The power morcellator: initially this surgical tool was thought to be a wondrous invention that would bring about a new era of non-invasive surgeries. Approval was granted by the U.S. Food and Drug Administration under a 501(k).
When a device is given approval under a 501(k), it is reviewed by the FDA’s Center for Devices and Radiological Health (CDRH). Any devices reviewed by this department do not have to undergo rigorous safety testing, as long as it can be shown that the device is “substantially equivalent” to a previously approved device. Devices that need to be evaluated before approval are researched by an entirely different department, the FDA’s Center for Drug Evaluation and Research.
Since the instrument first hit the market, it has been used in countless laparoscopic surgeries, including procedures such as hysterectomies and myomectomies. In most cases, a doctor will recommend that a woman has a hysterectomy or myomectomy performed because of uterine fibroids which are causing the uterus to expand to the point of pain or bleeding.
Unfortunately, as we have come to see, the use of a power morcellator during these procedures carries the great risk of the potential spread of undetected uterine cancer.
The First Five Lawsuits
Tracey & Fox reported on the first power morcellator lawsuit which was filed on March 14th, 2014 in the U.S.District Court for the Eastern District of Pennsylvania under case number 5:14-cv-1557. This lawsuit is both a negligence and wrongful death suit, filed by the widower of a woman who died after being diagnosed with leiomyosarcoma nine days after she underwent a laparoscopic hysterectomy performed using a power morcellator.
One month after this lawsuit was filed, the FDA released a safety warning regarding the use of power morcellators during gynecological surgeries, indicating that if the patient has undetected uterine cancer there is a chance the morcellator could spread those cancer cells to other areas of the body.
On May 1st, 2014, the second lawsuit was filed by a woman who only lived for another five months before passing away. Her widower has chosen to continue pursuing the complaint after her death. This lawsuit alleges the plaintiff had uterine cancer that was “upstaged” by the use of a power morcellator and resulted in stage 4 cancer. She was treated with both chemotherapy and radiation. This case is filed in the U.S. District Court for the Western District of New York under case number 6:14-cv-06218.
A few days later on May 13th, 2014, the third case was filed in the U.S. District Court for the Northern District of California under case number 5:14-cv-02209-EID. In May of 2012, the plaintiff had a hysterectomy performed to remove what she thought were benign fibroids. After her surgery she was informed that one of the fibroids contained leiomyosarcoma. Despite being treated with aggressive therapy she has now developed four lesions on her lungs thought to be metastatic leiomyosarcoma.
The fourth complaint came on October 9th, 2014. It was filed under case number 2:14-cv-02375-GEB-DAD in the U.S. District Court for the Eastern District of California. In this case, the plaintiff alleges that she was not “informed that the use of a power morcellator presents a risk of spreading undetected cancers.” After her hysterectomy, seven new cancerous tumors were found throughout her abdomen. Doctors suspect the cancer metastasized because the cancer cells were spread by a morcellator.
The fifth lawsuit came on January 26th, 2015 under case number 2:15-cv-10352-TGB-APP in the US District Court for the Eastern District of Michigan. In this case a woman claims she is now fighting uterine cancer that spread to her breasts and bones because of the power morcellator. She states that the morcellator is “unreasonably dangerous” and “defective in design.”
Of the first five lawsuits, only the first lawsuit has been settled for an undisclosed amount. The remaining four are scheduled to go to trial.