By Maurice Possley, David Voreacos and Jef Feeley – Jan 31, 2013

Johnson & Johnson (JNJ)’s DePuy unit took“inappropriate” steps to identify and eliminate risks in the design of 93,000 all-metal hip implants that J&J recalled, a company compliance manager told a California jury.

DePuy’s Jimmy Smith testified today 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 in the U.K. Analysts say the lawsuits may cost J&J billions of dollars.

Smith oversaw a 2011 review of a design team’s safety standards for the ASR hip cup, in which a metal ball atop the femur rotates. Smith said his audit found that a DePuy group used irrelevant controls in a so-called failure mode and effect analysis, or FMEA, before the ASR was sold in 2005 in the U.S.

“The audit found numerous failure modes that were assessed with either inappropriate or irrelevant controls,” Smith said in state court in Los Angeles.

A lawyer for Loren Kransky, 65, a Montana man who is suing DePuy over his failed hip, questioned Smith about controls that were supposed to help prevent such problems as the cup loosening in the hip or chromium and cobalt flecking into nearby tissue.

“We didn’t predict the levels of excessive wear and the loosening that have been identified,” Smith said. “They did their job, but they could have done it better.”

Kransky’s lawyers emphasize that DePuy marketed the ASR device as producing the least debris of any metal-on-metal cup, yet its high failure rates often involved excessive cup wear.

Defective Design

J&J, the world’s largest seller of health-care products, denies that it defectively designed the device or that it contributed to Kransky’s health problems. J&J is based in New Brunswick, New Jersey.

Kransky’s lawyers are trying to show that DePuy cut corners in designing the ASR, failed to test it in humans, and pushed the device over its own cheaper and safer hip, the Pinnacle.

Smith said the DePuy team that analyzed potential failures fell short in 13 areas, such as possible deformation of the ASR cup. The team used the best information it had at the time, he said. Smith didn’t specifically say that the ASR devices failed because of lapses in the design team’s safety standards.

Failure Rate

Kransky attorney Michael Kelly has told jurors that a DePuy analysis in September 2011 showed 37 percent of ASR hips failed within 4.5 years, and 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.

Jurors also heard testimony from Graham Isaac, an engineer in Leeds, England, who was questioned by Kelly about his work on the design of the device.

Isaac said the ASR had cups of 10 different diameters, yet DePuy performed laboratory testing on just one size. He said the company only tested it at one optimum angle of implant in the hip — 45 degrees — and not other positions that surgeons used.

“It was very difficult to test this device,” Isaac said.

It would have been costly and time-consuming to recalibrate simulator machinery and conduct tests on all sizes, Isaac said.

“It would have been too expensive,” he said. “It would have been very difficult to modify the machinery to test at high angles.”

Kelly asked: “Because it was difficult, did you consider not selling them?”

‘Testing Adequate’

“We considered the testing adequate,” Isaac said. “It was not perceived as a problem.”

Kelly questioned him about a design brochure that DePuy gave to doctors and that stated, “The wear performance of these bearings will be at least as good as existing DePuy metal-on-metal designs.”

He pointed out that by the time of launch, DePuy hadn’t tested other size heads to see if they were as good as existing designs. He asked how DePuy could make such a claim.

“You can make an inference,” Isaac said.

“Is that how your company does business, on the basis of inference?” Kelly asked.

“No,” Isaac said. “We aim to test as much as we can to show the product is safe. We do what we believe is necessary to assure the safety of the product.”

Isaac said that as early as 2002, he realized metal debris posed a risk to patients. He co-wrote a paper that said, among other points, that debris kills human cells.

Design Team

Kelly reviewed minutes of a surgeon design team meeting on Sept. 30, 2005. Several DePuy marketers attended. The orthopedic surgeons included Thomas Schmalzried and Thomas Vail, who are defendants in many of the 2,000 or so California lawsuits. DePuy paid Schmalzried more than $3 million in royalties. Vail testified yesterday by videotape that he got almost $2 million.

At the meeting, the surgeons discussed the possibility of including a toxicologist to “address the perceived risk of cancer due to metal ion release,” according to the minutes.

“Although it was agreed that this would be a useful study to undertake,” Schmalzried was concerned that “the information needs to be contextualized to allay fears rather than feed them,” according to the minutes.

‘Safe Level’

Kelly asked Isaac if it wasn’t true that when DePuy marketed the ASR, “you did not know what a safe level of metal ions was in a patient.”

“We don’t know and nobody knows,” Isaac said.

The U.S. Food and Drug Administration issued a Jan. 17 advisory about metal-on-metal hip implants. It 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.”

The FDA said it wasn’t recommending a specific metal-ion level as a trigger for revision surgery.

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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