DePuy Hips Recalled Over Safety Concerns

Feb. 6, 2013 - PRLog -- Despite previous assertions by Johnson & Johnson (J&J) that it withdrew its DePuy ASR hip implants from the market due to financial performance, one of its designers testified before a Los Angeles jury that the devices were actually pulled due to safety concerns.  Graham Isaac, an engineer who led the company’s hip-development program, testified that DePuy executives recalled 93,000 of the devices in the U.S. due to a “higher than expected” failure rate. Mr. Isaac testified in the first of over 10,000 lawsuits filed against J&J, claiming it defectively designed the ASR hip and failed to warn of its risks. Earlier in the trial, DePuy’s president testified via deposition that the company recalled the implants because they “did not meet the clinical needs for the product” and not because they were unsafe.

   At the time of the August 2010 recall, J&J advised that approximately 12 percent of the devices failed. It was revealed last week that J&J knew that the failure rate was actually closer to a 40 percent failure rate at least by September 2011, if not sooner. Additionally, DePuy engineers failed to consider the harmful effects of cobalt and chromium debris in designing the DePuy ASR hip implants, testified Robert Harrison, a professor at the University of California, San Francisco.  Harrison testified on behalf of the Plaintiff, Loren Kransky, that DePuy should have analyzed and tested for the effects of the metals before selling the ASR to thousands of patients in the U.S. Thousands of plaintiffs are claiming that the ASR generated metallic ions from a metal ball placed atop the femur and rotating in a metal cup implanted in the hip. This debris, created by the friction of the metals, can damage surrounding tissue and bones as well as cause systemic damage to the central nervous system, thyroid and heart. Harrison testified, “ I would have advised to do a very thorough and careful analysis of chromium and cobalt toxicity and the potential that this could be a problem from this particular hip design.”

   Harrison noted the California Poison Control System provides that cobalt levels greater that 7 micrograms per liter are harmful.   Mr. Kransky had a cobalt level of 53.6 nearly eight times the acceptable level. Once the ASR implant was removed, his level dropped to 5 micrograms per liter.  The Food and Drug Administration (FDA) issued an advisory regarding metal-on-metal hip implants and advised monitoring by a physician, noting that the agency, “does not have enough scientific data to specify the concentration of metal ions in a patient’s body or blood necessary to produce adverse systemic effects.”
Finally, Graham Isaac testified that he had received e-mails as far back as 2006 from surgeons complaining about complications and failure rates associated with the ASR, but that these complaints did not prompt DePuy to consider suspending sales of the ASR.  

Ennis & Ennis, P.A. continues to offer free, nationwide, confidential consultations to anyone who received a DePuy or other metal-on-metal hip device including the DePuy Pinnacle, Stryker Rejuvenate, ABGII and Accolade, Wright Conserve and Profemur and Biomet M2A Magnum by calling toll free 1-800-856-6405 or by going to www.ennislaw.com and completing an online case evaluation form.

www.bloomberg.com/news/2013-02-01/j-j-failed-to-weigh-risk-of-metal-debris-from-hips-witness-says.html
www.bloomberg.com/neews/2013/02/04/j-j-recalled-hips-over-safety-concerns-witness-testifies.html