Learned Intermediary Doctrine and the CGL Form

Q

We are preparing a risk management program for a potential client, a manufacturer of medical devices. This program will utilize some insurance coverage and other risk management practices. However, one of the company's vice presidents has asked about whether products liability coverage is necessary due to the “learned intermediary doctrine”. We are researching this doctrine and would like any information you can supply. Thank you.

New Jersey Subscriber

A

This doctrine is used by manufacturers such as your client (and pharmaceutical manufacturers) as a defense against a failure to warn products liability claim. Under the doctrine, a drug manufacturer or a medical supplies manufacturer is relieved of an independent duty to warn the ultimate user of prescription drugs or medical supplies so long as it has supplied “a learned intermediary,” such as a physician, with information about the potentially dangerous propensities of the drug or supply. In other words: the manufacturer has told another party about potential harmful side effects of its product; the other party is the intermediary between the manufacturer and the ultimate user; that other party is educated and capable enough to transfer that warning to the ultimate user of the product; therefore, the intermediary has assumed the duty to warn the user about the product. The manufacturer has, in effect, transferred his liability exposure to a third party.

The learned intermediary defense is accepted around the country, but there are two points your client should know before declining any liability insurance. First, the doctrine does not apply when the manufacturer is involved in direct marketing to the ultimate user. If your client markets his product directly to the public, bypassing the intermediary, he will be subject to claims if the advertising fails to provide adequate warnings, and injuries occur. Second, the CGL form will provide insurance coverage and defense for your client should a lawsuit be brought against him. Whether the basis for the lawsuit is primary liability due to defective product or misleading advertising, or secondary liability simply due to being a part of the whole chain of events that caused the injury, the CGL form will be there to aid the client in lessening the risk exposure.

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