Mensing did not alter case law on name-brand drugmakers' liability

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Decisions: Drugs

December 11, 2012

Mensing did not alter case law on name-brand drugmakers' liability 

The Supreme Court’s holding in Pliva, Inc. v. Mensing, 131 S. Ct. 2567 (2011), did not modify case law holding that name-brand manufacturers are not liable for harm caused by a generic drug, the Fifth Circuit Court of Appeals held.

Julie Demahy developed tardive dyskinesia after using metoclopramide, the generic version of the anti-nausea drug Reglan. She sued Wyeth, Inc., and Schwarz Pharma, Inc., which manufactured Reglan, and Actavis, Inc., which manufactured the generic version she used. Demahy voluntarily dismissed the claims against Wyeth and Schwarz, and the case proceeded against Actavis. Ultimately, the case was consolidated with Mensing. The Supreme Court ruled that the generic drug defendants were not liable, reasoning that because federal law requires generic labels to be the same as the name-brand labels, state laws requiring generic manufacturers to use safer labels are preempted.

After the ruling, Demahy moved for the U.S. district court to grant her relief from the order dismissing name-brand defendants Wyeth and Schwarz. She argued that Mensing undermined Foster v. Am. Home Prods. Corp., 29 F.3d 165 (4th Cir. 1994), a case that served as a foundation for Louisiana decisions holding that a party cannot be liable for damages caused by a product it did not manufacture. In Foster, the Fourth Circuit rejected similar claims to Demahy’s, holding that a name-brand manufacturer could not be liable for injuries caused by another manufacturer’s drug. In dicta, the court added that it believed the plaintiff could sue the generic manufacturers because they could add or strengthen warnings without prior FDA approval. Demahy argued that Foster’s holding that plaintiffs cannot recover against name-brand manufacturers is no longer valid because it was premised on the now-rejected idea that the plaintiffs could simply recover against the generic manufacturers.

Affirming, the Fifth Circuit rejected that argument, saying that Foster was not based on a plaintiff’s ability to sue a generic drug manufacturer, but on the conclusion that under Maryland law, a name-brand manufacturer has no duty to consumers injured by a product it did not manufacture. Thus, Foster and subsequent decisions based on it creating a similar rule in Louisiana remain valid. The court added that even if it did believe Mensing undermined Foster, the implicit reversal of a Fourth Circuit case interpreting Maryland law would have no bearing on Louisiana law.

Citation: Demahy v. Schwarz Pharma, Inc., 2012 WL 5261492 (5th Cir. Oct. 25, 2012).


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