New York, NY (PRWEB) December 16, 2011
Bernstein Liebhard LLP reports that on December 14, 2011, new legislation was introduced in the Senate that would require medical device manufacturers to track the performance of implants.* The bill would allow the U.S. Food and Drug Administration (“FDA”) to compel manufacturers to track implants after they are approved for sale. Currently, medical device manufacturers can bypass rigorous premarket testing and FDA inspection by utilizing the 510(k) process. In order to receive market clearance, manufacturers are only required to show that a new product is “substantially similar” to a product already on the market. In August 2010, DePuy Orthopaedics, a division of Johnson & Johnson, issued a worldwide recall of its ASR metal-on-metal hip implants. 37,000 Americans received the DePuy ASR hip implants, which were approved through the 510(k) system. Richard Blumenthal, one of three senators sponsoring the bill, said that the metal-on-metal hip implants are a “classic example” of why increased monitoring is needed. “There is clearly a need for scrutiny once products are implanted or used on patients,” he said. Since the ASR hip recall, the 510(k) process has been the subject of widespread criticism. In July, the Institute of Medicine urged the FDA abandon the 510(k) process, saying that it failed to protect patient safety.** Senator Herb Kohl, who also sponsored the bill, said, “Faulty medical devices, especially those implanted in the body, can have disastrous health impacts on patients . . . This legislation will help ensure that FDA can act quickly and decisively when there’s a problem and that the drive toward getting new technologies to market won’t come at the risk of patient safety.”
Senators Seek Information About DePuy Hip Implants And Vaginal Mesh Products
In addition to the legislative proposal, the senators sent letters to five of the largest medical device manufacturers requesting documents on how they track product safety and recall devices. Johnson & Johnson, manufacturer of both the DePuy Pinnacle hip replacement implants and the recalled DePuy ASR hip replacement implants, and C.R. Bard., the manufacturer of vaginal mesh, were two of the companies contacted. The senators also want to know when Johnson & Johnson first learned that the ASR hips were failing and how it tracked problems once they were reported.
The lawyers at Bernstein Liebhard LLP are actively filing cases on behalf of individuals allegedly injured by both artificial hip and vaginal mesh implants in the following actions: 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; 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 Pelvic Mesh/Gynecare Litigation (No. 006339-10 (NJ. Super. Ct.)), which is currently underway in the Superior Court of New Jersey.
For more information about filing a defective medical device lawsuit, contact an attorney at Bernstein Liebhard LLP at (877) 779-1414 or at info(at)consumerinjurylawyers(dot)com.
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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Felecia L. Stern, Esq.
Bernstein Liebhard LLP