SW Legal studies in Business

Pharmacy May Be Sued for Selling Prescription Drug Pulled from Market by FDA

Utah high court held that a claim of negligence by a patient, who had prescriptions filled by a pharmacy after the FDA had ordered the drug off the market, could proceed. Pharmacies are not necessarily protected by the learned intermediary rule in that instance as they are expected to use reasonable care.

Topic Torts
Key Words

Negligence; Learned Intermediary; Prescription Drug

C A S E   S U M M A R Y

In 1996, Dr. Poulson began prescribing fen-phen, an appetite suppressant medication, for Downing. For four years, Hyland Pharmacy filled Downing’s prescriptions for the drug. Later, Downing sued Hyland for continuing to fill prescriptions after it had been withdrawn from the market by the FDA and the manufacturer. Downing claimed Hyland was negligent for filling the prescriptions and for not removing fen-phen from its inventory. The trial court granted summary judgment in Hyland’s favor. Downing appealed.


Reversed and remanded. The question of whether a pharmacist owed a legal duty in fulfilling prescriptions for drugs that have been withdrawn from the market is a matter of law. Under the learned intermediary rule, the makers of drugs have a duty to warn only the physician prescribing the drug, and not the end user. That does not preclude, as a matter of law, Downing from bringing a negligence claim against the pharmacy. Pharmacists have a generally recognized duty to possess and exercise the reasonable degree of skill, care, and knowledge that would be exercised by a reasonably prudent pharmacist in the same situation. So the suit may proceed.


Downing v. Hyland Pharmacy, 194 P.3d 944 (Sup. Ct., Utah, 2008)

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