J&J Sold Transvaginal Mesh Implants After FDA Ordered Company To Cease Marketing
Bernstein Liebhard LLP, a New York law firm nationally recognized for its consumer protection and mass tort practices, reports that Johnson & Johnson (“J&J”), the manufacturer of certain transvaginal mesh implants, sold its Gynecare Prolift implants after the U.S. Food and Drug Administration (“FDA”) ordered the company to stop marketing the devices.* A June 26, 2012 Bloomberg News article reported on the chain of events – information that was obtained through court documents:
- In 2005, J&J began selling the Gynecare Prolift transvaginal mesh without seeking FDA approval. The company reasoned that it was substantially equivalent to Gynemesh, another type of transvaginal mesh also manufactured by J&J and approved by the FDA;
- In 2007, the FDA discovered that Gynecare Prolift was on the market, but that it had never been cleared. The FDA requested that an application for market approval be submitted;
- On August 24, 2007, the FDA sent J&J a letter asking the company to stop selling its Gynecare Prolift vaginal mesh products until the agency decided if the devices were “substantially equivalent” to other products on the market;
- The FDA cited 16 potential deficiencies and noted the “potential high risk for organ perforation” when surgeons performed the transvaginal mesh procedure for insertion;
- Notwithstanding the FDA’s order to stop sales, J&J continued to sell the Prolift mesh; and
- In May 2008, after nine months of negotiations with J&J’s Ethicon unit, the FDA ultimately cleared the transvaginal mesh implant. The FDA did not sanction the company for failing to comply with its earlier directive.
Currently, Ethicon Inc. and J&J are defending more than 1,400 transvaginal mesh implant lawsuits in both state and federal courts filed by individuals alleging that the Ethicon pelvic mesh implant systems caused them to develop vaginal mesh problems resulting in serious injuries. J&J’s violation of the FDA’s order will likely impact the litigation.
“Plaintiffs will demonstrate at trial that the Defendant manufacturers were non-compliant with FDA regulations at every step along the way and failed to disclose critical safety information to the Agency during the approval process,” commented Bernstein Liebhard LLP partner Jeffrey S. Grand, who serves as Co-Liaison Counsel in In re Pelvic Mesh/Gynecare Litigation, No. 6341-10 (N.J. Super Ct.) and In re Pelvic Mesh Litigation/Bard No. L-6339-10 (N.J. Super. Ct.), two consolidated actions of all pelvic mesh lawsuits filed in New Jersey state court.
Mr. Grand also serves on the Plaintiffs’ Steering Committee in the federal litigation, In re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation (“MDL No. 2327”), which is a consolidation of all the transvaginal mesh lawsuits filed in federal court against Johnson & Johnson, and its subsidiary, Ethicon, Inc. The federal transvaginal mesh lawsuits are currently pending in the U.S. District Court for the Southern District of West Virginia before Judge Joseph R. Goodwin.
The lawyers at Bernstein Liebhard LLP are actively representing clients and filing lawsuits on behalf of individuals allegedly injured as a result of receiving transvaginal mesh implants manufactured by J&J as well as other medical device companies.
Those who have suffered damages from pelvic mesh implants may be entitled to compensation for medical expenses, pain and suffering, lost wages and other injuries. Learn more by watching this pelvic mesh video, or by visiting our website.
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, including those who have been harmed by dangerous drugs, defective medical devices and consumer products. 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 nine consecutive years. Only two firms in the country have been selected for the Hot List nine years in a row.
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