J&J Failed to Weigh Hip Metal Debris Risk, Witness Says – Bloomberg.

J&J Failed to Weigh Hip Metal Debris Risk, Witness Says

By Maurice Possley, David Voreacos & Jef Feeley – Feb 2, 2013 3:01 PM ET

Johnson & Johnson (JNJ)’s DePuy unit failed to consider the harmful effects of chromium and cobalt debris in designing the 93,000 all-metal hip implants J&J later recalled, a toxicologist told a California jury.

DePuy should have analyzed and tested for the effects of those metals before selling ASR XL in the U.S. in 2005, Robert Harrison, a professor of medicine at the University of California, San Francisco, told jurors yesterday in state court in Los Angeles.

Harrison testified at the first of 10,000 lawsuits to go to trial over claims that J&J defectively designed the ASR hip and failed to warn of risks. At the time of the August 2010 recall, J&J said 12 percent failed. Analysts say the lawsuits may cost J&J billions of dollars. Harrison was a witness for Loren Kransky, a Montana man who is suing over his failed hip.

“I would have advised to do a very thorough and careful analysis of chromium and cobalt toxicity and the potential that this could be a problem from this particular hip design,” Harrison said. He also said DePuy should have done studies “before the product was put on the market.”

Lawyers for Kransky, 65, claim that DePuy poorly designed the ASR and failed to test it adequately. They say the ASR generated debris from a metal ball placed atop the femur and rotating in a metal cup implanted in the hip. That debris blackened tissue and entered the bloodstream, Kransky claims.

Harmful Levels

J&J, the world’s largest seller of health-care products, denies it defectively designed the ASR or that it contributed to Kransky’s elevated metal levels. J&J, based in New Brunswick, New Jersey, blames them on poor health, including his diabetes, high blood pressure and cholesterol, strokes and kidney cancer. Kransky, J&J argues, is a vasculopath, which means he has diseased blood vessels throughout his entire body.

Harrison said the California Poison Control System has said that cobalt levels above 7 micrograms per liter are harmful. Kransky, who had his ASR hip implanted in December 2007, had a level of 53.6 on Sept. 1, 2011, or almost eight times the acceptable level, he said. After Kransky had the ASR replaced in a revision surgery in February 2012, his level dropped to 5 micrograms per liter.

“The higher the dose, the greater the poisonous effect,” said Harrison, who was paid $500 hour an hour by the plaintiffs for his work on the case.

Harrison said the poisoning can damage tissues near the hip, and it can be systemic as the metal circulates in the bloodstream. The metals can kill cells, he said.

‘Not Poisonous’

On Jan. 17, the U.S. Food and Drug Administration issued an advisory about metal-on-metal hip implants that said the agency “does not have enough scientific data to specify the concentration of metal ions in a patient’s body or blood necessary to produce adverse systemic effects.”

Harrison was asked whether he agreed with a statement made by J&J attorney Alexander Calfo said in his opening statement on Jan. 25: “Chromium and cobalt and the ASR hip, ladies and gentlemen, they’re not poisonous. They did not poison Mr. Kransky.”

“I don’t agree,” Harrison said. “It’s just incorrect, plain and simple. It’s incorrect to say that chromium and cobalt are not poisonous. They are toxic. We’ve known this for decades.”

On cross-examination by Calfo, Harrison said he never did a study to determine the adverse level of chromium and cobalt.

DePuy Engineer

After Harrison’s testimony, Kransky attorney Michael Kelly resumed questioning of Graham Isaac, a DePuy engineer who testified Jan. 31 about his work on the design of the device.

Kelly asked Isaac about a series of e-mails about surgeons who complained of problems with ASR hips. On June 28, 2006, an e-mail between DePuy sales people discussed Dr. Paul Bom, a Netherlands orthopedic surgeon who implanted about 100 ASRs a year. He said that two patients had pain and high concentrations of metal ion levels about a year after their implant.

His results “show a significance in failure rates for the ASR,” said the e-mail. “He will not use the ASR any more for this reason.” The e-mail said Bom’s statement “is a huge problem for us as all other ASR users will listen to Dr. Bom.”

Isaac said he couldn’t recall if anyone told DePuy’s vigilance and complaint committee about Bom.

David Beverland, a surgeon in Northern Ireland, e-mailed Isaac on May 15, 2006, to report a second patient with problems.

“I’m just wondering if any of the other surgeons have had a similar problem,” he wrote. “Do you have any way of asking them.”

More Pain

Isaac said he talked to Beverland, a personal friend, although he can’t remember the conversation or if he logged the complaint internally. Kelly said Beverland quit using the ASR in May 2007 because his patients were having much more pain.

Asked if DePuy told other doctors about the experiences of Bom or Beverland, Isaac said: “You wouldn’t typically tell anyone that someone had stopped using our product or had started using it. We wouldn’t necessarily tell the physicians about a small number of cases until we were sure of the data.”

In March 2009, Beverland e-mailed a researcher at DePuy, saying he had implanted 158 ASR cups.

“My concern is that this is the tip of the iceberg and that there are many more patients out there having problems,” Beverland wrote. “Two new problems appeared last week.”

Kelly asked if Beverland’s complaints prompted DePuy to consider suspending sales of the ASR.

“I don’t believe we did,” Isaac said.

Beverland e-mailed Isaac in May 2010 to say that he had spoken with another British surgeon, Antoni Nargol, and both men agreed that their ASR failure rate was around 17 percent.

“This ASR problem has to date been the worst problem I have had in my surgical career — it has been a real nightmare – - I am still seeing at least one patient for revision at every problem clinic,” Beverland wrote. “It was a relief to speak to someone like Tony who has been having similar problems.”

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 mauricepossley@gmail.com; David Voreacos in Newark, New Jersey, at dvoreacos@bloomberg.net; Jef Feeley in Wilmington, Delaware, at jfeeley@bloomberg.net

To contact the editor responsible for this story: Michael Hytha at mhytha@bloomberg.net

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