Lina Medical reportedly settled a product liability lawsuit filed over its Xcise laparoscopic power morcellator, a type of device that’s been linked with spreading uterine cancer during uterine fibroid removal surgeries.
The lawsuit was filed in March 2014 by Scott Burkart in the U.S. District Court for Eastern Pennsylvania. Burkart’s wife, Donna Burkart, died Feb. 2, 2013, at age 53, 11 months after she underwent a robot-assisted supracervical hysterectomy and bilateral salpingectomy with uterine morcellation, according to court documents. Less than 2 weeks after her procedure, the lawsuit alleged, Burkart was informed that she had metastatic myelosarcoma.
“It is alleged that each and every defendant herein failed to warn about the possibility of seeding an undiagnosed sarcoma throughout the peritoneal cavity,” according to the lawsuit. “Defendants were each aware of the risks, complications, and/or adverse events associated with their products used for uterine morecellation [sic], specifically the Lina Xcise morcellator.”
The case, expected to be the 1st power morcellator lawsuit to go to trial, was settled for an undisclosed amount, Burkart’s lawyer François Blaudeau told the Wall Street Journal.
The FDA warned in April 2014 about power morcellators and the risk that they could spread undiagnosed cancer cells throughout women’s abdomens, prompting Johnson & Johnson (NYSE:JNJ) to shelve its line of the devices later that month. In November 2014 the safety watchdog added a “black box” warning to the labeling requirements for power morcellators, advising doctors that the devices be avoided in nearly all fibroid-removal procedures.
Attorneys for the Lina Medical couldn’t be reached for immediate comment, the newspaper reported, adding that Scott Burkart said he was glad the case didn’t have to go to trial and that his main goal was to make others aware of the risks.