FDA Reports Nearly 17,000 Adverse Events From Metal Hip Implants (press release)
Bernstein Liebhard LLP, a New York law firm nationally recognized for its consumer protection and mass tort practices, reports that there have been nearly 17,000 adverse events related to metal hip implants reported to the U.S. Food and Drug Administration (“FDA”) from 2000-2011.* Specifically, a June 21, 2012 Bloomberg News article analyzing the adverse events reported to the FDA during that time period highlighted the following:
- The reports almost quadrupled to 682 in 2008 from the year earlier, and rose again after DePuy, a subsidiary of Johnson & Johnson, issued a worldwide recall of the ASR hip implants in August 2010
- In 2011, the FDA received 12,137 adverse event reports associated with metal hip implants, compared with 6,332 associated with other types of hip implants, such as ceramic and plastic
- In 2011, the DePuy ASR hip implants accounted for 74 percent of the incident reports received by the FDA
- Revision surgery is the most commonly reported adverse event, which requires patients to undergo a second surgery in order to remove the defective hip replacement system; and
- To date, the FDA received 14,131 reports of patients who were forced to undergo revision surgery as well as 8,704 adverse event reports involving hip pain.
Given these staggering statistics, the lawyers at Bernstein Liebhard LLP continue to carefully monitor developments and reports on the safety of metal hip implants. In addition to actively representing and investigating claims on behalf of individuals who experienced hip replacement failure, the firm is currently providing free and confidential case evaluations.
FDA Addressing Safety Concerns About Metal Hip Implants Today And Tomorrow
An advisory panel to the FDA has convened to discuss the safety of metal hip replacements.** During the two-day hearing, which began today and will continue through tomorrow, experts, doctors, medical device manufacturers and patients are offering testimony in order for the FDA to evaluate the safety of the devices. Representatives from foreign health regulatory agencies are also participating in the hearing. Previously, the FDA has refrained from issuing specific restrictions on metal hip implantuse; however numerous studies and advisories from other national health regulatory agencies have found issues with the safety of metal hip implants. “In my personal opinion there is very little room, if any, for metal-on-metal implants because the alternatives we have on the market are likely safer and as effective,” Dr. Art Sedrakyan, professor of public health at Weill Cornell Medical College in New York, told The Huffington Post when asked to comment about this week’s hearing.***
Metal Hip Implants Adverse Events Lead To Mounting Litigation
Individuals who suffered from metal hip implant side effects are filing lawsuits against the manufacturers. According to Bloomberg News, Johnson & Johnson is currently facing more than 6,000 lawsuits related to its DePuy ASR and Pinnacle hip replacements in federal and state courts. The lawyers at Bernstein Liebhard LLP are actively involved in the following metal hip implant lawsuits: 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: 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.
The firm is also investigating cases concerning a metal hip implant manufactured by Wright Medical Technology, Inc. Lawsuits involving this hip replacement were recently consolidated in In re: Wright Medical Technology, Inc., Conserve Hip Implant Products Liability Litigation (“MDL No. 2329”), which is now pending in the U.S. District Court for the Northern District of Georgia. In addition, the firm is closely following the June 2012 Smith & Nephew recall of a metal liner component of its metal-on-metal hip implants.
Those who have experienced metal-on-metal hip implant side effects may be entitled to compensation for medical expenses, pain and suffering, lost wages and other injuries. Learn more about filing a hip replacement lawsuit by visiting our website, http://www.consumerinjurylawyers.com or by watching this metal hip implant video.
*bloomberg.com/news/2012-06-21/hip-implant-concerns-reached-16-800-in-a-decade-fda-says.html