Johnson & Johnson executives knew that a troubled artificial hip had a critical design flaw years before they recalled it in 2010. According to internal documents disclosed during a trial related to the device’s failure, the company had received numerous complaints from doctors about the device, the Articular Surface Replacement, or A.S.R. The A.S.R.’s flaw caused it to shed large quantities of metallic debris after implantation.
The complaints were being reported to the company even as it started marketing a version of the device in the United States in 2005. Executives in Johnson & Johnson’s DePuy Orthopaedics unit kept selling the A.S.R. as it was being abandoned by surgeons who worked as company consultants. However, the company concealed that information from physicians and patients. The records suggest that DePuy executives discussed ways of fixing the defect, but they apparently never took action and continued selling the devices.
The documents were introduced by Plaintiffs’ lawyers in Los Angeles Superior Court in the first A.S.R.-related lawsuit to go to trial. Plaintiffs’ lawyers referenced the documents in their opening arguments. The documents also showed that the model failed an internal test in 2007 in which engineers compared its performance to that of another of the company’s hip implants.
Despite years of complaints from doctors that the A.S.R. was failing early, DePuy executives insisted that the implant was working well before its recall in mid-2010. The company announced plans to phase out the model in late 2009, but said it was doing so due to slowing sales, not safety concerns. Alexander G. Calfo, a lawyer for DePuy, told jurors that DePuy had behaved ethically throughout the A.S.R. episode. Mr. Calfo said, “The evidence will show that DePuy acted as an extremely responsible manufacturer.”
Michael A. Kelly, a lawyer for plaintiff Loren Kransky, painted a far different picture of DePuy’s behavior. Mr. Kelly introduced a number of internal records that suggested that company executives’ concern for profits might have exceeded their worries about patients, including documents showing that DePuy officials never told doctors that the A.S.R. had failed an internal performance test against another hip offered by the company. Mr. Kelly said, “They did not report the data to American doctors. They changed the test and tested it against other things until they found one it could beat.”
The company faces more than 10,000 lawsuits in the United States in connection with the device. It is estimated that 93,000 patients worldwide received an A.S.R., with about one-third of them living in the United States.