- Alabama Supreme Court Rules Brand-Name Manufacturers Can Be Liable for Injuries Allegedly Caused By Generic Medications
- January 18, 2013 | Authors: Bridget M. Ahmann; John B. Gordon
- Law Firm: Faegre Baker Daniels - Minneapolis Office
A January 11, 2013 decision by Alabama's highest court could signal a new trend in the post-Mensing world of pharmaceutical litigation.
In Wyeth, Inc. v. Weeks, No. 1101397 (Ala. 2013), the Alabama Supreme Court ruled that a plaintiff could proceed against a brand-name manufacturer for failing to warn about its product's risks, even though the plaintiff only took the generic version of the medication manufactured by another company.
Underlying Facts and Procedural History
Plaintiff Danny Weeks brought suit in the U.S. District Court for the Middle District of Alabama, claiming he developed tardive dyskinesia, a movement disorder, after taking generic versions of the heartburn medication Reglan. Weeks sued the generic manufacturers, Actavis Elizabeth LLC and Teva Pharmaceuticals USA, as well as Wyeth LLC and Schwartz Pharma Inc., the brand-name manufacturers. Weeks claimed that the brand-name defendants failed to adequately warn about Reglan's risks.
Wyeth and Schwartz moved to dismiss, arguing that they could not be held liable for injuries caused by another company's product. The federal court denied the motion in part and granted in part, finding that Weeks might be able to proceed against the brand-name defendants under Alabama law if he could show that they had a duty to warn the prescribing physician and that Weeks had a right to enforce a breach of that duty. The federal court certified the question to the Alabama Supreme Court asking the high court to decide whether, under Alabama law, a medication company can be liable for fraud or misrepresentation based on statements made in connection with the brand-name product where the plaintiff in question ingested a generic version of that product manufactured by a different company.
Alabama Supreme Court Decision
The Alabama Supreme Court answered in the affirmative. It held: "Under Alabama law, a brand-name drug company may be held liable for fraud or misrepresentation (by misstatement or omission), 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."
The court stated that, because generic substitutions are allowed in all 50 states, a brand-name manufacturer could reasonably foresee that a physician prescribing a brand-name medication (or the generic version) would rely on the brand-name manufacturer's warning, even if the patient ultimately consumed the generic. Thus, the court concluded "it is not fundamentally unfair to hold the brand-name manufacturer liable for warnings on a product it did not produce because the manufacturing process is irrelevant to misrepresentation theories based" on an alleged failure to warn.
New Post-Mensing Trend?
With the Weeks opinion, Alabama joins only 2 other states - California and Vermont - in endorsing the so-called "innovator liability" theory. See Conte v. Wyeth, Inc., 168 Cal. App. 4th 89, 85 Cal.Rptr.3d 299, 315 (Cal. Ct. App. 2008) and Kellogg v. Wyeth, 762 F. Supp. 2d 694, 704 (D. Vt. 2010).
The leading case on this issue is Foster v. American Home Prods. Corp., 29 F.3d 165 (4th Cir. 1994). In Foster, the Unites States Court of Appeals for the Fourth Circuit, applying Maryland law, held that a brand-name medication manufacturer could not be held liable for injuries caused by a generic equivalent made by a different company, even though the generic manufacturer had adopted the brand-name manufacturer's label and warnings verbatim. To date, nearly every court faced with this question has followed Foster, even where the plaintiff's claims are based on fraud or misrepresentation theories.
This trend continued even after the U.S. Supreme Court decided in Pliva, Inc. v. Mensing, ---U.S. ---, 131 S.Ct. 2567, 180 L.Ed.2d 580 (2011), that failure to warn claims against generic manufacturers are preempted by federal law. This ruling essentially barred plaintiffs' claims against generic manufacturers. Thus, the combined effect of Foster and Mensing seemingly left plaintiffs injured by generic medications without a remedy. Legal practitioners and commentators waited to see whether Mensing would lead more courts to endorse innovator liability claims in an attempt to address this issue. Prior to Weeks, it seemed courts remained unwilling to go against Foster and its ever-growing progeny. But this new decision, the first of its kind from a state supreme court, likely will have some effect on future decisions.
While innovator liability is likely to remain the minority view, it is almost certain that at least a few other courts will adopt it in Weeks's wake. It remains to be seen how many other courts will follow Alabama's lead in the post-Mensing era, but the plaintiffs' bar will undoubtedly be energized by the decision.
Of course, even in jurisdictions endorsing innovator liability, plaintiffs' claims based on failure to warn theories remain vulnerable to traditional defenses, including lack of causation and the learned intermediary doctrine. As the Alabama Supreme Court noted in Weeks, the plaintiff must still prove that "but for the false representation made in the warning, the prescribing physician would not have prescribed the medication to his patient." Thus, in cases where this causal chain is broken - such as where the physician already knew of the risk or did not read the label prior to prescribing the medication - brand-name defendants still can successfully defend against these claims.