DePuy Pinnacle & ASR
The U.S. Food and Drug Administration approved the DePuy Pinnacle hip replacement system in 2000. Hip replacements generally consist of a femoral head attached to the femur, as well as an acetabular cup inside a concave area in the pelvis. This creates a ball-and-socket system, mimicking the original hip joint. There were options for the components of the ball-and-socket on the early Pinnacle product including ceramic-on-polyurethane; ceramic-on-metal; metal on polyurethane; ceramic-on-ceramic and metal-on-metal. The multiple services would allow physicians flexibility to select which model to use based on patient need.
The DePuy ASR XL System was launched in 2005 and was specifically developed to be used in total hip replacements. The product was launched using a 501(K) Clearance Process, which allows for devices substantially similar to those already approved to come to market with minimal testing. The A.S.R. consisted of both a metal ball and a metal cup and was one of many metal-on-metal hip implants that put patients at serious risk of complications.
Unfortunately, both the Pinnacle and ASR systems had serious problems, with studies revealed high failure rates and significant complications. A hip replacement lawyer at the Law Office of Jeffrey S. Glassman can help victims to pursue legal action for injury and disability caused by defective hip implants.DePuy Pinnacle & ASR Problems
In 2010, DePuy recalled both the Pinnacle and the ASR system because of a failure rate that far exceeded the norm. The majority of artificial hips last for at least 15 years before replacement is required. Unfortunately, internal projections from DePuy indicate that an estimated 40 percent of its hip replacement devices would fail within five years. This is a rate eight times higher than the five-year failure rate for most other hip devices.
Patients who experience a failure of their hip replacement device may suffer a bone fracture near the implant site; loosening of the implant; dislocation and significant pain; and metallosis or metal poisoning. Revision surgery is often required to remove the failed hip implant system and correct the problem. Mobility limitations may persist.
Because of the serious complications associated with DePuy Pinnacle and ASR products, patients have filed lawsuits against DePuy Orthopaedics. More than 8,600 ASR cases have been grouped together as part of a multidistrict litigation in Ohio while thousands of additional cases remain pending in state courts. An additional 5,400 claims arising from the Pinnacle systems are also pending in a MDL in the Northern District of Texas. MDLs allow for thousands of plaintiffs to retain individual cases while one judge decides on common pretrial issues.
Johnson & Johnson tentatively agreed to a $4 billion settlement to resolve some pending claims at the end of 2013. This is one of the largest payouts in history for a product liability claim arising from a defective medical device. The settlement includes patients who already had their A.S.R. systems removed and replaced. The agreement involves payments of approximately $350,000 in average compensation to affected patients, with amounts determined by both age and medical condition.
Patients who were harmed by the DePuy ASR or Pinnacle Systems need to understand options for settlement, multidistrict litigation and state court claims. Jeffrey Glassman Injury Lawyers can provide assistance to affected patients.