On November 27, 2009, the US Court of Appeals for the Eighth Circuit ruled that former brand name manufacturers of Reglan® (a prescription drug used to treat certain gastric disorders) could not be held liable for the injuries caused by their competitors’ generic versions of the drug. In doing so, the Eighth Circuit became the first appellate court to reject the California decision in Conte v. Wyeth, Inc.
In Mensing v. Wyeth, Inc., the plaintiff’s doctor had prescribed Reglan® to treat plaintiff’s diabetic gastroparesis. The pharmacy filled those prescriptions with generic versions of the drug (metoclopramide), pursuant to Minnesota’s drug substitution statute. After four years of ingesting generic metoclopramide, plaintiff allegedly developed tardive dyskinesia.
In her suit, plaintiff asserted various tort claims against both the brand name manufacturers of Reglan® and the manufacturers of the generic metoclopramide she had ingested. Among these were claims against the brand name manufacturers for fraud and negligent misrepresentation. Plaintiff asserted that the brand name manufacturers had failed to warn her (through her doctor) of the risks associated with long term use of their competitors’ generic drug — the so-called “innovator theory” of liability. In particular, plaintiff alleged that her doctor had relied on the brand name manufacturers’ labeling when deciding to prescribe metoclopramide. The US District Court for the District of Minnesota granted summary judgment in favor of the brand name manufacturers and plaintiff’s appeal followed.
The Mensing court, relying on Flynn v. American Home Prods. Corp., (Minn. App. 2001), affirmed judgment for the brand name manufacturers and held that, regardless of whether plaintiff’s doctor relied upon the brand name manufacturers’ warnings, the plaintiff had to show that those manufacturers owed her a duty of care in order to proceed on claims of fraud or negligent misrepresentation. The Eighth Circuit concluded that because she ingested only generic metoclopramide, there was no direct relationship between plaintiff and the brand name manufacturers of Reglan® that could give rise to such a duty. Thus, because plaintiff could not demonstrate that the brand name manufacturers owed her a duty of care, the Eighth Circuit affirmed the holding of the trial court dismissing claims against those defendants.
Significantly, as part of the decision, the Eighth Circuit became the first appellate court to consider and reject the Conte decision from California: the lone state court decision to have recognized innovator liability. (For more information on Conte, see Mayer Brown’s Client Alert “California Becomes First State to Recognize Innovator Liability.”) Joining the Fourth Circuit’s 1994 decision in Foster v. American Home Prods. Corp., which concluded that generic manufacturers were responsible for the content of their own labels, and which found no precedent for holding brand name manufacturers liable for injuries caused by their competitors’ generic products, the Mensing court reasoned that to hold brand name manufacturers liable in such situations would “stretch the concept of foreseeability too far.”
The Mensing court further observed that an “overwhelming majority of courts” that have considered the issue have reached the same conclusion. Indeed, in addition to Mensing, in October and November of 2009, district courts in the Southern District of Texas, the Southern District of West Virginia and the Western District of Louisiana each rejected invitations to recognize the innovator theory.1 Including these rulings, there are now 34 such decisions in 20 states (Alabama, Arkansas, Colorado, Florida, Georgia, Iowa, Kentucky, Louisiana, Maryland, Massachusetts, Minnesota, Nevada, New Jersey, New York, North Carolina, Oklahoma, Pennsylvania, Texas, Utah and West Virginia).
In the same opinion, the Eighth Circuit also held that Ms. Mensing’s claims against the manufacturers of the generic metoclopramide she ingested could proceed to discovery and were not, as the district court had held, preempted by federal law. That ruling will be summarized in a separate client alert.
The innovator theory of liability will again be considered in the appeals of three cases that are currently pending before the US Court of Appeals for the Sixth Circuit.
1. See Morris v. Wyeth, Inc., Civil Action No. 09-0854, 2009 WL 4064103 (W.D. La. Nov. 23, 2009); Meade v. Parsley, No. 2:09-cv-0038, 2009 WL 3806716 (S.D. W. Va. Nov. 13, 2009); Burke v. Wyeth, Inc., No G-09-82, 2009 WL 3698480 (S.D. Tex. Oct. 29, 2009).