http://www.yourlawyer.com/topics/overview/charite_spinal_discs Sat, 21 Nov 2009 15:24:24 -0800 pixel-app en http://www.yourlawyer.com/articles/read/12768 Fri, 13 Apr 2007 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12768
A Massachusetts state court earlier this week refused to dismiss four lawsuits filed against DePuy alleging the company's Charite Artificial Disc used to replace diseased or damaged spinal discs as an alternative to spinal fusion -- doesn't work for its intended purpose.

The plaintiffs in the four cases alleged the spinal device failed, causing serious and lasting damage.

The court refused to buy DePuy's defense that approval of the product by the Food and Drug Administration insulated the company from lawsuits based on product defect, a legal strategy known as pre-emption.

"In short, DePuy was claiming that since the FDA gave its approval for the disc's use, it was inoculated against claims of defect or negligence in its design," said one of the law firms representing the plaintiffs. "We demonstrated to the court that the pre-emption defense in this case went well beyond the pale."

In its ruling, the court said, "There is evidence to support the device does not perform in the manner which DePuy represented to the FDA that it must perform."

The plaintiff also cited promotional materials used by DePuy that they said misleadingly claimed, "The Charite Artificial Disc has a clinical history spanning 17 years. Its safety, efficiency and remarkable durability have been proven through thousands of implants worldwide," and that "Natural Motion is Back."

The plaintiffs also charged that DePuy failed to notify the FDA that it had modified the design of the Charite disc sold in Europe because of safety and effectiveness concerns, yet told the agency the changes were made for physician convenience.
]]> http://www.yourlawyer.com/articles/read/12044 Fri, 04 Aug 2006 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12044
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.

"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 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.

Dr. John Regan, a Beverly Hills surgeon who performs surgery using the artificial disc, said fusion might add stress on adjacent, healthier discs, increasing the risk of future damage.

In contrast, an artificial replacement disc is designed to keep the damaged area flexible, said Regan, who receives some royalties from DePuy unrelated to surgeries he has performed.

Some patients say the Charite disc has given them a new chance for an active lifestyle they thought had been lost forever.

Ron Osborn, 57, of Saugus, said he was surprised at how well his Charite disc has performed. The natural disc it replaced had deteriorated so much that the bones on his spine were crushing a major nerve, leaving him unable to walk for weeks at a time.

"Now I'm back," said Osborn, a sales manager for a golf company. "I've got 100% restoration. I have a back of a 20-year-old."

Similarly, Rick Zayed, 38, an aerospace mechanical engineer from Hermosa Beach, went from struggling to lift a laundry basket to swimming, running and mountain biking.

"So far, everything they said it would do, it's been doing," Zayed said.

But Dr. Allyson Fried-Cain, a former foot-and-ankle surgeon who has sued the manufacturer, said that she suffered such an increase in pain after a Charite disc implantation that she lost her practice and had to sell her Marina del Rey home.

"I couldn't do surgery anymore. I couldn't bend over," said Fried-Cain, 52, a former marathon runner whose back injury resulted from a car accident.

"This implant has destroyed my life," she said.

The Charite disc is advertised on its website with the trademarked slogan "natural motion is back," along with a photo of a family walking through a field.

The suits come as spinal surgery is becoming a very lucrative business, with at least $3.2 billion spent last year in the U.S. on spinal fusion.

Millions of Americans who suffer from persistent lower back pain are looking for relief, and employers lose billions of dollars every year from lost work time due to back pain.

Other medical device companies, including West Chester, Pa.-based Synthes Inc. and Minneapolis-based Medtronic Inc., are developing disc replacements.

"It's an enormous commercial opportunity," said Phil Nabone, a medical technology analyst at RBC Capital Markets.

But since its launch, the Charite disc has been controversial.

Although two national insurance carriers and 60 regional providers cover the device, a medical advisory panel for the Blue Cross Blue Shield Assn. said in an evidence-based review last year that there was "no immediately evident advantage" to using the artificial disc.

And this year, the U.S. Centers for Medicare and Medicaid Services questioned the disc's overall effectiveness.

The original two-year trial sent to the FDA showed only that the disc was no worse than a specific type of spinal fusion surgery, the agency said in a 45-page report released in May.

The study is sometimes criticized because it compared the disc with a spinal fusion technique that has fallen out of favor among surgeons.

The trial submitted to the FDA found that 57% of Charite patients achieved "overall clinical success," compared with 47% in the spinal fusion procedure. More than 3 in 5 Charite disc patients who were considered successes continued taking narcotic pain killers two years after the surgery; while 4 in 5 did so in the control group.

But a higher percentage of Charite disc patients suffered severe or life-threatening events than the spinal fusion group: 15% compared with 9%, according to an FDA clinical review.

As a result, the agency ruled that Medicare would bar coverage of the device for anyone older than 60. Local Medicare contractors were allowed to make the decision for anyone younger.

"This composite outcome is unconvincing as a demonstration of health benefit," the Medicare report said.

Some doctors are equally skeptical.

Dr. Sohail Mirza, a University of Washington medical professor, took issue with Charite disc's marketing slogan of "natural motion is back." It "implies that the artificial disc creates a normal spine; it does not," he wrote in the journal Spine last year.

"Contrary to optimistic marketing, the data … argue for caution by patients and surgeons. Hope for a cure of back pain and a marketing bonanza must be held in check," he wrote.

Dr. Charles Rosen, associate clinical professor of spine surgery at UC Irvine, said he has seen 10 patients since late last year, including Titsworth, complaining of worsening pain after they received the Charite disc.

Rosen said he believes the disc is unsafe and should never have been approved by the FDA. After the surgery, some patients suffered fracturing and an abnormal pulling apart of the joints of the spine, he said. Rosen said the two-year study was too short for a disc that will remain in the spine for many years; the average age of a disc recipient is 40.

"There is no solid evidence that this will last for more than five or 10 years and they will not need to have another operation," Rosen said.

Regan, who helped conduct the clinical trial for the Charite disc, said he is convinced the disc is good technology.

"When you focus on the failures, everyone's thinking, 'What's wrong with this?' " Regan said. "Then it spoils it for the many, many patients who are doing great."]]> http://www.yourlawyer.com/articles/read/10809 Tue, 11 Oct 2005 00:00:00 -0700 http://www.yourlawyer.com/articles/read/10809
Before the experimental surgery, he rated his pain as three on a 10-point scale. Today, three years after the surgery to place the Charité artificial disc into the lumbar part of his spine, Vranian's pain scores have almost reached 10. The 49-year-old California man can no longer work, and lives on daily doses of morphine to alleviate pain.

Vranian is one of 3,000 Americans who have undergone surgery to implant the Charité artificial disc, made by DePuy Spine, a division of Johnson & Johnson with headquarters in Raynham, Mass. Last October, the Food and Drug Administration approved the device, the first of its kind for the lumbar spine. More than a dozen other companies are developing similar devices.

But a growing number of surgeons are concerned that the studies conducted on the Charité artificial disc were fraught with problems.

"I'd like people to really understand the risks and the limited benefits," said Dr. Sohail Mirza, associate professor in the department of orthopedic and neurological surgery at the University of Washington in Seattle. Two papers outlining the results of a study used to gain FDA approval were published last month in the journal Spine. Mirza wrote an editorial in that issue outlining concerns about the artificial disc. Several other surgeons worried about the Charité artificial disc wrote online commentaries for the journal.

"If you are doing it to treat back pain, it didn't show much effect," Mirza said. The one study reviewed by the FDA followed 205 patients with the implanted disc and compared them with 99 others who had a spinal fusion with a device called a BAK cage that was popular in the 1990s. "The BAK is no longer being used today because it didn't work," Mirza said.

57 percent success rate

The latest study in Spine reported a 57 percent success rate for the Charité. That meant no major complications, no surgery to remove the device and patients reported a 25 percent improvement in daily function. Pain itself was not something the researchers took note of. "Most people still had pain after two years," Mirza said. "Most people were still taking narcotics."

"In any other surgical procedure a 57 percent success rate is nothing to be proud of," Mirza added.

He and others are concerned that millions of people suffer from chronic lower-back pain and lumbar disc degeneration, and that surgeons may be too quick to offer the artificial disc option without questioning the benefits and risks of long-term problems. The same artificial disc has been used in Europe for almost 20 years, but follow-up information on these patients is not readily available, Mirza said. One group in the Netherlands reported on complications in 27 patients, ranging from abdominal wall bleeding to erectile dysfunction and migration of the device that required surgery to move or remove it.

About 200,000 people in the United States undergo spinal fusion for lower-back pain every year. Since federal approval last October, the company has been hosting training sessions for surgeons. The Charité device itself costs around $12,000; surgery and hospital fees cost about $30,000.

Dr. Richard Toselli, worldwide vice president for research and development at DePuy Spine, said 3,000 people in the United States have had the disc surgically implanted since last fall. As with all new federally approved devices, the FDA keeps track of adverse reactions.

"There have been issues related to the disc and its adoption," Toselli said. "But it is safe and effective when used in the proper patients."

Problems with early study

Like most surgeons, Dr. Charles Rosen, an associate clinical professor at the University of California at Irvine, was initially intrigued by the new technique. But when he began reading the fine print on the study results, he saw red flags everywhere. First, he said, the company failed to include the first 75 patients enrolled in the experimental surgical study. "These were called 'training' patients," said Rosen. "This represented 25 percent of their sample." An FDA bio-statistician, Jianxiong Chu, agreed at a public hearing that "excluding patients biased the results."

Then Rosen began seeing patients, including Vranian, who were having problems with the disc.

"Patients want these discs," said Dr. Robert F. Heary, a neurosurgeon at the Spine Center of New Jersey and a professor at UMDNJ-New Jersey Medical School in Newark. "They see artificial hips and knees and assume it falls into the same category. But they are very different joints. That is a very big leap of faith."

The surgery itself is also riskier than hip or knee procedures. The device is put in through a small opening in the abdomen, a technique to gain access to the spine and avoid direct contact with the nerves. But if something happens - if the device slips or wears down - surgeons can't go through the abdomen again without risking life-threatening bleeds, Rosen said.

"Revisions are considered a nightmare," Heary added.

"Patients need to think carefully about this device," said Mirza. "This is not like getting a new car part, where it's in and you are set to go. This is a big deal, and it's not something you can undo without great risk." He also worries that surgeons are operating on people who are a decade or so younger than those who have been seeking spinal fusion. It's not clear how long the disc will last.

"I am not sure I would put it in me," Mirza added. "So I would have a hard time putting it in one of my patients."

Rosen said he asked the company and the FDA for supplemental reports on disc complications, but the FDA viewed those numbers as proprietary and the company also said no.

Mirza, who sat through an intensive training program for surgeons, said the complications with the disc were covered in a talk over dinner, rather than in the course itself.

Surgery requires great skill

Dr. Fabien Bitan, chief of spine surgery at Lenox Hill Hospital in Manhattan, has probably done more Charité implants than anyone in the country, around 200. His first experience was as a resident in France in the 1980s, when the disc first came out. Later, he was recruited to help design the U.S. trial.

"Is it the final product? Probably not," he said. "The problem is that whatever you say works today is going to be wrong in 10 years. But this is most likely the future."

He said that the device is difficult to implant, and surgeons do have better outcomes the more operations they do with it. "You need a lot of skill in anterior spinal surgery," he said. He's satisfied with the results in his hands. So are most of his patients, he said: 60 percent of them are almost pain-free.

Vranian said he was drawn to the experimental surgery because of the enthusiasm of his surgeons. "It sounded too good to be true," Vranian recalls. "My expectations were so high because of what my surgeons told me."

Doctors agree that surgery should not be the first treatment option for lower-back pain from disc degeneration. Three new European studies show that patients do just as well with aggressive rehabilitation.

A SPINAL SUCCESS STORY

For the first time in years, 50-year-old Amy Ruth of Huntington Station can turn over in her bed at night without waking up.

A decade ago, Ruth was pulling up carpet when she fell backward and damaged her lumbar disc. She spent years swallowing over-the-counter pain medicines. Nothing worked to alleviate the pain. In 1999, the disc ruptured, and surgeons went in to clean up the debris. Still, the pain persisted.

Last January, her surgeon, Dr. Arnold Schwartz, who has a Melville practice, suggested the artificial Charité disc. She had avoided fusion, the mainstay for lumbar surgery, because she heard that the recuperation was long and the surgery didn't always work. She had the procedure done in June, after months of phone calls and letters to her insurance company to get the surgery approved. Finally, her husband's insurance came through.

"Now, I can sit and stand without a problem," she said. In fact, she's back to living. While it once took her four hours to get dressed, today she only needs a few minutes. "The pain I had lived with for years is gone," she said, adding that she has a new pain that travels down her leg every so often. Her surgeon said it will go away in time. "I'm very happy I had this done," she added.]]> http://www.yourlawyer.com/articles/read/9719 Fri, 13 May 2005 00:00:00 -0700 http://www.yourlawyer.com/articles/read/9719
The company's Charite artificial discs last year became the first to hit the American market, offering a long-awaited alternative to complex spinal fusion surgery. Rosen, recently filmed by PBS performing another new procedure, likes to provide his patients with cutting-edge services.

So he set out to learn about the treatment. Specifically, he wanted to know if the discs could safely reduce chronic back pain while, unlike typical surgery, preserving motion. Charite backers say the new discs do just that and therefore offer the "potential to revolutionize spine surgery."

But Rosen says he found that the devices have regularly failed in Europe, leaving patients with life-threatening complications. He says he finds it "unbelievable" that the Food and Drug Administration ever approved the devices.

"Any prudent person, who does not have a financial conflict or industry tie, would reasonably conclude that their safety and effectiveness has not been proven by the FDA," says Rosen, an associate clinical professor of spine surgery at the University of California at Irvine. "These artificial disc replacements should be recalled by the FDA to protect the American public."

For its part, Johnson & Johnson portrays the implants as "the best solution for the appropriate patients" while stressing that "patient selection is key." In any case, banning the implants could hurt Johnson & Johnson and its competitors, who see the market as a lucrative growth opportunity.

Within years, some experts believe, the market for spinal discs could top $1 billion. Goldman Sachs analyst Lawrence Keusch says that Johnson & Johnson itself hopes to rake in $150 million on its brand-new spinal offering in 2005 alone. Meanwhile, companies like Medtronic (MDT:NYSE) and Stryker (SYK:NYSE) are busy designing artificial discs of their own.

In this last of five articles exploring potential conflicts of interest in the drug and medical device business, TheStreet.com examines how a potentially lucrative treatment can reach the market even as questions linger about its safety and effectiveness.

Failed Operation

To win over the FDA, Johnson & Johnson set out to establish that Charite discs work at least as well as Bagby and Kuslich, or BAK, cages used in spinal fusions. But Rosen saw an immediate problem with the study design.

"The stand-alone BAK is a failed operation; it hasn't been done in years," Rosen says. "So they picked the worst possible operation to compare these things to."

Sarah Colamarino, a spokeswoman for the DePuy Spine unit of Johnson & Johnson, says the BAK was "the standard treatment for single-level degenerative disc disease" at the time the study began.

Regardless, Rosen claims the company still failed to prove its case. An FDA transcript shows that the agency's own statistician portrayed the study as "strongly biased" in favor of Charite. The statistician also noted that the company had excluded important data about patients involved in the randomized clinical trials.

Rosen, for one, wants to know exactly what happened to the first 71 patients who underwent disc replacements during the "training" part of the study. After formally requesting that information and being stonewalled he has yet to learn much beyond what surfaced during last year's FDA hearing.

"It should be noted that the rate of adverse events was higher in the training subjects group compared to the randomized subjects in the study," Serio del Castillo, one of the FDA's lead reviewers for the disc, said during the hearing process. "However, please note that the training subjects were not included in the assessment of safety."

Instead, Rosen says, Johnson & Johnson ignored the first patients who underwent the surgery a full 25% of the group and simply counted the later cases instead. Ranjan Gupta, an award-winning medical researcher who has landed major grants from the National Institutes of Health, sees reason for concern.

"Any time you do a study, there are certain data that are considered outliers," Gupta acknowledges. "However and this is a big 'however' in almost all good studies, that is a very small percentage of the total sample size. Whenever a significant percentage is excluded, for any reason, it leaves a reviewer skeptical of the data analysis."

Colamarino says those patients spent more time in the operating room, lost slightly more blood and suffered a higher rate of adverse events than other participants in the study. However, she says, they actually had better clinical outcomes than the other patients based on two measures. She also stresses that Johnson & Johnson supplied the FDA with safety data on the training patients during the approval process.

Still, Brent Blumenstein a voting member of the FDA advisory panel specifically complained about omitted patients during the Charite hearing.

"The sponsor's definition of the ITT (intent-to-treat) population is incorrect because it deletes randomized patients," Blumenstein said. "To modify the definition of ITT or analysis by arm by deleting patients is tantamount to saying someone is only partly dead."

Like the rest of the panel members, Blumenstein nevertheless went on to vote for approval of the device anyway.

Warning Bells

The panel's decision came despite grave warnings from orthopedic surgeons in the field.

Granted, the first John Peloza was working as a consultant for Johnson & Johnson competitor Medtronic. But his concerns would later be amplified by testimony from a European surgeon who, while flown in for the FDA hearing by Medtronic as well, has studied the Charite discs extensively and implanted many of them himself.

Most importantly, Peloza stressed, the discs should last a lifetime in the fairly young patients who would be seeking them.

"Revision surgery to remove the implant will be potentially life-threatening in every case," he explained. "And at present, there is no consistently successful strategy to deal with a failed implant."

Thus, he said, the implants studied for just two years in the U.S. should be designed to last four decades. But Paul McAfee, a Johnson & Johnson consultant with a financial interest in the discs, indicated that he would be satisfied with far less.

"Well, I hope they will last 40 years," McAfee said during the hearing. But "honestly, to talk to the patients, 10 years is (a) pretty good outcome."

McAfee then went on to undermine one of the central arguments favoring implants over traditional and highly successful spinal fusions. Fans of the device say that it preserves motion and, in turn, reduces wear on nearby parts of the spine. But McAfee confessed that he "cannot find a single study on any motion-preserving device" that proves this theory.

Meanwhile, Andre van Ooij, a Danish surgeon who has tracked hundreds of the operations in Europe later offered evidence about the implant's drawbacks. He noted "retrograde ejaculation and erectile dysfunction" in men. He also cited leg complications in others and pointed to joint degeneration as an especially big problem.

"All of these patients have really terrible leg and back pain," said van Ooij. And "revision is dangerous and sometimes impossible."

Van Ooij went on to cite a 17-year study showing that more than half of Charite recipients wound up with fair or poor results. Moreover, he said, spinal fusion which could have been employed in the first place rarely offers relief to failed patients down the road.

"There was a fusion done, and this is the only one of the re-operations (among those studied) that the patient is satisfied" with, he said. "So I really would stress that it is not a good solution for the problem" in the end.

European Experience

Ironically, fans of Charite kept pointing to the European experience as proof of the disc's success. They also suggested that data from Europe where Charites have been on the market for 17 years reduced the need for extended clinical trials in the U.S.

But many who participated in last year's hearing, including the FDA's own expert engineer, expressed concern about the length of the U.S. study. They indicated that many complications would not even surface until well after the study had ended.

"I think that we have already all pretty much agreed that two years is probably not a safe length of time to follow these patients," said Maureen Finnegan, a voting member of the advisory panel with financial ties to the industry. "So I do think that there needs to be a long-term follow-up."

In the end, however, the panel unanimously recommended approval of the devices with some conditions attached. Specifically, the group called for continued monitoring of trial participants and specialized training for surgeons who will be performing the procedures.

During the FDA hearing process, the so-called Spine Arthroplasty Society had already promised to help with the latter.

"Until I read this transcript, I had never heard of this society," Rosen says. "Given that I am a university spine surgeon, one would think I might even be invited to join or participate."

Rosen marvels that such a society dedicated to a brand-new procedure in the U.S. market already exists in the first place. However, industry critics have long claimed that some professional and consumer advocacy groups are, in fact, little more than fronts for the big health care companies themselves. The SAS Web site, which discloses nothing about the society's funding, almost exclusively promotes the new artificial discs.

Of course, Johnson & Johnson itself has been busy marketing its new offering as well. The company is currently targeting orthopedic surgeons, including Rosen, with offers of specialized training courses.

As soon as the implants won FDA approval, in fact, the company was already pledging to intensively train orthopedic surgeons at sites all over the country so that they could begin doing the new operations as soon as possible.

But Rosen, for one, will not be among them.

"I think there are going to be thousands and thousands of people who suffer failures and wind up in chronic pain with no solution for it," he says. "I don't know how anyone, in good conscience, could put these things in knowing the past history and the potential for so many failures. It's just money over everything else, and it's just cruel."]]> http://www.yourlawyer.com/topics/overview/charite_spinal_discs Fri, 13 May 2005 00:00:00 -0700 http://www.yourlawyer.com/topics/overview/charite_spinal_discs Charité Spinal Discs
Many patients with degenerative disc disease who chose to have a Johnson & Johnson Charité spinal disc implanted are now finding that they have increased pain or similar pain levels as compared to before the operation and little improvement in their motion abilities.  Some patients are being required to have life-threatening revision surgeries. 

About Charité Spinal Discs
Johnson & Johnson’s (DePuy Spine) Charité spinal disc is the only artificial disc approved in the United States.  Before its approval in 2004, the manufacturer’s trial sought to prove only that the disc worked as well as its AcroFlex disc and the Bagby and Kuslich (BAK) cage used in spinal fusions, both of which have been abandoned by many surgeons due to high failure rates.  Furthermore, Johnson & Johnson did not include pain relief as a measure of the success of Charité in the trial.  The disc’s ability to preserve or restore natural motion was also not included in the study’s definition of “success.”  The trial only showed that 57% of patients who had the Charité disc surgery met modest success measures.  Despite the disappointing results, Johnson & Johnson markets the Charité disc with slogans such as “Natural motion is back.”TM and “An alternative to lumbar spinal fusion surgery.” An FDA transcript shows that an agency statistician portrayed the pre-approval study as biased in favor of Charité and as omitting important data from randomized clinical trials. 

Charité Disc Criticism
Charles Rosen of the University of California-Irvine Spine Center has expressed concern and asked that the FDA withdraw the discs from the market. He discussed his concerns in an article on TheStreet.com in May of 2005. Rosen questioned how Charité was approved due to its weak results and frequent life-threatening revision surgeries.  Rosen has spoken publicly about the discouraging of scientific debate on Charité at the annual meeting of the North American Spine Society. 

Free Charité Disc Case Evaluation
Patients who had the Charité spinal disc operation and who continue to suffer are encouraged to contact Parker & Waichman, LLP for a free case consultation.  Please fill out the form at the right or call 1-800-LAW-INFO (1-800-529-4636) today.]]>