Dancing Towards Disaster or the Race to Rationality: The Demise of the Learned Intermediary Standard and the Pharmacists’ Duty to Warn

James Barney, Dancing Towards Disaster or the Race to Rationality: The Demise of the Learned Intermediary Standard and the Pharmacists’ Duty to Warn, 39 Gonz. L. Rev. 399 (2004).

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On August 4, 1993, Heidi Happel, a woman with an allergy to aspirin, called her doctor complaining of severe menstrual cramps. Heidi sought a more effective pain reliever and her doctor, who had been treating her for almost a year and knew of her allergies, prescribed Toradol, a medication known in the medical community for its similarities to aspirin. Heidi’s doctor telephoned the prescription to a Wal-Mart pharmacy where Heidi previously filled six prescriptions. Wal-Mart routinely asked their patients of “their known allergies prior to dispensing medication.” In addition, Wal-Mart maintained a database of the patient’s information. After Heidi learned that the prescription had been phoned in, Heidi called her husband and asked him to pick up the medication after he finished work. When Heidi’s husband arrived at Wal-Mart, the Wal-Mart employee asked Heidi’s husband whether the recipient of the medication had any allergies. Heidi’s husband told the Wal-Mart employee that his wife had allergies “to aspirin, ibuprofen, and acetaminophen.” Neither the Wal-Mart employee nor the labels on the bottle warned Heidi’s husband of any contraindications. After Heidi took the first dose of Toradol, she began to experience respiratory problems including tightness in her chest. Within an hour, Heidi went into anaphylactic shock and was rushed to the emergency room.

On September 30, 1994, Heidi sued her doctor and Wal-Mart for negligence. Employing the logic of the “learned intermediary standard,” the trial court granted summary judgment in favor of Wal-Mart, holding that pharmacies owed no general duty to warn of either the drug’s side effects or the drug’s possible contraindications. The appellate court reversed, holding that Wal-Mart might owe Heidi a duty to warn of the dangerous side effects of Toradol “and decided that an issue of fact remained to be decided that precluded the granting of summary judgment.” However, the appellate court made it clear that the duty pharmacists owed to warn customers of dangerous side effects was a narrow one. According to the Illinois Appellate Court, an affirmative duty to warn the patient of dangerous side effects applied only “where defendant knew of Heidi’s allergies … and where defendant knew that injury or death was substantially certain to result.” The Illinois Supreme Court affirmed the appellate court’s decision because Wal-Mart was aware not only of Heidi’s drug allergies, but also of the fact that Toradol was contraindicated for persons such as Heidi with allergies to aspirin….Read More

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