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January 16, 2013

Liability of brand name drug maker for failure to warn physicians may extend to consumers of generics

By Michelle L. Oxman, JD, LLM

Wyeth, Inc., manufacturer of Reglan®, may be held liable to a patient allegedly injured by the generic version of the drug because Wyeth continued to have a duty to warn physicians of dangers or risks of which it learned after the drug was approved (Wyeth, Inc. v Weeks, January 11, 2013, Bolin, M). Wyeth could reasonably foresee that if physicians were not warned about the risks of injury that they would continue to prescribe Reglan® or an authorized generic substitute (metoclopramide); and would permit pharmacists to substitute the generic product. Although Wyeth did not manufacture the product that injured the patient, Danny Weeks (Weeks), it was the only party who could propose changes to the labeling or issuance of a "Dear Doctor" warning letter, and the injury was caused by the failure to warn, not defective manufacturing.

History of the case. Weeks developed tardive dyskinesia, a neurological disorder, after prolonged use of metoclopramide, the generic version of Reglan®. He sued both generic manufacturers and Wyeth, maker of the brand name drug. He alleged that Wyeth knew that the drug could cause tardive dyskinesia but intentionally suppressed its knowledge, failed to inform physicians of the dangers, and continued to market the drug as safe. A federal district court denied Wyeth's motion to dismiss the case on the ground that state law might allow Weeks to prevail if he could prove that Wyeth failed to warn physicians and that he was a beneficiary of the duty to warn. Because other federal courts in Alabama had rejected Weeks's theory of liability, and no state appellate rulings were available, the district court certified the question to the Alabama Supreme Court.

State products liability rule. Wyeth contended that the state's Extended Product Liability rule subsumed Weeks's claim because the rule made manufacturers liable only to the consumers of their products, not to consumers of products made by others. However, the court held that the rule did not eliminate tort claims involving injuries caused by fraud, negligence or wantonness. The court noted that every state had a law permitting substitution of generic drugs and many insurance plans commonly require substitution of generics where available, so that brand name drug makers reasonably could expect that their failures to warn physicians could result in injuries to the consumers of generics.

Effects of FDA regulation. Wyeth also claimed that the comprehensive regulation of prescription drugs by the Food and Drug Administration (FDA) preempted the state tort action. Reviewing the process for approval of new drugs, including the abbreviated process for approval of generics, the court noted that the detailed review of safety and effectiveness occurs with the application for approval of brand name drugs. The generic manufacturers must show that their drug is bioequivalent and therapeutically equivalent to the brand name drug. FDA regulations require the brand name manufacturer to report adverse events even after market approval and to report annually any information that might affect the safety, effectiveness or labeling of the drug. Only the brand name manufacturer may modify its labeling or issue a "Dear Doctor" warning letter to account for new information, subject to FDA approval.

Supreme Court precedent. The court also analyzed the Supreme Court's rulings on the preemption of state tort law regarding warning labels. The court followed Wyeth v Levine, where the Supreme Court ruled that there was no preemption because it was possible for the manufacturer to comply with both federal requirements and more stringent state law requirements for warnings. The Alabama court distinguished the Supreme Court ruling in PLIVA, Inc. v Mensing that the FDA labeling requirements preempt any more stringent state laws because generic makers must follow the brand name label exactly; they cannot comply with state requirements without violating federal law. The court also noted that the FDA relies on state regulation to supplement its enforcement efforts.

The case number is 1101397.

Attorneys: Anna Manasco Dionne, George R. Parker, Kevin C. Newson, Lindsey C. Boney IV and Philip H. Butler (Bradley Arant Boult LLP), Bryan A. Vines (Hare, Wynn, Newell and Newton, LLP), Leslie A. Benitez (Clark, Thomas & Winters) for Wyeth, Inc. Christopher B. Hood, William L. Bross IV and William L. Garrison Jr.(Heninger Garrison Davis LLC) for Danny Weeks and Vicki Weeks.

Companies: Wyeth, Inc.

MainStory: TopStory GenericDrugNews PrescriptionDrugNews PreemptionNews DrugBiologicalNews LabelingNews AlabamaNews

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