Defending claims related to prescribing drugs or using medical devices.

BUMC PROCEEDINGS 2002;15:102–104 Review of health care liability claims since the early 1990s shows that without interruption there has been some form of mass tort litigation involving medical devices or products. The 1990s began with the breast implant litigation that is finally now in its last death throes. The breast implant litigation was succeeded by the pedicle screw litigation, which was followed quickly by a short course of claims that focused on the Norplant birth control device. This was followed by claims that involved the diet drugs fenfluramine (Pondimin), dexfenfluramine (Redux), and phentermine (so-called “fen-phen” cases). After more than 3 years, these claims seem to be finally winding down. Now we are dealing with recent multimillion dollar judgments rendered in connection with troglitazone (Rezulin) and cisapride (Propulsid). Earlier this year, cerivastatin sodium (Baycol) was pulled from the market. Given this history, it is not unreasonable to expect future claims over that medication. This history also tells us that there will be litigation related to medical devices and medications in the future. Two common threads have run through all of these cases of mass medical product litigation. First, the health care providers involved in the utilization or prescription of these products were defendants and key players in these claims. Second, the manufacturers of these devices and products all made concerted efforts, at least early on, to place some, if not all, of the responsibility for any damages suffered by the patients at the feet of the involved health care providers. While the continued, determined efforts of the health care providers’ defense counsel have been successful so far in protecting these providers from liability, this battle will be ongoing and a key part of any future litigation that involves medical products or devices, particularly pharmaceuticals. To better educate prescribers on these claims, their exposure in these situations, and the manufacturers’ blame-shifting efforts, this article discusses a significant concern in this type of litigation, the “learned intermediary” doctrine. The learned intermediary doctrine is the primary defense used by medical product and device manufacturers in medical device and product litigation. This doctrine is utilized not only to defend the claims asserted against the manufacturer by patients but also to shift blame for patients’ injuries from the manufacturer to the health care provider who utilized or prescribed the product. In fact, it often appears that manufacturers expend more effort and resources to establish this defense than to defend their products. Thus, health care providers should be aware of and Defending claims related to prescribing drugs or using medical devices