Tissue Morcellator Lawsuit Filed Over Endometrial Stromal Sarcoma Recurrence After Hysterectomy

A former Georgia mayor and her husband have filed a lawsuit against Johnson & Johnson and its Ethicon subsidiary, alleging that a Gynecare tissue morcellator caused the recurrence of metastatic endometrial stromal sarcoma, spreading hidden cancer cells contained in the uterus throughout the plaintiff’s pelvis and abdomen. 

The complaint (PDF) was filed last week in the U.S. District Court for the Northern District of Georgia by Eva Galambos, the former Mayor of Sandy Springs, Georgia, and her husband John.

Galambos underwent a laparoscopic hysterectomy in January 2011, during which doctors used a Gynecare tissue morcellator sold by Johnson & Johnson’s Ethicon division to cut up her uterus and uterine fibroids, allowing the tissue to be removed during a minimally invasive procedure. However, Galambos and her husband allege that Johnson & Johnson, Ethicon and Vention Medical Inc. failed to warn about the high-risk that use of the laparoscopic morcellator may disseminate and upstage occult, or hidden, cancer.

According to the lawsuit, testing and evaluation prior to surgery showed no evidence of disseminated or metastatic cancer. However, a biopsy of tissue taken during the procedure revealed endometrial stromal sarcoma/leiomyosarcoma, which she was diagnosed with after the surgery. She was told that she was cancer free until April 2013, when she was diagnosed with a recurrence of metastatic endometrial sarcoma, involving the pelvis and left anterior abdominal wall.

“Had the Laparoscopic Power Morcellator used on Plaintiff not disseminated fulminated cancerous cells and tissue, she would not have suffered and been diagnosed with a recurrence of her endometrial stromal sarcoma,” states the complaint filed by Galambos and her husband. “The Laparoscopic Power Morcellator used on Plaintiff during her 2011 surgery caused this specific cancerous condition, profoundly and gravely injuring Plaintiff.”

Galambos raises allegations similar to those presented in a growing number of morcellation cancer lawsuits filed by women throughout the U.S. who have been diagnosed with the spread of endometrial stromal sarcoma, leiomyosarcoma or other uterine cancers following a laparoscopic hysterectomy or uterine fibroid removal.

Morcellation Cancer Concerns

Laparoscopic tissue morcellators are medical devices increasingly used in recent years to allow doctors to remove the uterus or uterine fibroids through a small incision in the abdomen, providing shorter recovery times and reduced risk of infection or other complications. However, over the past year, concerns have emerged over severe and potentially life threatening risks the devices may pose for women with occult or unsuspected sarcoma contained within their uterus.

In April 2014, the FDA announced that it was investigating the morcellation cancer risk, 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.

The Gynecare Tissue Morcellator, and all Ethicon-manufactured morcellators, were the subject of a morcellator recall issued by Ethicon in the summer of 2014. According to Johnson & Johnson and its subsidiary, company officials became convinced by emerging evidence that there was no safe way to conduct laparoscopic morcellation for uterine fibroid removal without potentially putting women at risk of spreading undiagnosed cancer. The company dominated the market at the time and was responsible for about three quarters of the morcellators on the market.

Galambos raises nearly identical claims to those brought by women diagnosed with the rapid dissemination of leiomyosarcoma, endometrial stromal sarcoma or other uterine cancers, indicating that they may have been avoided the aggressive disease if they had undergone other treatment options for symptomatic uterine fibroids, such as a 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.

The complaint filed by Galambos and her husband presents claims for negligence, designing a defective medical device, failure to warn, violation of Georgia consumer protection laws, and loss of consortium, seeking both compensatory and punitive damages.