Perez v. Wyeth Laboratories Inc.
734 A.2d 1245, 1999 N.J. LEXIS 1000, 161 N.J. 1 (1999)
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Rule of Law:
When a pharmaceutical manufacturer advertises a prescription drug directly to consumers (DTC), the learned intermediary doctrine does not apply, and the manufacturer has an independent duty to provide adequate warnings of the product's risks and side effects directly to consumers.
Facts:
- Wyeth Laboratories developed and marketed Norplant, a reversible contraceptive that is surgically implanted under the skin of a woman's upper arm and prevents pregnancy for up to five years.
- Beginning in 1991, Wyeth launched a massive direct-to-consumer advertising campaign for Norplant, placing ads on television and in popular women's magazines.
- The advertisements promoted Norplant's simplicity and convenience but, according to plaintiffs, did not warn of potential dangers or side effects.
- Plaintiffs were women who used Norplant and alleged they suffered from numerous side effects, including weight gain, headaches, mood swings, depression, and significant pain and permanent scarring resulting from complications during the removal procedure.
- Plaintiffs alleged that Wyeth was aware of studies indicating high rates of removal difficulty and pain but failed to provide this information to consumers in its advertisements.
Procedural Posture:
- Plaintiffs filed lawsuits in various New Jersey counties against Wyeth for injuries allegedly caused by the Norplant contraceptive.
- The cases were consolidated in the Superior Court, Law Division (trial court), and five 'bellwether' plaintiffs were selected for initial proceedings.
- Wyeth moved for summary judgment, arguing that the learned intermediary doctrine barred plaintiffs' failure-to-warn claims.
- The Law Division granted summary judgment for Wyeth, holding that the learned intermediary doctrine applied.
- Plaintiffs appealed the decision to the Superior Court, Appellate Division (intermediate appellate court).
- The Appellate Division affirmed the trial court's grant of summary judgment in favor of Wyeth.
- The Supreme Court of New Jersey granted the plaintiffs' petition for certification to review the issue.
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Issue:
Does the learned intermediary doctrine, which shields pharmaceutical manufacturers from liability for failure to warn if they adequately warn prescribing physicians of a drug's risks, apply when the manufacturer markets the drug directly to consumers?
Opinions:
Majority - O'Hern, J.
No, the learned intermediary doctrine does not apply when a pharmaceutical manufacturer markets a drug directly to consumers. Direct-to-consumer advertising alters the traditional physician-patient relationship and creates a direct duty on the part of the manufacturer to warn consumers of a product's risks. The historical premises of the doctrine—the physician as the exclusive decision-maker and the manufacturer's inability to communicate with the patient—are no longer valid in the age of mass media advertising. When manufacturers bypass the physician to appeal directly to the patient, they assume a duty to provide the patient with adequate information. While the New Jersey Products Liability Act addresses warnings to physicians, it does not codify the boundaries of the learned intermediary doctrine or preclude the court from creating this exception. The intervention of a prescribing physician does not automatically break the chain of causation, as patient pressure influenced by advertising can be a substantial factor in the physician's decision; this is a question for the jury. However, a manufacturer's compliance with FDA advertising regulations creates a rebuttable presumption that its warnings to consumers are adequate.
Dissenting - Pollock, J.
Yes, the learned intermediary doctrine does apply, even in the context of direct-to-consumer advertising. The majority ignores the plain language and legislative intent of the New Jersey Products Liability Act, which unambiguously codifies the learned intermediary doctrine by stating that for prescription drugs, the adequacy of a warning is determined by the knowledge of the 'prescribing physician.' The legislative history confirms the warning is owed to the physician, not the patient, and the statute was intended to make New Jersey law more favorable to manufacturers. The court is impermissibly substituting its own policy preferences for that of the Legislature, which was aware of direct-to-consumer advertising when it enacted the statute. Furthermore, Norplant is a poor case for creating this exception, as its surgical implantation and removal require significant involvement from a physician, ensuring the doctor's role as a true learned intermediary is not diminished.
Analysis:
This decision represents a significant evolution in products liability law by carving out a major exception to the long-standing learned intermediary doctrine. It responds directly to the modern reality of direct-to-consumer pharmaceutical advertising and the corresponding shift in the doctor-patient relationship toward more patient-driven decision-making. The ruling exposes pharmaceutical companies to greater potential liability by creating a direct duty to warn consumers, thereby opening a new avenue for plaintiffs to bring failure-to-warn claims against manufacturers. This precedent has influenced other jurisdictions to reconsider the scope of the doctrine in an era of multi-billion dollar consumer-facing drug marketing campaigns.
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