NEW YORK, Dec. 23, 2013 /PRNewswire/ -- As thousands of DePuy Pinnacle hip lawsuits (http://www.depuypinnacle-lawsuit.com/ ) alleging injuries due to a metal-on-metal version of the Pinnacle Hip Replacement System continue to move forward in courts throughout the country, Bernstein Liebhard LLP notes that a new study out of Oxford University has found that nearly 1 in 12 hip implants currently on the market is being sold without any evidence to prove they are safe or effective. In a statement issued on December 19th to announce their findings, the authors of the study pointed to the recent controversy surrounding metal-on-metal hip implants as evidence that orthopedic devices should be subjected to more stringent regulation.
"The metal-on-metal version of the DePuy Pinnacle hip was allowed to come to market in the U.S. without human clinical testing, and is now the subject of thousands of lawsuits. Amid growing concerns similar to those articulated in this study, the FDA has proposed a new regulation that would change the way these types of products come to market," says Bernstein Liebhard LLP, a nationwide law firm representing victims of dangerous drugs and medical devices. The Firm is currently offering free Pinnacle hip lawsuit reviews to individuals who may have been injured following implantation of the metal-on-metal version of the hip system.
Pinnacle Hip Lawsuits
According to court documents, the all-metal version of the DePuy Pinnacle hip replacement that utilized the Ultamet liner is now the subject of nearly 5,300 lawsuits that allege its metal-on-metal design caused plaintiffs to suffer serious complications, including metallosis, pseudotumor formation, and premature device failure, which often necessitate revision of the hip. The majority of Pinnacle hip lawsuits are currently pending in a multidistrict litigation underway in U.S. District Court, Northern District of Texas, where Jeffrey S. Grand, a partner with Bernstein Liebhard LLP, is serving on the Plaintiffs' Steering Committee. (In re: DePuy Orthopaedics Inc. Pinnacle Hip Implant Product Liability Litigation, MDL No. 2244)
Like other metal-on-metal hip implants, the all-metal version of the Pinnacle hip was brought to market under the U.S. Food & Drug Administration's (FDA) 510(k) clearance protocols, which do not require that a device undergo human clinical trials if the manufacturer can show it is "substantially equivalent" to a product that had been previously approved by the agency. In January 2013, amid growing concerns that metal-on-metal hips were subject to a higher rate of premature failure compared to hip implants made of other materials, the FDA proposed a new regulation that would no longer allow such devices to come to market under the 510(k) program. The agency also proposed a regulation that would require the manufacturers of all-metal hips already on the market to conduct post-market safety studies of their products in order to continue selling them.
In May 2013, DePuy Orthopaedics announced it would end sales of metal-on-metal hips, including the version of the Pinnacle hip system that utilized the Ultamet Liner. According to a Bloomberg.com article published at that time, the company's decision was based, in part, on recent FDA actions in regards to all-metal hips.
Individuals who suffered serious complications allegedly related to the all-metal version of the DePuy Pinnacle Hip Replacement System may be entitled to financial compensation for their injury-related damages. To learn more about the litigation involving the Pinnacle hip implant, please visit Bernstein Liebhard LLP's website. Free DePuy Pinnacle lawsuit reviews can also be obtained by calling (888) 340-4807 today.
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 11 consecutive years.
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Felecia L. Stern, Esq.
Bernstein Liebhard LLP
SOURCE Bernstein Liebhard LLP