Of an estimated 100 cases that have been filed against Johnson & Johnson’s Ethicon Unit that are related to the laparoscopic power morcellator, 70 have been settled over the past several months, according to a Wall Street Journal report.
The settlements made so far have ranged from $100,000 to over $1 million, and typically depend upon a woman’s age, medical condition, and whether she had children. J&J is currently in talks to resolve other morcellator claims it faces that have been consolidated in multidistrict litigation (MDL) in U.S. District Court for the District of Kansas, and the company also faces a handful of separate morcellation cases that still pend in state courts. J&J suspended sales of the power morcellator in April 2014 and withdrew it from the market in July 2014.
What are Power Morcellators?
Power morcellators are medical devices that cut up benign growths called fibroids so that doctors can remove the tissue through tiny incisions. Surgeons routinely used morcellators in tens of thousands of procedures annually before April 2014, when the U.S. Food and Drug Administration (FDA) issued a warning that women undergoing fibroid operations have a 1 in 350 chance of harboring a uterine sarcoma that can’t be reliably detected before the procedure. Morcellation can spray cancerous tissue within the abdomen and pelvis, significantly worsening a woman’s chances of long-term survival.
The U.S. Government Accountability Office (GAO) is currently probing why morcellators were allowed to remain on the market for two decades before the FDA issued the warning regarding uterine cancer. Though device applications and other records show the FDA knew early on that morcellators could spread dangerous cells, the agency said the magnitude of the risk wasn’t realized until the issue came into the spotlight in late 2013.The FDA has acknowledged that it has been notified by the GAO and plans to cooperate fully with the review.