Laparoscopic morcellator lawsuits are increasing slowly but surely, filed by injured women who had undiagnosed uterine cancer spread during a minimally invasive hysterectomy. Recently, according to the Wall Street Journal, a settlement has been reached in one of the first federal lawsuits.
Burkhart’s case was the first of several hysterectomy morcellation lawsuits, which allege that several different medical device manufacturers sold a defective and unreasonably dangerous product, and failed to warn about the serious risk of cancer women may face if the morcellator is used during a minimally invasive surgery.
There is no sure fire way for doctors to determine which women may have unsuspected sarcoma contained within the uterus.
What is Power Morcellator?
Power morcellators are medical devices used during minimally invasive laparoscopic hysterectomy and fibroid removal procedures. The device grinds up the uterus and uterine fibroids, allowing the easy removal of the tissues through a small incision in the abdomen.
Morcellator use has been curtailed over the past year, because of the risk that the devices may cause the spread of aggressive uterine cancers that were undiagnosed in the uterus.
2014 FDA Strong Cancer Risk Warning
In April 2014, the FDA issued a strong warning about the risk of power morcellation cancer, noting that one out of every 350 women undergoing surgery for uterine fibroids may actually have undiagnosed sarcoma.
An FDA advisory panel determined that there is no way to make power morcellators safer. The panel was unsure whether to recommend morcellators be recalled or that stronger warnings be placed on the devices.
Late last year, the FDA announced that it will allow hysterectomy morcellators to remain on the market with substantially stronger warnings about the risk of cancer.
Many hospitals have announced that they will no longer allow morcellation hysterectomy to be performed and some health care insurances will no longer cover the procedure.
How does Power Morcellator Increase Cancer Risk?
The grinding action of a power morcellator may cause widespread dissemination or spread of cancer cells throughout the abdomen and pelvis. This metastatic cancer spread significantly reduces long-term survival.
To date, about 20 power morcellator cancer cases have been filed in various federal and state courts through out the country.
All of the complaints shared similar allegations that morcellator use caused widespread leiomyosarcoma, endometrial stromal sarcoma or other uterine cancers diagnosed following a laparoscopic hysterectomy or fibroid removal surgery.
According to plaintiffs, the rapid spread of leiomyosarcoma, endometrial stromal sarcoma or other uterine cancers may have not occurred if alternative treatment options had been used, including traditional surgical hysterectomy performed vaginally or abdominally.
Federal Multidistrict Litigation Pending
In June, the U.S. Judicial Panel on Multidistrict Litigation (JPML) received notice seeking to transfer complaints filed in U.S. District Courts to one judge for coordinated handling during pretrial proceedings.
This is known as an MDL, or multidistrict litigation, and the centralizations of the lawsuits are designed to speed up the trials.
The plaintiffs are requesting that Lina Medical and other manufacturers of power morcellators be held with U.S. District Judge Kathryn H. Vratil in the District of Kansas.