New York, New York (PRWEB) July 10, 2014
As hysterectomy cancer lawsuits (http://www.morcellatorlawsuit2015.com/) against the manufacturers of power morcellators continue to mount in U.S. courts, Bernstein Liebhard LLP notes that a panel of advisors to the U.S. Food & Drug Administration (FDA) is meeting today to discuss ways to mitigate the cancer risks associated with these devices. Among other things, the Obstetrics and Gynecology Devices Panel will hear testimony from women whose uterine cancers were allegedly spread via power morcellators, as well as the surviving family members of such women. According to a report from The Washington Post, another focus of the hearing is likely to be the FDA’s 510(k) clearance program, which allowed power morcellators to come to market without clinical trials.*
“Our Firm has heard from far too many women who are now fighting advanced stage cancers following uterine morcellation. We will be monitoring this hearing very closely,” says Bernstein Liebhard LLP, a nationwide law firm representing victims of defective drugs and medical devices. The Firm is now evaluating morcellator lawsuits on behalf of women who may have experienced the spread of undiagnosed uterine sarcoma and other cancers due to uterine morcellation.
Power Morcellator Lawsuits
Power morcellators are used during laparoscopic hysterectomies and fibroid removals to shred tissue so that it can be removed via a small incision in the uterus. In April, the FDA issued an alert discouraging doctors from using the devices in minimally invasive gynecological surgeries due to the potential that they can disseminate undetected uterine cancer cells into the peritoneal cavity. According to the FDA, about 1 in 350 women undergoing fibroid removal has undetected cancer cells in their fibroids, and dissemination of these cells via morcellation can greatly reduce a patient’s odds of long-term survival.
According to a report prepared by FDA staff in advance of today’s meeting, the power morcellators currently on the market were approved via the agency’s 510(k) clearance program. This program does not require companies to prove a device’s safety and effectiveness via clinical trials, so long as it can be shown that the product is substantially equivalent in design to a device that was previously approved by the FDA.** According to The Washington Post, the 510(k) program has been a frequent target of critics, who assert that devices cleared in this matter are not sufficiently monitored once they come on the market.
As concerns surrounding power morcellators have grown, so too has the litigation involving the devices. According to court documents the husband of a 53-year-old woman who died from uterine cancer less than a year after she underwent power morcellation filed what may have been the nation’s first morcellator lawsuit in the U.S. District Court, Eastern District of Pennsylvania this past February. (Case No. 14 5557). On May 1, 2014 a similar complaint was filed in the U.S. District Court, Western District of New York on behalf of a woman who blames uterine morcellation for the spread of leiomyosarcoma in her abdominal cavity. (Case 6:14-cv-06218). Less than two weeks later, a case was filed in the U.S. District Court, Northern District of California on May 13, 2014 that claims the use of a Wolf Power Morcellator promoted the dissemination of uterine cancer cells throughout a woman's peritoneal cavity. (Case No. Case5:14-cv-02209-PSG)
Victims of uterine sarcomas or other cancers that were allegedly spread by a power morcellator may be entitled to file their own hysterectomy cancer lawsuit against the manufacturer of the device. To learn more about the risks potentially associated with power morcellators, please visit Bernstein Liebhard LLPs website. To obtain a free legal review, please call 800-511-5092.
*washingtonpost.com/national/health-science/fda-to-weigh-risks-of-potentially-cancer-spreading-device/2014/07/09/25265458-0072-11e4-b8ff-89afd3fad6bd_story.html, Washington Post, July 9, 2014
**fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/medicaldevices/medicaldevicesadvisorycommittee/obstetricsandgynecologydevices/ucm404148.pdf, FDA, July 8, 2014
About Bernstein Liebhard LLP
Bernstein Liebhard LLP is a New York-based law firm exclusively representing injured persons in complex individual and class action lawsuits nationwide since 1993. As a national law firm, Bernstein Liebhard LLP possesses all of the legal and financial resources required to successfully challenge billion dollar pharmaceutical and medical device companies. As a result, our attorneys and legal staff have been able to recover more than $3 billion on behalf of our clients. The Firm has been named by The National Law Journal to the Plaintiffs Hot List, recognizing the top plaintiffs firms in the country, for the past 12 consecutive years. Bernstein Liebhard LLP is the only firm in the country to be named to this prestigious list every year since it was first published in 2003.
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Felecia L. Stern, Esq.
Bernstein Liebhard LLP