Tags: defective | hip | ASR | DePuy

DePuy Chief Questioned Over Document Calling ASR Hip Defective

Wednesday, 13 Mar 2013 03:49 PM

Andrew Ekdahl, president of Johnson & Johnson’s DePuy orthopedic products unit, told a Chicago jury that the company recalled a hip implant in 2010 because it wasn’t meeting “clinical expectations.”

Ekdahl’s testimony came on the third day of a state court trial in which a 54-year-old Illinois woman, Carol Strum, claims her ASR XL hip was defective. The device, made of chromium and cobalt, failed three years after it was implanted, and she had it replaced in a so-called revision surgery.

J&J recalled the ASR after saying 13 percent failed within five years in the U.K., requiring revisions. Ekdahl answered questions today about a DePuy document filled out by company officials days before the recall. The document from the Health Hazard/Risk Evaluation Review Board listed three explanations for the recall. The company checked Class A for “defective product that would affect product performance and/or could cause health problems.”

“The revision rate was not acceptable,” Ekdahl testified. That was the reason for the recall, he said.

In his opening statement on March 13, J&J attorney Richard Sarver said the device was not defective.

‘Root Cause’

“Many factors contribute to the overall revision rate so a single root cause cannot be defined at this time,” Sarver said. “We absolutely didn’t say the product is a defective product. We said we don’t know. We need to figure this out.”

More than 10,000 lawsuits have been filed over the ASR. A Los Angeles jury last week awarded a Montana man $8.3 million in his lawsuit against the unit of New Brunswick, New Jersey-based Johnson & Johnson.

Jake Sergent, a spokesman for DePuy, said he couldn’t immediately comment on Ekdahl’s testimony.

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Andrew Ekdahl, president of Johnson & Johnson's DePuy orthopedic products unit, told a Chicago jury that the company recalled a hip implant in 2010 because it wasn't meeting clinical expectations.
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Wednesday, 13 Mar 2013 03:49 PM
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