Court: Pharmacy Can Be Liable for Dispensing Withdrawn Drugs

The Utah Supreme Court has ruled that a pharmacy may be held liable in negligence for continuing to fill prescriptions for a drug that has been withdrawn from the market by the Food and Drug Administration (FDA) and/or the manufacturer.

According to Steven Downing v. Hyland Pharmacy dba United Drug Hyland Pharmacy, Steven Downing had prescriptions filled for fen-phen by Hyland from February 1996 until September 2000. The FDA asked the manufacturers of the drug to voluntarily withdraw the drug from the market, following reports of heart disease and hypertension in people who had been using the drug.

Thus in 2004, Downing brought negligence claims against Hyland for continuing to fill prescriptions after the drug was withdrawn from the market by the FDA and manufacturer.

Hyland filed a summary judgment motion arguing that it was entitled to judgment because it acted as a reasonable, prudent pharmacy in filling Downing’s prescription and thus did not breach any duty owed to Downing.

The trial court granted Hyland’s summary judgment motion, noting that pharmacists are protected from liability if they fill a prescription as directed by the manufacturer or physician.

However, the Utah Supreme Court disagreed. “The learned intermediary rule does not preclude as a matter of law a negligence claim against a pharmacist for dispensing a prescribed drug that has allegedly been withdrawn from the market, and that pharmacists under such circumstances owe their customers a duty of reasonable care,” the high court wrote. Reversing the summary judgment, dismissing the plaintiff’s claims and remanding the case to the trial court for further proceedings, the court said, “This will presumably include the development of the record on the question of withdrawal of the drug and the standard of care for a reasonable pharmacist under the circumstances.”

Source: Utah Courts