While designing the all-metal hip implant, Johnson & Johnson failed safety tests they set forth, according to witness testimony, then altered the protocol rather than fixing the flaw itself. Loren Kransky is suing them for defects involved with their metal hip implants. Johnson & Johnson recalled 93,000 ASR hips in 2010 when they announced that 12% of the devices failed within the first five years. Last year, data showed the hips failed at a rate of 44% after seven years. Consultant George Samaras explained to jurors that the DePuy metal hip implants did not meet the safety standards they established, and cited an internal document that shows the ASR produced 16 times the chromium and cobalt debris than another product made by DePuy. The company passed the implant through the tests, even though it would have failed. “It’s horrible practice,” said Samaras. “That’s not what good engineers do. You are playing games with what the requirements for the device are.”

Kransky claims that Johnson & Johnson was negligent by failing to warn and creating a defective design. Samaras stated that DePuy’s criteria for the device had to be just as good as previous devices. Due to failing those tests, they instead found other devices that would make the ASR device look better. “They changed the test,” Samaras said. “They didn’t do what they were supposed to do, which is change the design.” An epidemilogist from the Dartmouth Medical School also testified that the Australian national registry data revealed the hip implant failed at a rate of 22% after five years passed, and 44% seven years after the device is implanted. Data was also reviewed from countries including Wales, Sweden, and England, noting the failure rate there is “extraordinarily high.” The ASR XL total hip replacement fails at a rate much higher than a typical hip replacement, according to the epidemilogist. He said that despite J&J’s claims that the rate of replacement rose due to publicity, a surgeon would not perform surgery without the right reasons. The jury also viewed a video-testimony from someone who led the design team for DePuy and oversaw a group that conducted failure mode and effect analysis, and he claimed DePuy used financial reasons to not conduct the re-design and DePuy never explained to surgeons the ASR failed and required revision surgeries at a larger rate than any other hip implant device, according to news reports.