Proper Scope Of Duty To Warn Before Court

By Jason M. Scally, October 8, 2001

The Supreme Judicial Court last week heard arguments in a case that could expand the duty of pharmacies in Massachusetts to warn against harmful side effects of medication.

In Cottam v. CVS Pharmacy, SJC No. 00-P-1287, a Superior Court jury had found a Reading pharmacy responsible for the plaintiff's injuries when they failed to warn him about a potentially life-changing condition even though they provided some warnings on other side effects.

Although the SJC's decision may ultimately turn on whether the defendant waived relevant defenses by not bringing them initially at trial, several judges questioned the parties' attorneys during oral arguments on what type of duty should exist for a pharmacy in this situation, indicating that they may address this issue for the first time.

Chief Justice Margaret H. Marshall observed during the arguments that no court in the country has imposed on pharmacists a duty to warn, although she said in this case, "We're presented with a jury finding that seems to say there was a duty."

While both sides conceded that there was no general duty to warn imposed upon pharmacists, the plaintiff's attorney, Ned C. Lofton of Wakefield, argued that "once you voluntarily undertake to perform a service, then you have a duty to perform that duty in a non-negligent way."

Lofton noted that the defendant pharmacy provided the plaintiff with some warnings about some of the side effects, but left out the one side effect that ultimately harmed the plaintiff.

But the defendant's attorney, Kenneth A. Cohen of Boston, argued that imposing such a duty on his client might cause other pharmacies to stop providing any type of warning to avoid liability.

"As a matter of law, the jury's apparent conclusion that the plaintiff had not been warned by the pharmacist should not have led to liability," the defense attorney argued before the SJC. "Settled national law holds that the pharmacy has no general duty to warn a patient about the possible side effects of medicine it provides pursuant to a doctor's prescription."

Cohen added that the defendant was not negligent because the warnings they did provide were accurate.

The parties' briefs are in the "SJC Docket" section of Lawyers Weekly's website,

Life-Changing Side Effect

The plaintiff, Robert L. Cottam, was given a prescription for the drug trazodone while completing outpatient treatment at a rehabilitation hospital in 1994.

He took the prescription for the drug to a CVS pharmacy in Reading, and was given the medication along with the "short form" of side effects from the drug.

It was the defendant's policy to provide customers with both the "short form" warnings, as well as "long form" warnings, which included a more comprehensive list of side effects.

The parties disputed whether the defendant gave the plaintiff the "long form" warning.

The "short form" side effect list provided the plaintiff with numerous side effects, but did not mention priapism — the condition that occurs when a man experiences a prolonged erection, not caused initially by sexual arousal, that does not subside after normal lengths of time and carries substantial medical risks if it lasts more than a few hours.

The plaintiff began taking the medication and noticed an unusual erection the next morning that did not go away.

By coincidence, he had a scheduled doctor's visit the following day, and once examined he was rushed into surgery.

But, because the plaintiff went without treatment for approximately 30 hours, he required an invasive procedure that left him impotent.

The plaintiff sued the doctor, the nurse and the pharmacy for negligence, but the doctor and nurse both settled before trial.

A jury found the pharmacy 51 percent responsible and the plaintiff 49 percent responsible, and awarded the plaintiff approximately $700,000 in damages.

After the defendant's judgment notwithstanding the verdict failed, it appealed to the Appeals Court, and the SJC took the case sua sponte.

Duty To Warn?

The plaintiff's main argument was that the defendant voluntarily undertook a duty to provide comprehensive warnings to their customers through promotional advertising and an internal policy.

According to Lofton, the plaintiff's attorney, the defendant had purchased a new computer that would print out a comprehensive list of side effects and harmful drug interactions for the medications they provided to their customers.

Lofton told Lawyers Weekly, "Once they embark upon a course to spend millions of dollars that appears to give you comprehensive side effects, they can't say they had no duty."

Although he conceded that pharmacists generally do not have a duty to warn, Lofton said "where they represent to the public through their advertising that they have this wonderful computer, then their duty becomes much greater than putting a sticker on a bottle."

In his brief, the plaintiff's attorney argued, "The principle that a duty voluntarily assumed, but negligently performed, will give rise to a cause of action if the negligence increases the risk of harm, or if the harm is suffered because of another's reliance upon the undertaking, has been long settled."

Lofton compared this case to the SJC's 1907 decision of Black v. New York, N.H. & H.R. Co., where a man was injured as he was being taken off of a train.

"They don't have a duty to take him off the train," he said. "But once they do, you have a duty to be careful about it."

But Cohen, the pharmacy's attorney, disagreed that his client undertook any duty to warn the plaintiff of all potential side effects.

"CVS's only duty was to ensure the accuracy of the warnings it did give," Cohen said in his reply brief. "There is no argument that CVS breached that limited duty."

He rejected the position that there was a voluntary assumption of duty on the part of his client, arguing that courts from other jurisdictions have rejected that theory.

"If you say that [voluntary assumption of duty] means they have to say everything, then they're going to be forced to say everything," the defense attorney said. "That's what the rest of the country has found to be counterproductive."

In his brief, Cohen noted that "[I]t is the doctor who has the duty to decide what warnings are appropriate in the particular case and to give them."

The defense attorney argued that even if there had been a duty to warn, the plaintiff could not have proved his burden without additional information provided by an expert.

"If you impose a duty on the pharmacist, then you need an expert to talk about what a reasonable professional would have done," Cohen said. "The plaintiff didn't have any experts."

"Serious Waiver Problem"

Although the issue of a pharmacist's duty to warn took center stage at oral arguments, that issue may not be addressed by the SJC because some of the defendant's arguments were not addressed initially at the trial court.

Justice Martha B. Sosman flatly stated during oral arguments that "there is a serious waiver problem in this case."

Lofton argued in his brief that "[I]t is well settled that an issue not raised in the trial court is deemed to be waived, and will not be considered in the appellate court."

The Wakefield attorney told Lawyers Weekly, "If you had a meritorious complete defense, why would you not bring it in the trial court?"

At oral argument, Lofton surmised that the only reason the defendant would not have asserted their defenses at trial was because of the strategy of not wanting the jury to hear that it told the plaintiff about some warnings, but not the one warning about priapism that turned out to be relevant.

Although Cohen agreed that his client's defenses were only being brought for the first time before the SJC, he argued that the court should hear arguments that the defendant had no duty to warn about all of the possible side effects.

Cohen noted that in the defendant's motion for directed verdict and its motion for judgment notwithstanding the verdict it preserved the defense by arguing that "plaintiff has failed to establish in the evidence a duty of a pharmacist to its customer."

Furthermore, the defense attorney asserted that "[t]he need to prove a breach of CVS's duty by expert testimony was properly preserved [because] the existence and scope of the duty to warn is completely intertwined with a determination of how the breach of such a duty must be proven."

Cohen said that appellate courts in Massachusetts have made an exception in the past when "the issue is interrelated with another issue which was preserved below."

The Boston attorney also said that the defendant had no duty to argue that it did not have a general duty to warn, because the plaintiff never claimed that the pharmacy had such a general duty.

Cohen also cited public policy reasons in support of the argument that his client's defenses should be taken into consideration, because "the imposition of such a duty would work a sea change in the current relationship between doctors, pharmacists and consumers."

SJC Also Considering Pharmacy Class-Action Rights

The Supreme Judicial Court also heard arguments recently on the rights of indirect consumers to sue a pharmaceutical company and other manufacturers under Chapter 93A for engaging in a price-fixing scheme involving vitamins.

Last October in Ciardi, et al. v. F. Hoffman-LaRoche, Ltd., et al., Superior Court Judge Margot Botsford concluded that a class of consumers should not be barred by the state's antitrust statute in bringing their Chapter 93A claim "to challenge alleged price-fixing or other forms of anticompetitive conduct."

The class action suit was brought on behalf of Massachusetts consumers who allegedly paid higher retail prices for a variety of products which contained vitamins as a result of a price-fixing scheme perpetrated by a number of manufacturers — some of which have already plead guilty to federal criminal anti-trust charges.

The defendants argued that the consumer protection statute does not allow for claims of unfair competition by indirect consumers because of policy concerns and the governing principle of statutory construction.

Although she found for the plaintiffs, Botsford sent the issue up to the Appeals Court for review, and the SJC took the case sua sponte.

According to Edward D. Rapacki of Boston, the attorney for the consumers, the defendants are basically asking the SJC to incorporate the law set out in the 1977 U.S. Supreme Court decision of Illinois Brick Co. v. Illinois, which held that even though direct purchasers may have passed on the increased cost to the indirect purchasers, the indirect purchasers do not have a remedy against the manufacturers.

But the plaintiffs' attorney argued that the plaintiffs have a right to sue for unfair and deceptive acts under Chapter 93A.

"Our argument is that the provisions of Chapter 93A mean what they say," Rapacki argued. "The statute was designed to provide a unique remedy for consumers that is not in any way cabined by federal interpretations of federal law."

For the defendants, the oral arguments marked the return of former SJC Judge Charles Fried who represented defendants BASF A.G. and BASF Corp. in front of his former colleagues.

Mary Morrissey Sullivan of Boston, attorney for Hoffman-LaRoche, Ltd., did not return phone calls prior to deadline, and other defense counsel could not be reached for comment.

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