The more information the FDA has to work with, the better it can manage medical device problems before they become widespread.
Washington, D.C. (PRWEB) April 24, 2013
The U.S. Food and Drug Administration has authorized a smartphone app for doctors to more easily report safety issues with high-risk medical devices such as metal-on-metal hip replacements, according to the Wall Street Journal.* The Rottenstein Law Group maintains a Hip Replacement Lawsuit Center that offers information on hip implants and filing a hip lawsuit, and represents clients in metal-on-metal hip lawsuits for such devices as the DePuy ASR, the Stryker ABII and Rejuvenate and the Biomet M2A Magnum.
The app is designed to make the reporting process more effective. According to the WSJ article, the FDA has relied on mandatory reporting from hospitals and device manufacturers but voluntary, sporadic reporting from doctors. The app would streamline the process, providing the agency with better information about side effects, injuries and deaths associated with medical devices.
“This is positive development for patient safety,” said Rochelle Rottenstein, principal of the Rottenstein Law Group. “The more information the FDA has to work with, the better it can manage medical device problems before they become widespread.”
This comes on the heels of an announcement that the Consumers Union sent the FDA a letter—backed with 11,000 signatures—this month asking the agency to ensure that metal-on-metal hip implants and surgical mesh undergo the FDA’s most stringent review processes.**
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.
The Rottenstein Law Group encourages metal-on-metal hip implant recipients to download an informational brochure from its website to learn more about metal-on-metal hip lawsuits and to speak with a hip lawyer.
*"FDA Device Surveillance to Tap Phone App," Wall Street Journal, April 23, 2013.
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.
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New York NY 10036
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rochelle (at) rotlaw (dot) com