Congress needs to strengthen the FDA’s powers to include the ability to stop the sale of devices that are harmful that are already on the market as well as prevent the marketing of those devices initially.
Athens, GA (PRWEB) March 27, 2012
Georgia transvaginal mesh attorney Henry G. Garrard III today applauded Consumer Reports for adding its voice to the growing chorus of patient safety advocates who are calling for major changes to the way medical devices are approved for the U.S. market.
According to a recent Reuters News report, the president of Consumer Reports sent an e-mail blast to 1 million people earlier this year that decried the U.S. Food and Drug Administration (FDA) clearance process that has allowed medical devices, including transvaginal mesh, to be sold in the U.S. without any prior safety testing. Consumer Reports’ advocacy arm has made the issue a top priority in 2012, Reuters said.
Garrard, a leader in defective transvaginal mesh litigation since 2006, said a publication such as Consumer Reports “helps to bring this important issue into the mainstream.”
Garrard currently serves as the lead counsel for the plaintiffs in a multidistrict litigation case (MDL) against one of the country’s largest transvaginal mesh manufacturers. The MDL, In re C.R. Bard, Inc. Pelvic Repair Systems Products Liability Litigation (MDL No. 2187), is being litigated in the U.S. District Court for the Southern District of West Virginia.
He and his firm also played a key role in successfully arguing for the creation of MDLs against three other transvaginal mesh companies: In re American Medical Systems, Inc. (MDL No. 2325), In re Boston Scientific Corp. (MDL No. 2326) and In re Ethicon, Inc. (MDL No. 2327). Those cases have all been transferred to the Southern District of West Virginia.
The four MDLs involve lawsuits filed by women across the country who claim they were harmed by being implanted with surgical mesh products for the treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
“We have seen women across the country suffer serious, permanent injuries from transvaginal mesh products that shouldn’t have been sold in the first place,” said Garrard, who is the managing partner of the Georgia law firm of Blasingame, Burch, Garrard & Ashley, P.C., and the co-chairman of the American Association for Justice’s Transvaginal Mesh Litigation Group.
“Any process that would allow these pelvic mesh devices to be marketed for implantation into the human body is woefully inadequate. That’s why we’ve been calling for changes for many years. It’s good to see so many other patient safety advocates join. Hopefully, it will spur our lawmakers to take action.”
As Reuters noted, one potential change to the FDA’s clearance process could result from the Safety of Untested and New Devices Act of 2012 (SOUND Devices Act).
Under what’s commonly called the 510(k) clearance process, medical devices can be cleared for the market if the manufacturer shows that the device has a design that is substantially similar to a product that has already been cleared.
“Congress needs to strengthen the FDA’s powers to include the ability to stop the sale of devices that are harmful that are already on the market as well as prevent the marketing of those devices initially,” Garrard said.
The SOUND Devices Act would appear to give the FDA that authority. According to a recent Bloomberg News article, the Act would also give the FDA the power to review previously cleared medical devices to check on whether they have any safety issues in their “device lineage.”
“This legislation is an important part of an overall approach to improving patient safety,” Garrard said. “We believe that litigation also plays an important role by holding manufacturers of defective medical products accountable and forcing them to change their ways.”
About Blasingame, Burch, Garrard & Ashley, P.C.
Blasingame, Burch, Garrard & Ashley, P.C., is an Athens, Georgia-based law firm that has been widely recognized for its ethics, skill and professionalism by Martindale-Hubbell®, The Best Lawyers in America, American College of Trial Lawyers, Super Lawyers and Law & Politics Media/Atlanta Magazine. Since 2006, the firm’s defective medical device and product liability lawyers have pursued claims involving defective transvaginal mesh products, including handling attorney referrals from co-counsel across the country. For more information, call the firm at (866) 354-3544 or use its online contact form.