The "learned intermediary" doctrine:
A) shields a physician from liability because of a drug company's mistake in dosage instructions
B) is invoked by regulatory agencies in their arguments in court arguments in support of new regulations
C) holds federal regulatory agencies supreme in all matters regarding control of product safety
D) holds that the FDA has gone too far in preventing new, effective drugs from reaching the market in less time
E) none of the other choices

Question

Quizplus · Accepted Answer

The "learned intermediary" doctrine refers to the legal principle that manufacturers of prescription drugs or medical devices fulfill their duty to warn end users of the risks associated with their products by providing the necessary information to the prescribing physicians (or other healthcare providers), who then act as intermediaries between the manufacturers and the patients. This doctrine does not directly relate to shielding physicians from liability due to drug company mistakes, regulatory agencies' court arguments, federal regulatory supremacy, or the FDA's drug approval process as described in the other choices.

The "Learned Intermediary" Doctrine