An orthopedic surgeon who helped design the all-metal hip implant that Johnson & Johnson (JNJ:US) recalled in 2010 told a jury the device wasn’t defective as he testified in the first of 10,000 cases to go to trial.
Thomas Vail told state court jurors in Los Angeles yesterday that he received almost $2 million in royalty payments for his work on the ASR XL device, which J&J’s DePuy unit first sold in the U.S. in 2005. The company recalled 93,000 ASR hips worldwide in 2010 after saying 12 percent failed within five years. Analysts say the lawsuits might cost J&J billions of dollars.
Vail was called as a witness by a lawyer for Loren Kransky, 65, who claims defective design, failure to warn and negligent recall. Surgeons implanted a metal cup in the hip and a metal ball atop the femur that rotated inside the cup.
Vail was asked if the implant was defective, which a plaintiff’s lawyer defined as “unreasonably dangerous and unfit for human use.”
“I have not used the term ‘defective’ to describe the ASR product,” Vail testified in a videotaped deposition.
The lawyer, Denman Heard, asked if he had any concerns about the device when DePuy announced the recall.
“At the time of the recall, I didn’t experience any safety concerns among the patients that I had implanted,” Vail said.
The company (JNJ:US), the world’s largest seller of health-care products, based in New Brunswick, New Jersey, denies Kransky’s claims.
In his opening statement, J&J’s lawyer Alexander Calfo said the ASR was properly designed. He said Kransky’s claim of elevated metal levels in his body can be traced to conditions including diabetes, high blood pressure and cholesterol, strokes and kidney cancer.
Kransky, the attorney said, is a vasculopath, which means he has diseased blood vessels throughout his entire body.
Jurors also heard from another orthopedic surgeon, Craig Swenson of La Jolla, California, who implanted more than 5,000 hip devices over three decades. Before those surgeries, he told patients that 90 percent of implants last 15 years and 80 percent last 20 years.
“The goal is to have one operation,” he said. “The second operation is harder than the first operation, so you’d like to get it right the first time.”
Swenson said he began using the ASR in 2006 after concluding it would last longer and create less debris than devices using plastic or ceramic.
The results weren’t good, he said. Of more than 200 ASR hips he implanted from 2006 to 2010, 38 percent have failed, he said. Kransky’s attorney John Gomez asked how that rate compared to other devices that Swenson had used.
“It’s not even close to what we were using before,” Swenson said. “I don’t think this is an acceptable failure rate. It’s a higher failure rate than any product I’ve ever used.”
He said one indicator that the device was failing was blood tests showing increasing levels of chromium and cobalt ions. He also said the device results in more hip dislocations and loss of bone, muscle and tissue than other devices.
Swenson said that a 60-year-old surfboard shaper got one hip replaced in 1992, and it still functions well. In 2008, he replaced the other hip with an ASR device. After one year, the patient developed pain, clicking and popping. Swenson replaced it in 2011.
Swenson said a “signature injury” of the ASR is black tissue caused by metal debris around the hip. He called it “the black hole.”
He said he stopped using the ASR because of high failure rates reported through national registries in the U.K. and Australia. The Australian failure rate reported in 2012 after seven years was 44 percent.
The U.S. Food and Drug Administration issued a Jan. 17 advisory regarding metal-on-metal hip implants, saying that 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 case is Kransky v. DePuy, BC456086, California Superior Court, Los Angeles County (Los Angeles).
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