Woman Sues Doctor For Ignoring Black Box Warning on Prescribed Drug

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. 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…medscape, Malpractice Case: Black Box Warnings Can Come Back to Bite in Court, Gordon T. Ownby, 2020

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.

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 experienced significant skin involvement on over half of her body, suffered ocular involvement, and required mechanical debridement and saline irrigation.

The patient sued Dr P, alleging that lamotrigine’s “black box” warned of life-threatening rashes and that factors that may increase the risk for rash include “exceeding recommended initial dose of lamotrigine.”

While Dr P could testify of past satisfactory experience with similar dose levels for other patients, the plaintiff would undoubtedly bring to trial an expert to describe why Dr P should have adopted a “start low and go slow” approach to avoid serious injury.

Significantly, Dr P’s generic documentation of informed consent lacked any reference as to why he departed from the commonly understood recommendations for avoiding the low-frequency/high-risk rash associated with steep lamotrigine dosing. The patient and Dr P resolved the litigation informally.