New York, NY (PRWEB) June 04, 2014
Alonso Krangle LLP has learned that Johnson & Johnson was warned by a pathologist in 2006 that its power morcellators presented a risk of spreading cancer when used during surgery to remove a woman’s uterus or uterine fibroids. Dr. Robert Lamparter’s warning was similar to a safety advisory issued in April 2014 by the U.S. Food & Drug Administration (FDA) that prompted Johnson & Johnson to suspend worldwide sales, promotion and distribution of laparoscopic power morcellators. Morcellation lawsuits also allege that the company knew about the risks associated with power morcellators but failed to warn doctors and their patients about them. The Pittsburgh Business Times has obtained a series of emails and letters between Johnson & Johnson representatives and Dr. Lamparter, a pathologist at Evangelical Community Hospital in Lewisburg, Pennsylvania, for 28 years before retiring in 2013. According to the Pittsburgh Business Times news report, Dr. Lamparter sent an email in February 2006 to Dr. David Robinson, then medical director of Women’s Health and Urology for Ethicon, a Johnson & Johnson subsidiary that manufactures power morcellators. Lamparter stated in his email that prescreening for cancer prior to morcellation surgery is not always effective since screenings typically miss “a certain number of malignancies.” Because of this, when power morcellation is used, the doctor continued, “the patient’s survival is jeopardized.” Dr. Robinson sent an email in February 2006 to Dr. Lamparter that said he sent Dr. Lamparter’s concerns in the form of a complaint to Ethicon’s World Wide Customer Quality Department. In April 2006, Dr. Robinson sent Dr. Lamparter another email stating that Ethicon would add a warning to the morcellator’s user instructions stating that the device may disseminate malignant tissue when a uterine tumor is present. In May 2006, Dr. Lamparter received a letter from Ethicon’s World Wide Customer Quality Department dismissing his complaint.
[m.bizjournals.com/pittsburgh/news/2014/05/30/j-j-alerted-in-2006-to-devices-surgical-risks.html?r=full, May 30,2014]
Morcellation is used during a hysterectomy (removing the uterus) or myomectomy (removing uterine fibroids) by slicing uterine tissue into pieces or fragments that can be taken out through small incision sites in the abdomen. The FDA issued a safety alert on April 17, 2014, warning that the use of the laparoscopic power morcellators could spread undetected cancer as the uterine tissue is removed from the abdomen. According to the FDA, data shows one in 350 women undergoing a hysterectomy or myomectomy is found to have an undetected uterine cancer, including leiomyosarcoma, a rare but aggressive cancer of smooth muscle cells that can spread through blood stream and affect the liver, blood vessels, the lungs and any other soft tissue in the body. Nearly two weeks after the FDA’s announcement, Johnson & Johnson suspended its sales of the device but said it would not take it completely off the market since morcellators are the best option for some patients who agree to use the device after they have been notified of the risks involved. By May 2014, hospitals across the country, including Cleveland Clinic and Temple University, discontinued using the devices, according to the Pittsburgh Business Times. The FDA’s Obstetrics and Gynecological Medical Device Advisory Committee will hold hearings in July on power morcellators.
[fda.gov/newsEvents/Newsroom/PressAnnouncements/ucm393689.htm, April 17, 2014]
[bizjournals.com/pittsburgh/blog/the-pulse/2014/04/j-j-suspends-marketing-of-controversial-surgical.html?page=all, April 30, 2014]
Court records indicate that morcellator lawsuits have been filed on behalf of women who were diagnosed with cancer after morcellation was used during a surgical procedure. Andy Alonso of Alonso & Krangle LLP and Dr. Francois Blaudeau with Heninger Garrison Davis, LLC, filed a morcellation lawsuit in the U.S. District Court, Western District of New York, against Ethicon on behalf of a New York woman who was diagnosed with uterine leiomyosarcoma in September 2012, after a power morcellator was used during her hysterectomy. (Case No. 6:14-cv-06218)
Court documents also show that a morcellation lawsuit was filed by a Berks County, Pennsylvania man on behalf of his 53-year-old wife who underwent a hysterectomy in March 2012 in which a power morcellator was used. The morcellator complaint alleges that the woman was diagnosed with metastatic leiomyosarcoma after the surgical procedure and died in February 2013. The lawsuit names as defendants, Ethicon, Blue Endo and Lina Medical, all of which manufacture morcellators (Case No. 5:14-cv-1557)
Find Out More About Filing A Morcellation 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 LLP
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 Morcellator Lawsuit, Please Contact Alonso Krangle Llp At 1-800-403-6191 Or Visit Our Website, 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, fightforvictims.com.