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From Products Liability Law Daily, May 4, 2015

Alabama abolishes judicially-created innovator liability theory

By Pamela C. Maloney, J.D.

On Friday, May 1, Alabama Governor Robert Bentley signed into law a bill designed to abolish the “innovator liability theory” created by the Alabama Supreme Court in Wyeth, Inc. v. Weeks (see Products liability Law Daily’s August 18 analysis). The new law is designed to protect manufacturers from liability regardless of the type of claims or theory of liability asserted for damages resulting from products they did not design, manufacture, sell, or lease, and provides that a manufacturer is not liable for damages if its design is copied without express authorization. The bill, which originated in the Alabama Senate, which passed it on March 17, 2015, was passed by the state’s House of Representatives on April 28 (Alabama Act No. 2015-106, approved May 1, 2015, effective November 1, 2015).

Background. In Weeks, the Alabama Supreme Court decided that Wyeth, Inc., the brand-name manufacturer of the drug, Reglan®, could be held liable for its failure to warn a patient about risks related to the long-term use of Reglan’s generic equivalent. The Alabama high court, in a self-proclaimed narrow holding, decided that the highly regulated prescription drug industry gave rise to unique circumstances in which a brand-name drug manufacturer retained a duty to warn consumers of risks in its competitor’s product, contrary to that of manufacturers in other industries. The decision came in response to a question certified to the state high court by the U.S. District Court for the Middle District of Alabama, which had denied Wyeth’s initial attempts at dismissal. Because there was no controlling precedent, the federal court had asked the state high court to decide whether a brand-name drug manufacturer could be held liable for a failure to warn about an injury caused by a generic version of the drug.

Innovator liability. In responding to the certified question, the majority in Weeks made several references to the phrase “innovator liability” and made arguments to distance its holding from something that would fit into that doctrine. The court reasoned that under an “innovator liability” theory, a manufacturer potentially could be liable for injuries that stemmed from any product copied from its own product. The court expressly indicated its holding created no such liability for drug manufacturers. Continually rejecting Wyeth’s argument that the case was one about products liability, the court held that Weeks did not claim the product he ingested was defective. Instead, the court reasoned, Weeks challenged only the labeling of Reglan and metoclopramide. The court determined that because of FDA regulation, Wyeth held relevant control over the labeling and was the one responsible for warning Week’s physician about risks associated with Reglan and its generic substitute. As such, the court noted that because its holding rested on the unique nature of the generic and brand-name drug labeling paradigm, and not on any defect in manufacturing, its holding was narrow and would not carry over into the realm of lawn mowers or power drills.

Act No. 2015-106. The new law specifically requires plaintiffs prove, among other elements, that the defendant designed, manufactured, sold, or leased the specific product which is alleged to have caused the injury on which the claim is based, and not a similar or equivalent product.

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