Rx & The Law
Do Pharmacists Have A Duty To Warn In Texas? - A Definite Maybe!
By
Kenneth R. Baker, B.S.Pharm., J.D.
Vice President, General Counsel
Pharmacists Mutual Insurance Company
In August 2000, an appellate
court in the State of Texas handed down a pharmacy law decision
in the case of Morgan v. Wal-Mart.[1] Until this
case, Texas courts had not ruled on a duty to warn case, so this
was a case of first impression
in Texas. Most recent decisions in other states had consistently expanded
the concept of pharmacist duty as including something more than the obligation
to correctly fill a prescription as written by the physician. Examples
of courts recognizing expanded professional duties for pharmacists are: the
Tennessee Appellate Court[2] (duty of drug review and duty to warn)
in 1990; the Indiana
Supreme Court[3] (duty to monitor and duty to warn); the Arizona
Court of Appeals[4] (duty to monitor and duty to warn) in 1994,
and the Missouri Court of Appeals[5] (duty of drug review and duty
to warn) in 1999. With this
recent history, the Texas Court’s decision came as a surprise. Recent
decisions have been clear and definitive, but not the Texas decision.
Do pharmacists
have a duty to warn in the State of Texas? The Texas Court
of Appeals managed to spend several pages analyzing the issue and yet failed
to completely answer the question. The Court’s answer can best
be described as “definitely maybe”. The Court should not
be completely castigated, however, since it did reach the correct answer under
the facts of
the case.
Cameron Pettus was a 13-year-old child who tragically
died in 1993 after taking desipramine for two years. The
prescriptions were first filled at Walgreen’s, but in August of 1992,
the prescription was transferred to Wal-Mart. Cameron began suffering
pain, numbness and other symptoms later identified by medical witnesses as
a result of hypereosinophilic syndrome,
a multi-system disease that affected several organs. The physician who performed
the autopsy on Cameron testified the condition was a result of taking desipramine. Physicians
testifying for Wal-Mart reached a different conclusion.
The mother
and father of the deceased child sued several physicians, the manufacturer,
Walgreen’s and Wal-Mart. All defendants, except Wal-Mart, settled
prior to trial, leaving only Wal-Mart who was charged with “failing
to properly warn intended users of the hazards and harms associat[ed] with
the use
of the product.[6]” Trial began in March 1999. When
it concluded the jury returned a finding that Wal-Mart was responsible
for 15% of
the verdict and the mother and father responsible for 9% and 2%, respectively. Wal-Mart
was ordered to pay slightly over one million dollars. Wal-Mart appealed,
as did the parents.
The Court of Appeals quickly determined
that the first question to be answered was “whether Wal-Mart owed
a legal duty to [Cameron and his parents] to warn them of the risks associated
with Cameron’s use of desipramine.[7]” The
Court correctly noted, “If no duty exists, there can be no negligence
liability.[8]” The
Court then began a lengthy, although not exhaustive, review of pharmacists’ “duty
to accurately fill” cases and “duty to warn” cases
from around the country. In its analysis, the Court seemed not
to have noticed the time line of these cases or any significance that
time may
have played in these
decisions. The Court did not seem to be aware of the extent of,
or significance of, recent changes in the profession of pharmacy. Also
missed was the importance of the changes in state court holdings over
a short period of time, most notably
the one hundred eighty degree shift in the Missouri position from the
decision in Kampe to the decision in Horner. In 1999 the Horner Court rejected the earlier decision, stating, “We reject the suggestion
in Kampe that the only functions which a pharmacist must perform to fulfill
his
duty is to dispense
drugs according to a physician's prescription.[9]”
The
Texas Court said, “[T]he prescriptions filled by Wal-Mart [did
not contain] clear errors or obvious inadequacies triggering a duty
to warn.[10]” However,
the Court added, “We do not imply that pharmacists may not warn
patients of potential adverse reactions or dangerous side effects;
we merely hold that
pharmacists are not legally obligated to do so.[11]”
At
this point in the decision, the Court seemed to stumble upon the
truly logical justification for its decision. The OBRA 90 regulations,
as enacted in Texas, provide, as they do in most states, that the
pharmacist should provide
information when counseling “which in the exercise of the pharmacist’s
professional judgment the pharmacist deems significant[12]”,
including “common
severe side effects or adverse effects or interactions[13]”. No
rules, the Court noted, “address a pharmacist’s role
with respect to uncommon adverse reactions[14]” such
as the one in this case. Indeed, in this
case several physicians failed to relate Cameron’s symptoms
with desipramine.
The Court ruled, “Therefore,
we hold that any liability of Wal-Mart’s
for negligently filling Cameron’s prescription for desipramine
must be based on neglect in the face of information on which a
reasonably prudent pharmacist
would have acted.[15]” The Court could have
stopped here noting that, as a matter of law, no reasonable practicing
pharmacist would be likely to consider
counseling a patient on such an obscure potential reaction as that
suffered by Cameron. Instead the Court seemed compelled to
go on. The Court noted
that the pharmacist’s role has changed “from a mere
dispenser of medication to a trusted professional who plays a vital
role in
patient treatment[16]”,
and concluding with “We do not imply that pharmacists may
not warn patients of potential adverse reactions or dangerous side
effects;
we merely hold that
pharmacists are not legally obligated to do so.[17]” But
the Court also said that if a prescription “contained clear
errors or obvious inadequacies[18]”,
this could trigger a duty to warn.
So what is the rule in Texas? The
Court’s holding is a pharmacist‘s
duty is judged by what a reasonably prudent pharmacist would have
done in the same or similar circumstances. That leads to
the conclusion that whether the pharmacist has a duty to warn is
a question of fact: “What would
the reasonably prudent pharmacist have done?” Since
a question of fact is for a jury to determine, a Texas jury could
determine that a pharmacist
may have a duty to warn of common, severe side effects. The
jury would make that determination based upon testimony from experts – practicing
pharmacists. On the other hand, following its holding, the
Court reached a conclusion that “pharmacists have no generalized
duty to warn . . . absent special circumstances.[19]” (emphasis
added).
So, the final answer to whether pharmacists
have a duty to warn in Texas is: “Definitely
maybe”.
[1] Morgan v. Wal-mart, ___ S.W.2d _____, (Tex App.-Austin 2000) [W.L]. Official
cite and page numbering is not yet available.
[2] Dooley v. Everett, 805 S.W.2d 380 (Tenn.App. 1990).
[3] Hooks SuperX, Inc. v. McLaughlin, 642 N.E.2d 514
(1994).
[4] Lasley v. Shrake’s Country Club Pharmacy, Inc., 880 P2d 1129 (Ariz.
Ct. App. 1994).
[5] Horner v. Spalitto, 1 S.W.3d 519 (Mo. Ct App. 1999)
[6] Morgan v. Wal-Mart, supra, at W.L. 4.
[7] Morgan, subra at W.L. 5.
[8] ID
[9] Horner v. Spalitto, 1 S.W.3d 519, 524 (Mo. App.
1999).
[10] Morgan, supra at W.L. 11.
[11] Morgan, supra at W.L. 14
[12] Morgan, supra at W.L. 11; Tex. Admin. Code § 291.33 et seq.
[13] Morgan, supra at W.L. 11; Tex. Admin. Code § 291.33 et seq.
[14] Morgan, supra at W.L. 11
[15] Morgan, supra at W.L. 12
[16] Morgan, supra at W.L. 14
[17] Morgan, supra at W.L. 14
[18] Morgan, supra at W.L. 14
[19] Morgan, supra at W.L. 14
This article discusses general principles
of law and risk management. It is not intended as legal advice. Pharmacists
should consult their own attorneys
and
insurance companies for specific advice. Pharmacists should be familiar with
the policies and procedures of their employers and insurance companies, and
act accordingly. |