Power Morcellator Lawsuit Claims Contend Power Morcellator Manufacturers Failed To Disclose That Their Medical Devices Allegedly Spread Undetected Leiomyosarcoma During Procedures To Remove Uterine Fibroids, Southern Med Law Reports.
Court records show a power morcellator lawsuit has been filed on behalf of a woman who contends the power morcellator used during surgery to remove uterine fibroids spread and upstaged cancer throughout her body. The complaint against Olympus Corp.’s subsidiary, Gyrus Acmi LP, is similar to morcellation cancer lawsuits already filed against laparoscopic power morcellator manufacturers, Karl Storz, Richard Wolf, Blue Endo, Lina Medical, and Ethicon Inc. The morcellator lawsuits contend the companies failed to warn doctors and their patients about the potential risks of their morcellators spreading undetected uterine cancer, including leiomyosarcoma.
The power morcellator lawsuit alleges that Gyrus’ PKS PlasmaSORD Bipolar Morcellator was used during surgery in 2011 to remove what the plaintiff’s doctors believed were benign uterine tumors. The power morcellator, however, “disseminated and seeded cancer” throughout the plaintiff’s abdominal area and accelerated the spread of the disease throughout her body, the lawsuit said. The complaint purports Olympus knew or should have known that its surgical device could spread and implant malignant uterine tissue fragments in the body. (Case No. 150900680, Court of Common Pleas, Philadelphia County, Pennsylvania)
“This is yet another tragic instance where a power morcellator allegedly spread undetected cancer cells during a procedure and worsened the plaintiff’s long-term prognosis,” says Dr. François Blaudeau, founder of Southern Med Law, which was the first law firm in the country to file a power morcellator lawsuit. The complaint was settled earlier this year and the firm is currently representing women in multiple power morcellation lawsuits against Ethicon Inc.
Laparoscopic power morcellators are used during minimally invasive surgeries such as a hysterectomy to remove the uterus or a myomectomy to remove uterine fibroids. The power morcellator has spinning blades that grind uterine tissue into fragments for removal through small incisions in the abdomen. The morcellated fragments may contain undiagnosed cancer, including leiomyosarcoma, a rare and aggressive form of cancer. The cancer cells can travel to various parts of the body if fragments are implanted in the abdomen and pelvic area or attach themselves to surrounding organs.
In November 2014, the FDA issued a warning that all but banned power morcellator use in the majority of women undergoing a hysterectomy or myomectomy. However, the FDA and its process for approving power morcellators came under fire by some members of Congress. The 12-member Congressional group criticized the FDA’s approval process as being too lax. Under the FDA’s 501(k) approval process, medical device manufacturers are not required to conduct clinical trials if they can show that their new device is safe and effective, and substantially equivalent to one that is already on the market. The congressional group called upon the U.S. Government Accountability Office (GAO) to investigate the FDA’s approval and monitoring of power morcellators and what the agency is doing to determine whether the devices should stay on the market.
[fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/, FDA, August 11, 2014]
[wsj.com/articles/members-of-congress-call-on-gao-to-investigate-surgical-tool-1438978884, Wall Street Journal, August 7, 2015]
In October, a 28 power morcellator lawsuit complaints pending in federal courts nationwide against Ethicon Inc, the largest maker of power morcellators, were consolidated and transferred to the U.S. District Court, District of Kansas, for coordinated pretrial proceedings. Lawsuits filed against other power morcellator manufacturers were not consolidated. The federally filed power morcellator cases allege the devices have the potential to spread cancer and morcellator makers failed to warn about the cancer risks associated with their surgical devices.
Southern Med Law is Led by Dr. François Blaudeau, an attorney and a practicing obstetrician/ gynecologist that is determined to stop the morcellator companies from injuring more women. The legal staff at Southern Med Law is an experienced group of attorneys who posses a deep understanding of the complex medical and legal questions at issue in all manner of product liability and personal injury claims. They’re not afraid to take on the nation’s largest corporations in their pursuit of justice, and are committed to ensuring that all victims have access to the type of aggressive legal advocacy that assures success.
Southern Med Law
François M. Blaudeau, MD JD FACHE FCLM Esquire
2224 1st Avenue North
Birmingham, Alabama 35203
Phone: (205) 547-5525
Fax: (205) 547-5526
Medical Negligence/MedicalDevice/Pharma/Qui Tam