Source: https://www.koponairdo.com/publications/emerging-trends-pharmacists-duty-warn-liability-pharmacist-prescription-properly-filled-update-regarding-learned-intermediary-doctrine
Timestamp: 2019-04-21 02:17:51+00:00

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It is common knowledge that under negligence law, pharmacists may incur liability for misfilling a prescription as prescribed by a customer’s physician. A more complicated question, however, deals with the potential liability for pharmacists when a prescription has been properly filled. The plaintiffs’ bar continues to battle for an erosion of the learned intermediary doctrine and for the imposition of a duty for pharmacists to provide verbal, as well as written warnings and counseling regarding a drug’s dangerous propensities, side effects, dosage and duration to the customer and/or the prescribing physician. This article will discuss the recent approaches by various courts in resolving this issue, as observed in recent cases from states such as Texas, Illinois, New York, Pennsylvania, and Florida.
This article will explore recent cases analyzing the application of the traditional learned intermediary doctrine and emerging exceptions to the doctrine. Second, the article will show how application of the reasonableness test imposes a much higher duty upon a pharmacist, resulting in liability to customers even though the prescription was properly filled. An understanding of these two distinct approaches will aid the pharmacy industry and pharmacy lawyers in opposing the plaintiffs’ bar’s tactics when they seek to expand the scope of the duty of the pharmacist to the customer. Finally, this article will analyze a hypothetical question in the context of a recent Illinois case addressing what the law requires of pharmacists in the area of warnings and counseling.
In those jurisdictions that follow the learned intermediary doctrine, pharmacists generally do not have a duty to issue warnings of a drug’s side effects directly to the customer. See e.g. Leesley v. West, 141, 518 N.E.2d 758, 762 (Ill. App. 3d 1988) (finding pharmacists do not have a duty to provide patients with a written copy of a prescription drug’s known risks and side effects). This rule extends from the law of products liability dealing with a manufacturer’s duty to issue warnings concerning prescription drugs. “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.” Morgan v. Wal-Mart Stores, Inc., 30 S.W. 3d 455, 462 (Texas App. 2000).
Under this system, the pharmacist is not to interfere with the physician’s medical judgment regarding proper warnings for the patient. “The pharmacist’s traditional role in this system of distribution is to accurately fill the prescription in accordance with the instructions provided by the prescribing physician.” Abrams v. Bute, 27 N.Y.S. 3d 58, 65 (N.Y. S. Ct. App. D. 2016). The rationale for this rule is that requiring the pharmacist to issue warnings directly to the customer “would require the pharmacist to learn the customer’s condition and monitor his drug use,” and “the pharmacist would [thus] have to interject himself into the doctor-patient relationship and practice medicine without a license.” Eldridge v. Eli Lilly & Co., 485 N.E.2d 551, 553, 555 (Ill. App. 4th 1985); see also Reyes v. Wyeth Lab., 498 F.2d 1264, 1276 (5th Cir. 1974) (finding that a physician understands the dangers involved in the use of a given drug and therefore acts as learned intermediary between manufacturer and patient); Corcoran v. CVS Health Corp., 2016 WL 948880 at *11 (N.D. Cal. Mar. 14, 2016) (reasoning that the pharmacist’s duty “has been construed narrowly, and absent special circumstances, courts refuse to extend it to encompass a duty to warn or an affirmative duty to counsel customers on the side effects of prescription drugs.”).
This doctrine recognizes that pharmacists “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.” Morgan, 30 S.W. 3d at 467. “The underlying rationale of the learned intermediary doctrine is that, with regard to prescription drugs, which are likely to be complex medicines, it is the prescribing physician who knows both the propensities of the drug and the susceptibilities of his patient, and who therefore is in the best position to prescribe a particular drug for the patient.” Happel v. Wal-Mart Stores, Inc., 766 N.E.2d 1118, 1126 (Ill. 2002).
The State of Texas provides a traditional framework for pharmacist liability and application of the learned intermediary doctrine. Under Texas law, “[i]n 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.” Morgan, 30 S.W. 2d at 461 (citing to Dunlap v. Oak Cliff Pharmacy Co., 288 S.W. 236, 237 (Tex. App.—Austin 1926) (reasoning 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”). Accordingly, “[a] pharmacist who inaccurately fills a prescription is therefore liable to the customer for resulting harm.” Morgan, 30 S.W.3d at 461.
Regarding properly filled prescriptions, Texas applies the learned intermediary doctrine. In Morgan, the plaintiffs alleged that their son’s death resulted from an adverse reaction to Desipramine, a prescription drug sold by a Wal-Mart pharmacist, and that the pharmacy was negligent in failing to properly warn of the hazards and harms associated with the use of that drug. At trial, the jury found in favor of the plaintiffs, finding that Wal-Mart was negligent in its failure to warn and that such failure proximately caused their son’s death. On appeal, Wal-Mart argued that its pharmacists had no duty to warn of Desipramine’s potential dangers because that was the duty of the prescribing physician. Plaintiffs argued that “the prescription contained a ‘clear error’” because the “Warnings” section of the Desipramine package insert “provides that the drug ‘is not recommended for use in children since safety and effectiveness in the pediatric age group have not been established.’” Morgan, 30 S.W. 2d at 461 (emphasis in original). The plaintiffs’ main contention was that their son “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.” Id. at 467-68. The appellate court reversed the trial court, finding no general duty of the pharmacist to warn of potential adverse reactions to prescription drugs.
Federal case law in Texas also finds no general duty to warn for pharmacists. In Wimm v. Jack Eckerd Corp., parents of a child who died after receiving several doses of codeine-based prescription cough syrup with improper instructions brought an action against the drugstore. Wimm, 3 F.3d 137, 138 (5th Cir. 1993). The plaintiffs’ first amended complaint alleged (1) negligent failure to warn “that it was dangerous to administer codeine to a child suffering from shortness of breath”; and (2) the cough syrup sold was “unreasonably dangerous because it was not accompanied by an appropriate warning.” An expert had testified that the child died from a lack of oxygen based on obstructed airways, and that the codeine ingested by the child had contributed to his death, although it “was taken in an appropriate, therapeutic amount.” However, the expert also explained that “a codeine-based cough syrup is not an appropriate drug to prescribe for a child suffering from shortness of breath, because codeine depresses the breathing function and sedates the patient, making him or her less sensitive to air hunger.” After the defendant drugstore moved for summary judgment on the claims in the first amended complaint, plaintiffs filed a response to the motion for summary judgment, and a motion for leave to file a second amended complaint. In plaintiffs’ proposed second amended complaint, they sought to add new claims, including one for the pharmacist negligently mislabeling the bottle of cough syrup to “indicate the proper dosage was two tablespoons every four hours,” although the physician had “prescribed a dosage of two teaspoons every four hours.” (emphasis added). The district court denied the plaintiffs’ motion for leave to file a second amended complaint and granted defendant’s motion for summary judgment. On appeal, the Fifth Circuit Court of Appeals affirmed the grant of summary judgment in favor of the defendant drugstore based on the pharmacist not having a general duty to warn that physician prescribed the wrong medicine. Id.
More recently, the Texas Supreme Court has restated that “the bedrock of our healthcare system is the physician-patient relationship, and the ultimate decision for any treatment rests with the prescribing physician and the patient.” Centocor, Inc. v. Hamilton, 372 S.W.3d 140, 166 (Tex. 2012). Thus, “[a]s a matter of both necessity and practicality, the duty to warn the patient of the potential risks and possible alternatives to any prescribed course of action rests with the prescribing physician.” In Centocor, a physician who administered a drug to a patient, but who was not the prescribing physician, did not have a duty to warn the patient of the drug’s potential side effect of lupus-like syndrome, even though he provided informational materials about the drug received from the drug’s manufacturer. The Court reasoned that “[w]ithin the context of prescription drug manufacturers, the underlying premise for the learned intermediary doctrine is that prescription drugs are complex and vary in effect, depending on the unique circumstances of an individual user, and for this reason, patients can obtain them only through a prescribing physician.” Id. at 153-54 (citing Reyes, 498 F.2d at 1276). Accordingly, “[i]n most prescription drug contexts, the learned intermediary doctrine applies and the duty to warn the patient rests solely with the prescribing physician.” Centocor, 372 S.W.3d at 167 (emphasis added); see In re Norplant Contraceptive Products Litig., 165 F.3d 374, 379 (5th Cir. 1999) (recognizing Fifth Circuit cases which applied Texas law and concluded that “as long as a physician-patient relationship exists, the learned intermediary doctrine applies”).
The learned intermediary doctrine, however, provides for certain exceptions in which a pharmacist must issue warnings regarding a drug’s known side effects. See Brumaghim v. Eckel, 944 N.Y.S.2d 329, 330-31 (N.Y. S. Ct. App. D. 2012) (finding that generally, a pharmacist will not incur liability unless “he or she failed to fill a prescription precisely as directed by the physician or was aware that the customer had a condition that would render the prescription of the drug at issue contraindicated.”). As the Court explained in Morgan, “unusual factual situations” warranting an exception to this general rule, for example, if the pharmacy “was or should have been aware of any contraindications” or had possessed any special knowledge of the patient’s medical history, that would have imposed a duty to warn. 30 S.W.3d at 465-67. The Illinois Supreme Court found such an exception to the learned intermediary doctrine in Happel.
The State of New York also applies the learned intermediary doctrine, but allows for exceptions to this general rule. The State of New York first adopted the learned intermediary doctrine in Martin v. Hacker, 628 N.E. 2d 1308, 1311 (New York, 1993), finding “the manufacturer’s duty to caution against a drug’s side effects is fulfilled by giving adequate warning through the prescribing physician, not directly to the patient.” “The pharmacist’s traditional role in this system of distribution is to accurately fill the prescription in accordance with the instructions provided by the prescribing physician.” Abrams, 27 N.Y.S. 3d at 65. Generally, a pharmacist will not incur liability unless “he or she failed to fill a prescription precisely as directed by the physician or was aware that the customer had a condition that would render the prescription of the drug at issue contraindicated.” Brumaghim v. Eckel, 944 N.Y.S.2d 329, 330-31 (N.Y. S. Ct. App. D. 2012).
In sum, we conclude that, when a pharmacist has demonstrated that he or she did not undertake to exercise any independent professional judgment in filling and dispensing prescription medication, that pharmacist cannot be held liable for negligence in the absence of evidence that he or she failed to fill the prescription precisely as directed by the prescribing physician or that the prescription was so clearly contraindicated that ordinary prudence required the pharmacist to take additional measures before dispensing the medication. Id. at 71.
Although the learned intermediary doctrine will not exempt pharmacists from a duty to issue warnings in all cases—as demonstrated by Morgan and Happel—some jurisdictions require pharmacists to issue warnings or provide counseling in a wider variety of situations. For example, under negligence law in Florida, a pharmacist’s duty of due and proper care has been applied such that a pharmacist may be found negligent when prescriptions are “unreasonable on their face because they were written in a quantity, frequency, dosage, or combination that a reasonable pharmacist would either have checked with the prescribing doctor or warned the patient.” Oleckna v. Daytona Discount Pharmacy, 162 So. 3d 178, 183 (Fla. App. 2015); see also Dee v. Wal-Mart Stores, Inc., 878 So. 2d 426, 427 (Fla. App. 2004) (holding a pharmacy that fills a prescription that is “unreasonable on its face” may be found liable for negligence).
The following fact pattern comes from a recently decided case dealing with a pharmacist’s duty to warn. First, consider what result would be expected when applying the traditional learned intermediary doctrine. Second, consider how that result might differ when applying the reasonableness standard.
What result when applying the traditional learned intermediary doctrine?
This hypothetical comes from the recently decided Illinois case, Hernandez v. Walgreen Co., 49 N.E.3d 453 (Ill. App. 1st 2015). The Court held the pharmacist had no duty to issue any warnings regarding the dangers of the methadone prescription. The Court refused to impose “a duty upon a pharmacy to alert a prescribing physician of a patient’s ‘excessive’ prescriptions” because such a duty “would clearly require the pharmacy to interject itself into the doctor-patient relationship.” The Court found the pharmacist did not have patient specific information on the customer showing the drug was contraindicated and, as a result, the exception to the learned intermediary doctrine did not apply. The pharmacist did not have a duty to monitor the customer’s prescription drug history.
Under the reasonableness test, the Plaintiff in Hernandez would have argued that the methadone prescription was facially unreasonable, given the quantity and duration of the methadone. Note how the Court in Oleckna reached a different result than Hernandez despite the similarity of the cases. In Oleckna, the Court found the plaintiff stated a negligence cause of action based on the pharmacist’s failure to warn of danger of taking prescriptions of Alprazolam and Hydrocodone issued in too close of proximity.
As this hypothetical illustrates, whether a court applies either the learned intermediary doctrine or the reasonableness test can alter the outcome of a failure to warn negligence action against a pharmacist. The traditional learned intermediary doctrine provides protection to pharmacists because it generally exempts them from issuing verbal warnings or counseling directly to customers, with the limited exception of situations in which a pharmacist has patient specific knowledge, such as a drug contraindication. The reasonableness test requires the pharmacist to follow up on prescriptions that appear facially inadequate, regardless of whether or not the pharmacist has patient specific information dealing with the propriety of the prescription. Accordingly, it is in the best interests of the pharmacy industry to advocate for application of the learned intermediary doctrine because it reflects the reality of the pharmacist’s role in filling medication prescriptions and it best protects the doctor-patient relationship.
Andrew Kopon Jr., a founding partner in the trial law firm of Kopon Airdo, LLC, Chicago, Illinois. President-elect of the International Association of Defense Counsel (IADC).

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