Tracey & Fox has reported that a widower in Pennsylvania has filed a lawsuit against Ethicon, a division of Johnson & Johnson, on behalf of his deceased wife.
Ethicon is the manufacturer of a surgical device known as the Morcellex Sigma Tissue Morcellator MX0200. This device, generally known as a power morcellator, is used in laparoscopic surgeries to slice tissue intended for removal into smaller pieces. While the morcellator cuts, it can also spread cells of the cut tissue to other internal areas. If a patient has undetected cancer and the morcellator cuts through that tumor, the cancer cells can be disseminated throughout the abdominal cavity resulting in metastasis that may have otherwise not occurred.
The lawsuit was filed in the United States District Court for the Eastern District of Pennsylvania under case number 2:15-cv-00553-JHS, and alleges that the deceased wife of the plaintiff died because her undiagnosed uterine cancer was spread throughout her body by the Morcellex Sigma Tissue Morcellator MX0200. On June 19th, 2012, she underwent a laparoscopic surgery known as a robotic total laparoscopic hysterectomy for the removal of uterine fibroids. Her surgeon used the power morcellator to remove the uterus.
Prior to her surgery, the patient had pre-surgical testing performed which showed no evidence of uterine cancer. Then, a biopsy of one of the uterine fibroids that were removed during her hysterectomy, returned with a diagnosis of leiomyosarcoma. The biopsy report stated that “the size and extent of the tumor cannot be assessed due to morcellation.”
Following her initial surgery, the patient had a robotic lymphandenectomy, bilateral salpingo-oophorectomy, and lysis of adhesions and peritoneal biopsy. Leiomyosarcoma was also found in her right fallopian tube and on January 9th, 2013, additional malignant cells were found in other regions of the abdominal cavity. Less than a month later she passed away.
The lawsuit alleges that the widower and his wife were never warned of the risks associated with the use of a power morcellator during her hysterectomy and in fact the “plaintiff’s were prevented from discovering this information sooner because the defendants herein misrepresented to the public and to the medical professional that the Laparoscopic Power Morcellator used on the plaintiff-decedent was safe to use for laparoscopic gynecologic surgery.”
The U.S. Food and Drug Administration released a safety warning in 2014, urging surgeons to stop using the power morcellator during gynecological laparoscopic surgeries.
For more information regarding this press release, call Tracey & Fox at (713) 322-5375.
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Sean Tracey
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