The Law Treats Consumers As Dumbies When It Comes To The Duty To Warn Of Dangerous Side Effects Of Prescription Medicines.


When a pharmaceutical company markets a new prescription medication that is known to have harmful side effects, what duty does it owe to warn consumers? Under existing law in New York and throughout the United States, the drug company has virtually no responsibility to warn consumers about the dangers of their medications.

Does this make sense? Of course not, but it is the law under the “learned intermediary” doctrine. The learned intermediary doctrine places a duty upon drug companies to warn physicians about the dangers of the drugs, for example the risk of ulcerative colitis from taking Accutane, but there is no duty to warn consumers. Drug companies can satisfy their duty to warn physicians about the risks of a drug through package inserts and the Physicians Desk Reference (a book that most consumers have never heard of).

If a physician is appropriately warned about dangerous side effects of a medication, the pharmaceutical company is not liable to a consumer who experiences harmful side effects. The rationale of this legal doctrine is that physicians are better able to understand the risks of a prescription medication and determine whether the risks are appropriate for their patients.

The rule suggests that it would be dangerous for a patient to acquire outside information (beyond that provided by the physician) about a prescription drug, even from the manufacturer, in order to be fully informed about the risks and benefits of a drug. Thus, the physician is the only source of information regarding the side effects of a drug.

It is dangerous to assume that doctors will convey the risks of a medication to their patients for a number of reasons. Number one: Pharmaceutical companies market their drugs directly to consumers through television and internet marketing, i.e., have you seen the Viagara commercials that are ubiquitous on the TV? The direct marketing of drugs to consumers should require drug manufacturers to warn consumers about defects in their products. It doesn’t.

Number two: With the increasing availability of prescription drugs on the internet, it is becoming more unlikely that the consumer will have a sit-down meeting with his or her physician about prescription drugs. One click of the computer keyboard is sometimes all it takes and voila, a new medication is being shipped from Canada to consumers in the U.S. In this example, the physician is not in the best position to warn a patient about the dangerous side effects of a drug.

Number three: Sample drugs are routinely distributed to consumers without the benefit of any written warnings from the drug company or the pharmacy.

In many cases, the physician is not actually functioning as the “learned intermediary” in the purchase of prescription medications with mass media advertising and the growing availability of prescription drugs on the internet. To address this problem, the Food and Drug Administration has proposed rules requiring consumer warnings on virtually all prescription drugs, but these rules have never been implemented due to intense lobbying from pharmaceutical companies.

Here’s a novel idea: Give consumers as much information about the dangerous side effects of drugs, so they can make a fully informed decision whether to take the drug. Relying on physicians to warn about drugs is an old, out-dated concept whose time has long passed. Give patients the information they need about drugs, instead of shielding them from the dangers like children.