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.
Generally, states that have addressed the scope of a pharmacist’s duty to warn and counsel adopt either one of two approaches. The first approach applies the traditional analysis of the learned intermediary doctrine. The learned intermediary doctrine provides that manufacturers have a duty to warn prescribing physicians of drug side effects, rather than the ultimate customer, because physicians are learned intermediaries with specific knowledge of their particular patient’s condition. The physician in turn determines what warnings to give the patient. This rule protects pharmacists from liability because pharmacists are not required to interfere with the physician’s medical judgment and are not required to become familiar with the customer’s health conditions. The second approach applies a reasonableness test. Under this standard, the pharmacist is to play a more active role in the prescription process by notifying either the physician or customer when a prescription appears “facially inadequate.”
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.
The Traditional Learned Intermediary Doctrine
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”).
Exceptions to the Traditional Learned Intermediary Doctrine
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.
In Happel, the Illinois Supreme Court found that when “special circumstances” are present, pharmacists “have a narrow duty to warn.” Happel, 766 N.E.2d at 1129. The special circumstances in Happel were the pharmacist’s knowledge of the plaintiff’s NSAID drug allergy, and that the drug prescribed was contraindicated for persons allergic to aspirin. The Court found a narrow duty to warn under these special circumstances, distinguishing prior Illinois decisions in Eldridge and Fakhouri v. Taylor, 618 N.E.2d 518 (Ill. App. 1st 1993). Eldridge held that “a pharmacist has no common law or statutory duty to refuse to fill a prescription simply because it is for a quantity beyond that normally prescribed or to warn the patient’s physician of that fact” reasoning that a “prescription which is excessive for one patient may be entirely reasonable for the treatment of another.” 485 N.E. 2d at 553-55. Fakhouri held that a pharmacist does not have a duty to warn the customer when the prescribed medication dosage exceeds the manufacturer’s recommended limits because the physician “presumably knows the patient’s current condition, as well as the patient’s complete medical history.” 618 N.E.2d at 521. In Happel, the Court found that unlike the situations in Fakhouri and Eldridge, which dealt with prescriptions “for a quantity in excess of normal use,” the court in Happel dealt with “a simple contraindication, which … means that the drug should not be given.” Happel, 766 N.E.2d at 1128 (citations omitted). Such a duty involves “no medical judgment simply to notify a physician or patient of such a contraindication.”
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).
Abrams offered clarification as to when a pharmacist must go further and issue warnings directly to the customer. There, a CVS customer who had just underwent hemorrhoid surgery died after taking an eight milligram prescription of hydromorphone. Abrams, 27 N.Y.S. at 61. The decedent customer alleged CVS was negligent in allowing her to take hydromorphone so soon after her surgery. CVS moved for summary judgment in the trial court and the motion was denied. On appeal, CVS argued that “as a matter of law” its duty to the customer “did not include any obligation to warn the decedent of the dangers of taking the prescribed dosage of hydromorphone or to take any steps to confirm that the prescription was not issued in error.” The Court rejected this argument, finding as follows:
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.
Applying this principle to the case at bar, the Court noted that CVS “established their prima facie entitlement to judgment as a matter of law” by submitting expert affidavits showing they merely filled the decedent customer’s prescription, as ordered, and did not undertake any professional judgment in filling the prescription, and the prescription was not “‘so clearly contraindicated’ that ordinary prudence required the pharmacist to take additional measures before dispensing the medication.” The decedent customer, failed to show a genuine issue of material fact because her expert failed to provide a basis for the conclusion that CVS “knew that the decedent was opioid-naive or otherwise assert that the CVS defendants had a duty to inquire in the absence of any specific knowledge regarding the decedent’s prior opiate use.” As a result, the Court overturned the trial court’s decision, finding no duty to warn in this case, but left open room for later decisions in which a pharmacist has such patient specific knowledge and a warning is required. The Court noted “the circumstances of each case will dictate the specific conduct required to satisfy a pharmacist’s duty.”
The Alternative Reasonableness Test
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).
In Oleckna, the Court found that based on the facts alleged, a decedent customer adequately stated a negligence cause of action against a pharmacist who had filled over thirty prescriptions of Alprazolam and Hydrocodone for the decedent customer. The decedent customer alleged these prescriptions “were issued too closely in time and days before Mr. Porter [the decedent customer] should have exhausted the preceding prescription.” Oleckna, 162 So. 3d at 180. The Court rejected the pharmacy’s argument that it had no duty beyond properly filling lawful prescriptions. The Court reasoned that a pharmacist’s duty “extends beyond simply following the prescribing physician’s directions.” Further, the Court found the pharmacist’s filling of the Alprazolam and Hydrocodone prescriptions unreasonable as alleged because the “Pharmacy filled, without question, numerous prescriptions that were so close together that Pharmarcy should have been put on notice that Mr. Porter [decedent customer] was getting too many pills within a short period.”
Pennsylvania has applied similar reasoning as the Florida Court did in Oleckna. Generally, under Pennsylvania law, pharmacists do not have a duty to issue warnings of a drug’s risks directly to the customer. Coyle v. Richardson-Merrell, Inc., 584 A.2d 1383, 1386 (Pa. 1989). Pennsylvania, however, recognized an exception to this rule in Riff v. Morgan Pharmacy, 508 A. 2d 1247 (1986). The reasoning in Riff goes beyond the typical exception to the learned intermediary doctrine that a pharmacist must issue warnings based on patient specific information, such as knowledge of a contraindication. In Riff, a migraine patient received a prescription of Cafergot suppositories with written instructions to take “every four hours for headache.” Id. at 1249. The pharmacist dispensed the suppositories with the instructions “‘insert one every 4 hours for headache’” written on the prescription label. After taking the suppositories as prescribed, the migraine patient developed a blood clot in her foot that led to a permanent injury. At trial, the jury found in favor of the plaintiff migraine patient and against the defendant pharmacy. The Court, on appeal, affirmed this jury verdict. In doing so, the Court rejected the pharmacy’s contention that it had no duty under the facts ascertained at trial. The Court found that a pharmacy is not merely “a warehouse for drugs” and a pharmacist is not merely in the position of “a shipping clerk who must dutifully and unquestionably obey the written orders of omniscient physicians.” Ultimately, the Court held the pharmacy breached its duty of care to the migraine patient “by failing to warn the patient or notify the prescribing physician of the obvious inadequacies appearing on the face of the prescription which created a risk of serious harm to the plaintiff.”
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.
a. Methadone Prescription:
A customer dies of methadone intoxication, and his estate sues the pharmacy for negligence. The customer had taken methadone pursuant to a doctor’s prescription from at least as early as 2008 to February 2010. The customer’s Estate contended the pharmacist was negligent for failing to properly examine the customer’s prescription history before dispensing the methadone. The Estate further argued the pharmacist was negligent for failing to recognize that the methadone was dispensed in “excessive quantities, and at intervals beyond those normally prescribed.”
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).