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Anversa v. Partners Healthcare System, Inc.

United States Court of Appeals, First Circuit

August 30, 2016

PIERO ANVERSA and ANNAROSA LERI, Plaintiffs, Appellants


          Tracy A. Miner, with whom Megan A. Siddall and Demeo LLP were on brief, for appellants.

          Roberto M. Braceras, with whom Jennifer L. Chunias and Goodwin Procter LLP were on brief, for appellees Harvard Medical School and Gretchen Brodnicki.

          Geoffrey M. Raux, with whom Michael J. Tuteur and Foley & Lardner LLP were on brief, for remaining appellees

          Before Thompson, Selya and Kayatta, Circuit Judges.

          SELYA, Circuit Judge.

         There is a time for every action, cf. Ecclesiastes 3:1 ("To every thing there is a season, and a time to every purpose . . . ."), including the bringing of suit. This case breathes life into that axiom.

         The context is the high-stakes world of academic medical research. The questions before us have their genesis in allegations that the plaintiffs (prominent medical researchers) used manipulated research data in articles reporting on studies supported by government funds. Responding to those allegations, the institutional defendants (including a medical school and a teaching hospital) triggered a unique federal statutory and regulatory scheme. Things did not go smoothly and, after some time elapsed, the plaintiffs repaired to the federal courts in search of relief (without awaiting the outcome of the administrative proceedings).

         Concluding that the suit was premature because the plaintiffs had not exhausted their administrative remedies, the district court dismissed the action. See Anversa v. Partners Healthcare Sys., Inc., 116 F.Supp.3d 22, 34-35 (D. Mass. 2015). The plaintiffs appeal. Their appeal raises novel questions at the federal appellate level concerning the interrelationship between the statutory and regulatory scheme and state-law causes of action touching upon its implementation. Answering those questions, we affirm the district court's application of the doctrine of administrative exhaustion but modify the judgment to ensure that the suit receives a full airing at the appropriate time.


         We begin with a description of the unique and highly detailed statutory and regulatory scheme that underlies this appeal. The federal government provides substantial funding for path breaking medical research. Fearful that these funds could be misused by researchers who might fabricate, falsify, or otherwise doctor research outcomes, Congress envisioned a need to establish procedures to address complaints of research misconduct. To this end, Congress created the Office of Research Integrity (ORI) within the Department of Health and Human Services (HHS), see 42 U.S.C. § 289b(a)(1), and tasked ORI with responsibility for carrying out regulations to be promulgated by the Secretary of HHS (the Secretary) for the investigation of research misconduct allegations, see id. § 289b(a)(2), (b)-(e).

         Among other things, the statute obligates the Secretary to promulgate regulations that define "research misconduct, " id. § 289b(a)(3)(A); to ensure that institutions receiving funds have a compliant "administrative process to review reports of research misconduct, " id. § 289b(b)(1); and to create a process for ORI itself to receive allegations of and reports about research misconduct, to carry out its own investigations as needed, and to take necessary remedial action, see id. § 289b(c). Relatedly, Congress tasked the Secretary with fashioning regulations that would facilitate ORI's oversight of institutional compliance with the research misconduct regulations. See id. § 289b(d). Congress also authorized the Secretary to appoint ORI's director, who must "be experienced and specially trained in the conduct of research, and have experience in the conduct of investigations of research misconduct." Id. § 289b(a)(2).

         The Secretary has responded to this statutory mandate by promulgating an elaborate regulatory mosaic. In that mosaic, "research misconduct" is defined as "fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results." 42 C.F.R. § 93.103. Establishing research misconduct requires a showing, by a preponderance of the evidence, of "a significant departure from accepted practices of the relevant research community" that is "committed intentionally, knowingly, or recklessly." Id. § 93.104.

         These standards inform a protocol which, mirroring congressional intent, creates a two-level process for review of research misconduct allegations. The first level occurs at the funded institution. An inquiry "is warranted" when the institution is made aware of "sufficiently credible and specific" allegations of research misconduct. Id. § 93.307(a)(3). Such an inquiry comprises "an initial review of the evidence to determine whether to conduct an investigation." Id. § 93.307(c). The institution generally "must complete the inquiry within 60 calendar days of its initiation unless circumstances clearly warrant a longer period, " and it must document the reasons for any delays in completing the inquiry. Id. § 93.307(g). The inquiry culminates in a written report - a report on which the target of the inquiry (the respondent) has the opportunity to comment. See id. § 93.307(e)-(f).

         If the inquiry finds a "reasonable basis for concluding" that some research misconduct involving federal funds has taken place, id. § 93.307(d)(1), and that particularized allegations of research misconduct "may have substance, " id. § 93.307(d)(2), the institution must notify ORI of the inquiry results within 30 days, sending along a copy of the inquiry report, see id. § 93.309(a). It must also give the respondent notice of the allegations that the investigation will explore. See id. § 93.310(c).

         From that point forward, the institution is obliged to conduct a "thorough and sufficiently documented" investigation, which "includes examination of all research records and evidence relevant to reaching a decision on the merits of the allegations." Id. § 93.310(e). The institution is expected to interview all relevant witnesses, see id. § 93.310(g), and to "[p]ursue diligently all significant issues and leads discovered that are determined relevant to the investigation . . . and continue the investigation to completion, " id. § 93.310(h). As with the earlier inquiry, the investigation culminates in a written report, on which the respondent has the opportunity to comment. See id. §§ 93.312(a), 93.313(g). This phase of the regulatory framework has its own temporal limitation: it provides that "[a]n institution must complete all aspects of an investigation within 120 days, " id. § 93.311(a), unless it requests and receives an extension from ORI, see id. § 93.311(b). Regardless of whether the investigation concludes that research misconduct occurred, the report, its findings and conclusions, all the relevant evidence, and any information about actions taken or pending by the institution must be forwarded to ORI. See id. § 93.315.

         Once ORI receives the investigation report and the related materials, it conducts its own assessment of the allegations. ORI has the authority to obtain additional input from virtually any source, supplement the evidence, and develop its own analysis. See id. § 93.403(d)-(e). Moreover, ORI may make independent findings as to whether research misconduct was committed and if so, by whom. See id. § 93.403(f). It also may recommend appropriate administrative action, which can range from the relatively mild (say, a letter of reprimand) to the relatively severe (say, debarment from eligibility to receive federal research funding). See id. § 93.407(a).

         Even beyond the notice requirements, opportunities for comment, and time limits described above, the regulatory framework contains protections for researchers facing investigation. For example, the regulations offer assurances of confidentiality, limiting disclosure of information about an ongoing proceeding "to the extent possible, to those who need to know." Id. § 93.108(a). So, too, the regulations require institutions to "[t]ake reasonable steps to ensure an impartial and unbiased investigation to the maximum extent practicable." Id. § 93.310(f). In this regard, institutions must ensure that those participating in the investigation have the "appropriate scientific expertise" and are not affected by "personal, professional, or financial conflicts of interest." Id.

         Should ORI find research misconduct, a respondent has access to an additional safety valve: a right to appeal that finding and any resulting administrative action to an administrative law judge (ALJ). See id. § 93.500(b). The ALJ's review of both ORI's finding and its proposed administrative action is de novo. See id. § 93.517(b). Withal, the ALJ "does not review the institution's procedures or misconduct findings." Id. When issued, the ALJ's decision serves as a recommendation to the Assistant Secretary for Health in HHS, who may affirm, modify, or reject it entirely. See id. § 93.523(b). In making those determinations, the Assistant Secretary uses familiar standards of review, such as whether particular findings are clearly erroneous or whether the decision (or any part of it) is arbitrary or capricious. See id. The Assistant Secretary's decision constitutes final agency action for most purposes, [1] subject to review in the federal courts under the Administrative Procedure Act (APA). See 5 U.S.C. § 701-706.

         Three other features of this statutory/regulatory scheme deserve mention. First, although ORI examines the institution's handiwork in determining whether to carry out its own investigation, see 42 C.F.R. § 93.403(c), there is no formal process for a respondent to prefer charges that an institution has violated the regulations in the course of either the inquiry or the first-tier investigation. The regulations do, however, provide a process by which ORI may, on its own initiative, probe an institution's compliance with the regulations and take appropriate enforcement action. See id. §§ 93.412-.413.

         Second, it is manifest that neither the statute nor the regulations contemplate enforcement by private parties. Instead, enforcement is left to the Secretary, acting ...

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