## Facts

- Wyeth marketed Norplant, an implantable prescription contraceptive intended to prevent pregnancy for up to five years.
- Wyeth conducted extensive direct-to-consumer advertising (including television and magazines) that highlighted Norplant’s benefits.
- Plaintiffs alleged the consumer-directed promotions did not disclose material risks and complications, including insertion and removal difficulties, even though warnings were provided to prescribing physicians.
- Multiple Norplant cases in New Jersey were consolidated; five plaintiffs were selected to litigate shared legal issues.
- Plaintiffs asserted product-liability failure-to-warn claims, alleging Wyeth owed consumers adequate risk warnings in light of its direct marketing.

## Issues

1. Whether a prescription drug manufacturer that engages in direct-to-consumer advertising may owe a duty to warn consumers directly, notwithstanding the learned-intermediary doctrine.
2. Whether summary judgment was proper where the adequacy of consumer-directed warnings and proximate cause depended on disputed facts.

## Decision

- The New Jersey Supreme Court reversed the grant of summary judgment for defendants and remanded.
- The court recognized an exception to the learned-intermediary doctrine when a manufacturer engages in direct-to-consumer advertising for prescription drugs.
- The court held that the adequacy of warnings in the consumer-directed advertising, and proximate causation, were jury questions on this record.

## Legal Principles

- Under the learned-intermediary doctrine, a prescription drug manufacturer generally satisfies its duty to warn by providing adequate warnings to the prescribing physician.
- When a manufacturer markets prescription drugs directly to consumers and its advertising omits or downplays material risks, the learned-intermediary doctrine does not automatically bar failure-to-warn claims based on inadequate consumer warnings.
- A manufacturer that chooses to communicate with consumers for marketing purposes may be held to ordinary product-liability warning standards as to those communications.
- In direct-to-consumer advertising cases, fact issues commonly include whether the advertising provided adequate risk information and whether different warnings would have affected the patient’s decisions and injury (proximate cause).

## Conclusion

The court held that direct-to-consumer prescription drug advertising can trigger a duty to warn consumers directly, creating an exception to the learned-intermediary doctrine and requiring a jury to assess warning adequacy and causation where disputed.


Perez v. Wyeth Lab'ys Inc., 161 N.J. 1, 734 A.2d 1245 (N.J. 1999)