When No Good Deed Went Unpunished: The First Decade

For about 10 years, one man was probably the best known surgeon and entrepreneur in the spine industry. His name was (and remains) Art Steffee, and he was the founder of AcroMed Inc. Dr. Steffee, who retired about nine years ago, opened up the excellent Preservation of Motion in the Spine meeting in Duck Key, Florida, this past week. It has been an incredibly long road from Cleveland in 1982 to a motion preservation meeting in Florida in 2007 for both Dr. Steffee and the spinal implant industry.

Nine years ago, Dr. Steffee agreed to sell his company to DePuy for $325 million and to settle roughly $100 million in lawsuits. AcroMed's sales that year were approaching $150 million.

Innovative technology

Art Steffee founded AcroMed in 1983 on the basis of a napkin sketch that Dr. Ralph Rashbaum (of the Texas Back Institute) made for a pedicle screw fixation system (that first system was called the "Texas Connection"). Taking that idea and combining it with local capital and his own creative thinking, Dr. Steffee started AcroMed. (Acro, in Greek, means extremity or peak.)

In 1982, a spine bone screw and plate was considered an unlikely surgical treatment by most surgeons. Today pedicle screws and plates are universal. But before pedicle screws and plates, patients with a deformed spine or in severe pain had to endure literally months trapped in a full body cast.

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In 1983 Dr. Steffee and Ed Wagner, a local Cleveland businessman and venture investor, founded AcroMed to bring to market a stainless steel bone screw and plate. Later the material was changed to titanium. He also introduced a new method to implant the screws and plates in the spine.

Before AcroMed, Dr. Steffee was the director of orthopedic services of the Cleveland Spine and Arthritis Center at Lutheran Medical Centre, and he had already pioneered several surgical techniques and developed a number of orthopedic implant devices.

In those days spinal implants were mostly hooks intended to correct spinal deformities, but which weren't very reliable. They could not be firmly attached to the spine. During a spine operation in the early 1980s, Steffee discovered, while cutting bone in the lower part of the spine, that he could place a standard long bone screw in the pedicle bone of the spine. Putting a bone screw into the pedicle, which allowed the head of the screw to sit between two sides of bone, created a solid fixation.

The spine actually has a limited amount of bone. Further, nerves and arteries are immediately adjacent, even intertwined with the bony structures of the spine. Screw placement was critical. This was the key problem for Dr. Steffee. One napkin sketch later and Steffee had a potential solution.

Bone plates of the time were, in fact, long bone-fracture plates with holes that did not match the anatomy of the spine. Dr. Steffee's solution was to make slots, not holes. in the bone plate so that screws could be adjusted during placement. Then, he placed the screws in first, before the plate! Which was counter-intuitive but dramatically reduced the risk of screw misplacement.

To do this, Steffee had to cut off the head of the traditional bone screw. After the screws were placed in the saddle of the pedicle bone, he positioned the bone plate over his headless screws and fixed them in place with a nut. His innovation will forever be known as the "variable screw placement" technique and it is one of the foundational inventions in spine.

When placed correctly, pedicle screw systems allowed patients a much easier postoperative course and quicker rehabilitation. The average hospital stay was cut by more than 50% to about 11 days. Later, the advent of the spine cage lowered hospital stays to about five days.

The battle over pedicle screws

Starting AcroMed set in motion a series of events that, in retrospect, can only be described as biblical. Indeed, between 1983 and 1998, no good deed of spine innovation went unpunished.

Dr. Steffee applied to the FDA for approval of his bone screws and plate for the spine in 1982. His application was denied. In 1984 the FDA classified the pedicle screw as Class III device. Dr. Steffee and his new company AcroMed had hoped that the FDA would recognize that these devices were bone plates and screws and would qualify under the Medical Device Amendments of 1976 (1976 Amendments, Public Law 94-295) as predicate devices.

In 1984, the FDA allowed AcroMed to market their products as bone plates and bone screws but did not specifically allowed their use in the spine. That approval would not come for another 12 bitter and difficult years.

Then came the lawsuits.

Nine years after AcroMed began selling its pedicle screws and plates, the television program 20/20 aired a segment that told a sensational story of metal hardware being put in patient's backs by unscrupulous doctors and companies and that these screws were not FDA approved for use in the spine.

Ultimately over 3,000 lawsuits were filed over pedicle screws. The suits began to gather momentum in 1993 and in 1995 metastasized to include the surgeon societies. The North American Spine Society (NASS) was sued over 400 times in 42 states. NASS, which is dedicated to surgeon training and education, had sponsored five continuing medical education (CME) activities that mentioned off-label uses of pedicle screws. Two other societies, the American Academy of Orthopaedic Surgeons and the Scoliosis Research Society, were also sued.

Essentially, the plaintiff's bar sued the physicians who used pedicle screws, the manufacturer of the pedicle screws, the surgeon societies that mentioned pedicle screws in their CME courses, and the individual faculty who taught the courses that included pedicle screws. Many people lost their jobs and faced serious legal costs during this witch hunt against the spine industry.

Every one of the cases against the surgeon societies was dismissed by 1999 for lack of evidence. AcroMed was forced to agree to a $100 million payment and that, as much as anything, prompted Art Steffee to sell his company to DePuy.

Sofamor Danek, which endured nearly as many lawsuits as AcroMed, never settled and fought every single suit. Leading Sofamor Danek in the war against the (really) Philadelphia legal cabal was the son of a Tennessee sharecropper, Ron Pickard. He won. Final score: Ron Pickard 2,999, legal jackals: 1 But that's a story for another Orthopedics This Week.

In 1990, FDA commissioner David Kessler launched an investigation of AcroMed and Dr. Steffee. In 1992, AcroMed received a warning from the FDA to stop promoting its spinal implants.

They were accused of making a profit. Seriously.

That all ended when pedicle screws were down-classified by the FDA in the late 1990s.

DePuy bought AcroMed in March 1998 for $325 million. Art Steffee retired to his farm outside of Pittsburgh. And that was that until last week, when who should stand up to deliver the keynote address at the Preservation of Motion in the Spine meeting in Florida - Dr. Art Steffee.

Putting current controversy in perspective

Dr. Steffee is older now, of course. Stepping up to the podium at the meeting last week took some effort. He talked without notes. A flood of memories no doubt were swirling in his mind. Perhaps he was remembering his now-famous address to orthopedic surgeons in 1982, when he described his new bone screw and plate idea.

What emerged from Dr. Steffee last week was a story about how difficult it is to be an innovator in spine. While he could certainly have been referring to himself, he talked instead about other innovators, and how an academic vendetta from the 1950s has grown and even to this very day reverberates through this industry and the halls of the agencies that set reimbursement policy.

Dr. Steffee started his talk by recalling Dr. Paul Harmon's work in 1952, when he implanted spheres in the disc space of patients suffering from degenerative disc disease. The spheres were manufactured by Austenal Corporation of York, Pennsylvania, and they were made from Vitallium. Dr. Harmon was pilloried for trying something so innovative as spine arthroplasty, and moved to South America to escape the attacks. He did eventually return to practice in California. In 1962, Dr. Harmon performed the first anterior lumbar fusion and published his results from 244 cases in Clin Orthop 26:107-27, 1963.

"Doing something new was not good for him," said Dr. Steffee.

Then a gentleman from Sweden, Ulf Fernstrom, developed a stainless steel ball bearing that acted as a ball joint in the spine. Beginning in the late 1950s, Fernstrom implanted 191 of his "Fernstrom Balls" in 101 patients. It was an attempt to achieve arthroplasty in the spine and to create center of rotation that was truly mobile. President John F. Kennedy is rumored to have been a Fernstrom Ball patient.

Dr. Steffee put up some X-rays of two- and three-level Fernstrom Balls. I was sitting next to Dr. Lisa Ferrara, who is one of the leading experts on the biomechanics of the spine, and she noticed immediately how good the alignment of the spine was with the Fernstrom balls implanted.

The Fernstrom Balls were implanted with minimal disruption to the structures of the spine, including the ligamenture. Later Dr. McKenzie from Alberta, Canada, began implanting the Fernstrom Ball. Interestingly enough, he had two of them implanted in himself.

Dr. Steffee showed pictures of a patient who'd had the Fernstrom Balls for 35 years and was doing fine.

Other reports in the literature are fairly positive about the Fernstrom Ball. Reitz and Joubert reported a total of 75 cervical disc arthroplasties performed with Fernstrom's Ball in 32 patients. One year later there were no neurological complications or subluxations of the Balls. In two cases there was intrusion into adjacent bone, but the clinical results remained excellent in both cases. The authors cautioned about the need for a two-year follow-up period before a final assessment of this surgical technique could be made.

Unfortunately, Dr. Fernstrom had an academic enemy - Dr. Carl Hirsch from Uppsala University Hospital in Sweden. Dr. Hirsch was appalled at the idea of spinal arthroplasty and attacked the Fernstrom Balls relentlessly. Joining him in this campaign was Dr. Hirsch's research assistant, Dr. Alf Nachemson.

Dr. Nachemson, who was born in Sweden in 1931 and died in 2006, called the use of the Fernstrom Balls "The Rape of the Spine" and, in the course of authoring more than 400 studies and articles became the dominant figure questioning spinal fusions and spinal arthroplasty.

His co-author on some of these studies was Dr. Richard Deyo of the University of Washington. Among his other accomplishments, Dr. Deyo petitioned the Center for Medicare and Medicaid services to deny coverage for the first spinal arthroplasty system approved by the FDA - the Charité.

Dr. Steffee, who has seen more and endured more in his efforts to innovate on behalf of patients, reminded the assembled surgeons at last week's meeting that spine arthroplasty actually started 55 years ago. The same group that attacked pedicle screws in the 1990s is attacking spine arthroplasty today and their animus, said Dr. Steffee, can be traced to the academic brawl between Dr. Ulf Fernstrom and Dr. Carl Hirsch.

And what of the Fernstrom Ball? Don't be surprised if it reemerges as the latest, new thing. And it will probably be made of PEEK.

Dr. Steffee's speech should be heard by every orthopedic resident, venture capitalist, and regulatory official. When Dr. Steffee concluded his remarks at last week's meeting, two generations of spine surgeons stood as one body and applauded and applauded and applauded.

Written by Robin Young, CFA