Wholey v. Amgen, Inc.

Summary

The Appellate Division, First Department, modified an order denying defendants' motion to dismiss claims arising from the use of Enbrel. The court limited the plaintiff's claims to injuries allegedly occurring after she ceased participating in the clinical trial, dismissed the General Business Law and fraud-related claims for insufficient pleading, and otherwise upheld claims concerning inadequate warnings and implied warranties. The court also held that punitive damages could be sought in connection with surviving claims, although there was no independent cause of action for punitive damages.

Holdings

1. As sponsors of a clinical trial, defendants owed no duty to Wholey as an enrollee for claims concerning injuries occurring during the clinical trial; those claims were therefore subject to dismissal.
2. The General Business Law §§ 349 and 350 claim was properly dismissed because the alleged practice of concealing information and failing to provide adequate warnings was not directed at consumers as a matter of law.
3. The claims for fraud, fraudulent misrepresentation, and fraudulent concealment were insufficiently pleaded because they did not satisfy the requisite particularity.
4. The learned intermediary doctrine did not require dismissal of claims alleging that Enbrel's warnings were inadequate because those claims were based on defendants' alleged failure to warn prescribing medical professionals, not on a failure to warn Wholey directly.
5. The claim that defendants breached the implied warranties of fitness and merchantability was sufficiently pleaded.
6. There is no independent cause of action for punitive damages, but plaintiffs may seek punitive damages in connection with otherwise viable substantive claims.

Questions Presented

1. Whether the clinical-trial sponsors owed Wholey a duty for injuries allegedly arising during her participation in the clinical trial.
2. Whether the complaint stated a consumer-oriented deceptive-practices claim under General Business Law §§ 349 and 350.
3. Whether the fraud, fraudulent-misrepresentation, and fraudulent-concealment claims were pleaded with the particularity required by CPLR 3016(b).
4. Whether the learned intermediary doctrine required dismissal of claims alleging inadequate drug warnings.
5. Whether the implied-warranty claims were sufficiently pleaded.
6. Whether punitive damages could be sought in connection with other substantive claims despite the absence of an independent cause of action for punitive damages.

Disposition

other