Johnson & Johnson Reportedly Settling Power Morcellator Cancer Cases

Tabitha KrugerDefective Medical Devices, Hot Topics, Johnson & Johnson

Lawsuit

Health care giant Johnson & Johnson has reportedly more than 70 lawsuits claiming uterine cancers were spread by the power morcellator, a controversial surgical tool.

In these lawsuits, the plaintiffs allege that the power morcellator used in their hysterectomies or uterine fibroid removal procedures spread leimyosarcoma—an aggressive form of uterine cancer that is hard to detect before surgery. Their product liability suits were filed against Johnson & Johnson’s Ethicon unit, which manufactures power morcellators.

Members of the medical community have expressed alarm about the safety of surgical procedures using power morcellators. The device has been widely used in minimally invasive uterine fibroid surgery or hysterectomies. The morcellator is inserted through a small incision in the abdomen and the rapidly spinning blades cut uterine tissue into tiny pieces that can be removed through the incision. But the morcellator can spread bits of tissue through the abdomen during the procedure and if this tissue contains cancer cells, the cancer can rapidly spread and grow, complicating treatment and diminishing the woman’s long-term survival chances.

The Food and Drug Administration says one in 350 women who undergo hysterectomy or fibroid surgery have an undetected uterine sarcoma—a much higher risk than earlier believed. In light of the concerns, 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. Though the device has not been banned, some manufacturers, including Johnson & Johnson, have stopped selling power morcellators.

Women who have had surgeries using the power morcellator should be aware symptoms that might signal cancer:

  • vaginal discharge, bleeding or spotting
  • abdominal or pelvic pain or a mass
  • abdominal or pelvic swelling
  • weight loss
  • nausea and vomiting

In October 2015, a multidistrict litigation (MDL) was formed to coordinate pretrial proceedings for the morcellator cases.  The Wall Street Journal reported that J&J began settling morcellator cases and nearly 70 have been settled. People familiar with the settlements say the amounts range from about $100,000 to $1 million, depending on such factors as the woman’s age, her medical condition, and whether she has children. Lawyers for the plaintiffs are reportedly urging quick action on these cases because many of the women are seriously ill.

In 2014, the FDA directed morcellator manufacturers to add a black box warning—the most serious warning—to materials for hospitals and surgeons. Despite the lawsuits and other pressure, the morcellator has not been removed from the market. In response to requests from Congress, the Government Accountability Office is investigating why the morcellator remained on the market for two decades before the FDA warned that the device could spread cancer.