|Luminaries weigh in on upcoming Wyeth v. Levine Supreme Court case. Source: Law Offices of Peter J. Mozena|
Merck, Wyeth and Bayer Healthcare withheld information from the FDA regarding the safety of certain drugs, costing tens of thousands of lives, according to an amicus curiae brief filed by 10 editors and authors of The New England Journal of Medicine (NEJM).
The 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 against the drug company alleges that the drug had inadequate warnings, whereas the company is arguing that the FDA’s authority to approve drug labeling preempts state laws governing product liability.
“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,” the NEJM editors wrote.
The brief highlights drugs that were withdrawn from the market due to safety reasons, including Merck’s Vioxx (rofecoxib), Bayer’s Trasylol (aprotinin) and Wyeth’s diet drug fen-phen and Redux (dexfenfluramine).
In an interview with the Associated Press, current NEJM editor Jeffrey M. Drazen, MD, said that if the court finds in favor of Wyeth, it could be “a disaster for consumers.” The FDA is overwhelmed trying to keep up with drug safety problem, Drazen said, and that defective drug lawsuits often find safety issues the FDA has missed.
NEJM editors wrote that the “FDA alone simply lacks the ability to serve as the sole guarantor of drug safety.” Without the discoveries found by plaintiff’s lawyers during the course of defective drug lawsuits, “the FDA would be stripped of an essential source of information that the agency has consistently relied on when making its regulatory decisions, and the American public would be deprived of a vital deterrent against pharmaceutical company misconduct.”
Many interested parties have submitted about how the Supreme Court should rule on the federal preemption issue presented by Wyeth v. Levine—several of which have submitted amicus briefs. The American Bar Association has compiled a list of all amicus briefs filed in connection with the Wyeth case.