Spinal bone screw litigation gets new life from Third Circuit.

A divided federal appeals court revived part of the mass tort litigation involving spinal bone screw devices, which have injured thousands of people, according to a lawyer representing plaintiffs in the cases.

The U.S. Court of Appeals for the Third Circuit on November 17 reinstated a state law claim that an industry consulting company had committed fraud against the Food and Drug Administration (FDA) in connection with the agency's 1986 approval of the bone screws. (In re: Orthopedic Bone Screw Products Liability Litigation, 159 F.3d 817 (3d Cir. 1998).)

"This decision is obviously significant for the litigants in this case because their claims have new life breathed into them," said Michael Fishbein, a Philadelphia attorney who serves on the Plaintiffs' Litigation Committee, which represents the injured plaintiffs.

Thousands of plaintiffs began suing the makers of spinal bone screws in the early 1990s after ABC's 20/20 television news magazine reported spinal surgery patients suffered debilitating back injuries from the screws.

Although the screws had not received FDA approval for spinal use, surgeons implanted them in the bones to help fuse two or three vertebrae. The procedure was designed to relieve the patients' original back pain, but conditions worsened for many. (Victims of Unapproved Spinal Operations Fight Back, TRIAL, Apr. 1995, at 12.)

The lawsuits were consolidated in federal multidistrict litigation in 1995 for discovery purposes. Many lawsuits are pending in state and federal courts across the country, and a federal jury in at least one case has returned a verdict for the plaintiff. (Reeves v. AcroMed Corp., No. CA91-4689 (E.D. La. Nov. 2/4, 1995).)

The Third Circuit ruling could make it easier for plaintiffs to prevail on the pending claims. They will now be able to argue that one defendant, Buckman Co., made misrepresentations to the Food and Drug Administration that were serious enough to have left them injured.

Buckman Co., a regulatory consultant, was hired by spinal bone screw maker AcroMed Corp. to help it obtain FDA marketing clearance for the medical devices.

Injured plaintiffs charged that Buckman obtained that clearance by saying AcroMed's product would be used for fusing long bones, such as those in arms and legs, rather than for fusing vertebrae. The FDA had twice rejected Buckman's applications for clearance when the consultant said the screws would be used in spinal surgery.

U.S. District Judge Louis Bechtle granted Buckman's motion to dismiss this "fraud on the FDA" claim. Reversing the lower court, Third Circuit Judge Walter Stapleton wrote, "We hold that the plaintiffs' `fraud on the FDA' theory of liability is not so at odds with traditional principles of tort law that [the defendant] is entitled to a dismissal of all claims against it at this stage."

Stapleton also found that state law claims of fraudulent misrepresentation would not be preempted by the federal Medical Devices Amendments Act of 1976, clearing a major obstacle for plaintiffs who are awaiting trial.

Writing in dissent, Judge Robert Cowen said, "The majority endorses a claim of `fraud on the FDA' under circumstances that will expose manufacturers to fraud liability for seeking desirable innovations in a product's use, distort the penalty scheme established by the [Food, Drug, and Cosmetic Act] and its regulations, and generate substantial liability when manufacturers respond to doctors' widely accepted practice of purchasing medical products for off-label uses."

Greg Ramirez, an Oxnard, California, plaintiff attorney who has lost two injury cases against spinal bone screw manufacturers, praised the majority decision. "The circuit court is certainly looking at the full scope of what happened in these cases. Other courts, both state and federal, have decided that, regarding fraud on the FDA, plaintiffs don't have standing to bring their claims. This case cuts against a lot of those decisions."