NEW YORK, June 19, 2017 /PRNewswire/ -- Johnson & Johnson's Ethicon, Inc. subsidiary has asked the U.S. Supreme Court to review a $3.3 million verdict awarded in a transvaginal mesh lawsuit involving the company's TVT-O mesh. The case was decided in September 2014, when a jury in the U.S. District Court, Southern District of West Virginia, found that TVT-O mesh was responsible for severe pain and other complications experienced by the plaintiff. The verdict was upheld in January by a 3-judge panel at the U.S. Court of Appeals for the 4th Circuit. However, in a petition for certiorari filed with the Supreme Court on May 23rd, Ethicon asserted that the appellate court had improperly excluded evidence pertaining to the U.S. Food & Drug Administration's 510(k) clearance process. (Huskey et al. v. Ethicon Inc. et al., case number 15-2118)
"Our Firm is representing hundreds of women who were allegedly injured due to Ethicon's transvaginal mesh products. We will be monitoring this appeal closely, as the outcome will impact other lawsuits involved in this litigation," says Sandy A. Liebhard, a partner at Bernstein Liebhard LLP, a nationwide law firm representing victims of defective drugs and medical devices. The Firm continues to investigate legal claims on behalf of women who suffered serious vaginal mesh complications, allegedly due to products marketed by Ethicon and other manufacturers.
Transvaginal Mesh Controversy
The lawsuit under appeal was the first bellwether case to go to trial in a multidistrict litigation that includes more than 28,000 Ethicon transvaginal mesh lawsuits. Thousands of additional claims involving devices marketed by C.R. Bard, Inc., American Medical Systems, Boston Scientific Corp., C.R. Bard, Inc. Cook Medical, Inc., have also been centralized in the Southern District of West Virginia.
In 2008, the U.S. Food & Drug Administration (FDA) warned that transvaginal mesh had been linked to at least 1,000 reports of serious injuries and complications over a three-year period. The agency issued an update in July 2011, after the number of complication reports related to transvaginal prolapse repair tripled. Among other things, the FDA modified its previous stance that such injuries were rare.
In 2016, the FDA finalized regulations that reclassified transvaginal mesh indicated for prolapse repair as Class III (high risk) medical devices. The new rules also made these devices ineligible for the agency's 510(k) clearance program, which had previously allowed such products to come to market without first undergoing human clinical trials.
In 2012, Ethicon announced it would stop selling four pelvic mesh devices, including Gynecare TVT Secur, Gynecare Prosima, Gynecare Prolift and Gynecare Prolift+M. The company attributed its decision to commercial concerns and maintained that the products were safe. However, the FDA had recently ordered Ethicon and 20 other vaginal mesh manufacturers to conduct further research into the risks associated with their implants.
Women who suffered serious complications allegedly associated with transvaginal mesh may be entitled to compensation for medical bills, lost wages, pain and suffering and more. To learn more, please visit Bernstein Liebhard LLP's website, or call 800-511-5092 to arrange for a free, no-obligation review of your potential claim.
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 $3.5 billion on behalf of our clients. Bernstein Liebhard LLP is honored to once again be named to The National Law Journal's "Plaintiffs' Hot List," recognizing the top plaintiffs firms in the country. This year's nomination marks the thirteenth year the firm has been named to this prestigious annual list.
Bernstein Liebhard LLP
10 East 40th Street
New York, New York 10016
ATTORNEY ADVERTISING. © 2017 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.
Sandy A. Liebhard, Esq.
Bernstein Liebhard LLP
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SOURCE Bernstein Liebhard LLP