Supreme Court Hands Drugmakers a Victory in SJS Lawsuit

July 6, 2013, 8:00AM. By Heidi Turner

Washington, DCA recent decision in a Stevens Johnson syndrome (SJS) lawsuit has given drugmakers a victory, and hurt patients and consumers. The lawsuit focused on allegations that a drug caused SJS symptoms, resulting in severe injuries to the plaintiff. Although lower courts found for the plaintiff, the US Supreme Court found for the drug maker.

The lawsuit involved Karen Bartlett, who in 2004 took a generic version of an anti-inflammatory drug called Clinoril (sulindac) for bursitis in her shoulder. After a few months passed, Bartlett developed Stevens-Johnson syndrome, which later developed into toxic epidermal necrolysis. Bartlett spent 10 weeks in the hospital, had 12 eye surgeries and two bouts of septic shock. She suffered burns to approximately 60 percent of her body and spent time in a medically induced coma. She is permanently scarred and cannot work.

At the time Bartlett took sulindac, the label did not carry a warning about the risk of Stevens-Johnson syndrome or toxic epidermal necrolysis, but that information was listed as an adverse reaction in the package insert. After Bartlett’s ordeal, the FDA recommended that all non-steroidal anti-inflammatory drugs include a warning about toxic epidermal necrolysis.

Bartlett sued Mutual Pharmaceutical, alleging sulindac was defectively designed. A lower court awarded the plaintiff $21 million. She was given $16.5 million for pain, suffering and loss of the enjoyment of life, and more than $3 million for past and future medical expenses.

According to Forbes (6/24/13), Mutual appealed the decision, arguing that federal law preempts design defect lawsuits against generic drugmakers. The basis for the argument is that under federal law, a generic drug is required to be designed the same as its brand-name counterpart.

The Supreme Court agreed with Mutual Pharmaceutical in a 5-to-4 opinion.

“Once a drug is approved, a manufacturer is prohibited from making any major changes to the qualitative or quantitative formulation of the drug product, including active ingredients, or in the specifications provided in the approved application. Generic manufacturers are also prohibited from making any unilateral changes to a drug’s label,” Justice Alito wrote for the majority in the decision.

Alito noted that Bartlett’s injuries were horrific and caused by tragic circumstances, but the majority found that federal law preempted New Hampshire state law, and the $21 million award was reversed.

The lawsuit was Mutual Pharmaceutical Co., Inc. v. Bartlett, No. 12-142.