FDA Safety Notices Can Affect Liability: Analysis
Attorneys Steven Gonzalez and Jeffrey Wasserstein (Hyman, Phelps & McNamara) say a recent New Jersey Supreme Court decision demonstrates that the issuance and wording of FDA safety notices can potentially affect the civil liability exposure of the customers of medical device manufacturers. Writing in their firm’s FDA Law Blog, the attorneys say the suit was filed after a patient died from a rare cancer following a hysterectomy performed with a power morcellation device that was the subject of an FDA safety communication about six months before the procedure. The communication discouraged the use of power morcellation due to the risk that the procedure could spread cancerous tissue in patients with undiagnosed uterine sarcoma.
The attorneys say the state’s punitive damages act requires clear and convincing evidence that the harm suffered was a result of a defendant’s acts or omissions and that the acts or omissions were either actuated by actual malice or accompanied by wanton and willful disregard as a deliberate act or omission with knowledge of a high degree of probability of harm to another person and reckless indifference to the consequences of the act or omission. The report says this is a higher standard than that required to prove ordinary or gross negligence.
The plaintiffs argued that using the power morcellator after receiving an FDA safety communication met the standard, but the court did not agree. The attorneys write that the court held that the FDA communication was advisory and did not constitute per se evidence of wanton disregard for the patient’s welfare.
The court also found that nothing in the facts of the case proved that the doctor acted with actual malice or willful and wanton disregard for the patient’s health. Rather, it said, there was evidence that the doctor informed the patient of the procedure’s risks.
The attorneys say the court was careful to state that although the defendants’ actions and omissions after the FDA communication did not demonstrate a wanton and willful disregard, a jury could still find that the actions established (XXX TENSE XXX)negligence, and thus the communication could play a role in further proceedings.
“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,” the attorneys conclude. “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.”