Dismissal of conspiracy claims in bone screw litigation affirmed by Third Circuit.

Thousands of plaintiffs alleging injuries from spinal bone screws cannot pursue conspiracy claims based on allegations that the medical device manufacturers, doctors, and a host of related defendants violated the Food, Drug, and Cosmetic Act (FDCA) by agreeing to a scheme to sell the devices without proper approval from the U.S. Food and Drug Administration.

The U.S. Court of Appeals for the Third Circuit upheld an earlier decision dismissing the claims by Senior U.S. District Judge Louis Bechtle, who is overseeing the pretrial portion of the multidistrict bone screw litigation, which is now entering its fifth year. (In re Orthopedic Bone Screw Products Liability Litigation, Nos. 98-1762, 98-1829, 1999 WL 796833 (3d Cir. Oct. 7, 1999).)

Some 5,000 plaintiffs filed suit in 1994 against manufacturers and distributors of bone screw devices, which consist of rods or plates that are screwed into the vertical axis of the lumbar spine to fuse vertebrae. The plaintiffs who received these implants contend the devices broke after they were placed or required removal, which in some cases proved impossible.

The plaintiffs later added a broad array of defendants to the litigation. These included the doctors who implanted the spinal bone screws, trade associations that conducted seminars on their use, and regulatory consultants who helped the manufacturers win Food and Drug Administration approval by supplying allegedly misleading information.

The plaintiffs charged that these defendants worked together in violation of the FDCA to promote and sell the bone screws for purposes not approved by the FDA. The devices had been approved only for use in long bones, not short ones like those found in the spine.

Unanimous opinion

Writing for the unanimous three-judge panel, Judge Anthony Scirica found that the plaintiffs' claims must fail because civil conspiracy and concert of action claims require an independent basis of tort liability. The FDCA, however, does not provide for a private right of action under any circumstances, making it impossible for the plaintiffs to establish the underlying tort needed to allege a conspiracy, the court found.

We are unaware of any jurisdiction that recognizes civil conspiracy as a cause of action requiring no separate tortious conduct," Scirica wrote in the opinion. "To the contrary, the law uniformly requires that conspiracy claims be predicated upon an underlying tort that would be independently actionable against a single defendant. A claim of civil conspiracy cannot rest solely upon the violation of a federal statute for which there is no corresponding private right of action."

Plaintiff argument

Plaintiff attorneys argued that case law and the Restatement (Second) of Torts [sections] 285 cmt. c (1977) hold that violations of federal statutes can serve as the foundation for common law tort liability. Scirica, however, rejected the application of this so-called per se liability doctrine, writing that the doctrine does not create an independent basis of tort liability.

"Rather, [the doctrine] establishes, by reference to a statutory scheme, the standard of care appropriate to the underlying tort," Scirica said. "Plaintiffs' theory would ... establish a private, state law cause of action for violations of the FDCA, so long as those actions are brought against more than one defendant. We do not believe the concept of per se liability supports such a result."