Define: Learned Intermediary

Learned Intermediary
Learned Intermediary
Quick Summary of Learned Intermediary

A learned intermediary is a person involved in the product distribution process who is knowledgeable about the associated risks and acts as a mediator between the manufacturer and the consumer. Their responsibility includes informing the consumer about any potential dangers, particularly in cases of products liability.

Full Definition Of Learned Intermediary

A learned intermediary is a person who serves as a middleman in the distribution chain from the manufacturer to the consumer and is knowledgeable about the product’s risks. This individual is tasked with informing the consumer about the potential risks associated with the product. For instance, in the context of prescription drugs, the learned intermediary is typically the prescribing physician, who is responsible for educating the patient about the potential risks and benefits of the drug before prescribing it. The patient relies on the physician’s expertise and knowledge to make an informed decision about whether to take the drug. In products liability cases, the learned intermediary defence is often used to argue that the manufacturer is not responsible for any harm caused by the product because the intermediary (such as the physician) failed to adequately warn the consumer about the risks.

Learned Intermediary FAQ'S

A learned intermediary is a legal doctrine that holds that a manufacturer or supplier of a product is not required to directly warn the end user of potential risks associated with the product if the manufacturer provides adequate warnings to an intermediary who is in a better position to communicate those risks to the end user.

A learned intermediary is typically a healthcare professional, such as a doctor or pharmacist, who is in a position to provide information and warnings about the risks associated with a particular product to the end user.

The rationale behind the learned intermediary doctrine is that healthcare professionals are in a better position to evaluate the risks and benefits of a particular product and to communicate those risks to the patient. This allows for more efficient and effective communication of important safety information.

The learned intermediary doctrine is most commonly applied to prescription drugs and medical devices, but it can also apply to other products where an intermediary is in a better position to communicate risks to the end user.

A learned intermediary is responsible for evaluating the risks and benefits of a particular product and for providing adequate warnings and information to the end user to ensure safe and effective use of the product.

Yes, a manufacturer can still be held liable if it fails to provide adequate warnings and information to the learned intermediary, or if it misrepresents the risks associated with the product.

In some cases, a patient may still be able to sue a manufacturer directly if the manufacturer’s actions or omissions directly caused harm to the patient, such as through fraudulent misrepresentation of the product’s risks.

There are some exceptions to the learned intermediary doctrine, such as when a manufacturer markets directly to consumers or when a product is found to have inherent dangers that cannot be adequately communicated by an intermediary.

The learned intermediary doctrine can be a defence for manufacturers in product liability cases, as it shifts the responsibility for communicating risks to the end user onto the intermediary.

Patients should consult with a qualified attorney who can evaluate the specific circumstances of their case and determine whether the learned intermediary doctrine applies.

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Disclaimer

This site contains general legal information but does not constitute professional legal advice for your particular situation. Persuing this glossary does not create an attorney-client or legal adviser relationship. If you have specific questions, please consult a qualified attorney licensed in your jurisdiction.

This glossary post was last updated: 17th April 2024.

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