Transvaginal Mesh Lawsuit News: Bernstein Liebhard LLP Notes FDA Proposal to Reclassify Transvaginal Mesh Used In Pelvic Organ Prolapse Repair
New York, New York (PRWEB) April 30, 2014 -- As transvaginal mesh lawsuits (http://www.transvaginalmeshlawsuithelp.com/) continue to mount in courts around the U.S., Bernstein Liebhard LLP notes that federal health regulators have moved to impose stricter regulations on surgical mesh products used to transvaginally repair pelvic organ prolapse. According to a statement issued on April 29, 2014, the U.S. Food & Drug Administration (FDA) has proposed new rules that, if finalized, would reclassify transvaginal mesh used to treat prolapse as high-risk medical devices. These products are currently classified as moderate risk.
According to a report from The Wall Street Journal, if the FDA’s proposed rules take effect, these devices would no longer be eligible for the agency’s 510(k) clearance process, which allowed transvaginal mesh to be approved without the benefit of human clinical trials. Manufacturers that are currently marketing these devices would also be required to submit new studies to the FDA demonstrating their safety and effectiveness if they intend to keep selling them.*
“Tens of thousands of women are pursuing vaginal mesh lawsuits after they allegedly sustained serious injuries from products meant to treat pelvic organ prolapse. Our Firm is pleased that the FDA is acting to address this risk,” says Bernstein Liebhard LLP, a nationwide law firm representing victims of defective drugs and medical devices. The Firm continues to offer free legal reviews to women who suffered mesh erosion, pain, scarring, infection and other serious vaginal mesh complications, allegedly due to transvaginal mesh products manufactured by American Medical Systems, Inc., Boston Scientific Corp., C.R. Bard, Inc. and Ethicon, Inc.
Vaginal Mesh Lawsuits
According to the FDA’s April 29th statement, the agency is proposing these new regulations because it “identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse.” The FDA has been reviewing the safety of transvaginal mesh used to treat prolapse, as well as stress urinary incontinence, since October 2008, when it first alerted the public to the serious risk of vaginal mesh complications associated with these products. In July 2011, the agency issued a second alert after it received thousands of additional reports of injuries associated with these devices. In September of that year, an FDA advisory panel recommended that transvaginal mesh used in prolapse repair be reclassified as high-risk devices.
Court documents indicate that more than 50,000 transvaginal mesh lawsuits have been filed against a number of companies in several litigations currently underway in U.S. District Court, Southern District of West Virginia, including American Medical Systems, Inc. (MDL No. 2325), Boston Scientific Corp. (MDL No. 2326), C.R. Bard, Inc. (MDL No. 2187) and Ethicon, Inc. (MDL No. 2327). All of the claims similarly allege that pelvic mesh products used to repair prolapse and incontinence caused plaintiffs to suffer debilitating vaginal mesh complications, and accuse the defendants of failing to provide adequate warnings regarding their risk. Jeffrey S. Grand, a partner with Bernstein Liebhard LLP, is serving on the Plaintiffs’ Steering Committee for the proceedings involving American Medical Systems, Boston Scientific, C.R. Bard, and Ethicon.
Mr. Grand is also serving as Co-Liaison Counsel in two multicounty litigations underway in New Jersey Superior Court for transvaginal mesh lawsuits involving products marketed by C.R. Bard and Ethicon. He was also a member of the Plaintiff’s trial team on the first Ethicon trial in that proceeding, which ended in March with a jury awarding $11 million in compensatory and punitive damages to a woman who was harmed by the Ethicon Gynecare Prolift device. (In re: Pelvic Mesh/Gynecare Litigation, No. 6341-10; In re: Pelvic Mesh Litigation/Bard, No. L-6339-10)
Women who allegedly experienced vaginal mesh complications following implantation of pelvic mesh to treat pelvic organ prolapse or stress urinary incontinence may be entitled to compensation from the manufacturer of their device. Learn more about filing a vaginal mesh lawsuit at Bernstein Liebhard LLP's website or the Firm's Facebook page: https://www.facebook.com/meshlawsuit. To obtain a free, confidential and no-obligation case review, please call 800-511-5092.
*online.wsj.com/article/BT-CO-20140429-719039.html, Wall Street Journal, April 29, 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.
Bernstein Liebhard LLP represents the victims of defective drugs and medical devices on a contingency-fee basis, and our clients are never expected to pay attorneys fees unless their case results in a successful recovery on their behalf. New York State’s contingency fee cap rules generally limit those fees to 33 1/3% of the total recovery. As a result, the Firm’s fees can be significantly lower than those assessed by attorneys in other states, which depending on the law may amount to as much as 40% or more of a plaintiff’s recovery.
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ATTORNEY ADVERTISING. © 2014 Bernstein Liebhard LLP. The law firm responsible for this advertisement is Bernstein Liebhard LLP, 10 East 40th Street, New York, New York 10016, 800-511-5092. Prior results do not guarantee or predict a similar outcome with respect to any future matter.
Contact Information:
Felecia L. Stern, Esq.
Bernstein Liebhard LLP
info(at)consumerinjurylawyers(dot)com
http://www.transvaginalmeshlawsuithelp.com/
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Felecia L. Stern, Transvaginal Mesh Lawsuit Help Center, http://www.transvaginalmeshlawsuithelp.com/, +1 800-511-5092, [email protected]
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