Health care giant Johnson & Johnson has reportedly settled nearly 90 percent of the cases involving cancer spread by the controversial surgical tool, the power morcellator.
The injured women claim that leimyosarcoma—an aggressive form of uterine cancer— was spread by the surgical tool during a hysterectomy or uterine fibroid removal procedure. These women have brought product liability lawsuits against Johnson & Johnson’s Ethicon unit, which manufactures power morcellators.
Women and their doctors have been alarmed about the safety of surgical procedures that use power morcellators. The power morcellator is used in minimally invasive uterine fibroid surgery or hysterectomy. The device is inserted through a small incision and its rapidly spinning blades cut uterine tissues into tiny pieces that can be removed through the incision. But bits of tissue can be spread through the abdomen during the procedure and if the tissue contains cancerous cells—which are virtually impossible to detect prior to surgery—the procedure can spread the cancer. Once spread, the cancer rapidly becomes more aggressive, greatly reducing the woman’s long-term survival chances.
The FDA calculates that one in 350 women who undergo hysterectomy or fibroid surgery has an undetected uterine sarcoma. Because the risk of spreading undetected cancer is much higher than earlier believed, many hospitals have restricted morcellator use to carefully screened patients who are least likely to harbor uterine sarcoma. A number of health insurers no longer cover routine use of the morcellator and some manufacturers have stopped selling the device.
In October 2015, a multidistrict litigation (MDL) was formed to coordinate pretrial proceedings for the morcellator cases. The Ethicon MDL litigation is centralized before U.S. District Judge Kathyryn H. Vratil in the District of Kansas. Earlier this year, the Wall Street Journal reported that J&J had settled nearly 70 of the cases. Settlement amounts are said to range from about $100,000 to roughly $1 million, depending on the woman’s age, her medical condition, and whether she has children, according to people familiar with the settlements. Lawyers for the plaintiffs are reportedly pushing for quick action because many of the women are seriously ill.
Symptoms that might signal cancer after a morcellator procedure include:
- vaginal discharge, bleeding or spotting
- abdominal or pelvic pain or a mass
- abdominal or pelvic swelling
- weight loss
- nausea and vomiting
In November 2014, the FDA directed manufacturers to add a black box warning to the morcellator’s labeling. The black box is the FDA’s most serious warning. Despite calls for the device to be banned, the morcellator remains on the market. The Government Accountability Office is investigating why the morcellator remained on the market for two decades before the FDA warned that the device can spread cancer.