What to tell patients about side effects

Man taking trazodone claims he was not told about priapism risk

Unknown Massachusetts venue

A 52-year-old man saw a psychiatrist for acute anxiety, panic attacks, and difficulty sleeping. The psychiatrist prescribed the alprazolam, 0.25 mg/d, for the anxiety symptoms and one or two tablets of trazodone, 50 mg at bedtime, to aid sleep.

At follow-up 2 weeks later, the patient reported he was feeling better, and the psychiatrist increased alprazolam to 0.5 mg tid.

The next morning, the patient woke with a painless partial erection, but was unconcerned because he had experienced this in the past. The erection persisted for 2 days. On the third morning, the patient went to the emergency department because the erection had become painful.

A urologist diagnosed the patient’s condition as priapism. After less-invasive treatment measures failed, the urologist performed surgery to extract clotted blood and inserted shunts to facilitate blood flow.

The patient was transferred to another facility and prescribed pain medication and an antiandrogen hormone to diminish the erection. Within 2 weeks following surgery, a black eschar covered the entire glans penis and necrotic tissue closed the meatus. Pain, eschar formation, and necrotic tissue on the patient’s glans penis persisted as long-term complications from priapism, resulting in permanent scarring, penile disfigurement, and inability to achieve an erection or have intercourse.

The patient claimed the psychiatrist never informed him of the risk of priapism associated with trazodone and failed to recommend immediate medical attention if this condition developed.

The psychiatrist maintained that although he had no memory of informing the patient of priapism risk, it would have been his custom to do so. The psychiatrist also contended that the length of time between the patient noticing the condition and seeking medical care constituted comparative negligence by the patient.

• A $300,000 settlement was reached.
  

Errant lamotrigine course
caused fatal hypersensitivity, estate alleges

Fairfax Country (VA) Circuit Court

A 43-year-old woman sought treatment for emotional difficulties. The psychiatrist diagnosed her with bipolar type II disorder and prescribed lamotrigine. Within 5 weeks, the patient developed Stevens-Johnson syndrome and died from its complications.

The patient’s estate claimed

• that the psychiatrist misdiagnosed the patient, who the estate alleged had posttraumatic stress disorder (PTSD).
  
• that prescribing lamotrigine was inappropriate because the patient didn’t have bipolar disorder and the drug is not first-line treatment for bipolar II disorder.
  
• the psychiatrist failed to inform the patient that lamotrigine may cause hypersensitivity reactions and neglected to obtain informed consent to use the drug.
  

The psychiatrist denied the charges, but at deposition and trial the psychiatrist’s sole causation expert admitted that the patient would not have died if she had not taken lamotrigine.

• The jury awarded the defendant $3 million. This was reduced to $1.65 million because of a statutory capitation.
  

Dr. Grant’s observations

These cases raise three potential malpractice issues:

• What happens if you misdiagnose a patient?
  
• Is it OK to use a treatment that is not “first-line”?
  
• How much do you have to tell patients about potential side effects?
  

Misdiagnosis. Because mental health symptoms usually do not fall neatly into categories, there is always potential for disagreement about a given diagnosis and to diagnosis incorrectly. When does a wrong diagnosis become malpractice?

A successful malpractice claim of misdiagnosis against a psychiatrist would likely be based on:

• failure to recognize the disorder
  
• improper treatment based on the misdiagnosis
  
• resultant harm caused by improper treatment.
  

In the latter case, misdiagnosing a patient with bipolar disorder if she suffered from PTSD would not be malpractice if the psychiatric evaluation fit the standard of care (A rash proposal for treating bipolar disorder”) and toxic epidermal necrolysis, and trazodone carries a risk of priapism. These potential adverse reactions require complete disclosure to the patient before starting treatment.

To be valid in court, informed consent must be documented in the patient’s chart. One study of 30 psychiatrists treating patients with antipsychotics found that only 23% of their patients’ charts had documentation of informed consent.⁷ Without proper documentation (Table 2), negligence claims are more likely to be successful.

Informed consent is a continuous process. After each visit summarize discussions about medications you had with the patient, document his or her response to medication, and note your reasons for continuing medication.⁹

Informed consent does not shield a psychiatrist from liability. For example, if the patient’s condition does not justify the risks of a certain medication, negligence could be proven even though the patient consented to the treatment. Having consent, however, provides evidence that the psychiatrist advised the patient of consequences of possible side effects.

 

Table 2

What to include when documenting informed consent

Diagnosis
Nature and purpose of the proposed treatment
Risks   Infrequent risks that pose a significant possibility of harm   Frequent risks that pose less danger
Reasonably expected benefits
Alternate treatments, their risks and benefits
Risks of no treatment
Source: Reference 8

Man taking trazodone claims he was not told about priapism risk

Unknown Massachusetts venue

A 52-year-old man saw a psychiatrist for acute anxiety, panic attacks, and difficulty sleeping. The psychiatrist prescribed the alprazolam, 0.25 mg/d, for the anxiety symptoms and one or two tablets of trazodone, 50 mg at bedtime, to aid sleep.

At follow-up 2 weeks later, the patient reported he was feeling better, and the psychiatrist increased alprazolam to 0.5 mg tid.

The next morning, the patient woke with a painless partial erection, but was unconcerned because he had experienced this in the past. The erection persisted for 2 days. On the third morning, the patient went to the emergency department because the erection had become painful.

A urologist diagnosed the patient’s condition as priapism. After less-invasive treatment measures failed, the urologist performed surgery to extract clotted blood and inserted shunts to facilitate blood flow.

The patient was transferred to another facility and prescribed pain medication and an antiandrogen hormone to diminish the erection. Within 2 weeks following surgery, a black eschar covered the entire glans penis and necrotic tissue closed the meatus. Pain, eschar formation, and necrotic tissue on the patient’s glans penis persisted as long-term complications from priapism, resulting in permanent scarring, penile disfigurement, and inability to achieve an erection or have intercourse.

The patient claimed the psychiatrist never informed him of the risk of priapism associated with trazodone and failed to recommend immediate medical attention if this condition developed.

The psychiatrist maintained that although he had no memory of informing the patient of priapism risk, it would have been his custom to do so. The psychiatrist also contended that the length of time between the patient noticing the condition and seeking medical care constituted comparative negligence by the patient.

• A $300,000 settlement was reached.
  

Errant lamotrigine course
caused fatal hypersensitivity, estate alleges

Fairfax Country (VA) Circuit Court

A 43-year-old woman sought treatment for emotional difficulties. The psychiatrist diagnosed her with bipolar type II disorder and prescribed lamotrigine. Within 5 weeks, the patient developed Stevens-Johnson syndrome and died from its complications.

The patient’s estate claimed

• that the psychiatrist misdiagnosed the patient, who the estate alleged had posttraumatic stress disorder (PTSD).
  
• that prescribing lamotrigine was inappropriate because the patient didn’t have bipolar disorder and the drug is not first-line treatment for bipolar II disorder.
  
• the psychiatrist failed to inform the patient that lamotrigine may cause hypersensitivity reactions and neglected to obtain informed consent to use the drug.
  

The psychiatrist denied the charges, but at deposition and trial the psychiatrist’s sole causation expert admitted that the patient would not have died if she had not taken lamotrigine.

• The jury awarded the defendant $3 million. This was reduced to $1.65 million because of a statutory capitation.
  

Dr. Grant’s observations

These cases raise three potential malpractice issues:

• What happens if you misdiagnose a patient?
  
• Is it OK to use a treatment that is not “first-line”?
  
• How much do you have to tell patients about potential side effects?
  

Misdiagnosis. Because mental health symptoms usually do not fall neatly into categories, there is always potential for disagreement about a given diagnosis and to diagnosis incorrectly. When does a wrong diagnosis become malpractice?

A successful malpractice claim of misdiagnosis against a psychiatrist would likely be based on:

• failure to recognize the disorder
  
• improper treatment based on the misdiagnosis
  
• resultant harm caused by improper treatment.
  

In the latter case, misdiagnosing a patient with bipolar disorder if she suffered from PTSD would not be malpractice if the psychiatric evaluation fit the standard of care (A rash proposal for treating bipolar disorder”) and toxic epidermal necrolysis, and trazodone carries a risk of priapism. These potential adverse reactions require complete disclosure to the patient before starting treatment.

To be valid in court, informed consent must be documented in the patient’s chart. One study of 30 psychiatrists treating patients with antipsychotics found that only 23% of their patients’ charts had documentation of informed consent.⁷ Without proper documentation (Table 2), negligence claims are more likely to be successful.

Informed consent is a continuous process. After each visit summarize discussions about medications you had with the patient, document his or her response to medication, and note your reasons for continuing medication.⁹

Informed consent does not shield a psychiatrist from liability. For example, if the patient’s condition does not justify the risks of a certain medication, negligence could be proven even though the patient consented to the treatment. Having consent, however, provides evidence that the psychiatrist advised the patient of consequences of possible side effects.

 

Table 2

What to include when documenting informed consent

Diagnosis
Nature and purpose of the proposed treatment
Risks   Infrequent risks that pose a significant possibility of harm   Frequent risks that pose less danger
Reasonably expected benefits
Alternate treatments, their risks and benefits
Risks of no treatment
Source: Reference 8

Man taking trazodone claims he was not told about priapism risk

Unknown Massachusetts venue

A 52-year-old man saw a psychiatrist for acute anxiety, panic attacks, and difficulty sleeping. The psychiatrist prescribed the alprazolam, 0.25 mg/d, for the anxiety symptoms and one or two tablets of trazodone, 50 mg at bedtime, to aid sleep.

At follow-up 2 weeks later, the patient reported he was feeling better, and the psychiatrist increased alprazolam to 0.5 mg tid.

The next morning, the patient woke with a painless partial erection, but was unconcerned because he had experienced this in the past. The erection persisted for 2 days. On the third morning, the patient went to the emergency department because the erection had become painful.

A urologist diagnosed the patient’s condition as priapism. After less-invasive treatment measures failed, the urologist performed surgery to extract clotted blood and inserted shunts to facilitate blood flow.

The patient was transferred to another facility and prescribed pain medication and an antiandrogen hormone to diminish the erection. Within 2 weeks following surgery, a black eschar covered the entire glans penis and necrotic tissue closed the meatus. Pain, eschar formation, and necrotic tissue on the patient’s glans penis persisted as long-term complications from priapism, resulting in permanent scarring, penile disfigurement, and inability to achieve an erection or have intercourse.

The patient claimed the psychiatrist never informed him of the risk of priapism associated with trazodone and failed to recommend immediate medical attention if this condition developed.

The psychiatrist maintained that although he had no memory of informing the patient of priapism risk, it would have been his custom to do so. The psychiatrist also contended that the length of time between the patient noticing the condition and seeking medical care constituted comparative negligence by the patient.

• A $300,000 settlement was reached.
  

Errant lamotrigine course
caused fatal hypersensitivity, estate alleges

Fairfax Country (VA) Circuit Court

A 43-year-old woman sought treatment for emotional difficulties. The psychiatrist diagnosed her with bipolar type II disorder and prescribed lamotrigine. Within 5 weeks, the patient developed Stevens-Johnson syndrome and died from its complications.

The patient’s estate claimed

• that the psychiatrist misdiagnosed the patient, who the estate alleged had posttraumatic stress disorder (PTSD).
  
• that prescribing lamotrigine was inappropriate because the patient didn’t have bipolar disorder and the drug is not first-line treatment for bipolar II disorder.
  
• the psychiatrist failed to inform the patient that lamotrigine may cause hypersensitivity reactions and neglected to obtain informed consent to use the drug.
  

The psychiatrist denied the charges, but at deposition and trial the psychiatrist’s sole causation expert admitted that the patient would not have died if she had not taken lamotrigine.

• The jury awarded the defendant $3 million. This was reduced to $1.65 million because of a statutory capitation.
  

Dr. Grant’s observations

These cases raise three potential malpractice issues:

• What happens if you misdiagnose a patient?
  
• Is it OK to use a treatment that is not “first-line”?
  
• How much do you have to tell patients about potential side effects?
  

Misdiagnosis. Because mental health symptoms usually do not fall neatly into categories, there is always potential for disagreement about a given diagnosis and to diagnosis incorrectly. When does a wrong diagnosis become malpractice?

A successful malpractice claim of misdiagnosis against a psychiatrist would likely be based on:

• failure to recognize the disorder
  
• improper treatment based on the misdiagnosis
  
• resultant harm caused by improper treatment.
  

In the latter case, misdiagnosing a patient with bipolar disorder if she suffered from PTSD would not be malpractice if the psychiatric evaluation fit the standard of care (A rash proposal for treating bipolar disorder”) and toxic epidermal necrolysis, and trazodone carries a risk of priapism. These potential adverse reactions require complete disclosure to the patient before starting treatment.

To be valid in court, informed consent must be documented in the patient’s chart. One study of 30 psychiatrists treating patients with antipsychotics found that only 23% of their patients’ charts had documentation of informed consent.⁷ Without proper documentation (Table 2), negligence claims are more likely to be successful.

Informed consent is a continuous process. After each visit summarize discussions about medications you had with the patient, document his or her response to medication, and note your reasons for continuing medication.⁹

Informed consent does not shield a psychiatrist from liability. For example, if the patient’s condition does not justify the risks of a certain medication, negligence could be proven even though the patient consented to the treatment. Having consent, however, provides evidence that the psychiatrist advised the patient of consequences of possible side effects.

 

Table 2

What to include when documenting informed consent

Diagnosis
Nature and purpose of the proposed treatment
Risks   Infrequent risks that pose a significant possibility of harm   Frequent risks that pose less danger
Reasonably expected benefits
Alternate treatments, their risks and benefits
Risks of no treatment
Source: Reference 8