Products Liability Law Daily Avandia warnings were adequate to avoid manufacturer’s liability
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Tuesday, February 16, 2016

Avandia warnings were adequate to avoid manufacturer’s liability

By Kathleen Bianco, J.D.

A patient’s negligent failure-to-warn claims against a manufacturer of a drug prescribed to treat her diabetes were properly dismissed, the U.S. Court of Appeals for the Third Circuit held. The court affirmed a lower court decision granting the manufacturer’s motion for judgment after finding that the patient failed to prove that her physician would have prescribed a different medication if the manufacturer had provided different or more prominent warnings regarding the risk of fractures associated with the drug (In re: Avandia Marketing, Sales Practices and Product Liability Litigation; Schatz v. GSK, February 12, 2016, Shwartz, J.).

A diabetic patient, who was prescribed Avandia for five years to treat her diabetes, suffered several bone fractures—a compression fracture of the spine and a fracture to three ribs and her scapula—allegedly as a result of her use of the drug. The patient filed a lawsuit against GlaxoSmithKline (GSK), the drug’s manufacturer, in which she asserted claims for negligence, negligent misrepresentation, breach of warranty, fraud, and unjust enrichment, based on GSK’s failure to adequately warn of the risks associated with the use of Avandia. GSK moved for summary judgment, contending there was no evidence that any failure to warn on its part was the proximate cause of the patient’s injuries. A federal district court in Pennsylvania rejected the patient’s attempt to file a sur-reply and granted the manufacturer’s motion for judgment, resulting in dismissal of the patient’s claims. The patient appealed the district court’s rulings in favor of the manufacturer.

Failure to warn. In order to prevail on the failure-to-warn claim, the patient was required to establish proximate cause by showing that had the manufacturer issued a proper warning to the patient’s prescribing physician, the physician would not have prescribed the drug to the patient and the injuries would have been avoided. The patient contended that summary judgment was not warranted because her physician’s testimony that he would have prescribed Avandia to the patient notwithstanding the risk of fracture was equivocal. Upon review, the appellate court disagreed, finding that the physician’s testimony, that he would have prescribed the drug to the patient even if he had been aware of the risks, was clear. Based on the facts, the court concluded that the patient had failed to present sufficient evidence to support her claim that an adequate warning would have prevented her injuries.

The case is No. 15-2059.

Attorneys: Peter D. Friday (Friday & Cox) for Linda Schatz. Jennifer K. Green (Pepper Hamilton) for GlaxoSmithKline LLC.

Companies: GlaxoSmithKline LLC.

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