The plaintiff, Robert L. Cottam, suffered permanent injury when he failed to seek timely medical attention for a side effect he experienced after taking the prescription drug trazodone for depression. He had obtained the drug at a CVS Pharmacy (CVS). Cottam alleges that CVS was negligent in failing to warn him of the side effect and its seriousness. 

 

In May of 1994, CVS implemented a computer system designed to provide its customers with written information about the risks and side effects of prescription drugs. The computer produced this information in one of two ways: a short, condensed form (short form) or a longer and more inclusive form (long form). CVS's corporate policy required its pharmacists to distribute the long form when filling new prescriptions. The CVS policy also required its pharmacists to review the information on both the long and short forms with the customer. Cottam testified that the pharmacist gave him only the short-form warning, which provided: 

 

"Possible Side Effects: Commonly: drowsiness. Very unlikely, but report: Dizziness, fainting, blood in urine, heart problems, breathing problems." 

 

The plaintiff testified that the pharmacist discussed the medication with him, but that the sole warning she provided was that the drug may cause drowsiness. The defendant pharmacist testified that she had given Cottam the long-form warning, which included a warning about the risk of priapism, defined as an erection that is persistent, not produced by sexual stimulation and not relieved by orgasm. Specifically, the long form included the following: "SIDE EFFECTS: ... Notify your doctor if you develop ... painful erections ...." The manufacturer's package insert, which Cottam also did not receive, and which was not in CVS's corporate policy to distribute, read: 

 

"Warnings: Trazodone has been associated with the occurrence of priapism in approximately 1/3rd of the cases reported, surgical intervention was required and, in a portion of these cases, permanent impairment of erectile function or impotence resulted. Male patients with prolonged or inappropriate erections should immediately discontinue the drug and consult their physician." 

 

The pharmacist admitted that she did not orally advise Cottam about the risk of priapism. The plaintiff's physician testified that he had warned Cottam that priapism was a potential side effect before prescribing the medication. 

 

Cottam took his first dose of trazodone at night before bed and awoke the next morning with an erection that persisted throughout the day. The erection became uncomfortable later that evening. Cottam did not contact his doctor, deciding instead to wait until the following day when he had a previously scheduled appointment with his primary care physician. He took his second dose of trazodone before bed that evening. On learning of Cottam's condition, the physician sent him immediately to a urologist. The urologist diagnosed Cottam's condition as priapism and immediately admitted him to the hospital to undergo emergency surgery. Because Cottam had waited approximately 30 h before seeking medical attention, the surgery left him permanently impotent. Ideally, Cottam should have sought medical Cottam claimed that he would have sought medical attention earlier had he been informed that priapism is a potential and serious side effect of trazodone. 

 

Case Analysis: To recover for negligence, a plaintiff must show "the existence of an act or omission in violation of a ... duty owed to the plaintiffs by the defendant." Subject to Massachusetts not having a law that requires a pharmacist to warn patients about adverse reactions that can occur with a given dispensed drug, this court looked to existing social values and customs, as well as to appropriate social policy. "A number of jurisdictions have addressed the issue, and the overwhelming majority hold that in general, a pharmacy has no duty to warn its customers of side effects. We similarly hold that, generally, a pharmacy has no duty to warn its customers of the side effects of prescription drugs."

 

Other jurisdictions have reached this result by extending to pharmacies the "learned intermediary doctrine ...." The doctrine provides that "a prescription drug manufacturer's duty to warn of dangers associated with its product runs only to the physician; it is the physician's duty to warn the ultimate consumer." 

 

However, a pharmacy may voluntarily assume a duty that would not otherwise be imposed on it. Massachusetts recognizes that "a duty voluntarily assumed must be performed with due care." If a person voluntarily assumes a duty or undertakes to render services to another that should have been seen as necessary for his or her protection, that person may be liable for harm caused because of the negligent performance of his or her undertaking. Where a pharmacy provides a detailed list of warnings, or, by way of advertising, promises to provide customers with information, it may thereby undertake a duty to provide complete warnings and information. We thus conclude that ... CVS's argument that it did not assume a duty to warn of all side effects would be unavailing. Also, of pertinent concern is that Cottam's physician provided testimony that he did instruct Cottam about the possible problem with priapism. Case 

 

Holding: Based upon the evidence and testimony of witnesses, the jury found CVS 51% negligent and Cottam 49% negligent, and awarded Cottam damages (after reduction for comparative negligence) in the amount of $357,000. The Supreme Court of Massachusetts affirmed the judgment. attention within six hours.

1. Does a pharmacy have a duty to warn its customers of the potential side effects of the prescription drugs it dispenses?