NEJM Files Amicus Brief in Supreme Court Preemption Case

Drugmakers Merck, Wyeth and Bayer Healthcare withheld important information from the FDA regarding the safety of certain drugs, costing tens of thousands of lives, according to 10 former and current editors and authors of The New England Journal of Medicine (NEJM).

“The drug companies have withheld key information from the FDA and ardently negotiated against stricter label warnings — all the while continuing to market their unsafe drugs to an unsuspecting public,” NEJM editors write in an amicus brief filed in the Supreme Court.
 
The brief highlights drugs that were withdrawn from the market due to safety reasons — Merck’s Vioxx (rofecoxib), Bayer’s Trasylol (aprotinin) and Wyeth’s diet drug fen-phen and Redux (dexfenfluramine).

Earlier this year, The Journal of the American Medical Association charged that Merck withheld mortality data on its painkiller Vioxx before its approval and that Merck employees guest-authored and ghostwrote medical articles about the drug. 

The amicus brief was filed last week in the Supreme Court’s upcoming case on preemption, Wyeth v. Levine. In the case, Wyeth is appealing a Vermont Supreme Court decision that upheld a $6.8 million jury award to Diana Levine after the firm’s anti-nausea drug Phenergan (promethazine HCl) was improperly administered, leading to the amputation of her arm.

Levine’s lawsuit says the drug had inadequate warnings and instructions. The company is arguing that the FDA’s authority to approve drug labeling trumps state laws governing product liability.

Paul Clement, the U.S. solicitor general, issued an opinion to the U.S. Supreme Court supporting preemption in the Wyeth v. Levine case. PhRMA, in a June 11 statement, says preemption allows the FDA to protect the public.