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

Gordon T. Ownby


November 09, 2020

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. He also discussed network therapy to assist the patient with sobriety.

Medscape Editor's Key Notes:
  • Pay attention to "black box" warnings on medications and understand the risks of deviating from dosage recommendations.

  • If departing from dosage recommendations, make sure your documentation of informed consent includes your reasoning behind the decision.

  • Consider using a "start low and go slow" approach for high-risk drugs to avoid serious injury.

Dr P's electronic chart described the discussion on medication as, "Explained rationale for medication choice, reviewed mixture of medications, discussed possible risks, benefits, effectiveness (if applicable), and alternative treatment with the individual (parent/guardian): Yes." The chart also states, "Individual: Understands information; Agrees to take medication."

Dr P's prescription for lamotrigine 100 mg stated: "Take ½ 100 mg tab daily 7 days; then 1 tab 7 days, then 1 ½ tab 7 days, then 2 tabs 9 days." Follow-up was to be in 4 weeks.

(The manufacturer's recommended dosing for lamotrigine was: 25 mg for 14 days; 50 mg for 14 days; 100 mg for 7 days; 200 mg for 7 days.)

The patient got the prescription filled, took the half-tablets over the next week, and then began taking a full tablet before developing a skin rash that led to her hospitalization several days later for Stevens-Johnson syndrome with toxic epidermal necrolysis.


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