Ethicon Morcellator MDL Judge Schedules Initial Status Conference for November 18

Shortly after the U.S. Judicial Panel on Multidistrict Litigation established consolidated pretrial proceedings for all Ethicon morcellator lawsuits filed on behalf of women who had aggressive uterine cancers spread by the medical device, the U.S. District Judge assigned to preside over the cases has scheduled an initial status conference.

Following oral arguments presented earlier this month, an Ethicon power morcellator MDL (multidistrict litigation) was established in the U.S. District Court for the District of Kansas, where cases filed throughout the federal court system will be centralized before Judge Kathyryn H. Vratil for coordinated handling during discovery and other pretrial proceedings.

Each of the claims involves similar allegations that women were diagnosed with the rapid spread of leiomyosarcoma, endometrial stromal sarcoma or other uterine cancers following the use of an Ethicon Gynecare morcellator during a laparoscopic hyesterectomy or myomectomy for symptomatic uterine fibroids.

Ethicon’s Gynecare division was the leading manufacturer of laparoscopic morcellators in recent years, which are medical devices used during minimally invasive surgery to allow the doctors to cut up and remove uterine fibroids or the uterus through a small incision in the abdomen. However, for women who may have undiagnosed and unsuspected sarcoma hidden within their uterus, the devices may pose a deadly risk, rapidly spreading the cancer cells throughout the abdomen.

In a practice and procedure order (PDF) issued on October 16, Judge Vratil indicated that an initial scheduling conference will be held on Wednesday, November 18 at 1:00 p.m., at the Robert J. Dole U.S. Courthouse in Kansas City.

The parties involved in the lawsuits have been directed to be prepared to discuss procedures that will facilitate the “expeditious, economical and just resolution of this litigation,” including the organizational structure of the litigation and discovery plans.

Judge Vratil indicates that the parties should anticipate a time line where common fact discovery in the litigation will be completed in less than 12 to 18 months. Thereafter, cases may be promptly remanded back to their original courts if Ethicon morcelletion settlements are not reached to resolve the claims.

Power Morcellator Cancer Concerns

Centralizing the Ethicon morcellator cases before Judge Vratil is designed to reduce duplicative discovery efforts into common issues in the cases, avoid conflicting rulings from different judges and to serve the convenience of the parties, witnesses and the courts.

Each of the lawsuits against Ethicon involve similar allegations that the medical device manufacturer 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.

Similar lawsuits have been filed against other manufacturers of power morcellators used in operating rooms throughout the U.S., including Karl Storz, Richard Wolf Medical Instruments, and Gyrus ACMI. While plaintiffs originally proposed that all cases, regardless of manufacturer, be centralized as part of one MDL, the U.S. JPML determined that there will be sufficient differences among each manufacturer’s power mocellator with respect to product design, development, testing, warnings and marketing to justify keeping them separate.

The litigation has emerged since early last year, when the FDA first warned about the uterine cancer risks with morcellation.

In April 2014, the FDA estimated that 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.

Two FDA advisory panels were convened by the agency, which 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 acknowledging 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.