Sunday, February 24, 2013

J&J Hip Designer Says He Gave Complaints to Marketers

By Maurice Possley & David Voreacos - Feb 23, 2013 12:01 AM ET

A California surgeon who designedJohnson & Johnson’s (JNJ) recalled metal hips testified that he gave complaints about the devices to the marketing department and never knew of the group designated to probe such matters.

The surgeon, Thomas Schmalzried, also told jurors in state court in Los Angeles yesterday that he made $3.6 million in royalties on the ASR hip. Since 2000, DePuy has paid him $20 million, mostly for work on other devices, Schmalzried said.

Schmalzried, who led the ASR surgeon design team, was testifying at the first of 10,000 lawsuits alleging defects in the device to go to trial. Analysts say the lawsuits could cost the company billions of dollars to resolve. DePuy employees earlier testified that company policy required that all complaints go to the vigilance and complaint department.

Asked on cross-examination if he sent surgeon complaints about hip failures there, he said: “They don’t have a vigilance department.”

He also was asked about Paul Arnott, the head of that department, who testified earlier in the trial.
“I can’t put a face with that name,” Schmalzried said.

J&J, the world’s largest seller of health-care products, recalled the hips in August 2010 when their failure rate reached 12 percent in the U.K. Since then, the failure rate hit 40 percent in Australia.

Defense Witness

The company called Schmalzried as a defense witness at a trial over a lawsuit by Loren Kransky, a retired prison guard. The company denies Kransky’s claims that it designed the ASR defectively or that it led to dangerous levels of metal ions. J&J, based in New Brunswick, New Jersey, says it properly warned of the risks.

Schmalzried, who made a royalty on almost every hip sold, said he worked to educate surgeons on the proper way to insert cobalt-and-chromium device. Surgeons put a metal cup in the hip and a ball atop the femur that rotated in the cup.

“The practical problem we faced was getting the cup inserted in the right position,” he said. “There was no cup that was not performing that was in proper position.”

He said the cup worked best when placed at no more than a 45 degree angle, which reduced the amount of wear that produced metal ions in the tissue and bloodstream.

“If you don’t put it in good, it’s not going to work good,” he said. “No matter whose device it is.”
Jurors have heard that some leading surgeons in the U.S. and Europe complained about the ASR’s design and failure rate. Schmalzried said he met with some of those doctors.

‘Good Position’

“I was in a very good position to try and help them if they were having issues,” he said.
Schmalzried, who implants as many as 250 hips annually, said he had put in 39 ASR devices through 2007 without failures. He has now put in 66 ASR hips and replaced at least 15, a failure rate of 23 percent, he said.

“It’s your expectation that number is probably going to go up?” Kransky’s attorney Michael Kelly asked on cross-examination.

“Probably,” Schmalzried said.

Schmalzried said the marketing department was his “primary conduit” for information about problems other surgeons were having with the ASR. He said that any time he learned a patient had an implant replaced through a revision surgery, he told the marketing department.

“It wasn’t their job to be doing the vigilance work, was it?” Kelly asked. “Marketing had nothing to do with vigilance?”

“I disagree with that,” Schmalzried said.

Schmalzried said he no longer implants metal-on-metal hips, citing “the evolution of available alternatives,” new technology, and stronger and more durable polyethylene cups.

The 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; David Voreacos in Newark, New Jersey, at

To contact the editor responsible for this story: Michael Hytha at

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