Braun v. Dep't of Health & Human Servs.

983 F.3d 1295

Allen R. BRAUN, Petitioner

v.DEPARTMENT OF HEALTH AND HUMAN SERVICES, Respondent

2019-1949

United States Court of Appeals, Federal Circuit.

Decided: December 21, 2020

George Chuzi, Kalijarvi, Chuzi, Newman & Fitch, PC, Washington, DC, argued for petitioner.

Tanya Koenig, Commercial Litigation Branch, Civil Division, United States Department of Justice, Washington, DC, argued for respondent. Also represented by Jeffrey B. Clark, Tara K. Hogan, Robert Edward Kirschman, Jr.

Before Newman, Dyk, and Taranto, Circuit Judges.

Dissenting opinion by Circuit Judge Newman.

Taranto, Circuit Judge.

Dr. Allen Braun worked at the National Institutes of Health (NIH) for almost 32 years as a research doctor with a specialty in neurological disorders, and he had tenured status since 2003. In 2016, the NIH, which is located within the U.S. Department of Health and Human Services, removed Dr. Braun from his position after an audit revealed that his records were incomplete for all but 9% of the human subjects who had participated in his research over the course of six years. Dr. Braun challenged that decision before the Merit Systems Protection Board (Board), arguing that an NIH policy required de-tenuring of tenured scientists (which NIH had not done in his case) before they could be removed for performance-related reasons and that the NIH committed certain other errors. The Board ruled that Dr. Braun's removal was proper under a provision of the cited NIH policy that allows removal "for cause" without de-tenuring, and it also rejected Dr. Braun's other challenges. Braun v. Dep't of Health & Human Servs. , No. DC-0752-16-0743-I-2, 2019 WL 1047556 (M.S.P.B. Feb. 28, 2019). We affirm.

I

A

Having worked as a research doctor at the NIH since the mid-1980s, Dr. Braun in 2003 became a tenured Senior Investigator for the National Institute on Deafness & Other Communication Disorders (Deafness Institute), a branch of the NIH. See J.A. 69–71 (describing "The Tenure Process"). He was the principal investigator for protocol study 92-DC-0178, which studied the effect of trauma on speech and language. Study participants were subjected to speech and language tests (by interview and by computer), hearing tests, electroencephalography, magnetoencephalography, electromyography, and magnetic resonance imaging (MRI).

Because his research involved human subjects, Dr. Braun submitted a standard research protocol to an NIH Institutional Review Board (IRB), a body operating with considerable independence from management and having as its primary purpose the protection of human subjects of study. J.A. 186; see also J.A. 172–75, 198. As approved by the IRB, Dr. Braun's protocol for screening subjects of the 92-DC-0178 study required an informed-consent form, a requirement to take a medical history from and conduct a physical examination of each subject, and an eligibility-screening questionnaire. See J.A. 156. The informed-consent form provided subjects with an overview of the study's risks, which were designated as minimal to none, apart from the MRIs. J.A. 158. The consent form explained that MRIs are associated with risks for subjects with pacemakers and electrical-device implants and that "[i]t is not known" whether MRIs are "completely safe for a developing fetus." Id. Accordingly, Dr. Braun's protocol also required female subjects within a specified age range to receive a pregnancy test. Id.

In March 2015, Dr. Braun notified his clinical director at the Deafness Institute that a deviation from the protocol had resulted in the running of an MRI scan on the wrong patient. After some initial reviews, the Deafness Institute retained an independent company to conduct an audit of Dr. Braun's records. The IRB—which had begun its own review of Dr. Braun's records—postponed its review until completion of the audit commissioned by the Deafness Institute.

The audit was completed in February 2016. J.A. 129. The auditors reviewed records from 424 subjects included in Dr. Braun's study (going back to 2009) to determine whether Dr. Braun had met the protocol's requirements for each one. J.A. 131 n.1. The results indicated that 14 subjects (3%) had either no informed-consent form (2 subjects) or an unacceptable consent form on file. J.A. 143. In addition, only about half (213 of the 424 subjects) of the participants had acceptable medical-history and physical-exam documentation: For some, there was no record that they had undergone history and physical screening, while for others the records were not signed by Dr. Braun (as required by the protocol). J.A. 144. Only 55% of the subjects had eligibility-screening questionnaires on file; and of those, only 26% had completed questionnaires. J.A. 145. Overall, complete records existed for only 38 of the 424 subjects—less than 9% of the participants whose records were reviewed. J.A. 147.

Given the audit results, the IRB determined that Dr. Braun's deviations from protocol constituted "serious, continuing non-compliance," and it suspended the study, while noting that the study could resume after "appropriate remediation." J.A. 84–85. The IRB permitted Dr. Braun to submit a plan for remediation, which he did on May 12, 2016. J.A. 86.

The following day, Dr. Braun received from Dr. Andrew Griffith, the Deafness Institute's Scientific Director, a Proposal to Remove him from his position at the NIH. J.A. 27–31 (Removal Proposal). The Proposal charged Dr. Braun with "[n]egligence in the performance of [his] duties" based on the audit results, which "demonstrated a pattern of repeated deviations from the requirements of [Dr. Braun's] approved protocol, NIH medical records policy, and accepted standards of medical practice." J.A. 28. The Proposal further explained that Dr. Braun's deviations from protocol—including having complete records for less than 9% of his subjects—"indicate[d] a consistent and continuous pattern o[f] gross negligence" and "could have exposed subjects to unnecessary harm and impacted the integrity of the research being conducted." J.A. 29. Those deviations "ma[de] it impossible for [Dr. Braun's] supervisors to trust" him to carry out his duties. Id.

On the same day (May 13, 2016) that he received the Proposal, Dr. Braun (through counsel) contacted Timothy Wheeles, Executive Officer for the Deafness Institute, who was to make the final removal decision. J.A. 39–40. He argued that the NIH had failed to follow its own policy in sending the Removal Proposal—specifically, the NIH Policy on Performance Management, Disciplinary Actions and Administrative Removals for Title 42 Employees (NIH Policy). J.A. 62–73. Critically for present purposes, that Policy provides that "[t]enured scientists must undergo the de-tenuring process before a performance-based action may be taken against them," NIH Policy § H(1), while permitting the agency to forgo the de-tenuring process when it removes tenured employees "for cause, e.g. , personal or scientific misconduct," NIH Policy § L(1). J.A. 67, 71. After receiving no response, Dr. Braun submitted his Written Reply to the Removal Proposal on June 3, 2016.

Ten days later, Mr. Wheeles announced his Decision on Proposed Removal, removing Dr. Braun for negligence in the performance of his duties. J.A. 32–38 (Removal Decision). He noted that the decision to remove Dr. Braun was based on the information set forth in the Removal Proposal, including its supporting documentation (i.e. , the NIH Policy, the NIH Table of Penalties, which recommends appropriate penalties for employee misconduct, and the independent audit results), as well as Dr. Braun's Written Reply. J.A. 32–35. Mr. Wheeles also conducted a penalty analysis in accordance with Douglas v. Veterans Administration , 5 M.S.P.R. 280 (1981). Although he found that Dr. Braun's length of tenure and lack of previous employment problems were mitigating factors, he ultimately rejected Dr. Braun's argument that deviations from his protocol did not increase the risks to his patients, stating that, because of the magnitude of the protocol violations, "there is no way to prove the validity and reliability of your research"; "you repeatedly failed to follow the requirements of the protocol, which is in place for the safety of the patients and the credibility of the research"; and "[t]his misconduct could tarnish the reputation of the [Deafness Institute] and the NIH." J.A. 35. Mr. Wheeles concluded: "Based on the serious, continuing non-compliance with your study protocols for at least the past six years, I have no confidence or trust in you to lead and manage a research study and staff, to publish with integrity, or to represent the [Deafness Institute] and NIH." Id. (emphasis omitted). The Removal Decision, dated June 13, 2016, stated that removal would not become effective until June 25, 2016. J.A. 33.

Knowing that Dr. Braun was defending a removal action before the NIH, the IRB contacted the Deafness Institute to inquire about Dr. Braun's employment status. On June 13, 2016, after Mr. Wheeles notified Dr. Braun of the decision to remove him, the Deafness Institute's Dr. Carter VanWaes contacted the IRB's Dr. Barbara Karp and asked her to call him. J.A. 94. That same day, Dr. Karp issued a memorandum stating: the IRB had been informed that Dr. Braun "will no longer be an NIH employee at the time of the planned IRB review" of Dr. Braun's remediation at an IRB meeting on June 15, 2016; "[t]he Institute plans to close the protocol"; and the matter was being removed from the IRB agenda. J.A. 95. It is undisputed that the NIH did not inform the IRB that Dr. Braun's removal would not become effective until June 25, 2016, ten days after the scheduled IRB meeting.

B

Dr. Braun appealed the Removal Decision to the Merit Systems Protection Board on July 19, 2016. The Board refiled his appeal about a year later. On February 28, 2019, an administrative judge issued an Initial Decision affirming the NIH's action, and the Initial Decision, under 5...