Learned Intermediary Doctrine and Oral Contraceptives

What is the learned intermediary doctrine?

The learned intermediary doctrine is a legal principle. Under the doctrine, prescription drug manufacturers are only required to inform doctors of the risks associated with taking prescription drugs. They are not required to give consumers a direct warning of the risks or side effects of taking a particular prescription drug. The underlying theory is that the doctor is in a better position to discuss the benefits, risks and side effects of a drug with the consumer.

Exception for oral contraceptives

In 1985, the Massachusetts Supreme Court carved out an exception to the learned intermediary doctrine for oral contraceptives. The court held that the manufacturer of an oral contraceptive could not rely on warnings to doctors to satisfy its duty to warn. Instead, the drug manufacturer has a duty to warn the ultimate user of oral contraceptives. The court found a direct duty to warn the birth control user because the doctor prescribing oral contraceptives has a largely passive role in the use of birth control pills. Once the initial prescription is written, there is little supervision by the doctor. Michigan courts have also recognized an exception to the learned intermediary rule for oral contraceptives and require manufacturers to provide direct warnings of risks to birth control users.

Minority view

Most courts do not recognize the oral contraceptive exception to the learned intermediary rule. The majority of courts hold that drug manufacturers do not have a duty to directly warn users of any risks associated with birth control pills. The majority holds that a drug manufacturer is only required to inform the doctor of any risks and side effects. It is the doctor's duty to act as a "learned intermediary" between the manufacturer and the oral contraceptive user. The drug manufacturer is relieved of any liability to an oral contraceptive user if it adequately informs the doctor of any risks or side effects. Of course, the prescribing doctor can be held liable for failing to adequately inform the oral contraceptive user of such risks or side effects.