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Two new product liability lawsuits are now pending in the federal court system against manufacturers of power morcellators, alleging that the controversial devices used during minimally invasive uterine fibroid surgery caused the spread of cancer throughout the bodies of two women.
The cases join a growing number of morcellation cancer lawsuits being filed nationwide, which all involve similar allegations that the manufacturers sold defective and unreasonably dangerous products, withholding information from women and the medical community about the risk that the devices may cause the rapid progression of leiomyosarcoma, endometrial stromal sarcoma or other uterine cancer.
Power morcellators are medical devices that have been commonly used during laparoscopic hysterectomies or myomectomies, allowing the doctors to cut up the uterus or uterine fibroids through a minimal incision in the abdomen. The devices are designed to provide a less invasive surgery, reducing recovery time and minimizing the risk of infection or other complications.
Over the past year, concerns have emerged about the risk of cancer with uterine fibroid morcellation, as some women undergoing the procedures may have unsuspected sarcoma contained within their uterus, which doctors are not able to diagnose prior to the surgery.
For these women, morcellation may cause the contained cancer cells to be spread throughout the body, resulting in a rapid upstaging of the uterine cancer to life-threatening degrees and greatly diminishing their overall quality of life.
Power Morcellator Lawsuits
Last week, at least two new cases were filed in the federal court system on behalf of women who allege that they may have avoided the spread of cancer if adequate warnings and information had been provided about the risk of morcellation during a laparoscopic hysterectomy for uterine fibroid removal.
Lisa Nielsen and her husband, Kurt, filed a complaint (PDF) in the U.S. District Court for the Eastern District of California on October 9, naming medical device manufacturer Gyrus ACMI as a defendant.
Prior to undergoing a hysterectomy during which a Gyrus bipolar morcellator was used, Nielsen indicates that she was unaware that she had cancer. More than a year after the uterine fibroid surgery, she discovered that she had cancer spread throughout her abdomen, which the lawsuit alleges was caused by the use of the Gyrus power morcellator during her hystectomy.
On October 10, a wrongful death complaint (PDF) filed by the family of Patricia Daley was removed from Maryland state court to the U.S. District Court system. The lawsuit alleges that uterine fibroid morcellators manufactured by Ethicon and Karl Storz were used during a robotic hysterectomy performed on Daley in 2011, after which she developed leiomyosarcoma, a particularly aggressive form of uterine cancer.
Failure to Warn About Morcellation Cancer Risk
As more women learn about the link between the diagnosis of leiomyosarcoma or other uterine cancer and the use of morcellators during fibroid surgery, it is expected that the number of similar product liability lawsuits filed nationwide will continue to increase.
Although questions about the risks associated with the devices has been mounting within the medical community for several years, the first public warnings from federal regulators about the issue did not come until April 2014, when the FDA urged doctors to stop using the devices for uterine fibroid removal.
The FDA estimated that 1 in every 350 women who underwent the procedure carried undiagnosed cancer cells in the fibroids, which may be spread by use of power morcellators. Since there is no way for doctors to diagnose the cancer prior to the surgery, the agency determined that the devices should be avoided during uterine fibroid removal.
A number of alternative treatment options are available for women with symptomatic uterine fibroids, including traditional surgical hysterectomy performed vaginally or abdominally, catheter-based blocking of the uterine artery, high-intensity focused ultrasound, drug therapy or a laparoscopic hysterectomy or myomectomy without the use of morcellation. These other surgical options do not carry the same risk of spreading unsuspected sarcoma.
To further evaluate the safety of power morcellators, the FDA held an advisory committee meeting over the summer. Among those who testified before the outside advisors to the agency was Colleen Daley, the sister of Patricia Daley, who asked the panel whether they would let their loved ones go through a procedure with odds like those associated with power morcellators.
Following two days of hearings, the advisory committees determined that there was no way to make power morcellators use safe, but split on whether to recommend that the FDA force a power morcellator recall or to just add further market warnings.
Johnson & Johnson’s Ethicon subsidiary has since announced that they will exit the power morcellator business, of which they previously had about 80% market share. While an Ethicon morcellator recall was issued in July, other manufacturers have not followed suit.
Nielsen’s lawsuit accuses Gyrus ACMI of negligence, strict product liability, breach of warranty, fraud and loss of services, and seeking $5 million in damages. The lawsuit also calls for punitive damages to punish the company for knowingly placing women at risk by not providing adequate warnings of power morcellator cancer to doctors and patients.
The Daley wrongful death lawsuit makes similar charges against Ethicon and Karl Storz, also calling for both compensatory and punitive damages.