Opinion ID: 2533543
Heading Depth: 1
Heading Rank: 5

Heading: FDA Order

Text: ¶ 19. Sanders argues that the trial court incorrectly relied on a FDA order to grant summary judgment to ANS. The FDA issued an order to ANS in February 2001, in which it denied ANS' request to reclassify the spinal-cord stimulator from a class III to a class II device. Sanders contends that the FDA order is inconsistent with the FDA regulations, which clearly define the spinal-cord stimulator as a class II device. In support of his position, Sanders cites Thomas Jefferson University v. Shalala, 512 U.S. 504, 520, 114 S.Ct. 2381, 2391, 129 L.Ed.2d 405 (1994), and Wyoming Outdoor Council v. U.S. Forest Service, 165 F.3d 43, 45 (U.S.App. D.C.1999), both of which concern an agency's interpretation of its regulations. ¶ 20. In Thomas Jefferson, the United States Supreme Court considered whether the Secretary of Health and Human Services' interpretation of medicare regulatory language was reasonable. Thomas Jefferson, 512 U.S. at 506, 114 S.Ct. at 2384. A hospital sought reimbursement for graduate medical-education costs. Id. at 507, 114 S.Ct. 2381. The Secretary denied some of the expenses as an impermissible redistribution of costs, and the hospital sought review. Id. at 511, 114 S.Ct. 2381. ¶ 21. The United States Supreme Court held that substantial deference must be given to an agency's interpretation of its own regulations. Thomas Jefferson, 512 U.S. at 512, 114 S.Ct. at 2386. The Court noted that deferral to the Secretary's interpretation was warranted unless an alternative reading is compelled by the regulation's plain language or by other indications of the Secretary's intent at the time of the regulation's promulgation. Id. (quoting Gardebring v. Jenkins, 485 U.S. 415, 430, 108 S.Ct. 1306, 1314, 99 L.Ed.2d 515 (1988)). This principle is more justifiable when the regulation concerns `a complex and highly technical regulatory program,' in which the identification and classification of relevant `criteria necessarily require significant expertise and entail the exercise of judgment grounded in policy concerns.' Id. (quoting Pauley v. BethEnergy Mines, Inc., 501 U.S. 680, 697, 111 S.Ct. 2524, 2534, 115 L.Ed.2d 604 (1991)). The United States Supreme Court upheld the Secretary's interpretation of its own regulations. Id. at 518, 114 S.Ct. 2381. ¶ 22. Likewise, in Wyoming Outdoor Council, the Council appealed a district-court decision which affirmed the United States Forest Service's interpretation of its own regulations. Wyoming Outdoor Council, 165 F.3d at 45. The Council argued that the Forest Service's authorization of oil and gas leasing on land located in the Shoshone National Forest in Wyoming violated its own regulations. Id. The court held that substantial deference is given to an agency's interpretation of its own regulations. Id. at 52. The interpretation of an agency's regulation is controlling unless it is plainly erroneous or inconsistent with the regulation. Id. (quoting United States v. Larionoff, 431 U.S. 864, 872, 97 S.Ct. 2150, 53 L.Ed.2d 48 (1977)). Again, the appellate court upheld the agency's interpretation of its own regulations. Id. at 54. ¶ 23. ANS contends that the trial court's order is not inconsistent with federal regulations. First, ANS contends that 21 C.F.R. Section 882.5880 defines a stimulator that has both internal and external components. The GenesisXP, however, is totally implantable. ANS argues that, when it initially sought reclassification of the GenesisXP from a class III to a class II medical device, it set forth the specific differences between the stimulator defined by the regulation and its stimulator. Notwithstanding the regulation's classification of a stimulator as a class II device, the FDA's order denied ANS' petition to reclassify the stimulator and stated that, because the stimulator was fully implantable in a human body, the FDA required the device to remain as a class III device.