Consumer Reports Targets FDA Approval Process: Recalled Hip Replacements And Vaginal Surgical Mesh Examples Of Failure
Bernstein Liebhard LLP endorses Consumer Reports attempts to effectuate changes in the way medical devices are approved by the U.S. Food and Drug Administration (“FDA”).* On March 12, 2012, Reuters reported on a campaign launched by Consumer Reports aimed at changing the FDA 510(k) process. Medical devices such as recalled hip replacements and vaginal surgical mesh implants received market clearance through the 510(k) process. Earlier this year, Consumer Reports President Jim Guest sent an email blast to one million Americans, writing “This isn’t science fiction. Millions of medical devices including artificial hips, contact lens solutions, heart stents and pacemakers are being recalled – 700 different products a year. And the vast majority of recalled products were never safety tested in humans, because the manufacturers claimed they were ‘similar’ to products already on the market.”
Recalled Hip Replacements And Vaginal Surgical Mesh Cleared By FDA “Loophole”
When asked to comment by Reuters on these efforts to initiate policy changes, Bernstein Liebhard LLP partner Felecia L. Stern said, “When clients call, they are livid when they find out how (the device) was approved. They say ‘I don’t understand how this was able to get on the market in the first place.’” The firm is currently representing clients in more than 200 hip replacement lawsuits against DePuy Orthopeadics, a subsidiary of Johnson & Johnson, over its recalled ASR hip implants. Unfortunately, as Ms. Stern noted, “[Our clients] are usually too overwhelmed by medical problems to get involved in activism.”
The DePuy hip replacement lawyers at Bernstein Liebhard LLP are actively filing cases on behalf of individuals who have been implanted with either or both types of artificial metal-on-metal hip implants manufactured by DePuy. The lawsuits allege that the ASR hip replacement and the metal-on-metal Pinnacle hip replacement systems were defectively designed. Bernstein Liebhard LLP is filing cases in the following actions: In re: DePuy Orthopaedics, Inc. ASR Hip Implant Products Liability Litigation (“MDL No. 2197”), which is currently underway in the U.S. District Court for the Northern District of Ohio and In re: DePuy Orthopaedics, Inc. Pinnacle Hip Implant Products Liability Litigation (“MDL No. 2244”), which is currently underway in the U.S. District Court for the Northern District of Texas. The firm is also investigating cases concerning another metal-on-metal hip implant manufactured by Wright Medical Technology, Inc. Lawsuits involving this hip replacement were recently consolidated in In re: Wright Medical Technology, Inc., Conserve Hip Implant Products Liability Litigation (“MDL No. 2329”), which is pending in the U.S. District Court for the Northern District of Georgia. Similar to the DePuy litigations, the Wright Medical hip lawsuits allege that the metal-on-metal Wright Conserve hip replacement systems were defectively designed.
Vaginal Surgical Mesh Also At Issue
In addition to citing the recalled hip replacements as an example of the flawed FDA 510(k) process, Reuters noted that transvaginal surgical mesh implants were cleared through that same process. According to Reuters, “[a]lmost every synthetic mesh device on the market today cleared through the 510(k) process was based on the ProteGen mesh, manufactured by Boston Scientific, even though it was recalled in 1999.” The lawyers at Bernstein Liebhard are actively filing cases in In re Pelvic Mesh/Gynecare Litigation, No. 6341-10 (N.J. Super Ct.), and In re Pelvic Mesh Litigation/Bard No. L-6339-10 (N.J. Super. Ct.), which are two consolidated actions of all the vaginal surgical mesh lawsuits filed in New Jersey state court.
For more information about filing a defective medical device lawsuit, contact an attorney at Bernstein Liebhard LLP at (877) 779-1414 or at firstname.lastname@example.org.
About Bernstein Liebhard LLP
Bernstein Liebhard LLP is a New York-based law firm exclusively representing injured persons in complex individual and class action lawsuits nationwide since 1993, including those who have been harmed by dangerous drugs, defective medical devices and consumer products. The firm has been named by The National Law Journal to the “Plaintiffs’ Hot List,” recognizing the top plaintiffs’ firms in the country, for the past nine consecutive years. Only two firms in the country have been selected for the Hot List nine years in a row.
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