Amanda Antell  |  May 23, 2014

Category: Legal News

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robotic surgery lawsuitNew York plaintiff Brenda Leuzzi has filed a morcellation cancer lawsuit against Ethicon Inc. for the injuries she allegedly suffered after using their morcellator robotic tool to remove a uterine fibroid during a robotic hysterectomy.

Leuzzi underwent a laparospopic procedure to remove a fibroid in her uterus, but it caused an aggressive cancer to spread throughout her body, according to her morcellation cancer lawsuit.

Leuzzi and her husband filed the morcellator cancer lawsuit on May 1 against Ethicon and its women’s health and urology division for the injuries Leuzzi allegedly suffered from their medical device. Leuzzi claims in her morcellation cancer lawsuit that she had no prior cancer indications before her robotic hysterectomy, and that she had chosen this procedure because it is not very invasive and because of its advertised efficiency.

However soon after Leuzzi’s surgery, doctors discovered that leiomyosarcoma cancer spread throughout her peritoneal cavity. Leiomyosarcoma is one of the deadliest forms of uterine sarcoma cancer. According to medical experts, this cancer can be spread by morcellators during a robotic hysterectomy, greatly reducing the survivability and quality of life for the patient.

Leuzzi alleges that Ethicon either knew or should have known about the risks of their morcellator products spreading cancer during robotic hysterectomy procedures, but failed to adequately warn patients about the potential side effects.

Several weeks before this morcellator cancer lawsuit was filed, the U.S. Food and Drug Administration (FDA) issued a warning regarding Ethicon’s morcellator devices. The statement said that the morcellators should not be used to remove uterine fibroids due to the possible risk of spreading cancers, which may be contained in the uterus. When Leuzzi received this warning, she filed her morecellation cancer lawsuit against Ethicon and its parent company, Johnson & Johnson, alleging negligence, false advertising, concealing information, and misrepresenting a product.

Leuzzi and her husband are seeking compensatory and punitive damages.

Additionally, Ethicon and Johnson & Johnson announced that all sales, distribution, and promotion of power morcellators will be halted until the FDA and the medical community can determine what to do regarding the morcellation injuries. The FDA intends to hold a meeting this summer to discuss possible remedies for the situation.

Overview of Morcellator Cancer Complications

Power morcellators are often used for robot-assisted hysterectomy procedures to cut uterus tissue so it can be safely removed through the abdomen. These devices allow the procedures to be minimally invasive procedures and reportedly reduce recovery time and risk of infection. While advertised to be efficient, the morecellator cancer injuries reported are quite troubling to the medical community due to how many women choose to use power morcellators for hysterectomy procedures.

According to the FDA, approximately one in 350 women who undergo uterine fibroid surgery have unsuspected sarcoma. Currently, there is no reliable way for doctors to identify whether or not women have sarcoma before using a morcellator device. As a result, the FDA is discouraging doctors from offering the device as a treatment option.

Due to the injuries these women have suffered, class action lawsuit lawyers are currently investigating the leiomyosarcoma (LMS), uterine sarcoma or other cancer that may have been spread during a robotic hysterectomy or uterine fibroid removal performed with a power morcellator. It is suspected that these medical devices were not adequately tested before being released to the market, and then used to perform hysterectomies or uterine myomectomy surgery.

Power morcellator devices that are being investigated for unintentional uterine cancer injuries include:

  • Ethicon Gynecare Morcellex
  • Blue Endo MoreSolution Tissue Morcellator
  • Karl Storz Rotocut G1 Morcellator

The morecellator cancer lawsuit is Brenda Leuzzi, et al. v. Ethicon Endo Surgery Inc., et al., Case No. 6:14-cv-06218, in the U.S. District Court for the Western District of New York.

In general, morcellator cancer lawsuits are filed individually by each plaintiff and are not class actions.

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