FOR IMMEDIATE RELEASE:
BIRMINGHAM, ALA The first Federal lawsuit has been filed against the morcellator manufancturer LiNA Medical by the family of Donna Burkhart from Reading, Pennsylvania. The family is represented by Dr. Francois Blaudeau, a prominent national surgeon and attorney of counsel with Heninger Garrison Davis, LLC. The case filed on March 14, 2014, alleges that the Morcellator Medical Device Manufacturer LiNA Medical failed to adequately warn surgeons regarding the risk of disseminated cancer following the use of their morcellator; failed to design a safer “closed” system that would prevent the spread of cancer cells, and failed to act when scientific studies revealed that disseminating cancer was occurring. Mrs. Burkhart surgery was in March 2012 and a power morcellator was used in the surgery. Mrs. Burkhart had not been warned about the risks of seeding her abdominal cavity from an undiagnosed sarcoma cancer. Mrs. Burkhart died less than a year later in February 2013.
Lawyers from several prominent national medical device plaintiff law firms including Heninger Garrison Davis and Alonso Krangle, representing multiple women and families are filing lawsuits across the country against a group of medical device manufacturers who manufacture and sell uterine morcellators to hospitals for use by minimally invasive gynecologists. These morcellator devices are used to remove solid uterine tumors called fibroids by literally chewing them up through a thin, narrow tube. The FDA recently warned surgeons and hospitals regarding the use of these devices due to the possibility that they could spread cancer cells throughout the abdominal cavity changing the stage and prognosis of Leiomyosarcoma, a rare type of uterine cancer.
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Additional lawsuits are being filed in several states alleging negligence, strict product liability, breach of express warranty, breach of implied warranty, and fraudulent misrepresentation and omission. Attorney Andy Alonso with the firm of Alonso Krangle in New York, along with Dr. Blaudeau, has filed a lawsuit of behalf of patient Brenda Leuzzi against Ethicon Endo Surgery, Inc., the leading manufacturer of disposable morcellators and looks forward to reviewing documents from the manufacturers to gain more insight on how this issue was ignored. Mrs. Leuzzi is undergoing advanced chemotherapy and radiation therapy her long-term prognosis is poor. Early investigations into the actions of Ethicon Endo Surgery indicate that there was knowledge of this issue relating to dissemination of cancer and that potential safety solutions including the deployment of a ballistic reinforced bag to avoid spillage of unsuspected cancer cells were available to the company but were not provided as part of the product sold to hospitals. Alonso notes that “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.”
“There is mounting evidence that much, much more should have been done to prevent these rare, but devastating, events of dissemination of cancer related to the use of the morcellator manufactured by these companies” says Dr. Blaudeau. Better screening of patients to avoid altogether using the morcellator in cases where large tumors with a higher risk of malignancy are encountered and the use of a reinforced intra-peritoneal bag every time a morcellator is used makes much more sense than what has been transpiring. “Minimally invasive surgery has tremendous benefits for patients all over the World, but safety for all patients is required and the failure of these morcellator manufacturers to deploy safety mechanisms as simple as the inclusion of a reinforced plastic bag is just not understandable” remarks Dr. Blaudeau. Many surgeons were not aware of the existence of special intra-peritoneal bags specifically designed for use with the morcellator and were unaware of how many patients were being negatively affected. “There is a justifiable sense of outrage on behalf of injured and dying patients and their families due to failure to address what were known complications of morcellator use that could have prevented. Its impossible to truly understand what these patients and their families have had to endure following the spread of cancer cells from an morcellator procedure performed without the proper use of an intraperitoneal bag” says Dr. Blaudeau.
Attorney Lew Garrison who has been involved in all of the major medical device litigations over the past twenty-five years commends the FDA for acting: “We are glad that the FDA has stepped in to evaluate morcellator use and that some of the manufacturers have now elected to stop selling their morcellators until the FDA evaluation is complete.” Garrison notes that “as the litigation progresses we expect to perform a systematic and thorough investigation with our co-counsel team across the country regarding what these manufacturers knew, when they knew it, and what they did about it. We will leave no stone unturned in representing these injured patients and their families.”
Heninger Garrison Davis is headquartered in Birmingham with offices in Atlanta, Los Angeles, New Jersey, New York and Washington, D.C. and focuses on Business Litigation, Class Actions and Mass Torts, Intellectual Property and Personal Injury. Please visit http://hgdlawfirm17.zeekeeinteractive.com to learn more about the firm.
Contact: Kristi Ozley
[email protected] Heninger Garrison Davis
2224 1st Avenue North Birmingham, Alabama 35203
(205) 326-3336
Toll Free: 1-800-241-9779
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