The first lawsuit out of what could potentially swell to a body of hundreds or more similar cases was filed against Johnson & Johnson unit Ethicon Endo-Surgery Inc. Thursday by a woman who alleges the company’s morcellator tool, commonly used to remove uterine fibroid tissue and growths, caused her to develop cancer after a 2012 surgical procedure.
Plaintiffs Brenda Leuzzi and her husband George Leuzzi filed the lawsuit in a New York federal court, claiming Ethicon failed to adequately test its Morcelex tool for safety before selling its line of morcellator products.
The company began selling morcellators in 1998 as a less invasive alternative to traditional uterine surgeries. The device consists of a tubular blade that grinds and removes uterine growths or even entire uteruses. About 50,000 women per year have undergone morcellator procedures since the devices were first introduced in the 1990s.
In April, the U.S. Food and Drug Administration (FDA) advised doctors to stop using power morcellators, warning that an estimated one in 350 women develops deadly asuterine sarcoma cancer after undergoing a morcellator procedure.
Power morcellation techniques are commonly used to break up and remove non-cancerous fibroids from the uterus. Fibroids are common and usually benign, but occasionally they can be cancerous. Using a morcellator on malignant fibroids can spread the cancer beyond the uterus, making the cancer harder to treat and possibly reducing the patient’s odds of long-term survival, the FDA said.
According to Law360, the Leuzzis allege that Johnson & Johnson and Ethicon claim their power morcellators were safe to use, thereby inducing “physicians and hospitals to use the same for patients and for patients to want to be treated with the same.”
On April 30, Johnson & Johnson announced it was suspending sales of all its morcellator products, which include the Gynecare Morcellex, Morcellex Sigma, and Gynecare X-tract, but did not plan on recalling the devices entirely, saying they may still be beneficial to women who have undergone a benefit/risk evaluation.