Johnson & Johnson executives knew years before they recalled a troubled artificial hip in 2010 that it had a critical design flaw, but the company concealed that information from physicians and patients, according to internal company documents disclosed Friday during a trial over the device’s failure.
The medical device giant 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 2005 in the United States. The A.S.R.’s flaw caused it to shed large quantities of metallic debris after implant and the model failed an internal 2007 test in which engineers compared its performance to another company hip implant, the documents show.
Still, executives of the company’s DePuy Orthaepedics unit kept selling the A.S.R. even as it was being abandoned by an increasing number of surgeons who were working as consultants to the company. DePuy executives discussed ways of fixing the defect but apparently never did so, the records suggest.
The documents were introduced Friday in Los Angeles Superior Court by plaintiffs’ lawyers 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.
For their part, 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, a lawyer for DePuy, Alexander Calfo, reiterated those positions, telling jurors that DePuy had acted ethically throughout the entire 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 Kelly, also introduced a number of internal records which suggested that the concern of company executives 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,” said Mr. Kelly. “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 will fail within five years in about 40 percent of patients who got one. That figure 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 as a way of trying to address problems associated with hips made from traditional materials like metal and plastic. But surgeons have largely abandoned them because their components can grind together, releasing metallic debris that damages a patient’s tissue and bone.
The A.S.R. was sold in two versions, 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 began telling DePuy that the A.S.R. was failing quickly after implant and company consultants soon stopped using it, records show.
The problem, internal DePuy records indicate, was the design of the cup component that fit into a patient’s hip socket. The cup, which was used in both the resurfacing and standard versions of the A.S.R., had an inside groove against which a surgeon pressed a tool in order to implant the component.
Johnson & Johnson Hid Flaw in Artificial Hip, Documents Show
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Johnson & Johnson Hid Flaw in Artificial Hip, Documents Show
