Ethicon Gynecare Morcellex Lawsuit Filed Over Leiomyosarcoma Cancer Death

An Arkansas man has filed a wrongful death lawsuit against Johnson & Johnson and it’s Ethicon subsidiary, alleging that use of the company’s Gynecare Morcellex morcellator during a hysterectomy caused the spread leiomyosarcoma cancer throughout his wife’s body, leading to her death. 

The complaint (PDF) was filed by Larry Don Powell in the U.S. District Court for the Western District of Arkansas on September 21, over the 2014 death of his wife, Kimberly.

The Gynecare Morcellex is a type of morcellator used during minimally invasive hysterectomies, allowing doctors to cut up and remove the uterus and uterine fibroids through a small incision in the abdomen. However, the device has been linked to a risk of spreading undiagnosed cancer cells that may be hidden within the uterus, rapidly upstaging aggressive cancerns like leiomyosarcoma.

Kimberly Powell underwent a robotic hysterectomy with morcellation in June 2011. It was only after the surgery that it was discovered that leiomyosarcoma cancer cells were in the shredded tissue, which was spread throughout her body cavity. As a result, the uterine cancer was rapidly upstaged, ultimately resulting in her death less than three years later.

“The leiomyosarcoma cancer tissue in Mrs. Powell would have remained encapsulated bur for the tissue shredding and tissue dissemination of the Gynecare Morcellex,” the lawsuit states. “The device, in cutting and shredding the uterine fibroid, ruptured the capsule containing the cancerous tissue and spread the shredded tissue in Mrs. Powell’s abdominal cavity. That action changed the course and prognosis of the leiomyosarcoma cancer which had been encapsulated, upstaging it and profoundly injuring the patient, leading to her death.”

Powell’s complaint joins a growing number of other power morcellator lawsuits filed against Ethicon and other manufacturers of similar devices used during laparoscopic or robotic hysterectomy procedures. The lawsuits allege that the manufacturers failed to adequately warn about the risk of undiagnosed uterine cancer being spread by morcellation.

Power Morcellator Cancer Litigation

While use of morcellators during minimally invasive hysterectomies has increased in popularity over the past decade, the devices have largely been abandoned in recent years, after doctors learned about the risk of spreading leiomyosarcoma, endometrial stromal sarcoma and other uterine cancers.

Recent estimates suggest that about one out of every 350 women undergoing surgery for symptomatic uterine fibroids may have unsuspected sarcoma contained within their uterus. For these women, power morcellation may disseminate the contained cancer throughout the body, rapidly advancing the leiomyosarcoma or other cancers to a very advanced stage.

The litigation over power morcellators has emerged since the FDA issued warnings about the risks associated with the device in April 2014, where the agency urged doctors to avoid performing the popular, minimally invasive uterine surgery, which an estimated 50,000 women per year have undergone over the past decade.

While the FDA has allowed laparoscopic morcellators to remain on the market, with much stronger warnings about the potential cancer risks, many hospitals have announced that they will no longer perform hysterectomy or uterine fibroid removal procedures with morcellation, indicating that there is no way to justify the risk.

In June, a group of plaintiffs involved in the litigation filed a motion to centralize the power morcellator litigation before one judge in the federal court system, as part of an MDL or multidistrict litigation.

A number of different manufacturers have opposed centralization of the power morcellator cancer lawsuits, arguing that there are too few cases and too many different products involved to justify establishing an MDL.

Johnson & Johnson’s Ethicon unit, which previously sold the majority of morcellators on the market, under the Gynecare Morcellex brand, has also urged the panel to reject the possibility of establishing separate MDLs for each different manufacturer. However, the company removed all Gynecare morcellators from the market in the summer of 2014, indicating that they saw no way to make them safe for women.

The U.S. Judicial Panel on Multidistrict Litigation will hear oral arguments on consolidation at an October 1 hearing.