Module 6 Positin Paper

Saray Perez, et al. v. Wyeth Laboratories, Inc., et al. (A-16-98) Argued March 2, 1999 — Decided August 9, 1999 O’HERN, J., writing for a majority of the Court. This appeal concerns Norplant, a Food and Drug Administration (FDA)-approved, reversible contraceptive that prevents pregnancy for up to five years. The Norplant contraceptive employs six thin, flexible, closed capsules that contain a synthetic hormone, levonorgestrel.

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The capsules are 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 diffuses through the capsule walls and into the woman’s bloodstream. Removal occurs during an in-office procedure, similar to the insertion process. Because of the procedural posture of this case, the Supreme Court was required to accept plaintiffs’ version of the facts as true. According to plaintiffs, 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, including weight gain, headaches, dizziness, nausea, diarrhea, acne, vomiting, fatigue, facial hair growth, numbness in the arms and legs, irregular menstruation, hair loss, leg cramps, anxiety and nervousness, vision problems, anemia, mood swings and depression, high blood pressure, and removal complications that resulted in scarring. Class action certification was denied and all New Jersey cases involving Norplant were consolidated in Middlesex County. Following a case management conference, Perez’s counsel sought a determination of whether the “learned intermediary” doctrine applied. The “learned intermediary” doctrine generally relieves a pharmaceutical manufacturer of an independent duty to warn the ultimate user of prescription drugs, so long as it has supplied the physician with information about a drug’s dangerous propensities. Five representative plaintiffs, including Perez, were selected to challenge Wyeth’s motion for summary judgment concerning the “learned intermediary” doctrine. Subsequently, 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. The trial court was not concerned with the effect that a warning had on the consumer plaintiffs because the Products Liability Act, N.J.S.A. 2A:58C-1 to -11, measures the adequacy of a warning based on the knowledge and characteristics of the health-care provider and not the ultimate consumer. The trial court further found that Perez and the other representative plaintiffs had failed to provide expert testimony to rebut the statutory presumption under the Products Liability Act that the manufacturer’s warning is adequate when it has been approved by the FDA. Finally, the trial court determined that Perez failed to establish that her injuries were proximately caused by any failure on the manufacturer’s part. On appeal, Perez and the other representative plaintiffs challenged the trial court’s failure to hear expert testimony on the adequacy of the warnings and the decision concerning proximate cause, maintaining that “it [had been] specifically agreed that the production of expert testimony would await the outcome of the decision on the issue of the learned intermediary doctrine.” The Appellate Division affirmed the trial court’s grant of summary judgment and its determination that the learned intermediary doctrine applied. The Appellate Division further noted that Section 6(d)(2) of the Restatement (Third) of Torts: Products Liability (1997) (Restatement) may require a warning when the physician or health-care provider has a “diminished role as an evaluator or decision maker,” in which case the manufacturer would have a duty to warn patients directly. However, the court agreed with the trial court that if the warning was legislatively deemed adequate and has been given to the proper party, then no warning defect existed under the Products Liability Law. The Supreme Court granted Perez’s petition for review. HELD: The “learned intermediary” doctrine does not apply to the direct marketing of drugs to consumers; 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.
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