Wednesday, February 13, 2013

J&J Hips Surgeon Says Failure Rate Alters View on Device


The lead surgeon-designer forJohnson & Johnson’s recalled metal-on-metal hip implants testified that he wouldn’t have sold the device if he knew it would have a failure rate of 20 percent or more.

Thomas Schmalzried testified by videotape in state court in Los Angeles late yesterday at the first of 10,000 lawsuits to go to trial over ASR hips recalled by J&J’s DePuy unit. When J&J recalled 93,000 hips in August 2010, it said 12 percent failed within five years, requiring replacement, or revision, surgery.

Schmalzried, a Los Angeles surgeon, was asked about an internal DePuy study in 2011 showing 35.8 percent failed within 4.57 years, requiring revisions. He said of 66 ASR hips he implanted, 11 required revisions.

“If you knew it was going to fail and have to be revised 20 percent of the time within four years, would you as a designer have recommended this product to be put on the market?” asked Michael Kelly, an attorney for Loren Kransky, 65, who is suing over the results of his hip implant.

“I would not have put the product on the market,”Schmalzried said. That rate of revision was “higher than some products that were in the marketplace at the time” the ASR was introduced in the U.S. in 2005, he said.

Prison Guard

Kransky, a retired Montana prison guard who alleges that DePuy defectively designed the device, claims surgeons complained for years about its failures before the recall. DePuy failed to warn properly of the risks, he says.

J&J, the world’s largest seller of health-care products, denies it designed the ASR defectively or that it contributed to Kerensky’s health problems. J&J, based in New Brunswick, New Jersey, says it properly warned of the risks.

Schmalzried said he got net royalties of 2 percent on most devices sold. He said he believed he had gotten royalties of between $2.5 million and $3 million. Kelly said he had calculated the royalties at $3.66 million. Schmalzried said he didn’t know the correct amount.

Another surgeon who designed the ASR, Thomas Vail, earlier told jurors that he got slightly less than $2 million in royalties.

The suing patients claim that the ASR left them in pain or immobilized by joint dislocations, infections and bone fractures. They also complain of high levels of cobalt and chromium ions from wear on the devices, in which a metal ball placed atop the femur rotates in a cup implanted in the hip.

FDA Study

Both the U.S. Food and Drug Administration and the U.K.’s Medicines & Healthcare Products Regulatory Agency have studied metal-on-metal hip devices. On Jan. 17, the FDA said it didn’t have enough scientific data to specify the concentration of metal ions in a patient’s body or blood that would cause harmful systemic effects.

The agency said it wasn’t recommending a specific metal-ion level as a trigger for revision surgery.
In Schmalzried’s deposition, taken on April 11, 12 and 13, 2012 and compressed to 20 minutes for the jury, Kelly asked about the level of metal ions that would raise concern.

Schmalzried said two parts per billion because “there is a very low occurrence of adverse local tissue reactions, which would include both bone and soft tissue in association with ion levels of that magnitude.”

‘Patient Safety’

Kelly asked: “Do you think that that is in the best interest of patient safety, to use the two parts per billion level as the way you use it?”

“As of today, yes,” Schmalzried said.

“A year ago, if we had had this conversation, what would your number have been?” Kelly asked.
“It may have been more consistent with the MHRA recommendation of 7,” Schmalzried said.
Kransky’s lawyers say his cobalt level was from 47 to 53 parts per billion before his surgery in February 2012 to replace a hip he had implanted in December 2007.

In his opening statement on Jan. 25, J&J lawyer Alexander Calfo said that Kransky’s metal levels were the result of his poor health, including diabetes, strokes, cancer, cholesterol, high blood pressure, and a history of smoking.

Kransky, Calfo said, is a vaculopath, which means he has diseased blood vessels throughout his body. His chronic kidney disease “impacted his ability to excrete cobalt chromium metal ions,” Calfo told jurors.

The 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; David Voreacos in Newark, New Jersey, at
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