We address the issue whether a pharmacy has a duty to warn its customers of the potential side effects of the prescription drugs it dispenses. 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. He had obtained the drug at a CVS Pharmacy (CVS). Cottam filed a complaint in the Superior Court alleging that CVS was negligent in failing to warn him of the side effect and its seriousness. Cottam also claimed negligence in failing to warn by his prescribing physician, Dr. Farrokh Khajavi, and by his therapist, Sheila McHatton. In its answer, CVS denied any negligence and asserted a number of affirmative defenses, including Cottam’s own contributory negligence. Both Dr. Khajavi and McHatton settled with Cottam before trial. A jury found CVS fifty-one per cent negligent and Cottam forty-nine per cent negligent, and awarded Cottam damages (after reduction for comparative negligence) in the amount of $357,000. CVS filed a timely appeal, and we transferred the case here on our own motion.
On appeal, CVS argues that, as a matter of law, it does not have a duty to warn its customers of possible side effects associated with prescription chugs, and that CVS did not assume a duty to warn its customers of all side effects by warning them of some side effects. In the alternative, CVS argues that, even if it has a duty to warn, the plaintiff must establish the scope and breach of the duty of a pharmacist by expert testimony, and that the plaintiff did not present such expert testimony at trial. CVS also claims that two evidentiary rulings by the trial judge each constituted reversible error: (1) the judge improperly prohibited CVS from rebutting the presumption that Cottam would have heeded a warning if given; and (2) the judge erred in admitting evidence of Cottam’s prior settlement of his claim against his doctor. We affirm.
1. Facts. We summarize the facts the jury could have found.
In March of 1994, Cottam was admitted to Boston Regional Medical Center for treatment for depression. Dr. Khajavi, the psychiatrist who treated Cottam, prescribed the prescription drug Trazodone. Dr. Khajavi instructed Cottam to continue taking the drug on his release from the hospital. Cottam filled his prescription for Trazodone at the CVS Pharmacy in Reading on August 16, 1994. At trial, Cottam testified that the pharmacist, Barbara Swanson, 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.”
He also testified that the pharmacist discussed the medication with him, but that the sole warning she provided was that the drug may cause drowsiness. Swanson 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 (but which it was not CVS’s corporate policy to distribute) read:
“WARNINGS: TRAZODONE HAS BEEN ASSOCIATED WITH THE OCCURRENCE OF PRIAPISM. IN APPROXIMATELY Vs OF THE CASES RE*319 PORTED, 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.”
Although this “warning” was the only “warning” in all capitalized letters in the package insert, priapism was not listed as a side effect, but as one of numerous adverse reactions for which “the causal relation has neither been confirmed nor refuted.” Swanson admitted that she did not orally advise Cot-tam about the risk of priapism. Dr. Khajavi tеstified 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. Hе took his second dose of Trazodone before bed that evening.
Cottam attended the appointment with his primary care physician the following morning, August 18, 1994. On learning of Cottam’s condition, the physician sent him immediately to a urologist. The urologist diagnosed Cottam’s condition as pri-apism and immediately admitted him to New England Memorial Hospital to undergo emergency surgery. Because Cottam had waited approximately thirty hours before seeking medical attention, the surgery left him pеrmanently impotent. Ideally, Cottam should have sought medical attention within six hours. 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.
2. A pharmacy’s duty to warn in general. Cottam argues that the issues of the pharmacy’s duty to warn and the extent of that duty are not properly before this court because CVS defended
To recover for negligence, a plaintiff must show “the existence of an act or omission in violation of a . . . duty owed to the plaintiff[s] by the defendant.” Dinsky v. Framingham,
Although a pharmacy clearly has the duty to fill prescriptions correctly, see Andreottala v. Gaeta,
Other jurisdictions have reached this result by extending to pharmacies the “learned intermediary doctrine,” a rule commonly applied to drug manufacturers. See note 1, supra. The doctrine is an exception to the general rule that a manufacturer or retailer of an unavoidably dangerous product must directly warn all foreseeable consumers of the dangers of its product. See MacDonald v. Ortho Pharm. Corp.,
In McKee v. American Home Prods. Corp., supra at 711, the Supreme Court of Washington concluded that the reasons for applying the learned intermediary doctrine to drug manufacturers apply with equal force to pharmacies. In both instances, the physician is in a better position to decide the information that is most pertinent to each particular patient because the physician has superior knowledge of the patient’s medical history and unique condition. Id.
This court has already recognized the learned intermediary doctrine in the context of prescription drug manufacturers. See MacDonald v. Ortho Pharm. Corp., supra at 136 (recognizing learned intermediary doctrine but creating exception for oral contraceptives). Because the physician is the appropriate person to perform the duty of warning a patient of the possible side effects of prescription drugs, we now extend this doctrine to pharmacies.
A few courts have imposed a duty on pharmacies that goes beyond merely filling prescriptions accurately. These cases, however, involve more than a simple failure to warn. For example, courts have held that a pharmacy could be found negligent for filling a prescription for what the pharmacist knew to be a lethal dose, see Homer v. Spalitto,
3. Voluntary assumption of a duty. Cottam’s primary theory at trial was not that all pharmacies have a duty to warn their customers of the side effects of prescription drugs, but rather that CVS voluntarily assumed such a duty when it provided him with a list of side effects of Trazodone. On appeal, CVS contends that the evidence was insufficient to establish its voluntary assumption of any duty to warn of all potential side effects of Trazodone. However, the arguments now put forward were not presented to the judge in CVS’s motion for a directed verdict, and CVS made no objection to the judge’s instructions on the subject of voluntary assumption of a duty. The issues are thus waived.
Because the issue is one of importance to both the industry and patient consumers, and has been thoroughly briеfed by the parties, we address it. A pharmacy, like any other person or entity, may voluntarily assume a duty that would not otherwise be imposed on it, and thus may voluntarily assume a duty to provide information, advice or warnings to its customers. Massachusetts recognizes that “a duty voluntarily assumed must be performed with due care,” and we have approved the principles pertaining to voluntary assumption of a duty as set forth in the Restatement (Second) of Torts § 323 (1965).
Defining the scope of the duty assumed is a fact-specific inquiry. For example, in Davis v. Westwood Group,
Other jurisdictions have applied these principles to pharmacies, defining the scope of the duty voluntarily undertaken based on the pharmacy’s communications with its customers. In Baker v. Arbor Drugs, Inc.,
When a pharmacy’s communication with a patient concerning a drug is limited to a single label warning of only one side effect, the pharmacy has undertaken a duty to warn correctly as to that specific side effect but has not undertaken a broader duty to warn of all potential side effects. In Frye v. Medicare-Glaser Corp.,
Here, Cottam correctly points out that the warning form he was given went beyond the single warning label at issue in Frye v. Medicare-Glaser Corp., supra. We agree that the present case is readily distinguishable. We note, however, that the Frye principles have been extended to a case where the pharmacist provided an information sheet listing several side effects and characterizing them as “unlikely.” Kasin v. Osco Drug, Inc.,
We reiterate that determination of the scope of the duty
4. The need for expert testimony. CVS argued bélow, and argues on appeal, that if it had any duty to warn, the plaintiff must prove the scope and breach of that duty by expert testimony. We disagree. The common-law duty to warn “necessitates a warning ‘comprehensible to the average user and . . . [one] conveying] a fair indication of the nature and extent of the danger to the mind of a reasonably prudent person.’ ” MacDonald v. Ortho Pharm. Corp., supra at 140, quoting Ortho Pharm. Corp. v. Chapman,
5. The exclusion of CVS’s evidence rehutting the inference that plaintiff would have heeded a warning. During its cross-examination of Cottam, CVS attempted to elicit testimony that Cottam continued to smoke cigarettes despite the health warnings on cigarette packages. CVS argued that such evidence
6. Evidence of the plaintiff’s prior settlement with his doctor. Cottam settled his claim against Dr. Khajavi, his prescribing physician, prior to the start of trial. CVS called Dr. Khajavi as a witness to testify that he had indeed warned Cottam that pri-apism was a side effect of Trazodone. Dr. Khajavi testified that he had repeatedly discussed the risks of Trazodone, including priapism, with Cottam, and that Cottam agreed to take the medication despite the fact that he was aware of its side effects. Over CVS’s objection, the judge permitted Cottam to cross-examine Dr. Khajavi about his settlement with Cottam. CVS maintains that the judge should hаve excluded this evidence as improper evidence of a settlement used to prove liability.
Although evidence of a prior settlement is not admissible to
Of course, аdmission of this evidence created the risk that the jury would perceive the settlement by Dr. Khajavi as an admission of his liability and, therefore, as rebutting CVS’s defense that Dr. Khajavi had warned the plaintiff. However, the judge, in the exercise of her discretion, permissibly could have concluded that fairness required that the jury be informed of the settlement. CVS was free to point out to the jury that the settlement was not an admission of liability by Dr. Khajavi. In fact, during pretrial discussions on the matter, the judge informed CVS that it could bring to the jury’s attention the fact that the settlement did not involve an admission of liability. CVS chose not to do so, but did present testimony through Dr. Khajavi that the suit against him was settled by his insurance company without his consent. In addition, the judge twice informed the jury that the settlement was not to be considered on the issue of CVS’s liability.
Judgment affirmed.
Notes
See, e.g., Pysz v. Henry’s Drug Store,
The Restatement (Second) of Torts § 323 (1965), provides: “One who undertakes, grаtuitously or for consideration, to render services to another which he should recognize as necessary for the protection of the other’s person or things, is subject to liability to the other for physical harm resulting from his failure to exercise reasonable care to perform his undertaking, if (a)
Cottam argues that CVS has waived this issue by fаiling to object to the evidence of the settlement at the time of Cottam’s cross-examination of Dr. Khajavi. Although CVS did not object to the questions regarding the settlement at the time they were asked, just prior to the time that Dr. Khajavi testified, CVS objected to any evidence regarding the settlement and directed the judge’s attention to a case holding that evidence of a settlement is inadmis
The judge’s final instruction to the jury was as follows:
“The question of settlement as to one of the witnesses, Dr. Khajavi in this case, is not evidence of negligence of the defendant CVS. And whatever may have happened as far as Dr. Khajavi is concerned is only relevant to your consideration and assessment of his credibility. In other words, did the settlement and the facts surrounding that settlement that have been presented to you influence ■ his testimony in this courtroom. It is not evidence from which you may make a decision as to the liability of CVS, nor is it a decision as to any other issue . . . .”