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Consumer Fraud Actions: The Applicability of the Learned Intermediary Doctrine
The learned intermediary doctrine has long been commonly used as a critical defense in personal injury pharmaceutical and medical device failure-to-warn claims. Under the established doctrine, recognized in nearly all states, a pharmaceutical or medical device manufacturer's duty to warn is fulfilled once it has educated the prescribing or implanting physician of the known risks and side effects associated with the product. See In re Norplant Contraceptive Prods. Liab. Litig., 215 F. Supp. 2d 795, 808 (E.D. Tex. 2002); Restatement (Third) of Torts: Prod. Liab. '6 (1998). The learned intermediary doctrine is premised on the principle that the physician has a 'duty to inform himself of the qualities and characteristics of those products which he prescribes for or administers to or uses on his patients, and to exercise independent judgment, taking into account his knowledge of the patient as well as the product.' Ecke v. Parke, Davis & Co., 256 F.3d 1013, 1018 (10th Cir. 2001). The learned intermediary doctrine provides a powerful defense in defeating elements of failure-to-warn claims, such as duty and causation. There is no doubt the learned intermediary doctrine remains an effective tool in defeating pharmaceutical and medical device failure-to-warn claims.
In response to pharmaceutical and medical device companies' mounting litigation successes ' based in large part on the learned intermediary doctrine ' plaintiffs have begun seeking creative ways to circumvent the difficulties they traditionally face in product liability personal injury suits. One new vehicle that is quickly gaining popularity is non-personal injury consumer fraud actions. In contrast to traditional product liability claims, consumer fraud claims usually are based on state statutory consumer protection statutes. Although consumer protection statutes vary from state to state, in most states, a plaintiff must generally allege facts demonstrating that: 1) plaintiff is a consumer; 2) the defendant engaged in acts that were false, misleading, or deceptive; 3) the plaintiff relied on these false, misleading, or deceptive acts; and 4) these acts were a proximate cause of the plaintiff's injuries. See 58 Food Drug L.J. 269, 282 (2003).
Due to the relative novelty of these types of claims, there is much uncertainty surrounding if and how well-established defenses to traditional product liability claims will translate in non-personal injury consumer fraud actions. At the forefront of this uncertainty is the applicability of the learned intermediary doctrine in consumer fraud actions involving pharmaceuticals or medical devices. Of course, due to the varying applications of state consumer protection statutes, pharmaceutical and medical device manufacturers may find themselves in situations where the learned intermediary doctrine will be limited or inapplicable. For example, some state consumer protection statutes do not require a showing of causation or reliance. However, for the most part, the learned intermediary doctrine remains a viable defense. Although there is by no means an abundance of case law on the issue at this time, the general trend appears to weigh in favor of the learned intermediary doctrine in consumer fraud actions.
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