance is unlikely to be an adequate defense in a malpractice allegation.

Infection, then rapid death

HIGH FEVER, DIARRHEA, LETHARGY, SPREADING RASH, and other symptoms in a 16-month-old boy led to an ED visit. The child died about 3 hours later from meningococcemia and sepsis caused by Neisseria meningitidis (Waterhouse-Friderichsen syndrome).

PLAINTIFFS’ CLAIM The ED physician failed to properly monitor and treat the child’s deteriorating condition from meningococcemia and septic shock.

THE DEFENSE The child received proper treatment, but his condition was too far advanced to prevent his death.

VERDICT Illinois defense verdict.

COMMENT Urgent evaluation and treatment—even today—can be imperative to help prevent the sequelae of meningococcemia.

No tests ordered, despite baby’s yellowing skin

Many studies suggest that our ability to judge bilirubin levels on the basis of skin color is rather limited.

A 5-DAY-OLD INFANT’S YELLOW COMPLEXION led his worried mother to take him to a family practice. The physician assistant (PA) who examined the child noted yellowing of his face and chest. When the baby’s doctor arrived at the office unexpectedly, the PA consulted with her. The mother was given standard infant care instructions; no orders for diagnostic testing were issued.

Two days later the baby’s skin became yellower and he appeared lethargic. His mother brought him to a clinic, where she was told to take him to the hospital immediately. Testing at the hospital revealed an elevated bilirubin level. The infant developed kernicterus and suffered brain damage, resulting in developmental delays and cerebral palsy.

PLAINTIFF’S CLAIM The physician was negligent in failing to test and treat the infant promptly. The mother claimed that the physician had treated her older son for jaundice, as well. The mother also claimed that the physician noted the infant’s skin color but did nothing.

THE DEFENSE The infant’s sclera were white and he was alert and active when examined. The mother didn’t follow the instructions given to her.

VERDICT $6.25 million Delaware verdict.

COMMENT Many studies suggest that our ability to judge bilirubin levels on the basis of skin color is rather limited. It’s hard to imagine not doing a simple test in this situation.

Amputation blamed on tardy Dx of compartment syndrome

PAIN IN HER RIGHT LEG AND KNEE prompted a woman in her 60s to go to the emergency department (ED). She couldn’t remember any specific event or trauma that might have triggered the pain. Her history included deep vein thrombosis, pulmonary embolism, diabetes, hypertension, placement of a Green-field filter, and right knee replacement. She was taking warfarin; her international normalized ratio (INR) in the ED was 5.0. A physician diagnosed joint effusion and sent the patient home on pain killers.

Two days later, the patient returned to the ED complaining of numbness in her leg and excruciating pain in her right calf. She was seen by a different physician, who ordered a surgical consultation. Evaluation revealed a lack of sensation in her right foot, a dorsalis pedis pulse undetectable by Doppler ultrasound, and inability to dorsiflex or plantarflex the right foot.

Compartment syndrome was diagnosed and an emergent fasciotomy performed. The patient suffered extensive muscle and tissue death and became septic, necessitating an above-knee amputation. While recuperating and waiting for a prosthesis, the patient fell from her wheelchair, fracturing her dominant arm and shoulder in several places.

PLAINTIFF’S CLAIM No information about the plaintiff‘s claim is available.

THE DEFENSE No information about the defense is available.

VERDICT $890,000 Virginia settlement.

COMMENT When the diagnosis is ambiguous, close follow-up and reevaluation is key to avoiding a hefty settlement.

Abnormal labs go unnoted, patient goes into septic shock

A 52-YEAR-OLD WOMAN went to the ED because of vomiting and weakness. Her fingers and toes were blue; she was tachycardic and hypotensive. A pacemaker/defibrillator had been implanted 3 weeks earlier. The woman’s history included cardiomyopathy, eczema, renal failure, and lumbar fusion requiring maintenance narcotic medication. When initial blood tests showed hypokalemia, she was given potassium and general fluid resuscitation.

The ED physician also ordered a complete blood count, which automatically included differential and band counts. The patient’s bands were high and her platelets low, but these results weren’t noted.

The patient improved after receiving fluids; her longtime physician admitted her to the hospital with a diagnosis of hypokalemia and narcotic withdrawal. He ordered repeat blood work for the following morning.

That evening, another doctor, who was covering for the patient’s physician, received calls from nurses reporting that the patient was complaining of increased pain in her extremities. He diagnosed Raynaud’s syndrome and ordered medication. The patient’s physician also diagnosed Raynaud’s syndrome when he saw her the next morning; he noted that she was improving and ordered her diet to resume. The results from the second CBC, performed that morning, weren’t noted in the patient’s chart.

The covering doctor was on duty again in the evening and again received calls reporting that the patient was in pain. The following morning the patient went into septic shock. She was diagnosed with a staph infection and transferred to the ICU, where she died of sepsis and multi-organ failure a few days later.

PLAINTIFF’S CLAIM The doctors and nurses were negligent in failing to note the abnormal band and platelet counts for 44 hours. The physicians should have recognized signs and symptoms of infection and administered antibiotics. The hospital should have reported the laboratory results and findings of infection to the physicians.

THE DEFENSE The patient’s physician maintained that the patient’s signs and symptoms weren’t consistent with infection. He didn’t order a differential blood test and wasn’t aware that the hospital performed it automatically. He claimed that the results weren’t available to him on the first 2 days; the hospital and nurses claimed that the results were available.

The covering doctor argued that he was only the on-call physician, never actually saw the patient, and had no duty to follow up on the blood tests. The hospital maintained that the nurses had no duty to look at the laboratory results unless requested to do so and that the physicians hadn’t asked them to do so.

VERDICT $500,000 Illinois verdict against the patient’s physician; high/low agreement of $3 million/$150,000 between plaintiff and hospital ($150,000 to be set off from the verdict against the physician).

COMMENT If a test is ordered, review it promptly. Ignorance is unlikely to be an adequate defense in a malpractice allegation.

Infection, then rapid death

HIGH FEVER, DIARRHEA, LETHARGY, SPREADING RASH, and other symptoms in a 16-month-old boy led to an ED visit. The child died about 3 hours later from meningococcemia and sepsis caused by Neisseria meningitidis (Waterhouse-Friderichsen syndrome).

PLAINTIFFS’ CLAIM The ED physician failed to properly monitor and treat the child’s deteriorating condition from meningococcemia and septic shock.

THE DEFENSE The child received proper treatment, but his condition was too far advanced to prevent his death.

VERDICT Illinois defense verdict.

COMMENT Urgent evaluation and treatment—even today—can be imperative to help prevent the sequelae of meningococcemia.

No tests ordered, despite baby’s yellowing skin

Many studies suggest that our ability to judge bilirubin levels on the basis of skin color is rather limited.

A 5-DAY-OLD INFANT’S YELLOW COMPLEXION led his worried mother to take him to a family practice. The physician assistant (PA) who examined the child noted yellowing of his face and chest. When the baby’s doctor arrived at the office unexpectedly, the PA consulted with her. The mother was given standard infant care instructions; no orders for diagnostic testing were issued.

Two days later the baby’s skin became yellower and he appeared lethargic. His mother brought him to a clinic, where she was told to take him to the hospital immediately. Testing at the hospital revealed an elevated bilirubin level. The infant developed kernicterus and suffered brain damage, resulting in developmental delays and cerebral palsy.

PLAINTIFF’S CLAIM The physician was negligent in failing to test and treat the infant promptly. The mother claimed that the physician had treated her older son for jaundice, as well. The mother also claimed that the physician noted the infant’s skin color but did nothing.

THE DEFENSE The infant’s sclera were white and he was alert and active when examined. The mother didn’t follow the instructions given to her.

VERDICT $6.25 million Delaware verdict.

COMMENT Many studies suggest that our ability to judge bilirubin levels on the basis of skin color is rather limited. It’s hard to imagine not doing a simple test in this situation.

Amputation blamed on tardy Dx of compartment syndrome

PAIN IN HER RIGHT LEG AND KNEE prompted a woman in her 60s to go to the emergency department (ED). She couldn’t remember any specific event or trauma that might have triggered the pain. Her history included deep vein thrombosis, pulmonary embolism, diabetes, hypertension, placement of a Green-field filter, and right knee replacement. She was taking warfarin; her international normalized ratio (INR) in the ED was 5.0. A physician diagnosed joint effusion and sent the patient home on pain killers.

Two days later, the patient returned to the ED complaining of numbness in her leg and excruciating pain in her right calf. She was seen by a different physician, who ordered a surgical consultation. Evaluation revealed a lack of sensation in her right foot, a dorsalis pedis pulse undetectable by Doppler ultrasound, and inability to dorsiflex or plantarflex the right foot.

Compartment syndrome was diagnosed and an emergent fasciotomy performed. The patient suffered extensive muscle and tissue death and became septic, necessitating an above-knee amputation. While recuperating and waiting for a prosthesis, the patient fell from her wheelchair, fracturing her dominant arm and shoulder in several places.

PLAINTIFF’S CLAIM No information about the plaintiff‘s claim is available.

THE DEFENSE No information about the defense is available.

VERDICT $890,000 Virginia settlement.

COMMENT When the diagnosis is ambiguous, close follow-up and reevaluation is key to avoiding a hefty settlement.

Abnormal labs go unnoted, patient goes into septic shock

A 52-YEAR-OLD WOMAN went to the ED because of vomiting and weakness. Her fingers and toes were blue; she was tachycardic and hypotensive. A pacemaker/defibrillator had been implanted 3 weeks earlier. The woman’s history included cardiomyopathy, eczema, renal failure, and lumbar fusion requiring maintenance narcotic medication. When initial blood tests showed hypokalemia, she was given potassium and general fluid resuscitation.

The ED physician also ordered a complete blood count, which automatically included differential and band counts. The patient’s bands were high and her platelets low, but these results weren’t noted.

The patient improved after receiving fluids; her longtime physician admitted her to the hospital with a diagnosis of hypokalemia and narcotic withdrawal. He ordered repeat blood work for the following morning.

That evening, another doctor, who was covering for the patient’s physician, received calls from nurses reporting that the patient was complaining of increased pain in her extremities. He diagnosed Raynaud’s syndrome and ordered medication. The patient’s physician also diagnosed Raynaud’s syndrome when he saw her the next morning; he noted that she was improving and ordered her diet to resume. The results from the second CBC, performed that morning, weren’t noted in the patient’s chart.

The covering doctor was on duty again in the evening and again received calls reporting that the patient was in pain. The following morning the patient went into septic shock. She was diagnosed with a staph infection and transferred to the ICU, where she died of sepsis and multi-organ failure a few days later.

PLAINTIFF’S CLAIM The doctors and nurses were negligent in failing to note the abnormal band and platelet counts for 44 hours. The physicians should have recognized signs and symptoms of infection and administered antibiotics. The hospital should have reported the laboratory results and findings of infection to the physicians.

THE DEFENSE The patient’s physician maintained that the patient’s signs and symptoms weren’t consistent with infection. He didn’t order a differential blood test and wasn’t aware that the hospital performed it automatically. He claimed that the results weren’t available to him on the first 2 days; the hospital and nurses claimed that the results were available.

The covering doctor argued that he was only the on-call physician, never actually saw the patient, and had no duty to follow up on the blood tests. The hospital maintained that the nurses had no duty to look at the laboratory results unless requested to do so and that the physicians hadn’t asked them to do so.

VERDICT $500,000 Illinois verdict against the patient’s physician; high/low agreement of $3 million/$150,000 between plaintiff and hospital ($150,000 to be set off from the verdict against the physician).

COMMENT If a test is ordered, review it promptly. Ignorance is unlikely to be an adequate defense in a malpractice allegation.

Infection, then rapid death

HIGH FEVER, DIARRHEA, LETHARGY, SPREADING RASH, and other symptoms in a 16-month-old boy led to an ED visit. The child died about 3 hours later from meningococcemia and sepsis caused by Neisseria meningitidis (Waterhouse-Friderichsen syndrome).

PLAINTIFFS’ CLAIM The ED physician failed to properly monitor and treat the child’s deteriorating condition from meningococcemia and septic shock.

THE DEFENSE The child received proper treatment, but his condition was too far advanced to prevent his death.

VERDICT Illinois defense verdict.

COMMENT Urgent evaluation and treatment—even today—can be imperative to help prevent the sequelae of meningococcemia.

Question: Mary visited her twin sister, Cecilia, in the hospital where she had recently undergone brain surgery. During the visit and in full view of Mary, Cecilia developed status epilepticus after a nurse erroneously gave her Dilaudid instead of Dilantin. Mary was petrified by the incident and developed insomnia, nightmares, and depression, which required psychiatric treatment. Which of the following choices is best?

A. Mary can sue for negligent infliction of emotional distress.

B. Mary can sue irrespective of whether she is a close family member.

C. Mary can sue even if she had learned of the events via telephone, so long as she can prove she suffered diagnosable mental distress as a result.

D. A and B are correct.

E. All are correct.

Answer: A. Negligent infliction of emotional distress (NIED) is a tort in which the plaintiff, usually a bystander, develops significant emotional distress after observing shocking injuries to a primary victim. For a NIED lawsuit to be successful, courts insist that the bystander-claimant meet rather strict criteria, which include being a close relative and having directly observed the injuries contemporaneously with the tortious conduct. New York, for example, permits only spouses and immediate family members to sue.

At common law, there was no recovery for NIED, the rationale being that psychiatric complaints are often minor and transient, and symptoms are susceptible to falsification or magnification. Furthermore, it was feared that such recovery will open the floodgates to litigation, with claims being filed by assorted victims for alleged mental distress brought about by property damage and work stress.

However, over the past 50 years, NIED has emerged as a specific compensable tort. Bystanders, so-called “secondary victims,” can file lawsuits when they suffer mental harm as a result of having observed the primary victim’s injuries, but who were themselves not the direct object of the tortfeasor’s negligence.

Courts may require the plaintiff to sustain some physical injury in addition to mental anguish, to have experienced an “impact,” or to be in the “zone of danger.” These limitations have sometimes proved awkward in practice. For example, Georgia was once asked to decide whether the requirement of impact was satisfied where a circus horse evacuated his bowels onto the plaintiff’s lap. (It answered in the affirmative!) The impact rule has since been abandoned in most jurisdictions, although Illinois continues to require the plaintiff to establish a concomitant physical injury or impact in malpractice cases. It also has ruled that expert testimony was unnecessary to prove the element of emotional distress where an obstetrician allegedly did not arrive for more than an hour and the baby died with its head stuck in the birth canal.

Many jurisdictions have adopted a variant of the so-called California or Dillon test, which focuses on bystander foreseeability and satisfying three “proximities”: 1) physical proximity, that is, the bystander is located at the scene; 2) temporal proximity, that is, personally observes the accident; and 3) relational proximity, denoting the bystander’s close relationship to the primary victim. These criteria stemmed from the seminal California decision of Dillon v. Legg, where a mother witnessed the tragic death of her infant daughter at the scene of a traffic accident, and then experienced severe emotional distress thereafter. At no time did the mother sustain an impact, nor was she in any zone of danger. California has subsequently imposed the additional requirement that the claimant must be contemporaneously present at the event scene and aware of the resulting harm.

NIED is best understood as a duty inquiry, that is, when the tortfeasor owes a duty to someone other than the primary injured victim. Absent a finding of duty, the plaintiff’s cause of action will fail. This explains the court’s findings in a malpractice case where a mother was successful in her suit against an obstetrician after her baby sustained anoxic encephalopathy during delivery. The court chose to characterize her as a direct victim rather than a bystander, to whom a duty of care was already owed as part of the doctor-patient relationship. This nullified the defendant’s argument that she did not contemporaneously observe the baby’s injury, a requisite element under California law.

In the medical setting, whether a duty exists is also linked to the relationship of the bystander to the patient. This became an issue in a New Jersey case of negligent medical care and wrongful death. The patient died of complicating infections after a long hospital stay. The plaintiff, engaged but unmarried to the decedent, advanced a bystander claim for NIED, asserting that he shared an intimate familial relationship. The court ruled against him, holding that his relationship with the decedent patient failed to meet the “marital or intimate familial relationship” requirement. Furthermore, for liability, the plaintiff must have contemporaneously observed the act of malpractice and its fatal effect on the patient, which the court decided he did not. The court referenced its earlier holding that a misdiagnosis normally does not create the kind of horrifying scene that is a prerequisite for recovery.

On the other hand, a Rhode Island plaintiff was able to proceed with her claim for NIED after a defendant hotel negligently delayed 14 minutes before calling an ambulance for her husband who had sustained and subsequently died from a heart attack. The court held that, unlike a medical malpractice claim, the plaintiff was not required to know at the time that the defendant had failed to summon an ambulance.

In Commonwealth countries, the tort of NIED is referred to as nervous shock. As in the United States, the claimant has to be a close relative who is involved in the immediate aftermath of a horrifying event, and sustains foreseeable psychological harm leading to a well-defined psychiatric illness.

This column, “Law & Medicine,” appears regularly in Internal Medicine News, a publication of Elsevier. Dr. Tan is former professor of medicine and adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. It is adapted from the author’s book, “Medical Malpractice: Understanding the Law, Managing the Risk” (Hackensack, N.J.; World Scientific Publishing Company, 2006). For additional information, readers may contact the author at [email protected].

Question: Mary visited her twin sister, Cecilia, in the hospital where she had recently undergone brain surgery. During the visit and in full view of Mary, Cecilia developed status epilepticus after a nurse erroneously gave her Dilaudid instead of Dilantin. Mary was petrified by the incident and developed insomnia, nightmares, and depression, which required psychiatric treatment. Which of the following choices is best?

A. Mary can sue for negligent infliction of emotional distress.

B. Mary can sue irrespective of whether she is a close family member.

C. Mary can sue even if she had learned of the events via telephone, so long as she can prove she suffered diagnosable mental distress as a result.

D. A and B are correct.

E. All are correct.

Answer: A. Negligent infliction of emotional distress (NIED) is a tort in which the plaintiff, usually a bystander, develops significant emotional distress after observing shocking injuries to a primary victim. For a NIED lawsuit to be successful, courts insist that the bystander-claimant meet rather strict criteria, which include being a close relative and having directly observed the injuries contemporaneously with the tortious conduct. New York, for example, permits only spouses and immediate family members to sue.

At common law, there was no recovery for NIED, the rationale being that psychiatric complaints are often minor and transient, and symptoms are susceptible to falsification or magnification. Furthermore, it was feared that such recovery will open the floodgates to litigation, with claims being filed by assorted victims for alleged mental distress brought about by property damage and work stress.

However, over the past 50 years, NIED has emerged as a specific compensable tort. Bystanders, so-called “secondary victims,” can file lawsuits when they suffer mental harm as a result of having observed the primary victim’s injuries, but who were themselves not the direct object of the tortfeasor’s negligence.

Courts may require the plaintiff to sustain some physical injury in addition to mental anguish, to have experienced an “impact,” or to be in the “zone of danger.” These limitations have sometimes proved awkward in practice. For example, Georgia was once asked to decide whether the requirement of impact was satisfied where a circus horse evacuated his bowels onto the plaintiff’s lap. (It answered in the affirmative!) The impact rule has since been abandoned in most jurisdictions, although Illinois continues to require the plaintiff to establish a concomitant physical injury or impact in malpractice cases. It also has ruled that expert testimony was unnecessary to prove the element of emotional distress where an obstetrician allegedly did not arrive for more than an hour and the baby died with its head stuck in the birth canal.

Many jurisdictions have adopted a variant of the so-called California or Dillon test, which focuses on bystander foreseeability and satisfying three “proximities”: 1) physical proximity, that is, the bystander is located at the scene; 2) temporal proximity, that is, personally observes the accident; and 3) relational proximity, denoting the bystander’s close relationship to the primary victim. These criteria stemmed from the seminal California decision of Dillon v. Legg, where a mother witnessed the tragic death of her infant daughter at the scene of a traffic accident, and then experienced severe emotional distress thereafter. At no time did the mother sustain an impact, nor was she in any zone of danger. California has subsequently imposed the additional requirement that the claimant must be contemporaneously present at the event scene and aware of the resulting harm.

NIED is best understood as a duty inquiry, that is, when the tortfeasor owes a duty to someone other than the primary injured victim. Absent a finding of duty, the plaintiff’s cause of action will fail. This explains the court’s findings in a malpractice case where a mother was successful in her suit against an obstetrician after her baby sustained anoxic encephalopathy during delivery. The court chose to characterize her as a direct victim rather than a bystander, to whom a duty of care was already owed as part of the doctor-patient relationship. This nullified the defendant’s argument that she did not contemporaneously observe the baby’s injury, a requisite element under California law.

In the medical setting, whether a duty exists is also linked to the relationship of the bystander to the patient. This became an issue in a New Jersey case of negligent medical care and wrongful death. The patient died of complicating infections after a long hospital stay. The plaintiff, engaged but unmarried to the decedent, advanced a bystander claim for NIED, asserting that he shared an intimate familial relationship. The court ruled against him, holding that his relationship with the decedent patient failed to meet the “marital or intimate familial relationship” requirement. Furthermore, for liability, the plaintiff must have contemporaneously observed the act of malpractice and its fatal effect on the patient, which the court decided he did not. The court referenced its earlier holding that a misdiagnosis normally does not create the kind of horrifying scene that is a prerequisite for recovery.

On the other hand, a Rhode Island plaintiff was able to proceed with her claim for NIED after a defendant hotel negligently delayed 14 minutes before calling an ambulance for her husband who had sustained and subsequently died from a heart attack. The court held that, unlike a medical malpractice claim, the plaintiff was not required to know at the time that the defendant had failed to summon an ambulance.

In Commonwealth countries, the tort of NIED is referred to as nervous shock. As in the United States, the claimant has to be a close relative who is involved in the immediate aftermath of a horrifying event, and sustains foreseeable psychological harm leading to a well-defined psychiatric illness.

This column, “Law & Medicine,” appears regularly in Internal Medicine News, a publication of Elsevier. Dr. Tan is former professor of medicine and adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. It is adapted from the author’s book, “Medical Malpractice: Understanding the Law, Managing the Risk” (Hackensack, N.J.; World Scientific Publishing Company, 2006). For additional information, readers may contact the author at [email protected].

Question: Mary visited her twin sister, Cecilia, in the hospital where she had recently undergone brain surgery. During the visit and in full view of Mary, Cecilia developed status epilepticus after a nurse erroneously gave her Dilaudid instead of Dilantin. Mary was petrified by the incident and developed insomnia, nightmares, and depression, which required psychiatric treatment. Which of the following choices is best?

A. Mary can sue for negligent infliction of emotional distress.

B. Mary can sue irrespective of whether she is a close family member.

C. Mary can sue even if she had learned of the events via telephone, so long as she can prove she suffered diagnosable mental distress as a result.

D. A and B are correct.

E. All are correct.

Answer: A. Negligent infliction of emotional distress (NIED) is a tort in which the plaintiff, usually a bystander, develops significant emotional distress after observing shocking injuries to a primary victim. For a NIED lawsuit to be successful, courts insist that the bystander-claimant meet rather strict criteria, which include being a close relative and having directly observed the injuries contemporaneously with the tortious conduct. New York, for example, permits only spouses and immediate family members to sue.

At common law, there was no recovery for NIED, the rationale being that psychiatric complaints are often minor and transient, and symptoms are susceptible to falsification or magnification. Furthermore, it was feared that such recovery will open the floodgates to litigation, with claims being filed by assorted victims for alleged mental distress brought about by property damage and work stress.

However, over the past 50 years, NIED has emerged as a specific compensable tort. Bystanders, so-called “secondary victims,” can file lawsuits when they suffer mental harm as a result of having observed the primary victim’s injuries, but who were themselves not the direct object of the tortfeasor’s negligence.

Courts may require the plaintiff to sustain some physical injury in addition to mental anguish, to have experienced an “impact,” or to be in the “zone of danger.” These limitations have sometimes proved awkward in practice. For example, Georgia was once asked to decide whether the requirement of impact was satisfied where a circus horse evacuated his bowels onto the plaintiff’s lap. (It answered in the affirmative!) The impact rule has since been abandoned in most jurisdictions, although Illinois continues to require the plaintiff to establish a concomitant physical injury or impact in malpractice cases. It also has ruled that expert testimony was unnecessary to prove the element of emotional distress where an obstetrician allegedly did not arrive for more than an hour and the baby died with its head stuck in the birth canal.

Many jurisdictions have adopted a variant of the so-called California or Dillon test, which focuses on bystander foreseeability and satisfying three “proximities”: 1) physical proximity, that is, the bystander is located at the scene; 2) temporal proximity, that is, personally observes the accident; and 3) relational proximity, denoting the bystander’s close relationship to the primary victim. These criteria stemmed from the seminal California decision of Dillon v. Legg, where a mother witnessed the tragic death of her infant daughter at the scene of a traffic accident, and then experienced severe emotional distress thereafter. At no time did the mother sustain an impact, nor was she in any zone of danger. California has subsequently imposed the additional requirement that the claimant must be contemporaneously present at the event scene and aware of the resulting harm.

NIED is best understood as a duty inquiry, that is, when the tortfeasor owes a duty to someone other than the primary injured victim. Absent a finding of duty, the plaintiff’s cause of action will fail. This explains the court’s findings in a malpractice case where a mother was successful in her suit against an obstetrician after her baby sustained anoxic encephalopathy during delivery. The court chose to characterize her as a direct victim rather than a bystander, to whom a duty of care was already owed as part of the doctor-patient relationship. This nullified the defendant’s argument that she did not contemporaneously observe the baby’s injury, a requisite element under California law.

In the medical setting, whether a duty exists is also linked to the relationship of the bystander to the patient. This became an issue in a New Jersey case of negligent medical care and wrongful death. The patient died of complicating infections after a long hospital stay. The plaintiff, engaged but unmarried to the decedent, advanced a bystander claim for NIED, asserting that he shared an intimate familial relationship. The court ruled against him, holding that his relationship with the decedent patient failed to meet the “marital or intimate familial relationship” requirement. Furthermore, for liability, the plaintiff must have contemporaneously observed the act of malpractice and its fatal effect on the patient, which the court decided he did not. The court referenced its earlier holding that a misdiagnosis normally does not create the kind of horrifying scene that is a prerequisite for recovery.

On the other hand, a Rhode Island plaintiff was able to proceed with her claim for NIED after a defendant hotel negligently delayed 14 minutes before calling an ambulance for her husband who had sustained and subsequently died from a heart attack. The court held that, unlike a medical malpractice claim, the plaintiff was not required to know at the time that the defendant had failed to summon an ambulance.

In Commonwealth countries, the tort of NIED is referred to as nervous shock. As in the United States, the claimant has to be a close relative who is involved in the immediate aftermath of a horrifying event, and sustains foreseeable psychological harm leading to a well-defined psychiatric illness.

This column, “Law & Medicine,” appears regularly in Internal Medicine News, a publication of Elsevier. Dr. Tan is former professor of medicine and adjunct professor of law at the University of Hawaii, Honolulu. This article is meant to be educational and does not constitute medical, ethical, or legal advice. It is adapted from the author’s book, “Medical Malpractice: Understanding the Law, Managing the Risk” (Hackensack, N.J.; World Scientific Publishing Company, 2006). For additional information, readers may contact the author at [email protected].

Question: Following a negligently performed tubal ligation, a 45-year-old multiparous woman subsequently became pregnant and delivered her fifth child, who was born healthy. Which of the following choices is best?

A. Both mother and child can sue for damages.

B. Mother can sue doctor for negligent tubal ligation and wrongful birth.

C. Child, even if perfectly healthy, can sue for wrongful life.

D. Child will most likely prevail if he was born with birth disabilities.

E. Life, even if imperfect, is always better than nonlife, so nobody will be successful in any lawsuit.

Answer: B. Negligently performed sterilization procedures such as vasectomy or tubal ligation can form the basis for a malpractice lawsuit. Should the parents file a claim, the lawsuit is confusingly termed wrongful birth (or better, wrongful pregnancy).

The law has traditionally barred a wrongful life action. The prime reason given is that life, even if imperfect, is always preferable to nonlife. Besides, it would be impossible to assess the quantum of damages since it would necessarily require placing a monetary worth on human existence. The seminal case is the 1967 New Jersey decision in Gleitman v. Cosgrove. The mother had contracted rubella during early pregnancy and the doctor had wrongly assured her that no harm would come to the fetus. As a result, she did not seek to terminate her pregnancy. In rejecting the child’s wrongful life claim, the court asserted that the "infant plaintiff would have us measure the difference between his life with defects against the utter void of nonexistence, but it is impossible to make such a determination." Concerned that it would otherwise be viewed as advocating abortion, the court also denied the mother’s separate claim for wrongful birth, choosing instead to focus on the "unmeasurable, and complex human benefits of motherhood and fatherhood."

New Jersey’s position has since changed, and in Berman v. Allan, it allowed damages for maternal emotional distress though not for medical and other expenses of raising the child. The court, however, continued to reject the infant’s claim for wrongful life. But in 1984, it allowed such a claim under very special circumstances. The infant was born with multiple congenital abnormalities (blindness, deafness, and mental retardation) after the physician had failed to diagnose rubella in the mother. By the time the case was brought, the statute of limitations had lapsed, barring the parents from filing an action. The court held that "a child or his parents may recover special damages for extraordinary medical expenses incurred during infancy, and that the infant may recover those expenses during his majority."

It was once argued that the defendant doctor owes no duty where his/her tortious acts or omissions had resulted in the birth of a healthy if unplanned child, since the benefits to the parents of having a healthy child outweigh any detriments. This line of reasoning has gradually eroded, and parents can now recover damages for pecuniary losses and even emotional distress for wrongful birth. The damages cover the physical, emotional, and financial costs of pregnancy and delivery, but not the costs associated with the normal rearing of a healthy child. In exceptional cases, courts have awarded limited damages to the parents for some child-rearing costs (for example, where the child is physically or mentally handicapped).

However, the legal situation is quite different for the infant. In the case of a failed sterilization or abortion procedure, for example, only the parents – not the infant – will have redress at law. Courts continue to refuse claims brought by healthy infants for wrongful life, adopting the reasoning in Berman that the infant is in essence claiming that its very life is wrongful, but it has not suffered any damage recognizable by the law by being brought into existence. Even an infant with birth disabilities will not prevail in the vast majority of jurisdictions, with California being a notable exception. One of the latest courts to deny a claim for wrongful life was the South Carolina Supreme Court.

Finally, we should distinguish wrongful birth and wrongful life cases from those cases in which a doctor inflicts harm on the fetus in utero (for example, by administration of a teratogenic drug). A lawsuit would then be available to the injured infant, but there is controversy surrounding when the legal duty to the fetus arises (that is, before fetal viability, after viability, or even preconception, such as in cases of genetic damage to an ovum from physical, chemical, or radiologic injury). There is also an issue as to whether a stillborn fetus has a cause of action for wrongful death, or whether the child has first to be born alive. The resolution of this question centers in part on the language and intent of each state’s wrongful death statute.

This column, "Law & Medicine," regularly appears in Internal Medicine News, an Elsevier publication. Dr. Tan is former professor of medicine and adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. It is adapted from the author’s book, "Medical Malpractice: Understanding the Law, Managing the Risk" (2006). For additional information, readers may contact the author.

Question: Following a negligently performed tubal ligation, a 45-year-old multiparous woman subsequently became pregnant and delivered her fifth child, who was born healthy. Which of the following choices is best?

A. Both mother and child can sue for damages.

B. Mother can sue doctor for negligent tubal ligation and wrongful birth.

C. Child, even if perfectly healthy, can sue for wrongful life.

D. Child will most likely prevail if he was born with birth disabilities.

E. Life, even if imperfect, is always better than nonlife, so nobody will be successful in any lawsuit.

Answer: B. Negligently performed sterilization procedures such as vasectomy or tubal ligation can form the basis for a malpractice lawsuit. Should the parents file a claim, the lawsuit is confusingly termed wrongful birth (or better, wrongful pregnancy).

The law has traditionally barred a wrongful life action. The prime reason given is that life, even if imperfect, is always preferable to nonlife. Besides, it would be impossible to assess the quantum of damages since it would necessarily require placing a monetary worth on human existence. The seminal case is the 1967 New Jersey decision in Gleitman v. Cosgrove. The mother had contracted rubella during early pregnancy and the doctor had wrongly assured her that no harm would come to the fetus. As a result, she did not seek to terminate her pregnancy. In rejecting the child’s wrongful life claim, the court asserted that the "infant plaintiff would have us measure the difference between his life with defects against the utter void of nonexistence, but it is impossible to make such a determination." Concerned that it would otherwise be viewed as advocating abortion, the court also denied the mother’s separate claim for wrongful birth, choosing instead to focus on the "unmeasurable, and complex human benefits of motherhood and fatherhood."

New Jersey’s position has since changed, and in Berman v. Allan, it allowed damages for maternal emotional distress though not for medical and other expenses of raising the child. The court, however, continued to reject the infant’s claim for wrongful life. But in 1984, it allowed such a claim under very special circumstances. The infant was born with multiple congenital abnormalities (blindness, deafness, and mental retardation) after the physician had failed to diagnose rubella in the mother. By the time the case was brought, the statute of limitations had lapsed, barring the parents from filing an action. The court held that "a child or his parents may recover special damages for extraordinary medical expenses incurred during infancy, and that the infant may recover those expenses during his majority."

It was once argued that the defendant doctor owes no duty where his/her tortious acts or omissions had resulted in the birth of a healthy if unplanned child, since the benefits to the parents of having a healthy child outweigh any detriments. This line of reasoning has gradually eroded, and parents can now recover damages for pecuniary losses and even emotional distress for wrongful birth. The damages cover the physical, emotional, and financial costs of pregnancy and delivery, but not the costs associated with the normal rearing of a healthy child. In exceptional cases, courts have awarded limited damages to the parents for some child-rearing costs (for example, where the child is physically or mentally handicapped).

However, the legal situation is quite different for the infant. In the case of a failed sterilization or abortion procedure, for example, only the parents – not the infant – will have redress at law. Courts continue to refuse claims brought by healthy infants for wrongful life, adopting the reasoning in Berman that the infant is in essence claiming that its very life is wrongful, but it has not suffered any damage recognizable by the law by being brought into existence. Even an infant with birth disabilities will not prevail in the vast majority of jurisdictions, with California being a notable exception. One of the latest courts to deny a claim for wrongful life was the South Carolina Supreme Court.

Finally, we should distinguish wrongful birth and wrongful life cases from those cases in which a doctor inflicts harm on the fetus in utero (for example, by administration of a teratogenic drug). A lawsuit would then be available to the injured infant, but there is controversy surrounding when the legal duty to the fetus arises (that is, before fetal viability, after viability, or even preconception, such as in cases of genetic damage to an ovum from physical, chemical, or radiologic injury). There is also an issue as to whether a stillborn fetus has a cause of action for wrongful death, or whether the child has first to be born alive. The resolution of this question centers in part on the language and intent of each state’s wrongful death statute.

This column, "Law & Medicine," regularly appears in Internal Medicine News, an Elsevier publication. Dr. Tan is former professor of medicine and adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. It is adapted from the author’s book, "Medical Malpractice: Understanding the Law, Managing the Risk" (2006). For additional information, readers may contact the author.

Question: Following a negligently performed tubal ligation, a 45-year-old multiparous woman subsequently became pregnant and delivered her fifth child, who was born healthy. Which of the following choices is best?

A. Both mother and child can sue for damages.

B. Mother can sue doctor for negligent tubal ligation and wrongful birth.

C. Child, even if perfectly healthy, can sue for wrongful life.

D. Child will most likely prevail if he was born with birth disabilities.

E. Life, even if imperfect, is always better than nonlife, so nobody will be successful in any lawsuit.

Answer: B. Negligently performed sterilization procedures such as vasectomy or tubal ligation can form the basis for a malpractice lawsuit. Should the parents file a claim, the lawsuit is confusingly termed wrongful birth (or better, wrongful pregnancy).

The law has traditionally barred a wrongful life action. The prime reason given is that life, even if imperfect, is always preferable to nonlife. Besides, it would be impossible to assess the quantum of damages since it would necessarily require placing a monetary worth on human existence. The seminal case is the 1967 New Jersey decision in Gleitman v. Cosgrove. The mother had contracted rubella during early pregnancy and the doctor had wrongly assured her that no harm would come to the fetus. As a result, she did not seek to terminate her pregnancy. In rejecting the child’s wrongful life claim, the court asserted that the "infant plaintiff would have us measure the difference between his life with defects against the utter void of nonexistence, but it is impossible to make such a determination." Concerned that it would otherwise be viewed as advocating abortion, the court also denied the mother’s separate claim for wrongful birth, choosing instead to focus on the "unmeasurable, and complex human benefits of motherhood and fatherhood."

New Jersey’s position has since changed, and in Berman v. Allan, it allowed damages for maternal emotional distress though not for medical and other expenses of raising the child. The court, however, continued to reject the infant’s claim for wrongful life. But in 1984, it allowed such a claim under very special circumstances. The infant was born with multiple congenital abnormalities (blindness, deafness, and mental retardation) after the physician had failed to diagnose rubella in the mother. By the time the case was brought, the statute of limitations had lapsed, barring the parents from filing an action. The court held that "a child or his parents may recover special damages for extraordinary medical expenses incurred during infancy, and that the infant may recover those expenses during his majority."

It was once argued that the defendant doctor owes no duty where his/her tortious acts or omissions had resulted in the birth of a healthy if unplanned child, since the benefits to the parents of having a healthy child outweigh any detriments. This line of reasoning has gradually eroded, and parents can now recover damages for pecuniary losses and even emotional distress for wrongful birth. The damages cover the physical, emotional, and financial costs of pregnancy and delivery, but not the costs associated with the normal rearing of a healthy child. In exceptional cases, courts have awarded limited damages to the parents for some child-rearing costs (for example, where the child is physically or mentally handicapped).

However, the legal situation is quite different for the infant. In the case of a failed sterilization or abortion procedure, for example, only the parents – not the infant – will have redress at law. Courts continue to refuse claims brought by healthy infants for wrongful life, adopting the reasoning in Berman that the infant is in essence claiming that its very life is wrongful, but it has not suffered any damage recognizable by the law by being brought into existence. Even an infant with birth disabilities will not prevail in the vast majority of jurisdictions, with California being a notable exception. One of the latest courts to deny a claim for wrongful life was the South Carolina Supreme Court.

Finally, we should distinguish wrongful birth and wrongful life cases from those cases in which a doctor inflicts harm on the fetus in utero (for example, by administration of a teratogenic drug). A lawsuit would then be available to the injured infant, but there is controversy surrounding when the legal duty to the fetus arises (that is, before fetal viability, after viability, or even preconception, such as in cases of genetic damage to an ovum from physical, chemical, or radiologic injury). There is also an issue as to whether a stillborn fetus has a cause of action for wrongful death, or whether the child has first to be born alive. The resolution of this question centers in part on the language and intent of each state’s wrongful death statute.

This column, "Law & Medicine," regularly appears in Internal Medicine News, an Elsevier publication. Dr. Tan is former professor of medicine and adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical, or legal advice. It is adapted from the author’s book, "Medical Malpractice: Understanding the Law, Managing the Risk" (2006). For additional information, readers may contact the author.

Question: A 45-year-old woman consulted her family physician for a breast lump. She has no family history of breast cancer and no other risk factors. The physician was unable to palpate the mass, so he reassured the patient and scheduled a follow-up appointment in 6 weeks. Patient forgot her appointment, but returned a year later complaining of an enlarging mass, which proved to be malignant. Which of the following statements is best?

A. The physician is justified in asking the patient to return for a repeat exam, as this can be shown to constitute customary standard of care.

B. National clinical practice guidelines require a screening mammogram in this case.

C. The physician will definitely prevail by relying on the latest practice guideline as a shield against a lawsuit.

D. Patient will win simply by choosing a different supporting guideline.

E. Clinical guidelines are just that, a guide, and carry no legal significance.

Answer: A. As no mass was palpated in this low-risk patient, whether the physician should have immediately ordered a mammogram would depend on factors such as family history, menstrual history, chest radiation, and age. The defense expert will testify that scheduling a recheck in 6 weeks in lieu of an immediate mammogram meets the legal standard of care. Additionally, the physician will attempt to use the recent national practice guidelines on screening mammography (age 50 and older, as opposed to the older guidelines that recommended screening starting at age 40) as exculpatory evidence. The plaintiff may refer to other guidelines, although her best arguments are that in her case, mammography would have been diagnostic, not screening, and that she should have received a reminder regarding her missed appointment.

Practice guidelines are defined by the Institute of Medicine as "systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances." Some 2,000 guidelines have been developed by medical organizations and governmental agencies, as well as insurance carriers, managed care organizations, and others. These guidelines purport to define the best evidence-based medicine. If they are arrived at by consensus of an authoritative body of experts, courts will tend to view them as reflective, though not necessarily dispositive, of customary medical standards (Pollard v. Goldsmith). On the other hand, guidelines become less credible if they primarily are written to reduce health care costs.

Practice guidelines have been variously described as recipes, parameters, and rudimentary road maps, and physicians have been slow to adopt them, including those promulgated by authoritative federal organizations such as the Agency for Healthcare Research and Quality.

Notwithstanding their limitations, guidelines should not be dismissed as having no legal significance. They are usually allowed into evidence, much like textbooks and scientific articles, as an exception to the hearsay rule of evidence (learned treatise exception). However, some jurisdictions such as Maryland have ruled them inadmissible as evidence in courts of law. At the other extreme, states such as Maine allow doctors to elect to be covered by practice guidelines, with such compliance constituting evidence against any allegation of negligence.

Practice guidelines are double-edged swords, as they may be used in some jurisdictions either to exculpate or inculpate, i.e., exonerating or implicating the doctor. Both plaintiff and defense attorneys are increasingly confronting guideline issues. Still, the proliferation of practice guidelines has tended to increase, not decrease, the use of medical experts. Guidelines frequently are written to underscore a minimal rather than an ordinary or customary standard. Negligence is about breaching an objective customary standard, and guidelines may meet, exceed, or even fall below that standard. Both the plaintiff and defendant are required to produce experts to legally establish what constitutes standard as opposed to substandard care.

Medical standards are issues of fact that are ultimately determined by the jury, not the judge. It is highly unusual therefore for a judge in a jury trial to decide what constitutes the proper standard.

This column, "Law and Medicine," regularly appears in Internal Medicine News, an Elsevier publication. Dr. Tan is professor of medicine and former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical or legal advice. It is adapted from the author’s book, "Medical Malpractice: Understanding the Law, Managing the Risk" (2006). For additional information, readers may contact the author at [email protected].

Question: A 45-year-old woman consulted her family physician for a breast lump. She has no family history of breast cancer and no other risk factors. The physician was unable to palpate the mass, so he reassured the patient and scheduled a follow-up appointment in 6 weeks. Patient forgot her appointment, but returned a year later complaining of an enlarging mass, which proved to be malignant. Which of the following statements is best?

A. The physician is justified in asking the patient to return for a repeat exam, as this can be shown to constitute customary standard of care.

B. National clinical practice guidelines require a screening mammogram in this case.

C. The physician will definitely prevail by relying on the latest practice guideline as a shield against a lawsuit.

D. Patient will win simply by choosing a different supporting guideline.

E. Clinical guidelines are just that, a guide, and carry no legal significance.

Answer: A. As no mass was palpated in this low-risk patient, whether the physician should have immediately ordered a mammogram would depend on factors such as family history, menstrual history, chest radiation, and age. The defense expert will testify that scheduling a recheck in 6 weeks in lieu of an immediate mammogram meets the legal standard of care. Additionally, the physician will attempt to use the recent national practice guidelines on screening mammography (age 50 and older, as opposed to the older guidelines that recommended screening starting at age 40) as exculpatory evidence. The plaintiff may refer to other guidelines, although her best arguments are that in her case, mammography would have been diagnostic, not screening, and that she should have received a reminder regarding her missed appointment.

Practice guidelines are defined by the Institute of Medicine as "systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances." Some 2,000 guidelines have been developed by medical organizations and governmental agencies, as well as insurance carriers, managed care organizations, and others. These guidelines purport to define the best evidence-based medicine. If they are arrived at by consensus of an authoritative body of experts, courts will tend to view them as reflective, though not necessarily dispositive, of customary medical standards (Pollard v. Goldsmith). On the other hand, guidelines become less credible if they primarily are written to reduce health care costs.

Practice guidelines have been variously described as recipes, parameters, and rudimentary road maps, and physicians have been slow to adopt them, including those promulgated by authoritative federal organizations such as the Agency for Healthcare Research and Quality.

Notwithstanding their limitations, guidelines should not be dismissed as having no legal significance. They are usually allowed into evidence, much like textbooks and scientific articles, as an exception to the hearsay rule of evidence (learned treatise exception). However, some jurisdictions such as Maryland have ruled them inadmissible as evidence in courts of law. At the other extreme, states such as Maine allow doctors to elect to be covered by practice guidelines, with such compliance constituting evidence against any allegation of negligence.

Practice guidelines are double-edged swords, as they may be used in some jurisdictions either to exculpate or inculpate, i.e., exonerating or implicating the doctor. Both plaintiff and defense attorneys are increasingly confronting guideline issues. Still, the proliferation of practice guidelines has tended to increase, not decrease, the use of medical experts. Guidelines frequently are written to underscore a minimal rather than an ordinary or customary standard. Negligence is about breaching an objective customary standard, and guidelines may meet, exceed, or even fall below that standard. Both the plaintiff and defendant are required to produce experts to legally establish what constitutes standard as opposed to substandard care.

Medical standards are issues of fact that are ultimately determined by the jury, not the judge. It is highly unusual therefore for a judge in a jury trial to decide what constitutes the proper standard.

This column, "Law and Medicine," regularly appears in Internal Medicine News, an Elsevier publication. Dr. Tan is professor of medicine and former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical or legal advice. It is adapted from the author’s book, "Medical Malpractice: Understanding the Law, Managing the Risk" (2006). For additional information, readers may contact the author at [email protected].

Question: A 45-year-old woman consulted her family physician for a breast lump. She has no family history of breast cancer and no other risk factors. The physician was unable to palpate the mass, so he reassured the patient and scheduled a follow-up appointment in 6 weeks. Patient forgot her appointment, but returned a year later complaining of an enlarging mass, which proved to be malignant. Which of the following statements is best?

A. The physician is justified in asking the patient to return for a repeat exam, as this can be shown to constitute customary standard of care.

B. National clinical practice guidelines require a screening mammogram in this case.

C. The physician will definitely prevail by relying on the latest practice guideline as a shield against a lawsuit.

D. Patient will win simply by choosing a different supporting guideline.

E. Clinical guidelines are just that, a guide, and carry no legal significance.

Answer: A. As no mass was palpated in this low-risk patient, whether the physician should have immediately ordered a mammogram would depend on factors such as family history, menstrual history, chest radiation, and age. The defense expert will testify that scheduling a recheck in 6 weeks in lieu of an immediate mammogram meets the legal standard of care. Additionally, the physician will attempt to use the recent national practice guidelines on screening mammography (age 50 and older, as opposed to the older guidelines that recommended screening starting at age 40) as exculpatory evidence. The plaintiff may refer to other guidelines, although her best arguments are that in her case, mammography would have been diagnostic, not screening, and that she should have received a reminder regarding her missed appointment.

Practice guidelines are defined by the Institute of Medicine as "systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances." Some 2,000 guidelines have been developed by medical organizations and governmental agencies, as well as insurance carriers, managed care organizations, and others. These guidelines purport to define the best evidence-based medicine. If they are arrived at by consensus of an authoritative body of experts, courts will tend to view them as reflective, though not necessarily dispositive, of customary medical standards (Pollard v. Goldsmith). On the other hand, guidelines become less credible if they primarily are written to reduce health care costs.

Practice guidelines have been variously described as recipes, parameters, and rudimentary road maps, and physicians have been slow to adopt them, including those promulgated by authoritative federal organizations such as the Agency for Healthcare Research and Quality.

Notwithstanding their limitations, guidelines should not be dismissed as having no legal significance. They are usually allowed into evidence, much like textbooks and scientific articles, as an exception to the hearsay rule of evidence (learned treatise exception). However, some jurisdictions such as Maryland have ruled them inadmissible as evidence in courts of law. At the other extreme, states such as Maine allow doctors to elect to be covered by practice guidelines, with such compliance constituting evidence against any allegation of negligence.

Practice guidelines are double-edged swords, as they may be used in some jurisdictions either to exculpate or inculpate, i.e., exonerating or implicating the doctor. Both plaintiff and defense attorneys are increasingly confronting guideline issues. Still, the proliferation of practice guidelines has tended to increase, not decrease, the use of medical experts. Guidelines frequently are written to underscore a minimal rather than an ordinary or customary standard. Negligence is about breaching an objective customary standard, and guidelines may meet, exceed, or even fall below that standard. Both the plaintiff and defendant are required to produce experts to legally establish what constitutes standard as opposed to substandard care.

Medical standards are issues of fact that are ultimately determined by the jury, not the judge. It is highly unusual therefore for a judge in a jury trial to decide what constitutes the proper standard.

This column, "Law and Medicine," regularly appears in Internal Medicine News, an Elsevier publication. Dr. Tan is professor of medicine and former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical or legal advice. It is adapted from the author’s book, "Medical Malpractice: Understanding the Law, Managing the Risk" (2006). For additional information, readers may contact the author at [email protected].

Failure to biopsy “cyst” delays cancer diagnosis

A 42-YEAR-OLD WOMAN consulted a dermatologist in October about a suspicious lesion on her face. The dermatologist diagnosed a benign cyst. The patient wanted the lesion removed; the dermatologist instead told her to return in the spring. He didn’t perform a biopsy or refer the patient to a plastic surgeon for a biopsy.

By the following May, the patient observed that the lesion was growing, comprising 2 lumps instead of 1, and had become inflamed. She immediately consulted the dermatologist, who maintained that the lesion was a cyst and didn’t biopsy it. He injected cortisone to shrink the lesion.

When the patient visited her family physician the next day for an unrelated matter, the doctor expressed concern about the facial lesion and referred the patient to a plastic surgeon, who performed a biopsy. The biopsy revealed liposarcoma.

The patient underwent 4 surgeries and extensive radiation therapy. The surgery severely disfigured her face. She subsequently developed necrosis of the cheek bone, necessitating surgical debridement and leading to the loss of 4 teeth. Extensive burns to her mouth, face, and neck as well as scar tissue made it difficult for her to open her mouth to eat and speak. She ultimately underwent 8 reconstructive facial operations.

PLAINTIFF’S CLAIM The dermatologist was negligent in failing to perform a biopsy. If the cancer had been diagnosed in October, it could have been excised easily with 1 surgery; the patient wouldn’t have needed extensive radiation or reconstructive surgeries. The delay in diagnosis increased the risk of recurrence and spread of the cancer.

THE DEFENSE Referral to a plastic surgeon was discussed in October, a claim the patient denied. The patient would have required the same treatment even if the cancer had been diagnosed in October because the cancer had been deep in the jaw muscle for several years, and had become more aggressive and appeared as a lesion on the face shortly before the patient’s initial visit.

VERDICT $5.35 million Pennsylvania verdict.

COMMENT Timely biopsy of skin lesions is imperative, particularly at a patient’s request or when a change is noted.

Did history of headaches hinder a thorough evaluation?

A THROBBING HEADACHE that became increasingly worse over 48 hours prompted a 43-year-old woman to go to her doctor’s office. She reported nausea, vomiting, and photophobia to the covering physician. The woman had a history of headaches, which she attributed to previous ear surgery. The physician prescribed pain and antinausea medications and told the patient to follow up with her regular primary care physician.

The patient went home and fell asleep on her couch; she subsequently died in her sleep. An autopsy cited bacterial meningitis as the cause of death.

PLAINTIFF’S CLAIM The question of whether the covering physician should have considered bacterial meningitis turned on whether the patient had nuchal rigidity. Witnesses called by the plaintiff testified that the patient couldn’t move her neck during the period in question.

THE DEFENSE The physician conceded that if he’d observed nuchal rigidity, he would have considered bacterial meningitis. He testified that the patient didn’t have nuchal rigidity but that he hadn’t recorded that finding.

VERDICT $1.45 million Massachusetts settlement.

COMMENT Although most headaches are explained by relatively benign causes, serious problems such as meningitis or hemorrhage should always remain in the differential diagnosis. And complete documentation is key to a successful malpractice defense.

Failure to biopsy “cyst” delays cancer diagnosis

A 42-YEAR-OLD WOMAN consulted a dermatologist in October about a suspicious lesion on her face. The dermatologist diagnosed a benign cyst. The patient wanted the lesion removed; the dermatologist instead told her to return in the spring. He didn’t perform a biopsy or refer the patient to a plastic surgeon for a biopsy.

By the following May, the patient observed that the lesion was growing, comprising 2 lumps instead of 1, and had become inflamed. She immediately consulted the dermatologist, who maintained that the lesion was a cyst and didn’t biopsy it. He injected cortisone to shrink the lesion.

When the patient visited her family physician the next day for an unrelated matter, the doctor expressed concern about the facial lesion and referred the patient to a plastic surgeon, who performed a biopsy. The biopsy revealed liposarcoma.

The patient underwent 4 surgeries and extensive radiation therapy. The surgery severely disfigured her face. She subsequently developed necrosis of the cheek bone, necessitating surgical debridement and leading to the loss of 4 teeth. Extensive burns to her mouth, face, and neck as well as scar tissue made it difficult for her to open her mouth to eat and speak. She ultimately underwent 8 reconstructive facial operations.

PLAINTIFF’S CLAIM The dermatologist was negligent in failing to perform a biopsy. If the cancer had been diagnosed in October, it could have been excised easily with 1 surgery; the patient wouldn’t have needed extensive radiation or reconstructive surgeries. The delay in diagnosis increased the risk of recurrence and spread of the cancer.

THE DEFENSE Referral to a plastic surgeon was discussed in October, a claim the patient denied. The patient would have required the same treatment even if the cancer had been diagnosed in October because the cancer had been deep in the jaw muscle for several years, and had become more aggressive and appeared as a lesion on the face shortly before the patient’s initial visit.

VERDICT $5.35 million Pennsylvania verdict.

COMMENT Timely biopsy of skin lesions is imperative, particularly at a patient’s request or when a change is noted.

Did history of headaches hinder a thorough evaluation?

A THROBBING HEADACHE that became increasingly worse over 48 hours prompted a 43-year-old woman to go to her doctor’s office. She reported nausea, vomiting, and photophobia to the covering physician. The woman had a history of headaches, which she attributed to previous ear surgery. The physician prescribed pain and antinausea medications and told the patient to follow up with her regular primary care physician.

The patient went home and fell asleep on her couch; she subsequently died in her sleep. An autopsy cited bacterial meningitis as the cause of death.

PLAINTIFF’S CLAIM The question of whether the covering physician should have considered bacterial meningitis turned on whether the patient had nuchal rigidity. Witnesses called by the plaintiff testified that the patient couldn’t move her neck during the period in question.

THE DEFENSE The physician conceded that if he’d observed nuchal rigidity, he would have considered bacterial meningitis. He testified that the patient didn’t have nuchal rigidity but that he hadn’t recorded that finding.

VERDICT $1.45 million Massachusetts settlement.

COMMENT Although most headaches are explained by relatively benign causes, serious problems such as meningitis or hemorrhage should always remain in the differential diagnosis. And complete documentation is key to a successful malpractice defense.

Failure to biopsy “cyst” delays cancer diagnosis

A 42-YEAR-OLD WOMAN consulted a dermatologist in October about a suspicious lesion on her face. The dermatologist diagnosed a benign cyst. The patient wanted the lesion removed; the dermatologist instead told her to return in the spring. He didn’t perform a biopsy or refer the patient to a plastic surgeon for a biopsy.

By the following May, the patient observed that the lesion was growing, comprising 2 lumps instead of 1, and had become inflamed. She immediately consulted the dermatologist, who maintained that the lesion was a cyst and didn’t biopsy it. He injected cortisone to shrink the lesion.

When the patient visited her family physician the next day for an unrelated matter, the doctor expressed concern about the facial lesion and referred the patient to a plastic surgeon, who performed a biopsy. The biopsy revealed liposarcoma.

The patient underwent 4 surgeries and extensive radiation therapy. The surgery severely disfigured her face. She subsequently developed necrosis of the cheek bone, necessitating surgical debridement and leading to the loss of 4 teeth. Extensive burns to her mouth, face, and neck as well as scar tissue made it difficult for her to open her mouth to eat and speak. She ultimately underwent 8 reconstructive facial operations.

PLAINTIFF’S CLAIM The dermatologist was negligent in failing to perform a biopsy. If the cancer had been diagnosed in October, it could have been excised easily with 1 surgery; the patient wouldn’t have needed extensive radiation or reconstructive surgeries. The delay in diagnosis increased the risk of recurrence and spread of the cancer.

THE DEFENSE Referral to a plastic surgeon was discussed in October, a claim the patient denied. The patient would have required the same treatment even if the cancer had been diagnosed in October because the cancer had been deep in the jaw muscle for several years, and had become more aggressive and appeared as a lesion on the face shortly before the patient’s initial visit.

VERDICT $5.35 million Pennsylvania verdict.

COMMENT Timely biopsy of skin lesions is imperative, particularly at a patient’s request or when a change is noted.

Did history of headaches hinder a thorough evaluation?

A THROBBING HEADACHE that became increasingly worse over 48 hours prompted a 43-year-old woman to go to her doctor’s office. She reported nausea, vomiting, and photophobia to the covering physician. The woman had a history of headaches, which she attributed to previous ear surgery. The physician prescribed pain and antinausea medications and told the patient to follow up with her regular primary care physician.

The patient went home and fell asleep on her couch; she subsequently died in her sleep. An autopsy cited bacterial meningitis as the cause of death.

PLAINTIFF’S CLAIM The question of whether the covering physician should have considered bacterial meningitis turned on whether the patient had nuchal rigidity. Witnesses called by the plaintiff testified that the patient couldn’t move her neck during the period in question.

THE DEFENSE The physician conceded that if he’d observed nuchal rigidity, he would have considered bacterial meningitis. He testified that the patient didn’t have nuchal rigidity but that he hadn’t recorded that finding.

VERDICT $1.45 million Massachusetts settlement.

COMMENT Although most headaches are explained by relatively benign causes, serious problems such as meningitis or hemorrhage should always remain in the differential diagnosis. And complete documentation is key to a successful malpractice defense.