Johnson & Johnson has been quietly settling consumer lawsuits over power morcellator incidents. According to a report by The Wall Street Journal, the company has already settled approximately 70 cases and is working on settling more. The Judicial Panel on Multidistrict Litigation consolidated several power morcellator cases against J&J’s Ethicon unit in U.S. District Court for the District of Kansas just a few months ago.
For the past two decades, power morcellators have been used in laparoscopic procedures. The power morcellator is used by surgeons to grind up uterine tissue during hysterectomies and myomectomies for laparoscopic removal. They quickly became popular as the risks of morcellation were viewed to be much better than the potential adverse events of alternative procedures, like open hysterectomy. J&J manufactured about 75 percent of the morcellators on the market
Several years ago, women began to allege that they developed uterine cancer as a result of the medical device. The issue with power morcellators appears to be that as the device blends up cancerous cells, it spreads them around the abdominal cavity. While the FDA cleared several morcellators for use in the 90s, reports about the devices spreading cancer and subsequent deaths did not surface until December 2013. As a result of the increased risk of spreading serious cancer cells, the FDA issued a warning and J&J pulled its devices off the market.
A number of health systems and hospitals have since stopped performing hysterectomies with morcellation. Some health insurers, including Highmark and United Healthcare, have said they will not cover the use of morcellators during hysterectomies. However, the devices are still commercially available from some companies and some surgeons continue to use them.
Women and families affected by morcellators continue to file federal and state lawsuits against the manufacturers. J&J faces 30 federal cases in Kansas alone. Ethicon, the largest manufacturer of the devices, denied knowledge of morcellator dangers prior to December 2013. Last year, the FBI reportedly began investigating what J&J knew about the risks before the recall.
In September, the Government Accountability Office said that it planned to investigate how the surgical devices were sold for so long before widespread safety concerns were raised. A dozen members of Congress petitioned GAO to look into the regulatory clearance, marketing, training, and adverse event reporting associated with morcellator use. Petitioners also asked what FDA is doing to ensure the devices, are safe.
Women who have developed uterine cancer or leiomyosarcoma after a laparoscopic procedure where a power morcellator was used should immediately contact an attorney who handles product liability cases involving medical devices. If you have lost a loved one following this type of procedure, you may also have a claim under wrongful death laws.