Thursday, March 14, 2013

Chicago Trial started: J&J’s Ekdahl Says Hip Recalled for Clinical Reasons


Bloomberg Businessweek

March 13th

Andrew Ekdahl, president of Johnson& Johnson (JNJ)’s DePuy orthopedic products unit, told a Chicago jury that the company recalled 93,000 hip implants in August 2010 because they weren’t meeting “clinical expectations.”

Ekdahl’s testimony came on the third day of a state court trial in which Carol Strum, 54, claims her ASR XL hip was defective. Strum, an Illinois nurse, had the all-metal device implanted in 2008, and she had it replaced three years later in a so-called revision surgery. Strum’s lawsuit is the second of 10,750 over the ASR hips to go to trial.

“The revision rate was not acceptable,” Ekdahl testified. That was the reason for the recall, he said.
J&J recalled the ASR after saying 13 percent failed within five years in the U.K., requiring revisions. Ekdahl was asked about a DePuy document signed by top company officials days before the recall. The document, from the Health Hazard/Risk Evaluation Review Board, listed three possible explanations for the recall. DePuy checked Class A for “defective product that would affect product performance and/or could cause health problems.”

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

‘Many Factors’

“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.’

To say the recall “is an admission of a defect, it is absolutely absurd,” according to Sarver.
A Los Angeles jury last week found that the ASR was defective and awarded $8.3 million to a Montana man in the first hip-implant case to go to trial against DePuy, a unit of New Brunswick, New Jersey-based Johnson & Johnson. J&J is the world’s largest seller of health-care products.
In his opening statement, Strum’s attorney Denman Heard told jurors that the ASR design flaws caused it to shed chromium and cobalt debris into surrounding tissue. Surgeons implanted a metal cup in the hip and a metal ball, placed atop the femur, rotated inside the cup. DePuy claimed its design would last longer than other products.

“Before Carol Strum ever had the ASR put into her body, DePuy knew that the design flaws in this defective device could cause it to shed those particles into patients, causing tissue death, causing high blood metal ion levels and the need for the serious and unnecessary second surgery,” Heard said.
The case is Strum v. DePuy, 2011-L-9352, Circuit Court of Cook County, Law Division (Chicago).
To contact the reporters on this story: David Voreacos in Newark at; Andrew Harris in the Chicago federal courthouse at

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