Important Decision on Drug Manufacturer's Failure to Warn

Two year old Andreas Perry developed lymphoblastic lymphoma, a potentially deadly cancer two years ago. In accordance with Andreas’ doctor’s prescription, his parents were treating eczema with the topical ointment, Elidel. Andreas’ parents filed a lawsuit against Novartis Pharmaceutical Co., alleging amongst other things that Novartis had negligently failed to warn users – especially pediatric users – of the potential cancer risk from Elidel’s use on the skin.

By March 10, 2005, the Food & Drug Administration (FDA) had issued a health advisory cautioning that Elidel could be a cancer-causing drug, and on January 10, 2006, the FDA required warnings to that effect. At the time Andreas’ parents were using the drug, however, Novartis was not violating any FDA labeling requirement. Although Andreas’ parents argued that Novartis knew of the cancer risk in 2003 when they were treating his eczema with the drug, Novartis’ lawyers argued that the federal FDA regulations preempted state tort law and required dismissal of the Perry’s lawsuit. Judge Dalzell, of the U.S. District Court for the Eastern District of Pennsylvania, disagreed. Even though the FDA filed an amicus brief arguing for federal preemtpion, Judge Dalzell ruled that unless the FDA had affirmatively found that scientific evidence supported the adequacy of a particular label, a failure to warn case could still be pursued based on state tort law. Significantly, Judge Dalzell wrote that state lawsuits challenging drug companies for insufficient warnings on their labels, provided an important backup to FDA scrutiny of new drugs, which was not always scrutiny enough to protect public safety.