Court: Pharmacy Can Be Liable for Dispensing Withdrawn Drugs

While nearly 100 pharmacists and the hospitals they work for face fines for failing to remove a blood thinner from their shelves after a federal recall last winter according to the California state Board of Pharmacy. 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ruled that a pharmacy may be held liable in negligence for continuing to fill prescriptions for a drug that has been withdrawn from the market by the Food and Drug Administration (FDA) and/or the manufacturer.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Thus in 2004, Downing brought negligence claims against Hyland for continuing to fill prescriptions after the drug was withdrawn from the market by the FDA and manufacturer.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as a matter of law a negligence claim against a pharmacist for dispensing a prescribed drug that has allegedly been withdrawn from the market, and that pharmacists under such circumstances owe their customers a duty of reasonable care,” the high court wrote.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.”

In California, the recalled drug heparin was found 94 times in inspections of all 533 hospitals in California, and at least 16 hospitals administered the drug to patients, according to the state Board of Pharmacy. Fines range from $2,500 to $5,000.

“This was really an alert that the recall system doesn’t work,” Virginia Herold, head of the state’s pharmacy board, told The Associated Press.

Regulators have not released the full list of hospitals involved. However, documents obtained by the Daily Journal show newborns were allegedly given heparin at the University of California San Francisco Medical Center and Children’s Hospital of Central California in Madera. Both hospitals are appealing the charges.

Heparin, which is often used in premature children to prevent blood clots, has come under scrutiny because of accidental life-threatening overdoses given to babies. The Federal Drug Administration issued a drug recall in February because “a higher than usual number” of patients reported adverse effects to heparin, which include chest pain, dizziness and headache.

The Associated Press contributed to this story.

Topics California Manufacturing