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Does a Prescription Drug Company Have a Duty to Warn Consumers of Oral Contraceptive Risks?


Learned Intermediary Doctrine


In general, prescription drug manufacturers are not required to warn consumers of the risks associated with prescription drugs. The drug manufacturers are only required to inform the doctor of such risks. It is the prescribing doctor’s duty to inform the consumer of any risks or side effects. This legal principle is called the learned intermediary doctrine. The theory is that the doctor is in a better position than the manufacturer to discuss the benefits, risks and side effects of a drug with the consumer.



Side Effects Linked to Oral Contraceptive Use


The most serious side effects linked to oral contraceptives or birth control pills are strokes, heart attacks, blood clots, tumors and birth defects. Birth control pills also interact with certain other drugs, including some epilepsy drugs, diabetic medication and hypertension drugs. There can also be interactions between certain vitamins and birth control pills. Finally, there is an increased risk of heart attack or stroke in women who smoke while taking birth control pills.



Exception to Learned Intermediary Doctrine for Oral Contraceptives


In the mid-1980s, a few cases in Massachusetts and Michigan recognized an exception to the learned intermediary doctrine for oral contraceptives. The courts concluded that birth control pills were significantly different from other prescription drugs in several ways. For one thing, their use was only loosely supervised by the doctor after the drugs were prescribed. Even though the U.S. Food and Drug Administration (FDA) already required a warning label for prescription drugs, the courts held the manufacturer had a duty to directly warn consumers of any risks from taking birth control pills. The manufacturer could not rely on warnings to doctors to relieve it of liability. This is the minority view today.



Majority of Courts Uphold Learned Intermediary Doctrine for Oral Contraceptives


The majority of courts hold that the drug manufacturer has no duty to warn consumers directly of any risks associated with taking birth control pills. In March 2003, the Wisconsin Court of Appeals held that a drug company’s package insert warning on an oral contraceptive complied with FDA standards. The insert stated the dangers that were known or reasonably knowable at the time. In this case, the oral contraceptive user developed Stevens-Johnson Syndrome (SJS), which led to blindness. She sued the drug manufacturer for failing to warn of the possible connection between using the manufacturer’s oral contraceptive and SJS. The court held that the manufacturer had not violated FDA regulations by failing to add an SJS warning to the package insert. There was no evidence that the manufacturer had any actual or constructive knowledge that its oral contraceptive could cause SJS. In addition, the court found that the oral contraceptive user failed to prove that, if properly warned, she would have stopped taking the oral contraceptive.

Copyright 2011 LexisNexis, a division of Reed Elsevier Inc.


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