Opinion ID: 2533543
Heading Depth: 1
Heading Rank: 6

Heading: Preemption, premarket approval, and Riegel

Text: ¶ 24. Sanders claims that the trial court erred by finding that the spinal-cord stimulator was a class III device. This finding, in turn, provided the trial court with the means to consider ANS' argument that, because it is as a class III device, Sanders's claims are preempted by federal statute and by federal caselaw in Riegel v. Medtronic, Inc., 552 U.S. 312, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008). ¶ 25. The federal statute at issue is Section 360k, which provides in part: (a) General rule Except as provided in subsection (b) of this section, no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement (1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter. 21 U.S.C. § 360k (2006). ¶ 26. In Riegel, the United States Supreme Court considered whether the preemption clause in the MDA barred common-law claims of safety and effectiveness of a medical device that had premarket approval by the FDA. Riegel, 552 U.S. at 315, 128 S.Ct. 999; see also 21 U.S.C. § 360k (2006). Charles Riegel had a coronary angioplasty following a heart attack. Id. at 320, 128 S.Ct. 999. During the procedure, the Evergreen Balloon Catheter, marketed by Medtronic and designated as a class III device, ruptured, causing a heart block. Id. Riegel subsequently had to have emergency coronary bypass surgery. Id. Riegel filed suit in the New York federal district court, alleging that Medtronic's catheter violated New York common law. Id. However, the district court held that Riegel's claims of strict liability; breach of implied warranty; and negligence in the design, testing, inspection, distribution, labeling, marketing, and sale of the device were preempted by the MDA. Id. at 320-21, 128 S.Ct. 999. ¶ 27. The United States Court of Appeals for the Second Circuit affirmed the district court, holding that the Riegels' claims were preempted by federal law. Riegel, 552 U.S. at 321, 128 S.Ct. 999. The basis of the appellate court's decision was that if the Riegels' claims were successful, they would impose state requirements that differ from, or added to the device-specific federal requirements. Id. at 321, 128 S.Ct. 999. See 21 U.S.C. § 360k (2006). ¶ 28. The United States Supreme Court granted certiorari. Riegel, 552 U.S. at 321, 128 S.Ct. 999. The Court held that the FDA premarket approval process imposes requirements, and it is specific to individual devices. Id. at 323, 128 S.Ct. 999. The premarket approval is considered the federal safety review of the device, with safety, as opposed to equivalence, being the key consideration. Id. Once premarket approval is granted, the device has almost no deviations from the specifications in its approval application, for the reason that the FDA has determined that the approved form provides a reasonable assurance of safety and effectiveness. Id. When analyzing whether the claims relied on a requirement that was different from, or in addition to, any requirement pursuant to the federal law for the device and that relate[d] to the safety or effectiveness of the device, the United States Supreme Court determined that safety and effectiveness were the essence of the Riegels' claims. Id. Further, the Court determined that the common-law causes of action for negligence and strict liability do impose `requirement[s]' and would be pre-empted by federal requirements specific to a medical device. Id. at 323-24, 128 S.Ct. 999. The United States Supreme Court affirmed the Court of Appeal, which had determined that the MDA preempted the Riegels' claims. Id. at 330, 128 S.Ct. 999. ¶ 29. We find that the trial court did not err by finding that the GenesisXP was a class III medical device, and as such, Sanders's claims were barred, because the claims were subject to federal preemption. The record shows that the FDA regulates medical devices pursuant to the FDCA. The federal government amended the FDCA in regard to medical devices with the MDA. This act provided that devices introduced after May 28, 1976, automatically received a class III designation. It was undisputed that the GenesisXP was introduced after May 28, 1976. The GenesisXP, pursuant to the MDA, was classified as a class III device. ¶ 30. In an attempt to have the GenesisXP reclassified from a class III device to a class II device, ANS petitioned the FDA in 1999. The record contains the FDA's denial of ANS' request at reclassification. In its 2001 denial letter, the FDA unequivocally stated that the stimulator was automatically classified into class III. The record also has a FDA public notice. The FDA again designated ANS' stimulator as a class III device in its public notice of denial of petition to reclassify the device. The FDA stated that ANS could not place the device into commercial distribution unless it was reclassified or subjected to premarket approval. ANS sought premarket approval. In 2002, the FDA approved ANS' application for premarket approval. ¶ 31. Sanders does not dispute the FDA documentation; rather he relies on the definition of the stimulator as described in the regulations. See 21 C.F.R § 882.5880 (2010). The regulation does provide a class II designation for spinalcord stimulators that have an internal and external component. However, as the evidence shows and as the FDA was aware, the GenesisXP is a fully implantable device. Further, the FDA order, the notice of denial of petition, and the premarket approval correspondence all make clear that the FDA itself considered ANS' GenesisXP stimulator to be a class III device. Consequently, while other stimulators that may have an internal and external component are generally considered class II devices, the FDA did not view the GenesisXP in the same light, so much so that ANS sought the arduous premarket approval process for the device. ¶ 32. Viewing the evidence in the light most favorable to Sanders, we find that no genuine issue to any material fact as to whether the GenesisXP is a class III device. Further, Sanders's claims are similar in nature to the claims asserted by the Riegels in Riegel, 552 U.S. at 320, 128 S.Ct. 999. Like the Riegels' claims, Sanders's claims challenge the safety and effectiveness of a class III device that has received premarket approval by the FDA, imposing requirements that are different or in addition to MDA federal requirements. Therefore, the trial court did not err by barring Sanders's claims under the MDA.