Learned intermediary

From WikiMD's Food, Medicine & Wellness Encyclopedia

Learned Intermediary is a legal doctrine or principle that is commonly applied in product liability cases, particularly those involving prescription drugs and medical devices. The doctrine holds that manufacturers of these products have fulfilled their duty of care when they provide all of the necessary information to a "learned intermediary," who then communicates this information to the end user or consumer.

Overview[edit | edit source]

The Learned Intermediary Doctrine is based on the premise that certain products are complex and require an intermediary with the appropriate knowledge and expertise to interpret the manufacturer's warnings and instructions. This is particularly true in the case of prescription drugs and medical devices, where the intermediary is typically a healthcare professional such as a doctor or pharmacist.

The doctrine is used as a defense in product liability lawsuits. If a manufacturer can demonstrate that it provided all of the necessary information to the learned intermediary, it can potentially avoid liability for injuries caused by the product.

Legal Implications[edit | edit source]

The Learned Intermediary Doctrine has significant legal implications. It can protect manufacturers from liability in cases where the end user was harmed by the product, as long as the manufacturer provided all necessary information to the learned intermediary. However, the doctrine is not universally accepted, and its application can vary from one jurisdiction to another.

In some cases, courts have rejected the doctrine, arguing that manufacturers have a direct duty to warn end users. This is particularly true in cases involving direct-to-consumer advertising of prescription drugs.

Criticisms[edit | edit source]

Critics of the Learned Intermediary Doctrine argue that it allows manufacturers to evade responsibility for their products. They contend that manufacturers should be required to provide clear and comprehensive warnings directly to consumers, rather than relying on intermediaries.

Others argue that the doctrine is outdated, particularly in the context of modern healthcare where patients often have direct access to information about prescription drugs and medical devices.

See Also[edit | edit source]

Learned intermediary Resources
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Contributors: Prab R. Tumpati, MD