ASR Hip Design Failed Safety Test, Data Hidden by J&J, Witness Claims

A trial witness in a hip implant case against Johnson & Johnson (J&J) in Los Angeles state court reportedly asserted that the companys ASR hip replacement devices did not pass its own safety standards due to fault in design, online news reports, further claiming that the company modified its safety rules to cover flawed hip implants instead of addressing the defects. George Samaras, a biomedical engineer, quoted documents showing that now-recalled DePuy ASR all-metal hip implants have the tendency to produce 16 times more chromium and cobalt metal fragments to the blood compared to a different product still developed by the J&J subsidiary, DePuy, according to online media reports. Despite the flaw in hip design, the devices still has not actually failed the safety review, after the company found another device for comparison, giving the ASR the upper-hand. John Baron, an epidemiology expert witness who appeared before Samaras, also cited study results by an Australian national registry, revealing a notably high failure rate of 22 percent in five years, and 44 percent for seven years for the ASR XL hip system. The first among 10,000 lawsuits to go to trial was reportedly filed by a 65-year old Montana-based plaintiff, Loren Klansky, who allegedly suffered from severe side effects from one of DePuys ASR hip replacement implants. Klansky, a retired prison officer, filed claims including defective design, negligent recall, and failure to warn over an ASR XL Acetabular System which he received in 2007, and had replaced in 2012. Despite the plaintiffs allegations, the company still reportedly denied the claims, saying that Kransky asserts that his device released metal ions into his body and that as a result he developed elevated chromium and cobalt levels, and emphasizing that the hip device specifically warned that metal ions may be released from the hip implant into the body and that additional surgery may be required., in a Nov. 21 court filing.

In 2010, J&J voluntarily pulled out 93,000 ASR hip devices worldwide, 37,000 of which were in the United States, due to a considerably high failure rate of 12 percent in five years, according to online reports. Records also show that the New Jersey-based company estimated in an internal research that 40 percent of the metal-on-metal implants may fail in less than five years. Such information has not been publicly disclosed until two years following the so-called DePuy ASR hip replacement product recall. The DePuy Hip Recall Information Center at depuyhiprecall.us offers comprehensive information about safety problems and related issues involving DePuy ASR hip implants. Sources: bloomberg.com/news/2013-01-28/j-j-failed-its-own-safety-test-in-hip-design-witnesstestifies.html nytimes.com/2013/01/23/business/jj-study-suggested-hip-device-could-fail-inthousands-more.html?_r=0 bloomberg.com/news/2013-01-18/j-j-said-to-offer-implant-pact-that-may-reach-2billion.html