Rottenstein Law Group Hopeful that Congress Will Pass Legislation That Permits FDA to Refuse to Approve Medical Devices That Are Similar to Products Recalled for Safety Issues
(New York, NY, February 15, 2012) The Rottenstein Law Group, which represents clients with claims stemming from the dangerous effects of vaginal mesh, hopes Congress adopts the Safety Of Untested and New Devices Act of 2012 (SOUND Devices Act), which would prevent medical devices from being approved for sale by the U.S. Food and Drug Administration (FDA) based solely on their similarity to devices that have been pulled from the market.
Introduced by a group of Democratic lawmakers lead by Representative Ed Markey of Massachusetts, the SOUND Devices Act (HR3847) seeks to close “a significant loophole” in the FDA process used to clear “approximately 90 percent of the medical devices authorized for commercial sale,” according to Representative Markey’s Web site.
The FDA device clearance system that the SOUND Devices Act seeks to correct is known as the 510(k) approval process that allows manufacturers to obtain FDA approval for a medical device without subjecting it to human testing. To qualify for 510(k) approval, a device need only be “substantially similar” to a device already on the market, known as a “predicate.” A device approved under the 510(k) process can then be used as a predicate itself when manufacturers later seek FDA approval for newer devices that are deemed similar to it.
If enacted, Representative Markey’s bill would, among other things, give the FDA the ability to reject a device application based on a device that has been recalled or is in the process of being removed from the market for major safety issues. It would also require companies to inform the FDA if any products in their new device’s “predicate lineage” have caused serious harm.
The SOUND Devices Act is specifically intended to help decrease the likelihood of consumers ever agin experiencing injuries similar to “the devastating effects that resulted from defective bladder mesh implants,” according to Representative Markey’s Web site. Many of the vaginal mesh products that allegedly caused many consumers devastating harm were granted FDA approval based on their similarity to devices that were once cleared for sale, but have since been removed from the market because it became clear they are dangerous. Johnson & Johnson, for example, is “battling lawsuits” over a vaginal mesh product that got FDA approval based on its similarity to a device that was “pulled from the market more than a decade ago for safety reasons,” according to a Bloomberg article that ran on October 27, 2011.
Anyone seeking more information about vaginal mesh can visit the Rottenstein Law Group’s Vaginal Mesh Lawsuit Information Center. The site has vital information about the dangers of this medical device, along with easy-to-use social media features that allow for easy sharing on sites like Facebook and Twitter. Visitors are also encouraged to link to their own Web sites and blogs in order to spread the word about defective medical products and dangerous drugs.
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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