Perez v. Wyeth Laboratories, Inc.

Superior Court of New Jersey, Law Division, Middlesex County · 1997 · Torts

Tortsproducts liabilityfailure to warnprescription drugslearned intermediary doctrineNorplantcontraceptivesfailure to warn

Facts

Plaintiffs alleged personal injuries from using the Norplant contraceptive system and specifically argued that Wyeth failed to warn of pain and scarring associated with removal. Each plaintiff received Norplant through a physician or, in one case, a certified women's health nurse authorized to prescribe and insert it, and each provider testified that Wyeth's labeling fairly or sufficiently described Norplant's risks and benefits or that the provider already knew the relevant risks and still considered Norplant safe and effective. Wyeth's labeling had been approved by the FDA and specifically warned that removal difficulties could include scarring, bruising, ulceration, sloughing, and the possible need for an additional visit and incision. Plaintiffs offered affidavits saying they personally would not have chosen Norplant had they known of painful removal and scarring, but they offered no expert opinion that Wyeth's warnings were inadequate or that different warnings would have changed the providers' prescribing decisions.

Issue

Does the learned intermediary doctrine apply to Norplant, a prescription contraceptive, despite plaintiffs' arguments for exceptions based on contraceptive decision-making and direct-to-consumer advertising? If so, did plaintiffs present sufficient evidence to overcome the presumption that Wyeth's FDA-approved warnings were adequate and to show that any different warning would have altered the prescribing decisions of their healthcare providers?

Rule

For prescription drugs in New Jersey, the manufacturer ordinarily satisfies its duty to warn by providing adequate warnings to the prescribing physician or other qualified healthcare provider, not directly to the patient. Under N.J.S.A. 2A:58C-4, an FDA-approved prescription drug warning carries a rebuttable presumption of adequacy, and a plaintiff must prove both inadequacy and proximate cause by showing that an adequate warning would have altered the provider's decision to prescribe the drug.

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One of 10 multiple-choice questions for this case. Pick an answer to see why.

In Newark, Dana Ruiz received a prescription migraine injection from Dr. Leo Mercer after discussing treatment options. Dana later sued the manufacturer, alleging its website and package materials never directly warned her about a risk of severe rebound headaches, although the prescribing information given to Dr. Mercer described that risk.

Under the governing rule, which argument gives the manufacturer the strongest basis for defeating Dana's failure-to-warn claim?

Explanation. For prescription drugs, the manufacturer ordinarily discharges its warning duty by adequately warning the prescribing physician or other qualified healthcare provider, not the patient herself. The rule focuses on the learned intermediary's role in evaluating the drug's risks and benefits for the individual patient. The other choices misstate the doctrine.