Learned Intermediary Doctrine: Pharmaceutical Company Loses the Adequate Warning Battle But Wins the War on Causation


In Pustejovsky v. PLIVA, Inc., ____ F.3d ____, 2010 WL 3928770 (Oct. 8, 2010), the U.S. Court of Appeals for the Fifth Circuit affirmed summary judgment against a plaintiff alleging that inadequate drug labeling caused her to suffer a neurological disorder. Plaintiff Martha Pustejovsky brought suit against PLIVA, Inc., manufacturer of metoclopramide (MCP), a generic drug for gastroesophageal reflux disease, alleging that PLIVA failed to adequately warn of the true magnitude of the risks associated with long-term MCP use. Pustejovsky claimed that, but for inadequate warning of the risk of tardive dyskinesia (TD), which causes involuntary facial spasms, her doctor never would have prescribed Pustejovsky MCP for a three-year period.

As a federal court sitting in diversity, the Fifth Circuit applied Texas' learned intermediary doctrine, which states that a drug manufacturer is not liable for failing to adequately warn of a prescription drug's side effects when the manufacturer "properly warns a prescribing physician of the dangerous propensities of its products . . . ." Id. at *3. Additionally, manufacturer liability will not exist unless the inadequate warning was a "producing cause" of the plaintiff's injuries—that is, a proper label would have stopped the doctor from prescribing the drug in a way that caused the patient's injuries.

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