Ethicon Morcellator Lawsuit Filed Over Death from Disseminated Uterine Cancer

The family of a Missouri woman has filed one of the latest in a growing number uterine cancer lawsuits over power morcellators, alleging that a device manufactured by Johnson & Johnson’s Ethicon subsidiary caused cancer to be disseminated during a robotic hysterectomy.

The complaint (PDF) was filed in the U.S. District Court for the Western District of Missouri on December 3, following the death of Carl Cecilia Merrill in August due to the spread of a rare, malignant cancer called leiomyosarcoma.

Merrill underwent a robot-assisted hysterectomy and uterine fibroid removal surgery in December 2012, at which time an Ethicon Gynecare morcellator was used to allow the doctors to remove the uterus and fibroid laparoscopically, through a minimal incision in the abdomen. However, the device allegedly caused undiagnosed uterine cancer to be disseminated throughout her peritoneal cavity, rapidly upstaging the cancer from its earliest, and most treatable stage, to its most deadly.

The wrongful death lawsuit was filed by Merrill’s life partner, Terry Shafer, alleging that Ethicon knew or should have known about the significant uterine cancer risks associated with their power morcellators, but failed to provide adequate warnings for consumers or the medical community. The complaint also lists Merrill’s sister, Doris Simpson, as a plaintiff.

Uterine Cancer Dissemination Risk from Morcellators

Concerns about the risk of power morcellators disseminating uterine cancer have gained widespread attention in the medical community over the past year, with FDA estimates suggesting that about 1 in 350 women undergoing laparoscopic uterine fibroid removal may have unsuspected sarcoma cells in the fibroids.

Since there is no way for doctors to detect the uterine cancer before using morcellators to grind up the uterus or uterine fibroids, the FDA urged doctors to avoid using the devices for laparoscopic hysterectomy or myomectomy procedures in April 2014.

Following an FDA advisory panel meeting this summer, all Ethicon power morcellators were recalled by the manufacturer, which acknowledged at that time that the devices pose an unreasonable risk of disseminating uterine cancer. The Johnson & Johnson subsidiary called for hospitals to voluntarily return all laparoscopic surgery morcellators, indicating that it will no longer sell the devices since there is no way to make them safe.

Following an FDA investigation into the uterine cancer risk with power morcellators, the agency announced November 24 that it is adding a black box warning to uterine morcellators that remain on the market, which is the strongest warning that can be place on a medical device.

In addition to the new warning, the FDA indicated that power morcellators should not be used with women near menopause or post-menopausal, or in women who could have tissue removed through the vagina or via a small incision. The contraindication essentially prohibits the use of the devices in the vast majority of women who undergo laparoscopic uterine morcellation procedures.

Power Morcellator Cancer Litigation

The Beverly lawsuit Ethicon of negligence, breach of warranty, strict liability, fraudulent misrepresentation and omission, negligent misrepresentation, and violation of Missouri consumer protection laws, seeking both compensatory and punitive damages.

The complaint joins a growing number of similar uterine cancer lawsuits that are now being pursued on behalf of individuals nationwide diagnosed with disseminated uterine cancer following a minimally invasive, laparoscopic surgery.

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.