The Pedicle Screw Lawsuit Feeding Frenzy
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 (AAOS) and the Scoliosis Research Society (SRS), 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.
