Patient-Specific Risks Fall Outside Utah’s Learned Intermediary Rule for Pharmacists

Introduction

In Jensen v. Walgreen Co., 2025 UT 41 (Utah Oct. 2, 2025), the Utah Supreme Court clarified the scope of the learned intermediary rule in negligence cases involving pharmacists. The case arose from the death of Steven Jensen, a chronic oxycodone user whose physician prescribed clonazepam, a benzodiazepine. The combination is known to significantly increase the risk of severe respiratory depression and death, and is the subject of an FDA “black box” warning. When Jensen filled the clonazepam prescription at Walgreens, the pharmacy’s system generated a severe drug-interaction alert, which the pharmacist manually overrode without contacting the prescriber. Jensen died less than thirty-six hours later from oxycodone-clonazepam toxicity.

Jensen’s estate and family sued Walgreens for negligence, including failure to warn. Walgreens sought summary judgment, arguing that under the learned intermediary doctrine, the prescribing physician (as the “learned intermediary”) bears the duty to warn of drug risks, and pharmacists owe no such duty when they fill FDA-approved medications as written. The district court denied summary judgment; Walgreens pursued an interlocutory appeal.

The central issue was whether the learned intermediary rule categorically shields a pharmacist from a negligence-based duty to warn under these facts. The Court held it does not. When a pharmacist has knowledge of a patient-specific risk—or where a prescription bears an obvious facial error or the drug is not FDA-approved—the learned intermediary rule does not relieve the pharmacist of the generally recognized duty of reasonable care.

Summary of the Opinion

The learned intermediary rule in Utah exempts pharmacists from duties to warn about the general risks and side effects of FDA-approved prescription drugs. It does not curtail a pharmacist’s general duty of care in negligence when patient-specific risks are known or when facially obvious errors exist.
Patient-specific risks include circumstances where the pharmacist knows, from records, alerts, or other information, that a particular combination, dose, or characteristic poses heightened danger to the specific patient.
The Court affirmed denial of summary judgment to Walgreens. The pharmacy’s alert and records established evidence that the pharmacist knew of a patient-specific risk; thus, the learned intermediary doctrine did not eliminate the pharmacist’s duty as a matter of law.
The Court also rejected Walgreens’ alternative causation argument. Even though the physician testified he would have confirmed the prescription if contacted, a genuine factual dispute remained as to whether a pharmacist warning to Jensen would have changed his behavior.
The case was remanded for further proceedings, with the pharmacist’s duty governed by the ordinary standard of care applicable to reasonably prudent pharmacists in similar circumstances.

Analysis

Precedents Cited and Their Influence

The Court’s reasoning rests on a careful synthesis of Utah’s strict liability jurisprudence, negligence principles, and persuasive authority from other jurisdictions.

Hahn v. Armco Steel Co., 601 P.2d 152 (Utah 1979): Utah adopted Restatement (Second) of Torts § 402A strict products liability. This set the stage for later analysis distinguishing design defect from warning-based claims.
Grundberg v. Upjohn Co., 813 P.2d 89 (Utah 1991): Utah adopted comment k to § 402A, classifying all prescription drugs as “unavoidably unsafe” in design, thereby foreclosing strict liability design-defect claims against drug manufacturers and sellers if properly prepared and accompanied by appropriate warnings. Crucially, Grundberg did not foreclose failure-to-warn theories.
House v. Armour of Am., Inc., 929 P.2d 340 (Utah 1996): Reaffirmed that inadequate warnings can render a product unreasonably dangerous under Utah law, preserving failure-to-warn theories even where strict design liability is limited by comment k.
Schaerrer v. Stewart’s Plaza Pharmacy, Inc., 2003 UT 43, 79 P.3d 922: Utah adopted the learned intermediary doctrine in the strict liability context and extended it to pharmacists as “sellers” of prescription drugs. Schaerrer emphasized the regulatory framework and potential disruption to the physician-patient relationship if pharmacists were compelled to warn of general drug risks. However, Schaerrer resolved the negligence claim on causation grounds and expressly left open the doctrine’s scope in negligence. A statement suggesting pharmacists are insulated if they fill as prescribed was deemed non-binding dicta and later rejected as a categorical rule.
Downing v. Hyland Pharmacy, 2008 UT 65, 194 P.3d 944: The Court acknowledged that the learned intermediary rule can sensibly apply in negligence, but held it does not apply where a pharmacist dispenses a drug withdrawn from the market (i.e., not FDA-authorized). Downing recognized the national trend limiting the doctrine to general side effects and not to known patient-specific risks, excessive doses, contraindications, or obvious prescription errors. It declined, however, to comprehensively define the doctrine’s negligence contours—until this case.

The Court also drew on a robust body of persuasive out-of-state authority limiting the learned intermediary doctrine when pharmacists have knowledge of patient-specific risks or when prescriptions contain obvious errors:

Happel v. Wal-Mart Stores, Inc., 766 N.E.2d 1118 (Ill. 2002): Pharmacist liable where pharmacy knew of patient’s aspirin allergy and filled a contraindicated prescription; doctrine does not apply when pharmacist already knows patient-specific danger.
Klasch v. Walgreen Co., 264 P.3d 1155 (Nev. 2011) (en banc): Duty arises when pharmacist knows of a customer-specific risk; pharmacist must exercise reasonable care by warning the patient or notifying the prescriber.
McKee v. American Home Products Corp., 782 P.2d 1045 (Wash. 1989) (en banc): Pharmacists must be alert to patent errors, including lethal dosages, known contraindications, and incompatible prescriptions; imposing such a duty does not intrude on the practice of medicine.
Additional authorities in line with this approach include Moore v. Mem’l Hosp. of Gulfport, Hand v. Krakowski, Pittman v. Upjohn Co., Ferguson v. Williams, Cottam v. CVS Pharmacy, Nichols v. Central Merch., Inc., Gassen v. East Jefferson Gen. Hosp., Horner v. Spalitto, Stebbins v. Concord Wrigley Drugs, and Walls v. Alpharma USPD, Inc. These cases collectively support the majority view that the learned intermediary doctrine does not shield pharmacists from negligence liability when they possess knowledge of patient-specific dangers or when prescriptions are facially erroneous.

Legal Reasoning

The Court recharacterizes the learned intermediary doctrine in negligence as an exception to the general rule that pharmacists owe patients a duty of reasonable care. The general duty requires a pharmacist to possess and exercise the skill, care, and knowledge of a reasonably prudent pharmacist under similar circumstances.

Under this decision, the exception applies narrowly: it relieves pharmacists of any duty to warn about the general risks associated with FDA-approved drugs because the prescribing physician is best positioned to evaluate and communicate those general risks. However, the exception does not apply when:

the pharmacist has knowledge of a patient-specific risk (for example, from pharmacy records, interaction alerts, known allergies, a patient’s unique characteristics, or known concomitant medications),
the dispensed drug is not authorized for sale by the FDA (as in Downing), or
the prescription contains an obvious error on its face that a reasonably competent pharmacist should recognize (e.g., obviously lethal dosages, incompatible drugs, known contraindications, or inconsistent quantities/instructions).

The Court emphasizes that the learned intermediary rule’s core policy—preserving the physician-patient relationship and avoiding the imposition on pharmacists of a physician’s role—does not justify immunity when the pharmacist already knows of a patient-specific risk or encounters an obvious error. In such cases, imposing a duty does not require pharmacists to practice medicine but to exercise professional competence within their domain, such as addressing known interactions flagged by pharmacy systems.

Importantly, the Court separates duty from standard of care. It declines to specify precisely what conduct is required (e.g., whether to warn the patient, contact the prescriber, refuse to fill), leaving those specifics to be established by the applicable standard of care through expert testimony and professional norms. The holding concerns duty only: when the exception does not apply, the pharmacist retains the general duty of reasonable care.

Applying these principles, the Court finds that Walgreens’ own records and an insurer-generated interaction warning put the pharmacist on notice of a severe, patient-specific risk stemming from the oxycodone-clonazepam combination. Because the pharmacist overrode the alert and filled the prescription without contacting the prescriber or otherwise addressing the risk, the learned intermediary doctrine does not bar the negligence claim at the duty stage.

On causation, the Court finds a triable issue. Even though the prescriber testified he would have reconfirmed the prescription if called, the record contains evidence that Jensen and his wife were already concerned about side effects, and that a warning from the pharmacist could have deterred Jensen from taking the clonazepam. Viewing the evidence in the light most favorable to the nonmovants, summary judgment on causation was improper.

Impact

This opinion significantly clarifies Utah law and aligns it with the majority rule nationwide. Key implications include:

Pharmacist duty clarified: In Utah negligence cases, pharmacists remain exempt from warning about general risks of FDA-approved drugs under the learned intermediary doctrine. But when they possess information about a patient-specific risk or encounter an obvious prescription error—or the drug is not FDA-authorized—the doctrine offers no shield at the duty stage.
Workflow and policies: Community and chain pharmacies should reassess policies on alert overrides, documentation, and counseling. When systems flag severe interactions, pharmacists should follow established procedures consistent with the profession’s standard of care—e.g., evaluating the alert, checking records, considering prescriber consultation, and performing appropriate patient counseling—recognizing that the legal duty exists in these circumstances.
Litigation posture: Defendants can still contest breach, causation, and damages; the opinion does not create per se liability. Plaintiffs will likely develop expert testimony on standards of care for managing interaction alerts, contraindications, and high-risk combinations, especially those with black box warnings.
Physician-pharmacist coordination: The decision encourages interprofessional communication without intruding on medical decision-making. Pharmacists need not practice medicine but should act within their professional competencies when faced with patient-specific risks.
Risk management and training: Pharmacies should invest in training on patient-specific risks, alert fatigue, and documentation of interventions. Policies should address when to warn the patient, when to contact the prescriber, and when to decline to fill pending clarification—all issues that will inform the standard of care in future cases.
Regulatory compliance: While the opinion focuses on tort duty, pharmacies should align practice with Utah’s Pharmacy Practice Act, Board of Pharmacy rules, and professional guidelines on counseling and drug utilization review, as those materials often inform the standard of care.

Complex Concepts Simplified

Learned intermediary rule: A doctrine that typically places the duty to warn of general risks of prescription drugs on the prescribing physician rather than the manufacturer or pharmacist. In negligence, Utah now treats this as a narrow exception: it applies to general risks of FDA-approved drugs, not to patient-specific risks, non-FDA-authorized drugs, or obvious prescription errors.
Patient-specific risk vs. general risk: General risks are the common side effects and dangers known to apply broadly to all patients (e.g., nausea, drowsiness). Patient-specific risks arise from a patient’s unique characteristics or circumstances known to the pharmacist—such as allergies, comorbidities, concurrent medications, or an alert indicating a severe interaction for this particular patient.
Black box warning: The FDA’s most serious warning, signifying a risk of death or serious harm. Presence of a black box warning heightens the foreseeability and seriousness of risks but does not, by itself, define the legal duty; it is part of the context for the standard of care.
Duty vs. standard of care: Duty asks whether the law requires a defendant to act with reasonable care. Standard of care asks what specific actions a reasonably prudent professional would take in the situation. The Court decides duty as a matter of law but leaves the standard of care to be proven through evidence and expert testimony at trial.
Dicta vs. holding: Dicta is language in a judicial opinion not necessary to the decision and not binding. Here, a sentence in Schaerrer implying broad pharmacist protection when filling as prescribed was treated as dicta and not controlling, especially in negligence contexts.
Summary judgment and causation: Summary judgment is only proper when no genuine dispute of material fact exists. Even if a prescriber would have reaffirmed a prescription, a plaintiff may still show that a pharmacist warning would have altered the patient’s conduct, creating a triable issue on causation.

Conclusion

Jensen v. Walgreen Co. sets a clear and consequential rule for Utah negligence law: the learned intermediary doctrine no longer functions as a blanket shield for pharmacists who fill prescriptions as written. Instead, it is a narrow exception limited to warnings about general risks of FDA-approved medications. When a pharmacist knows of patient-specific risks, encounters an obvious prescription error, or dispenses a drug not authorized by the FDA, the doctrine does not displace the pharmacist’s general duty to act as a reasonably prudent pharmacist would in the same situation.

The Court’s approach harmonizes Utah law with the national mainstream and reaffirms that modern pharmacy practice includes professional vigilance: responding reasonably to patient-specific information, system alerts, and known contraindications. While the opinion preserves traditional respect for the physician-patient relationship, it recognizes pharmacists’ distinct and complementary role in patient safety. Going forward, negligence claims will turn on proof of breach, causation, and damages under the applicable standard of care, but they will not be defeated at the threshold by an overbroad invocation of the learned intermediary rule.

Case: Jensen v. Walgreen Co., 2025 UT 41, Supreme Court of Utah, opinion by Justice Petersen, joined by Chief Justice Durrant, Associate Chief Justice Pearce, Justice Hagen, and Justice Pohlman. Decided October 2, 2025.