Suits TargetJ&J Discs

By Melissa Davis
Senior Writer

6/5/2006 7:16 AM EDT

Dane Titsworth had spent months in agony when he first saw the television advertisement for patients suffering from failed disc-replacement surgery.

Feeling desperate, Titsworth called the telephone number on the screen. He heard back from a Chicago-area law firm within days.

Pete Flowers, a partner at that firm, counts Titsworth among "several hundred" clients who are suing Johnson & Johnson (JNJ:NYSE) over problems with the company's Charite artificial discs.

Flowers has formally filed a handful of cases already and plans to keep on adding more. He portrays the damages involved as "extremely substantial."

Charite discs, introduced to the U.S. market with much fanfare less than two years ago, are meant to last a lifetime. But they can require life-threatening revision surgeries when they fail. And Flowers feels that they fail far too often.

"Most of these people are between 25 and 45 years old," he says of his clients. "A lot of them have lost their jobs, their spouses, their families, their houses -- everything."

For its part, Johnson & Johnson's orthopedic device unit, DePuy, continues to stand behind the Charite, saying that it enjoyed very high satisfaction scores among patients who received it during clinical trials and that failure rates have been "trending lower" since its approval. Meanwhile, the company says that it carefully evaluates any complaints about the disc that come to its attention.

The Charite lawsuits come as orthopedic device makers scramble for new ways to grow -- and attract some criticism in the process. The companies have been accused of developing new devices that seem like gimmicks at best -- and health threats at worst -- as they seek to reignite their once-highflying stocks.

Today, presents a three-part series that takes a closer look at some of the industry's latest offerings.

Natural Motion

Even Johnson & Johnson itself has expressed some disappointment with the Charite's domestic launch. In late 2004, the company seemed poised to capitalize on a new opportunity by offering the first-ever artificial disc approved for use in the U.S. market. The company quickly won over patients who were sometimes otherwise faced with spinal fusion by promising that "natural motion is back" through use of the new Charite disc being marketed by its DePuy Spine division.

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."

FDA spokeswoman Heather Howell told that the agency could offer no details about a panel review for the ProDisc or disclose if one will even be held. Rather, she said, the public must rely on the company itself for any information.

Synthes told that no FDA panel hearing will be held on the ProDisc and that no study results have yet been published on the device.

Rosen got nowhere with the FDA, either. So he next contacted a powerful senator bent on reforming the agency.

"The process of approval and monitoring of both of these disc replacements by the FDA has occurred under suspicious and secretive circumstances that suggest that this is the work of undue influence by industry," Rosen insisted in a February letter to Senate Finance Chairman Charles Grassley. "I believe this presents a real danger to the American people in a circumstance of money triumphing over patient care."

Rosen, who claims no financial conflicts himself, hopes to one day share his warning with a wider audience through formal testimony before the U.S. Senate.

Weighing the Risks

In the meantime, Rosen continues to do his homework.

After much prodding, for example, he finally got the FDA to send him 67 reports on adverse events involving the Charite. He found the information sorely incomplete and worrisome in nature.

Some "71% of reports were generated by 'company representatives' only, [and] not one report to the FDA concluded any device malfunctioned or was defective -- including the 11 cases where the device intrinsically malfunctioned with the plastic dissociating from the metal plate," Rosen says. Also, "it is striking that only 15% of retrieved specimens [artificial discs] were sent to the manufacturer for analysis. It is accepted widely -- and with little question -- that retrieval and analysis of any implant is critical for both evaluation and research."

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:NYSE) -- instead.

Meanwhile, at least one major player has deliberately refrained from pushing a disc onto the U.S. market. Zimmer (ZMH:NYSE) 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.

"We have a lot of clients with these double-level disc replacements," Flowers says. "DePuy may claim it can't control rogue doctors. But it's not like the doctors have 20 discs in their office. They call DePuy -- and there's a DePuy rep there [during the operation] -- so DePuy clearly knows what's going on."

To be fair, DePuy promotes Charites for the treatment of single-level disc disease only.

Meanwhile, Rosen regularly fields emails and telephone calls from suffering patients who underwent disc replacements involving the Charite and similar devices. He has successfully operated on two of those patients, including Titsworth, so far. He has no idea yet whether he can help the rest.

Titsworth feels better, but remains disabled at the age of 45. He says he's no longer "walking around with a broken spine" after Rosen repaired some of the damage caused by his device. Still, even now, he's no longer walking around very much at all.

He misses playing with his toddler, riding motorcycles with his teenage son and gardening with his wife. He misses "anything and everything," in fact.

"Walking down to the mailbox semi-pain-free would be nice," he says. "I watch TV. That's what I do. This is my life."

To be sure, however, he can remember feeling far worse before his latest surgery.   "They would ask me to rate my pain on a scale of 1 to 10, and I would say, '1,000,'" he recalls. "I lost my job. I almost lost my family. I'm surprised I'm even here."