Defenses and Affirmative Defenses
Product and Tort Defenses
Under the learned intermediary doctrine, a manufacturer of prescription drugs or medical devices discharges its duty to warn by providing adequate warnings to the prescribing healthcare provider. The provider, exercising independent medical judgment, is responsible for conveying relevant risks to the patient.
The doctrine shifts the causation inquiry. Even if a warning was inadequate, the plaintiff must generally show that an adequate warning would have changed the prescriber's decision.
Alternative Names:
Learned Intermediary Rule
Why it Matters?
The doctrine is central to pharmaceutical and device defense, and it makes the prescriber's deposition the pivotal event in most failure-to-warn cases. A prescriber who testifies that he or she was aware of the risk and would have prescribed the product regardless typically defeats warning causation entirely.
Frequently Confused with
Related terms
Frequently asked questions
Does the doctrine apply to over-the-counter products?
How does direct-to-consumer advertising affect the doctrine?
