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Shattered Hopes From J&J's Spinal Disc

The once-promising Charite device faces hundreds of lawsuits.

Early on, before the pain resurfaced and grew so bad that she begged for paralysis, Randi Reichley-Guyton seemed like an ideal spokesperson for the Charite artificial spinal disc now being marketed by

Johnson & Johnson

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.

Reichley-Guyton worked as a fashion consultant for Victoria's Secret and spent her spare time playing sports until a back injury immobilized her in the late 1990s. Eager to restore her active lifestyle, she viewed the Charite disc replacement -- a promising but at the time unproven procedure in the U.S. -- as an attractive alternative to the typical fusion surgery.

"I was the first 'success' story," she recalls. "But I was actually the second patient to have the surgery here. The first one didn't want to talk. Maybe I should have taken that as a bad sign."

Initially, Reichley-Guyton fared quite well. Shortly after her surgery in 2000 at a trial site in Ohio, she portrayed the Charite as the answer to her prayers in a story published by

The Columbus Dispatch

. She says that she went on to promote the Charite ahead of regulatory approval in other interviews, arranged by the device's maker, as well.

But Reichley-Guyton's time in the spotlight proved short-lived.

"They used me as their spokesperson for six months, until something failed," she says. "Then it was like I had the plague. I no longer existed."

Desperate for relief, Reichley-Guyton is now among hundreds of Charite recipients suing Johnson & Johnson, claiming the device has massive shortcomings.

Johnson & Johnson paid $325 million for the Charite's maker, Link Spine, four years ago in an effort to gain first-mover advantage in what appeared to be a lucrative new market. The company has so far failed to convince Medicare and other insurers of the device's long-term value, however, and as a result Charite procedures have struggled for reimbursement. Johnson & Johnson faces a growing pile of product-related lawsuits to boot.

The Charite, which is meant to last decades in the young patients who receive them, has led to numerous failures after just three years on the market. Thus, even fans of artificial discs -- worried about the future of rival devices made by Synthes and

Medtronic

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-- complain about the Charite and its threat to a potential multibillion-dollar "motion preservation" industry.

For its part, Johnson & Johnson says the Charite is a successful option for the right patients in capable surgeons' hands. The company argues that the Charite's U.S. Food and Drug Administration approval, offering so-called "pre-emption" over state court actions, shields the device from liability claims. The company has managed to derail at least one big Charite case using the pre-emption argument already.

Last month, however, the U.S. Supreme Court agreed to consider a similar case filed against Medtronic that could determine whether FDA approval truly pre-empts state lawsuits. Regardless, Reichley-Guyton's own case, and hundreds of others like it, will continue to move forward on the basis of arguments that Johnson & Johnson misled the FDA when gaining the approval that supposedly carries that protection.

Reichley-Guyton, for one, says that her own Charite failed despite paperwork documenting its success. She therefore questions the validity of the data on which the FDA's blessing was based.

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"I'm not saying the disc might not have worked for some," she admits. "For six months, it worked for me. ... But now -- even after it's been approved -- nine out of 10 doctors I talk to say they wouldn't put one of these things in anybody."

A Johnson & Johnson representative couldn't be reached for comment specifically on Reichley-Guyton's case, but the company reiterated in an emailed statement that the FDA has approved the Charite as safe and effective.

Seeking Approval

To be fair, Johnson & Johnson had not yet purchased Charite's maker when Reichley-Guyton's problems with the disc first arose. Still, because she waited years for a doomed remedy as Johnson & Johnson took control of Charite and its clinical trial, she feels like a victim of the company nonetheless.

Technically, Reichley-Guyton no longer suffers from the same pain that led to her original disc replacement. Six months after that operation, the pain that was once in her right leg reignited in her left leg and grew more acute over time.

Yet rather than removing the disc and fusing her spine, Reichley-Guyton says, experts insisted that her new disc worked fine and that another disc needed replacement instead.

"They told me I would have to wait until FDA approval

for Charite before they could fix it" because the study allowed only single-level disc replacements, she explains. Meanwhile, "every time I would go in to fill out the paperwork, they would say: 'Negate the pain on your left side. That's not from the disc replacement. How's everything on your right side feel?'"

At first, Reichley-Guyton says that she offered positive answers because she wanted to help further the study along so she could get another operation. But eventually, she says, she started flipping over the FDA forms and sharing her true condition on the back.

Reichley-Guyton has no idea whether the FDA ever saw her written comments. Years later, however, she learned that the agency had finally approved the Charite for sale.

Relieved, Reichley-Guyton rushed back to her doctor for a second surgery that, because of its intricate nature, posed far more risks than she ever knew. She survived but regrets the operation and, at 46, now feels that she has no real life at all.

"You know that 'successful' disc they put in me?" she asks. "As soon as they opened me up, they jerked it out and put in an upgrade. Then they had to squish in another disc above it -- even though there really wasn't enough room -- because that was where the problem area was supposed to be.

"I have never gotten up and been able to move since that second surgery."

Filing Suit

Pete Flowers, a Chicago-area attorney working together with a major law firm, represents Reichley-Guyton and hundreds of other patients -- ranging in age from 18 to 52 -- who face similar dark fates. Together, those patients have filed a slew of lawsuits that raise questions about whether the Charite ever deserved FDA approval at all.

For starters, the plaintiffs argue, Johnson & Johnson's DePuy Spine unit altered Charite's design during clinical trials not because of physician convenience, as it claimed, but because of concerns about the device's safety and effectiveness. Moreover, the plaintiffs insist, DePuy made unfounded promises about the Charite that helped lead to the device's approval.

Two former high-ranking FDA officials, cited in court papers, have indicated that DePuy must be held accountable as a result. In a ruling issued this spring, denying DePuy's effort to dismiss the lawsuits, a Massachusetts superior court seemed to agree.

"DePuy's

FDA application makes repeated reference to certain fundamental characteristics of the Charite disc ... all of which appear to be inextricably tied to the FDA's conclusion that the medical benefits of the device outweigh any safety concerns," the court states. But "there is evidence that the device does not perform in the manner which DePuy represented to the FDA that it must perform."

DePuy insists that the court has yet to weigh the actual evidence involved and says it will vigorously defend itself as the lawsuits -- now entering the discovery stage -- move through the court system.

Flowers continues to field calls from Charite recipients who have suffered devastating failures in the meantime. Many of those clients, left totally disabled, lie helplessly in bed and dream of better days.

"In my mind, I'm still the person who laid down seven years ago for surgery," Reichley-Guyton says. "I close my eyes, and I'm still playing shortstop and volleyball. I still have my dreams.

"That is the person," she concludes, "I believed I would always be."