The United States Supreme Court has decided not to review Pliva v. Huck, an Iowa Supreme Court decision that held federal law does not preempt failure to update claims against generic drug manufacturers. Pliva challenged the ruling on the ground such claims were covered under the federal preemption memorialized in the 2011 U.S. Supreme Court decision Pliva v. Mensing.
The plaintiff in Huck claimed that taking Pliva’s generic version of Reglan (metoclopramide) caused her to develop the neurological disorder tardive dyskinesea. Plaintiff sued, alleging Pliva’s failure to update its warning label to reflect language approved by the FDA in 2004 caused her injuries. The “updated” warning expressly included tardive dyskinesea as a possible side effect of taking the medication. The Iowa Supreme Court held that the preemption established in Mensing didn’t apply because Pliva could have updated its label without violating federal law.
Huck demonstrates that the protection provided to generic drug makers is incomplete. There continues to be multiple efforts to eliminate or reduce that protection, including legislative efforts; regulatory efforts; and other lawsuits (e.g. Fulgenzi v. Pliva, Inc., Teva Pharmaceuticals USA, Inc. v. Superior Court of California, Morton Grove Pharmaceuticals v. Adams, Sparkell, et al.).
[T]he protection provided to generic drug makers is incomplete.
Indeed, the FDA is still formulating its policy concerning updates to generic drug warning labels. In 2013, the FDA proposed a modification to the existing regulations that would allow generic drug manufacturers to independently update their warning labels, without obtaining prior FDA approval. This rule, which has been the subject of a heated debate, would effectively eliminate the preemption protection established in Mensing.
The FDA held a public hearing last Friday on the proposed rule, as well as an alternative rule proposed by the Pharmaceutical Research and Manufacturers of America and the Generic Pharmaceutical Association. The alternative proposal would establish an expedited review process for generic drug warning label updates, while also keeping Mensing’s preemption protection intact.
The FDA is still accepting comments on its proposed rule until April 27 and has declared its intent to have a policy finalized by September 30, 2015. Those wishing to leave a comment can do so by visiting www.regulations.gov and typing FDA-2013-N00500 in the search box.