Tuesday, February 19, 2013

J&J Sales Rep Told Surgeon of Hip Problems, Jury Told


A Montana surgeon testified he stopped using Johnson & Johnson’s ASR all-metal hip device eight months before the company recalled it because he was warned about problems with the implant by a sales rep.

Peter Wendt, testifying yesterday by videotape in state court in Los Angeles, said he implanted 76 ASRs, including one in Loren Kransky, 65, of Montana. Kransky’s lawsuit is the first of 10,000 to go to trial over claims that J&J’s DePuy unit defectively designed the 93,000 hips recalled in August 2010 and failed to warn of the risks.

Wendt said he dropped the ASR after talking to DePuy’s Dan Harrington, who worked with him for years. Harrington, he said, told him “there’s some problems with this, we are going to pull it. You really shouldn’t be using it anymore.”

Before that, DePuy never told him about patients who experienced debris from the cobalt and chromium devices, said Wendt, who practices in Anaconda, Montana. He said he never knew DePuy studied a redesign to try to prevent the problems. Had he known either, he said, he would have stopped using the device.

J&J, the world’s largest seller of health-care products, denies that it defectively designed the device or that it contributed to the health problems of Kransky. J&J is based in New Brunswick, New Jersey.
Wendt said he began using the ASR because DePuy said the device had a success rate of more than 98 percent.

‘Acing’ Test

“That was like acing the test,” he said.

At the time of the recall, J&J said that 12 percent of its hips failed in the U.K. within five years. An Australian registry showed the failure rate last year exceeded 40 percent. Analysts say the lawsuits may cost J&J billions of dollars.

Wendt said that since he stopped using the ASR, he has replaced nine or 10, and patients have had four others removed because of pain, excessive wear or fluid build-up.

When Harrington told him to stop using the ASR, Wendt said, he hadn’t seen adverse effects. Those emerged later, he said, including tissue damage and discoloration because of metal ions.

He said he performed Kransky’s surgery in December 2007 without complications from his other medical conditions --diabetes, hypertension and vascular problems.

The surgeon who replaced Kransky’s hip in February 2012, Jeffrey Hansen, testified by videotape that he inaccurately wrote in his medical notes that the joint had loosened. He said Kransky’s lawyers coached him to make the statement, which he believed would expedite payment for the surgery.

‘Being Poisoned’

He said he also erred when he wrote: “Because this patient is basically being poisoned by the metal ions, I think he should still consider his hip revision.”

The word poison, he said, was used by the Kranskys
“Perhaps I should have put it in different fashion,” he said. “The word poison is pretty, pretty, I guess that’s pretty toxic.”

In his opening statement on Jan. 25, J&J attorney Alexander Calfo said Hansen would admit he was coached.

“The evidence will show, Dr. Hansen will tell you, ‘I drank the Kool-Aid,’” Calfo said. Hansen didn’t say those words yesterday. His testimony resumes today

Jurors also heard videotaped testimony yesterday from Christopher Hunt, a DePuy bioengineer, about an ASR surgeon design team meeting in September 2005.

The jury was shown his draft minutes of the meeting, which reported that the group discussed adding a toxicologist to“address the perceived risk of cancer due to metal ion release.”

‘Useful Study’

“Although it was agreed that would be a useful study to undertake, concern was raised that the information should be strictly controlled in the event of it showing a negative answer,” the minutes said. “There was skepticism that would be able to produce answers to questions that have been circulating for a significant time already.”

No study was ever done and a toxicologist was never added.

Hunt was part of a group that spent three years studying a possible redesign of the ASR to reduce wear and the release of metal ions. He sought to convey to his superiors that “more wear was occurring than was expected or intended,” he testified.

“This was a problem we had to solve,” he said.

The Kransky case is Kransky v. DePuy, BC456086, California Superior Court, Los Angeles County (Los Angeles). The consolidated federal case is In re DePuy Orthopedics Inc., ASR Hip Implant Products Liability Litigation, 10-MD-2197, U.S. District Court, Northern District of Ohio (Toledo).
To contact the reporters on this story: David Voreacos in Newark at dvoreacos@bloomberg.net; Jef Feeley in Wilmington, Delaware at jfeeley@bloomberg.net

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