Friday, October 14, 2011

Strange result due to decision in Pliva v Mensing

As you probably remember, back in June the Supreme Court issued a decision PLIVA v. Mensing on the right to sue in state court when a generic drug maker fails to change its label to warn consumers of new harmful side-effects. Go here and here for some background and lots of links.  In a 5 to 4 decision, the Court decided that federal law preempts state lawsuits because their effect could be to force the defendants to offer labeling that is different from what appears on the label of the brand-name drug.

As you probably also remember, in March 2009 the Court decided 6-3 in Wyeth v. Levine that federal law did not preempt a failure to warn case.

Now here is the interesting part:  if you take the facts of Wyeth and substitute the drug used with a generic brand one, the case is preempted.  So let's say the plaintiff, suffering from pain and nausea, goes to the hospital and is administered an injection of "Phenergan".  The injection is accidentally put in plaintiff's artery instead of her vein and the resulting vascular injury requires amputation of plaintiff's right arm. Under Wyeth v. Levine, if that drug is a brand name, the claim is not preempted, but because that drug is, in fact, a generic the court in Schork v. Baxter Healthcare Corporation, 2011 U.S. Dist. LEXIS 107687 (S.D. Ind. Sept. 22, 2011) decided the claim is preempted under the ruling in Pliva.

Thanks to the Drug and Device Law Blog for the information.

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