Brand Name Drug Maker Can be Liable for Injuries from a Generic Version


The Alabama Supreme Court in Wyeth v. Weeks has reaffirmed its ruling in a case questioning whether a brand-name drug maker can be held liable for injuries from a generic version.

Plaintiffs Danny and Vicki Weeks sued drug manufacturers for injuries that Danny Weeks allegedly suffered as a result of his long term use of prescription drug Reglan. The Alabama Supreme Court in January, 2013 held that Alabama law permits a drug company to be held liable for alleged misrepresentations it made about its own name brand drug even when the plaintiff took another company’s generic equivalent.

A month later, Pfizer, along with Wyeth LLC and Schwarz Pharma, Inc., petitioned for rehearing and asked the Alabama Supreme Court to reject “innovator liability.” In short, it held that “innovators” — companies that create new and original products can be held liable for damages caused by other companies who create generic versions of their products.


Over 78% of retail drug sales in the United States are generic. Courtesy of Elza Fiúza/ABr – Agência Brasil.

This month the Alabama Supreme Court by a 6-3 majority reaffirmed its prior decision and held that:

“In the context of inadequate warnings by the brand-name manufacturer placed on a prescription drug manufactured by a generic manufacturer, 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, not on manufacturing defects in the product itself, but on information and warning deficiencies, when those alleged misrepresentations were drafted by the brand-name manufacturer and merely repeated, as allowed by the (Food and Drug Administration), by the generic manufacturer.”

The majority said its decision to reaffirm does not turn products-liability law, or tort law, “on its head.” “Nor are we creating a new tort of ‘innovator liability,’ as has been suggested.”

In so ruling, the Alabama Supreme Court joined California and Vermont in adopting the so-called “innovator liability doctrine.” However, the Alabama Supreme Court became the first state supreme court in the country to recognize brand-name manufacturer liability for a generic drug sold by another manufacturer, departing from “the overwhelming majority of courts” that have rejected the innovator liability theory.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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