JAMA Editors Oppose Wyeth on Preemption Case

Share this article:

An editorial in the October issue of The Journal of the American Medical Association (JAMA) has sided with the plaintiff in a heated case involving preemption. The AMA editors went against the drug industry in Wyeth v. Levine a case that has huge ramifications for a drug company's exposure to patient lawsuits.

The editorial takes the position that the right to sue drug makers in state court is an important protection for patients, an argument that goes against Wyeth's position that patients shouldn't have the right to sue in state court for harms caused by drugs that have passed federal standards. Wyeth's position is based on a doctrine called preemption that states federal law preempts state law.

In Wyeth v. Levine, the plaintiff claimed that she lost her arm as a result of a side effect due to a Wyeth product.

The JAMA editorial states: “the drug and device regulation process is at best an inexact and incomplete science. Until these deficiencies in the system are remedied, some patients inevitably will continue to experience harm from the use of newly marketed products as well as from use of other approved medications. … The Wyeth v Levine ruling will have far-reaching and profound implications for patients and drug safety. If the court rules in favor of Wyeth, endorsing preemption, patients will lose an irreplaceable method for seeking remedies for injuries resulting from pharmaceutical agents that were approved by FDA.”

JAMA's editorial comes in the wake of a similar position take by rival publication the New England Journal of Medicine (NEJM) that filed an amicus brief in August, supporting the plaintiff and opposing Wyeth's claim.

Both the Pharmaceutical Research and Manufacturers Association (PhRMA) and the Bush administration filed amicus briefs supporting Wyeth.

The Supreme Court is set to hear oral arguments for Wyeth v. Levine in November.


Share this article:
You must be a registered member of MMM to post a comment.

Email Newsletters

More in News

Five things for Pharma Marketers to know: Friday, August 29

Five things for Pharma Marketers to know: Friday, ...

Takeda closes out a good-news, bad-news kind of week, AstraZeneca adds a new clinical trial for its experimental PD-1, and researchers link a funeral to the Ebola outbreak.

Amgen sends PCSK9 to FDA

Amgen sends PCSK9 to FDA

Evolocumab holds the FDA's first filed biologics license application for the class.

Consultants expect M&A tempo to continue

Consultants expect M&A tempo to continue

PwC anticipates that divestitures will fuel late-2014 deals, but notes that the noise around early deals and the financials don't fully match up.