DePuy Orthopedics, a subsidiary of Johnson & Johnson, announced a recall of the ASR XL hip replacement system in August 2010, following reports of serious medical complications. During hip replacement surgery, a cup-type device is placed into the hip socket. A small hole is drilled into the center of the femur for placement of an artificial stem. A metal ball is placed on top of the stem prior to its insertion into the cup or socket. The results of clinical research studies have revealed significant design defects in the metal-on-metal ASR XL system. The cup is reported to be very shallow, resulting in excessive friction between the cup and the heavy metal ball. The weight of the system stresses the stem, causing bone weakening and femur fractures. The consistent scraping of metal on metal causes fragments of cobalt and chrome to enter the bloodstream and infiltrate organs and tissues. Component fragmentation has resulted in bone, joint, tissue and nerve damage. Deaths have been reported due to toxic levels of chromium and cobalt in the circulatory system.
The DePuy recall was a result of findings from a clinical study that estimated approximately one in eight patients experienced hip replacement failure after five years. Many patients who have undergone hip replacement surgery with the DePuy ASR system required revision surgery. During revision procedures, surgeons have discovered large cysts, known as pseudotumors, which must be broken open and drained prior to removal. The growth of pseudotumors may infiltrate the lymph nodes, resulting in organ damage and systemic infections. Leukemia and other life-threatening blood disorders have been reported due to cobalt and chromium poisoning linked to the ASR XL system.
The ASR XL system first became available in the United States in 2005. The manufacturer, Johnson & Johnson, was granted preliminary clearance from the United States Food and Drug Administration, referred to as the FDA. Approval was granted to market the device without clinical trials and research studies necessary to determine the safety and efficacy of the system. Following reports of product failure, DePuy Orthopedics issued a voluntary recall in March 2010, which was almost two years after the first lawsuits were filed. At the beginning of 2010, shortly before the recall was announced, DePuy reported it was phasing out the system due to declining sales. In March 2010, the New York Times reported that DePuy Orthopedics and Johnson & Johnson issued its first warning to health care providers and consumers regarding the high failure rate of the ASR XL hip replacement system.
Lawsuits against DePuy Orthopedics and Johnson & Johnson have been filed nationwide. Allegations include defective design of the system, failure of the manufacturer to inform healthcare providers and consumers of the inherent risks associated with the system and delay in issuing a recall. The first U.S. lawsuit was filed in June 2010, alleging that DePuy and Johnson & Johnson were aware of problems associated with the ASR XL system early in the design process, yet failed to correct the problems and failed to inform surgeons and patients of serious complications and high failure rates associated with the system. Following the initial onslaught of product liability and personal injury lawsuits, DePuy offered reimbursement for medical costs associated with revision surgery. Revision surgery involves complex procedures, including removal of the defective system, bone grafting, fracture repair and joint resurfacing before a new hip replacement device can be implanted. Although DePuy has offered to pay for revision surgeries, the company refuses compensation for economic losses during the lengthy recovery process.
It was recently announced that the United States Judicial Panel on Multi-District Litigation has transferred pending cases to the Northern District of Ohio for pretrial proceedings. Individuals have filed personal injury, product liability, medical malpractice and wrongful death actions as a result of the ASR XL system. It is estimated that thousands of ASR hip replacement lawsuits will be filed against DePuy and Johnson & Johnson by mid-2012.
A group of medical researchers and scientific engineers have referred to the ASR recall as one of the "largest disasters in the history of orthopedic devices." The mass tort litigation involving the ASR XL hip replacement system may become the largest in U.S. history.