Opinion ID: 2533543
Heading Depth: 1
Heading Rank: 3

Heading: Whether Sanders's claims against ANS are barred by the MDA's preemption clause.

Text: ¶ 13. The trial court granted summary judgment in ANS' favor. In so doing, the trial court distinguished the GenesisXP from the spinal-cord-stimulator definition provided by the regulations on the basis of its characteristics. The trial court stated in part: Under the authority granted to it under the Federal Food, Drug, and Cosmetic Act, the FDA has promulgated certain regulations designed to implement the Act. Relevant to the present cause of action, 21 C.F.R. § 882.5880 classifies an implanted spinal cord stimulator for pain relief as a class II device. However, this regulation specifically identifies an implanted spinal cord stimulator for pain relief as a device consisting of an implanted receiver ... and an external transmitter ... Id. at (a)(emphasis added). No regulation has been issued regarding a fully implantable spinal cord stimulator. Coupled with the fact that the GenesisXP was introduced after May 28, 1976, and thus, was automatically classified as a class III device, and that the FDA denied ANS' request to reclassify the device, which prompted ANS to start the premarket approval process, the trial court barred Sanders's claims. The trial court barred the claims because (1) the FDA regarded the spinal-cord stimulator as a class III device, and (2) Riegel v. Medtronic, Inc., 552 U.S. 312, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008), preempted state-law claims challenging the safety and effectiveness of class III devices. ¶ 14. On appeal, Sanders argues that the trial court erred by granting summary judgment in favor of ANS. Sanders claims that the GenesisXP is a class II device as defined by federal regulations. Further, he claims that the trial court erred by basing its decision on a FDA order which was inconsistent with the FDA's own regulations. That order effectively designated the GenesisXP as a class III device. Consequently, Sanders asserts that the trial court erred by finding that the device had a class III designation, because that classification subjected the state-court causes of action to preemption under federal law. See Riegel v. Medtronic, Inc., 552 U.S. 312, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008). ¶ 15. On the other hand, ANS argues that the trial court correctly found that the GenesisXP was a class III device. ANS argues that federal regulations have not addressed a totally implantable spinal-cord stimulator. Nevertheless, ANS maintains that, because the device had been introduced into the market after May 28, 1976, pursuant to the FDCA, it automatically received a class III designation. In further support of its position, ANS relies on the FDA's denial of ANS' request to reclassify the GenesisXP from a class III to class II status, the FDA's premarket approval of the device, and the United States Supreme Court holding in Riegel, 552 U.S. 312, 128 S.Ct. 999.