Our firm is currently involved in representing clients who are experiencing significant hip pain, immobility, or have had to undergo additional hip revision surgery due to the recall of the defective DePuy ASR Hip Implant. If you need an experienced medical device attorney to help you protect your rights and obtain compensation, The Carlson Law Firm is here to help you.
In August, 2010, DePuy Orthopaedics Inc., a division of Johnson & Johnson, recalled its ASR XL Acetabular System after years of patient complaints and high failure rates. The artificial hip, once aggressively marketed as a "breakthrough design" that would last longer and provide patients more natural movement, has failed worldwide at unusually high rates leaving thousands of patients in inexplicable pain and suffering.
Common reactions to the defective medical device include:
- Fatigue
- Hip fractures and/or hip dislocation
- Limping or favoring one leg
- Difficulty standing or walking
- Crunching and/or popping noises from the hip
- Tissue inflammation, infection and necrosis
- Severe pain
DePuy introduced the ASR Hip System into the US market in 2005, gaining FDA approval by claiming the metal-on-metal design was substantially similar to another DePuy hip implant called "Ultima." Unlike new drugs, current FDA rules allow critical implants to be sold without clinical testing if the device resembles an implant already approved and used on patients. As The New York Times reported in December, 2010, this FDA "loophole" let DePuy introduce the ASR Hip System into the stream of commerce without undergoing the normally required clinical trials. In fact, the Ultima used a cup that had a totally different design that the one used with the ASR system.
In 2008, concerns began to emerge amid research reports in the UK that the metal-on-metal design of the ASR System produced high levels of metallic debris from wear. The debris, usually cobalt and chromium, could cause severe inflammatory responses in some patients, damaging muscles and other soft tissue. Further, excess metal in the bloodstream can cause cardiomyopathy, hypothyroidism, and neurotoxicity.
A 2008 report of the MHRA, the UK equivalent to the FDA, found evidence that many ASR patients had elevated blood levels of cobalt and chromium. Since the beginning of 2008, the FDA received about 400 complaints on the ASR involving patients who received it. The number of those complaints understated the product's problems, however, as many doctors and hospitals never bother to file reports with the FDA.
Representing DePuy ASR Hip Implant legal matters in Texas, Arkansas and nationwide. Contact our product liability attorneys immediately for a free initial consultation.
Another major issue with the implant has to do with the metal on metal nature of the mechanism. As the implant fails and the metal parts rub together, small particles of cobalt and chromium are released into the body, causing Metallosis or Heavy Metal Toxicity. Symptoms and reactions to this excess metal in the blood stream can include Cardiomyopathy, Hypothyroidism, and Neurotoxicity. Other Symptoms of Metallosis are:
- Fatigue
- Groin or Thigh Pain
- Intense Pain at Implant Site
- Nerve Palsy
- Spontaneous Dislocation
- Rashes
In early 2009, researchers in England determined that the design of the ASR cup was at the heart of the problem. The interior of the ASR cup was so shallow, research asserted, that it was particularly vulnerable to edge-loading and shredding debris.
Another major issue with the ASR Hip system has to do with the higher than normal failure rate for hip implants. Unpublished data from a national hip replacement registry in the UK indicated that about 12 to 13% of patients with an ASR Hip System needed a second hip replacement within 5 years. On average, hip replacements last 15 years or more. Still, DePuy continued to market the implant in the United States, claiming them to be safe and effective despite knowledge of high failure rates and other issues.
In December, 2009, the ASR Hip System was taken off the Australian market after research determined that the ASR system had a higher than normal failure rate during a 5 year period. Shortly thereafter, DePuy announced that the ASR Hip System would be phased out of the market "due to declining sales, not safety concerns." DePuy had sales of about $5.4 billion in 2009.
Ironically, on March, 2010, just months after saying it was phasing out the ASR system because of slowing sales, DePuy issued a safety alert to doctors indicating that the device appeared to have a high early failure rate in some patients. DePuy stated that the data showed that the risk was highest "for patients of small stature, a group that typically includes women, and patients with weak bones."
In June, 2010, a Florida woman became the first person to file a lawsuit against DePuy for harm caused by the ASR system. The federal suit claimed that the woman received a DePuy ASR Acetabular cup in March, 2008, and began experiencing "extreme weakness in her hips and quadriceps" following surgery. Less than one year later, she required a second surgery, during which doctors found that the device had catastrophically failed.
Finally, in August, 2010, DePuy issued a worldwide recall for the ASR Hip System. The recall came in the wake of a series of recalls for Johnson & Johnson, including liquid children's Tylenol in the US and Acuvue contact lenses in Japan and Europe.
Currently, thousands of lawsuits against DePuy and Johnson & Johnson are being filed in a Multi-District Litigation process in Ohio. If you have had a hip replacement since 2005 and are experiencing pain or were required to undergo another surgery after receiving bad hip replacement, it is important you:
- Know that every person with an ASR Hip Implant has a claim against DePuy
- File a claim right away if you have or will have revision surgery
- Do NOT waive your right to medical privacy
- Do NOT waive your legal rights
- Do NOT sign DePuy or Broadspire's release
- Contact us immediately for a free consultation regarding your rights and options
The Carlson Law Firm has an experienced team of product liability attorneys ready to assist you with your ASR Hip Implant case. Contact our product liability attorneys so we can set you on the path to recovery!
