Last week, in a
published decision, a California District Court of Appeal ruled that the manufacturer of a name-brand drug could be liable for injuries caused by a generic version sold by a different manufacturer in
Conte v. Wyeth, Inc.
In
Conte, the plaintiff developed a neurological condition, allegedly due to her use of a generic version of Reglan (a drug manufactured and marketed by Wyeth and which is used to treat gastroesophageal reflux disease). The plaintiff, who admitted she only took a generic version that was not manufactured by Wyeth, sued Wyeth on theories of fraud, fraudulent concealment, and negligent misrepresentation (she also sued the generic drug manufacturers and her doctor on other theories). Essentially, her claims were that she was "injuriously overexposed to [the generic] due to their dissemination of false, misleading, and/or incomplete warnings about the drug's side effects."
On appeal, the court reversed the trial court's dismissal of the claims against Wyeth and held as follows:
We hold that the common law duty to use due care owed by a name-brand
prescription drug manufacturer when providing product warnings extends not only
to consumers of its own product, but also to those whose doctors foreseeably
rely on the name-brand manufacturer’s product information when prescribing a
medication, even if the prescription is filled with the generic version of the
prescribed drug.
Essentially, the court relied on foreseeability to support its decision, stating that it was "eminently foreseeable that a physician might prescribe [the generic] in reliance on Wyeth’s representations about Reglan." Accordingly, the court had "no difficulty concluding that Wyeth should reasonably perceive that there could be injurious reliance on its product information by a patient taking [the generic]." Thus, the court concluded, "[a]s the foreseeable risk of physical harm runs to users of both name-brand and generic drugs, so too runs the duty of care."
Additional Notes:- In its analysis, the court relied on a Fourth Circuit case,
Foster v. American Home Products Corp., 29 F.3d 165 (4th Cir. 1994).
-Unsurprisingly, commentators have sharply criticized this decision. For example, the
Drug and Device Law blog noted that the court utilized the plaintiff's negligent misrepresentation theory "as an end around decades of product liability precedent."
-The court dodged the issue of federal preemption as an "inappropriate use of judicial resources," given the plaintiff's concessions that her doctor did not rely on any representation from the generic drug manufacturers.
-See
here for a Law.com article on the case.