The DePuy hip replacement recall litigation continues to grow in the United States. More than 2,600 people have filed lawsuits in the American federal court system about the De Puy ASR hip replacements. Some analysts estimate that there are 20 new DePuy hip lawsuits per day. Johnson & Johnson, the corporate parent of DePuy Orthopaedics, may face liability as much as $1 billion because of its metal on metal hip replacement products. More than 37,000 patients in the United States were implanted with DePuy ASR hips.
Litigation against Johnson & Johnson may increase outside the United States as well. Thousands of Australian patients were implanted with DePuy metal on metal hips. Australian patients are now suffering the same complications suffered by American patients as a result of their DePuy hip implants. Scores of Australian patients have already undergone revision surgeries to replace their recalled hip implans. According to reputable Australian newspapers, Johnson & Johnson has "reimbursed" thousands of patients who filed claims about DePuy implants.
Australian news media reports reveal outrage against the country's regulatory process because of the DePuy hip crisis. In Australia, the key regulatory agency for medical devices and drugs is the Therapeutic Goods Administration (TGA). The TGA is the Australian equivalent of the Food & Drug Administration (FDA) in the United States. Media reports indicate that the TGA did not adequately respond to negative information about DePuy implant failures.
Reports show that Johnson & Johnson discussed the "unacceptable" failure rate for its DePuy implants with the TGA, but the TGA did not respond effectively. Specifically, Johnson & Johnson advised the TGA that its DePuy implants had a high revision surgery rate - patients were undergoing surgeries to have their implants replaced much sooner than expected.
The TGA did not remove DePuy hip implants from the Australian medical market after receiving information about the high failure rate. According to records, the TGA failed to even meet for 18 months after receiving the news. The TGA received the information in May 2008 but did not meet again until December 2009. The agency announced that DePuy's implants should be recalled at the December 2009 meeting. At that same meeting, TGA members complained that the agency's response was delayed and ineffective.
The hip implants were not recalled in the United States until August 2010. The FDA did not force Johnson & Johnson to recall the products. Instead, Johnson & Johnson voluntarily recalled two of its DePuy implants - the DePuy ASR Hip Resurfacing System and the DePuy ASR XL Acetabular Hip System. Johnson & Johnson has not instituted a De Puy Pinnacle recall, but litigation about that medical device is growing as well.