Archived Facts

New York, NY (PRWEB) March 27, 2012

Bernstein Liebhard LLP reports on new legislation proposed by Representative Edward Markey (D-MA) which will alleviate concerns and reform the 510(k) loophole in the U.S. Food and Drug Administrations (FDA) approval process for medical devices.* Currently, medical device manufacturers can utilize the 510(k) process to receive market approval for devices such as surgical mesh without having to undergo rigorous clinical testing by claiming that the devices are substantially similar to prior versions, even if the prior versions have been recalled.** The new bill, Safety of Untested and New Devices (SOUND) Act, would give the FDA authority to request documentation from manufactures to demonstrate that a new products design has addressed and fixed potential problems if it is based on a prior version with safety issues. During a press conference on March 22, 2012, Representative Markey cited vaginal mesh complications stemming from transvaginal surgical mesh devices, which were approved under the current system, to support his calls for reform. According to the Boston Globe, Markey said in an interview following the briefing that he hoped the legislation would be added to a larger bill about medical devices that Congress is set to vote on at the end of May. [The] loophole in our current law actually requires the FDA to approve certain kinds of medical devices even if they have reason to believe [the devices] may harm or even kill patients, Markey said.

In light of this latest development, Bernstein Liebhard LLP partner Jeffrey S. Grand, who is serving as co-liaison counsel in the New Jersey transvaginal surgical mesh lawsuits against Johnson & Johnson and C.R. Bard, another medical device manufacturer, commented The problems with transvaginal mesh have become a serious public health issue and are indicative that the FDA approval process needs reform. While we believe further reform is needed, this bill is a step in the right direction.

Vaginal Mesh Complications and Mounting Litigation Supports Need For New Legislation

According to the Boston Globe, an FDA spokesperson, Karen Riley, while not officially endorsing the bill, said that the agency has raised the issue of the loophole of the 510(k) process to members of Congress and believes that the new legislation would provide appropriate protections for public health. As Riley told the Boston Globe, a new device is five times as likely to be recalled with a design flaw if it is based on an older device that was itself pulled for safety problems.

Markey appeared at the briefing for the bill with Jay Nevarez, a woman from Colorado who experienced transvaginal mesh complications after receiving a vaginal mesh implant that was based on a previously recalled device. Nevarez is just one of many individuals involved in pelvic mesh litigation litigation against Johnson & Johnson/Ethicon. The Gynecare TVT vaginal mesh implant Nevarez received was approved by the FDA based on its similar design to Boston Scientifics ProtoGen, which was recalled nearly a decade earlier due to the post-surgical complications it caused. As a result of the vaginal mesh complications, Nevarez told the Boston Globe, I lost my job and my health, and am in the process of losing my home.

The lawyers at Bernstein Liebhard are actively filing cases 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.), which are two consolidated actions of all the vaginal surgical mesh lawsuits filed in New Jersey state court.

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