FDA Safety Communications: A Potential Provider Pitfall

The New Jersey Supreme Court, in its August 25, 2022 opinion in Mirian Rivera v. Valley Hospital, Inc., 2022 N.J. LEXIS 679 (NJ Aug. 25, 2022), https://www.njcourts.gov/attorneys/assets/opinions/supreme/a_25_26_27_21.pdf?c=lmL, considered whether a provider’s use of a medical device that is the subject of an FDA safety communication constitutes per se evidence of wanton disregard, which would warrant punitive damages. The Court found that in this case it did not, although it left open that it could be evidence of negligence, which could result in compensatory damages.  The Court’s analysis also leaves open the possibility that other FDA communications could result in punitive damages.

Case Summary

Plaintiffs (heirs and executor) in this case filed complaints seeking compensatory and punitive damages on numerous counts after a patient’s death from leimyosarcoma, a rare cancer that cannot be reliably diagnosed preoperatively, following the hysterectomy the patient underwent at defendant Valley Hospital with the use of a power morcellation device by defendant Dr. Howard Jones. Approximately six months before the patient’s surgery, the FDA issued a Safety Communication discouraging the use of power morcellation due to the risk that the procedure could spread cancerous tissue in patients with undiagnosed uterine sarcoma.

The New Jersey Punitive Damages Act (PDA) provides that “punitive damages may be awarded . . . only if plaintiff proves, by clear and convincing evidence,” both “that the harm suffered was the result of defendant’s acts or omissions,” and that defendant’s acts or omissions were either “actuated by actual malice” or were “accompanied by wanton and willful disregard of persons who foreseeably might be harmed.”  Id. at 2; N.J.S.A. 2A:15-5.12(a). The PDA further defines “wanton and willful disregard” as “a deliberate act or omission with knowledge of a high degree of probability of harm to another and reckless indifference to the consequences of such act or omission.”  N.J.S.A. 2A:15-5.10. This is a higher standard than that required to prove ordinary or gross negligence.

The Court found that plaintiffs’ claims did not meet this standard for punitive damages. Notably, the Court found “the FDA Communication was purely advisory in nature, so the use of the power morcellator after that communication does not constitute per se evidence of wanton disregard” for plaintiff’s safety.  Rivera v. Valley Hosp., Inc., at 3. The Court also found that “nothing in the facts before the Court suggests that [Dr. Jones] acted with actual malice or with wanton and willful disregard of” the plaintiff’s health and, in fact, there was evidence he informed the patient of the procedure’s risks.  Id.  Specifically, the Court did not agree that FDA’s communication of a less than 1% risk that patients undergoing this treatment would have undiagnosed uterine sarcoma constituted the defendant’s “knowledge of a high degree of probability of harm.”  Id. The Court was even more persuaded that defendant Valley Hospital’s conduct did not constitute wanton and willful disregard, as it took proactive steps shortly after the issuance of the FDA Communication to respond to the advised risk of power morcellation.

The Court was careful to state that although defendants’ actions and omissions after the FDA Safety Communication did not demonstrate a wanton and willful disregard, a jury could still find those actions establish defendants’ negligence.  Thus, the Safety Communication could play a role in further proceedings in the case.

Why this Case Matters

This case demonstrates that a court can consider a provider’s actions taken in response to public FDA safety notices when determining whether a patient’s harm resulted from that provider’s negligence or recklessness, as well as the form of the communication.  Here, the court deemed FDA’s communication to be advisory and that it left ample room for provider discretion.  Depending on the wording of other FDA notices, that may not always be the case.

The specific actions a provider takes with regard to a safety communication could still provide evidence of actual malice or wanton and willful disregard, even though that standard was not met in this particular case. Additionally, providers could also be subject to ordinary negligence where, as here, an FDA Safety Communication discourages a certain type of product or procedure and directs providers to inform patients of the specific risk involved but the provider fails to properly inform patients (e.g., by obtaining appropriate informed consent). Thus, this decision serves as a reminder that the issuance and wording of FDA safety notices can potentially impact the civil liability exposure of the customers of medical device manufacturers.