A hip replacement made by Johnson & Johnson (JNJ)’s DePuy unit fails in the U.K. as often as 49 percent of the time, or four times what the company cited in recalling the device last year, a British orthopedists’ group said.
The British Orthopaedic Association and the British Hip Society said in a statement this week that data on the ASR XL Acetabular System from four surgeons show the rate of second operations, or revisions, ranges from 21 percent after four years to 49 percent after six years.
“It’s probably the best indicator so far of what the failure rate is likely to be,” John Skinner, an orthopedic surgeon and chairman of the groups’ expert advisory group on metal bearing hips, said in a telephone interview. “As far as I can tell, it’s reliable.” Skinner said the data haven’t undergone peer review required for publication.
DePuy recalled both the ASR XL and an ASR hip resurfacing system in August. At the time, the company cited unpublished data from the National Joint Registry of England and Wales saying 13 percent of ASR XL patients required second surgeries in five years, and 12 percent of patients with the resurfaced hips needed such operations within five years. Both devices use metal balls and sockets to replace ailing hips. The orthopedists didn’t report on the resurfacing system in the statement.
‘DePuy Remains Committed’
“Since the recall decision was made, DePuy has worked to provide patients and surgeons with the information and support they need,” Mindy Tinsley, a DePuy spokeswoman, said in an e- mailed statement. “DePuy remains committed to addressing reasonable and customary costs of testing and treatment for reasons related to the recall, including revision surgery if necessary.”
J&J fell 31 cents to $60.40 at 4:15 p.m. in New York Stock Exchange composite trading. The shares have declined 2.3 percent this year. The DePuy unit, which also makes spinal-care products, generated $5.59 billion in sales last year, 9.1 percent of total revenue for Johnson & Johnson, according to data compiled by Bloomberg.
Only the ASR XL was approved for sale in the U.S., where 37,000 were implanted. New Brunswick, New Jersey-based J&J, the world’s largest health-care company, faces 600 lawsuits in the U.S. so far over the devices. Lawyers suing the company on behalf of patients have said the damages could cost DePuy billions of dollars.
Skinner said that about 10,000 of the hips were implanted in the U.K., including 5,000 or so resurfacing devices and 5,000 of the ASR XL prostheses, also known as total-hip replacements.
The group said that “well researched and audited results” of these devices “show a higher than anticipated early failure rate.” The 21 percent revision rate at 4 years could rise to 35 percent “if all currently known painful implants progress to revision,” according to the statement.
The two-page statement, obtained by Bloomberg News, said the four sets of data were presented last week at the British Hip Society Annual Conference.
The statement limits itself to commentary on large diameter metal-on-metal implants, without defining “large diameter.”
DePuy said in its August recall statement that revision rates would probably be highest for ASR head sizes less than 50 millimeters (0.2 inch) in diameter, generally the types implanted in female patients.
“Based on the results presented, the use of large diameter metal-on-metal bearings in primary total hip replacement should be carefully considered and possibly avoided,” the U.K. panel wrote.
“The results were at a level where we thought it was best to act now,” Skinner said. “The purpose is to tell British surgeons that the ASR XL patients are likely to have a higher rate of revision on the basis of this data, if it turns out to be correct.”
David Floyd has submitted his resignation as president of DePuy Orthopaedics, the maker of the hip replacements, Lorie Gawreluk, a company spokeswoman, said last week. Floyd is leaving at the end of March to “pursue other interests,” she said, declining to be more specific.
“These are catastrophic failures,” John Restaino, an attorney and co-chairman of the plaintiffs’ science committee in federal litigation over the device in the U.S., said in a phone interview. “A revision rate of 49 percent after six years is astounding,” Restaino, a former podiatric surgeon, said.
Plaintiffs have brought product-liability, negligence and failure-to-warn claims against DePuy over the devices, and are seeking medical costs, lost wages and compensation for their pain and suffering. More than 350 lawsuits have been consolidated in federal court in Ohio, and more than 220 are pending in California state court. Another group of cases is pending in New Jersey state court.
The statement by the British orthopedists “suggests that DePuy has a bigger problem on its hands than it has acknowledged,” said Lexi Hazam of Lieff Cabraser Heimann & Bernstein LLP in San Francisco, who is representing clients in DePuy hip lawsuits.
J&J bought DePuy for $3.5 billion in 1998. A year earlier, London-based Smith & Nephew Plc had introduced the Birmingham Hip Replacement, or BHR, a device that built on the metal-on- metal designs of the 1960s and 1970s which had fallen out of favor as metal-on-polyethylene grew popular.
Cup in Socket
The BHR consists of a cup implanted in the pelvic hip socket, or acetabulum, and a cap that covers, or resurfaces, the ball-shaped head of the thigh bone, or femur, that fits into the pelvic socket.
DePuy began selling a similar device, the ASR Hip Resurfacing System, outside the U.S. in 2003. The ASR XL Acetabular System involves a cup and a ball that sit atop a stem driven into the femur, requiring more bone loss than in a resurfacing.
DePuy hip sales slowed at the end of last year, hurt by the recalls, said Michael Mahoney, J&J’s worldwide chairman for medical devices, in a March 2 presentation at an investor conference. DePuy is still the world’s leading seller of artificial hips, he said.
The company took a $280 million charge in the fourth quarter to pay for the recall, according to a Jan. 25 earnings statement.
“We’re setting the right high bar for the industry in how we’re managing the recall. But it is something that we’re continuing to work through,” Mahoney said at the conference. “We’ll see the impact of ASR diminish throughout, as we move forward in 2011.”
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