Like many other patient advocates, Mr. Burke believes that had metal-on-metal hip implants been subjected to more stringent premarket scrutiny, their safety issues may have been detected and their sales prevented.
New York, New York (PRWEB) June 28, 2012
Daniel Burke, Senior Litigation Counsel at Parker Waichman LLP, a national law firm dedicated to protecting the victims of defective hip implants, is dismayed by remarks made yesterday by a DePuy Orthopedics official during a U.S. Food & Drug Administration (FDA) advisory panel meeting examining the safety of metal-on-metal hip implants. According to a report in the Wall Street Journal, Paul Voorhorst, the director for biostatistics and data management for DePuy Orthopaedics, said in his presentation that not all metal-on-metal implants are the same, and asserted that the clinical performance of each device should be evaluated on its own merits.
According to Mr. Burke, to do as Mr. Voorhorst suggests would conflict with the way most metal-on-metal hip implants currently receive clearance from the FDA.
"It is ironic that when they file with the FDA for a 510k, fast-track approval, the manufacturers claim their new metal-on-metal hip implant is substantially similar to others on the market," said Mr. Burke. "Now they say metal-on-metal hips should be individually evaluated when it comes to failures, without having subjected their own devices to more stringent analysis during the approval process.”
According to Parker Waichman LLP, the majority of metal-on-metal hip replacement devices used in total hip replacements were cleared for sale through the FDA's 510(k) protocols, which allows manufacturers to forgo human testing if they can show a device is similar to a predicate product that has already been brought to market. Like many other patient advocates, Mr. Burke believes that had metal-on-metal hip implants been subjected to more stringent premarket scrutiny, their safety issues may have been detected and their sales prevented.
Metal-on-metal hip implants have been the subject of growing concerns since the August 2010 worldwide recall of the DePuy Orthopaedics’ ASR Hip Resurfacing System and ASR Acetabular System. Since then, a number of studies have found evidence that the recipients of metal-on-metal hip implants may face a significant risk of developing serious complications, including tissue damage, device failure, additional surgeries, disability, and possibly cancer. In February, for example, the British Medical Journal alerted the public about potentially high levels of metallic ions released by all-metal hip implants. The following month, the authors of a study published in The Lancet called for a ban on the devices, after finding that metal-on-metal implants failed at a rate of 6 percent in five years, as opposed to the 1.7 to 2.3 percent seen in their plastic or ceramic equivalents.
Yesterday, the FDA’s Orthopaedic and Rehabilitation Devices Panel began a two-day meeting to discuss the risks and benefits of metal-on-metal hip replacement devices. In a report issued in advance of the meeting, FDA staff revealed that its review of recent data suggests that metal-on-metal hip replacement systems are likelier to fail than other hip implant devices. According to the agency, metal-on-metal hip replacement devices were associated with some 16,800 adverse event reports from 2000 to 2011. The vast majority of those reports, more than 14,000, involved revision surgery to remove a failing metal-on-metal hip implant. In 2011, metal-on-metal hip implant complaints made to the FDA totaled 12,137, compared with only 6,332 associated with other types of hip replacement systems
Parker Waichman LLP is representing scores of people who have suffered serious injuries, including pain, premature hip implant failure, and the need for revision surgery, allegedly due to the defective nature of metal-on-metal hip implants. Lawsuits involving DePuy Orthopaedics’ ASR hip implant devices have been consolidated in a multidistrict litigation before Judge David A. Katz in the U.S. District Court for the Northern District of Ohio (MDL 2197). Additional claims involving a metal-on-metal version of DePuy’s Pinnacle hip implant system have been consolidated in a multidistrict litigation before Judge James E. Kinkeade in the U.S. District Court for the Northern District of Texas (MDL 2244). Parker Waichman LLP also recently filed several lawsuits on behalf of plaintiffs allegedly injured by metal-on-metal hip implants manufactured by Biomet Orthopedics.
Parker Waichman LLP continues to offer free legal consultations to victims of metal-on-metal hip implant injuries. If you or a loved one experienced premature failure of your implant or other health problems associated with a metal-on-metal hip device, please contact their office by visiting the firm’s Defective Hip Implants page at yourlawyer.com. Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636).
For more information regarding defective hip implant lawsuits and Parker Waichman LLP, please visit: yourlawyer.com or call 1-800-LAW-INFO (1-800-529-4636).
Parker Waichman LLP
Gary Falkowitz, Managing Attorney