The learned intermediary doctrine and its effects on prescribing physicians.

BUMC PROCEEDINGS 2003;16:359–361 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 by the US House of Representatives in March 2003)—this legislation has not been passed by the US Senate. From a medicolegal standpoint, this litigation will likely be part of the health care liability claim landscape for some time. One of the key facets to this litigation for prescribing physicians is the learned intermediary doctrine. This defense has been utilized by manufacturers in all of the pharmaceutical claims mentioned. The effect of this defense, if successful, is to shift the focus, and ultimate responsibility, for any failure to warn about the medication’s risks from the manufacturer to the prescribing physician. This may move the prescribing physician from being a low-profile, minor defendant in these claims to being a primary target and possibly the sole target. In product liability cases, Texas, like most other states, has adopted Section 402A of the Restatement (Second) of Torts (1). Under the Restatement, a manufacturer is liable for the products it sells if they are in “a defective condition unreasonably dangerous to the user or consumer” (2). A product is unreasonably dangerous if there is a defect in its design or marketing (3). A medication is defectively designed if the risks of harm associated with the medication’s use outweigh its benefit (4). A medication is improperly marketed, a so-called “marketing defect claim,” if the manufacturer did not provide proper instructions about how to use the medication or did not adequately warn about the medication’s risks (4). The learned intermediary doctrine is utilized by pharmaceutical manufacturers in response to marketing defect claims. In a marketing defect claim, the manufacturer is liable if 2 facts are The learned intermediary doctrine and its effects on prescribing physicians