The president of Johnson & Johnson’s DePuy unit testified via videotape that the recall of 93,000 all-metal hip implants was not because of concerns about safety.
The first of 10,000 lawsuits against J&J is being tried at a court in Los Angeles. The case involves a Montana man whose hip failed.
The company president said the implants did not meet “clinical needs” for the product. Despite repeated questioning about the safety of the products, he would not say the product was unsafe. The company also denies that the device contributed to the plaintiff’s health problems despite testimony that he had “alarming” levels of chromium and cobalt debris in his body.
Internal analysis from DePuy showed ASR implants had a failure rate of 37 percent at about 4 ½ years. At the time of the product recall in 2010, DePuy claimed the failure rate was 12 percent.
The seven-year revision rate in Australia is reportedly 44 percent. DePuy will not forecast what the rate could reach in the United States or describe what rate would be considered acceptable.
One surgeon emailed DePuy in 2008 to report concerns that the ASR cup was not large enough and did not stimulate enough body ingrowth. An email from a company engineer earlier in 2008 claimed the ASR could cause “extreme metal ion levels.” The documents were introduced as the plaintiff seeks to show the company was aware of safety concerns years before the 2010 recall.