Weeks Defies Years Of Jurisprudence, Allowing Innovator Liability For Generic Drugs

Last week the Alabama Supreme Court adopted brand-name manufacturer liability for a generic drug sold by another company, becoming the first state supreme court to do so. Wyeth, Inc. v. Weeks, No. 1101397 (Ala. Jan. 11, 2013). The court held that a generic drug user could foreseeably rely on a brand-name drug warning and maintain a failure to warn claim against the brand-name manufacturer, even when the plaintiff did not ingest that manufacturer's drug.

CERTIFIED QUESTION FROM DISTRICT COURT

Danny and Vicki Weeks filed suit against four pharmaceutical companies in federal district court, alleging injury from long-term use of metoclopramide, the generic form of Reglan. They claimed that Mr. Weeks ingested generic metoclopramide manufactured by Teva and Actavis. Plaintiffs also named Wyeth and Schwarz, the manufacturers of brand-name Reglan, even though they never alleged that Mr. Weeks ingested the brand-name drug. Instead, they sued Wyeth and Schwarz on a theory that the brand-name manufacturers had a duty to warn all users of the drug based on federal requirements that all generic labels be identical to the brand-name label. Faced with this question and conflicting precedent, the district court certified the question to the Alabama Supreme Court, specifically:

Under Alabama law, may a drug company be held liable for fraud or misrepresentation (by misstatement or omission), based on statements it made in connection with the manufacture or distribution of a brand-name drug, by a plaintiff claiming physical injury from a generic drug manufactured and distributed by a different company?

The Alabama Supreme Court answered in the affirmative, joining a small group of courts to do so. Cf. Conte v. Wyeth, 168 Cal. App. 4th 89 (2008); Kellogg v. Wyeth, 612 F. Supp. 2d 421 (D. Vt. 2008).

MENSING SETS THE STAGE

The court began its analysis with a discussion of Wyeth v. Levine, 555 U.S. 555 (2009), and PLIVA v. Mensing, 131 S.Ct. 2567, 564 U.S. __ (2011), highlighting "the seeming contradiction in preemption claims against a generic manufacturer in PLIVA but allowing state-law tort claims in Wyeth." The court also examined several federal court decisions applying Alabama law, which had found that brand drug manufacturers may not be held liable to a plaintiff who ingested a generic drug. See Mosley v. Wyeth, 719 F. Supp. 2d 1340 (S.D. Ala. 2010); Overton v. Wyeth, Inc., No. CA 10-0491-KD-C (S.D. Ala. Mar. 15, 2011); Simpson v. Wyeth, Inc., No. 7:10-cv-01771-HGD (N.D. Ala. Dec. 9, 2010).

Common to these federal court decisions was their holding that...