Learned intermediary is a defense doctrine used in the legal system of the
United States
The United States of America (U.S.A. or USA), commonly known as the United States (U.S. or US) or America, is a country primarily located in North America. It consists of 50 states, a federal district, five major unincorporated territori ...
. This doctrine states that a manufacturer of a product has fulfilled its duty of care when it provides all of the necessary information to a "learned intermediary" who then interacts with the consumer of a product. This doctrine is primarily used by pharmaceutical and medical device manufacturers in defense of
tort
A tort is a civil wrong that causes a claimant to suffer loss or harm, resulting in legal liability for the person who commits the tortious act. Tort law can be contrasted with criminal law, which deals with criminal wrongs that are punishable ...
suits.
In a clear majority of states, the courts have accepted this as a liability shield for pharmaceutical companies.
This doctrine was adopted by the Supreme Court of Canada in ''Hollis v Dow Corning Corp.'', 129 DLR 609 (1995).
History
The use of the term "learned intermediary" was first used in the
Eighth Circuit
The United States Court of Appeals for the Eighth Circuit (in case citations, 8th Cir.) is a United States federal court with appellate jurisdiction over the following United States district courts:
* Eastern District of Arkansas
* Western Distr ...
decision of ''Sterling Drug v. Cornish'' (370 F.2d 82, 85), in 1966, and has now become the prevailing doctrine in the majority of jurisdictions in the United States.
Dissent
Recently, this doctrine has been called into question due to the increased use of
direct to consumer advertising
Direct-to-consumer advertising (DTCA) refers to the marketing and advertising of pharmaceutical products directly to consumers as patients, as opposed to specifically targeting health professionals. The term is synonymous primarily with the adv ...
, whereby drug manufacturers market pharmaceutical products to individuals rather than to doctors. For example, in ''Rimbert v. Eli Lilly & Co.'', 577 F. Supp. 2d 1174, 1218-19 (D. N.M. 2008), the District Court of New Mexico reasoned that the "dramatically increased marketing directed to consumers . . . would persuade the Supreme Court of New Mexico that the justification for the learned-intermediary doctrine is quickly becoming, if not already the case, outdated." However, other recent cases have declined to adopt this so-called "direct-to-consumer advertising" exception to the learned intermediary doctrine. ''See DiBartolo v. Abbott Labs.'', 2012 WL 6681704 (S.D.N.Y. Dec.21, 2012), ''Centocor Inc. v. Hamilton'', 372 S.W.3d 140, 161 (Tex. 2012), ''Calisi v. Abbott Labs.'', 2013 WL 5462274 (D. Mass. Feb. 25, 2013).
External links
Article about the doctrine{{law-term-stub
Legal doctrines and principles