Victory in New Jersey Court Rejecting Punitive Claims Over FDA Device Warning

Epstein Becker Green represented amicus curiae a New Jersey advocacy organization before the New Jersey Supreme Court.

The EBG team convinced the court to reject a punitive damages claim against a group of physicians and a hospital for their decision to treat a patient with a power morcellator after the U.S. Food and Drug Administration (FDA) issued a safety communication discouraging the use of power morcellation.

Following a hysterectomy that she underwent at the hospital using the power morcellation device, the patient passed away from a rare cancer that cannot reliably be diagnosed preoperatively. The plaintiffs—the heirs and the executor of the patient’s estate—claimed that the physician who treated the patient was aware that two of three differential diagnoses were cancer and, therefore, should have reasonably suspected that the patient had cancer and should not have used the power morcellation device. The plaintiffs also alleged that the treating physician never explained the risks of power morcellation to the patient and that her lack of informed consent provided a basis for awarding punitive damages.

The trial court denied the defendants’ motion for summary judgment on the plaintiffs’ punitive damages claim, and the Appellate Division denied leave to appeal the trial court’s decision. In reaching its conclusion, the New Jersey Supreme Court held that the facts in evidence were not sufficient for a jury to find that either the doctors or the hospital acted with actual malice or wanton disregard for the patient’s health and safety.

Results may vary depending on your particular facts and legal circumstances.