Braun v. Hhs

Court of Appeals for the Federal Circuit·Decided December 21, 2020·No. 19-1949·Published

Opinion

United States Court of Appeals for the Federal Circuit

ALLEN R. BRAUN,

Petitioner

v.

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Respondent

2019-1949

Petition for review of the Merit Systems Protection Board in No. DC-0752-16-0743-I-2.

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.

2 BRAUN v. HHS

Opinion for the court filed by Circuit Judge TARANTO.

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, magnetoencephalo-

BRAUN v. HHS 3

graphy, 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 4 BRAUN v. HHS

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 physicalexam 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

BRAUN v. HHS 5

“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.

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