Perez v. Wyeth Labs, Inc. - 161 N.J. 1, 734 A.2d 1245 (1999)

Rule:

In New Jersey, as elsewhere, it is the accepted proposition that a pharmaceutical manufacturer generally discharges its duty to warn the ultimate users of prescription drugs by supplying physicians with information about the drug's dangerous propensities.

Facts:

The Norplant contraceptive employed six thin, flexible, closed capsules that contain a synthetic hormone, levonorgestrel. The capsules were implanted under the skin of a woman's upper arm during an in-office surgical procedure characterized by the manufacturer as minor. A low, continuous dosage of the hormone diffused through the capsule walls and into the woman's bloodstream. Removal occured during an in-office procedure, similar to the insertion process. Wyeth began a massive advertising campaign for Norplant in 1991, which it directed at women rather than at their doctors. Wyeth advertised on television and in women's magazines, such as Glamour, Mademoiselle, and Cosmopolitan. None of the advertisements warned of any dangers or side effects associated with Norplant, but rather praised its convenience and simplicity. Wyeth also sent a letter to physicians advising that it was about to launch a national advertising program in magazines that the physicians' patients may read. In 1995, several women began to file lawsuits in various New Jersey counties claiming injuries that resulted from their use of Norplant. Their principal claim was that Wyeth, distributors of Norplant in the United States, failed to warn adequately about the side effects associated with the contraceptive. Class action certification was denied and all New Jersey cases involving Norplant were consolidated in Middlesex County. The trial court dismissed those plaintiffs' complaints, concluding that even when a manufacturer advertises directly to the public, and a woman is influenced by the advertising campaign, a physician nevertheless retains the duty to weigh the benefits and risks associated with a drug before deciding whether the drug is appropriate for the patient. Thus, the trial court held the "learned intermediary" doctrine applicable to plaintiffs' actions.

Issue:

Does the “learned intermediary” doctrine apply to direct marketing of drugs to consumers?

Answer:

No.

Conclusion:

Prescription drug manufacturers that market their products directly to consumers should be subject to claims by consumers if their advertising fails to provide an adequate warning of the product's dangerous propensities. The "learned intermediary" doctrine is based on four premises: (1) reluctance to undermine the doctor-patient relationship; (2) absence of need for the patient's informed consent; (3) inability of drug manufacturer to communicate with patients; and (4) complexity of the subject. However, consumer-directed advertising of pharmaceuticals belies each of these premises. Prescription drug manufacturers that market their products directly to consumers should be subject to claims by consumers if their advertising fails to provide an adequate warning of the product's dangerous propensities. In determining whether the warnings are adequate, drug manufacturers should be entitled to the rebuttable presumption that they have satisfied their duty to warn ultimate consumers about the potential harmful side effects of its product if their warnings comply with FDA regulations.