The Learned-Intermediary Doctrine—Pharmacy Protections and Responsibilities

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Written By: Paul Sparkman
Senior Associate Editor, American Journal of Trial Advocacy

          A manufacturer of a dangerous product generally must warn the consumer of potential injury resulting from the use of its product. However, in many cases drug manufacturers avoid liability for failing to warn of dangers because the learned-intermediary doctrine has shifted the duty to inform the consumer elsewhere.[i] The doctrine holds that liability for failure to warn about side-effects and other inherent dangers of prescription drugs and other treatments should not be attributed to the drug manufacturers.[ii] Instead, the prescribing physician is responsible for informing the patient of the risk.[iii]

          The physician has knowledge of medicine, the patient specifically, and the required information about the drug; is thus in the best position to make an informed choice for the patient in prescribing the drug and warning the patient of any side-effects.[iv]  The informed (learned) context in which the doctor operates interrupts the chain of causality that otherwise might extend from the manufacturer of a dangerous product to the consumer.[v] The Connecticut Supreme Court discussed one rationale for the doctrine stemming from comment (k), § 402A from the Restatement (2d) of Torts.[vi] If a product is inherently dangerous but overall useful to society, the manufacturer should not be held to strict liability for providing society with the benefit of the product.[vii]

            Dietz v. Smithkline Beecham Corp. illustrates the principle well. That case involved a claim by the widow of a man who committed suicide after being prescribed and beginning to take Paxil, a popular SSRI.[viii] Dr. Zuppa—the physician who prescribed the medication to Dietz—was aware of the potential side-effects, including the slight increased risk of suicide in children and adolescents.[ix] He took that into account when he prescribed the medication, reasoning that the benefit of the drug for that patient outweighed the risk.[x] The Eleventh Circuit applied Georgia law, quoting the supreme court’s concise description of the rule:

a prescription drug [manufacturer] . . . does not have a duty to warn the patient of the dangers involved with the product, but instead has a duty to warn the patient’s doctor, who acts as a learned intermediary between the patient and the manufacturer. The rationale for the doctrine is that the treating physician is in a better position to warn the patient than the manufacturer, in that the decision to employ prescription medication . . . involves professional assessment of medical risks in light of the physician’s knowledge of a patient’s particular need and susceptibilities.[xi]

The court reasoned that the physician’s choice to prescribe the medication severed the causal chain, so the drug company was not liable for failing to warn the patient of the risks.

            There are exceptions to the rule in various fact-specific situations. For example, summary judgment based on the learned-intermediary doctrine has been denied where the patient has kept the remainder of a prescription after not finishing it, and used it after it was recalled from the market.[xii] The physician is not responsible for notifying every patient to whom he prescribed the recalled medication.[xiii] Moreover, courts are not in total agreement regarding the applicability of the doctrine to prescription contraceptives.[xiv] Thus, depending on the nature of the claim and medication involved, the doctrine may not apply.

          The prevailing opinion is that pharmacists are not learned intermediaries themselves, though they possess a great degree of knowledge on the subject at hand.[xv] Additionally, the doctrine may help pharmacies and pharmacists avoid liability in cases in which the plaintiff asserts that filling a prescription written by the doctor was negligent behavior given the pharmacist’s knowledge of the drug and its potential effects.[xvi] The claim would assert that the doctor should not have prescribed the medication, and the pharmacist’s intervention could have avoided the patient’s injury; therefore, the pharmacist is liable for not stepping in. The courts have often held that the doctor is the learned intermediary in cases like that one, and so the pharmacist is not liable for dispensing the medication.

          Nichols v. Central Merchandise illustrates a claim against a pharmacy.[xvii] Nichols, the plaintiff, was pregnant and had a urinary tract infection.[xviii] Her doctor prescribed Gantanol, knowing that she was pregnant and knowing about the risks involved with the drug.[xix] The pharmacist, an employee of Super D Drugs, did not inform Nichols about the risks in taking the drug while pregnant, and her baby was born without hands or feet.[xx] The court reasoned that the pharmacist was not responsible for questioning the prescription of the doctor, as doing so would improperly insert the pharmacist into the role of physician, which was often outside the scope of the pharmacist’s knowledge.[xxi] Thus, the physician is the learned intermediary even as it pertains to a pharmacist.[xxii]

          Some courts have found it appropriate to refine the doctrine further. In Klasch v. Walgreen Co., the defendant pharmacy had a protocol by which the system flagged allergies and other important notes about patients.[xxiii] On this occasion, Klasch had downplayed the significance of a sulfa allergy to her doctor, who prescribed Bactrim (which is sulfa-based) for a urinary tract infection.[xxiv] The prescription was flagged by the system regarding Klasch because of the sulfa allergy about which she had informed them previously.[xxv] Klasch informed the pharmacist that she did not really have an allergy to the substance.[xxvi] She was allergic, and died days later as a result of being administered the medication.[xxvii]

          Klasch was the first case in which Nevada had a chance to adopt the learned intermediary doctrine; they did so and chose to limit its scope in the same opinion.[xxviii] The court’s reasoning relied to a great degree on that of the Supreme Court of Illinois’s in Happel v. Wal-Mart Stores, Inc.[xxix] The facts of that case were similar to those in Kasch—the Wal-Mart pharmacist filled a prescription that was contraindicated by the patient’s allergy to aspirin.[xxx] The court created a narrow exception to the learned-intermediary doctrine in which the pharmacist must warn the patient or doctor where he has knowledge that the prescribed drug or drugs are contraindicated for the patient.[xxxi] This would maintain the distinction between the pharmacist and the physician while still protecting the patient in situations in which the necessary knowledge is available to the pharmacist as well.[xxxii]

            The learned-intermediary doctrine is a defense to a claim that one has failed to inform the consumer of certain risks associated with the use of a product. Though the defense was originally created to shield pharmaceutical companies from unmanageable requirements of information distribution, it expanded to shield pharmacists and pharmacies in some cases from liability where they filled prescriptions. Some courts, though, have made an exception in cases in which the pharmacist can see that the prescription would cause harm to the patient as it is written. In those cases, depending on the jurisdiction, the pharmacist is required to inform either the patient or the physician of the problem before going forward. There are other exceptions to these rules, and this is often a fact-specific inquiry depending on the jurisdiction’s interpretation of the doctrine.

[i] Construction and application of learned-intermediary doctrine, 57 A.L.R. 5th § 2a (2020).

[ii] Id.

[iii] Id.

[iv] Vitanza v. Upjohn Co., 778 A.2d 829, 836-37 (2001).

[v] Dietz v. Smithkline Beecham Corp., 598 F.3d 812, 816 (11th Cir. 2010).

[vi] Vitanza, 778 A.2d at 837.

[vii] Id.

[viii] Dietz, 598 F.3d at 814.

[ix] Id.

[x] Id. at 814-15.

[xi] Id. at 815 (quoting McCombs v. Synthes (U.S.A.), 587 S.E.2d 594, 594 (Ga. 2003)).

[xii] Nichols v. McNeilab, Inc., 850 F. Supp. 562, 565 (E.D. Mich. 1993).

[xiii] Id.

[xiv] Construction and application of learned-intermediary doctrine, supra note 1 at 2a.

[xv] Id.

[xvi] E.g., Nichols v. Cent. Merch., 817 P.2d 1131, 1133 (1991).

[xvii] Nichols, 817 P.2d at 1132.

[xviii] Id.

[xix] Id.

[xx] Id.

[xxi] Id. at 1133.

[xxii] Id.

[xxiii] 264 P.3d 1155, 1157 (Nev. 2011).

[xxiv] Klasch, 264 P.3d at 1156.

[xxv] Id. at 1156-57.

[xxvi] Id. at 1157.

[xxvii] Id.

[xxviii] Id. at 1159.

[xxix] Id.; 766 N.E.2d 1118 (2002).

[xxx] Klasch, 264 P.3d at 1159.

[xxxi] Id. at 1160.

[xxxii] Id.

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