“Learned intermediary” is a common defense used by defendants in personal injury cases; and in particular, prescription drug and medical device cases.

Intermediary in this case means “middle man.” Learned intermediary doctrine says that there is a middle man, someone between you and the pharmaceutical manufacturer or the medical device company, who is, in the eyes of the law, charged with the knowledge about the drug or device.

That doctor is the person who the manufacturing companies communicate with and keep apprised of updates, and advise with respect to the suitability and efficacy of their drug or device. As a patient or consumer, all or most of the information that you know about the particular drug or medical device, comes from that doctor (as opposed to the drug or device manufacturer.)

How does this affect your personal injury case?

Under the learned intermediary doctrine, makers of prescription drugs and medical devices are not obligated to directly warn patients about the risks associated with their products. Drug and medical device manufacturers fulfill their obligation to the patient or end-user by providing adequate warnings of side effects and complications to the prescribing physician.

Failure to Warn

Suppose you had a medical device implanted in you. The device is defective and you suffer severe injuries as a result. All of the information that you have about that medical device came through your doctor.

A common theory of liability in a medical device or pharmaceutical case is what is known as failure to warn. A manufacturer can be held liable for failing to provide adequate safety warnings on a product, if someone is injured by consuming or using that product. Under the learned intermediary rule, the prescription drug or medical device maker fulfills its duty to warn by warning the prescribing doctor of the dangers of using the drug or device.

So if the manufacturer of the device does not warn you about the complications you have experienced, then the only way that you could have a claim is if the doctor also was misled by the manufacturer and says that he would not have implanted you with the device had he known of the harm that it would cause.

Alternatively, if the doctor were to say that—regardless of what he might have been told by the manufacturer, even if he knew of all the risks associated with the product, he still would have implanted the device in you—then you could not have a failure to warn claim against the manufacturer. That’s what learned intermediary is all about.

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