Has Your Hip Been Replaced?

ROTTENSTEIN Law Group LU HAS YOUR HIP BEEN RECALLED? DePuy Orthopaedics, a subsidiary of Johnson & Johnson, has recalled its ASR XL ACETABLULAR SYSTEM and ASR HIP RESURFACING SYSTEM. But evidence shows that the company was aware of the problem for over two years before taking any action. What went wrong? What's the problem? Each ASR device replaces a worn or weakened part of the hip, which consists of a socket and a rounded bone that fits into Pelvis that socket like a ball. 2005 ASR is introduced in the U.S. after J&J The ASR can fail by becoming loose ... and DePuy get special permission from the FDA to skip clinical trials and begin selling the devices right away. Many orthopedic ... fracturing the bone around the implant .. ASR doctors believe that the "socket" companies knew their device ASR "ball" was flawed from the start. 2008 MHRA A report to the Medicines and Healthcare products Regulatory Agency (the British equivalent of the FDA) finds "evidence of genetic damage in patients with certain metal hip implants" (such as the ASR system). ... dislocating the implant's ball and ASR devices socket. The FDA receives approximately can cause 400 swelling, pain, difficulty walking and possibly pseudotumors. individual complaints from Metal particles can flake off the ASR and enter the patients who received ASR hip replacements. bloodstream, causing: Femur ALVAL (aseptic lymphocyte-dominated vasculitis associated lesion) - adverse tissue reaction to metal particles and ions that have chipped off and been absorbed into the bloodstream. 2009 WOMEN are DePuy voluntarily withdraws the ASR system from the Australian market. especially susceptible to these problems. 2010 J&J/DePuy announce that they will phase out sales of the ASR hip replacement system by the end of the year, "REVISION" and sends letters to doctors is just another term for a second surgery. The recall means warning of the devices' high early failure rate. that patients who have already undergone one surgical procedure to replace a hip now must undergo another. March 10, 2010 13% 70 The New York Times The New York Times reports that DePuy sent letters warning that data from of patients require a second surgery to replace their failed artificial hip within five years of the Australian Medical Device Registry show a higher-than-expected failure rate of the ASR system within just a few years of surgery, and especially in smaller patients or those receiving an ASR device - which is much higher than the industry standard failure rate of 3%. 3% with weak bones. Some Typically, replacement people consider this a hips are expected to last three times as long - 15 "silent recall." years or more. May 2010 The London Times reports: "Doctors are warning that metal debris originating from the defective implants Severe hip swelling can cause non-cancerous tumors, severe swelling and sinew damage." June 2010 Sinew A Florida woman files the first lawsuit against DePuy damage for harm caused by the ASR system. The federal suit claims that the woman received a DePuy ASR acetabular cup in March 2008 and began experiencing "extreme weakness in her hip and quadriceps" following surgery. Less than one year later, she required a second What took so long? surgery, during which doctors found that the device had catastrophically failed. J&J knew its device was faulty in 2008. Why did it take two years to issue a worldwide recall? J&J and DePuy were selling what they knew were malfunctioning July 2010 and dangerous implants to people hoping for a quick and relatively painless recovery back to a normal life. The companies netted billions of dollars during a time when reports – and even the manufacturers themselves – were warning doctors of the products' risks. The FDA notifies the public that DePuy is recalling its ASR hip implant Who has a case? cups. Aug. 2010 If you received an ASR device manufactured by J&J/DePuy, you might have a case against the manufacturers. J&J/DePuy issues a worldwide recall Although J&J has announced that it intends to What J&J offers to cover assist recipients of the recalled devices and pay for of both the ASR Hip Resurfacing System and the ASR XL Acetabular System. "Reasonable" costs of doctor visits, tests and the costs of doctor visits, tests, and procedures procedures associated with the recall, you might have suffered harm that the manufacturer is not volunteering to compensate you for. To recover damages, you might Total injury need to sue. The amount of your potential monetary recovery will relate to the severity of your harm. Damages (a money award) can include compensation for your actual medical costs (including expected future costs), lost earnings, and pain and suffering.