Power Morcellator Lawsuits Consolidated; More Lawsuits Filed

Washington, DCAs more power morcellator lawsuits are filed, the US Judicial Panel on Multidistrict Litigation has consolidated more than 20 lawsuits into a multidistrict litigation. The MDL - number 2652 - was approved in October and as of December 15, 2015, held 30 lawsuits consolidated for pretrial proceedings. Those lawsuits allege women were put at increased risk of serious complications due to the use of morcellation for myomectomy.

Power morcellation is used in a non-invasive hysterectomy or myomectomy. The procedures are done to break down benign uterine fibroids. The US Food and Drug Administration (FDA) has warned that around 1 in 350 women who are diagnosed with benign fibroids actually have uterine sarcoma. Uterine sarcoma, however, can’t be diagnosed prior to the hysterectomy.

During power morcellation, the patient’s uterine tissue is broken down into smaller pieces so it can be removed through a smaller incision. Power morcellation is used in place of traditional surgery to remove fibroids because it involves a smaller incision and typically has lowered risk of blood loss and infection. In women with uterine sarcoma, breaking up of the tissue can increase the risk that cancerous tissue will spread throughout the patient’s abdomen and pelvis. This puts the patient at a greater risk of death from aggressive cancer.

Lawsuits have been filed against the makers of some power morcellation devices, alleging women developed serious, aggressive cancer known as leiomyosarcoma throughout their body as a result of power morcellation. Among the companies facing lawsuits is Johnson & Johnson, whose Ethicon division makes the Ethicon Gynecare Morcellex Tissue Morcellator. That device has reportedly been withdrawn from the market, although morcellators made by other companies are reportedly still in use. Around 45 lawsuits have been filed in state or federal court.

Following the filing of lawsuits, the US Government Accountability Office (GAO) announced it was investigating the use of laparoscopic power morcellators. Citing the deaths of “hundreds, if not thousands of women in America,” 12 members of Congress wrote to the GAO requesting it look into the matter.

“Morcellators and nearly all other devices were authorized under a system that has long been criticized as too lenient, while the FDA has defended the process as a good balance between innovation and safety,” The Wall Street Journal (8/7/15) reported.