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
- 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.
- 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.