The family of a woman who died in 2013 after undergoing a hysterectomy at Brigham and Women’s Hospital has sued the medical center. The wrongful death lawsuit, was filed earlier in June in Suffolk County Superior Court in Boston. The complaint names the operating surgeon and device manufacturer Karl Storz GmbH & Co. KG.
According to Rick Kaitz, the husband, the hospital knew of the risks of the device, the laparoscopic power morcellator, in potentially spreading undiagnosed cancers but failed to warn his wife of the risk. Erica Kaitz died in December 2013 at age 52, about eighteen months after undergoing the surgery.
Power Morcellator Company Settles Wrongful Death Claim
Lina Medical recently reported that it has agreed to settle Scott Burkhart’s wrongful death claim of his wife, who had undiagnosed leiomyoscarcoma spread throughout her body by a Lina power morcellator.
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.
What is Power Morcellator?
Power morcellators are medical devices used during thousands of 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 decreased 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.
Johnson & Johnson, which was the largest manufacturer of the device, pulled its version off the market last July.
2014 FDA “Black Box” Strongest 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. 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.
Brigham and Women’s Hospital Under Fire
According to the The Wall Street Journal, doctors at Brigham and Women’s continued to use the power morcellator for two years after compiling data in 2011 that questioned the safety of the device and its risks. Brigham said in November that the data was too limited in 2011 to support a change in hospital practice.
The hospital began limiting use of the device in December 2013, acknowledging it had spread cancer in two patients, Ms. Kaitz in 2012, and then-40-year-old Amy Reed in 2013. Dr. Reed, an anesthesiologist, now has advanced cancer.
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 for women.
According to a recent filing with the U.S. Judicial Panel on Multidistrict Litigation, there are at least 22 lawsuits involving morcellators that have been filed in 16 federal courts, and an additional 300 cases are under investigation. Several other lawsuits are pending in state courts, the filing said.
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.