by Dan Margolies, Heartland Health Monitor
More than two dozen lawsuits related to a laparoscopic device used to break up fibroid tissue in women’s bodies have been consolidated in federal court in Kansas City, Kan.
The device, known as a power morcellator, was the subject of a U.S. Food and Drug Administration warning in November 2014. 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 that 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.
Surgeons use power morcellators 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 one in 350 women undergoing a hysterectomy or myomectomy – a surgical procedure to remove fibroids – is found to have an unsuspected uterine sarcoma, including a rare and aggressive cancer called leiomyosarcoma.
Most of the suits consolidated in federal court were brought against Ethicon, a subsidiary of Johnson & Johnson, which 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 in Kansas City, Kan.
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