J. Donald Henson, Sr. v. HHS

In the United States Court of Appeals For the Seventh Circuit ____________________ No. 17-1750 J. DONALD HENSON, SR., Plaintiff-Appellant, v. DEPARTMENT OF HEALTH AND HUMAN SERVICES, et al., Defendants-Appellees. ____________________ Appeal from the United States District Court for the Southern District of Illinois. No. 14-CV-908 — David R. Herndon, Judge. ____________________ SUBMITTED MARCH 9, 2018 * — DECIDED JUNE 15, 2018 ____________________ Before WOOD, Chief Judge, and BAUER and HAMILTON, Cir- cuit Judges. HAMILTON, Circuit Judge. Plaintiff J. Donald Henson, Sr., appeals from the district court’s grant of summary judgment * We have agreed to decide this case without oral argument because the briefs and record adequately present the facts and legal arguments, and oral argument would not significantly aid the court. See Fed. R. App. P. 34 (a)(2)(C). 2 No. 17-1750 for defendants on his claims under the Freedom of Infor- mation Act, 5 U.S.C. § 552. We affirm. Under the Food, Drug, and Cosmetics Act, “Class III” medical devices are those that support or sustain human life, that are of substantial importance in preventing impairment of human health, or that present a potential, unreasonable risk of illness or injury. See Riegel v. Medtronic, Inc., 552 U.S. 312, 317 (2008); 21 U.S.C. § 360c(a)(1)(A). Class III devices must un- dergo scientific and regulatory review before they are mar- keted. See 21 U.S.C. § 360e; 21 C.F.R. §§ 814.1 et seq. Plaintiff Henson sent the Food and Drug Administration requests under the Freedom of Information Act seeking doc- uments related to the premarket approval process for a glu- cose monitoring system. The agency produced documents re- sponsive to Henson’s requests. He was not satisfied with the response, so he sued, alleging that the agency failed to satisfy its obligations under the Freedom of Information Act. The agency then reprocessed Henson’s requests and provided him with responsive documents totaling 8,000 pages. In his amended complaint, Henson alleges that he is dia- betic, that he had observed 14 deficiencies with his own glu- cose monitor, and that he contacted the agency to relay his concerns. Henson says that, after speaking with the Ombuds- man for the Center for Devices and Radiological Health (“CDRH”), the branch of the FDA responsible for overseeing the premarket approval process, he sent the agency 46 re- quests for documents related to the premarket approval pro- cess for the glucose monitor. Henson also sent ten letters, la- belled sequentially from “R-1” to “R-10,” that he contends were new requests, but none of those letters was answered. The FDA eventually provided Henson with more than 7,000 No. 17-1750 3 pages in response to his requests. Henson then called and wrote to two FDA employees, insisting that the agency was withholding documents to which he was entitled. But Hen- son’s calls and letters went unanswered. In his complaint, he named the agency and the two agency employees as defend- ants. He also attached two summaries detailing the requests that he made to the agency. Henson asked the court to order ...

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