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Ethicon Settles Morcellator Cancer Lawsuits for $100K-$1M

Ethicon Settles Morcellator Cancer Lawsuits for $100K-$1M

March 30, 2016 — Johnson & Johnson’s subsidiary Ethicon has reportedly settled about 70 lawsuits involving women who were injured by uterine cancer after undergoing a hysterectomy with the company’s now-withdrawn morcellators.

The Wall Street Journal reports that settlement amounts range between $100,000 and $1 million. Terms of each settlement were not disclosed and negotiations continue. The settlements will resolve the majority of roughly 100 lawsuits pending against the company.

Ethicon once dominated the market for laparoscopic morcellators, but suspended sales in April 2014 and pulled all products off the market three months later. The actions came after the FDA issued a Safety Communication to warn about the risk of cancer. The FDA said 1 in 350 women who has a hysterectomy for fibroids actually has undiagnosed uterine cancer.

Morcellators use spinning blades to slice up uterine tissue into tiny pieces. They save time in the operating room, but increase the risk of disseminating uterine cancer throughout a woman’s pelvis and abdomen.

In November 2014, the FDA placed a “Black Box” label on morcellators and warned against using them in the “vast majority” of hysterectomies. However, the agency rejected demands to ban the devices outright.

The U.S. Government Accountability Office is still investigating why it took the FDA two decades to warn about the risk of spreading cancer. In the past, hand-operated morcellators were almost always used with surgical containment bags. When electric morcellators became popular in the 1990s, the bags were rarely used.

Some doctors raised concerns as early as 2006, but most experts believed the risk of spreading cancer was low. Only about 1 in 10,000 women in the general population has undiagnosed uterine cancer. Unfortunately, a much higher percentage of women who choose to have a hysterectomy for painful or bleeding fibroids have cancer — about 1 in 500 have highly-aggressive leiomyosarcoma.

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