Artificial Disc Recipients Take Legal Steps
There are success stories, but more than two dozen patients claim the device is too riskyAug 4, 2006 | Los Angeles Times
Since the moment a decade ago when Dane Titsworth picked up a box and a disc in his spine burst, he has been in ever-worsening pain.
So it was with great hope that the Bakersfield building maintenance manager agreed last year to a new procedure. It meant replacing the deteriorating disc in his lower back with a Charite-brand artificial one the first artificial replacement disc approved in the U.S.
"The artificial disc was going to restore my full motion and relieve all my pain," he recalled being told by his doctor. "I would be like a new person."
But after the surgery, he said, the pain became excruciating, virtually immobilizing him. He could no longer work, garden, play catch or ride his motorcycle. After about 10 months on sick leave, he lost his job.
"It failed," said Titsworth, 45, a married father of a 13-year-old son and 2-year-old daughter. "It's pretty much stopped my life." And now he is suing the disc's maker, DePuy Spine Inc., a Raynham, Mass.-based subsidiary of Johnson & Johnson.
Used in Europe since the 1980s and approved by the Food and Drug Administration in 2004, the Charite disc is marketed as an alternative to spinal fusion and is part of the growing and sometimes controversial use of spinal surgery.
The disc's maker says the product is safe and has helped thousands of patients. But DePuy had no comment on Titsworth's case or 27 similar lawsuits filed since January. Five involve California plaintiffs.
The suits allege that the disc is "unreasonably dangerous."
"They've designed a defective product that does not work as intended or as advertised, and in fact causes some horrific side effects," said Titsworth's lawyer.
DePuy spokeswoman Debbie Williams says the product garnered high satisfaction rates among patients and surgeons in a two-year, industry-funded study that was filed with the FDA before its approval.
"As with all surgical procedures, there is a potential for adverse events or complications," Williams said in an e-mail. Still, "the clinical evidence shows the Charite artificial disc is an effective treatment and an option for appropriate patients."
She said that the product "preserves some motion" and "has demonstrated a shorter recovery time compared to fusion." Spinal fusion, the leading surgical treatment for damaged discs, involves placing bone grafts around two or more of the vertebrae during surgery. The body then heals the grafts over several months, which "welds" the vertebrae into a rigid section.
Dr. John Regan, a Beverly Hills surgeon who performs surgery using the artificial disc, said fusion might add stress on adjacent, healthier discs, increasing the risk of future damage.
In contrast, an artificial replacement disc is designed to keep the damaged area flexible, said Regan, who receives some royalties from DePuy unrelated to surgeries he has performed.
Some patients say the Charite disc has given them a new chance for an active lifestyle they thought had been lost forever.
Ron Osborn, 57, of Saugus, said he was surprised at how well his Charite disc has performed. The natural disc it replaced had deteriorated so much that the bones on his spine were crushing a major nerve, leaving him unable to walk for weeks at a time.
"Now I'm back," said Osborn, a sales manager for a golf company. "I've got 100% restoration. I have a back of a 20-year-old."
Similarly, Rick Zayed, 38, an aerospace mechanical engineer from Hermosa Beach, went from struggling to lift a laundry basket to swimming, running and mountain biking.
"So far, everything they said it would do, it's been doing," Zayed said.
But Dr. Allyson Fried-Cain, a former foot-and-ankle surgeon who has sued the manufacturer, said that she suffered such an increase in pain after a Charite disc implantation that she lost her practice and had to sell her Marina del Rey home.
"I couldn't do surgery anymore. I couldn't bend over," said Fried-Cain, 52, a former marathon runner whose back injury resulted from a car accident.
"This implant has destroyed my life," she said.
The Charite disc is advertised on its website with the trademarked slogan "natural motion is back," along with a photo of a family walking through a field.
The suits come as spinal surgery is becoming a very lucrative business, with at least $3.2 billion spent last year in the U.S. on spinal fusion.
Millions of Americans who suffer from persistent lower back pain are looking for relief, and employers lose billions of dollars every year from lost work time due to back pain.
Other medical device companies, including West Chester, Pa.-based Synthes Inc. and Minneapolis-based Medtronic Inc., are developing disc replacements.
"It's an enormous commercial opportunity," said Phil Nabone, a medical technology analyst at RBC Capital Markets.
But since its launch, the Charite disc has been controversial.
Although two national insurance carriers and 60 regional providers cover the device, a medical advisory panel for the Blue Cross Blue Shield Assn. said in an evidence-based review last year that there was "no immediately evident advantage" to using the artificial disc.
And this year, the U.S. Centers for Medicare and Medicaid Services questioned the disc's overall effectiveness.
The original two-year trial sent to the FDA showed only that the disc was no worse than a specific type of spinal fusion surgery, the agency said in a 45-page report released in May.
The study is sometimes criticized because it compared the disc with a spinal fusion technique that has fallen out of favor among surgeons.
The trial submitted to the FDA found that 57% of Charite patients achieved "overall clinical success," compared with 47% in the spinal fusion procedure. More than 3 in 5 Charite disc patients who were considered successes continued taking narcotic pain killers two years after the surgery; while 4 in 5 did so in the control group.
But a higher percentage of Charite disc patients suffered severe or life-threatening events than the spinal fusion group: 15% compared with 9%, according to an FDA clinical review.
As a result, the agency ruled that Medicare would bar coverage of the device for anyone older than 60. Local Medicare contractors were allowed to make the decision for anyone younger.
"This composite outcome is unconvincing as a demonstration of health benefit," the Medicare report said.
Some doctors are equally skeptical.
Dr. Sohail Mirza, a University of Washington medical professor, took issue with Charite disc's marketing slogan of "natural motion is back." It "implies that the artificial disc creates a normal spine; it does not," he wrote in the journal Spine last year.
"Contrary to optimistic marketing, the data … argue for caution by patients and surgeons. Hope for a cure of back pain and a marketing bonanza must be held in check," he wrote.
Dr. Charles Rosen, associate clinical professor of spine surgery at UC Irvine, said he has seen 10 patients since late last year, including Titsworth, complaining of worsening pain after they received the Charite disc.
Rosen said he believes the disc is unsafe and should never have been approved by the FDA. After the surgery, some patients suffered fracturing and an abnormal pulling apart of the joints of the spine, he said. Rosen said the two-year study was too short for a disc that will remain in the spine for many years; the average age of a disc recipient is 40.
"There is no solid evidence that this will last for more than five or 10 years and they will not need to have another operation," Rosen said.
Regan, who helped conduct the clinical trial for the Charite disc, said he is convinced the disc is good technology.
"When you focus on the failures, everyone's thinking, 'What's wrong with this?' " Regan said. "Then it spoils it for the many, many patients who are doing great."