More On

Court Applies Two Landmark Drug Rulings, Rejecting One

In the drug liability arena, the questions of federal pre-emption and generic drug maker liability arose in landmark rulings of 2008 and 2009. In November, the 8th Circuit revisited both issues in Mensing v. Wyeth.

In the pre-emption case Wyeth v. Levine, the U.S. Supreme Court in March 2009 rejected Wyeth's defense that FDA approval of drug labeling pre-empted state failure-to-warn claims. The high court wrote that the pre-emption defense was a "cramped reading" of the FDA's regulations concerning changes to drug labels.

On appeal, the 8th Circuit affirmed summary judgment for the brand name manufacturers but reversed the judgment in favor of the generics.

Addressing the pre-emption argument, the court wrote that the drug maker defendants failed to show it was impossible to comply with both the state and federal laws. The generics could have, for instance, contacted the FDA to request a label change. Since they didn't make such a request, it was impossible to know how the FDA would have acted, but the court relied upon the "presumption against pre-emption" that Levine set forth (see "Even Playing Field").

Associate Editor

Melissa Maleske

Bio and more articles

Join the Conversation

Advertisement. Closing in 15 seconds.