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In response to a recent request to centralize all federal morcellation cancer lawsuits before one judge, several manufacturers of the controversial medical devices indicate they are opposed to establishing consolidated pretrial proceedings for the litigation.
There are currently at least 22 product liability complaints pending throughout the federal court system against different manufacturers of power morcellators, each raising similar allegations that the devices caused the spread of uterine cancers during a laparoscopic hysterectomy or myomectomy.
Power morcellators have been used during minimimally invasive uterine fibroid removal procedures in recent years, allowing the doctors to cut up the uterus or fibroids and remove the tissue through a small incision in the abdomen.
While these procedures are designed to reduce recovery time and the risk of infections or other complications, morcellators have largely been abandoned within the medical community over the past year, due to a risk that they may cause the spread of aggressive cancers that were previously contained and hidden within the uterus.
Uterine cancer lawsuits over power morcellators are currently pending in 16 different U.S. District Courts, each raising nearly identical allegations that the manufacturers failed to provide adequate warnings for women or the medical community about the potential risks.
To avoid duplicative discovery into common issues and conflicting pretrial rulings from different judges, a group of plaintiffs filed a motion with the U.S. Judicial Panel on Multidistrict Litigation (JPML) last month, seeking to centralize the cases in one court for coordinated pretrial proceedings.
On July 10, responses were filed by Johnson & Johnson’s Ethicon subsidiary (PDF), Karl Storz (PDF), Richard Wolf Medical Instruments (PDF), and Gyrus ACMI (PDF), with each medical device manufacturer opposing the creation of a power morcellator MDL (multidistrict litigation).
The manufacturers maintain that there are too few cases and too many different products involved in the morcellator litigation to justify establishing centralized proceedings in the federal court system.
Johnson & Johnson’s Ethicon unit, which previously sold the majority of morcellators on the market, has also urged the panel to reject the possibility of establishing separate MDLs for each different manufacturer.
“An Ethicon-only MDL — which Plaintiffs have not requested — makes no more sense,” the Ethicon response brief states. “Plaintiff-specific discovery is a major part of every product-liability case, but these cases, which allege that a doctor’s use of a power morcellator during surgery worsened the prognosis of a patient’s already existing cancer, are individualized to an entirely different degree. Moreover, contrary to Plaintiffs’ speculation, the number of Ethicon morcellator cases is likely to stay very low.”
Power Morcellator Litigation
The litigation over power morcellators has emerged over the past year, following FDA warnings in April 2014, which warned about the uterine cancer risks with morcellation.
FDA estimates suggest 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.
While the FDA has allowed laparoscopic morcellators to remain on the market, with much stronger warnings about the potential cancer risks, many hospitals have announced that they will no longer perform hysterectomy or myomectomy procedures with morcellation, indicating that there is no way to justify the risk.
As more families learn about the link between morcellation and uterine cancers diagnosed in recent years, a growing number of product liability complaints are expected to be filed against the manufacturers in the coming months.
Plaintiffs seek to centralize cases brought in the federal court system before U.S. District Judge Kathryn H. Vratil in the District of Kansas, where the litigation would be managed in a manner similar to a power morcellator class action. However, each claim would remain an individual lawsuit, and may be remand back to the U.S. District Court where it was originally filed if settlements or other resolutions are not reached following pretrial proceedings and a series of bellwether trials.
Oral arguments over whether to establish a power morcellator MDL are likely to be heard during an upcoming hearing session scheduled for October 1, in New York City.