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The Black Box Is Not the Standard of Care, but...

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 five years, anxiety for three years, and paranoia for two 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.

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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 at times she felt “paranoid,” the young lady denied hallucinations, showed no suicidal or homicidal ideations, and demonstrated good insight and judgment.

Dr. P assessed 1) Bipolar I disorder without psychotic behavior; and 2) 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 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 four 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.

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 of rash include “exceeding recommended initial dose of lamotrigine.”

While Dr. P could testify of past satisfactory experience with similar dose levels for other patients, 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.

Actual testimony from medical expert witnesses — not written guidelines or manufacturer warnings — still rules the day in medical malpractice litigation. But those guidelines and warnings will still come into evidence, and without a documented and detailed rationale for a physician’s departure from those guidelines, defending such care will always be an uphill battle.   

Gordon Ownby is CAP’s General Counsel. Questions or comments related to “Case of the Month” should be directed to