The Supreme Court of New Jersey held in Perez v. Wyeth Labs, Inc., 734 A.2d 1245 (1999) that: (1) pharmaceutical manufacturers who engage in direct-to-consumer (DTC) advertising are liable for the failure to provide adequate product warnings to consumers and are not exempt from the learned intermediary doctrine; (2) a manufacturer's warning is given a rebuttable presumption of adequacy if it complies with Food and Drug Administration (FDA) regulations; and (3) the physician's role in prescribing drugs does not break the chain of causation for a manufacturer's failure to warn patients when the manufacturer has engaged in DTC advertising.

The plaintiffs, individual women who had received Norplant implants, alleged that Wyeth-Ayerst Laboratories (Wyeth) failed to warn adequately of side-effects associated with the contraceptive during its massive DTC advertising campaign in the early 1990s. They initially filed individual lawsuits involving the Norplant device beginning in 1995, and the cases were subsequently consolidated in one action. Pursuant to a case management conference, plaintiffs' counsel selected five bellwether plaintiffs to challenge Wyeth's motion for summary judgment. The trial court held that the learned intermediary doctrine applied even in the context of DTC advertising, and dismissed the case.

The learned intermediary doctrine allows pharmaceutical manufacturers to discharge their duty to warn patients of prescription drug dangers by supplying doctors with information regarding the drug's propensity to cause harm. Thus, Wyeth argued that the doctors who prescribed and implanted the Norplant device had the sole duty to inform their patients of the device's potential dangers and side-effects. The Supreme Court of New Jersey rejected this argument, holding that the learned intermediary doctrine cannot be used to discharge the duty to warn when the prescription drug is marketed directly to consumers. The court noted that DTC advertising encourages patients to pressure their doctors to prescribe the advertised drug, thus altering the traditional doctor-patient relationship on which the learned intermediary doctrine was originally predicated.

The court then held that the manufacturer's duty to warn consumers in DTC advertising would be presumptively adequate if the advertising complied with FDA regulations. Consumers may submit proof to rebut this presumption of adequacy. The court noted, however, that because current FDA-approved advertising will, by definition, be "fair and balanced . . . [f]or all practical purposes, absent deliberate concealment or nondisclosure of after-acquired knowledge of harmful effects, compliance with FDA standards should be virtually dispositive of [these] claims." Id. at 1259.

Last, the court held that the mere fact that the doctor is the intermediary through which the patient receives the prescription drug, does not break the manufacturer's chain of causation. The court noted that patients form "preconceived expectations about treatment" based on DTC advertising, and that doctors may, therefore, be pressured to relent to patients' demands for advertised drugs even if it is not in their best interest. However, because a doctor's judgment is not totally eclipsed, the court held that neither the doctor nor the pharmaceutical manufacturer should be "entirely relieved from their respective duties to warn." Id. at 1262-63. Instead, the manufacturer may seek indemnity, contribution, or exoneration based on the doctor's role in prescribing the drug. A jury is then to decide whether the manufacturer's role in the case constitutes a proximate cause of the harm to the patient.

The implications of this ruling will be most felt by pharmaceutical manufacturers engaging in DTC marketing campaigns, because the ruling could lead to new consumer lawsuits against the pharmaceutical companies. The ruling may also implicate the FDA, because it sets the regulatory scheme for DTC marketing of drugs. This ruling serves to protect the patients' interests in ensuring that adequate information is disclosed regarding the side-effects of prescription drugs.