Personal Injury Law

Preemption Victory Against Generic Drug Manufacturers!

By Brian F. LaBovick, Esq.

Congratulations on the valiant efforts of the legal team of The Public Justice Foundation and the Center for Constitutional Litigation (CCL) for winning a huge victory against generic drug manufacturers in the Mensing v. Wyeth, Inc., case.  The U.S. Court of Appeals for the Eighth Circuit ruled that federal preemption can't be used by generic drug manufacturers to avoid liability for failing to warn of their drugs' dangers.

According to this ruling, an FDA approval for a generic drug does not does NOT preempt claims against the drug makers for failing to warn consumers of known risks.  Justices in this case,  included: Hon. Roger L. Wollman - Sioux Falls, SD, Hon. Diana E. Murphy, Minneapolis, MN and Hon. Kermit E. Bye - Fargo, ND

In Mensing v. Wyeth, the Eighth Circuit's decision concluded with the following:

Mensing has stated a viable claim against the generic metoclopramide manufacturers. Far from prohibiting them from taking steps to warn
their customers of new safety hazards, federal law requires such action. For the
reasons stated we reverse the judgment in favor of the generic manufacturers but
affirm the judgment as to the name brand manufacturers.

Arthur Bryant, Executive Director, Public Justice and the Public Justice Foundation made an excellent point when he recently shared the following message: 

The Eighth Circuit emphasized that generic manufacturers, like name-brand drug companies, "bear primary responsibility for their drug labeling at all times." Lawsuits like Ms. Mensing's, the court said, do not "obstruct the purposes and objectives" of federal drug regulation "in any way." Instead, they help achieve the "fundamental" purpose of federal regulation-ensuring that "all marketed drugs remain safe."

Click here to read the Court Opinion on Mensing v. Wyeth, Inc.

We are headed in the right direction of improving drug safety and holding pharma giants, both brand and generic, accountable for their actions.

Time will tell what impact this decision has on the future of generic pharmaceuticals.

Full post as published by LaBovick Injury Law Blog on November 30, 2009 (boomark / email).