Feb. 19 (Bloomberg) -- A Montana man suing Johnson & Johnson’s DePuy unit over his metal-on-metal hip implant told a Los Angeles jury he feared that a follow-up surgery to replace his failed device would kill him.
Loren Kransky, 65, testified that he dreaded the so-called revision surgery he had last February to remove his ASR hip implanted in December 2007. Kransky, a retired prison guard, said he was in constant pain, couldn’t walk and believed debris from the chromium and cobalt device was poisoning him.
“I didn’t want to have the hip done because I had 25 surgical procedures done prior to that,” Kransky told a state court jury. “I thought that surgery was going to kill me. I thought I was going to die.”
Kransky testified during the first of 10,000 lawsuits to go to trial over the ASR device. J&J, the world’s biggest seller of health-care products, recalled 93,000 ASR hips in August 2010 after saying at least 12 percent failed. Since then, the failure rate has climbed, reaching 40 percent in Australia. Analysts say it could cost J&J billions of dollars to resolve the lawsuits.
J&J, based in New Brunswick, New Jersey, denies Kransky’s claims that it defectively designed the device and failed to warn of the risks. J&J attorney Alexander Calfo says Kransky’s claim of elevated metal levels in his body can be traced to conditions including diabetes, high blood pressure and cholesterol, strokes and kidney cancer.
Kransky, Calfo said, is a vasculopath, which means he has diseased blood vessels throughout his entire body. Jurors heard Kransky say he had no choice but to get the revision.
“I came to believe that I was going to have to do it because I was told that something in my body was poisoning me,” Kransky said. “I was told it could be the hip. I thought, ‘I’m going to die either way.’ One way would be slow and one would be fast. I took the lesser of two evils.”
Before then, he said, he experienced “a kind of stabbing type of pain. It was debilitating. I couldn’t do anything, couldn’t walk long distances.”
Kransky said he couldn’t rehabilitate properly after a stroke, couldn’t use the bathroom freely, and couldn’t sleep at night. He needed a wheelchair, which was “humiliating.”
“I didn’t want anybody to see me in a wheelchair,” Kransky said. “I was always independent and strong. Here I am in a wheelchair.”
On cross-examination, J&J attorney Michael Zellers showed jurors medical records from Kransky’s personal physician, Thomas Trotsky. When Kransky first complained of pain in his hip in 2008, Trotsky diagnosed it as bursitis.
Zellers also suggested that Kransky fell before having the ASR implanted and that the falls resulted from balance problems caused by his other health conditions.
Jurors also heard from Paul Arnott, DePuy’s complaint and vigilance manager since 2003. He testified that while all reports of ASR revisions were supposed to go to his department, many didn’t. Instead, he said, many went to a University of Hamburg professor, Michael Morlock, a consultant to the company. Jurors heard from another witness that surgeons sent explanted hips to Morlock.
“DePuy sales people were informing surgeons to send all revisions to Professor Morlock and not report to the complaint department,” Arnott testified.
Morlock, he said, considered his work to be independent research and not part of DePuy’s complaints process.
“We would want all revisions reported to us,” Arnott said. “He said it was not his job to decide what information should be passed on to surgeons, but that if it helped surgeons do their work better, it should be.”
Arnott said that he prepared a recall letter in January 2010, or eight months before J&J recalled the hips. The company’s Health Hazard Evaluation committee rejected a recall, he said, and sent a so-called field safety notice.
“The HHE committee, based on all the available data that they reviewed, didn’t feel that it warranted a return of medical device to the manufacturer,” he said.
The case is Kransky v. DePuy, BC456086, California Superior Court, Los Angeles County (Los Angeles).
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