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From Products Liability Law Daily, May 2, 2016

Generic drug manufacturer entitled to judgment on state law warning claims

By Kathleen Bianco, J.D.

A majority of state law claims against a generic drug manufacturer by an individual who suffered serious side effects after ingesting its product were preempted by federal law, a federal district court in Alabama held. While the court determined that the claims alleging inadequate warning and failure to send “Dear Doctor” letters fell squarely within the purview of federal preemption, the patient’s claim that the generic manufacturer had failed to update its label in a timely manner after additional warnings had been approved for the brand name drug was not found to be subject to preemption. Nevertheless, the court concluded that the generic manufacturer was entitled to judgment on the state law claim because the patient had failed to assert facts establishing that the manufacturer’s inaction had been the cause of her injuries. (Woods v. Wyeth, LLC, April 29, 2016, Bowdre, K.).

From approximately 2005 to 2009, the patient ingested the generic drug, metoclopramide, which later caused her serious negative side effects. The patient’s physician had prescribed Reglan, a drug first approved by the Food and Drug Administration (FDA) in 1980, but had not prohibited the use of a generic drug as a substitute. After ingesting metoclopramide, the patient contracted tardive dyskinesia, an incurable neurological movement disorder, and Parkinsonism. The patient alleges that, had the brand name defendants and generic defendants properly warned her doctors of the risks of taking metoclopramide, her doctors would not have prescribed the drug, and she would not have experienced these adverse health effects.

The patient filed suit against both the brand name manufacturer of Reglan and the generic manufacturer of metoclopramide asserting claims for fraud/misrepresentation by misstatement or omission; strict liability/Alabama Extended Manufacturers Liability Doctrine (“AEMLD”); failure to warn; breach of implied warranty; breach of express warranty; negligence and wantonness; and negligence/violation of FDA requirements. Pending before the court is the generic manufacturer’s motion for judgment on the pleading.

Preemption. In PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), the U.S. Supreme Court established the precedent that state law claims against a generic drug manufacturer are preempted by federal law. In Mensing, the Supreme Court held that state law requirements against generic drug manufacturers must be preempted by federal law if it would be impossible for a manufacturer to satisfy both federal and state standards. Based on this precedent, the district court determined that judgment in favor of the generic drug manufacturer was appropriate in regard to the inadequate warning claim and the failure to send “Dear Doctor” warning updates. However, the patient’s failure to update label claim was deemed to be outside the scope of federal preemption because it merely asserted that the generic manufacturer had not met the federal requirements. Thus, it would have been possible for the generic manufacturer to comply with both state and federal law by updating its labels promptly after the Federal Drug Administration approved the changes to the brand name drug labeling.

Failure to update labeling. Even though the failure to update claim was not subject to federal preemption, the claim still failed as a matter of law. Under Alabama’s learned intermediary doctrine, a prescription drug manufacturer has a duty to advise the prescribing physician of any potential dangers that may result from the drug’s use. In the case at hand, the patient alleged that the generic manufacturer failed to provide adequate warning to her physician because it had not updated its labeling to conform to changes in the brand name drug’s labeling. This argument is unavailing because the evidence submitted established that the patient’s doctor had prescribed the brand name drug, Reglan, which had contained the warnings that the patient alleged were missing from the generic product. Thus, the patient’s physician was found to have relied upon the brand name drugs warnings when prescribing the drug to the patient. Based on this, the court found that the patient had failed to show proximate causation, an essential element of her claim. Accordingly, the state law claim failed as a matter of law.

The case is No. 2:13-cv-543-KOB.

Attorneys: Craig P. Niedenthal (Shunnarah Injury Lawyers, PC) for Linda Woods. F M Haston, III (Bradley Arant Boult Cummings LLP) for Wyeth LLC, Wyeth Pharmaceuticals, Inc. d/b/a ESI Lederle, Inc. and Pfizer, Inc.

Companies: Wyeth LLC; Wyeth Pharmaceuticals, Inc. d/b/a ESI Lederle, Inc.

MainStory: TopStory PreemptionNews WarningsNews DrugsNews AlabamaNews

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