Suits Target J&J Discs

John Peloza, a spine surgeon in Dallas, says he has personally removed a Charite with "pits, abrasions and cracks in the surface" after just two years of use. Peloza warned the FDA against approving the device in the first place. He likes the ProDisc better, but sees problems with it as well. He has little information on the Flexicore, which is under development by Stryker, but feels the disc has "significant design flaws."

Peloza favors the Maverick -- which he is testing for Medtronic (MDT Quote) -- instead.

Meanwhile, at least one major player has deliberately refrained from pushing a disc onto the U.S. market. Zimmer (ZMH Quote) has begun selling a lumbar disc it inherited through an acquisition in markets overseas, but has no plans to do so here.

"My opinion hasn't changed one iota in three years -- including when everybody was hot to trot on the Charite and all of that," Zimmer CEO Ray Elliott told investors at a Morgan Stanley conference this spring. "I don't like plaintiff lawyers, plaintiff counsel in this country. ... I just don't like first-generation lumbar discs. I think people are going to be sorry they did that."

Seeking a Recall

Flowers sure hopes so. He says his clients want the Charite removed from the market -- to prevent future failures -- as much as they want damages for themselves.

"They think that this has got to be stopped," he says. "A lot of them are suicidal, and no one really knows what the fix is."

DePuy insists that the device works well for patients in the hands of the right surgeons.

But Titsworth feels that he chose the most qualified surgeon possible, a lead investigator for the Charite who has performed numerous disc replacements at one of the most respected hospitals in Los Angeles. However, Titsworth says, the doctor replaced two of his discs with Charites -- even though the FDA has approved just single-level replacements.