On August 15, 2014, the Alabama Supreme Court held for the second time in Wyeth v. Weeks, No. 1101397 (Ala. 2014) that a plaintiff who took only the generic version of the heartburn medication Reglan could nevertheless proceed against the manufacturers of the brand-name product.
Plaintiff Danny Weeks brought suit against the generic and brand-name manufacturers, claiming he developed tardive dyskinesia after using generic Reglan.
Having first ruled on this issue in January 2013, the Alabama Supreme Court agreed in June 2013 to reconsider its previous decision, which came to the same conclusion. The original decision was 8-1; the new decision is 6-3.
Brand-Name Manufacturers' Liability Based on Misrepresentation, Not Product Defect
In concluding again that the brand-name manufacturers could be held liable under Alabama law, the court emphasized that, under these circumstances, liability is premised not on product defect, but on the alleged misrepresentations in the brand-name product's labeling, which FDA regulations require generic manufacturers to use:
[T]he fraud or misrepresentation claim that may be brought under Alabama law against a drug manufacturer based on statements it made in connection with the manufacture of a brand-name prescription drug by a plaintiff claiming physical injury caused by a generic drug manufactured by a different company is premised upon liability not as a result of a defect in the product itself but as a result of statements made by the brand-name manufacturer that Congress, through the FDA, has mandated be the same on the generic version of the brand-name drug.
The court also stated that it was not creating a new "innovator liability" tort or "turning products-liability law . . . on its head" because the ruling applies only to brand-name and generic drug manufacturers, which the court says have a "unique relationship" due to the distinctive federal statutory and regulatory framework in which they operate.
There were three dissenting opinions. Chief Justice Moore opined that the court should not have addressed the issue given that no "critical facts" were before it. Justice Murdock stated that plaintiffs' inability to hold a generic drug-maker accountable after the U.S. Supreme Court decided Pliva, Inc. v. Mensing, ___U.S. ___, 131 S.Ct. 2567, 180 L.Ed.2d 580 (2011) (which held that failure-to-warn claims against generic manufacturers are pre-empted by federal law) "is not a ‘wrong' that this or any court should attempt to correct with a second ‘wrong.'" Justice Parker observed that, where a plaintiff did not consume the brand-name manufacturer's drug, the applicable federal statutes and regulations did not require the court "to ignore, modify, or override" the "bedrock legal principles of duty and privity," and predicted that the court's modification of these principles in this area could have "grave and unforeseen effects" in others.
Weeks Still the Minority View
Despite the Alabama Supreme Court's doubling down on this issue, it remains in the minority. The vast majority of courts to address this issue have rejected so-called "innovator liability" claims. To date Alabama (Weeks), California (Conte v. Wyeth, Inc., 85 Cal. Rptr. 3d 299 (Cal. Ct. App. 2008)), Vermont (Kellogg v. Wyeth, 762 F. Supp. 2d 694 (D. Vt. 2010)) and Illinois (Dolin v. SmithKline Beecham Corp., No. 12 C 6403, 2014 WL 804458 (N.D. Ill. Feb. 28, 2014)) are the only states with opinions to the contrary.
The Sixth Circuit Court of Appeals rejected Dolin, the most recent of these minority opinions, holding that the Illinois Supreme Court would not hold brand-name manufacturers liable for injuries caused by generic drugs. See In re Darvocet, Darvon, & Propoxyphene Prods. Liab. Litig., 2014 WL 2959271 at *22-24 (6th Cir. June 27, 2014).
Darvocet represents the prevailing view, as demonstrated by the numerous decisions — including approximately 29 handed down since the Alabama Supreme Court's first January 2013 Weeks decision — that have held that a brand-name drug manufacturer cannot be liable for injuries arising from the plaintiff's use of another company's generic products.
So, brand-name drug companies still have a very strong argument against "innovator liability" claims in most jurisdictions. Moreover, even in those few states where such claims remain viable, brand-name companies can still mount the traditional defenses, including lack of causation and the learned intermediary doctrine.