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Hip Implant’s Risks Inadequately Assessed, DePuy Report Found in 2010 – NYTimes.com.

Implant Risk Was Assessed Inadequately, Court Is Told


Published: January 31, 2013

A review conducted internally by Johnson & Johnson soon after it recalled a troubled hip implant found that the company had not adequately assessed the device’s potential risks before it was used in more than 90,000 patients, court testimony on Thursday showed.

The engineering report, which was done in 2010, also found that Johnson & Johnson’s orthopedic unit had used inadequate or incorrect standards in trying to assess some of those risks before first selling the implant in 2003. The device at issue — the Articular Surface Replacement, or A.S.R. — proved to be among the most flawed orthopedic devices sold in recent decades.

The report was introduced on Thursday in Los Angeles Superior Court, in the first A.S.R.-related lawsuit to go to trial against the DePuy Orthopaedics division of Johnson & Johnson. More than 10,000 similar lawsuits have been filed in the United States.

In videotaped testimony shown in court, Jimmy Smith, a compliance manager at DePuy, was asked about the report, and he said it indicated that company officials had not used appropriate engineering controls to try to anticipate the device’s problems.

“They did their job, but they could have done it better,” Mr. Smith said.

Separately, a DePuy engineer, Graham Isaac, testified on Thursday that before selling the A.S.R., the company only tested its performance on laboratory equipment at one angle of implantation.

Depending on the surgical technique and a patient’s build, orthopedic surgeons can implant the cup component of an artificial hip at a variety of angles. And because the A.S.R. had a design flaw, normal variance from the single angle at which DePuy had tested it made it more likely for the joint’s cup and ball components to strike each other, releasing metallic debris inside a patient.

DePuy conducted the post-mortem review of the A.S.R. in November 2010, just three months after it recalled the all-metal implant, but it never released the analysis. It also, apparently, did not conduct a similar review in response to the mounting number of complaints about the device that it received from doctors and others in 2008 and 2009.

Lorie Gawreluk, a spokeswoman for DePuy, said that she could not comment on any details of the lawsuit, but that the company believed that the evidence would show it acted appropriately. The trial’s proceedings were monitored over the Courtroom View Network.

The A.S.R. is projected to fail within five years in about 40 percent of patients who received the implant. That early failure rate, which is expected to grow over time, is many times higher than the failure rate for most hip replacements.

In the post-recall review in 2010, DePuy engineers examined the criteria and “controls,” or standards, that were used nearly a decade earlier when company officials tried to anticipate how the A.S.R. might perform. Because the version of the device that was sold in the United States was never clinically tested in patients, officials used the controls to assess the implant.

Among other things, DePuy officials failed to anticipate that the A.S.R. would have a high rate of wear as a patient moved, even though the control referenced in the device’s records demonstrated “that the product is more likely to experience contact between the head and rim” than competing implants.

In previously recorded testimony presented in court on Wednesday, DePuy’s president, Andrew Ekdahl, was shown an e-mail in which he was warned about the A.S.R.’s problems nearly three years before it was recalled.

Mr. Ekdahl and other DePuy executives have asserted that they acted properly and in a timely fashion to the device’s problems. The company spokeswoman, Ms. Gawreluk, said Mr. Ekdahl would not be made available for an interview.