Health Law Daily Wrap Up, TOP STORY—11th Cir.: No duty for pharmaceutical company to provide medication guide to patient, (Mar 11, 2021)

By Brian Craig, J.D.

Alabama’s learned intermediary doctrine bars a negligence per se wrongful death claim for failure to provide a medication guide.

The U.S. Court of Appeals for the Eleventh Circuit has held that Alabama’s learned intermediary doctrine bars a negligence per se wrongful death claim brought against the pharmaceutical company that produces the generic version of amiodarone, used to treat atrial fibrillation. In affirming the federal district court in Alabama’s grant of summary judgment in favor of the pharmaceutical company, the Eleventh Circuit held that under Alabama law, pharmaceutical companies that sell prescription drugs are required to warn only the prescribing physician, who acts as a "learned intermediary" between manufacturer and consumer. Because the pharmaceutical company had not duty to provide the patient with a medication guide, the Eleventh Circuit concluded that the learned intermediary doctrine bars the negligence per se claim (Cook v. Wyeth Pharmaceuticals, Inc., March 9, 2021, per curiam).

A physician prescribed amiodarone tablets to treat a man’s atrial fibrillation. The patient filled his prescription at a pharmacy and followed the prescribed 90-day course of treatment. Four years later, the man died stemming from acute and chronic respiratory failure and pulmonary fibrosis. The man’s estate brought a claim against the pharmaceutical company that produced the generic version of amiodarone supplied to the patient by the pharmacy. The man’s widow, acting on behalf of estate, argued that the patient did not receive a medication guide with the amiodarone prescription. The estate brought a wrongful death action against the pharmaceutical company, specifically alleging a failure-to-warn, negligence per se claim. The district court in Alabama granted summary judgment in favor of the pharmaceutical company concluding that the claims are barred by Alabama’s learned intermediary doctrine and preempted by federal law. The estate appealed to the Eleventh Circuit.

Learned intermediary doctrine. The Eleventh Circuit held that Alabama’s learned intermediary doctrine bars the claims brought against the pharmaceutical company for failure to include a medication guide. Under the learned intermediary doctrine adopted by the Alabama Supreme Court, the adequacy of a manufacturer’s warning is measured by its effect on the prescribing physician, to whom it owes a duty to warn, and not by its effect on the patient. A prescription-drug manufacturer fulfills its duty to warn by providing adequate warnings to the learned intermediaries who prescribe the drug. Pharmaceutical companies that sell prescription drugs are required to warn only the prescribing physician, who acts as a "learned intermediary" between manufacturer and consumer.

The estate argued that the pharmaceutical company violated its duty under Alabama law when it sold amiodarone without all necessary labeling. Specifically, the estate argued that the pharmaceutical company varied from the labeling requirements in federal regulations by failing to ensure a medication guide was provided to the patient. The court found no probative evidence to show that the pharmaceutical company—and not someone else in the supply—failed to provide adequate medication guides, which is the basis for the deceptive business practices claim. The pharmaceutical company had no duty to provide a medication guide to the patient. Therefore, appeals court concluded that Alabama’s learned intermediary doctrine bars the negligence per se claim.

Preemption. The Eleventh Circuit declined to address the preemption issue. Because preemption is a principle derived from the Supremacy Clause, the federal appeals court must first analyze whether each claim can stand under state law, and only then decide the preemption questions where necessary.

The case is No. 20-11926.

Attorneys: Edward K. Wood, Jr. (Wood Law Firm, LLC) for Heather Moore Cook. Jennifer Snyder Heis (Ulmer & Berne, LLP) for Par Pharmaceutical, Inc.

Companies: Par Pharmaceutical, Inc.

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