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Court documents suggest that settlements have been reached in several Ethicon morcellation lawsuits brought on behalf of women who had aggressive uterine cancers spread during a laparoscopic hysterectomy or fibroid removal surgery, but discovery is set to move forward in dozens of other cases that have not been resolved.
Power morcellators are surgical devices used during minimally invasive hysterectomy and myomectomy procedures, allowing surgeons to cut up and remove the uterus or uterine fibroids through a small incision in the abdomen. However, a number of manufacturers of these hysterectomy surgical devices now face lawsuits alleging they are unreasonably dangerous and caused hidden cancers contained within the uterus to be spread throughout the abdomen.
Since October, all product liability lawsuits filed against Johnson & Johnson’s Ethicon subsidiary have been consolidated in the federal court system as part of an MDL, or multidistrict litigation. Before concerns about the link between morcellators and cancer emerged early last year, Ethicon was the leading manufacturer of the surgical device in the U.S.
Cases filed by women and families throughout the U.S. are centralized for pretrial proceedings before U.S. District Judge Kathyryn H. Vratil in the District of Kansas to reduce duplicative discovery into common issues in the cases, avoid conflicting rulings from different judges and to serve the convenience of the parties, witnesses and the courts.
In a scheduling order (PDF) issued on December 24, Judge Vratil outlined a discovery plan for the litigation, which calls for written discovery to begin early next month and indicates that most non-expert discovery will be completed within one year. This may allow the court to schedule a series of bellwether trials to begin by mid-2017, if agreements are not reached by the manufacturer to resolve large numbers of cases.
It appears that Ethicon has already reached some morcellator settlements with women and families, as at least two attorneys previously appointed to serve in leadership roles in the litigation are seeking to resign from the Plaintiffs’ Steering Committee (PSC), indicating that all of their clients have settled their claims in the MDL.
Despite indications that Ethicon is willing to consider settling morcellation cancer lawsuits early in the litigation process, Judge Vratil indicated in the order that it remains premature for the court to require mediation or any other form of alternative dispute resolution (ADR) at this point. However, Judge Vratil indicates that the Court itends to revisit the issue of ordering Ethicon morcellator settlement negotiations at later status conferences.
Power Morcellator Cancer Concerns
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.
The litigation has emerged since April 2014, when 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.
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, the panels 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.
In addition to cases over Ethicon morcellators, similar lawsuits have been filed against other manufacturers of the hysterectomy surgical devices, including Karl Storz, Richard Wolf Medical Instruments, and Gyrus ACMI.
As part of the coordinated proceedings in the Ethicon morcellators MDL, if the manufacturer fails to settle or otherwise resolve cases, it is expected that Judge Vratil will schedule a series of “bellwether” trials to help the parties gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation.
The next status conference before Judge Vratil is scheduled for January 6, 2016, at which time the Court is expected to discuss proposed orders regarding discovery in cases where plaintiffs are extremely ill or at risk of dying, as well as orders regarding product identification and preservation of pathology evidence in the cases.