Manufacturers Of Drugs And Medical Devices Rely Upon Physicians As Learned Intermediaries

A product manufacturer has a duty to warn users of the potential risks of its product as well how to use it safely. An exception to this general rule is carved out by the learned intermediary doctrine which requires the manufacturer of a drug or medical device to warn the prescribing physician, not the end user. That physician is viewed as the learned intermediary between the manufacturer and the patient.

Doctors are required to obtain the informed consent of their patients by informing about treatment, so it is felt they are in the best position to advise patients about the risks and benefits of a drug or device. A prescribing doctor has the advantage of knowing the particular patient and is able to respond to specific questions raised by that patient, whereas the manufacturer can only provide a generally written product insert. These and other justifications gave rise to the learned intermediary doctrine.

An example

Consider medical devices like breast implants, for example. A woman considering implants is likely to approach her oncologist or a plastic surgeon for information on implants, including the risks and contraindications. The manufacturer communicates the warnings to the surgeon who is obligated to relay those to the patient. By adequately advising the physician, the manufacturer avoids liability for any failure by the doctor to adequately advise the patient/user.

However, even if the manufacturer fails to warn the doctor of a risk (e.g., infection), it is not liable if the physician was independently aware of the risk or if the warning would not have changed the physician’s decision to prescribe the medical device. The manufacturer has no duty to warn of those dangers generally appreciated by the medical community.

Direct to consumer advertising

Although manufacturers of drugs and medical devices generally have no duty to warn the end users directly, that line is blurred if the manufacturer markets the drug or device directly to the consumer. Examples include ubiquitous magazine and television advertisements for certain prescription drugs such as Claritin and herpes medications.

Prescription drugs and medical devices are regulated by the Food and Drug Administration (FDA). The FDA controls the approval to market drugs and devices and regulates the advertising of those products. In the last few years, the FDA has finalized the requirements for manufacturers who market devices and prescription drugs directly to consumers and now provides them with guides and documents about drug and device advertisements.

Direct to consumer advertising must include a brief summary of the manufacturer’s package insert in the advertisement. Contraindications and side effects must be disclosed and the consumer must be advised how to easily obtain the full product insert. Manufacturers regularly provide toll-free numbers so consumers can order inserts. They typically list the full product insert on the company’s website.

Courts around the country have had difficulty reaching a consensus on the effect of these direct marketing efforts on the learned intermediary doctrine. If the manufacturer in essence speaks directly to the user via advertisements and spurs desire for the product, isn’t the physician’s role reduced? New Jersey’s Supreme Court noted that “the premises on which the learned intermediary doctrine rests” are altered by advertising directed to consumers. In Perez v. Wyeth Laboratories, our highest court held that the learned intermediary doctrine would not preclude direct liability to a consumer for a manufacturer who advertised its Norplant contraceptive in magazines like Cosmopolitan.

Courts in most other states continue to recognize that directly advertised products are still prescription drugs only available to patients via a learned intermediary. The majority of courts in this country continue to require doctors to advise patients of the risks despite direct advertising and will not hold the manufacturer liable when there is a failure to warn by the physician.

Over the counter medications

The learned intermediary doctrine provides protection for the manufacturer of prescription drugs and medical devices. However, the manufacturer may not rely upon the doctrine for problems arising from its over the counter medications. Consider the manufacturer of Tylenol. If a person is harmed by a bad reaction to Tylenol 3, the manufacturer will argue it had no duty to directly warn the consumer of contraindications, instead relying on the physician who prescribed this medication. Contrast problems arising from over the counter Tylenol. Since there is no doctor as intermediary between the end user and the manufacturer, the learned intermediary doctrine is not available. The manufacturer would be liable for a failure to warn of any risks or contraindications not listed on its product label. By marketing directly to the consumer in over the counter strength, the manufacturer opted to forego the shelter of the doctrine.

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