Cottam v. CVS Pharmacy

• Court: United States State Supreme Judicial Court of Massachusetts
• Writing for the Court: COWIN, J.
• Citation: 764 NE 2d 814,436 Mass. 316
• Decision Date: 01 October 2001
• Parties: ROBERT L. COTTAM v. CVS PHARMACY.

436 Mass. 316
764 NE 2d 814

ROBERT L. COTTAM
v.
CVS PHARMACY

Supreme Judicial Court of Massachusetts, Middlesex.

October 1, 2001.

March 14, 2002.

Present: MARSHALL, C.J., GREANEY, IRELAND, SPINA, COWIN, SOSMAN, & CORDY, JJ.

436 Mass. 317

Kenneth A. Cohen (U. Gwyn Williams with him) for the defendant

Ned C. Lofton for the plaintiff.

COWIN, J.

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 drugs, 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.

436 Mass. 318

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). Although CVS's computers automatically generated the short form unless the computer operator hit a key to print the long form, CVS's corporate policy required its pharmacists to distribute the long form when filling new prescriptions. CVS policy also required its pharmacists to review the information on both the long and short forms with the customer

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 ASSOCATED WITH THE OCCURRENCE OF PRIAPISM. IN APPROXIMATELY 1/3 OF THE CASES REPORTED,

436 Mass. 319

SURGICAL INTERVENTION WAS REQUIRED AND, IN A PORTION OF THESE CASES, PERMANENT IMPAIRMENT OF ERETILE FUNCTION OR IMPOTENCE RESULTED. MALE PATIENTS WITH PROLONGED OR INAPROPRIATE ERECTIONS SHOULD IMMEDATELY DISCONTINUE THE DRUG AND COSULT 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 Cottam about the risk of priapism. Dr. Khajavi 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.

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 priapism 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 permanently 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

436 Mass. 320

the case on a different theory. CVS's basic position, as demonstrated by its request for jury instructions, motion for a directed verdict, and motion for judgment notwithstanding the verdict, was that to the extent it had assumed any duty, it had fulfilled it, and that the plaintiff had not met his burden of proving a breach of the duty by expert testimony or otherwise. CVS did not draw the judge's attention to the issues whether a duty existed and if so, to what extent. Having failed to raise these issues below, CVS cannot assert them now. Nevertheless, these issues were fully briefed by the parties and are likely to arise in other cases. Thus, we exercise our discretion and discuss the issues of duty and the scope of the duty that has been assumed. See Clark v. Rowe, 428 Mass. 339, 341 (1998) (court will review claim not properly preserved where issue is unanswered in Commonwealth, is likely to arise again, and has been fully briefed by parties); McSweeney v. Cambridge, 422 Mass. 648, 653 (1996) (court reviewed claim not properly preserved where issue was of importance to public)

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, 386 Mass. 801, 804 (1982). See Davis v. Westwood Group, 420 Mass. 739, 742 (1995). The existence of a duty is a question of law to be resolved by the judge. Id. at 743, and cases cited. In deciding whether a particular defendant has a duty in the circumstances, "we look to existing social values and customs, as well as to appropriate social policy." Id. See O'Sullivan v. Shaw, 431 Mass. 201, 203 (2000).

Although a pharmacy clearly has the duty to fill prescriptions correctly, see Andreottala v. Gaeta, 260 Mass. 105, 109 (1927); Nesci v. Angelo, 249 Mass. 508, 511 (1924), we have not addressed the issue whether a pharmacy has a duty to warn its customers of the risks and side effects of the drugs it dispenses. 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.¹ We similarly hold

436 Mass. 321

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," 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., 394 Mass. 131, 135, cert. denied, 474 U.S. 920 (1985), quoting H.P. Hood & Sons v. Ford Motor Co., 370 Mass. 69, 75 (1976). The learned intermediary doctrine in this context 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." McKee v. American Home Prods. Corp., 113 Wash. 2d 701, 709 (1989). The rationale for the doctrine is that physicians have the duty to inform...