Thursday, January 31, 2013

New details emerge during ongoing hip implant trial.

In continuing coverage on claims alleging Johnson & Johnson's DePuy unit failed to warn consumers that its ASR hip implants were defective, Bloomberg News (1/31, Possley, Voreacos, Feeley) reports DePuy President Andrew Ekdahl on Wednesday "told jurors the company recalled 93,000 all-metal hip implants because they 'did not meet the clinical needs for the product,' not because they were unsafe." Ekdahl testified "by videotape at the first of 10,000 cases to go to trial over patient claims that J&J defectively designed the implants and failed to warn of the risks before the recall of the ASR devices in August 2010. At the time, J&J said that 12 percent of the devices failed in the UK."
        The New York Times (1/31, B2, Meier, Subscription Publication, 1.68M) adds that last year, the "Times reported that DePuy executives decided in 2009 to phase out the A.S.R. and sell existing inventories weeks after the Food and Drug Administration asked the company for more safety data about the implant." Moreover, the FDA "told the company at that time that it was rejecting its efforts to sell the resurfacing version of the device in the United States because of concerns about 'high concentration of metal ions' in the blood of patients who received it." However, details emerged on Wednesday, indicating DePuy "never disclosed the F.D.A. ruling to regulators in other countries where it was still marketing the resurfacing version of the implant."

No comments:

Post a Comment