J&J Failed to Conduct Adequate Safety Tests Before ASR Hip Recall
Johnson & Johnson did not adequately assess and try to change design risks in the DePuy ASR hip replacement implant before the DePuy ASR hip recall, according to an internal J&J review conducted months after the recall. The recall affected 93,000 devices worldwide and has spurred thousands of lawsuits. “They did their job, but they could have done it better,” a DePuy compliance manager said in his testimony during the first DePuy ASR hip lawsuit to go to trial in Los Angeles, California.
The engineering report found that the company used “inappropriate” standards to assess risks with the ASR hip replacement implant. The company used irrelevant controls in a failure mode and effect analysis (FMEA) conducted before the ASR went to market. According to the witness, the team fell short in 13 areas, including problems with the design of the ASR cup, which was prone to fretting and corrosion.
“We didn’t predict the levels of excessive wear and the loosening that have been identified,” the witness said.
Engineer Testified on Limited Testing for DePuy ASR Hip Replacement
An English engineer who worked on the design of the ASR hip implant also testified during the trial. Though the ASR hip implant had 10 different cup sizes, DePuy only performed clinical tests on one size, and only tested the device at one optimum angle of implant, ignoring other positions that surgeons used. Natural variances with the angle of implantation can lead to increased risk of metal debris shedding because of the design flaw of the ASR cup. According to the witness, “it was very difficult to test this device,” and “it would have been too expensive” to conduct tests on all the possible ways of using the device.
A DePuy projection from September 2011 estimates that almost 40 percent of the ASR hip replacement implants will fail within five years of surgery, which is eight times higher than the failure rates for many other models of metal hip implants.
DePuy ASR Hip Recall Lawsuit Seeks Compensation for Victims’ Injuries
Over 10,000 DePuy ASR hip recall lawsuits have been filed against J&J, alleging that the company designed a dangerous product and failed to warn patients about the risks of metallosis and high failure rates. Many recipients of the ASR hip implant had to undergo revision surgery to remove the device. Lawsuits are underway in both federal and state courts.
If you received a DePuy ASR hip implant and experienced hip replacement failure or other complications, speak to a lawyer at our Firm today to learn more about how to protect your legal rights. You may be entitled to compensation for your medical expenses, lost wages, pain and suffering, and more. Call (877) 779-1414 to learn more.