Thursday, January 31, 2013

J&J’s Ekdahl Says Hips Recalled Because of Clinical Needs


Andrew Ekdahl, the president ofJohnson & Johnson (JNJ)’s DePuy unit, told jurors the company recalled 93,000 all-metal hip implants because they “did not meet the clinical needs for the product” and not because they were unsafe.

Ekdahl testified yesterday by videotape at the first of 10,000 cases to go to trial over patient claims that J&J defectively designed the implants and failed to warn of the risks before the recall of the ASR devices in August 2010. At the time, J&J said that 12 percent of the devices failed in the U.K. Analysts estimate the lawsuits could cost J&J billions of dollars.

Ekdahl, who became DePuy president in January 2012, had previously worked as a marketing executive. A lawyer for Loren Kransky, 65, a Montana man who is suing DePuy over his failed hip, repeatedly questioned Ekdahl about whether the company withdrew the hips because they were unsafe.

“It was taken off the market because it did not meet the clinical needs for the product in the marketplace,” Ekdahl said in a videotaped deposition taken in December 2012 and shown yesterday to state court jurors in Los Angeles.

J&J, the world’s largest seller of health-care products, denies that it defectively designed the device or that it contributed to Kransky’s health problems. J&J is based in New Brunswick, New Jersey.
Kransky attorney Michael Kelly asked Ekdahl a half-dozen ways whether DePuy considered ASR hips to be unsafe or harmful to patients. Each time, Ekdahl referred to clinical needs.

Acceptable Rate

Kelly has told jurors that an internal DePuy analysis in September 2011 showed 37 percent of ASR hips failed within 4.5 years, and that Australian national registry data showed in 2012 that 44 percent failed after seven years. Patients with failed hips need replacement surgery known as a revision.
In answering Kelly’s questions about the recall, Ekdahl said that the ASR didn’t have an acceptable revision rate.

“What was the acceptable revision rate?” Kelly asked.

“I don’t think we put a revision rate on paper and said this is a revision rate that was acceptable,” Ekdahl said in a deposition that may be played in many other lawsuits.
Kelly asked how many revisions DePuy forecasts for the U.S.
“We’re not forecasting a revision rate,” Ekdahl said.

Kelly asked why the U.S. rate of revision wouldn’t reach 40 percent, as in Australia. Ekdahl said he doesn’t know what the rate will be. About 32,000 patients had ASR devices implanted in the U.S., said Ekdahl, who said that “somewhere in the neighborhood of 15 to 20 percent” of those hips had failed.

Surgeon Complaints

Kelly questioned Ekdahl about DePuy’s handling of safety complaints that surgeons filed with the company about the device. Thousands of lawsuits claim the ASR device left them in pain or immobilized by joint dislocations, infections and bone fractures. Many also claim the devices shed chromium and cobalt into the bloodstream, raising those metals to harmful levels.

One surgeon, William Griffin, e-mailed Ekdahl and others on Dec. 18, 2008, to say he had “concerns about the design and have started to see failures consistent with my concerns.”Surgeons implanted a metal cup in the hip and a metal ball atop the femur that rotated inside the cup. Griffin said the ASR didn’t stimulate enough bony ingrowth, the cup was too small, and the design created sharp edges.
“DePuy should at least de-emphasize the ASR cup while the clinical results are studied,” Griffin wrote. “I do not use the ASR. The ASR is not the only bad design out there but it certainly is not as good as some of the others.”

Clinical Team

Kelly asked if the e-mail went to DePuy’s clinical team.

“I believe this was reported to our clinical team,”Ekdahl said. “I just don’t recall who did it. We should have done it. I’m assuming that we did it. I don’t recall.”

Kelly asked about DePuy discussions in 2008 to redesign the ASR cup. A company engineer, Graham Isaac, e-mailed Ekdahl on April 30, 2008, to say the ASR is “susceptible to extreme metal ion levels,” which a competitor product didn’t face.

“We need to discuss that at the earliest possible opportunity as I believe it means that we need to start any ASR upgrade sooner than our previous plans had suggested,” Isaac wrote.
Ekdahl said that in response to the e-mail, he spoke to people on the marketing team.
Throughout the videotape yesterday, Kelly pursued various lines of questioning based on DePuy e-mails and internal documents that he contends show that company officials knew years before the 2010 recall that the ASR was failing.

‘Project Alpha’

Kelly showed documents related to DePuy’s deliberations in 2008 to redesign the ASR cup through “Project Alpha.” That project was never completed.

He asked Ekdahl about minutes of a May 2008 meeting in Las Vegas. Those minutes listed weaknesses of the ASR, including deformation and loosening of the cup.

At a September 2009 meeting of the company’s U.S. board overseeing joint devices, officials said the revision rate of the ASR XL device was two or three times that of another DePuy implant, the Pinnacle. It said that the impending publication of Australian registry data would be “very damaging to the ASR.”

DePuy ended Australian sales months before they halted in the U.S.
The Kransky case is Kransky v. DePuy, BC456086, California Superior Court, Los Angeles County (Los Angeles).

To contact the reporters on this story: Maurice Possley in Los Angeles Superior Court at; David Voreacos in Newark, New Jersey, at; Jef Feeley in Wilmington, Delaware, at

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