Posted 29 January 2013

Bloomberg: After Failing Testing, J&J Altered Approval Criteria for Now-Recalled Hip Implants

2700

At the beginning of 2012, The New York Times made something of a sensational claim: Johnson & Johnson had worked to privately phase out its now-controversial metal-on-metal hip implants in 2009 after US regulators approached the company with concerns about their durability and patient safety. In response to that report, the company indicated that the two events were "unrelated," but now new and potentially troubling information is emerging from a Los Angeles courtroom shows the recall may be the least of the company's worries.

The company is currently facing the first of nearly 10,000 lawsuits that are expected to go to trial regarding the safety of its DePuy ASR (articular surface replacement) XL Acetubular metal-on-metal implants. The product was cleared by the US Food and Drug Administration (FDA) in 2005 through its 510(k) pathway, which requires companies to show a product is "substantially equivalent" to a predicate device.

However, the device has become something of a case study for advocates of reform, who argue that the implantable device should have undergone a more rigorous premarket evaluation process in light of its potential-and later actualized-risks to patients.

The 510(k) process is supposed to be a shortcut to showing that products are safe, typically excusing companies of any requirements to conduct clinical trials as long as they are able to show through testing that a product is safe for its intended purpose.

But Bloomberg reports that when J&J's own hip implant products failed its own design safety testing, the company "changed the protocol instead of fixing the flaw," according to witness testimony at the trial. That witness, George Samaras, a consultant, testified that internal testing showed the product produced "16 times more chromium and cobalt debris in the body than any other DePuy product," which should have caused the product to fail testing, Bloomberg reported.

The devices have since been shown to fail at unexpectedly high rates as the result of the wear and tear of the metal-on-metal hips, which can cause metal shavings to enter a patient's tissue and bloodstream. Though the product has been recalled from many markets as the result of its risks, r

egulators have not yet established whether the elevated rates of cobalt or chromium in a patient's bloodstream are cause for concern.

The trial has also cast a harsh light on the company's failure mode and effect analysis (FMEA), with jurors seeing videotaped testimony of the leader of DePuy's design team explaining that the company had "scrapped efforts to redesign the ASR cup because of financial and business reasons," according to Bloomberg.

Read the entire Bloomberg article here.