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(Medical-NewsWire.com, May 22, 2014 ) New York, NY -- Alonso Krangle LLP has filed a morcellation lawsuit against Ethicon, Inc., a subsidiary of Johnson & Johnson and the manufacturer of a power morcellator. The morcellator lawsuit was filed on behalf of a Fairport, New York woman who was diagnosed with cancer after undergoing a Robot-assisted hysterectomy with uterine morcellation. The complaint was filed in the U.S. District Court for the Western District of New York (Case No. 6:14-cv-06218).
“Ethicon Endo Surgery’s Morcellex device was the leading device sold in the United States; and that as an industry leader Ethicon Endo Surgery had a special responsibility to lead in regard to provide safe morcellator use for all patients.” – Andy Alonso of Alonso Krangle LLP
The Morcellation lawsuit contends that the woman did not have cancer prior to having the surgical procedure in September 2012, but within the same month, was diagnosed with uterine leiomyosarcoma. The complaint alleges that Ethicon and Johnson and Johnson were aware of the risks, complications or adverse events of using a morcellation device such as the Morcelex morcellator and failed to warn of the dangers and hazards of using the product for uterine morcellation.
The lawsuit was filed two weeks after the U.S. Food & Drug Administration (FDA) issued a safety warning on the use of laparoscopic power morcellation during a hysterectomy (the removal of the uterus) and myomectomy (the removal of uterine fibroids). Based on its analysis of currently available data, the FDA’s warning stated its concern over the risk of morcellators spreading undetected cancerous tissue within a woman’s abdomen and pelvis during gynecological surgery.
Morcellation is a procedure that divides uterine tissue into fragments so the smaller pieces can be taken out through small incision sites in the abdomen. The FDA estimated that one in 350 women undergoing a hysterectomy or myomectomy to remove uterine fibroids has uterine cancer, including leiomyosarcoma, and morcellator use will shorten their chances of survival.
[fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm393576.htm, April 17, 2014]
Four Boston-area doctors called for a halt to laparoscopic power morcellation in a draft paper published in the December 2013 New England Journal of Medicine. The doctors examined 10 studies involving 30,000 women who had undergone morcellation and found that nearly 1 in 400 women had uterine sarcoma in the tissue removed during the procedure.
[online.wsj.com/news/articles/SB10001424052702304866904579266714199128946, December 19, 2013]
According to an article in the JAMA (The Journal of the American Medication Association) Network, morcellation can be performed with an electric morcellator or by hand with a knife, and some experts say either way the technique is performed may be too risky under any circumstance, given the possibility of spreading undetected cancer called uterine leiomyosarcoma, a rare and deadly disease which starts in the smooth muscle cells of the uterine wall. The article cited a study that found 2 of 7 patients with presumed stage I uterine leiomyosarcoma, and 1 of 4 patients with presumed stage I smooth muscle tumors had disseminated intraperitoneal disease after morcellation.
[jama.jamanetwork.com/article.aspx?articleid=1828691, March 5, 2014]
As a result of these reports the Pittsburgh Business Times reported the University of Pennsylvania, Cleveland Clinic, Brigham and Women’s Hospital and Massachusetts General Hospital recently suspended the use of laparoscopic power morcellators because of the risks associated with the medical devices.
[bizjournals.com/pittsburgh/blog/the-pulse/2014/04/hysterectomy-procedure-continues-at-upmc-with.htm, April 28, 2014]
Johnson & Johnson announced on April 28, 2014, that it was suspending global marketing, sales and distribution of morcellation devices manufactured by Ethicon, a subsidiary of Johnson & Johnson. Reuters reported that Johnson & Johnson maintained that it was not removing the morcellators completely from the market, but suspending the use only until the role of the products in treating fibroids is redefined by the medical community.
[reuters.com/article/2014/04/30/us-johnson-johnson-device-idUSKBN0DG06G20140430, April 30, 2014]
Another morcellator lawsuit was filed involving the laparoscopic power morcellation device in March of this year, by a Berks County Pennsylvania man whose wife died after undergoing a hysterectomy in March 2012 in which a morcellator was used. According to the morcellation lawsuit, filed in the U.S. District Court, Eastern District of Pennsylvania, the 53-year-old woman was diagnosed with metastatic leiomyosarcoma, a rare form of soft tissue cancer and died in February 2013. The morcellation lawsuit, named Ethicon Inc., Blue Endo and Lina Medical as defendants. These companies all manufacture morcellation devices (Case No. 5:14-cv-1557)
Leiomyosarcoma is a cancer of smooth muscle cells that can occur in the uterus, stomach and intestines, walls of all blood vessels, and skin. While this cancer is very rare, there is no reliable test to diagnose potential malignancy in fibroids before a woman undergoes morcellation. If the cancer is present during morcellation, the cells can be spread throughout the body, quickly changing a stage 1 cancer into stage 4.
Learn More About Filing A Morcellation Cancer Lawsuit
If you or a woman you love developed leiomyosarcoma following morcellation, you may want to consider filing your own morcellation cancer lawsuit. To learn more about the legal options available to you, please contact Alonso Krangle LLP today by filling out our online form or calling 1-800-403-6191.
About Alonso Krangle LLLP
Andres Alonso And David Krangle, Attorneys With Almost 40 Years Of Collective Legal Experience, Have Focused Their Law Practice On The Handling Of Significant Personal Injury Cases, Defective Drug And Medical Device Litigation, Construction Site Accidents, Nursing Home Abuse, Medical Negligence, Qui Tam/Whistleblower Actions And Consumer Fraud Cases. A Nationwide Law Firm Representing Injured Victims Throughout The U.S., Alonso Krangle Llp Is Headquartered In Long Island, New York, With Offices In New York City, And New Jersey. To Discuss Filing A Morcellation Lawsuit, Please Contact Alonso Krangle Llp At 1-800-403-6191 Or Visit Our Website, Http://Www.Fightforvictims.Com
For More Information About Alonso Krangle Llp Or To Join The Fight And Be A Part Of Our Team, Please Contact Us At 1-800-403-6191 Or Visit Our Website, http://www.fightforvictims.com
Contact:
Alonso Krangle LLP
445 Broad Hollow Road
Suite 205
Melville, New York 11747
Toll-FREE 1-800-403-6191
Tel: 516-350-5555
Fax: 516-350-5554
Alonso Krangle LLP
Dave Krangle
1-800-403-6191
DKrangle@alonsokrangle.com
Source: EmailWire.Com 
Source: EmailWire.com
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