A consumer’s doctor prescribed Reglan for the patient’s Gastroesophageal Reflux. The doctor relied upon information published in the package inserts for Reglan, the Physicians' Desk Reference, or otherwise disseminated by the brand name manufacturers of Reglan. The consumer’s pharmacist filled the prescription for Reglan with its generic equivalent, metoclopramide. The consumer ingested the prescription drug metoclopramide for one year. At no point did she ingest Reglan. She subsequently developed a neurological disorder called tardive dyskinesia, allegedly as a result of long-term use of metoclopramide.
The consumer sued the manufacturers of the prescription drug Reglan and its generic equivalent, metoclopramide. The suit under Arkansas law alleged strict products liability, negligence, gross negligence, fraudulent misrepresentation, negligent misrepresentation, fraudulent concealment, and breach of the implied warranties of merchantability and fitness for a particular purpose.
The United States District Court for the Eastern District of Arkansas ruled that all of the consumer's claims were either not viable under Arkansas law or were preempted by the federal law governing drug product labeling. The court dismissed the claims against the manufacturers, as well as consumer's amended complaint. The consumer appealed.
The Eighth Circuit U.S. Court of Appeals affirmed in part, reversed in part, and remanded. The court held that: the fact that the consumer only ever used generic prescription drug precluded consumer's claims under Arkansas product liability law against name brand manufacturer; the district court was required to consider whether the consumer's non-warning breach of implied warranty claims adequately stated viable claims separate from her failure to warn claims; remand was warranted of the consumer's design defect claims; and failure to update labeling claims were precluded by the learned intermediary doctrine.
The fact that the consumer only ever used the generic version of Reglan, rather than name brand Reglan, precluded the consumer's claims of negligence, misrepresentation, fraud, or suppression of evidence under the Arkansas Product Liability Act (APLA) against the name brand manufacturers. Arkansas law requires product identification for all product liability actions. The consumer stipulated that at no point did she ingest Reglan or any other product manufactured or distributed by one of the brand manufacturers. Therefore, she could not she hold them liable under Arkansas law and the district court did not err in granting the brand manufacturers' motion for summary judgment.
The district court was required to consider whether the consumer's non-warning breach of implied warranty claims adequately stated viable claims separate from her failure to warn claims, which were preempted by federal law, and failure to do so warranted remand. Accordingly, the court reversed the dismissal of the consumer's non-warning breach of implied warranty claims and remanded for further consideration as to whether they adequately state viable claims under Arkansas law and if so, whether the generic manufacturers can nonetheless establish preemption.
The court held that remand was warranted of the consumer's design defect claims to determine whether the claim was preempted by federal law. To succeed on a design defect claim under Arkansas law, a plaintiff must establish that a product was in a defective condition, that the defective condition rendered the product unreasonably dangerous, and that the defect proximately caused the complained-of injury. Arkansas used the consumer expectations test to determine whether a product was unreasonably dangerous. Consequently, it was unclear whether Arkansas offered the generic drug manufacturers an opportunity, consistent with federal obligations, to somehow alter an otherwise unreasonably dangerous drug.
The court held that the consumer’s failure to update labeling claims were precluded by the learned intermediary doctrine. Under Arkansas’s learned intermediary doctrine, a drug manufacturer may rely on a prescribing physician to warn the ultimate consumer of the risks of a prescription drug. A manufacturer's inadequate warning is not a proximate cause of a plaintiff's harm so long as the prescribing physician had independent knowledge of the risk that the inadequate warning should have communicated. The consumer’s doctor relied upon information published in the package inserts for Reglan, the Physicians' Desk Reference, or otherwise disseminated by the brand name manufacturers of Reglan. This precluded the consumer's failure to update labeling claims under Arkansas law.
See: Fullington v. Pfizer, Inc., 2013 WL 3491060 (C.A.8 (Ark.), July 15, 2013) (not designated for publication).
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication