Name-Brand Drug Formulator Not Liable For Generic Formulation

Chief District Judge Robert J. Conrad, Jr. of the Western District of North Carolina recently held that the manufacturer of a name-brand formulation of a drug is not liable for injuries that a plaintiff alleged suffered as a result of taking the generic version of the drug. Couick v. Wyeth, Inc., No. 3:09-cv-210, 2010 WL 785952 (W.D.N.C. Mar. 8, 2010). The Court granted the name-brand defendants’ motion for summary judgment.

From July 2002 to April 2007, Plaintiff Mary Cleo Couick took generic metoclopramide pills for treatment of gastroesophasgeal reflux. Reglan, the name-brand version of the drug, was manufactured by Wyeth, Inc. and Schwarz Pharma, Inc. Couick stipulated that she only took the generic version of this drug. However, Couick filed suit against both the name-brand manufacturers and generic manufacturers claiming that they failed to adequately warn her doctors about the risks associated with metoclopradmide, which caused her to develop tardive dyskinesia.

Against name-brand manufacturers, Couick brought claims for negligence, breach of undertaking special duty, misrepresentation by omission, negligent misrepresentation, constructive fraud, fraud by concealment, intentional infliction of emotional distress, negligent infliction of emotional distress, unfair and deceptive trade practices, breach of express warranty, and breach of implied warranties. In response, name-brand manufacturers filed a motion for summary judgment.

The Court first found that since “[e]ach of [Couick's] claims [are] based on the premise that Wyeth and Schwarz are liable for Couick’s physical condition because they failed to adequately warn Couick’s doctors about the dangers of metoclopramide,” Couick’s claims, while masked in various legal theories, were a single claim for products liability.

The Court then held that under clear North Carolina and Fourth Circuit authority, a “name-brand manufacturer’s statements regarding its drug [cannot] serve as the basis for liability for injuries caused by another manufacturer’s drug.” As a result, the Court granted name-brand manufacturers’ motion for summary judgment.

This case is instructive to products liability practitioners in two main respects. First, despite a plaintiff’s artful pleading, claims based upon personal injury or property damage as a result of the manufacture, construction, design, selling, advertising, etc. of the product, is generally considered only one claim under a state’s products liability law. Second, the rule that a name-brand manufacturer is not liable for injuries caused by another manufacturer remains intact. See Foster v. Am. Home Products Corp., 29 F.3d 165 (4th Cir. 1994). Recently, we have reported on a number of cases here against drug manufacturers. This re-affirmed rule will become particularly important as these types of suits increase.

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