Women are coming forward with allegations that the use of a laparoscopic power morcellator for uterine treatments either spread cancer or led to recurrent fibroids. Attorneys for several plaintiffs in power morcellator lawsuits will tell a panel of federal judges Oct. 1 in New York that 22 cases situated in 16 federal districts ought to be centralized for coordinated pretrial management before U.S. District Court for the District of Kansas.
Whether to centralize power morcellator lawsuits is but one decision that the U.S. Judicial Panel on Multidistrict Litigation must make after hearing attorneys’ arguments. Centralization is intended to make the pretrial process more efficient and to minimize time constraints on the court, on witnesses and on others involved in the cases.
Several power morcellator manufacturers are defendants in these actions, including Johnson & Johnson’s Ethicon division, Karl Storz, Gyrus ACMI, and Richard Wolf Medical Instruments. Each opposes centralization.
The U.S. Food and Drug Administration issued two warnings about power morcellation in 2014. The first was cautionary, but the second FDA communication issued in November 2014 bluntly declared, “In an updated safety communication, originally issued in April 2014, the FDA warns against using laparoscopic power morcellators in the removal of the uterus (hysterectomy) or fibroids (myomectomy) in the vast majority of women.”
The agency further recommended that power morcellator makers provide patients of the procedure a “boxed warning” that reads, in part, “Uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer and decrease the long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices.”
Morcellators, in the FDA’s words, are “medical devices used during different types of laparoscopic (minimally invasive) surgeries. These can include certain procedures to treat uterine fibroids, such as removing the uterus (hysterectomy) or removing the uterine fibroids (myomectomy). Morcellation refers to the division of tissue into smaller pieces or fragments and is often used during laparoscopic surgeries to facilitate the removal of tissue through small incision sites.”
The intentions may be good. But here is the rub, according to the FDA: “Based on a quantitative analysis of currently available data, the FDA estimated that approximately 1 in 350 women who are undergoing hysterectomy or myomectomy for fibroids is found to have an unsuspected uterine sarcoma. If laparoscopic power morcellation is performed in these women, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival.”
All of these cases do not go to trial. Indeed, as LexisNexis reported, a power morcellator wrongful death lawsuit was settled for $800,000, “according to a motion for court approval filed Aug. 20 in the U.S. District Court for the Eastern District of Pennsylvania.”
Types of cancer that can be spread using a morcellator include:
- Uterine cancer
- Uterine sarcoma
- Endometrial stromal sarcoma
- Metastatic leiomyosarcoma
Any woman diagnosed with such a condition after undergoing a power morcellator procedure for hysterectomy or myomectomy may want to talk to an attorney to explore legal options. Reich & Binstock is one firm handling power morcellator litigation, and the firm, which operates in all 50 states, is offering a free consultation to any woman who comes forward.