March 30, 2016 — Johnson & Johnson is settling lawsuits filed by women whose undiagnosed uterine cancer was upstaged by the company’s now-recalled hysterectomy device, according to the Wall Street Journal.
About 100 lawsuits are pending against Johnson & Johnson’s Ethicon subsidiary, manufacturer of the most popular brand of laparoscopic power morcellators. The devices were used in tens of thousands of hysterectomies per year before they were pulled off the market in July 2014.
Anonymous sources told the WSJ that Ethicon has settled nearly 70 lawsuits over the past few months, and several more are in negotiations. Individual settlements vary by case, but some have ranged from $100,000 to roughly $1 million.
Ethicon suspended sales of morcellators in April 2014 and withdrew them from the market three months later. The action was not technically a recall, but it coincided with FDA warnings that 1 in 350 women undergoing a hysterectomy for fibroids actually has undiagnosed uterine sarcoma.
The spinning blades of a morcellator are used to shred the uterus into tiny pieces that can be easily sucked out of a woman’s abdomen in minimally-invasive surgery. Unfortunately, morcellators can also spread cancerous tissue throughout the abdomen and pelvis, significantly worsening a woman’s chances of long-term survival.
In November 2014, the FDA required a “Black Box” warning about cancer and recommended against using morcellators in the “vast majority” of women undergoing a hysterectomy. However, the agency stopped short of banning the devices altogether. The U.S. Government Accountability Office is now investigating why it took the FDA two decades to issue warnings about cancer.
Hand-operated morcellators have been on the market for many years, but electric “power morcellators” were not popularized until the 1990s. Unfortunately, they were rarely used with surgical containment bags because most experts believed the risk of cancer was low. Fewer than 1 in 10,000 women in the general population has undiagnosed cancer. However, women who have hysterectomies to treat bleeding or painful fibroids are much more likely to have cancer. About 1 in 500 has undiagnosed leiomyosarcoma, a highly-aggressive form of uterine cancer.
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