Malpractice Case: Black Box Warnings Can Come Back to Bite in Court

Malpractice Case: Black Box Warnings Can Come Back to Bite in Court

Gordon T. Ownby

Disclosures

November 09, 2020

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Though drug manufacturers' recommended dosages and "black box" warnings do not establish the standard of care, they can certainly create a glidepath for a plaintiff's case against a physician.

A 21-year-old woman presented to Dr P, a psychiatrist, for alcohol dependence. Dr P took a history of depression and mood swings for 5 years, anxiety for 3 years, and paranoia for 2 years. She reported being diagnosed several years earlier with bipolar disorder but did not recall the medications she took at that time. She lived with her grandmother during her teen years following her father's DUI incarceration and her mother's immigration issues. The patient had her own recent DUI convictions, was unemployed and on probation, and was undergoing a divorce.

Dr P charted the patient being appropriately attired, in no apparent acute distress. Her mood was somewhat depressed, but her affect was mood congruent and her speech was topical, logical, and coherent with normal pitch and tone. Though she said that at times she felt "paranoid," she denied hallucinations, showed no suicidal or homicidal ideations, and demonstrated good insight and judgment.

Dr P assessed bipolar I disorder without psychotic behavior as well as alcohol dependence. His plan was to prescribe a trial of lamotrigine for mood stabilization.

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