More than two dozen lawsuits alleging that a laparoscopic device used to break up fibroid tissue caused cancerous cells to spread in women’s bodies have been consolidated in federal court in Kansas City, Kansas.
The device, known as a power morcellator, was the subject of a U.S. Food and Drug Administration warning last November. The agency said it posed a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus and shouldn’t be used on most women.
Lawsuits alleging manufacturers of the device failed to provide patients with adequate warning of the risks have been filed in more than a dozen states. The Wall Street Journal reported in July that a lawsuit filed against device maker Lina Medical ApS and expected to be the first to go to trial was settled on undisclosed terms.
Power morcellators are drill-like devices that surgeons can use to make small incisions and break up uterine fibroids. Most women develop such fibroids but they usually don’t cause symptoms.
In some cases, however, the fibroids can lead to prolonged menstrual bleeding, pelvic pain and other conditions.
The FDA estimated that about 1 in 350 women undergoing a hysterectomy or myomectomy – a surgical procedure to remove fibroids – for the treatment of fibroids is found to have an unsuspected uterine sarcoma, including a very rare and aggressive cancer called leiomyosarcoma.
Most of the suits consolidated in federal court Kansas City, Kansas, were brought against Ethicon, a subsidiary of Johnson & Johnson. Johnson & Johnson voluntarily withdrew the device from the market last year. The cases have been assigned to U.S. District Judge Kathryn H. Vratil.
"There are other manufacturers of these devices, but it's only the cases against (Ethicon) that were consolidated," said Thomas J. Preuss, a Kansas City attorney representing a plaintiff in one of the actions.
He said Vratil has a lot of experience handling what is known as multi-district litigation, one reason the cases may have been consolidated here.
Dan Margolies, editor of the Heartland Health Monitor team, is based at KCUR. You can reach him on Twitter @DanMargolies.
