A lawsuit was filed last month in a New York federal court against Ethicon Endo-Surgery Inc., a Johnson & Johnson unit, over its morcellator product. This was the first suit involving this product, which is used in a now controversial uterine fibroid removal procedure. The U.S. Food and Drug Administration (FDA) has warned that use of this product could spread cancerous tissue outside of the uterus. The suit, filed in New York federal court, claimed the company did not adequately test its Morcelex product for potentially dangerous side effects. Plaintiffs Brenda Leuzzi and George Leuzzi, who filed the suit, claim that Brenda was diagnosed with cancer after undergoing a robot-assisted hysterectomy with morcellation in 2012.
For those who don’t already know, Laparoscopic power morcellation is a technique used to treat mostly non-cancerous fibroids. It uses a device to break uterine tissue into fragments that can be removed through an incision in the stomach, according to the FDA. Although uterine fibroids are common and usually benign, they may occasionally be cancerous, the agency said. If women with such unsuspected cancerous fibroids undergo morcellation, there is a risk of spreading those cancerous fragments beyond the uterus, making such cancers harder to treat, the agency warned. The Leuzzis alleged in their suit:
Defendants warranted that said product or products, including the Morcelex morcellator, were safe for use, which had the natural tendency to induce physicians and hospitals to use the same for patients and for patients to want to be treated with the same.
The Plaintiff claims were based on negligence, strict product liability and breach of express warranty. Ethicon made a decision after the FDA warning to suspend sales of its morcellation devices around the world, saying it was awaiting more guidance from the agency. The Plaintiffs are represented by David B. Krangle and Andres F. Alonso, who are with Alonso Krangle, a firm with offices in both New York and New Jersey. They did a very good job for the Plaintiffs.
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