Court Rules against Johnson & Johnson in Stevens Johnson Syndrome Case

February 11, 2011, 5:30PM. By Heidi Turner

Los Angeles, CAA recent lawsuit involving Stevens Johnson Syndrome may result in a drug company changing its warning label. A California state appeals court has found that Johnson & Johnson knew about the risk of Stevens Johnson Syndrome, sometimes known as SJS, with its drug Motrin but did not warn consumers. Although the US Food and Drug Administration (FDA) does not currently require a warning about SJS, the courts might require a change to labeling separate from the FDA.

According to the California state appeals court, as noted by Jim Edwards in an article for BNET (02/11/11), Johnson & Johnson knew about the risk of Stevens Johnson Syndrome since the 1980s, but did not update its warning label for Motrin (known generically as ibuprofen) as sold in the US. Johnson & Johnson reportedly, however, warned customers in foreign companies—such as Germany—about the risk of SJS and its more severe form, Toxic Epidermal Necrolysis (TEN).

The lawsuit in question was that of Christopher Trejo, who sued Johnson & Johnson following an incident in which he used Motrin and developed TEN at age 15. His lawsuit alleged Johnson & Johnson knew about the risks of SJS and TEN but did not provide specific warnings. Furthermore, he alleged that the drugmaker and McNeil Consumer Healthcare Division misrepresented results of a study to the FDA when over-the-counter approval for Motrin was sought.

Trejo sought punitive damages in the case. A trial court allowed the claim for punitive damages, leading Johnson & Johnson to appeal the ruling. Johnson & Johnson claimed Trejo could not show that the drugmaker acted with malice because the FDA approved Motrin's label without specific mention of SJS or TEN.

The California appeals court found that Johnson & Johnson could have proposed a specific warning to alert consumers about the risk of SJS or TEN, but did not do so. Furthermore, the court found that regulations allow changes to labels that add or strengthen a warning, precaution or adverse reaction without FDA approval.

"…it has remained a central premise of federal drug regulation that the manufacturer bears responsibility for the content of its label at all times. It is charged both with crafting an adequate label and with ensuring that its warnings remain adequate as long as the drug is on the market," the judges noted.

The court also noted that foreign Motrin labels contained information about SJS and TEN. Therefore, despite following FDA compliance with the label, the court has ruled that Johnson & Johnson could have done more to warn consumers about the risk of Stevens Johnson Syndrome and Toxic Epidermal Necrolysis. This does not mean that Trejo has won a lawsuit against the company. It means he can seek punitive damages in his lawsuit.