Henson v. Dep't of Health & Human Servs.
Opinion
Plaintiff J. Donald Henson, Sr., appeals from the district court's grant of summary judgment for defendants on his claims under the Freedom of Information Act,
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
.,
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, 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 pages in response to his requests. Henson then called and wrote to *873 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
,
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
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 those patients' medical histories, as well as agency employees' cell-phone numbers and the personal email *874 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
Henson resists this conclusion by arguing that § 552(a)(4)(F) allows suits against individuals. That provision allows the court, when ordering the production of records, to question whether agency personnel have acted arbitrarily or capriciously and whether discipline is warranted. But under the statute, the issue of any discipline is left to the agency, not a court. See
id
. We agree with our colleagues in other circuits that a plaintiff may not sue an individual agency employee for violating the Freedom of Information Act. See
Drake v. Obama
,
Second, the magistrate judge did not err by staying discovery and setting a briefing schedule for summary judgment. Henson argues that the judge's decision constituted an improper order "directing" the agency to file a motion for summary judgment. He also contends that the judge lacked authority to set a briefing schedule because no written referral from the district judge exists in the record.
We do not understand the magistrate judge's order as Henson does. The magistrate judge reasoned that, in cases under the Freedom of Information Act, it is prudent to entertain summary-judgment motions before discovery. The magistrate judge's decision to grant the stay and set a briefing schedule was within his considerable discretion to manage the court's docket to ensure the "just, speedy, and inexpensive" resolution of this case. See Fed. R. Civ. P. 1, 6(b) ;
Dietzv. Bouldin
, --- U.S. ----,
Third, we turn to the merits of the district court's grant of summary judgment. Henson disputes both the adequacy of the agency's search and the applicability of the Act's exemptions 4, 5, and 6 in this case.
We begin with whether the agency's search was adequate, a question that we review
de novo
. See
Rubman v. U.S. Citizenship & Immigration Servs.
,
The undisputed facts show here that the agency's search for responsive documents was reasonable. Holzerland's affidavit establishes that the agency searched its database by the premarket-approval number assigned to the glucose monitor Henson inquired about. The agency also had the recipients of Henson's letters and those representatives with whom Henson had met search their files for responsive documents. Kotler attested that, in response to Henson's request for documents about a meeting he had with the agency's general counsel, the general counsel searched his files. Other documents responsive to Henson's requests of the ombudsman were identified, Kotler described, through a search of files. Kotler also detailed how Henson's other requests were handled in a similar manner. The agency also provided Henson with responsive documents after reviewing the documents and creating a Vaughn index. Henson has no basis for suggesting that these were not reasonable efforts to locate responsive documents to his many (and often repetitive) requests. We agree with the district court that the agency undertook a search reasonably calculated to uncover all relevant documents.
We next turn to whether the agency properly withheld or redacted documents pursuant to the Act's exemptions. We examine
de novo
whether the district court had an adequate factual basis for its decision. See
Patterson v. I.R.S.
,
Henson's challenge to the adequacy of the judge's factual basis fails. Henson had the agency's
Vaughn
indices yet did not point to specific claims of exemption with which he disagreed. Neither Henson nor the agency filed the indices with the district court. And although Henson argued in the district court that the agency did not narrowly construe the exemptions to the Act's disclosure mandate, as it is required to do, see
Patterson
,
The district court would have had a stronger factual basis for its decision if the judge had reviewed the
Vaughn
indices or conducted an
in camera
review of at least a reasonable sample of the documents. See, e.g.,
Solar Sources
,
Still, this is an adversary process. Henson was in the better position to focus the judge on the contested issues. He had the ability to identify which redactions he believed were unsupported, rather than objecting generally, as though every entry in the Vaughn indices gave insufficient grounds for redaction. Rather than ask a busy district judge to examine documents (in this case Henson asked the judge to examine over 67,000 documents) or to parse the Vaughn indices as an original matter, it is better to put the burden on the plaintiff to identify with particularity the claims of exemption he was challenging, at least where the Vaughn indices appear facially adequate, as they do here.
We recognize that the burden remains on the government to justify decisions not to disclose information, see
In this appeal, as a precautionary step, we opted to order the agency to file the indices in this appeal. That is not how future cases should proceed as a matter of course. Rather, if
Vaughn
indices are created (they are not required in every case, see, e.g.,
Solar Sources
,
Because Henson's challenge to the judge's factual basis fails, we next examine whether the judge clearly erred in upholding the agency's claims of exemption. We find no clear error.
The judge found that the agency properly invoked exemption 4 to withhold "information relating to the raw material used in the manufacturing process, raw material used in the testing process, and the pump's battery film." Exemption 4 protects from disclosure "matters that are ... trade secrets and commercial or financial information obtained from a person and privileged or confidential."
We see no clear error in the judge's determination that the materials used to manufacture the glucose monitor and its battery film were exempt from disclosure as trade secrets or were otherwise confidential. Henson provided no evidence to the district judge contradicting Holzerland's declaration that the agency redacted information relating to the materials used to make the monitor and its battery film. The Vaughn indices confirm that the agency limited its redactions pursuant to exemption 4 to these kinds of information. There is no evidence that the manufacturer of the glucose monitor disclosed the information that the agency redacted, nor is there evidence that the raw materials do not have economic value by virtue of remaining confidential. Because there is no evidence that the materials used to make the monitor and the battery film have been made public, there is no reason to doubt that substantial competitive harm could befall the manufacturer if that information were released to the public.
The district judge also did not clearly error in finding that exemption 5 applied to the agency's pre-decisional and deliberative documents and communications protected by the attorney-client privilege. Exemption 5 allows an agency to withhold "inter-agency or intraagency memorandums or letters that would not be available by law to a party other than an agency in litigation with the agency."
Finally, there was no clear error in the judge's determination that the agency properly applied exemption 6, which excuses the disclosure of "personnel and medical files and similar files the disclosure of which would constitute a clearly unwarranted invasion of personal privacy."
Based on the affidavits provided to the district court and the
Vaughn
indices, the agency redacted medical information about the manufacturer's patients and the contact information for employees of the manufacturer and the agency. We agree with the district court that this information was protected by exemption 6 because the revelation of personal identifying information tips the scales in favor of non-disclosure. See
The judgment of the district court is AFFIRMED.
Reference
- Full Case Name
- J. Donald HENSON, Sr., Plaintiff-Appellant, v. DEPARTMENT OF HEALTH AND HUMAN SERVICES, Et Al., Defendants-Appellees.
- Cited By
- 26 cases
- Status
- Published