Rottenstein Law Group Applauds Congressional Efforts to Close Dangerous Medical Devices Approval Loophole


WEBWIRE – Monday, April 02, 2012

(New York, NY, April 2, 2012) The Rottenstein Law Group, which represents clients with claims stemming from the severe side effects of defective medical devices, is fully supportive of the efforts of Congressman Edward J. Markey to achieve “closure of dangerous medical device loophole.”
Congressman Edward J. Markey (D-Mass.) late last month released a comprehensive new report titled “Defective Devices, Destroyed Lives: Loophole Leaves Patients Unprotected from Flawed Medical Devices.” Rep. Markey’s report highlights the federal loophole that requires the U.S. Food and Drug Administration (FDA) to clear new medical devices that are similar to an earlier model, even if that model was recalled for a major safety defect. This loophole in the 510(k) medical device approval process, named after its section in the law, has allowed a number of defective products to enter the market, causing serious harm, and in some cases even death.
According to a March 22 press release from Rep. Markey’s office, “The 510(k) process should really be called ‘510 pray’ since patients should hope and pray that the medical device implanted in them won’t cause serious harm,” said Markey, a senior member of the Energy and Commerce Committee, which has jurisdiction over the FDA. “The SOUND Devices Act closes a major loophole in the current 510(k) device approval process. I will fight to include this bill in the FDA legislation that Congress will consider this summer as part of the Medical Device User Fee Act to ensure that medical devices are not repeating known defects.”
In February, Reps. Markey, Henry A. Waxman (D-Calif.), Jan Schakowsky (D-Ill.) and Rosa DeLauro (D-Conn.), introduced H.R. 3847, the Safety of Untested and New Devices Act of 2012 (SOUND Devices Act). This bill would close a major loophole in the device approval process known as the 510(k), by ensuring that new medical devices are not cleared by the FDA if they are based on earlier products that were pulled from the market for causing injuries or other serious harm to the patients they were implanted in. The SOUND Devices Act provides the FDA with the ability to reject a device application based on a predicate that it has been recalled or in the process of being removed from the market due to major safety issues.
Rochelle Rottenstein, principal of the Rottenstein Law Group, says, “This is just the sort of corrective legislative action we need now. The public will benefit immeasurably if Congress addresses this problem, and the sooner the better.”
The Rottenstein Law Group implores anyone with a friend or relative who has received a dangerous medical device to reach out to that person and recommend that he or she consult with a physician immediately, and then speak to a qualified personal injury lawyer. RLG is currently evaluating cases involving such defective medical devices as the DePuy ASR and Pinnacle hip replacement systems, the Wright Medical Conserve and Profemur Z hip systems and, and all manufacturers’ vaginal mesh products.
About the Rottenstein Law Group
The Rottenstein Law Group is a New York-based law firm that represents clients in mass tort actions. The firm was founded by Rochelle Rottenstein, a lawyer with over two decades of experience in compassionate representation of clients in consumer product injury, mass tort, and class action law suits. For more information, please visit their Web site, or call (888) 9-ROT-LAW.



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Nava Brahe
PR Manager
The Rottenstein Law Group
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