Take Two of These and Sue Me in the Morning: Efficacy of the Learned Intermediary Doctrine in Prescription Drug Failure to Warn Cases

Authors

Robert J. Friedman, Washington Court of Appeals, Division Two

First Page

278

Document Type

Article

Abstract

Under the Learned Intermediary Doctrine - elaborated below and representing the majority approach to manufacturer liability in prescription drug cases - Rex holds no recourse against the pharmaceutical manufacturer of Drug X. While logic would seem to impose a manufacturer duty to the ultimate user, for purposes of tort liability in prescription drug cases it is the physician, not the patient, deemed to be the consumer. Thus, so long as the manufacturer conveys sufficient warning of possible side effects to the prescribing physician Dr. Pharm alone, a learned intermediary, the pharmaceutical manufacturer is absolved from any liability to Rex - the ultimate user of the drug. Representing an exception to ordinary tort doctrines of manufacturer-to- consumer duty, the reasoning and policy behind the Learned Intermediary Doctrine will be explored below. Common exceptions to the doctrine, as well as the role of warnings generally in tort law, will be discussed Shortcomings of the doctrine - causing the public to be put at unnecessary risk - will be related, and novel solutions will be presented for shoring up the flaws, ultimately leading to a doctrine better serving of its intended policy aims, and more protective of the general public. Back to our legally powerless ailing patient Rex, who has suffered an unintended side effect from the medication he was prescribed - should any of the following altered scenarios have an effect on his ability to hold the pharmaceutical manufacturer liable? Whether Rex merely telephoned his doctor to receive the prescription instead of visiting in person? Whether he telephoned his doctor's office but only spoke to a doctor's assistant instead of the doctor? Whether he went inside the pharmacy to pick up his prescription instead of utilizing the drive-thru? Whether, once inside the store, the pharmacist informs Rex of the medication's common possible side effects? Whether the pharmacist does not convey this information? Whether the bottle containing the medication conveys the medication's common possible side effects, or whether along with the medication Rex is provided a thick packet of literature which somewhere inside conveys the medication's common possible side effects? Whether a television or radio commercial advertising the medication commonly aired and such advertisement was seen or heard by Rex? These quandaries will similarly be explored below.

Recommended Citation

Robert J. Friedman, Take Two of These and Sue Me in the Morning: Efficacy of the Learned Intermediary Doctrine in Prescription Drug Failure to Warn Cases, 22 St. Thomas L. Rev. 278 (2010).
Available at: https://scholarship.stu.edu/stlr/vol22/iss2/5