Wednesday, February 6, 2013

J&J Failed to Forecast Flaws Leading to Recall, Jury Told

( I prin ted this becuase I don;t recall any discussion of Project Alpha below.)


Johnson & Johnson (JNJ) failed in developing an all-metal hip implant to forecast key flaws that led to its recall in 2010, a project manager told jurors in the first of 10,000 lawsuits over the device to go to trial.

Lawyers for plaintiff Loren Kransky seek to show in a trial that began Jan. 25 in state court in Los Angeles that J&J’s DePuy unit knew its ASR hip implant had design defects and hid them from doctors. Magnus Flett was the first witness, and he told how DePuy analyzed what might cause the ASR hips to fail.

Kransky’s lawyers claim the implanted metal cups didn’t stimulate ingrowth of surrounding bone, making them unstable in the hip. They also claim the shallow design of the ASR cups, in which a metal ball atop the femur rotates, led to toxic debris of cobalt and chromium ions in the bloodstream. Analysts estimate the lawsuits could cost J&J billions of dollars.

Flett led a design team and oversaw a group conducting a so-called failure mode and effect analysis, or FMEA, of a cup that was shallower than other cups. Kransky attorney Michael Kelly asked if the group foresaw that the “likelihood of lack of bony ingrowth” would be “almost never.”

“We have forecast it to be minimum,” responded Flett, whose videotaped testimony resumed today.
The company denies Kransky’s claims, including failure to warn, defective design and negligent recall. In his opening statement, Alexander Calfo, a lawyer for J&J, said Kelly stitched together “snippets of e-mails, smidgens of depositions and sound bites of memos” to paint a false picture of DePuy.

‘Plain Truth’

In his opening statement, Kelly said that while DePuy advised doctors ideally to place the cup at a 45 degree angle in the hip, a study showed more than half of implants were placed at wider angles. DePuy began selling ASR devices in Europe in 2004 and in the U.S. in 2005. Soon after that, doctors began reporting that the cup could be unstable and lead to the release of metal ions, Kelly said.
“Isn’t it true that DePuy didn’t know in 2008, 2007, 2006, 2005, ’04, all the way down to the design, DePuy had no idea what the acceptable range was for the placement of the ASR?”Kelly asked Flett. “Isn’t that the simple and plain truth?”

“I think the data as we started to get it indicated angles above 55 gave us increased ion results,” Flett said.

Increased Wear

Flett said that he joined DePuy to work on the ASR design after spending 15 years working on automotive brake systems.

J&J, based in New Brunswick, New Jersey, recalled the hip devices after saying U.K. data showed the ASR failed in more than 12 percent of patients after five years. Kelly said internal J&J documents show 37 percent of ASR hips failed after 4.6 years. An Australian joint registry showed that 44 percent failed after seven years, he said.

Kelly, in his opening statement, displayed a DePuy document from Sept. 27, 2007, describing how “massively increased wear”can occur when the cup is “oriented at a steep angle.” Thecompany could “significantly redesign” the ASR to remove a groove, or ridge, that was part of the cup’s design, according to the document.

He referred to a May 2, 2008, e-mail in which Paul Berman, DePuy’s head of U.S. marketing, said, “We will ultimately need a cup redesign but the short-term action is manage perceptions.”

‘Project Alpha’

Kelly referred to a Berman e-mail on July 2, 2008, about sales representatives “telling surgeons DePuy is making an emergency change to the ASR cup. We must keep the ASR 2 project under total wrap, particularly in the U.S. where we will not make the change immediately. As expected, the competition will use this information against us.”

Berman also wrote: “Lastly, I propose any future reference to ASR 2 is Project Alpha. Please be cognizant about who you discuss this project with, particularly outside the company.”
In testimony today, Flett said DePuy scrapped efforts to redesign the ASR cup because of financial and business reasons. He said that DePuy never told surgeons that the ASR failed and required followup surgeries known as revisions at a rate that was eight times that of another company hip device, the Pinnacle.

“I don’t believe that was clinically relevant,” he said.
Flett also discussed a proposal to study the performance of the ASR against the Pinnacle, another metal-on-metal device.

“This study seems like suicide to me,” he said in an e-mail. Flett testified that he likened such a study to suicide because “it will prove that one is better than the other and they are both our products and that means one will be worse.”

Sales Stopped

He said DePuy stopped selling the device in late 2009.
“We didn’t see the sales of the product continuing the way we wanted, so we took it off the market,” Flett said.

Another witness, Dr. George Samaras, testified as an expert for Kransky’s lawyers and criticized DePuy’s failure mode and effect analysis.

J&J 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.

The company 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 cost could exceed $2 billion if most plaintiffs accept the terms. Lawyers for hip recipients rejected the offer, the people said.

J&J has said that Kransky’s claims of elevated metal levels in his body can be traced to his other health problems. Kransky smoked since he was 12 and was exposed to the defoliant chemicalAgent Orange when he served as a U.S. Air Force mechanic inVietnam. He suffers from diabetes, coronary artery disease, highblood pressure, and kidney disease. He had two strokes and suffers from kidney cancer, according to the company.

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