|||TEXAS COURT OF APPEALS, THIRD DISTRICT, AT AUSTIN
|||August 10, 2000
|||JACQUELYN MORGAN AND CHARLES PETTUS, INDIVIDUALLY AND AS HEIRS TO THE
ESTATE OF CAMERON PETTUS/WAL-MART STORES, INC. D/B/A WAL-MART, APPELLANTS
WAL-MART STORES, INC. D/B/A WAL-MART/JACQUELYN MORGAN AND CHARLES PETTUS, INDIVIDUALLY AND AS HEIRS TO THE ESTATE OF CAMERON PETTUS, APPELLEES
|||FROM THE DISTRICT COURT OF TRAVIS COUNTY, 126TH JUDICIAL DISTRICT NO.
95-07922, HONORABLE F. SCOTT MCCOWN, JUDGE PRESIDING
|||Before Justices Jones, Yeakel and Patterson
|||The opinion of the court was delivered by: Jan P. Patterson, Justice
|||As amended September 14, 2000
|||The issue presented is whether pharmacists have a duty under Texas law
to warn of potentially adverse reactions to prescription drugs. Jacquelyn
Morgan and Charles Pettus ("plaintiffs") sued Wal-Mart Stores,
Inc. individually and as heirs to the estate of their minor child, Cameron
Pettus. Plaintiffs alleged that Cameron's death in August 1993 was caused
by an adverse reaction to Desipramine, a prescription drug sold to Morgan
for Cameron's use by a Wal-Mart pharmacist. A jury found that Wal-Mart's
negligent failure to warn of the known dangers of Desipramine was a proximate
cause of Cameron's death, and the trial court assessed actual damages of
$1,012,000, together with pre- and post-judgment interest. We reverse the
judgment of the trial court and render a take-nothing judgment in favor
|||Jacquelyn Morgan gave birth to Cameron Pettus on January 31, 1979. After
her divorce from Cameron's father Charles in 1985, Morgan was awarded managing
conservatorship of Cameron and his older sister Regina. In 1989, Cameron
began sixth grade at Cornerstone Christian School in Leander. Morgan, who
taught both fifth and sixth grade at Cornerstone, was his teacher. Morgan
testified that through various school-related seminars and workshops, she
had become aware of and interested in Attention Deficit Hyperactivity Disorder
("ADHD"). As Cameron's teacher, she began to notice that he exhibited
what she perceived as behavior consistent with ADHD, such as hyperactivity,
difficulty completing assigned tasks, and difficulty remaining quiet. Seeking
a professional's opinion, Morgan took Cameron to Neil King, a psychologist
who had previously evaluated other students at Cornerstone for ADHD.
|||King told Morgan that the information she provided him about Cameron's
behavior indicated that Cameron had ADHD, and he asked whether she would
like to try a course of medication. Morgan agreed. King also asked Morgan
if Cameron experienced mood swings. Based on her affirmative answer, King
recommended Desipramine, which he described as an antidepressant effective
in controlling mood swings in children. King suggested Morgan make an appointment
with Dr. Lorraine Schroeder to obtain a prescription for Desipramine.
|||Morgan met with Dr. Schroeder on April 26, 1991. In her deposition, Schroeder
testified that she and Morgan discussed several medications, including Ritalin,
Dexedrine, Cylert, and Desipramine. Schroeder testified that Morgan stated
her brother was taking Desipramine for adult ADHD, and Schroeder told Morgan
her son was taking Imipramine, which is chemically similar to Desipramine.
Schroeder further testified that she showed Morgan an entry for tricyclic
antidepressants in the Physician's Desk Reference.*fn1
The entry described common side effects associated with the group of antidepressants,
such as dry eyes and mouth and increased pulse rate. Schroeder also explained
to Morgan that she watched her own son closely for rapid heartbeat. Based
on her own knowledge of Desipramine and Morgan's familiarity with the drug,
Schroeder prescribed Desipramine for Cameron.*fn2
|||Cameron began taking Desipramine in April 1991 at age twelve after Morgan
purchased the drug at a Walgreen's pharmacy. Morgan testified that the pharmacist
did not provide her with any information about the drug, nor did she ask
any questions of the pharmacist.
|||In June 1991, Morgan took Cameron to a Pro Med minor emergency center
after he complained of chest and groin pain. The doctor at Pro Med told
Morgan that Cameron was probably experiencing "musculoskeletal"
pain related to his participation in sports. Morgan testified that when
she informed Dr. Schroeder of the Pro Med visit, Schroeder agreed with the
Pro Med doctor's diagnosis and did not express any concern about Cameron's
use of Desipramine.
|||In September 1991, Cameron again complained of chest pains. Morgan took
him to the Round Rock Hospital emergency room where he was diagnosed with
pleurisy. Morgan testified that she found this diagnosis curious because
she understood pleurisy to be a secondary illness that typically followed
a primary illness. The treating physician at the hospital told Morgan that
Cameron's condition would "clear up on its own." Morgan informed
the doctors at the hospital that Cameron was taking Desipramine, but they
did not attribute Cameron's chest pains to the drug.
|||On August 21, 1992, Morgan requested a transfer of Cameron's prescription
from Walgreen's to Wal-Mart because Wal-Mart was less expensive. Morgan
testified that when she went to Wal-Mart to pick up the medication, she
"walked in and asked for the prescription for Cameron. And the checkout
person gave me the prescription and charged me the money for it and I left
and went home." The parties agree that no Wal-Mart pharmacist orally
counseled Morgan about Desipramine's possible side effects; they also agree
that Wal-Mart did not give Morgan the drug manufacturer's package insert,
which contains substantial technical information about Desipramine, including
warnings of potential adverse reactions.*fn3
Pursuant to valid prescriptions from Dr. Schroeder, Morgan purchased Desipramine
three more times at Wal-Mart, the last time in February 1993.*fn4
Morgan testified that at no time did a Wal-Mart pharmacist advise her of
anything with respect to the drug.
|||Irene Franklin, a pharmacist at the Wal-Mart where Morgan purchased Desipramine,
testified that during a typical ten-hour shift in 1992 and 1993, she filled
about 150 prescriptions. Although Franklin could not recall meeting Morgan,
Franklin identified a Wal-Mart business record indicating that on October
24, 1992, she filled a prescription for 25 milligrams of Desipramine for
Cameron Pettus. Franklin testified that Wal-Mart computers generate two
documents each time a prescription is filled. The first document is a prescription
label; the second document contains the patient's receipt and information
from a national database about the drug, such as its generic name, common
uses, and possible side effects. Franklin testified that it is common practice
at Wal-Mart to staple the sheet containing the receipt and drug information
to the outside of the bag in which the drug is placed. Morgan specifically
denied receiving from Wal-Mart any printed warnings about Desipramine, although
she acknowledged that she disposed of all paperwork related to the drug
after Cameron's death.
|||Franklin further testified that it is not uncommon to fill a prescription
for a tricyclic antidepressant and that common problems reported by persons
taking such drugs are dry eyes, dry mouth, and constipation. Franklin testified
that when she filled the Desipramine prescription on October 24, 1992, she
was aware the prescription had been transferred from Walgreen's and thus
assumed Morgan had already been adequately informed of the proper use and
possible side effects of the drug. Therefore, Franklin did not feel it was
necessary to give Morgan any warnings beyond those typically found on the
pages generated by Wal-Mart's computers.*fn5
|||In July 1993, Cameron visited his father, Charles Pettus, for two weeks.*fn6
Before Cameron left home, he complained to Morgan of feeling "itchy."
Pettus testified that when he picked up Cameron from Morgan's house, he
noticed red bumps and a large scrape on Cameron's legs. Cameron attributed
the bumps to mosquito bites he had received while camping and the scrape
to a bicycle accident. During his visit with Pettus, Cameron complained
of a lump near his groin. Pettus took Cameron to a Pro Med clinic on July
16, 1993. Pettus testified that Cameron told the treating physician that
he was taking Desipramine to treat his ADHD. The doctor concluded that Cameron
had an infected lymph node from the mosquito bites and prescribed antibiotics.
Pettus purchased the antibiotics at an Albertson's grocery store pharmacy.
He testified that Cameron told the pharmacist he was taking Desipramine,
but Pettus could not recall the pharmacist expressing any particular concern.
|||Pettus further testified that the wounds on Cameron's legs darkened over
the next several days. During the early morning hours of July 19, 1993,
Cameron awoke complaining of pain in his chest and penis. Pettus drove Cameron
to Seton Northwest Hospital. After taking x-rays, running tests on Cameron's
blood, and placing him on an I.V., the physicians told Pettus that Cameron
was dehydrated, which Pettus found unusual because Cameron was an active
child who drank "tons of fluid all the time."
|||The next night, Cameron again complained of chest pains and numbness in
one of his arms, and Pettus returned to Seton. After an examination, one
of the doctors took Pettus aside and suggested that Cameron was imagining
his ailments. Pettus returned Cameron to Morgan the next day. Pettus testified
he never informed Dr. Schroeder of Cameron's health problems nor did he
speak to Morgan about Cameron's medical problems, although he did send the
paperwork he had received at Pro Med and Seton with Cameron so he could
give it to Morgan.
|||Upon Cameron's return home, Morgan observed the large, dark wounds on
his legs. Cameron told Morgan he had been to the emergency room and was
taking antibiotics. Cameron's condition worsened overnight, so the next
morning Morgan called Dr. Schroeder, who was unavailable. Dr. Woodall, an
associate of Dr. Schroeder's at PCA Medical Group of Texas, agreed to examine
Cameron. After receiving the results of chest x-rays and blood work, Woodall
instructed Morgan to immediately take Cameron to Brackenridge Children's
|||The next day, July 23, a surgeon at Brackenridge removed one of Cameron's
lymph nodes. The surgeon told Morgan that Cameron would be fine, although
he expressed surprise that the lymph node was "necrotic, blackened
and dead" rather than swollen. Shortly after surgery, Cameron became
extremely agitated and scared. He told Morgan he needed to go to the bathroom
and that he felt like he was dying. Attempts to put an I.V. into his arm
failed, and nurses were forced to give him a groin I.V. Soon thereafter,
Cameron slipped into a coma. On August 2, 1993, Cameron was declared brain
dead and removed from life support.
|||Dr. James Sharp prepared a report that day in which he concluded that
Cameron died of "[h]ypereosinophilic syndrome, a multi-system disease
with primary organ systems involved being his liver, kidney and central
nervous system." Morgan and Pettus allowed Dr. Roberto Bayardo to perform
an autopsy on Cameron. Dr. Bayardo also opined that Cameron died of hypereosinophilic
syndrome, which he described as "a syndrome that consists of a high
number of eosinophils in the blood, also in the bone marrow.*fn7
And as a result of that, there is involvement of the heart, the lungs, the
liver and several other internal organs." Bayardo concluded that Cameron
suffered the hypereosinophilic syndrome as a result of taking Desipramine.*fn8
|||In their original petition filed June 26, 1995, plaintiffs sued Dr. Schroeder,
Dr. Woodall, PCA Medical Group of Texas, Neil King, Sidmak Laboratories,
Walgreen's, and Wal-Mart. Plaintiffs later amended their petition to name
several other defendants.*fn9
Before trial began in March 1999, plaintiffs settled or dismissed their
claims against Dr. Schroeder; Dr. Woodall; PCA Medical Group of Texas; Neil
King; Sidmak Laboratories; Walgreen's; and Terence MacConnell, M.D., individually
and d/b/a Pro Med, leaving Wal-Mart as the only remaining defendant.
|||In their amended petition, plaintiffs alleged Wal-Mart was negligent in
the sale of Desipramine "by failing to properly warn intended users
of the hazards and harms associated with the use of the product." Plaintiffs
contended that Wal-Mart's negligence was the proximate cause of Cameron's
health problems and death, as well as their own mental anguish, loss of
consortium, and loss of family relationship. After a three-day trial, the
jury was asked whether the death of Cameron Pettus was proximately caused
by the negligence of any of the following parties: Wal-Mart, Walgreen's,
Dr. Schroeder, Jacquelyn Morgan, or Charles Pettus. The jury answered affirmatively
in each case and apportioned responsibility for Cameron's death in the following
manner: Dr. Schroeder-60%; Wal-Mart-15%; Walgreen's-14%; Morgan-9%; Pettus-2%.
Based on these answers and the jury's answers to the damage questions, the
trial court ordered that Morgan and Pettus, as heirs to the estate of Cameron
Pettus, recover $674,500 in actual damages from Wal-Mart. The trial court
also ordered that both Morgan and Pettus individually recover $168,750.
|||On appeal, Wal-Mart argues that as a matter of law its pharmacists had
no duty to warn of the potential dangers of Desipramine because that duty
rested with the prescribing physician. Wal-Mart further contends that even
if it did owe such a duty, there is legally and factually insufficient evidence
to prove that Wal-Mart's failure to warn was a proximate cause of damages.
Jacquelyn Morgan and Charles Pettus also appeal, arguing that there is legally
insufficient evidence to support the jury's findings that their negligence
proximately caused Cameron's death.
|||A common law negligence action has three elements: (1) a legal duty owed
by one person to another; (2) a breach of that duty; and (3) damages proximately
resulting from the breach. See Prasel v. Johnson, 967 S.W.2d 391, 394 (Tex.
1998). Thus, the threshold question in this case is whether Wal-Mart owed
a legal duty to the plaintiffs to warn of the risks associated with Cameron's
use of Desipramine. Whether a duty exists is a question of law for the reviewing
court to decide under the facts surrounding the occurrence in question.
See Lefmark Management Co. v. Old, 946 S.W.2d 52, 53 (Tex. 1997). If no
duty exists, there can be no negligence liability.
|||In filling and refilling prescriptions, pharmacists are required to exercise
the high degree of care that a very prudent and cautious person would exercise
under the same or similar circumstances in that business. See Burke v. Bean,
363 S.W.2d 366, 368 (Tex. Civ. App.-Beaumont 1962, no writ); see also Speer
v. United States, 512 F. Supp. 670, 679 (N.D. Tex. 1981) (citing Burke).
This Court has held that pharmacists owe purchasers of prescription medication
"the highest practicable degree of prudence, thoughtfulness and vigilance
and the most exact and reliable safeguards consistent with the reasonable
conduct of the business in order that human life may not constantly be exposed
to the danger flowing from the substitution of deadly poisons for harmless
medicines." Dunlap v. Oak Cliff Pharmacy Co., 288 S.W. 236, 237 (Tex.
Civ. App.-Austin 1926, writ ref'd). A pharmacist who inaccurately fills
a prescription is therefore liable to the customer for resulting harm.*fn10
|||While it is apparent then that Wal-Mart owed the plaintiffs a duty to
dispense Desipramine in accordance with Dr. Schroeder's prescription, no
Texas court has yet considered whether a pharmacist is also obligated to
warn customers of potential hazards or side effects of prescribed drugs.
See Alison G. Myhra, The Pharmacist's Duty to Warn in Texas, 18 Rev. Litig.
27, 32 (1999). A majority of courts considering this question have held
that a pharmacist has no such duty when the prescription is proper on its
face and neither the physician nor the manufacturer has required that the
pharmacist give the customer any warning. See David J. Marchitelli, Annotation,
Liability of Pharmacist Who Accurately Fills Prescription for Harm Resulting
to User, 44 A.L.R.5th 393, 411-20, 470-75 (1996); 28 C.J.S. Drugs and Narcotics
§ 52 (1996); 25 Am. Jur. 2d Drugs and Controlled Substances §§ 239, 241
(1996). The reluctance of courts to hold pharmacists liable for injuries
caused by drugs accurately dispensed according to the terms of a valid prescription
can be attributed to the application of the "learned intermediary"
doctrine, which typically acts as an exception to a manufacturer's duty
to warn customers in products liability cases. See Steven W. Huang, The
Omnibus Reconciliation Act of 1990: Redefining Pharmacists' Legal Responsibilities,
24 Am. J. L. and Med. 417, 423 (1998); see also Restatement (Second) of
Torts § 402A cmt. k (1965).
|||According to this doctrine, the manufacturer of a prescription drug has
a duty to adequately warn the prescribing physician of the drug's dangers.
The physician, relying on his medical training, experience, and knowledge
of the individual patient, then chooses the type and quantity of drug to
be prescribed. See Rolen v. Burroughs Wellcome Co., 856 S.W.2d 607, 609
(Tex. App.-Waco 1993, writ denied). The physician assumes the duty to warn
the patient of dangers associated with a particular prescribed drug. See
id.; see also Alm v. Aluminum Co., 717 S.W.2d 588, 591-92 (Tex. 1986); Reyes
v. Wyeth Lab., 498 F.2d 1264, 1276 (5th Cir. 1974) (doctor understands dangers
involved in use of given drug and therefore acts as learned intermediary
between manufacturer and patient).
|||A leading case in which the learned intermediary doctrine was applied
to a negligence action against a pharmacy is McKee v. American Home Products
Corp., 782 P.2d 1045 (Wash. 1989). In McKee, the plaintiff received prescriptions
from her doctor for an appetite suppressant known as Plegine. See 782 P.2d
at 1046. The Physician's Desk Reference entry for Plegine cautions that
it is a potentially addictive amphetamine; therefore, its use should be
discontinued within a few weeks to avoid addiction. See id. Notwithstanding,
McKee's doctor authorized refills of the drug for ten years, and two pharmacists
filled the prescriptions without warning McKee of the possible side effects
of extended use. See id. at 1047. McKee sued the drug manufacturer, the
prescribing physician, and the pharmacists for damages sustained as a result
of her addiction to Plegine. See id. McKee argued that her pharmacists were
negligent in selling her Plegine without warning of its adverse effects
and for failing to provide her the drug manufacturer's package insert. See
|||In a 5-4 decision, the Washington Supreme Court concluded that the learned
intermediary doctrine, normally applied to the relationship among physician,
patient, and manufacturer, applied with equal force to the relationship
among physician, patient, and pharmacist. See id. at 1050-51. The court
reasoned that in both circumstances, the physician was in the best position
to "relate the propensities of the drug to the physical idiosyncrasies
of the patient."*fn11
Id. at 1050. The court therefore held that McKee's pharmacists did not have
a duty to warn her of the dangerous propensities of Plegine, nor were they
legally obligated to give her the drug manufacturer's package insert containing
See id. at 1054-55.
|||This holding is consistent with the decisions of many other states that
have addressed the issue of whether to impose on pharmacists a duty to warn
of adverse side effects. For example, in Pysz v. Henry's Drug Store, 457
So.2d 561 (Fla. Dist. Ct. App. 1984), a pharmacist had filled the plaintiff's
prescription for Quaaludes for more than nine years. See 457 So.2d at 561.
Pysz alleged that the pharmacist's failure to warn him of the addictive
propensities of Quaaludes constituted negligence. The Florida appeals court
stated that although a pharmacist might in some instances possess greater
knowledge than a physician of the adverse effects of drugs, "it is
the physician who has the duty to know the drug that he is prescribing and
to properly monitor the patient." Id. at 562. The court concluded that
the pharmacist, who had properly filled a lawful prescription, had no duty
to warn the plaintiff of adverse reactions and affirmed the trial court's
dismissal of Pysz's complaint.*fn13
In an effort to limit its decision to the facts before it, the court noted,
without elaboration, that it could conceive of a factual situation that
would support a plaintiff's claim of negligence against a pharmacist who
lawfully filled a valid prescription. See id.
|||In Stebbins v. Concord Wrigley Drugs, Inc., 416 N.W.2d 381 (Mich. Ct.
App. 1987), Bonnie Stebbins was seriously injured when a car driven by a
man taking the antidepressant Tofranil struck her car. See 416 N.W.2d at
383. Stebbins settled with the other driver and sued his prescribing physician
and pharmacist for negligence, alleging that they had failed to warn the
patient of Tofranil's side effects, which include drowsiness. See id.
|||The Michigan appeals court began its consideration of the pharmacist's
liability by citing the general rule that pharmacists owe patients a high
standard of care in filling prescriptions and may be held liable for negligently
dispensing a drug other than that prescribed. See id. at 387. Relying on
Pysz, the court concluded that "a pharmacist has no duty to warn the
patient of possible side effects of a prescribed medication where the medication
is proper on its face and neither the physician nor the manufacturer has
required that any warning be given to the patient by the pharmacist."
Id. at 387-88.*fn14
The court emphasized that its decision did not apply to a situation in which
a pharmacist knows of a particular patient's unique medical problems or
where a pharmacist fills incompatible prescriptions. See id. at 388.
|||The courts of Illinois have likewise refused to impose on pharmacists
a duty to warn of adverse side effects. In Jones v. Irvin, 602 F. Supp.
399 (S.D. Ill. 1985), the plaintiff alleged she had suffered injuries as
a result of her consumption of an excessive amount of Placidyl and other
prescribed drugs. The Illinois district court concluded that K-Mart had
no duty to notify the customer that she was being overmedicated because
the duty to warn of a prescription drug's adverse effects falls squarely
on the prescribing physician. See 602 F. Supp. at 402. Furthermore, the
court placed upon the patient the duty to notify the physician of other
drugs the patient is taking and upon the drug manufacturer the duty to notify
the physician of any adverse effects in administering the drug. See id.
The court concluded that "[p]lacing these duties to warn on the pharmacist
would only serve to compel the pharmacist to second guess every prescription
a doctor orders in an attempt to escape liability." Id. As in Pysz
and Stebbins, the district court stressed the narrow application of its
holding, stating that it applied only to prescription drugs and that pharmacists
still owed customers the highest degree of prudence in filling a prescription.
See id. at 402-03.
|||When faced with the same issue, Illinois state courts also refused to
impose a duty to warn on pharmacists. See Frye v. Medicare-Glaser Corp.,
605 N.E.2d 557 (Ill. 1992); Kirk v. Michael Reese Hosp., 513 N.E.2d 387
(Ill. 1987); Fakhouri v. Taylor, 618 N.E.2d 518 (Ill. App. Ct. 1993); Eldridge
v. Eli Lilly & Co., 485 N.E.2d 551 (Ill. App. Ct. 1985). In Eldridge,
the plaintiff's wife died of an overdose of prescription drugs. See 485
N.E.2d at 552. He sued the pharmacy that filled her prescriptions, alleging
that it had been negligent in dispensing drugs in quantities beyond those
normally prescribed. In rejecting the plaintiff's claim, the court adopted
the reasoning in Jones, noting that placing on pharmacists the duty urged
by the plaintiff would require pharmacists to learn of the customer's condition
and monitor drug usage, functions the court concluded were more appropriately
undertaken by physicians.*fn15
See id. at 553.
|||In Fakhouri, the appellate court of a different district reached the same
conclusion with respect to a wrongful death claim brought against a K-Mart
pharmacy. The plaintiff alleged K-Mart had been negligent in failing to
warn the deceased that his prescription for Imipramine was in excess of
the manufacturer's recommended limits. See 618 N.E.2d at 519. The court,
relying on the learned intermediary doctrine, refused to impose upon K-Mart
a duty to warn of excessive prescriptions. The court held:
|||To impose a duty to warn on the pharmacist would be to place the pharmacist
in the middle of the doctor-patient relationship, without the physician's
knowledge of the patient. Furthermore, under Illinois law, the duty of the
manufacturer runs to the physician and not to the patient. Therefore, it
is illogical and unreasonable to impose a greater duty on the pharmacist
who properly fills a prescription than is imposed on the drug's manufacturer.
Id. at 521 (citations omitted).
|||In Kirk, the Illinois Supreme Court was asked to determine whether a hospital
negligently failed to warn a patient that prescribed drugs would diminish
his ability to safely operate an automobile. See 513 N.E.2d at 391. The
court stated that the determination of whether a duty exists is an issue
of law and that one factor to be taken into account in making the determination
is whether the harm suffered by the plaintiff was reasonably foreseeable.
See id. at 396. Because there was no allegation that the hospital knew or
had reason to know that drug warnings were not given to the patient by his
prescribing physician, the court held that the hospital had no duty to warn
the patient of the dangers of using the drug. See id.
|||In Frye, the plaintiff alleged that although the pharmacy had no initial
duty to warn of adverse side effects, it voluntarily undertook such a duty
by placing a warning label on the prescription drug container. See 605 N.E.2d
at 558. The pharmacist testified by deposition that when a prescription
is filled, the pharmacy's computers generate two documents: a container
label identifying the patient, prescribing physician, and dosage indicated
by prescription, and a document suggesting warning labels that might be
affixed to the container. See id. at 558-59. The computer suggested three
labels warning of drowsiness, impairment of driving ability, and the potential
adverse effect of mixing the drug with alcohol. See id. at 559. The pharmacist
testified that she placed only the "drowsy eye" sticker on the
container because in the past customers had reacted negatively to the alcohol
sticker. See id.
|||The court rejected the plaintiff's contention that the defendant pharmacy
undertook to warn of all the potential dangers in taking the drug by placing
a single warning sticker on the package, reasoning that the imposition of
such a duty would discourage pharmacists from placing any warning labels
on drug containers. See id. at 560. The court opined that "consumers
should principally look to their prescribing physicians to convey the appropriate
warning regarding drugs, and it is the prescribing physician's duty to convey
these warning to the patients." Id. at 561.
|||While a majority of courts that have considered whether a pharmacist has
a duty to warn a patient of the adverse side effects of prescription medication
has rejected the imposition of such a duty, unusual factual situations have
arisen in which courts have felt compelled to impose a duty beyond mechanically
dispensing drugs pursuant to a physician's directions. For example, in Hand
v. Krakowski, 453 N.Y.S.2d 121 (N.Y. App. Div. 1982), a doctor prescribed
certain psychotropic drugs to an alcoholic patient. See 453 N.Y.S.2d at
122. The drugs were contraindicated with the use of alcohol. See id. at
123. Although its records identified the patient as an alcoholic, the pharmacy
dispensed the drugs to her over a period of six years without warning her
of the danger. See id. at 122. The patient died at age fifty-five of pancreatitis
associated with a severe degree of cirrhosis. See id.
|||The New York appellate court reversed the summary judgment granted in
favor of the defendant pharmacy. See id. at 123. The court held that because
the dispensing pharmacists knew that the decedent was an alcoholic and knew,
or should have known, that the prescribed drugs were contraindicated with
alcohol, a fact question existed regarding whether they had a duty to warn
the patient of the danger involved. See id.*fn16
|||A Pennsylvania appellate court upheld a jury verdict against a pharmacy
in a case in which a physician omitted in a prescription a statement pertaining
to maximum safe dosage. See Riff v. Morgan Pharmacy, 508 A.2d 1247 (Pa.
Super. Ct. 1986). A physician prescribed Cafergot suppositories to Patricia
Riff to treat her migraine headaches. See 508 A.2d at 1249. The prescription
instructed her to insert one in the rectum "every four hours for headache."
See id. Trial testimony showed that the maximum dosage for Cafergot suppositories
accepted in the medical literature is two per headache, with no more than
five to be used in one week. See id. A pharmacist filled the prescription
without issuing any additional warnings. See id.
|||Over the next four months, Riff experienced three severe migraine headaches,
and she used the suppositories as directed by her physician and pharmacist.
See id. For the first headache, Riff used three or four suppositories over
approximately twelve hours; for the second, she used fifteen to seventeen
suppositories over three or four days; for the third headache, Riff used
five or six suppositories over two days. See id. Soon thereafter, Riff experienced
discomfort in her right foot, and doctors determined she was suffering from
diminished blood circulation caused by a toxic overdose of Cafergot. See
|||The court upheld the jury's verdict finding the pharmacy negligent for
failing to warn Riff of the obvious inadequacies appearing on the face of
the prescription. See id. at 1251-52. In doing so, the court expressly rejected
the defendant pharmacy's contention that its only duty was to accurately
fill the prescription. See id. at 1251.*fn17
|||In sum, courts holding that pharmacists owe their customers a duty beyond
accurately filing prescriptions do so based on the presence of additional
factors, such as known contraindications, that would alert a reasonably
prudent pharmacist to a potential problem.*fn18
We do not dispute that a pharmacist may be held liable for negligently filling
a prescription in such situations, but we cannot discern from the relevant
case law a trend towards imposing a more general duty to warn.
|||Nor do we conclude that existing Texas statutory law imposes such a duty.
The plaintiffs contend that under the Texas Pharmacy Act and the administrative
rules adopted pursuant to the Act, pharmacists have a general duty to warn
customers of potential adverse side effects. See Tex. Occ. Code Ann. §§
551.001-566.151 (West 2000). Plaintiffs argue that the duty arises by implication
from the mention of "patient counseling" in the Act's definition
of "practice of pharmacy," see id. § 551.003(33)(D), as well as
from several references to pharmacists counseling or communicating with
patients in the Administrative Code. See, e.g., 22 Tex. Admin. Code §§ 291.31;
291.33(b)(1)(D), (c)(1)(A), (c)(2)(A)(i)(I); 291.34(c)(3); 291.36(c)(2)(B)(iv),
(d)(3)(A)(i)(IV) (2000). Plaintiffs emphasize the Code's repeated references
to pharmacists communicating to patients information regarding "common
severe side effects or adverse effects or interactions." Id. §§ 291.33(c)(1)(A)(i)(iv);
|||While these administrative rules demonstrate that pharmacists in Texas
are trusted professionals with varied and important responsibilities, they
cannot be reasonably read to impose a legal duty to warn patients of the
adverse effects of prescription drugs. The imposition of a generalized duty
to warn would unnecessarily interfere with the relationship between physician
and patient by compelling pharmacists seeking to escape liability to question
the propriety of every prescription they fill. Furthermore, a patient faced
with an overwhelming number of warnings from his or her pharmacist may decide
not to take a medication prescribed by a physician, who has greater access
to and knowledge of the patient's complete medical history and current condition
than the pharmacist. Instead of imposing such an onerous and counter-productive
duty, the administrative rules reinforce the notion that although pharmacists
act as final auditors of the technical accuracy of a prescription and its
appropriateness with respect to a patient's known condition and medication
record, they do not possess the extensive knowledge of a physician with
respect to a patient's complete medical history and are thus not legally
obligated to warn a patient of adverse drug reactions.*fn19
|||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.
Having reviewed the entire record, we find no basis to conclude that the
Wal-Mart pharmacists breached their duty of care when they filled Cameron's
prescription for Desipramine.
|||Dr. Schroeder prescribed Desipramine to treat Cameron's ADHD. Cameron's
mother Jacquelyn Morgan filled the prescription first at Walgreen's, then
at Wal-Mart. There is no evidence that Sidmak Laboratories, the manufacturer
and distributor of Desipramine, gave any special instructions to pharmacies
such as Wal-Mart to warn patients of potential adverse reactions to the
drug. Moreover, although Cameron experienced severe discomfort while taking
Desipramine, at no time did even one of the many doctors that examined him
warn Cameron, Morgan, or Pettus of the potential adverse side effects of
Desipramine or contact the pharmacists to instruct them to give such a warning.
Indeed, the record reveals that the doctors did not attribute Cameron's
ailments to Desipramine at all.
|||Furthermore, it is undisputed that Wal-Mart sold Desipramine to Morgan
according to the terms of Dr. Schroeder's prescription. Plaintiffs do not
allege that Wal-Mart possessed any special knowledge of Cameron's medical
history that would impose upon it an additional duty to warn him, Morgan,
or Pettus of the particular dangers of Desipramine. Nor do the plaintiffs
contend that Wal-Mart was or should have been aware of any contraindications.
Plaintiffs instead argue that the prescription contained a "clear error"
because the Desipramine package insert, in a section labeled "Warnings,"
provides that the drug "is not recommended for use in children since
safety and effectiveness in the pediatric age group have not been established."
(Emphasis added.) Plaintiffs contend that Cameron was a child as contemplated
by this warning and that therefore Wal-Mart negligently dispensed to him
a product it knew or should have known was inappropriate.
|||The "Dosage and Administration" section of the package insert
provides: "Not recommended for use in children. Lower dosages are recommended
for elderly patients and adolescents." (Emphasis added.) The insert
further provides that "[t]he usual adolescent and geriatric dose is
25 to 100 mg daily." Clearly, there is a recognized pharmacological
distinction between children and adolescents. The question then is whether
there was evidence presented at trial to prove that at the time Wal-Mart
sold Morgan Desipramine for Cameron's use, Cameron was a child.
|||Cameron was twelve years old when he began taking Desipramine in April
1991. When Wal-Mart first sold Morgan the drug for Cameron's use, Cameron
was thirteen years old. When Wal-Mart filled the prescription for the fourth
and final time in February 1993, Cameron was fourteen years old. The plaintiffs'
pharmacy expert, Dr. Thomas O' Donnell, testified extensively at trial about
the responsibilities of a pharmacist in filling a prescription. Dr. O'Donnell
was asked by plaintiffs' counsel what the Wal-Mart pharmacist should have
done when filling Cameron's prescription to meet the standard of care of
a reasonably prudent pharmacist. O'Donnell testified, "I would insist
on talking to the mother. Ask what the drug is being used for. I mean, it's
an unusual drug in a 12-year-old. Doesn't mean it can't be used, but it's
an unusual drug. This is a drug that's usually used for depression in adults."
(Emphasis added.) Furthermore, O'Donnell agreed that a twelve-to-fourteen
year old was an adolescent "from a medical standpoint and as a pharmacist."
|||The plaintiffs do not address O'Donnell's testimony but rather contend
that the testimony of Wal-Mart pharmacist Irene Franklin and pediatric hematologist
Dr. Mahoney provides sufficient evidence that Wal-Mart sold Desipramine
to Cameron when he was a child and thus breached its duty of care. Wal-Mart
specifically points to Franklin's testimony that "children shouldn't
be prescribed Desipramine" and Mahoney's assertion that Cameron was
a child. We note initially that Franklin's statement does not speak to whether
Cameron was a child at the relevant time; it merely echoes the warning from
the Desipramine package insert. Furthermore, Mahoney's statement concerning
Cameron's classification as a child, when read in context, instead supports
Wal-Mart's position that Cameron was an adolescent when he was sold Desipramine.
The relevant exchange is as follows:
|||Q: Doctor was Cameron Pettus a child?
|||A: He is a-he was an adolescent, yes.
|||Q: Is there a distinction between children and adolescents?
|||A: He is under 18. And so, we consider anybody under 18 a child, adolescent,
and consider them together in viewing hematologic disorders.
|||Q: If there is a biologic or drug cause for hypereosinophilia, is it your
opinion that the disease or disorder course is going to be different if
you are under 18 than if you are over 18?
|||A: I can only speculate on that. It certainly could be different. Can
drug reactions be different in children as opposed to adults? Yes.
|||Q: So, for your purposes Cameron Pettus was a child and shouldn't be treated
like an adult?
|||First, we note that Mahoney, who is not a pharmacist, limited the application
of his testimony to "viewing hematologic disorders"; the testimony
thus has no application to a pharmacist's decision to dispense a drug in
accordance with a physician's valid prescription. Next, Mahoney admitted
to lumping children and adolescents together in his analysis in order to
contrast these groups to adults. Finally, his testimony about drug reactions
emphasizes that he is drawing a distinction not between children and adolescents
but between children/adolescents and adults.
|||Mahoney's testimony therefore is not evidence that Cameron was a child,
rather than an adolescent, when Wal-Mart sold Morgan Desipramine for his
use. See Kindred v. Con/Chem, Inc., 650 S.W.2d 61, 63 (Tex. 1983) ("When
evidence offered to prove a vital fact is so weak as to do no more than
create a mere surmise or suspicion of its existence, the evidence is no
more than a scintilla and, in legal effect, is no evidence.") The only
testimony pertaining to this question comes from plaintiffs' pharmacy expert
O'Donnell, who unequivocally testified that for pharmalogical purposes,
Cameron was an adolescent. We therefore reject the plaintiffs' argument
that the prescriptions filled by Wal-Mart contained clear errors or obvious
inadequacies triggering a duty to warn.
|||We acknowledge that the pharmacist's role has changed in the last few
decades from a mere dispenser of medication to a trusted professional who
plays a vital role in patient treatment. See Riff, 508 A.2d at 1251 (pharmacist
is much more than "shipping clerk who must dutifully and unquestioningly
obey the written order of omniscient physicians"). We understand that
modern pharmacies employ advanced computer systems that can analyze drug
interactions in seconds, thus preventing the sale of potentially fatal drugs
to consumers, and we encourage the use of such systems. Nonetheless, in
light of the learned intermediary doctrine, which we find applicable to
the relationship among physician, patient, and pharmacist, we hold that
pharmacists have no generalized duty to warn patients of potential adverse
reactions to prescription drugs absent some special circumstances not present
here. 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. We reverse the judgment of the trial
court and render a take-nothing judgment in favor of Wal-Mart. Because our
resolution of Wal-Mart's first issue resolves this appeal, we need not consider
Wal-Mart's causation issue or the plaintiffs' single appellate issue.
|||Reversed and Rendered
pharmacist Irene Franklin testified that there are approximately ten tricyclic
antidepressants currently on the market, including Desipramine, Imipramine,
Amitriptyline, Clomipramine, and Pamelor.
trial, Morgan testified that "[Schroeder] told me how to use the medication.
She didn't talk to me about any serious adverse reactions at all."
Morgan also disputed Schroeder's testimony that Morgan related to her information
about an adult brother taking Desipramine.
Laboratories, Desipramine's manufacturer and distributor, provided the Desipramine
package insert to Wal-Mart. The insert contains two full pages of extemely
fine print detailing in technical and scientific terminology the drug's
clinical pharmacology, indications and usage, contraindications, warnings,
precautions, adverse reactions, overdosage, and dosage and administration.
The warnings section provides: "USE IN CHILDREN: Desipramine hydrochloride
is not recommended for use in children since safety and effectiveness in
the pediatric age group have not been established. (See ADVERSE REACTIONS,
Cardiovascular)." The adverse reactions section provides: Note: Included
in the following listing are a few adverse reactions that have not been
reported with this specific drug. However, the pharmacologic similarities
among the tricyclic antidepressant drugs require that each of the reactions
be considered when desipramine hydrochloride is given. * * * * Cardiovascular:
hypotension, hypertension, palpitations, heart block, myocardial infarction,
stroke, arrhythmias, premature ventricular contractions, tachycardia, ventricular
tachycardia, ventricular fibrillation, sudden death. There has been a report
of an "acute collapse" and "sudden death" in an eight-year
(18 kg) old male, treated for two years for hyperactivity. There have been
additional reports of sudden death in children. (See WARNINGS, Use in Children).
* * * * Neurologic: numbness, tingling, paresthesias of extremities, incoordination,
alaxin, tremors, peripheral neuropathy, extrapyramidal symptoms, seizures,
alteration in EEG patterns, tinnitus. Anticholinergic: dry mouth, and rarely
associated sublingual adenitis, blurred vision, disturbance of accommodation,
mydriasis, increased intraocular pressure, constipation, paralytic iteus,
urinary retention, delayed micturition, dilatation of urinary tract. Allergic:
skin rash, petechiae, urticaria, itching, photosensitization (avoid excessive
exposure to sunlight), edema (of face and tongue or general), drug fever,
cross sensitivity with other tricyclic drugs. Hematologic: bone marrow depressions
including agranulocytosis, eosinophila, purpura, thrombocytopenia. The adverse
reactions section also includes psychiatric, gastrointestinal, and endocrine
do not allege that Wal-Mart inaccurately filled the prescription for Desipramine
on any of these occasions.
sample Wal-Mart information sheet for Desipramine was admitted as an exhibit
at trial. The sheet lists prescription number, patient's name, doctor's
name, drug name, generic name, common uses, "how to use this medicine,"
cautions, and possible side effects. The side effects section provides:
SIDE EFFECTS, that may go away during treatment, include dry mouth, constipation,
blurred vision, drowsiness, dizziness, headache, nausea, unpleasant taste,
or an increased appetite especially for sweets. If they continue, or are
bothersome, check with your doctor. If you notice effects not listed above,
contact your doctor, nurse, or pharmacist.
testified that during one of Cameron's weekend visits before the July 1993
visit, he and Cameron had discussed Desipramine. Pettus stated that Cameron
told him the drug "made him feel weird, slowed him down." Pettus
testified he told Cameron that "if I was taking something and [it]
made me feel weird, slowed me down, where I wasn't myself, I would personally
not take it." Pettus further testified that during Cameron's July 1993
visit, he could not recall seeing Cameron take any medication.
Henry Clayman, a professor of medicine in immunology at the University of
Colorado Medical School, explained at trial that eosinophils are a component
of the white blood cell count. Clayman stated that it is normal for a patient's
eosinophils to comprise up to 5% of the total white blood cell count. A
patient with an eosinophil count in excess of 5% is described as having
eosinophilia; hypereosinophilia is a term used to describe an even greater
presence of eosinophils. Dr. Sharp's August 2 report states that on July
23, 30% to 45% of Cameron's white blood cells were eosinophils.
trial, Dr. Clayman testified for the plaintiffs. Based on his review of
Dr. Bayardo's autopsy report, the medical records of Brackenridge Hospital,
and other documents, he also concluded that Cameron's death was caused by
a hypereosinophilic reaction to Desipramine. Dr. Donald Mahoney, a pediatric
hematologist/oncologist, testified for Wal-Mart. Mahoney, who described
himself as an expert on disorders of white blood cells in children, stated
he found no evidence that Cameron's hypereosinophilic syndrome with corresponding
multi-organ failure was caused by an adverse reaction to Desipramine.
other named defendants are as follows: Brackenridge Hospital; Daughters
of Charity Health Services of Austin d/b/a Seton Northwest; Round Rock Hospital,
Inc. d/b/a Round Rock Hospital a/k/a Epic Healthcare Management Company
a/k/a Epic Healthcare Services, Inc.; Arthur Boone, M.D.; Terence P. MacConnell,
M.D., individually and d/b/a Pro Med Emergency Centers d/b/a Pro Med-N d/b/a
Pro Med North d/b/a Pro Med South; Sangetta Agrawala, M.D.; Capitol Anesthesiology
Association; Lawrence C. Dill, M.D.; Lefayne Hodde, M.D.; Manuel Martin,
M.D.; Asma Siddiqui, M.D.; Richard Covey, C.R.N.A.; and Robert W. Porter,
M.D. Of these additional defendants, only Terence MacConnell, M.D., individually
and d/b/a Pro Med Emergency Centers d/b/a Pro Med-N d/b/a Pro Med North
d/b/a Pro Med South was ever served with citation in this cause.
See Burke, 363 S.W.2d at 367-68 (pharmacist sold Oxsoralen capsules to patient
instead of prescribed Oxacholin tablets); Peavy v. Hardin, 288 S.W. 588,
588-89 (Tex. Civ. App.-El Paso 1926, no writ) (pharmacist filled coco quinine
prescription with coco quinidine); Dunlap, 288 S.W. at 236-38 (pharmacist
filled prescription for Seilers antiseptic tablets with Diamond antiseptic
tablets, a highly poisonous bichloride of mercury).
See also Nichols v. Central Merchandise, Inc., 817 P.2d 1131, 1133 (Kan.
Ct. App. 1991) (applying learned intermediary doctrine to negligence case
against pharmacist); Leesley v. West, 518 N.E.2d 758, 762-63 (Ill. App.
Ct. 1988) (neither drug manufacturer nor pharmacist can be reasonably expected
to know medical history or condition of individual patient); Ingram v. Hook's
Drugs, Inc., 476 N.E.2d 881, 885 (Ind. Ct. App. 1985) (same); Kinney v.
Hutchinson, 449 So.2d 696, 698 (La. Ct. App. 1984) (same).
For a detailed discussion of a pharmacist's duty with respect to manufacturers'
package inserts, see Laws v. Johnson, 799 S.W.2d 249, 251-55 (Tenn. Ct.
App. 1990). Laws was prescribed Timoptic, a prescription liquid eye drop
medication. See 799 S.W.2d at 249. The plastic bottle containing the drug
was sent to the pharmacy by Merck, the manufacturer, in a small cardboard
box with a printed insert. See id. The insert contained the technical information
and warnings typical of a manufacturer's package insert, including a warning
of potential adverse cardiovascular reactions. See id. at 249-50. Before
dispensing the Timoptic, the pharmacists removed the insert. See id. at
250. After experiencing a heart attack, Laws sued the pharmacists alleging
they were guilty of negligence for removing the insert. See id. Relying
on the learned intermediary doctrine, the Tennessee court of appeals held
that the removal of the insert did not wrongfully deprive Laws of warnings
concerning his medication. See id. at 254. The court emphasized that its
decision did not abrogate a patient's right to know; it merely identified
the physician as the party with the duty to pass the manufacturer's warnings
on to the patient. See id.; see also Walker v. Jack Eckerd Corp., 434 S.E.2d
63, 67-68 (Ga. Ct. App. 1993) (no duty to warn imposed on pharmacists who
are provided with manufacturers' literature warning of potential adverse
effects if certain drug dosages are exceeded).
See also Ramirez v. Richardson-Merrell, Inc., 628 F. Supp. 85, 87-88 (E.D.
Penn. 1986); Bichler v. Willing, 397 N.Y.S. 57, 58 (N.Y. App. Div. 1977)
(pharmacist who fills prescription as directed by physician has no duty
to warn patient of dangerous adverse reactions); Batiste v. American Home
Prods. Corp., 231 S.E.2d 269, 274 (S.C. Ct. App. 1977) (same).
See also Adkins v. Mong, 425 N.W.2d 151, 153 (Mich. Ct. App. 1988) (no duty
on part of pharmacist to monitor and intervene in customer's reliance on
drugs prescribed by licensed physician). But see Baker v. Arbor Drugs, Inc.
544 N.W.2d 727, 731 (Mich. Ct. App. 1996) (defendant pharmacy may voluntarily
assume a duty to warn by advertising computer system that monitors customers'
medication profiles for adverse drug interactions).
The plaintiff in Eldridge also alleged that the Illinois Pharmacy Practice
Act, which provides that pharmacists are to dispense medications "in
good faith," imposed on pharmacists a duty to warn. Although "good
faith" as used in that context was defined by the Illinois legislature
to include a consideration of unusual dosages and the like, the court concluded
that the statute imposed no duty to warn. See 485 N.E.2d at 554. For similar
rejections of statutory arguments, see Fakhouri, 618 N.E.2d at 521-22 (noting
that legislature, by providing that Illinois Pharmacy Practice Act was not
meant to interfere with lawful practice of physicians, dictated that physicians,
not pharmacists, have duty to decide which drugs to prescribe); Ingram,
476 N.E.2d at 884-85 (language in the definition of "practice of pharmacy"
concerning pharmacist giving advice does not create mandatory duty to warn);
Kampe v. Howard Stark Professional Pharmacy, Inc., 841 S.W.2d 223, 225-26
(Mo. Ct. App. 1992) (same).
See also Lasley v. Shrake's Country Club Pharmacy, Inc., 880 P.2d 1129,
1132-34 (Ariz. Ct. App. 1994) (whether pharmacist's failure to warn of drug
interactions violates duty of care is question of fact for the jury); Hook
Super X, Inc. v. McLaughlin, 642 N.E.2d 514, 517-20 (Ind. 1994) (pharmacist
has duty to cease refilling prescription if he has personal knowledge that
customer is taking medication more quickly than prescribed); Dooley v. Everett,
805 S.W.2d 380, 383-86 (Tenn. Ct. App. 1990) (refusing to apply learned
intermediary doctrine, court held that whether pharmacist has duty to warn
customer of potential drug interaction is issue of fact preventing summary
judgment); Stebbins, 416 N.W.2d at 388 (suggesting that pharmacist's knowledge
of patient's unique medical problems may alter rule that pharmacist has
no duty to warn of possible side effects of prescribed medication).
See also Heredia v. Johnson, 827 F. Supp. 1522, 1525 (D. Nev. 1993) (while
generalized duty to warn is inappropriate, pharmacist's duty of due care
necessarily includes duty to fill prescriptions as prescribed, properly
label them, and be alert for "plain error"); Gassen v. East Jefferson
Gen. Hosp., 628 So.2d 256, 258 (La. Ct. App. 1993) (pharmacist has no duty
under Louisiana law to warn patient of adverse reactions but does have limited
duty to "inquire or verify from prescribing physician clear errors
or mistakes in the prescription").
See, e.g., Hand, 453 N.Y.S.2d at 123 (contraindications); Riff, 508 A.2d
at 1251 (obvious errors on the face of the prescriptions); Dooley, 805 S.W.2d
at 386 (incompatible prescriptions); Pittman v. Upjohn Corp., 890 S.W.2d
425, 435 (Tenn. 1994) (special instructions given by manufacturer to pharmacist
to warn patient of potential adverse reactions). That such factors might
lead to the imposition of negligence liability, even in cases in which a
pharmacist lawfully fills a valid prescription, was anticipated by the Michigan
appeals court in Stebbins and the Florida appeals court in Pysz. See supra
pp. 15-17. Furthermore, the Supreme Court of Washington in McKee expressly
stated that pharmacists have a duty "to be alert for clear errors or
mistakes in the prescription." 782 P.2d at 1055.
See, e.g., Tex. Occ. Code Ann. § 157.001 (West 2000) (physician may delegate
to pharmacist acting under physician's supervision the performance of specific
acts of drug therapy management); Tex. Admin. Code § 291.33(b)(2)(B)(i)
(pharmacists may provide drug therapy management as delegated by a physician).
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