Liability for Dispensing a Withdrawn Drug

Dr. Fink is professor of pharmacy law and policy at the University of Kentucky College of Pharmacy, Lexington.

Issue of the Case

When a patient has been receiving a medication that is withdrawn from the market by the FDA, does the pharmacist have an obligation to discontinue dispensing the medication and tell the patient about the regulatory action or contact the prescriber?

Facts of the Case

This case involves the now notorious combination of medications known as “fen—phen” (fenfluramine and phentermine) once used for weight reduction but later determined to cause a rare but very serious heart valve disorder. On September 15, 1997, the FDA issued an order withdrawing approval for marketing the product in interstate commerce.

The patient/plaintiff in this case had been started on the medication during February 1996 and continued taking it until September 2000. He filed suit against the pharmacy in 2004. The allegations advanced by the patient/ plaintiff were 3-fold—that the pharmacy was negligent to continue to dispense the medication after the FDA’s action withdrawing the product from the market; that it was negligent for the pharmacy not to remove the product from its inventory following the administrative action; and that it was negligent for the patient not to be warned about the regulatory status of the medication.

The defendant pharmacy responded by arguing that it had acted as a reasonable and prudent pharmacy would have done under the same or similar circumstances. It filed a motion for summary judgment, arguing that no trial was needed because the evidence was so overwhelmingly in its favor that a reasonable jury presented with the same evidence could only decide in favor of the party making the motion. This motion is made after the pretrial discovery process has been completed but before the trial begins. If the judge grants the motion for summary judgment, the proceedings end, and no trial is necessary.

The trial court judge granted the motion for summary judgment in favor of the defendant pharmacy. He relied on the precedent of a case decided by the state supreme court, wherein it was ruled that pharmacists are insulated from liability if prescriptions are dispensed as directed by the prescriber or the manufacturer. This is known as the learned intermediary doctrine, which is based on the notion that the manufacturer knows a great deal about the product’s positive and negative aspects, which are communicated to the prescriber who then evaluates them in light of his or her knowledge of the patient’s condition and health history. Thus, the prescriber is the “intermediary” between the producer of the product and the patient, and the prescriber hopefully makes a learned decision by weighing all the information at hand.

The Court’s Ruling

The state supreme court, however, reinstated the plaintiff’s claim and sent the case back to the trial court for further proceedings, having framed the legal question as being whether a pharmacy has a legal duty to the patient when dispensing drugs that have been withdrawn from the market by the FDA or the manufacturer. The learned intermediary doctrine does not shield a pharmacy from potential liability if the medication it provided has been withdrawn from the market by the relevant regulatory agency.

The Court’s Reasoning

The court looked at the precedential case in which it had stated that “although pharmacists can be held liable for negligence if there is a breach of duty, pharmacists are protected from claims if they fill [sic] a prescription precisely as directed by the manufacturer or physician.” Taking that precedent into account, the supreme court emphasized that the protections for the pharmacy under the learned intermediary doctrine “extend only to warnings about general side effects of the drugs in question, but not to specific problems known to the pharmacist, such as prescriptions for excessively dangerous amounts of the drugs or for drugs contraindicated by information about a patient.” A

Accordingly, the case was returned to the trial court, with the focus of that proceeding being on the legal standard of due care applicable to pharmacies in such circumstances. The supreme court pointed out relevant information, including testimony of experts in the profession, as well as standards expressed in statutes and regulations, that should be taken into consideration. Finally, the supreme court reiterated a statement it had made when ruling in the precedential case: “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.”