On Dec. 10, 2007, the
Massachusetts Supreme Judicial court handed down a decision that, in a single
brushstroke, significantly expanded the scope of a physician’s duty beyond the
traditional obligation towards his or her patient. In Coombes
v. Florio, 450 Mass. 182 (2007), a deeply divided Court held that a
physician owes a duty of reasonable care to everyone foreseeably put at risk by
the physician’s failure to warn of the side effects of his or her treatment of
a patient. Although the majority decision, authored by Justice Roderick L.
Ireland, with Justices Francis X. Spina and Judith A. Cowin joining, is
striking in its expansion of the scope of a physician’s duty, the various
dissenting opinions are equally notable for the depth of divisions expressed by
the Court. This article examines the majority and dissenting opinions, and the
case’s likely impact on medical malpractice litigation and health care delivery
by Massachusetts physicians.
Background
The facts that give rise to the Coombes
case are tragic. On March 22, 2002, 9-year-old Kevin Coombes was struck and
killed by an automobile when the driver, David Sacca, lost consciousness while
behind the wheel. The cause of the accident was never determined. At the time
of the accident, Sacca was 75 years old and had been diagnosed with a number of
medical conditions, including asbestosis, chronic bronchitis, emphysema, high
blood pressure and metastatic lung cancer that had spread to his lymph nodes.
He was under the care of multiple specialists. Dr. Roland Florio was Sacca’s
primary care physician and was responsible for coordinating all of the medications
prescribed to Sacca.
The medications that Sacca was taking at the
time of the accident include Oxycodone, Zarxolyn, Predinsone, Flomax,
Potassium, Paxil, Oxazepam and Furosemide. Florio failed to warn Sacca that
these drugs carried potential side effects including drowsiness, dizziness,
lightheadedness, fainting, altered consciousness and sedation. He further
failed to warn Sacca not to drive a motor vehicle while taking these
medications. Prior to the accident, Sacca did not report any of the
aforementioned side effects to Florio and did not report any trouble operating
an automobile.
The plaintiff brought a lawsuit alleging that
Florio negligently failed to warn Sacca of the known potential side effects of
the medications prescribed to him, and failed to warn him not to drive, which
ultimately resulted in the death of Coombes. The trial court granted summary
judgment in favor of Florio on the grounds that there was no doctor-patient
relationship between Florio and Coombes, and thus Florio owed Coombes no duty.
The plaintiff appealed and the Supreme Judicial Court took the case on its own
motion. The Supreme Judicial Court reversed the judgment, concluding that a
duty could be found between Florio and Coombes, and remanded the case to the
trial court for further proceedings.
The majority opinion (Ireland, with Spina
and Cowin joining)
The Court began its decision by clarifying the
nature of plaintiff’s claim. Noting the lack of a physician-patient
relationship between Florio and Coombes, the Court observed that plaintiff is
unable to bring a medical malpractice claim. Instead, the claim proceeds under
ordinary principles of negligence. Under general principles of tort law, the
linchpin of a negligence claim is the presence of a duty flowing from the
defendant to plaintiff. A duty may be found when the risk of harm is
recognizable or foreseeable to the actor. The Court determined that there is a
foreseeable risk of an automobile accident caused by driving under the
influence of prescription medication with side effects that cause diminishment
of a patient’s mental capacity. By this reasoning, the Court found that the
physician defendant “owes a duty of care to all persons who are foreseeably
endangered by his conduct, with respect to all risks which make the conduct
unreasonably dangerous.” Coombes at 187 (quoting Tarasoff
v. Regents of Univ. of Cal., 551 P.2d 334 (1976)). Consequently, in
the majority opinion, the Court held that the physician owes a duty of
reasonable care to everyone foreseeably put at risk by his failure to warn of
the side effects of his treatment of a patient.
The Court furthermore specifically declined to
limit liability for a doctor’s duty to warn to situations where the drugs in
question were used in the presence of the physician, as other jurisdictions
have done. See, e.g., Cheeks v. Dorsey, 846 So.2d 1169, 1173
(Fla.Dist.Ct.App. 2003); Lester v. Hall, 126 N.M.
404, 406-407 (1998). The rationale behind the reluctance to keep the scope of liability
narrow is that the burden involved is not heavy. The Court reasoned that the
duty to third parties does not require anything further than what would satisfy
the duty that the physician already owes to his or her patient under existing
Massachusetts tort law. Cottam v. CVS Pharmacy, 436
Mass. 316 (2002), an informed consent case, sets out a
physician’s duty to provide appropriate warnings about side effects when
prescribing medication. Furthermore, the physician’s duty does not extend to
third parties with respect to decisions regarding which medication to
prescribe.
Acknowledging a concern that its decision could
negatively impact rates for medical malpractice insurance, as well as the
number of statutes enacted by the Legislature that limit the liability of
physicians in order to keep malpractice insurance rates down, the Court left to
the Legislature the task of determining whether to impose further limits on the
scope of a doctor’s liability.
The dissenting opinions (Greaney,
concurring in part, dissenting in part; Marshall dissenting; Cordy dissenting)
Justice John M. Greaney concurred in part and
dissented in part, finding that when a physician has knowledge of a danger that
may be posed to others by a patient’s decision to operate a motor vehicle under
the influence of a prescribed medication and fails to warn the patient of the
risks involved, the imposition of a limited liability to others is appropriate,
in the interests of preventing the tragedy that occurred in the Coombes
case from happening again. Greaney does, however, take issue with the
“extraordinary” creation of a precautionary duty previously unknown in common
law, and one which goes beyond the relief requested in the case.
Greaney’s dissent is based upon a disagreement
with the majority’s conclusion that the proffered relief is based upon
principles of ordinary negligence, rather than settled medical malpractice law.
He observes that this outcome leads to the imposition of a sweeping legal duty
of care on the part of physicians to virtually everyone who may come in contact
with one of his or her patients. He particularly takes issue with the equation
by the majority of the prescribing of medications to “unreasonably dangerous”
conduct, similar to the reckless storage of firearms, which creates a general
affirmative duty of care to others. Greaney suggests that such a stance
intrudes upon the traditional physician-patient relationship. He finds that a
physician should not, in ordinary circumstances, be held legally responsible
for the safety of others, on the highway or elsewhere, based on medical
treatment afforded a patient.
Greaney does find that a physician has a duty to
warn the patient of potentially dangerous side effects of a medication. The
duty arises, however, solely within the context of the physician-patient
relationship, and is owed strictly to the patient. Nevertheless, the violation
of that duty, within the framework of the standard of care principles of
medical malpractice law, may, in certain circumstances, result in liability in
negligence to others who are foreseeably injured as a direct result of the
violation.
Chief Justice Margaret H. Marshall offers a
particularly assertive dissent to the majority opinion, and also disagrees with
Greaney’s more nuanced take. Marshall holds the line regarding the expansion of
a physician’s duty, and takes the position that the Superior Court properly
granted summary judgment on the grounds that Florio owed no duty to the
decedent.
In particular, Marshall disagrees with the
majority’s assertion that Cottam imposes a blanket
duty to warn a patient of the adverse side effects of medication. Noting that Cottam
was an informed consent case, Marshall underscores the language of
the opinion that leaves to the physician the decision to warn their patients on
occasions when they find it to be necessary and relevant. Rather than offering
a strict rule to warn as a matter of course, the Cottam decision
defers to the physician’s reasoned judgment on whether a warning is necessary.
By reconfiguring the Cottam decision in this fashion, Marshall
suggests that the majority is interfering with the physician-patient
relationship, with deleterious results. She states, “The physician’s concern
for a patient’s ability to assess information about needed and appropriate
treatment would be forced to compete with concern for an amorphous, but
widespread, group of third parties whom a jury might one day determine to be
‘foreseeable’ plaintiffs.” Coombes at 203.
Cordy’s dissent echoes that of Marshall. Cordy
acknowledges that the Court has, under limited circumstances, recognized a duty
where an unreasonably dangerous condition involves the foreseeable negligent
conduct of an intermediary. He disagrees that such a situation is presented
when a physician prescribes a medication for a patient. He distinguishes the
normal scenario involving an inherently dangerous situation, one requiring a
stock warning, and the process of communication involved in the
physician-patient relationship, in which the patient is the sole focus and the
advantages and risks of a particular treatment are discussed and weighed. Cordy
expresses concern that a doctor’s advice and judgment will be greatly affected
by the majority holding, raising the specter that the patient will now simply
be handed a printout of all possible side effects and be asked to read and sign
as a substitute for a discussion more tailored to the physician’s judgment
about the patient’s particular situation and needs.
Cordy cites other policy concerns as well. He
states, “it is hard to imagine a plaintiff’s attorney failing in negligence
cases to sue not just the negligent party who caused the injury but also his or
her doctor,” increasing costs and threatening the confidentiality of the
treatment records called into question by the third party. Coombes
at 212.
Analysis
The Coombes decision does not
change the scope of the physician’s duty to the patient vis-à-vis informed
consent discussions prior to prescribing medications. What it does change is
the scope of persons that physicians are liable to as a result of the
physician’s interactions with his or her patients. Under previous Massachusetts
law, third parties such as Coombes were not included in the potential scope of
a physician’s liability because there was no physician-patient relationship.
This decision expands that scope to include third parties injured as a result
of a physician’s failure to warn a patient not to drive while on impairing
medications.
The Cottam decision, prominently
discussed by the Court, focuses on the information a patient is entitled to
with respect to prescription medications and includes reference to a
physician’s judgment in that regard. Ireland quotes language directly from the Cottam
opinion, underscoring that physicians are obligated to inform
patients of side effects they deem “necessary and relevant” for patients to
know in making an informed decision. Coombes at 188 (quoting Cottam
v. CVS Pharmacy at 321). In the Coombes case, it is
unrebutted that Florio failed to issue a warning against driving immediately
prior to the events in question. Whether a warning was necessary and relevant,
however, is the question that remains at issue. At trial, expert testimony will
be needed to address this question. With respect to the determination of
liability, the Coombes case will proceed in Superior Court like
any other medical malpractice case, with an inquiry as to whether the standard
of care required such a warning.
In terms of medical malpractice law, the basic
tenets regarding the standard that physicians are held to are undisturbed. In
addition to the obligations set out in Cottam as discussed by the
Court, a physician has, and continues to have, a duty to his or her patient to
comply with the standard of care expected of the average physician practicing
in that specialty at the time and under the circumstances. See, e.g., Brune
v. Belinkoff, 354 Mass. 102 (1968). A
physician also owes his or her patient the duty to disclose all significant
medical information that is material to an informed decision by the patient on
whether to proceed with the proposed treatment. See, e.g., Precourt
v. Frederick, 395 Mass. 689 (1985); Harnish v. Children’s
Hosp. Med. Ctr., 387 Mass. 152, 155 (1982). Accordingly, the duty
that a physician owes to his or her patient remains unchanged.
An important question is whether the majority
opinion’s language about side effects involving mental impairment will create a
de facto standard of care regarding warnings on those side effects in
connection with driving. Ireland states in his opinion, “When the side effects
in question include drowsiness, dizziness, fainting or other side effects that
could diminish a patient’s mental capacity, this warning serves to protect the
patient from, for example, the foreseeable risk of an automobile accident.” Coombes
at 188. From a liability standpoint, physicians prescribing
medications with the aforementioned side effects would be prudent to keep in
mind their obligation to provide a warning about driving, if they find it to be
necessary and relevant for the patient. The same considerations require a
careful documentation of the advice and instruction rendered.
There will likely be some increase in the number
of cases filed against physicians as a result of the Coombes
decision. Physicians may become unwilling participants in automobile accidents
as parties undertake discovery to determine whether the influence of prescription
medication was a factor in causing the accident. If so, the Legislature will
need to step in with protective legislation in order to avoid an increase in
malpractice insurance rates and an exodus of physicians from the commonwealth.
Conclusion
It remains to be seen what the outcome of the Coombes
case will be in Superior Court. Time will also tell whether there is an appreciable
increase in the cases being filed on behalf of third parties against
physicians. In the mean time, physicians should be counseled against practicing
defensive medicine as a result of this decision, because the nature of their
duty to patients with regard to prescribing medications remains unchanged.