Vaginal Mesh Lawsuit Update: Ethicon Ordered To Disclose FDA Communications

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Vaginal mesh lawsuits subject to new order, requiring Ethicon to produce communications with the FDA regarding post-market surveillance studies on transvaginal mesh implants, Bernstein Liebhard LLP reports.

Vaginal mesh lawsuits included in the consolidated action, In re Pelvic Mesh/Gynecare Litigation, No. 6341-10 (N.J. Super Ct.), are subject to a newly issued Case Management Order following a July 19, 2012 status conference, Bernstein Liebhard LLP reports.* On August 8, 2012, the Honorable Carol E. Higbee, who is overseeing all of the vaginal mesh lawsuits filed in New Jersey state court, issued an Order requiring Johnson & Johnson subsidiary, Ethicon, to produce all communications and correspondence between the company and the U.S. Food and Drug Administration (“FDA”) related to Section 522 Orders. Issued by the FDA, a Section 522 Order mandates a medical device manufacturer to conduct post-surveillance studies of a device that has the potential to cause injury when implanted into patients.

Transvaginal Mesh Manufacturers Scrutinized By FDA

In January 2012, the FDA ordered more than 30 transvaginal mesh manufacturers to provide up to three years of data on the safety and effectiveness of transvaginal mesh implant procedures. The companies had 30 days to comply with the FDA mandate.** On June 4, 2012, Ethicon announced plans to halt sales of four of its transvaginal mesh implant systems. Ethicon asked the FDA for 120 days to cease commercialization. In addition, Ethicon also requested that the FDA place the existing 522 orders requiring additional studies for the transvaginal mesh implants on hold. Notwithstanding Ethicon’s decision to cease sales of the transvaginal mesh implants, pursuant to the August 8, 2012 Case Management Order, Ethicon must still turn over all related correspondence and communications with the FDA to plaintiffs.

The lawyers at Bernstein Liebhard LLP are actively representing clients and filing lawsuits on behalf of individuals allegedly injured as a result of receiving vaginal mesh implants manufactured Ethicon as well as those made by other medical device companies. Firm partner Jeffrey S. Grand 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.    

Bernstein Liebhard LLP is continuing to evaluate claims and actively file vaginal mesh lawsuits on behalf of individuals injured by transvaginal mesh. Those who have suffered damages from vaginal mesh implants may be entitled to compensation for medical expenses, pain and suffering, lost wages and other injuries. Learn more by watching this transvaginal mesh video, or by visiting our website, For more information, contact a transvaginal mesh lawyer at Bernstein Liebhard LLP today at (877) 779-1414.

*August 8, 2012 Case Management Order

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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ATTORNEY ADVERTISING. © 2012 Bernstein Liebhard LLP. The law firm responsible for this advertisement is Bernstein Liebhard LLP, 10 East 40th Street, New York, New York 10016, (212) 779-1414. The lawyer responsible for this advertisement in the State of Connecticut is Amy L. Abate. 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

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