Products Liability Law Reporter

A New York appellate court held that a patient who was allegedly injured after using the drug Enbrel may bring claims against drug manufacturers for insufficient warnings.

Here, a patient who allegedly suffered injury after using Enbrel sued several drug manufacturers that had sponsored a clinical trial, alleging that the drug’s warning labels were inadequate. The plaintiff also claimed defective manufacturing and fraud. The defendants moved to dismiss. The trial court granted the motion in part and denied it in part.

Affirming, the appellate court held that the defendants, as sponsors of a clinical trial, owed the plaintiff no duty of care as an enrollee in the trial. Citing case law, the court found that the plaintiff’s claims regarding Enbrel must be limited to those arising after she ceased participating in the clinical trial and was prescribed the drug as a patient. The court found that the learned intermediary doctrine does not warrant dismissal of the plaintiff’s claims that Enbrel’s warning labels were inadequate. The claims are not based on the defendants’ alleged failure to warn the plaintiff directly, but for the failure to provide sufficient warnings to medical professionals, the court said.

Finally, the court held that the plaintiff’s fraud claims must be dismissed. The failure to provide adequate warnings by concealing information is not a practice directed at consumers, the court concluded.

Citation: Wholey v. Amgen, Inc., 165 A.D.3d 458 (N.Y. App. Div. 2018).

Plaintiff counsel: Ari Kresch, New York City.