The Learned Intermediary Doctrine and Its Effects on Prescribing Physicians

Abstract

Over the past 13 years, one constant in the field of health care liability claims has been litigation over medical devices and products. The 1990s began with the silicone gel breast implant litigation. The balance of the 1990s was devoted to litigation on Norplant and the diet drug combination fenfluramine-phentermine (fen-phen); these cases are still ongoing. The new millennium has opened with litigation regarding the medications Propulsid, Rezulin, Vioxx, Celebrex, OxyContin, and Baycol. The Baycol litigation represents a trend where the pharmaceutical company seeks to deflect the criticism toward the prescribing physicians. The manufacturer that touted the efficacy, safety, and benefit of its medication now wants to have the public and legal community view the prescriber as the culprit. While there have been efforts at “tort reform” both federally and in numerous state legislatures—reform that includes some protections for pharmaceutical claims (e.g., HR 5 passed