The legal action over pedicle screws has become the case that just won’t die. The pedicle screw litigation has dragged on for nearly five years with enough recent sensational twists and turns to leave neurosurgeons and medical equipment companies alike dazed and confused. A trip to the United States Supreme Court, overturned jury verdicts, disqualified expert witnesses and, yes, even surgeons joining the proceedings as plaintiffs, have thrown this ever-complex litigation into a spin.
A Trip to the Land’s Highest Court
The United States Supreme Court granted certiorari to Buckman Company vs. Plaintiff’s Legal Committee in June. Less than one percent of all lawsuits in the United States make it to the Supreme Court. The Supreme Court will hopefully define what weight Federal Drug Administration (FDA) approval has and the possibilities of legal action against medical equipment companies and physicians for devices used with FDA approval.
The Buckman case is one of the original class action suits. The plaintiffs allege Buckman, on behalf of Acromed, fraudulently obtained FDA approval of the Variable Screw Placement Spinal Plate Fixation System in 1986. The FDA had rejected Buckman’s two previous applications to market the device to surgeons. A third application, which separated the device into its component parts and indicated the screw would be used in the arm and leg bones rather than the spine, received approval.
The lawsuit alleges Buckman committed fraud because it intended, and did, market the screws for use in the spine all along. The FDA did not approve pedicle screws for use in spinal surgery until 1995, years after they were routinely applied in spine surgery. The federal district court dismissed the case, stating federal regulation of medical devices barred any private lawsuits and reasoning any penalty for wrongdoing would have to be brought by the FDA itself. The decision was appealed and the Third U.S. Circuit Court of Appeals in Philadelphia reinstated the lawsuit and stated makers of medical devices can be sued in state courts over alleged defects in their products, regardless of FDA status. The Supreme Court will now attempt to shed some light on the debate. Arguments will be heard this October with a decision expected in early 2001.
Surgeon Sues Pedicle Screw Manufacturers
In a unique twist, an orthopedic surgeon has filed a lawsuit against DePuy Acromed and Medtronic Sofamor Danek, claiming the companies misled him about the FDA status of their respective pedicle screw systems and caused him to be sued in over 34 pedicle-screw related lawsuits. Richard A. Balderston, a Philadelphia orthopedic surgeon on staff at Pennsylvania Hospital and Jefferson University Hospital and who limits his practice to spine surgery, was part of the Spinal Fixation Study Group in 1985 that first began testing the use of the screws in the spine. Dr. Balderston alleges 1) the manufacturers misled him about the true FDA status of the pedicle screw through their marketing techniques; 2) he relied on the manufacturers to obtain proper FDA approval for the screws in the spine because they were marketing their use in the spine; and 3) these misrepresentations caused him to not be able to obtain proper informed consent from the patients he implanted the screws in. Besides recovering legal costs, he claims the number of lawsuits against him has damaged his reputation and he has suffered a loss of profits to his practice.
Court Rules Pedicle Screws Could Not Have Been Defective
A Pennsylvania judge overturned a $1.5 million jury verdict against Stuart Pharmaceutical Company, reasoning the pedicle screws couldn’t possibly have been defective, as the jury found. The plaintiff had the Cotrel-Duboussett (CD) spinal fixation system implanted in her spine, and over the next year her curvature was reduced by 30 degrees and she became asymptomatic. Four years later, she suffered pain and numbness and it was found her spine had not fused and one of the CD rods hadd fractured. The plaintiff alleged the rod was defective because the grooved surface caused premature breakage. She sued Stuart Pharmaceutical and the jury awarded a $1.5 million verdict. However, within days of the judgment, the judge, reasoning that the rod lasted three years beyond its intended use, overturned the jury’s verdict.
An End in Sight?
Many courts are beginning to dismiss pedicle screw cases because of the statute of limitations. Under the statute of limitation rules, a plaintiff has two years to bring a lawsuit against a product manufacturer and one year to bring a medical malpractice law suit against a physician. The clock begins running when the plaintiff “discovers” he might have a problem. The U.S. Court of Appeals for the Fourth Circuit has ruled that the onset of any post-surgical pain is a “discovery” for pedicle screw cases, regardless of when the screws are eventually removed from the spine or found to be malfunctioning by the surgeon. Surely, there is more to come, but, overall, it appears that the juggernaut of pedicle screw litigation may finally be approaching an end.
Barbara Peck is former AANS Communications Manager and currently attends law school at Case Western Reserve University in Cleveland.