346
Opinion of the Court
tially equivalent to a device in commercial distribution," § 807.87(l).
In 1984, AcroMed sought § 510(k) approval for its bone screw device, indicating it for use in spinal surgery. See In re Orthopedic Bone Screw Products Liability Litigation, 159 F. 3d 817, 820 (CA3 1998). The FDA denied approval on the grounds that the Class III device lacked substantial equivalence to a predicate device. See ibid. In September 1985, with the assistance of petitioner, AcroMed filed another § 510(k) application. "The application provided additional information about the . . . device and again indicated its intended use in spinal surgery. The FDA again rejected the application, determining that the device was not substantially equivalent to a predicate device and that it posed potential risks not exhibited by other spinal-fixation systems." Ibid. In December 1985, AcroMed and petitioner filed a third § 510(k) application.
"AcroMed and [petitioner] split the . . . device into its component parts, renamed them 'nested bone plates' and '[cancellous] bone screws' and filed a separate § 510(k) application for each component. In both applications, a new intended use was specified: rather than seeking clearance for spinal applications, they sought clearance to market the plates and screws for use in the long bones of the arms and legs. AcroMed and Buckman claimed that the two components were substantially equivalent to predicate devices used in long bone surgery. The FDA approved the devices for this purpose in February 1986." Ibid.
Pursuant to its designation by the Judicial Panel on Multi-district Litigation as the transferee court for In re: Orthopedic Bone Screw Liability Litigation, MDL No. 1014, the District Court for the Eastern District of Pennsylvania has been the recipient of some 2,300 civil actions related to these medical devices. Many of these actions include state-law
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