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A panel of federal judges has decided to consolidate all federal laparoscopic morcellation lawsuits filed against Johnson & Johnson’s Ethicon subsidiary by women who had uterine cancer spread by the medical device, but rejected a call to include similar cases brought against other manufacturers.
Following oral arguments presented earlier this month, the U.S. Judicial Panel on Multidistrict Litigation (JPML) issued a transfer order (PDF) this morning, indicating that more than two dozen product liability lawsuits involving cancer allegedly spread by Ethicon power morcellators will be centralized before U.S. District Judge Kathyryn H. Vratil in the District of Kansas for coordinated discovery and pretrial proceedings, as part of an MDL or Multi-District Litigation.
Ethicon was the leading manufacturer of laparoscopic morcellators, which have been increasingly used over the past decade during minimally invasive hysterectomy and myomectomy procedures for removal of symptomatic uterine fibroids. However, morcellation has been largely abandoned within the medical community due to the risk that some women may have undiagnosed cancer cells contained within the uterus that can be spread throughout the body during morcellation, rapidly upstaging leiomyosarcoma, endometrial stromal sarcoma and other cancers.
All of the lawsuits involve similar allegations, indicating that Ethicon knew or should have known about the risk that laparoscopic morcellation may disseminate uterine cancer, yet failed to adequately warn the medical community or women deciding to undergo a minimally invasive procedure instead of a traditional hysterectomy or myomectomy.
Centralizing the cases before one judge as part of a morcellator MDL is designed to reduce duplicative discovery into common issues, avoid conflicting rulings from different courts and to serve the convenience of the parties, witnesses and the judicial system.
In addition to lawsuits against Ethicon, similar complaints have been brought against other morcellator manufacturers, including Karl Storz, Richard Wolf Medical Instruments, and Gyrus ACMI.
While plaintiffs asked the U.S. JPML to centralize all claims brought against any manufacturer, regardless of the specific device used during the hysterectomy or uterine fibroid removal, the panel determined that an industry-wide MDL for morcellation lawsuits was not appropriate.
“While there will be some factual issues as to the risk of occult cancer in women undergoing hysterectomies and myomectomies that are common to all defendants, we find that the individual issues that result from the differences among each defendant’s power morcellator with respect to product design, development, testing, warnings, and marketing will predominate over the common issues,” wrote the U.S. JPML in the order issued October 15.
Power Morcellator Cancer Concerns
The litigation over power morcellators has emerged over the past two years, following an FDA statement in April 2014, which warned about the uterine cancer risks with morcellation.
FDA indicated at that time that estimates suggest one out of every 350 women undergoing surgery for symptomatic uterine fibroids may actually have undiagnosed and unsuspected sarcoma contained within the uterus. For these women, morcellators may rapidly spread cancerous cells throughout the body, rapidly upstaging leiomyosarcoma, endometrial stromal sarcoma or other uterine cancers to an advanced stage that is difficult to treat and often fatal. This may greatly reduce the likelihood of long-term survival and the woman’s overall quality of life.
In the summer of 2014, two panels of FDA advisors determined that there was no safe way to use power morcellators for uterine fibroid removal. However, they could not agree on whether to recommend that the agency demand a power morcellator recall or simply add a black box warning.
Shortly afterwards, Ethicon, who previously dominated the power morcellator market, decided that it will no longer manufacturer the devices, essentially issuing an Ethicon power morcellator recall after determining that there is no way to make the devices safer.
While the FDA has allowed laparoscopic morcellators to remain on the market, with much stronger warnings about the potential cancer risks, many hospitals and doctors have announced that they will no longer perform hysterectomy or myomectomy procedures with morcellation, indicating that there is no way to justify the risk.