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Prior to DePuy ASR Recall, J&J President Advised Hip Surgeon Sale of Device Would Be Ceased, Without Explanation

Feb 11, 2013

A California surgeon said DePuy Orthopaedic’s President told him the company was halting sales of its ASR metal-on-metal hip implant months before a global recall was issued on the device.

According to a Bloomberg report, DePuy President David Floyd did not explain to surgeon Craig Swenson during that lunch meeting in March 2010 why the division of healthcare giant Johnson & Johnson was deciding to stop sales of the metal-on-metal hip implant. It would be in August of that year that DePuy eventually issued a global recall on the hip implants.

As the trial involving one Montana man who claims the DePuy ASR metal-on-metal hip implant is defective continues in a Los Angeles Superior courtroom this week, the company still insists that decision to stop sales of the failed hip implant was the result of the device not meeting the company’s clinical standards. Lawyers representing Loren Kransky, 65, aim to prove that DePuy executives were aware of the defects associated with the ASR metal-on-metal hip implant and have conspired to hide that evidence while sticking to the line that it failed to meet their expectations.

Kransky is the first of more than 10,000 victims of the ASR metal-on-metal hip implant who say the device caused them to suffer severe pain, inflammation, loosening of the device, and to have it removed long before it was touted to last, to have their complaint reach a jury trial. In other legal action against DePuy, the orthopaedic medical device subsidiary of Johnson & Johnson, more than 7,000 lawsuits making similar claims have been consolidated as part of a federal Multidistrict Litigation. Bellwether trials for those victims are expected to begin later this year.

In addition to the claims of severe pain and device failures, victims of the DePuy ASR and other metal-on-metal hip implants also say they’ve been exposed to dangerous levels of metallic ions caused by the all-metal component parts of this and other hip implants rubbing together during normal use. In previous testimony offered in the California trial, other surgeons have testified that elevated metallic ion levels of cobalt and chromium, as seen in recipients of the ASR hip implant, cause them to suffer severe organ and tissue damage, causing a “black hole” of dead tissue to surround the hip implant.

Swenson testified on Friday that he met Boyd in La Jolla, Calif., in March 2010. To that point, he had already implanted at least 200 patients with the DePuy ASR hip implant. He was not told why the company was going to halt sales of the device. “There was no part of the conversation that there was any significant problem or that patients needed any special care,” Swenson told jurors during his testimony, according to the Bloomberg report.

The surgeon previously testified that 38 percent of the recipients who he implanted with the DePuy ASR hip implant had suffered some degree of device failure. He was also aware and told jurors that Floyd also visited eight other San Diego-area surgeons during that same time and delivered the same news, all without disclosing the reason why.

In previous testimony given at this trial in its first two weeks, surgeons including Swenson said that had repeatedly informed executives at DePuy that they were noticing an unusually high early failure rate with the ASR metal-on-metal hip implant.

Several former and current executives at DePuy confirmed in their testimony that they were aware of these reports but that the company never admitted there were safety issues associated with the ASR hip implant. Engineers on the ASR device project also confirmed that minimal safety testing was conducted on it before it was approved for use globally in 2003 and two years later in the U.S.

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