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Artificial Disc Recipients Take Legal Steps

There are success stories, but more than two dozen patients claim the device is too risky.

August 01, 2006|Rong-Gong Lin II | Times Staff Writer

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.

For The Record
Los Angeles Times Tuesday August 08, 2006 Home Edition Main News Part A Page 2 National Desk 1 inches; 39 words Type of Material: Correction
Artificial spinal disc: An Aug. 1 article in the Business section about lawsuits filed over an artificial replacement disc for the spine misspelled the last name of Phil Nalbone, a medical technology analyst at RBC Capital Markets, as Nabone.

"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 Peter Flowers, 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.

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