FDA labeling rule upsets trial lawyers

The American Association for Justice, the renamed Trial Lawyers Association of America, is unhappy with a newly-published rule from the US Food and Drug Administration, which sets restrictions on a drugmaker's ability to change the wording of product warnings. Gerie Voss, the director of regulatory affairs for the lawyers' group, told Bloomberg News that "the final rule is going to give drug and [medical] device companies the ability to claim complete immunity for failing to warn about potentially hazardous side effects of prescription drugs and medical devices."

Not surprisingly, given that the move could seriously limit the opportunities of trial lawyers to conduct expensive and sometimes highly-lucrative law suits on behalf of patients, the Pharmaceutical Research and Manufacturers of America (PhRMA) welcomed the FDA move. The group's senior vice president, Ken Johnson, said that the FDA would provide patients and health care professionals alike with "balanced information."

More significantly, the timing of the move comes before what could be a landmark law suit involving federal regulatory pre-emption of individual US states' tort legislation. On November 3, the US Supreme Court is due to hear opening arguments in Levine versus Wyeth (Marketletters passim), which concerns a $6.8-million damages award against the US drug major over the labeling of a nausea drug, Phenergan (promethazine for injection). The plaintiff from Vermont, Diana Levine, suffered an adverse event after the drug was injected into an artery, despite a product warning label, which was ruled "inadequate" by the state courts.