Women Involved In Morcellator Cancer Lawsuit Claims Contend They Were Diagnosed With Uterine Cancer After Undergoing A Hysterectomy Or Myomectomy Using Power Morcellators Are Represented By Southern Med Law
The growing number of power morcellator cancer lawsuits alleging that laparoscopic power morcellators spread cancer in women during gynecological surgeries and the warning issued by the U.S. Food and Drug Administration (FDA) have prompted calls for investigations into the medical device, comments Southern Med Law, which filed the first power morcellator lawsuit in a U.S. federal court. The latest call has come from 12 bipartisan members of Congress who recently asked the U.S. Government Accountability Office (GAO) to conduct a probe of power morcellators and why the FDA “took so long” to warn about the medical devices’ potential to spread cancer. The GAO conducts investigations for the U.S. Congress. In their August 7 letter to the GAO, the lawmakers wrote that “hundreds, if not thousands, of women in America are dead” due to the controversial medical device, according to a Wall Street Journal report. Among the directions give to the GAO was to determine whether the FDA’s expedited process for approving medical devices “sufficiently identified” the cancer risk before power morcellators entered the marketplace, and what the FDA is doing to decide whether power morcellators should remain on the market. It will be a few weeks before the GAO decides whether to follow through on the Congress members’ request, the Wall Street Journal said.
[wsj.com/articles/members-of-congress-call-on-gao-to-investigate-surgical-tool-1438978884?mod=rss_Politics_And_Policy, August 7, 2015]
“We are representing to many women in power morcallator lawsuits. These manufacturers need to be held accountable for their non-disclosure of the risks associated with power morcellation and potential to develop leiomyosarcoma or uterine cancer” said Dr. François Blaudeau, a founding partner of Southern Med Law. In July, Dr. Blaudeau settled the first federally filed morcellator cancer lawsuit involving Donna Burkhart, a 53-year-old Pennsylvania resident who died of disseminated leiomyosarcoma in February 2013, which she developed after undergoing a power morcellator hysterectomy in March 2012. The lawsuit was filed on behalf of her husband, Scott Burkhart, and against morcellator manufacturers, LiNA Medical APS, Kebomed AB & LiNA Medical US. The lawsuit was settled for an undisclosed amount.(Case No. 5:14-cv-1557, U.S. District Court, Eastern District of Pennsylvania)
Court documents describe power morcellators as medical devices that slice the uterus or uterine fibroids into fragments so that they can be removed through small (laparoscopic) incisions in the abdomen. As the uterine tissue is removed, the undiagnosed cancer cells contained in the tissue spreads into the peritoneal cavity. Power morcellators have the potential to not only spread cancer, but upstage the disease as well, court documents state. According to the Wall Street Journal, power morcellators were approved in 1991 through the FDA’s 510(k) process in which medical device manufacturers only had to show whether their products were equivalent to a medical device already on the market.
In November, the FDA issued a strong warning that all but banned the use of power morcellators. The FDA determined that power morcellators should be avoided in the majority of women who require a hysterectomy (removal of the uterus) and a myomectomy (removal of uterine fibroids) because of the product’s potential to spread undiagnosed cancer which greatly reduces a woman’s chances for long-term survival.
[fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm424443.htm, November 24, 2014]
The law firm notes a news media report in June that the FBI is conducting an investigation into power morcellators due to the controversy surrounding the device. According to a CBS report, the FBI’s probe includes questioning Johnson & Johnson, the largest morcellator manufacturer, about whether the company’s Ethicon unit knew, and how long they knew, about the cancer risks associated with its power morcellators. Johnson & Johnson suspended global sales of its surgical morcellators in wake of the FDA’s warning that the devices spread undetected cancer cells during surgery.
[pittsburgh.cbslocal.com/2015/06/15/fbi-investigating-johnson-johnson-over-morcellators/, June 15, 2015]
About Southern Med Law And Filing A Power Morcellator Lawsuit
Southern Med Law is a full service law firm representing victims of negligence, personal injuries, medical malpractice, dangerous drugs, faulty medical devices and defective products. Led by Dr. François Blaudeau, an attorney and a practicing obstetrician/ gynecologist, and the legal staff at Southern Med Law possesses a deep understanding of the complex medical and legal questions at issue in all manner of power morcellators. They’re not afraid to take on the manufacturers to make them accountable and enable all of their clients to have the aggressive legal representation they deserve.
Southern Med Law
François M. Blaudeau, MD JD FACHE FCLM Esquire
2224 1st Avenue North
Birmingham, Alabama 35203
Medical Negligence/MedicalDevice/Pharma/Qui Tam