J&J Failed to Warn of Hip Implant’s Risks, Jurors Told

Johnson & Johnson failed to warn doctors of the risks of defective metal hip implants that it didn’t test properly, a lawyer told a Los Angeles jury in the first of 10,000 lawsuits over the device to go to trial.

Loren Kransky, a retired prison guard who got an ASR XL hip implant in 2007, sued in state court in 2011 and had the device replaced last year. J&J, the world’s biggest seller of health-care products, withdrew the devices in August 2010 after citing U.K. data showing more than 12 percent failed within five years.

“The ASR XL was dangerous and it was defective in design and we will prove it,” Michael Kelly, Kransky’s lawyer, said today in his opening statement. “This hip, this medical implant, incorporated dangers to an extent beyond what any reasonable doctor would have anticipated or expected.”

Kelly claimed that debris from the metal ball sliding against the metal cup caused metal ions to enter Kransky’s bloodstream, and one of his doctors said the poison would kill him without replacement surgery. Kelly said J&J’s DePuy Orthopaedics unit knew the ASR hips were failing and never told doctors. Analysts estimate that the litigation could cost J&J billions of dollars.

Sound Bites

J&J and DePuy deny Kransky’s claims, including failure to warn, defective design and negligent recall. In his opening, J&J lawyer Alexander Calfo said Kelly stitched together “snippets of e-mails, smidgeons of depositions and sound bites of memos” to paint a false picture of DePuy.

“When you hear the evidence of what actually happened with Mr. Kransky, you will see that story you just heard really isn’t the story,” Calfo told jurors. “DePuy is simply not the company the Kransky lawyers claim.”

J&J faced 10,100 lawsuits through September, according to a regulatory filing. Most pretrial collection of evidence is consolidated in federal court in Toledo, Ohio, where 7,240 cases are pending, and California state court in San Francisco, where more than 2,000 cases are filed. Other cases were filed in state courts around the U.S.

The company said in January 2012 that it had spent about $800 million on hip recalls during the prior two years. J&J didn’t provide an estimate of its product-liability costs.

Rejected Offer

J&J offered to pay more than $200,000 a case to settle most of the 10,000 lawsuits, according to five people familiar with the matter. The deal’s cost could exceed $2 billion if most plaintiffs accept the terms. Lawyers for hip recipients have so far rejected the offer, the people said.

Kelly said DePuy designed a metal cup that was supposed to stay squarely in the hip and not shed debris into the body. The design failed on both counts, he said, releasing cobalt and chromium debris into patients as the cup loosened, he said. DePuy did limited testing in machines and not people, he said.

“They chose not to do a controlled clinical study on people,” Kelly said.

DePuy, which sold the device around the world, began getting reports of problems as early as January 2005, he said. He cited a June 2005 e-mail from an Irish marketing official who said she was “quite concerned about our failure rate.”

She also wrote an e-mail in June 2006 about a doctor in the Netherlands who was considered a “key opinion leader” and who conducted a study that found “significant failure for the ASR,” according to Kelly. The doctor said he wouldn’t implant the device anymore, Kelly said.

‘Big Problem’

“This isn’t some doctor who is invisible, untrained or inept,” he said. DePuy had information that “we have a big problem. A key opinion leader for an entire country is done with us.”

J&J said in court papers that Kransky smoked since he was 12, broke his back when he was 15, and was exposed to Agent Orange when he served as a U.S. Air Force mechanic in Vietnam. He suffers from diabetes, coronary artery disease, high blood pressure, and kidney disease. He had two strokes and suffers from kidney cancer, according to the company.

Kelly said that in October 2011, Kransky had as much as seven times the normal level of cobalt in his body. Cobalt, he said, kills human cells.

Kransky’s lawyers are planning to call doctors who treated him to testify the former guard was “poisoned by the chromium and cobalt” released by the artificial hip, according to court filings.

In his opening, Calfo said that cobalt and chromium from the ASR hips don’t poison patients, including Kransky.

“The ASR was thoroughly tested and was researched before it was ever used,” Calfo said.

Massive Attack

Kransky’s medical conditions also weren’t caused by the ASR hip. Kransky, he said, had “a massive sustained attack on his blood vessels totally unrelated to the ASR.”

Kransky’s diabetes, high blood pressure and elevated cholesterol caused his health problems, Calfo said.

“Mr. Kransky had extensive medical conditions affecting his health long before he got the ASR,” Calfo said.

Calfo said that Kransky’s kidney problems compromised his body’s ability to flush chromium and cobalt, which weren’t at high enough levels to cause health problems.

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).

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