Innovator Liability Opens Doors to Recovery for Generic Drug Consumers

January 28, 2013

After the U.S. Supreme Court decided PLIVA, Inc. v. Mensing in 2011, generic drug users were left searching for possible avenues of legal recovery after incurring injury.  The Mensing decision, which held that state law failure-to-warn claims cannot be brought against generic drug manufacturers, was premised on the reasoning that by federal regulation, manufacturers of generic drugs must use the same bottle labels as their brand name counterpart.[1]

This controversial decision has since made the ability to bring a successful lawsuit against generic drug manufacturers near impossible.  The theory of Innovator Liability, which holds the brand-name manufacturer responsible for injury resulting from the generic drug, has been tested as a work around to this decision.  This theory has been defeated in court on many occasions, with the argument made that one company does not owe a duty to those taking a drug manufactured by an entirely different company.  But on January 11, 2013, the Alabama Supreme Court significantly advanced this theory, becoming the first state supreme court to hold that a brand-name company may be held liable for fraud or misrepresentation to a plaintiff claiming injury caused by a generic drug manufactured by a different company.[2]

In Wyeth, Inc. et. al. v. Weeks, et. al., the plaintiff was injured after using the generic form of the brand-named drug, Reglan, and pursued a lawsuit against the manufacturers of Reglan.[3]   The Alabama Court looked directly at Mensing to seemingly address the fundamental problem with that decision:  the lack of fairness stemming from the fact that generic drug manufacturers cannot change the drug label and must, as a matter of law, use the same label as the brand manufacturer.  After first acknowledging that it is not possible for a generic manufacturer to change their warning labels without violating federal requirements, the Court found that:

In the context of inadequate warnings by the brand-name manufacturer placed on a prescription drug manufactured by a generic-drug manufacturer, it is not fundamentally unfair to hold the brand-name manufacturer liable for warnings on a product it did not produce. . .when those alleged misrepresentations were drafted by the brand-name manufacturer and merely repeated by the generic manufacturer.[4]

The Court addressed the issue of foreseeability by reasoning that the requirement that generic labels be the same as brand-name labels makes it foreseeable that any defect in the labeling will be repeated in the generic form and cause harm to the user of the generic product.  Even more, it is foreseeable that a physician prescribing the drug will rely on the warning drafted by the brand-name manufacturer even if the patient ultimately ends up consuming the generic version.[5]

Through exploring various theories of liability and proposing new legislation, many attempts have been made to address the holding in Mensing to allow recovery for generic drug users who are otherwise left without a remedy.  The Alabama Supreme Court’s ruling is a significant progression in this effort. The reasoning and holding in Weeks may become a guide for other high courts to follow in the future, and the adoption of the Innovator Liability theory in more jurisdictions will only increase the opportunity for consumers  to seek and obtain a just recovery for injuries sustained as a result of  inadequate warning labels on the bottles of generic drugs.



[1] PLIVA v. Mensing, 131 S. Ct. 2567 (2011).

[2] Wyeth, Inc. et. al. v. Weeks, et. al., 2013 Ala. LEXIS 2 (Ala. July 11, 2013).

[3] Wyeth, Inc., 2013 LEXIS 2, at *2-3.

[4] Id. at *59. 

[5] Id. at *47-48.

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