The PMA process would be a huge step toward ensuring these devices are safe and effective before they are implanted into patients.
New York, NY (PRWEB) April 22, 2013
The Consumers Union, the organization that publishes Consumer Reports, sent the U.S. Food and Drug Administration a letter this month asking the FDA to ensure that metal-on-metal hips and surgical mesh undergo the FDA’s most stringent review processes.* The Rottenstein Law Group, noting that the letter was backed by the signatures of 11,000 people, applauds the call for increased scrutiny. RLG, a metal-on-metal hip implant law firm, maintains a DePuy Hip Replacement Lawsuit Center at http://www.rotlaw.com/depuy-asr-hip/, designed to provide information on the ASR implant and how to pursue lawsuits.
Metal-on-metal hip implants, such as the DePuy ASR and the Stryker ABII and Rejuvenate, were allowed to be fast-tracked through the FDA’s 510(k) process because they resembled previously approved hip replacement systems. This meant that device manufacturers such as Johnson & Johnson and Stryker were able to bypass clinical studies that are used to demonstrate safety and effectiveness, according to the New England Journal of Medicine.**
“The Consumers Union and its co-signers are asking for the FDA to require that all devices go through the agency’s premarket approval process,” said Rochelle Rottenstein, principal of the Rottenstein Law Group. “The PMA process would be a huge step toward ensuring these devices are safe and effective before they are implanted into patients.”
The first trials in the federal multidistrict litigation (MDL-2197, U.S. District Court for the Northern District of Ohio) are set to begin on June 3, according to court documents. DePuy recalled the ASR in August 2010, according to the New York Times. ***
The Rottenstein Law Group encourages metal-on-metal hip implant recipients to download an informational brochure from its website to learn more about DePuy ASR lawsuits and to speak with a DePuy hip lawyer.
About THE ROTTENSTEIN LAW GROUP
The Rottenstein Law Group is a New York-based firm that represents clients nationwide in mass tort actions. The firm was founded by Rochelle Rottenstein, who has more than two decades of experience as a lawyer, to represent clients hurt by defective medical devices and drugs. (Attorney advertising. Prior results do not guarantee a similar outcome.)
The Rottenstein Law Group, LLP
Rochelle Rottenstein, Esq.
321 W. 44th Street
New York NY 10036
(212) 933-9500 (office phone)
(212) 933-9980 (facsimile)
rochelle (at) rotlaw (dot) com