J. Donald Henson, Sr. v. HHS

Court of Appeals for the Seventh Circuit·Decided June 15, 2018·No. 17-1750·Published

Opinion

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, Circuit 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).

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for defendants on his claims under the Freedom of Information 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 undergo scientific and regulatory review before they are marketed . 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 documents related to the premarket approval process for a glucose monitoring system. The agency produced documents responsive 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 diabetic , that he had observed 14 deficiencies with his own glucose monitor, and that he contacted the agency to relay his concerns. Henson says that, after speaking with the Ombudsman 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 requests for documents related to the premarket approval process for the glucose monitor. Henson also sent ten letters, labelled 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

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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 Henson ’s calls and letters went unanswered. In his complaint, he named the agency and the two agency employees as defendants . He also attached two summaries detailing the requests that he made to the agency. Henson asked the court to order the production of the withheld documents.

On the defendants’ motion, the district judge dismissed the two agency employees from the case, concluding that the Act “does not create a cause of action for a suit against an individual employee of a federal agency.” A magistrate judge then granted the agency’s request for a stay of discovery because cases under the Act generally proceed to discovery only after a plaintiff’s case survives a motion for summary judgment . Rather than move for summary judgment, however, the agency asked the court to stay the case so it could reprocess Henson’s requests by conducting a new search for responsive documents. The agency said it would give Henson documents responsive to his requests on a rolling basis and a so-called Vaughn index—a list of each redacted or withheld document cross-referenced with the exemption that the agency asserts is applicable. See Solar Sources, Inc. v. United States, 142 F.3d 1033, 1036 n.3 (7th Cir. 1998); Vaughn v. Rosen, 484 F.2d 820, 826–28 (D.C. Cir. 1973). The court granted the stay.

After the agency had reprocessed Henson’s requests, the court lifted the stay and the agency moved for summary judgment . The agency argued that it had conducted a reasonable search for all documents responsive to Henson’s requests and that it had properly withheld and redacted documents pursuant to the exemptions to disclosure listed in 5 U.S.C.

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§ 552(b)(4)–(6). In support of its motion, the agency provided the affidavits of two employees: Sarah Kotler, the agency’s Director of the Division of Freedom of Information, and William Holzerland, the Director of the Division of Information Disclosure for the CDRH. Their affidavits detailed the following information: The two directors sent documents in response to 18 of Henson’s requests and to some of his letters. They did not respond to the remainder, including Henson’s letters, because the requested materials were either outside of the Act’s scope, duplicative of Henson’s other requests, or available on the agency’s website. The agency also appended to its motion tables describing the 18 requests and Henson’s “R” letters, the scope of the search undertaken by the agency, and the production following the stay. The affidavits also described why the agency had redacted records pursuant to certain of the Act’s exemptions to disclosure. The defendants did not file with their motion for summary judgment the Vaughn indices themselves. The agency later said it withheld them so as not to burden the district court.

Judge Herndon granted summary judgment for the defendants . He first determined that the affidavits established that the agency performed an adequate search for the documents requested by Henson. The judge also concluded that the agency had applied the Act’s exemptions correctly to withhold or redact documents: exemption 4 for trade secrets relating to the raw materials used to manufacture the glucose monitor, the raw materials used in the testing process, and the pump’s battery film; exemption 5 for “pre-decisional and deliberative ” agency documents; and exemption 6 for documents that identified patients who had reported feedback to the agency or the manufacturer of the glucose monitor and

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those patients’ medical histories, as well as agency employees ’ cell-phone numbers and the personal email addresses of the manufacturer’s employees. See § 552(b)(4)–(6).

On appeal, Henson raises three challenges. First, he argues that the district court should not have dismissed one of the agency employees as a defendant. He contends the disciplinary provisions of § 552(a)(4)(F) cannot be enforced unless individual agency employees are proper defendants under the Act. Second, he argues that the magistrate judge erred by staying the case pending the agency’s motion for summary judgment. Third, Henson argues generally that the district court erred in granting summary judgment on the merits. We address these arguments in turn.

First, we agree with the district court that the Act does not authorize suits against the individuals named in Henson’s complaint. Under 5 U.S.C. § 552(a)(4)(B), “on complaint, the district court . . . has jurisdiction to enjoin the agency from withholding agency records and to order the production of any agency records improperly withheld from the complainant .” (Emphasis added.) The statute defines “agency” as “each authority of the Government of the United States, whether or not it is within or subject to review by another agency, but does not include—(A) the Congress; (B) the courts of the United States; (C) the governments of the territories or possessions of the United States; (D) the government of the District of Columbia.” 5 U.S.C. § 551(1). An individual employee is not an “agency” as defined by the Act. The district court properly dismissed the claims against the two agency employees.

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