Today’s post is actually about a medical malpractice case.  But it involves the interplay between an FDA “Safety Communication” and punitive damages, so we thought it was worth looking at.

In Rivera v. Valley Hospital, Inc., 2022 WL 3650726 (NJ Aug. 25, 2022), plaintiff is the representative of the estate of a woman who passed away from leiomyosarcoma, a rare uterine cancer.  The decedent had been experiencing symptoms that caused her to seek treatment with a gynecologic surgeon.  She met with the surgeon 4 times prior to undergoing surgery.  At her second appointment, her surgeon informed her that her MRI revealed a uterine fibroid that required surgery.  Subsequent conversations with the decedent and between her physicians concerned the type of surgery; whether decedent would undergo a laparoscopic hysterectomy or a myomectomy—an open procedure that would have a longer recovery time and be more painful.  Ultimately, the decedent opted to have a hysterectomy.  That procedure involved the use of a power morcellation device—a device that cuts tissue into smaller pieces to allow it to be removed via a small incision.  Her surgeon’s records indicate he discussed the risk of morcellation of a malignancy with the decedent.  The decedent did not recall discussing a morcellation device but did testify that her surgeon told her he would “chop up” her uterus.  Unfortunately, the pathology following the decedent’s surgery revealed the leiomyosarcoma and despite treatment, decedent passed away about a year after surgery. 

Approximately six months before decedent’s surgery, the FDA issued a “Safety Communication” warning that the use of a morcellation device in uterine fibroid surgery “poses a risk of spreading unsuspected cancerous tissue.”  The FDA data showed that approximately .28% of woman with uterine fibroids have an unsuspected cancer and that use of the morcellation device can cause the tissue to spread into the abdomen and pelvis worsening the patient’s prognosis.  The communication advised patients and surgeons to “carefully consider alternative treatment options” and “discouraged” the use of the device in these types of procedures.  Id. at *5. 

Immediately following the FDA Communication, the hospital, its administrators, and surgeons (including decedent’s surgeon) began to discuss the issue and what steps they should take.  Within days, the hospital convened a “power morcellation group” tasked with drafting an informed consent form that would reflect the FDA’s concerns.   Work on the informed consent form went on for several months, but the actual form was never implemented either before or after the decedent’s surgery.

Following the decedent’s surgery, the FDA issued an updated “Safety Communication”, and this time recommended a black-box warning be added to the device’s label.  One month after the update, the hospital discontinued use of the device.  Id. at *7.

After discovery, which laid out the above facts, defendants moved for partial summary judgment to dismiss plaintiff’s punitive damages claims.  The trial court denied the motions finding there was an issue of material fact as to whether defendants acted with “wanton and willful disregard” for plaintiff’s safety.   Id.  Defendants sought leave to appeal which was denied by the appellate division but granted by the New Jersey Supreme Court.  The NJ Supreme Court reviewed the denial of summary judgment de novo. 

Punitive damages in New Jersey are governed by the Punitive Damages Act (“PDA”) which requires “clear and convincing evidence” of “actual malice” or “wanton and willful disregard.”  Importantly, “[t]his burden of proof many not be satisfied by proof of any degree of negligence including gross negligence.”  Id. at *10.  Before analyzing the facts, the court explained that the PDA was established to “enforce more restrictive standards in the awarding of punitive damages.”  Id.  Punitive damages cannot be awarded for careless, negligent, or even grossly negligent conduct.                 

Based on the facts, the court was unable to find clear and convincing evidence to support a claim for punitive damages.  Plaintiffs had no evidence that defendants were motivated by actual malice or a wanton or willful disregard for safety.  Notably, the FDA Communication was not enough.  The FDA did not recall the device, nor did it prohibit uterine fibroid surgery using the device.  As a matter of law, the FDA Communication was insufficient to establish a basis for punitive damages:

Given the purely advisory nature of the FDA Communication, any argument that seeks to treat the use of the power morcellator after that communication as per se evidence of wanton and willful disregard for [decedent’s] safety falls short of meeting the clear and convincing standard required by the PDA.

Id. at *11. 

As to decedent’s surgeon, while the records and informed consent form are not explicit regarding the use of the morcellation device, neither do they contain anything suggesting the doctor acted with malice to substantiate a finding of punitive damages.  Id. at *12.  Nor is there any evidence of a deliberate act or omission “with knowledge of a high degree of probability of harm to another with reckless indifference to the consequences.”  Id.  All medical procedures have risks and here the FDA noted a less than 1% risk of an unsuspected uterine sarcoma.  So, the FDA Communication did not satisfy the punitive damages requirement of a “high degree of probability of harm.” 

Finally, even if the medical providers acted negligently, plaintiff cannot simply recast negligence as wanton and willful based on the same alleged conduct.  Plaintiff could not articulate how the same conduct they alleged supports their negligence claim was also clear and convincing evidence of actual malice or wanton and willful disregard to support an award of punitive damages. Punitive damages are limited to exceptional cases, and this was not one of them.