Reuters: Regulatory News: J&J metal hip failed because of toxic debris -expert at trial

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J&J metal hip failed because of toxic debris -expert at trial Feb 1st 2013, 21:40 Fri Feb 1, 2013 4:40pm EST * Plaintiff had high levels of cobalt, chromium * FDA: insufficient evidence for metals/health correlation By Deena Beasley LOS ANGELES, Feb 1 (Reuters) - Toxicity caused by debris from a metal-on-metal hip implant meant that the device had to be removed from a 66-year-old man who is suing manufacturer Johnson & Johnson, according to expert testimony heard at the trial on Friday. "I concluded that his hip failed because of the toxic exposure," said Robert Harrison, an occupational medicine specialist at the University of California, San Francisco, who was not involved in treating plaintiff Loren Kransky but did review the medical records. The testimony was heard in Los Angeles Superior Court in the first lawsuit to go to trial involving all-metal hips made by J&J's DePuy unit. More than 10,000 U.S. lawsuits have been filed since the hips were recalled from the market in 2010. As many as 500,000 Americans are estimated to have received metal-on-metal hip replacements. Lawyers for Kransky argue that J&J was aware of the defects in the ASR hip implants, including the risk of poisoning from cobalt and chromium metal debris, even before it started selling the devices in 2004. Kransky's blood tests showed that his levels of cobalt and chromium reached as much as seven times normal after he received the ASR hip. The Food and Drug Administration last month proposed that companies making all-metal hip replacements provide additional information proving they are safe and effective before being allowed to continue selling them. The agency said it was not recommending a specific level of metals in the blood as a trigger for revision surgery because there was not enough evidence to demonstrate a correlation between those levels and patient outcomes. J&J attorney Alex Calfo said the amount of cobalt measured in Kransky was not enough to cause any adverse systemic health effects. Trial testimony earlier in the week included DePuy executives explaining that the ASR hip was tested in the laboratory at a single angle of implantation. Plaintiffs' lawyers contend that they should have tested it using multiple angles. All-metal hip implants were developed to be more durable than traditional implants with ceramic or plastic components, but have been shown to fail at a higher rate than traditional implants. A J&J study presented at the trial showed that the company had estimated that 37 percent of the devices would fail within about five years of implant surgery. Link this Share this Digg this Email Reprints

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