Suits Target J&J Discs

DePuy has struggled to convince some big insurers to cover the device, however, as payers continue to question both its safety and effectiveness. Meanwhile, just last month, the Centers for Medicare and Medicaid Services issued a formal noncoverage decision on the device -- though with a hard-sought concession that ranks as an important victory for the spine industry as a whole.

After fielding hundreds of comments in support of the Charite, nearly 80% of them form letters inked by a back institute with investments in the disc, CMS backed down a bit and said that it would refuse coverage only for patients over 60 and allow local decisions on the rest. HealthPoint Capital, a major orthopedic merchant bank, quickly applauded the move.

"Not everyone thought Charite was the be-all and end-all," the firm admitted last month. "But even people who didn't think highly of the Charite recognized the broader implications of CMS's decision. In particular, private payers would likely not cover the device or any similar devices, which -- beyond the obvious effect on patients -- would send a negative signal to all companies developing lumbar and cervical artificial discs."

Protesting the ProDisc

Meanwhile, Switzerland-based Synthes could launch U.S. sales of the first Charite competitor very soon.

Early this year, Synthes announced that it had received an "approvable" letter from the Food and Drug Administration for its new ProDisc. The agency deemed the device safe and effective, though it is withholding full approval until it can inspect the company's manufacturing facilities.

Charles Rosen, founding director of the University of California-Irvine Spine Center, was stunned. An early and outspoken Charite critic -- who says he has seen some failures himself -- Rosen initially considered the ProDisc news a mistake.

He quickly zipped off a letter to the FDA, asking if he had somehow missed the meeting that led to the agency's recommendation.

"I believe it would be inappropriate for the FDA to review a marketing application for this device without having a public advisory panel meeting," Rosen stressed. "Such a meeting is important given the questionable results -- and even dangerous consequences -- of the Charite artificial disc."