Senate Introduces Bill To Track Implant Failure Rates

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 demand medical device producers to track the efficiency of implants.* The bill would permit the U.S. Food and Drug Administration (“FDA”) to compel producers to track implants after they are approved for sale. At present, medical device producers can bypass rigorous premarket testing and FDA inspection by utilizing the 510(k) approach. In order to receive industry clearance, producers are only required to show that a new item is “substantially similar” to a product already on the market place. In August 2010, DePuy Orthopaedics, a division of Johnson &amp Johnson, issued a worldwide recall of its ASR metal-on-metal hip implants. 37,000 Americans received the DePuy ASR hip implants, which had been approved by means of the 510(k) technique. Richard Blumenthal, one of 3 senators sponsoring the bill, said that the metal-on-metal hip implants are a “classic example” of why elevated monitoring is required. “There is clearly a need for scrutiny once goods are implanted or used on patients,” he stated. Considering that the ASR hip recall, the 510(k) procedure has been the subject of widespread criticism. In July, the Institute of Medicine urged the FDA abandon the 510(k) approach, saying that it failed to protect patient safety.** Senator Herb Kohl, who also sponsored the bill, mentioned, “Faulty medical devices, especially those implanted in the physique, can have disastrous wellness impacts on patients . . . This legislation will aid ensure that FDA can act speedily and decisively when there’s a difficulty and that the drive toward acquiring new technologies to industry won’t come at the danger of patient safety.”    

Senators Seek Data About DePuy Hip Implants And Vaginal Mesh Items

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 &amp Johnson, manufacturer of each the DePuy Pinnacle hip replacement implants and the recalled DePuy ASR hip replacement implants, and C.R. Bard., the manufacturer of vaginal mesh, had been two of the organizations contacted. The senators also want to know when Johnson &amp Johnson first learned that the ASR hips were failing and how it tracked problems when 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 presently underway in the U.S. District Court for the Northern District of Texas In re: DePuy Orthopaedics, Inc. ASR Hip Implant Merchandise Liability Litigation (“MDL No. 2197”), which is at present 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 presently underway in the Superior Court of New Jersey.    

For much more information about filing a defective medical device lawsuit, get in touch with an lawyer at Bernstein Liebhard LLP at (877) 779-1414 or at information(at)consumerinjurylawyers(dot)com.

* more-monitoring-of-implants.html?_r=1

** after-fda-clearance-senators-say.html

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 because 1993, which includes those who have been harmed by dangerous drugs, defective medical devices and consumer goods. The firm has been named by The National Law Journal to the “Plaintiffs’ Hot List,” recognizing the leading 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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