arthritis, Cobalt chrome, Cobalt poisoning, DePuy, DePuy ASR Hip, depuy hip recall, DePuy Hip Recall Litigation, DePuy Lawsuit, DePuy Orthopaedics, Food & Drug Administration, Hip Replacement, Johnson, Los Angeles, Metal on metal hip, metal-on-metal hips, metallosis, Reuters, science, Superior Court of Los Angeles County, University of California San Francisco
J&J metal hip failed because of toxic debris -expert at trial
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 companiesmaking 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.
- J&J metal hip failed because of toxic debris – expert at trial | Reuters (earlsview.com)
- DePuy ASR Hip Lawsuit News: Expert Testifies on Toxicity of Metal Debris, Notes Bernstein Liebhard LLP (earlsview.com)
- DePuy ASR Hip Lawsuit News: Expert Testifies on Toxicity of Metal Debris, Notes Bernstein Liebhard LLP (prweb.com)
- J&J Failed to Weigh Hip Metal Debris Risk, Witness Says – Bloomberg (earlsview.com)
- J&J Had ‘Inappropriate’ Risk Controls for Hip, Jury Told – Bloomberg (earlsview.com)
- J&J Failed Own Safety Test in Hip Design, Witness Says – Bloomberg (earlsview.com)
- J&J metal hip failed because of toxic debris – expert at trial (medcitynews.com)
- Trial underway in hip implant lawsuit – latimes.com (earlsview.com)
- HELLO – Earth to Major Tom – What Planet is this guy on? At trial of Johnson & Johnson recalled hip implants, doctor testifies device wasn’t defective | NJ.com (earlsview.com)
- J&J Said to Offer Implant Pact That May Reach $2 Billion – Bloomberg (earlsview.com)