The company had received complaints from doctors about the device, the Articular Surface Replacement, or A.S.R., even as it started marketing a version of it in the United States in 2005. The A.S.R.’s flaw caused it to shed large quantities of metallic debris after implantation, and the model failed an internal test in 2007 in which engineers compared its performance to that of another of the company’s hip implants, the documents show.
Still, executives in Johnson Johnson’s DePuy Orthopaedics unit kept selling the A.S.R. even as it was being abandoned by surgeons who worked as consultants to the company. DePuy executives discussed ways of fixing the defect, the records suggest, but they apparently never did so.
Plaintiffs’ lawyers introduced the documents on Friday in Los Angeles Superior Court during opening arguments in the first A.S.R.-related lawsuit to go to trial. The company faces more than 10,000 lawsuits in the United States in connection with the device. An estimated 93,000 patients worldwide received an A.S.R., about one-third of them in the United States.
DePuy executives insisted before the A.S.R.’s recall in mid-2010 that the implant was working well, despite years of complaints from doctors that it was failing early. In late 2009, the company announced plans to phase out the model but said it was doing so because of slowing sales, not safety concerns.
In opening arguments — followed remotely over the Courtroom View Network — a lawyer for DePuy, Alexander G. Calfo, reiterated those positions, telling jurors that DePuy had behaved ethically throughout the A.S.R. episode.
“The evidence will show that DePuy acted as an extremely responsible manufacturer,” Mr. Calfo said.
But a lawyer for Loren Kransky, the plaintiff in the case, painted a far different picture of DePuy’s behavior for jurors in his opening arguments.
The lawyer, Michael A. Kelly, also introduced a number of internal records that suggested that company executives’ concern for profits might have exceeded their worries about patients. For example, Mr. Kelly said, DePuy officials never told doctors that the A.S.R. had failed an internal performance test against another company hip.
“They did not report the data to American doctors,” Mr. Kelly said. “They changed the test and tested it against other things until they found one it could beat.”
The A.S.R. represents one of the biggest medical device failures in recent decades. According to DePuy’s internal estimates, it is projected to fail within five years in about 40 percent of patients who received one. That is eight times the failure rate of most orthopedic implants.
The A.S.R. belonged to a once-popular class of hip implants introduced about a decade ago in an attempt to address problems associated with hips made from traditional materials like metal and plastic. But surgeons have largely abandoned devices in that class because their components can grind together, releasing metallic debris that damages a patient’s tissue and bone.
DePuy sold two versions of the A.S.R., one used in an alternative hip replacement called resurfacing and one used in standard hip replacement. Only the version used in standard replacements was sold in the United States.
In 2003, DePuy began selling the resurfacing version of the A.S.R. outside the United States in an effort to catch up with a competing device known as the Birmingham hip. But by 2005, some doctors had begun telling DePuy that the A.S.R. was failing quickly after implantation, and company consultants soon stopped using it, records show.
Article source: http://www.nytimes.com/2013/01/26/business/johnson-johnson-hid-flaw-in-artificial-hip-documents-show.html?partner=rss&emc=rss
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