New York, New York (PRWEB) January 17, 2013
Metal-on-metal hip implants could soon be subject to much stricter regulation, Bernstein Liebhard LLP reports. According to an article appearing in The New York Times today, the U.S. Food & Drug Administration (FDA) will soon propose that all-metal hips be classified as high-risk devices. Currently, metal-on-metal replacements are classified as moderate risk. The proposed reclassification would make the implants ineligible for the FDA’s 510(k) clearance process, which allows a device to come to market without human testing if a manufacturer can show it is similar to a previously approved product. According to the Times, the new regulations would require manufacturers of all-metal hips to prove the devices were safe and effective before they could continue selling existing ones or obtain approval for new metal-on-metal designs. Those requirements could cause some manufacturers to stop selling the hip implants, the Times said.*
In addition to the new regulations for all-metal hips, the Times reported that the FDA is also expected to advise patients who have received the implants to undergo routine testing to detect levels of metallic ions in their blood if they are experiencing pain or other symptoms.*
“We have been waiting for this news from the FDA for a long time. We continue to hear from metal-on-metal hip replacement patients who have suffered painful and debilitating injuries, many of whom have been forced to undergo risky revision surgery to have their device replaced,” says Bernstein Liebhard LLP, a nationwide law firm representing the victims of defective drugs and medical devices. The Firm is actively filing lawsuits involving metal-on-metal hip implants marketed by a number of manufacturers, and continues to offer free legal evaluations to alleged victims of all-metal hips.
Metal-on-Metal Hip Implant Lawsuits
According to The New York Times, metal-on-metal hip replacements have been implanted in some 500,000 U.S. patients. The FDA has been reviewing the devices amid concerns that metal particles shed by all-metal hips can result in an adverse local tissue reaction called metallosis that causes damage to bone and/or tissue surrounding the implant and joint. There are also some medical case reports of patients in which high levels of metal ions in the bloodstream may have caused other types of symptoms or illnesses elsewhere in the body, including effects on the heart, nervous system, and thyroid gland, according to the agency. In May 2011, the FDA issued orders for postmarket surveillance studies to manufacturers of metal-on-metal hip systems.**
A number of metal-on-metal hip implant manufacturers have been named in lawsuits alleging the devices are prone to premature failure, and can expose patients to dangerous amounts of metal ions. The lawyers at Bernstein Liebhard LLP are actively filing claims in the multidistrict litigation established in the U.S. District Court, Northern District of Ohio, for actions involving the DePuy ASR hip implant (MDL No. 2197). The firm is also involved in the federal litigation underway in the Northern District of Texas concerning the metal-on-metal DePuy Pinnacle hip device (MDL No. 2244). Bernstein Liebhard LLP partner Jeffrey Grand is serving on the Plaintiffs’ Steering Committee in the Pinnacle hip litigation.
Free case evaluations are also being offered to patients impacted by the July 2012 Stryker Rejuvenate recall, and the June 2012 Smith & Nephew metal liner recall. In addition, Bernstein Liebhard LLP continues to investigate cases concerning the Biomet M2a Magnum hip implant, as well as Wright Profemur and Conserve metal hip implants.
Individuals who have suffered metallosis, hip implant failure, and other serious complications as a result of a metal-on-metal hip replacement may be entitled to compensation for their medical bills, lost wages, pain and suffering, and other damages. A wealth of information about metal-on-metal hip implant lawsuits is available at Bernstein Liebhard’s website http://www.consumerinjurylawyers.com/ . For additional information, please contact one of our attorneys today by calling 1-877-779-1414.
About Bernstein Liebhard
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 10 consecutive years.
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10 East 40th Street
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Felecia L. Stern, Esq.
Bernstein Liebhard LLP