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.
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.
"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 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.
