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 ?
Though the learned intermediary doctrine is well established in both Canada and the United States, there are likely to be some differences in the application of the doctrine even between these two neighboring countries.
The Karl court found that "a mere twenty-one states have expressly adopted the learned intermediary doctrine.
Cheney, Not Just For Doctors: Applying the Learned Intermediary Doctrine to the Relationship Between Chemical Manufacturers, Industrial Employers, and Employees, 85 NW.
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.
The sophisticated user variation of the learned intermediary doctrine is sometimes referred to as the "sophisticated intermediary.
If the case had been tried, I doubt that Lilly would have been granted a jury instruction about the learned intermediary doctrine.
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.
The learned intermediary doctrine holds that when a drug maker properly warns a prescribing physician of the dangerous risks of its product, the manufacturer is excused from warning each patient who receives the drug.