Ethicon Laparscopic Power Morcellation Lawsuits Consolidated into MDL

Santa Clara, CAAs lawsuits against the makers of power morcellators begin piling up, a federal judicial panel has coordinated more than two dozen such suits into a Multidistrict Litigation or MDL. The lawsuits all claim that the medical devices, which are used in laparoscopic surgeries, have caused women to develop aggressive cancers.

While the number of cases brought so far remain small, with about 45 lawsuits filed in federal and state court on behalf of women or their family members, on October 15, the US Judicial Panel MDL determined there could be more cases coming: they noted that 650,000 women per year have surgeries or hysterectomies due to uterine fibroids and, until last year, were likely to have them done laparoscopically with power morcellators.

All the lawsuits allege that a power morcellator used to remove uterine fibroids or the uterus during a hysterectomy led to cancer, “recurrent parasitic fibroids” or other injuries. According to court documents, attorney representing women who have filed suits believe there could be more than 300 cases filed over power morcellators. The judicial panel has ordered consolidation of most of the federal lawsuits in Kansas.

There are several power-morcellator manufacturers, all of whom opposed the creation of an MDL. The judicial panel has, however, limited its order for consolidation to cases filed against Johnson & Johnson’s Ethicon Inc. unit, which faces the most lawsuits of any defendant. As of October 15, 22 lawsuits had been filed against Ethicon in federal court.

The FDA has warned that approximately 1 in 350 women who are undergoing power morcellation for benign fibroids in fact have an unsuspected type of cancer known as a uterine sarcoma. The use of laparoscopic power morcellation increases the risk that cancerous tissue within the uterus will be spread throughout the patient's abdomen and pelvis, decreasing the patient's chances of survival.

When the FDA issued its warning, it noted that women undergoing hysterectomy or myomectomy for uterine fibroids should not have surgery that involves the use of a power morcellator. There is currently no way to determine prior to surgery whether a patient's fibroids are in fact cancerous. Meanwhile, there are other surgeries to perform successful hysterectomy or myomectomy for fibroids that do not share a risk of spreading cancer, though they may have longer recovery times.

Manufacturers of power morcellators have been requested by the FDA to update their warning to include two contraindications and a boxed warning on the product label.