New Safety Act for Faulty Medical Devices Long Overdue Says Texas Defective Products Attorney
Waxahachie, TX (Law Firm Newswire) February 27, 2012 - Hip implants, knee replacement devices, and vaginal and hernia mesh products are the latest defective medical devices that have caused serious injuries in patients. “New technologies should not get fast-tracked, only to have patient safety compromised,” said Waxahachie personal injury attorney John Hale, of The Hale Law Firm. “Better efforts should be in place to institute recalls quicker and put more safeguards in place to protect patients.”
Late last year, legislation was introduced to discover problematic medical devices sooner and manage recalls better. The three Senators behind the legislation also sent investigative letters to five top companies that had recalled medical devices to learn how they conduct post-market surveillance and manage recalls. The Medical Device Patient Safety Act would enable the Food and Drug Administration to mandate clinical studies post-market for devices that are deemed riskier, especially if they were cleared in the 510(k) expedited review process. The FDA could mandate conditional clearance pending on safety studies in the 510(k) process too. Also, the bill would implement Government Accountability Office guidelines for recalls.
“The bipartisan efforts to get this legislation passed show that the FDA needs to be able to act quickly when patient harm is identified,” said Hale. “Defective devices increase personal health care costs and suffering, hurt our economy, and lessen the credibility of other products that might be perfectly safe. The glitz of pharmaceutical marketing must be tempered by tougher regulations and FDA safeguards.”
Individuals should seek prompt legal counsel when dealing with a defective medical device. John Hale is a Texas defective products lawyer and Ellis County personal injury lawyer helping injury victims near Dallas, Texas. Learn more at http://www.hale911.com/.
The Hale Law Firm
100 Executive Court, Suite 3
Waxahachie, TX 75165
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