Learned Intermediary Doctrine

What is a Learned Intermediary Doctrine and how does it work?

Learned Intermediary Doctrine: How Does It Work?

One of the defenses that frequently comes up in product liability litigation is the “learned intermediary” doctrine. This term comes from a 1966 Court decision where the Court reasoned that, in situations involving prescription drugs, “the purchaser’s doctor is a learned intermediary between the purchaser and the manufacturer.” The defense is based on the “pivotal role that physicians play in the distribution of prescription products and because prescription drugs are likely to be complex medicines, esoteric in formula and varied in effect”. This doctrine is now recognized in the majority of States.

Here is how the concept works: a manufacturer of prescription drugs or medical devices fulfills its duty to warn consumers of any risks associated with its products by warning the prescribing physician of the proper use and risks of the manufacturer’s product. Thus, the manufacturer’s duty is to warn doctors and not patients or the public. This acts a defense in any later lawsuits where a patient alleged the manufacturer did not warn them of any side effects or danger areas.

Rules Behind The Learned Intermediary Doctrine

The three basic reasons behind the rule are:
1) the prescribing physician is in the best position to give a warning and can provide an independent medical decision as to whether use of the drug or medical device is appropriate for treatment of a particular patient;
2) manufacturers lack the effective means to communicate directly with each patient; and,
3) imposing a duty to warn upon the manufacturer would unduly interfere with the physician-patient relationship.

Different States, Different Rules

However, the learned intermediary doctrine is treated differently in different states.

Some States have established the rule it as a defense in cases involving prescription drugs and medical devices. Some States have even extended the protection afforded by the learned intermediary doctrine to pharmacists.

Pharmacists may not have a duty to warn patients about the potential side effects of medication unless such warnings were included in the prescription received from the physician

Some States have limited the learned intermediary doctrine to drug manufacturers because of the “unique relationship between physician and patient.”

Some States have refused to recognize the doctrine at all.

Some States have said that, in order to recover for failure to warn under the learned intermediary doctrine, a plaintiff must show:
(1) that the defendant failed to warn the physician of a risk associated with the use of the product not otherwise known to the physician; and
(2) that the failure to warn the physician was both a cause in fact and proximate cause of the plaintiff’s injury.


Even in the States where it is an accepted legal doctrine, certain exceptions have been carved into the doctrine. The first exception is for vaccines administered in public, or at a mass clinic, where a physician is not generally involved. Another exception is for contraceptive medications and devices, where the patient is actively involved in the decision and the products are used for extended periods of time without medical assessment or supervision.   

In addition to these generally accepted exceptions, continuing challenges to the learned intermediary doctrine continue to arise.

For example, one Court adopted an exception to the learned intermediary doctrine for cases in which the manufacturer engaged in direct-to-consumer advertising.  Another Court carved out a new exception by determining the learned intermediary doctrine did not apply where the drug manufacturer prepared an informational video for doctors to provide to their patients which did not discuss the side effect experienced by the plaintiff


Thus, cases involving direct marketing or managed care makes it less likely that the learned intermediary doctrine will be applied. Although the majority of state and federal court opinions continue to apply the learned intermediary doctrine, it remains to be seen how courts will consider the doctrine in the future.

This is an important consideration for clients of TheLawFirm.com injured by defective medical devices or bad drugs. Did your doctor warn you? What did your doctor tell you? Do you live in a State where this doctrine applies? Was there direct to consumer marketing? Was there ongoing medical assessment? These are the types of questions that will need to be asked, and answered, in assessing your case.

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