The practice of medicine is constantly evolving as evidenced by changes in treatments, the addition and removal of medications from the market, and communications by the Food and Drug Administration (FDA) offering advisories, warnings, and other information.

This month’s case involves an FDA Safety Communication regarding a device which later caused injury that led to the death of a patient. The question presented in this case was whether the plaintiff could pursue a claim for punitive damages against the hospital, administrators, and physician.

Facts of the Case

In 2014, the patient, Ms R, sought treatment for uterine fibroids from Dr J, a gynecologic surgeon at the hospital. Ms R met with the physician four times prior to having surgery. The first meeting was for an exam and biopsy. At their second appointment, Dr J informed Ms R that the endometrial biopsy sample revealed noncancerous tissue, and the physician discussed the various treatment options with the patient.

By the third appointment, Ms R informed Dr J that she had decided to proceed with surgical treatment of the fibroids. The physician told the patient that traditional surgery would result in longer healing time and greater postoperative pain, and that a better option was laparoscopic hysterectomy. In 2014, laparoscopic hysterectomy was performed using a power morcellator, which would cut tissue into small pieces to facilitate removal laparoscopically. In a letter to Ms R’s endocrinologist, Dr J noted that he had “counseled the patient about the risk of morcellation including morcellation of a malignancy.”

At the fourth appointment, Ms R signed a consent form agreeing to laparoscopic hysterectomy. The form described the procedure in simple terms and did not mention the use of a power morcellation device. Ms R had the surgery in October 2014. Postsurgical pathology, however, revealed malignant Stage 4 leiomyosarcoma, a rare cancer. Ms R immediately began cancer treatment but passed away in September 2015.

Six months prior to Ms R’s surgery, the FDA issued a Safety Communication discouraging the use of power morcellation. The communication estimated that “1 in 350 women undergoing surgery for the treatment of fibroids is found to have an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma.” It stated that “[i]f laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival.”

Following the FDA communication, hospital administrators and Dr J exchanged emails about the use of power morcellation. They considered factors including that without the morcellator the surgeries would be open, increasing morbidity, and that the numbers at the hospital didn’t support the FDA’s 1 in 350 number. They also discussed informed consent. A group was convened within the hospital to draft an informed consent form. The form had been prepared and approved by the hospital’s legal department but had not been implemented prior to Ms R’s surgery.

One month following Ms R’s surgery, the FDA issued an updated communication explicitly warning against the use of power morcellators in most cases. The hospital then discontinued use of the device.

Ms R’s widower (the plaintiff) sued numerous defendants, including Dr J, the hospital, administrators, and risk manager. In addition to compensatory damages, the plaintiff was seeking punitive damages to ‘punish’ the hospital for allowing use of the device and Dr J for not properly warning the patient of the risks.

The defendants asked the trial court to dismiss the plaintiff’s claim for punitive damages, but the trial court denied the motion to dismiss. After an appeals court refused to hear the defendants’ appeal, the case was accepted by the state’s Supreme Court.