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Posts Tagged ‘FDA’

A Rose By Any Other Name: Alabama Supreme Court Denies Creating Tort of Innovator Liability for Brand-Name Drug Manufacturers, But Its Decision Creates A Pathway for Innovator Liability for Brand-Name Drug Manufacturers

Posted on: August 21st, 2014

By: Michael P. Bruyere and Michael J. Eshman

After the U.S. Supreme Court’s decision in Pliva, Inc. v. Mensing, 131 S. Ct. 2567 (2011) holding that a generic drug manufacturer generally cannot be liable for a failure-to-warn state law claim because of its duty of sameness – to match the warning provided by the brand-name drug manufacturer – we anticipated that this would lead to creative theories of liability from plaintiffs’ lawyers representing people who allege injuries from ingestion of a generic drug.  One such theory, the innovator liability theory, which seeks to hold a brand-name manufacturer liable for the alleged injuries produced by ingestion of a generic drug, has routinely been rejected by courts across the country because there is no relationship between the brand-name drug manufacturer and the person alleging injury.  See e.g. Guarino v. Wyeth, LLC, 719 F.3d 1245 (11th Cir. 2013) (applying Florida law).

This past week, the Alabama Supreme Court gave new life to innovator liability claims in that state.  See Wyeth, Inc. v. Weeks, 2014 WL 4055813 (Ala. Sup. Ct., August 15, 2014) (Westlaw).  The court held that a brand-name drug manufacturer could be liable based on fraud or misrepresentation for injuries allegedly caused by ingestion of a generic version of its drug.  The court based its ruling on the unique federal regulations in the prescription drug industry that prevent a generic drug manufacturer from altering the warning provided by the brand-name drug manufacturer.  The court indicated that it did not intend to create a new tort of “innovator liability,” but its decision creates a pathway for just that in the prescription drug context.  The court may not have created a new tort, but it created a pathway for consumers of generic drugs who have never ingested the brand-name drug to recover against brand-name drug manufacturers.  The net result is that innovator liability against brand-name drug manufacturers is alive and well in Alabama, for the time being.

We expect there will be reactions to this decision from other courts and potentially the FDA and/or Congress.  In the interim, we expect an increase in claims against brand-name drug manufacturers by people who never ingested their drugs, based on the adequacy of the warnings that accompanied the generic drugs they actually ingested.