Artificial Disc Recipients Take Legal Steps

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Artificial Disc Recipients Take Legal Steps

There are success stories, but more than two dozen patients claim the

device is too risky.

By Rong-Gong Lin II, Times Staff Writer

August 1, 2006

http://www.latimes.com/business/la-fi-discs1aug01,1,5526869.story

Since the moment a decade ago when Dane Titsworth picked up a box and

a disc in his spine burst, he has been in ever-worsening pain.

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 & .

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 Flowers, Titsworth's lawyer.

DePuy spokeswoman Debbie 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, " 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. 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. 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. "

Spinal disc implant

The Food and Drug Administration in 2004 approved the first

artificial spinal disc to replace a diseased or damaged disc. The

procedure is a surgical alternative to spinal fusion.

Spinal fusion

Performed on about 300,000 Americans each year, this process is used

to treat degenerative disc disease, serious back injury and scoliosis.

* Damaged spinal discs are removed and replaced with bone grafts. The

body then heals the grafts over several months to form a single bone,

similar to healing a fracture.

* Metal screws and rods keep vertebrae in position while bone grafts

heal.

The artificial disc

Tears, scar tissue and loss of water content can weaken spinal discs,

which cushion the spine between each of its 24 vertebrae. The Charite

artificial disc, manufactured by & 's DePuy Spine

Inc., is designed to relieve the pain of degenerative disc disease Ñ

which occurs primarily in the two lowest discs--while restoring some

freedom of movement that fusion does not.

* End plates made of medical-grade cobalt- chromium alloy are

sandwiched around a polyethylene core.

* To avoid damaging the spinal cord, surgeons make an incision near

the belly button, then navigate past organs, nerves and vessels to

reach the damaged disc.

--

Sources: Dr. Regan, Cedars-Sinai Medical Center; DePuy Spine

Inc.; North American Spine Society. Graphics reporting by

Greenberg