J&J Study Predicted 37% Hip-Failure Rate

One year after Johnson & Johnson (JNJ) pulled 93,000 metal hip implants from the market, the company internally estimated that 37 percent of the devices would fail within 4.6 years, according to newly unsealed court records.

J&J faces 10,000 lawsuits over its ASR hips, which it pulled in August 2010 after citing U.K. joint registry data showing that more than 12 percent failed within five years. The estimate of triple the failure rate publicly cited by J&J came in documents unsealed Jan. 18 in the lawsuit of Loren Kransky in state court in Los Angeles.

Jurors are scheduled to hear opening statements on Jan. 25 in Kransky’s case, the first to go to trial against J&J, the world’s biggest seller of health-care products. 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.

The failure-rate estimate came in pretrial testimony of Paul Voorhorst, a biostatistician for J&J’s DePuy unit, which made the hips. A plaintiff’s lawyer, Brian J. Devine, asked Voorhorst about a graph showing the company’s review of 554 implanted hips through September 2011, and how many would fail, requiring follow-up replacement surgery known as revisions.

“That means that 37 percent are expected to fail at 4.57 years, correct?” Devine asked Voorhorst.

“The estimated revision rate at that time would be 37 percent,” Voorhorst said. “That’s correct.”

‘Patient Interests’

Lorie Gawreluk, a DePuy spokeswoman, said that the company was “looking out for patient interests by analyzing data” on the ASR hip system.

She said the analysis cited by Voorhorst “was based on a small, limited set of data that could not be used to generalize the revision rate for ASR, unlike published data from national joint registries that include large numbers of patients and detailed revision information.”

The J&J hips were made from a cobalt and chromium alloy used in two related models -- the ASR XL Acetabular System, and the ASR Hip Resurfacing System. In announcing its recall, J&J cited unpublished data from the U.K. showing that within five years, 13 percent of ASR XL hips failed and needed revision, and 12 percent of the ASR Hip Resurfacing Systems failed.

In March 2011, the British Orthopaedic Association and the British Hip Society said preliminary data put the ASR XL’s failure rate in the U.K. as high as 49 percent after six years.

Metal Debris

Lawyers for patients claim that debris from the metal ball sliding against the metal cup causes tissue death around the joint and may increase the amount of metal ions in the bloodstream to harmful levels. Patients who sued typically cite pain and say they are immobilized by joint dislocations, infections and bone fractures.

Claims by Kransky include failure to warn, negligent recall and manufacturing defect.

At the Kransky trial, “DePuy will vigorously defend itself and believes the evidence to be presented will show the company acted appropriately and responsibly,” Gawreluk said.

Kransky, 65, is a retired prison guard who got a hip implant in 2007 and had it replaced in 2012. J&J’s lawyers asked Judge Stephen Czuleger to bar Kransky’s doctors from testifying their patient was “poisoned by the chromium and cobalt” released by the artificial hip, according to publicly filed court documents.

‘Poisoning’

Thomas Trotsky, Kransky’s primary care doctor, said in a deposition that his observations of Kransky over the years led him to conclude that “something was poisoning Mr. Kransky, and, of course, we thought it was the hip,” according to a Jan. 7 court filing.

Trotsky said he and his medical colleagues suspected Kransky was suffering from exposure to “heavy metal poisoning” and they were “unable to identify any other factor besides the prosthetic hip” that could be causing it, according to the documents.

While J&J opposed the motion, the judge ruled Jan. 18 that the doctors can testify. J&J’s lawyers argued that Kransky’s attorneys are seeking to “inflame the jury or appeal to their emotions” by having the doctors testify the former prison guard had been poisoned by the hip’s components.

J&J, based in New Brunswick, New Jersey, said in a November filing with the U.S. Securities and Exchange Commission that it increased reserves “due to anticipated product liability litigation and costs associated with” the ASR hips. The company didn’t specify the amount of the increase.

$800 Million

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.

J&J faced 10,100 suits over the hips through September, according to the November filing. Most pretrial collection of evidence has been 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 have been filed in state courts around the U.S.

In a Jan. 4 court filing, J&J said Kransky has 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.

Kransky’s case was chosen from those pending in the California Judicial Council Coordinated Proceeding before Judge Richard Kramer in San Francisco.

‘Rationalization’

Kransky’s lawyers said in a Jan. 7 court filing that DePuy decided in September 2009 through a process called “rationalization” to stop selling ASR hips for business reasons. They quoted a November 2009 memo from Paul Berman, DePuy’s U.S. director of hip marketing, to the sales force.

“This global rationalization is consistent with DePuy’s strategy to streamline its portfolio, reduce cost and reallocate resources to high growth brands and technologies that best meet the current and future needs of surgeons and patients,” Berman wrote, according to the filing.

DePuy “has consistently claimed it recalled the ASR for purely ‘financial reasons,’” Kransky’s lawyers wrote. DePuy then “attempted to pivot off that position, claiming the real reason it recalled the ASR was for a ‘remedial or precautionary measure,’” the lawyers wrote.

Kransky’s lawyers argued that DePuy sought to deem the recall a “remedial measure” so that it could exclude certain evidence from the trial.

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

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

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