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Pharmacy Sued for Failing to Warn of Priapism

Larry M. Simonsmeier, JD, RPh
Published Online: Thursday, September 1, 2005   [ Request Print ]

Issue of the Case

A Massachusetts court was asked whether a pharmacy had a duty to warn a patient of an antidepressant's potential side effects, particularly when the pharmacy had a policy to provide extensive written information with each new prescription.

Facts of the Case

The defendant pharmacy implemented a computer system designed to provide customers with information about the risks and side effects of prescription drugs. The computers produced either a short form or a longer form. The short form was automatically generated unless the operator hit a key to print the long form. Pharmacy policy required the longer version with all new prescriptions. Pharmacists were required to review the information on both the short and long forms with the patient.

The plaintiff was admitted to the hospital for treatment of depression, where a psychiatrist prescribed trazodone. Upon discharge, the plaintiff had the prescription filled at the defendant pharmacy. He testified at trial that the pharmacist gave him only the short warning form. Both that form and the pharmacist's oral counseling focused primarily on the risk of drowsiness.

The plaintiff took his first dose of medication before bedtime. He awoke the next morning with an erection that persisted throughout the day. He decided to talk to his primary care physician the next day during a scheduled appointment. He took a second dose at bedtime that evening.

Upon seeing his physician the following day, the plaintiff was immediately referred to a urologist, who admitted him to the hospital for emergency surgery. Because the plaintiff had waited 30 hours before seeking medical attention, the surgery left him permanently impotent. The plaintiff argued that he would have seen a doctor earlier if he had been informed that priapism was a serious side effect of his drug therapy. He sued the psychiatrist, his primary care physician, and the pharmacy.

The Court's Ruling

The plaintiff settled with the other defendants but proceeded to trial against the pharmacy. The jury found the pharmacy 51% negligent and the plaintiff 49% negligent. The plaintiff was awarded $357,000 in damages, after the reduction for his own contributory negligence. An appellate court affirmed the decision of the jury, holding that while a pharmacy generally has no duty to warn its customers, in this case the pharmacy voluntarily assumed a duty to provide the information.

The Court's Reasoning

To recover for negligence, a plaintiff must prove the commission of an act (or failure to act) in violation of some duty owed by the defendant to the plaintiff. While recognizing that a pharmacy clearly has the duty to dispense the right drug in the right dose, the court concluded that a pharmacy has no duty to warn of the side effects of prescription drugs.

In reaching its decision, the court adopted the "learned intermediary doctrine" based on an examination of a number of cases from other jurisdictions. This doctrine holds that the physician is the appropriate intermediary to interpret the drug manufacturer's warnings and to inform patients of risks based on their medical history and unique needs.

The court went on to discuss a few cases that have imposed a duty on pharmacies that goes beyond merely accurately dispensing prescriptions. In each of these instances, the pharmacist failed to act on specific knowledge of a lethal dose or danger to a particular patient. Based on this line of reasoning, the court in this case limited its conclusion by holding that there is no duty to warn when a pharmacist has no specific knowledge of an increased danger to a patient.

The court, however, held that a pharmacy can voluntarily assume a duty not otherwise imposed on it. If a person voluntarily undertakes to render services to others for their protection, that person may be liable for harm caused because of negligent performance of the undertaking.

In the court's eyes, when a pharmacy communicates with a patient about a single label warning of only one side effect (ie, "do not drive or operate machinery"), it has not undertaken a broader duty to warn of all potential side effects. When a pharmacy provides information that could reasonably be understood by a patient as a complete list of side effects, however, then it is appropriate to impose a duty commensurate with what it appears to have undertaken.

The long form of the pharmacy's patient information leaflet included a warning to notify a physician if painful erections developed. The jury apparently believed this form was not given to the plaintiff and that he may have reasonably believed all the side effects were included in the short form, which focused on drowsiness. Thus, the pharmacy neglected to perform according to the voluntary standards it had established for dispensing new prescriptions.

Larry M. Simonsmeier is Emeritus Professor of Pharmacy Law at Washington State University College of Pharmacy.

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