Downing v. Hyland Pharmacy

1 According to the FDA,
(continued...)
2008 UT 65
This opinion is subject to revision before final
publication in the Pacific Reporter.
IN THE SUPREME COURT OF THE STATE OF UTAH
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Steven Downing, 	No. 20060771
Plaintiff and Appellant,
v.
Hyland Pharmacy dba United 	F I L E D
Drug Hyland Pharmacy,
Defendant and Appellee. 	September 16, 2008
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Third District, Salt Lake
The Honorable Tyrone E. Medley
No. 040917216
Attorneys: 	D. David Lambert, Leslie W. Slaugh, Provo,
for plaintiff
Jesse C. Trentadue, Kevin D. Swenson, Salt Lake City,
for defendant
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DURHAM, Chief Justice:
INTRODUCTION
¶1 	This appeal raises two related questions: 	(1) whether
a pharmacy may be held liable in negligence for continuing to
fill prescriptions for a drug that has been withdrawn from the
market by the Food and Drug Administration (FDA) and/or the
manufacturer; and (2) whether a pharmacy may be held liable in
negligence for failing to warn the patient of the drug’s status.
The district court granted summary judgment to Hyland Pharmacy on
both questions, concluding that this court’s decision in
Schaerrer v. Stewart’s Plaza Pharmacy, Inc., 2003 UT 43, 79 P.3d
922, precluded the plaintiff’s claims. 	We reverse.
BACKGROUND AND PROCEDURAL HISTORY
¶2 	In early 1996, Dr. Jerry Poulson began prescribing fen-
phen, 1 an appetite suppressant medication, for Steven Downing.

1 (...continued)
[f]en-phen refers to the . . . combination of
fenfluramine and phentermine. 	Fenfluramine
(“fen”) and phentermine (“phen”) are
prescription medications . . . approved by
the FDA for many years as appetite
suppressants for the short-term (a few weeks)
management of obesity. 	Phentermine was
approved in 1959 and fenfluramine in 1973
. . . . 	[S]ome physicians . . . prescribed
fenfluramine or dexfenfluramine in
combination with phentermine, often for
extended periods of time, for use in weight
loss programs. 	Use of drugs in ways other
than described in the FDA-approved label is
called “off-label use.” 	In the case of fen-
phen . . . no studies were presented to the
FDA to demonstrate either the effectiveness
or safety of the drugs taken in combination.
Questions and Answers about Withdrawal of Fenfluramine (Pondimin)
and Dexfenfluramine (Redux),
http://www.fda.gov/cder/news/phen/fenphenqa2.htm (last visited
August 26, 2008).
No. 20060771 	2
From February 1996 until September 2000, Hyland filled Downing’s
prescriptions for fen-phen.
¶3 	On August 16, 2004, Downing brought negligence claims
against Hyland for continuing to fill prescriptions for
fenfluramine, brand name Pondimin, after it was withdrawn from
the market by the FDA and the manufacturer, Wyeth-Ayerst
Laboratories (Wyeth). 	Downing alleged that the pharmacy
negligently filled his fen-phen prescriptions and failed to
remove Pondimin from its shelves and inventory after the
withdrawal. 	Hyland subsequently filed a summary judgment motion
arguing that it was entitled to judgment as a matter of law
because it acted as a reasonable prudent pharmacy in filling
Downing’s prescription and thus did not breach any duty owed to
him. 	The trial court granted Hyland’s summary judgment motion,
holding that Schaerrer protects pharmacists from liability if
they fill a prescription as directed by the manufacturer or
physician. 	See Schaerrer, 2003 UT 43, ¶¶ 33, 35. 	We have
jurisdiction pursuant to Utah Code section 78A-3-102(3)(j) (Supp.
2008).
STANDARD OF REVIEW
¶4 	In reviewing a district court’s grant of summary
judgment, we afford no deference to the lower court’s legal

3 	No. 20060771
conclusions and review them for correctness. 	Schaerrer, 2003 UT
43, ¶ 14. 	The granting of summary judgment is appropriate only
in the absence of any genuine issue of material fact and where
the moving party is entitled to judgment as a matter of law.
Utah R. Civ. P. 56(c). 	Thus, in reviewing a district court’s
grant of summary judgment, we review the facts and all reasonable
inferences in the light most favorable to the nonmoving party.
Surety Underwriters v. E & C Trucking, Inc., 2000 UT 71, ¶ 15, 10
P.3d 338.
¶5 	The question of whether a pharmacist owes a legal duty
in prescribing drugs that have been withdrawn from the market by
the FDA and/or the manufacturer is a question of law, which we
review for correctness, granting no deference to the trial
court’s conclusions. 	Palmer v. Oregon Short Line R. Co., 98 P.
689, 696 (Utah 1908); State v. Blake, 2002 UT 113, ¶ 6, 63 P.3d
56.
ANALYSIS
¶6 	It appears from the record that the trial court assumed
for purposes of its summary judgment ruling that the allegations
in plaintiff’s complaint regarding the withdrawal of the drug
from the market by the manufacturer at the request of the FDA
were true. 	Hyland nowhere in its argument or pleadings in the
trial court or in this court specifically denied the accuracy of
that assertion, although it did raise foundational objections to
exhibits offered by plaintiff in connection with the summary
judgment proceedings establishing that fact, and raised the
possibility with the trial judge that Hyland had not in fact
received notice of the withdrawal. 	In any event, as mentioned
above, the trial judge apparently premised his holding on the
legal conclusion that under no set of circumstances could Hyland
be held liable for negligence in filling prescriptions issued by
a physician under Schaerrer. 	We disagree.
¶7 	Schaerrer involved a products liability claim based on
a pharmacy’s failure to warn of general side effects and/or
dangerousness of an FDA-approved drug (fen-phen, prior to the
time of its alleged removal from the market) prescribed by a
licensed physician. 	2003 UT 43, ¶ 20. 	We adopted the learned
intermediary rule for purposes of exempting pharmacists from
strict products liability, noting the classic concerns that the
rule is intended to address. 	Id. ¶ 22. 	We also made it clear,
however, that the rule made sense in the context of a highly
regulated distribution system for prescription drugs:
So long as a pharmacist’s ability to
distribute prescription drugs is limited by

2 See, e.g., Fagan v. Amerisource Bergen Corp., 356 F. Supp.
2d 198, 212 (E.D.N.Y. 2004) (“New York courts have held that
absent any allegation that a pharmacy failed to fill a
prescription precisely as directed by the manufacturer and/or
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No. 20060771 	4
the highly restricted, FDA-regulated drug
distribution system in this country, and a
pharmacist cannot supply a patient with
prescription drugs without an intervening
physician’s prescription, we will not impose
a duty upon the pharmacist to warn of the
risks associated with the use of prescription
drugs.
Id. 	Many courts examining the learned intermediary rule have
applied it to negligence as well as products liability claims.
See, e.g., Koenig v. Purdue Pharma Co., 435 F. Supp. 2d 551, 554-
55 (N.D. Tex. 2006) (applying the intermediary rule to strict
products liability and negligence claims brought against
pharmaceutical companies under a failure to warn theory);
Krasnopolsky v. Warner-Lambert Co., 799 F. Supp. 1342, 1345
(E.D.N.Y. 1992) (“With regard to the liability of drug
manufacturers, ‘where the theory of liability is failure to warn,
negligence and strict liability are equivalent.’” (quoting Fane
v. Zimmer, Inc., 927 F.2d 124, 130 (2d Cir. 1991))); Kirk v.
Michael Reese Hosp. & Med. Ctr., 513 N.E.2d 387, 396 (Ill. 1987)
(finding that the protection afforded by the learned intermediary
rule in strict products liability claims also extended to
negligence claims for failure to warn); Elliott v. A.H. Robins
Co. (In re New York County Diet Drug Litig.), 691 N.Y.S.2d 501,
502 (N.Y. App. Div. 1999) (“Since there is no allegation that the
pharmacy defendants failed to fill the prescriptions precisely as
they were directed by the manufacturers and physicians . . .
there is no basis to hold the pharmacists liable under theories
of negligence, breach of warranty or strict liability.”). 	We
agree with these courts that the rule makes sense in negligence
as well as strict liability contexts.
¶8 	The majority of recent decisions discussing the rule,
however, have recognized limits or exceptions to its scope in the
negligence context, concluding that its protections extend only
to warnings about general side effects of the drugs in question,
but not to specific problems known to the pharmacist such as
prescriptions for excessively dangerous amounts of the drug or
for drugs contraindicated by information about a patient. 	These
holdings attempt to account for the nature of modern pharmacy
practice and to apply traditional common law negligence rules to
that practice. 2

2 (...continued)
physician, or that the plaintiff had a condition of which the
pharmacist was aware, rendering prescription of the drug at issue
contraindicated, there is no basis to hold the pharmacy liable
under theories of negligence, breach of warranty, or strict
liability.”); Heredia v. Johnson, 827 F. Supp. 1522, 1525 (D.
Nev. 1993) (“At a minimum, a pharmacist must be held to a duty to
fill prescriptions as prescribed and properly label them (include
the proper warnings) and be alert for plain error.”); Walls v.
Alpharma USPD, Inc., 887 So. 2d 881, 885 (Ala. 2004) (agreeing
with the Washington Supreme Court’s conclusion that a pharmacist
“has a duty to accurately fill a prescription and to be alert for
clear errors or mistakes in the prescription”); Lasley v.
Shrake’s Country Club Pharmacy, Inc., 880 P.2d 1129, 1133-34
(Ariz. Ct. App. 1994) (recognizing the possibility of liability
by holding that the question of whether a pharmacist breached a
standard of care by failing to warn a patient of the highly-
addictive nature of a drug or of drug interactions was a question
for the trier of fact); Deed v. Walgreen Co., No. CV03082365 15,
2004 Conn. Super. LEXIS 3412, at *15 (Nov. 15, 2004) (holding
that a pharmacist has a duty to warn in circumstances where
“(1) a pharmacy or pharmacist has specific knowledge of potential
harm to specific persons in particular cases; or (2) the pharmacy
or pharmacist makes a representation that they will engage in a
process of evaluation of the possible effects caused by the
administration of a drug or combination of drugs; or (3) there is
something patently and unambiguously wrong with the prescription
itself, e.g., it is or should be plain that the medication
prescribed provides a fatal dose to the patient.”); Dee v. Wal-
Mart Stores, Inc., 878 So. 2d 426, 427 (Fla. Dist. Ct. App. 2004)
(“A pharmacy must use due and proper care in filling a
prescription. 	When a pharmacy fills a prescription which is
unreasonable on its face, even though it is lawful as written, it
may breach this duty of care.” (citation omitted)); Happel v.
Wal-Mart Stores, Inc., 766 N.E.2d 1118, 1129 (Ill. 2002) (“[A]
narrow duty to warn exists where, as in the instant case, a
pharmacy has patient-specific information about drug allergies,
and knows that the drug being prescribed is contraindicated for
the individual patient. In such instances, a pharmacy has a duty
to warn either the prescribing physician or the patient of the
potential danger.”); Gassen v. E. Jefferson Gen. Hosp., 628 So.
2d 256, 259 (La. Ct. App. 5 Cir. 1993) (“[A] pharmacist has a
limited duty to inquire or verify from the prescribing physician
clear errors or mistakes in the prescription.”); Cottam v. CVS
Pharmacy, 764 N.E.2d 814, 823 (Mass. 2002) (finding that where a
pharmacist has undertaken a duty, it was appropriate to impose
upon the pharmacist “a duty commensurate with what it appeared to
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5 	No. 20060771

2 (...continued)
have undertaken”); Stebbins v. Concord Wrigley Drugs, Inc., 416
N.W.2d 381, 387-88 (Mich. Ct. App. 1987) (“[A] pharmacist has no
duty to warn the patient of possible side effects of a prescribed
medication where the prescription is proper on its face
. . . .”); Horner v. Spalitto, 1 S.W.3d 519, 523-24 (Mo. Ct. App.
1999) (finding that although the physician is in the best
position to determine what drug to prescribe to the patient, the
pharmacist’s duties should not be defined as merely that of an
order filler. 	Thus holding that pharmacists are in the best
position to alert the prescribing physician where a prescription
is outside a normal range or where there are any
“contraindications relating to other prescriptions the customer
may be taking as identified by the pharmacy records, and to
verify that the physician intended such a dose for a particular
patient”); Hand v. Krakowski, 453 N.Y.S.2d 121, 122-23 (N.Y. App.
Div. 1982) (recognizing a possibility of a duty on a pharmacy to
warn an alcoholic patient because it knew or should have known
that the drug prescribed to the alcoholic patient was
contraindicated for individuals who were alcoholics); Ferguson v.
Williams, 374 S.E.2d 438, 440 (N.C. Ct. App. 1988) (“While a
pharmacist has no duty to advise absent knowledge of the
circumstances . . . once a pharmacist is alerted to the specific
facts and he or she undertakes to advise a customer, the
pharmacist then has the duty to advise correctly.”); Riff v.
Morgan Pharmacy, 508 A.2d 1247, 1253 (Pa. Super. Ct. 1986)
(allowing expert testimony that the failure of the pharmacy to
notify the prescribing physician of obvious inadequacies on the
face of the prescription was negligent); Pittman v. Upjohn Co.,
890 S.W.2d 425, 434 (Tenn. 1994) (holding that a pharmacist may
have a duty to warn where he knew that the physician failed to
relay to the patient certain warnings the manufacturer required
be given to the patient); Morgan v. Wal-Mart Stores, Inc., 30
S.W.3d 455, 466-67 (Tex. App. 2000) (holding that although
pharmacists have no general duty to warn, pharmacists may be held
liable for negligently filling a prescription and neglecting
information on the face of the prescription where a reasonably
prudent pharmacist would have acted); McKee v. Am. Home Prods.
Corp., 782 P.2d 1045, 1052-55 (Wash. 1989) (holding that a
pharmacist has a duty “to be alert for clear errors or mistakes
in the prescription,” such as where a prescription contains
obvious lethal dosages, inadequate instructions, known
contraindications, or incompatible prescriptions).
No. 20060771 	6
¶9 	We observed in Schaerrer that pharmacists have a
“generally recognized duty to possess and exercise the reasonable
degree of skill, care, and knowledge that would be exercised by a
reasonably prudent pharmacist in the same situation,” 2003 UT 43,
¶ 35 (internal quotation marks and citation omitted), but we were

7 	No. 20060771
not required in that case to address the interface between that
standard and the learned intermediary rule. 	We do not address
that interface here, except to note that our application of the
rule in Schaerrer does not mean that we will not limit its
application to negligence claims when the facts and public policy
require such limitation.
¶10 	We conclude that this is such a case. 	The facts
alleged here state a cause of action for negligence as a matter
of law. 	A pharmacist owes the consumer a duty of reasonable care
with respect to the sale of drugs not authorized for sale by the
FDA or the manufacturer. 	Our declaration that a duty exists does
not, however, establish what the pharmacist’s standard of care
is; that is a factual matter that must be examined on remand.
“[W]here the question is one simply of determining, under all the
facts, whether a legal duty is created, the question is one of
law,” Palmer, 98 P. at 696, but “[o]rdinarily, whether a
defendant has breached the required standard of care is a
question of fact for the jury,” Jackson v. Dabney, 645 P.2d 613,
615 (Utah 1982) (citation omitted).
¶11 	This difference between duty--a question of law, and
standard of care is treated in Prosser and Keeton:
It is better to reserve “duty” for the
problem of the relation between individuals
which imposes upon one a legal obligation for
the benefit of the other, and to deal with
particular conduct in terms of a legal
standard of what is required to meet the
obligation. In other words, “duty” is a
question of whether the defendant is under
any obligation for the benefit of the
particular plaintiff; and in negligence
cases, the duty is always the same--to
conform to the legal standard of reasonable
conduct in the light of the apparent risk.
What the defendant must do, or must not do,
is a question of the standard of conduct
required to satisfy the duty.
W. Page Keeton et al., Prosser and Keeton on the Law of Torts
§ 53 (5th ed., Lawyer’s ed. 1984).
¶12 	The Arizona Court of Appeals examined this problem very
effectively in Lasley v. Shrake’s Country Club Pharmacy, Inc.,
pointing out that health care providers (including pharmacists)
are “held to a higher standard of care than that of the
ordinarily prudent person when the alleged negligence involves

No. 20060771 	8
the defendant’s area of expertise.” 	880 P.2d 1129, 1132 (Ariz.
Ct. App. 1994) (citing Bell v. Maricopa Med. Ctr., 755 P.2d 1180,
1182 (Ariz. Ct. App. 1988)). 	Expert testimony and relevant
statutory and regulatory standards will be relevant to
establishing what the standard of care is for a pharmacist
filling prescriptions for a drug withdrawn from the market at the
request of the FDA. 	It will be for the fact-finder to determine
what the standard is and whether it was breached in this case.
CONCLUSION
¶13 	We hold that the learned intermediary rule does not
preclude as a matter of law a negligence claim against a
pharmacist for dispensing a prescribed drug that has allegedly
been withdrawn from the market, and that pharmacists under such
circumstances owe their customers a duty of reasonable care. 	We
thus reverse the summary judgment dismissing the plaintiff’s
claims and remand this case to the trial court for further
proceedings. 	This will presumably include the development of the
record on the question of withdrawal of the drug and the standard
of care for a reasonable pharmacist under the circumstances.
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¶14 	Associate Chief Justice Durrant, Justice Wilkins,
Justice Parrish, and Justice Nehring concur in Chief Justice
Durham’s opinion.