learned intermediary doctrine


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learned intermediary doctrine

The legal doctrine that a pharmaceutical manufacturer need only advise or warn physicians, and not the public at large, of the potential hazards of the drugs it produces. Under this doctrine physicians act as agents for the public when they prescribe medications. Their education and clinical experience help them decide when to use a medication and when, because of safety concerns, to avoid its use. Exceptions to the doctrine are illustrated by direct-to-consumer drug advertising (e.g., on television or the Internet) in which pharmaceutical companies present their products directly to patients without the physician acting as intermediary. Synonym: learned intermediary rule
See also: doctrine
References in periodicals archive ?
Learned Intermediary Doctrine has been recognized for almost 50 years
Nearly every state has applied the learned intermediary doctrine to shield pharmaceutical manufacturers from liability for
These conditions, the court opined, mark "[s]ignificant changes in the drug industry [that] post-dated the adoption of the learned intermediary doctrine in the majority of states in which it is followed." (20) Finding that drug companies now spend millions of dollars marketing their products to consumers (both through advertising and company and product web sites), the Karl court determined that the manufacturer, not the physician, is the one best suited to advise patients of the risks and benefits of its drugs.
Almost all jurisdictions follow the learned intermediary doctrine with regard to claims involving prescription drugs.
The learned intermediary doctrine, as articulated by the supreme court in Kirk, absolves a prescription-drug manufacturer of the duty to directly warn the consumer of its prescription drugs.
Part I of this note will outline the learned intermediary doctrine, discussing its rationales and treatment by the Restatement (Third) of Torts.
At least one New Jersey court held that although the state rejected the learned intermediary doctrine in the context of direct-to-consumer advertising of prescription drugs, the intervening medical judgment of a physician still creates causation problems.
It may be possible to circumvent the learned intermediary doctrine by introducing into evidence handouts and other "patient education" tools.
The documents and materials generated during an internal investigation are, in essence, ultimately protected by the learned intermediary doctrine because they are used to create an adequate warning.