Hysterectomy Morcellation Lawsuit Set for Trial to Begin in November 2015

A trial date has been set in one of the first lawsuits filed over hysterectomy morcellation, which caused the death of a Pennsylvania woman by spreading aggressive leiomyosarcoma following a minimally invasive surgery for uterine fibroids.

In March 2014, Scott Burkhart filed a product liability lawsuit against LINA Medical, claiming the company failed to adequately warn the medical community about the risks associated with their morcellators, which are medical devices used during laparoscopic hysterectomy and myomectomy procedures to allow the surgeon to cut up and remove uterine fibroids through a small incision in the abdomen.

The complaint (PDF) was filed on behalf of his wife, Donna, who died of metastatic leiomyosarcoma in February 2013, after unsuspected cancer contained within her uterus was cut up and spread throughout her body.

Burkhart’s case was the first of several dozen hysterectomy morcellation lawsuits filed by families nationwide, which allege that several different medical device manufacturers sold a defective and unreasonably dangerous product, failing to warn about the serious risk of cancer women may face if the morcellator is used during a minimally invasive surgery, as there is no reliable way for doctors to detect which women may have unsuspected sarcoma contained within the uterus.

A scheduling order (PDF) was issued last month in the case by U.S. District Judge Edward G. Smith, indicating that all fact discovery must be completed by July 30, with challenges to the admissibility of expert testimony and any motions in limine filed by the end of October 2015. The parties have been ordered to take part in a settlement conference next month, and trial is scheduled to begin in the U.S. District Court for the Eastern District of Pennsylvania on November 3, 2015.

Cancer Risks with Hysterectomy Morcellation

Concerns about the risk of morcellators spreading cancer following a laparoscopic hysterectomy or uterine fibroid removal gained widespread attention within the medical community in April 2014, when the FDA announced that it was investigating the risk and warned doctors to avoid uterine fibroid morcellation after estimating that 1 out of every 350 women may have unsuspected sarcoma.

An FDA advisory panel was convened over the summer to evaluate the available data on the controversial devices, which resulted in a determination that there is no way to make power morcellators safer. However, the panel was split on whether to recommend morcellators be recalled or that stronger warnings be placed on the devices.

In a widely criticized move, the FDA announced in November that it will allow hysterectomy morcellators to remain on the market with substantially stronger warnings about the risk of cancer and more limited indications for appropriate use of the devices.

Many hospitals have already announced that they will no longer perform a hysterectomy with morcellation, and many experts agree that the vast number of prior procedures performed involving the device are no longer appropriate.

In recent months, a growing number of women and families nationwide have been filing morcellation cancer lawsuits against the manufacturers of these devices, alleging that inadequate warnings have been provided for patients and the medical community for years. The Burkart lawsuit was one of the first, if not the first, to be filed.

Plaintiffs allege that the rapid spread of leiomyosarcoma, endometrial stromal sarcoma or other uterine cancers may have been avoided if any number of different alternative treatment options available for women with symptomatic uterine fibroids had been used, including traditional surgical hysterectomy performed vaginally or abdominally, catheter-based blocking of the uterine artery, high-intensity focused ultrasound, drug therapy and laparoscopic hysterectomy or myomectomy without use of morcellation.