It should be noted that information presented at a recent FDA hearing on uterine morcellation raised questions as to whether informed consent would be enough to mitigate risks, or if the procedure should be banned entirely.
New York, New York (PRWEB) August 06, 2014
As morcellator lawsuits (http://www.morcellatorlawsuit2015.com) continue to move forward in U.S. courts, Bernstein Liebhard LLP notes a new report which suggests that informed consent should be obtained from patients before they undergo uterine morcellation. In an article published online in the American Journal of Obstetrics & Gynecology (AJOG), researchers from NorthShore University Health System and the Mayo Clinic acknowledged that the use of power morcellators in laparoscopic hysterectomy and fibroid removals can result in the spread and upstaging of undetected uterine cancers, and assert that patients should be fully informed of this risk so that they can make their own decisions regarding such procedures. *
“Our Firm has heard from a number of women who allegedly experienced the spread of uterine sarcoma and other cancers due to power morcellators. It should be noted that information presented at a recent FDA hearing on uterine morcellation raised questions as to whether informed consent would be enough to mitigate risks, or if the procedure should be banned entirely ,” 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 Morcellators and Cancer
Power morcellators are used in laparoscopic hysterectomies and fibroid removals to shred tissue so that it can be easily removed through a small incision in the abdomen. In April, the U.S. Food & Drug Administration (FDA) warned that use of the devices in gynecological procedures could spread undetected uterine cancer cells throughout a woman’s body. Last month, the agency convened a meeting of outside advisors to further investigate the issue, at which time a number of patients and their family members asked the FDA to ban power morcellators.**
Court records indicate that a number of morcellator lawsuits are now pending in U.S. courts, all of which allege the devices caused the spread of cancers in women who underwent uterine morcellation. The first was filed in February in the U.S. District Court, Eastern District of Pennsylvania by the husband of a 53-year-old woman who died from uterine cancer less than a year after she underwent power morcellation (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) That case was followed by the May 13th filing of a complaint in U.S. District Court, Northern District of California, which alleges 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)
In recent weeks, the controversy surrounding uterine morcellation has only grown. For example, a study published in the Journal of the American Medical Association on July 22nd reported that as many as 1 in 368 women undergoing such procedures may have undiagnosed cancers present in their uterus. While women over 65 were more likely to have undetected cancer, the study found that 32 percent of the morcellation patients with undiagnosed disease were younger than 50.***
Since the publication of that study, a power morcellator recall was announced by Johnson & Johnson’s Ethicon, Inc. unit. In a notice posted on its website, the company said it was pulling its Gynecare Morcellex, Gynecare X-Tract and Morcellex Sigma morcellator systems from the market because the risks and benefits associated with such devices remain uncertain.****
Patients whose cancers may have been spread via uterine morcellation could be entitled to file a morcellator lawsuit against the manufacturer of the device used in their surgery. To learn more about the risks potentially associated with power morcellators, please visit Bernstein Liebhard LLP's website. To obtain a free legal review, please call 800-511-5092.
*ajog.org/article/S0002-9378%2814%2900795-9/abstract?rss=yes?rss=yes, ACOJ, July 26, 2014
**bostonglobe.com/lifestyle/health-wellness/2014/07/11/agreement-reached-whether-fda-should-ban-hysterectomy-cutting-tool/EkXZaFAUUnT5HZ7DBQvWbM/story.html, Boston Globe, July 11, 2014
***jama.jamanetwork.com/article.aspx?articleid=1890400, JAMA, July 22, 2014
****ethicon.com/sites/default/files/managed-documents/Ethicon%20Morcellation%20Devices%20Customer%20Letter%20Final.pdf, Ethicon, Inc., July 30, 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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Bernstein Liebhard LLP