New York, NYFollowing a warning by the US Food and Drug Administration (FDA) that Laparoscopic Power Morcellation could further the spread of cancerous cells outside of the uterus, a unit of Johnson & Johnson (J&J) has been hit with the first of what could amount to a wave of lawsuits regarding the device.
Morcellation has evolved to become one of the preferred treatments for uterine fibroids, a common complaint amongst middle-aged women involving the appearance and painful buildup of fibrous tissue within the uterus. Such tissue is usually benign, although in some cases cancerous tissue can become intermingled with non-cancerous fibroids and go largely undetected.
Morcellation is one way of getting rid of the fibroids through minimally invasive laparoscopic surgery. The morcellation device succeeds in breaking the fibrous uterine tissue into fragments, which are then removed through a small incision in the stomach.
Patients heal much more quickly, freeing up hospital beds for other patients - and laparoscopic procedures appear to be on the rise.
However, there have been cases when morcellation has succeeded in spreading undetected cancerous tissue beyond the uterus, where it can be much harder to treat. The J&J unit responsible for the Morcelex device suspended all sales of its morcellator following the issuance of a safety warning by the FDA. Ethicon Endo-Surgery Inc. has stated it will re-introduce the device, according to reports, once it receives further direction from the federal drug and medical device regulator.
That cautionary stance has not derailed the onset of lawsuits. According to court records, plaintiffs Brenda and George Leuzzi recently filed an action in federal court in New York, alleging a diagnosis of cancer following a laparoscopic power morcellation hysterectomy in 2012. The particular procedure was robot-assisted.
“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 Leuzzis said in their suit.
In response, a spokesperson for the manufacturer pointed out that “Ethicon morcellation devices have always included cautions in their instructions for use,” said Sheri Woodruff, “about the potential spread of malignant, or suspected malignant, tissue.”
Some hospitals have announced protocol changes surrounding use of morcellation, in hysterectomy, fibroid removal or laparoscopic power morcellation myomectomy. Now, power morcellation will not occur unless the surgical team uses a bag in which to contain all fibroids and uterine tissue in order to prevent the spread of potentially cancerous tissue. Other hospitals have stopped using power morcellation altogether.
It is important to note that power morcellation is not banned, and the Ethicon Morcelex has not been formally recalled. Ethicon has simply suspended new sales of the device temporarily. Hospitals with power morcellators on hand are free to continue using the device, or not, as they see fit.
Critics decry power morcellation as just another entry in the dangerous medical procedures playbook.
The case is Brenda Leuzzi et al. v. Ethicon Endo-Surgery et al., Case No. 6:14-cv-06218, in the US District Court for the Western District of New York.
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