Tuesday, February 5, 2013

J&J Recalled Hips Over Safety Concerns, Witness Testifies

Johnson & Johnson (JNJ)’s DePuy unit pulled its all-metal artificial hips off the market in 2010 because of safety concerns about the device, one of its designers told a Los Angeles jury.
Reports that ASR XL hip implants had a “higher than expected” failure rate prompted DePuy executives to recall 93,000 of the devices in the U.S., Graham Isaac, an engineer who led the company’s hip-development program, testified today in the state court trial of a Montana man’s lawsuit.
The failure rate “was a safety issue, right?” Michael Kelly, who is representing former prison guard Loren Kransky in the case, asked Isaac. The engineer agreed.

Isaac testified in 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 its risks.

At the time of the August 2010 recall, J&J said, 12 percent of the devices failed. Plaintiffs contend DePuy officials knew the failure rate was higher than publicly disclosed. Analysts say the lawsuits may cost J&J billions of dollars in damages.

Design, Testing

Kransky, 65, claims that DePuy designed the ASR poorly and failed to test it adequately. The ASR generated debris from a metal ball placed atop the femur and rotating in a metal cup implanted in the hip, he alleges. That debris blackened tissue and entered the bloodstream, potentially poisoning hip recipients, Kransky claims.

Kelly 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.
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.

Metal Levels

J&J, based in New Brunswick, New Jersey, argues the metal levels were the result of Kransky’s 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.

Earlier in the trial, DePuy’s president testified in a deposition played to jurors that the company recalled the implants because they “did not meet the clinical needs for the product” and not because they were unsafe.

Kelly is seeking to convince jurors that chromium and cobalt debris generated by the faulty devices caused heavy metals to build up in the bloodstreams of hip recipients like Kransky and led to illnesses.

Ion Exposure

Isaac, based in England, told jurors today that regardless of whether an artificial hip is all metal or made up of different components, “patients are always exposed to ions” of the materials. Still, the engineer acknowledged DePuy officials didn’t disclose that all hip designs generate such exposure to ASR patients.

“That would have been the incorrect thing to do,” Isaac testified.

The engineer also noted scientists and doctors haven’t agreed as to what a safe ion-exposure level would be for humans. When Kelly asked if being exposed to as much as 50 microns of the ions would be safe, Isaac acknowledged “that would be high.”

Asked if he would have recommended DePuy not put the ASR hip on the market if he knew it would expose recipients to 50 microns of the ions, the engineer said, “In all likelihood, no.”

During cross-examination by DePuy’s lawyer, Isaac told jurors that the company followed “recognized developmental procedures” in designing the artificial hip and tested it extensively.
“We did more testing on the ASR than any other product we put on the market,” he said.
The Kransky case is Kransky v. DePuy, BC456086, California Superior Court, Los Angeles County (Los Angeles).

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