State v. Karl

Brief Fact Summary.

Nancy Gellner’s (Plaintiff) estate brought a products liability/medical malpractice action against the manufacturer of Propulsid and the doctor who prescribed it after Plaintiff died three days after taking the drug.

Synopsis of Rule of Law.

West Virginia products liability law applies the same duty to warn consumers of the risks of their products to prescription drug manufacturers as it does to other manufacturers. 

Facts.

Plaintiff died three days after taking Propulsid, a drug manufactured and distributed by the pharmaceutical company, Janssen. Plaintiff’s estate filed a products liability/medical malpractice action against both Janssen and Plaintiff’s primary care physician, Dr. Wilson, who prescribed the drug. The trial court denied Janssen’s motion for summary judgment, rejecting Janssen’s argument that the learned intermediary doctrine prevented recovery. Janssen appealed.

Issue.

Does West Virginia products liability law hold prescription drug manufacturers to the same duty to warn consumers of the risks of their prescription drugs as the manufacturers of other products?

Held.

(Davis, C.J.) Yes. West Virginia products liability law applies the same duty to warn consumers of the risks of their products to prescription drug manufacturers as it does to other manufacturers.  West Virginia does not recognize the learned intermediary doctrine, which would provide an exception to the duty to warn for pharmaceutical companies. Under the doctrine, the manufacturer would satisfy its duty so long as it warns the prescribing physician of the risks. The prescribing physician, the “learned intermediary†would then be responsible for advising individual patients of the associated risks of the drugs prescribed. A slight majority of courts have adopted the learned intermediary doctrine, but their justifications for doing so are outdated or unpersuasive. The courts who have adopted it base their decisions on several factors: 1) the difficulty manufacturers have in warning the ultimate users of the drugs; 2) patients’ reliance on the judgment of their doctor; 3) the physicians are the ones selecting the drugs to be prescribed; 4) the belief that physicians are in the best position to provide the appropriate warnings to their patients; and 5) a concern that warning consumers directly might interfere with the doctor/patient relationship. These concerns may have been sound when the doctrine was first adopted in 1925, but the drug industry has changed. Pharmaceutical companies spend large amounts on advertising directly to consumers and the internet provides easily ascertainable information on prescription drugs. It is now much easier and more effective for pharmaceutical companies to communicate directly with consumers. At the same time, the relationship between doctors and patients has also changed. Informed consent laws require the patient to make more decisions and the doctor to be less paternalistic. Doctors have less time with patients so they have less time to go over the risks and benefits associated with a particular drug. With these changes, there is less of a concern about interfering in a doctor/patient relationship. The Restatement (Third) of Torts recognizes the learned intermediary doctrine, but includes an exception to the doctrine where the manufacturer knows or should know that a physician will not be in a position to provide an adequate warning. If pharmaceutical companies can be required to warn consumers under this exception, then they should always be able to do so. A requirement to warn consumers of the risks of a prescription drug is not unreasonable given that the company receives the financial benefit of the sale of the drug and the consumer bears the risks of using it. Doctors have certain duties and responsibilities concerning prescribing medications and the manufacturers should carry some of that responsibility as well. Writ denied.

Dissent.

(Albright, J.) Some cases do warrant the learned intermediary doctrine, so it should not be abandoned altogether. The doctrine is still needed when the drug at issue is not one that is widely advertised and where the doctor did actually assume the role of a “learned intermediary†in advising and recommending a certain drug to the patient.

Concurrence.

(Maynard, J.) The dissent’s argument would lead to an unfair result because the manufacturers bombard consumers with advertisements for drugs. There is no reason the manufacturers should then be exempt from the general duty to warn and leave the doctors to shoulder all responsibility to the consumer.

Discussion.

The “learned intermediary†doctrine shifts responsibility for failures to warn consumers from the drug manufacturers to the doctors. The courts that have adopted the doctrine do so based on the understanding that requiring the manufacturer to warn the physician and not the consumer is reasonable in light of the fact that prescription drugs are complex and varied and that prescribing physicians are in the best position to consider the individual patient and exercise medical judgment. Regardless of the duty owed by manufacturers, doctors have an independent duty to warn a patient of the risks associated with treatment. Under the “learned intermediary†doctrine, a manufacturer avoids liability only if the warning to the doctor is “adequate and not misleading.