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, www.masslaw.com.
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.
© 2001 Lawyers Weekly Inc., All Rights Reserved.