Posted: 02 May 2014 11:10 AM PDT
A product liability lawsuit has been filed by a New York woman who says that use of an Ethicon morcellator to remove a uterine fibroid during a robotic hysterectomy caused the spread of an aggressive cancer throughout her body.
The complaint (PDF) was filed by Brenda Leuzzi and her husband, George, in the U.S. District Court for the Western District of New York on May 1, naming Ethicon Endo Surgery, Inc. and Ethicon Women's Health and Urology as defendants.
Leuzzi indicates that she had no cancer diagnosis prior to undergoing a robotic hysterectomy during which surgeons used an Ethicon Gynecare Morcellex power morcellator, which allowed doctors to remove her uterus and uterine fibroids during a minimally invasive procedure.
According to allegations raised in the complaint, the morcellator used during the robotic hysterectomy spread leiomyosarcoma cancer throughout her peritoneal cavity
Power morcellators are often used during robot-assisted hysterectomy procedures to cut the uterus tissue into small pieces that can be removed through the abdomen. These minimally invasive procedures are promoted as a way to reduce recovery time and the risk of infections.
The lawsuit comes only a few weeks after the FDA issued a warning late last month, indicating that power morcellators should not be used to remove uterine fibroids, due to the risk of doctors unintentionally spreading cancer that may be contained within the uterus.
Approximately 1 in 350 women who undergo uterine fibroid surgery have unsuspected sarcoma, according to the FDA. There is no reliable way for doctors to identify these women and diagnose the cancer prior to use of a morcellator, so the regulatory agency urged doctors to no longer use the devices.
Leiomyosarcoma is one of the deadliest forms of uterine sarcoma cancer. This aggressive cancer can be quickly spread by morcellators during a robotic hysterectomy, greatly reducing the survivability and quality of life for the woman.
Leuzzi alleges that Ethicon knew or should have known about the risks of morcellators spreading cancer during a robotic hysterectomy, but failed to adequately warn about the potential risk or to make the device safer. The lawsuit also names as defendants unnamed companies which also made, marketed, designed and sold minimally invasive gynecological products that were used on the plaintiff. It also includes unnamed individuals who did the same.
The complaint includes claims for negligence, strict product liability, breach of warranty, fraudulent misrepresentation and omission. Leuzzi's husband is also pursuing a claim for the loss of services, society, companionship and consortium of his wife. The couple is seeking both compensatory and punitive damages.
The robotic hysterectomy cancer lawsuit comes just days after Ethicon's parent company, Johnson & Johnson, announced that it was halting sales, distribution and promotion of all power morcellators until the FDA and the medical community can determine the correct course of action regarding morcellation procedures. The agency intends to hold a meeting this summer to look at those options.
Through Ethicon, Johnson & Johnson controlled most of the power morcellator market, with 71% of all power morcellator sales in 2011.
As more women and families learn that advanced stage leiomyosarcoma diagnosed following uterine fibroid surgery may have been spread by morcellators, it is expected that a growing number of similar lawsuits will be filed against Ethicon and other manufacturers of these devices.