Court Opinion

ID: 4029727
Source: CourtListenerOpinion
Date Created: 2016-08-30 18:00:29.784216+00
Date Added: 2024-06-11T14:29:08.263579
License: Public Domain

United States Court of Appeals
                       For the First Circuit

No. 15-1897

                  PIERO ANVERSA and ANNAROSA LERI,

                       Plaintiffs, Appellants,

                                 v.

              PARTNERS HEALTHCARE SYSTEM, INC., ET AL.,

                       Defendants, Appellees.

          APPEAL FROM THE UNITED STATES DISTRICT COURT
                FOR THE DISTRICT OF MASSACHUSETTS

          [Hon. Denise J. Casper, U.S. District Judge]

                               Before

                    Thompson, Selya and Kayatta,
                           Circuit Judges.

     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.

                           August 30, 2016
            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

                                      - 2 -
administrative exhaustion but modify the judgment to ensure that

the suit receives a full airing at the appropriate time.

I.   STATUTORY AND REGULATORY FRAMEWORK

               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,

                                        - 3 -
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

                                 - 4 -
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

                                         - 5 -
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

                                          - 6 -
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

                                    - 7 -
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 through ORI and the

Assistant Secretary for Health.

               Finally,       the   statute    itself      contains    no     explicit

exhaustion       requirement.         While    the    district     court     found   an

      1
      We say "for most purposes" because a recommendation for
debarment or suspension from receiving federal research funds only
becomes final after ratification by a different official. See 42
C.F.R. § 93.523(c).

                                          - 8 -
exhaustion requirement to be implicit in the statutory scheme, see

Anversa, 116 F. Supp. 3d at 31-32, it is unnecessary (for reasons

to which we shortly shall return) for us to pass upon this aspect

of the district court's decision — and we do not do so.             Instead,

we resolve this appeal on the basis of the district court's

alternate holding (its administrative exhaustion ruling).

II.       FACTUAL OVERVIEW

               The    raw   facts,    outlined   in    the   complaint,    are

essentially undisputed for present purposes.             The plaintiffs are

two high-profile medical researchers, Dr. Piero Anversa and Dr.

Annarosa Leri.        At the time of the underlying events, both of them

held faculty appointments at Harvard Medical School (Harvard).2

In    addition       to   their   teaching   roles,   both   plaintiffs   were

intimately involved with a cardiac stem cell research laboratory

at Brigham and Women's Hospital (the Brigham): Dr. Anversa led the

lab, and Dr. Leri toiled as a principal investigator there.               The

Brigham, it should be noted, is not only a Harvard teaching

hospital but also a founding member of the Partners HealthCare

System (Partners).

               In 2012, questions arose about the authenticity of data

that appeared in an article co-authored by the plaintiffs and other

      2
      At oral argument in this court, plaintiffs' counsel reported
that both of her clients have left Harvard and are now working in
Switzerland.

                                       - 9 -
scientists, including a researcher at Lawrence Livermore National

Laboratory (LLNL).      Shortly after the publication of this paper in

the journal "Circulation," the LLNL researcher reported to the

plaintiffs that discrepancies existed between the data LLNL had

provided and the data presented in the paper.               Dr. Anversa asserts

that he repeatedly asked the Brigham lab member who received the

LLNL data if the presentation in the paper was accurate and

received assurances that everything was in order.                         But LLNL

persisted; it reported the discrepancies to Gretchen Brodnicki,

Harvard's Dean for Faculty and Research Integrity.

           On     January     10,    2013,    Dean    Brodnicki     informed      the

plaintiffs that Harvard and the Brigham were going to begin a joint

inquiry    into     allegations       of     research    misconduct.            These

allegations related not only to the "Circulation" paper but also

to an article co-authored by the plaintiffs and other collaborators

that had appeared in another journal, "The Lancet," in 2011.

           The inquiry took substantially longer than the 60 days

allotted   in   the   regulations.           One   reason   was    that   (as   Dean

Brodnicki told the plaintiffs in March of 2013) the inquiry was

expanded   to     encompass    yet   another       allegation     relating   to    an

unpublished manuscript submitted in 2013 to "The Lancet" and the

journal "Science." The inquiry panel did not submit a draft report

to the plaintiffs for their comments until January 8, 2014.                       The

final panel inquiry report was issued on February 28, 2014.                       The

                                      - 10 -
plaintiffs allege that the report recommended retraction of the

2011 "Lancet" and 2012 "Circulation" papers, that the lab be

evaluated for its appropriateness as a training ground for budding

researchers,    and   that    the   inquiry     proceed     to    a    full-blown

investigation.    The plaintiffs further allege that "[t]he inquiry

panel found no evidence that [the plaintiffs] ever participated in

falsifying or fabricating research data or results, or that they

even knew of any research misconduct at the time it occurred," but

nonetheless recommended proceeding to an investigation "on the

theory that Dr. Anversa should be held responsible for arguably

negligent failure to investigate" research misconduct.

            Simultaneous     with   their    receipt   of   the       final   panel

inquiry report, the plaintiffs were notified that Harvard and the

Brigham    intended   to   commence     an    investigation.           The    three

scientists who composed the inquiry panel were appointed to serve

on the investigation panel, and a fourth member was added a few

weeks later.    On three separate occasions — twice in 2014 and once

in 2015 (after suit had been commenced) — the investigation was

expanded   to   include    additional       research   papers     beyond      those

identified in the panel inquiry report.           Betimes, Harvard and the

Brigham have sought — and ORI has granted — multiple extensions to

the 120-day investigatory period.3

    3 At oral argument in this court, counsel for Harvard reported
that the deadline for completing the investigation authorized by

                                    - 11 -
III.   TRAVEL OF THE CASE

             In December of 2014 — while the investigation was still

in progress — the plaintiffs sued Partners, the Brigham, Harvard,

Dean Brodnicki, and Dr. Elizabeth Nabel (the Brigham's president).

Their complaint limned claims under Massachusetts law for tortious

interference with business relations, invasion of privacy, and

unfair and deceptive business practices.               The complaint also

charged Partners, the Brigham, and Harvard with breach of contract

based on a claim that the ORI regulations are incorporated into

their employment contracts with those institutions.

             The plaintiffs alleged that both the completed inquiry

and the ongoing investigation failed to comply with pertinent

regulations.     Specifically, they alleged that the inquiry panel

applied the wrong standard in recommending an investigation and

that   its   report     was   riddled   with   other      errors.    See   id.

§ 93.104(b).      They also ascribed a host of failings to the

investigation panel, claiming (for example) that some of its

members lacked the requisite scientific expertise and that some

were either biased due to their participation in the flawed inquiry

or labored under conflicts of interest.         See id. § 93.310(f).       The

plaintiffs    further    lamented    that    both   the    inquiry   and   the

the most recent ORI extension is November 1, 2016.           The
investigation panel, we were told, is in the process of drafting
its report.

                                    - 12 -
investigation        have   been     subject    to   egregious    and     unwarranted

delays.    See id. §§ 93.307(g), .311(b).                Finally, the plaintiffs

alleged that Dr. Steven Gygi (a member of both the inquiry and

investigation panels), Dean Brodnicki, and Dr. Nabel separately

transgressed         confidentiality         obligations        imposed     by      the

regulations.4        See id. § 93.108.

               The   plaintiffs      seek    money    damages     and     unspecified

declaratory relief.           With respect to damages, they say that the

manifold       failures     that   occurred     during    the    inquiry     and    the

investigation caused them harm.                They claim, for instance, that

they missed out on a number of promising employment and other

professional opportunities, and lost a lucrative offer for the

purchase of Dr. Anversa's company. They also claim that Dr. Leri's

promotion to a full professorship at Harvard was delayed and that

they have suffered reputational injury.

               The defendants moved to dismiss.               See Fed. R. Civ. P.

12(b)(1), (6).         They contended, inter alia, that the plaintiffs

should    be    required     to    exhaust     administrative     remedies       before

bringing suit.            The district court agreed and dismissed the

complaint without prejudice.            See Anversa, 116 F. Supp. 3d at 35.

The   court     held   that    the    statutory      scheme    governing    research

      4The plaintiffs allege that Dr. Gygi resigned from the
investigation panel in September of 2014, acknowledging that he
had discussed the investigation with a colleague.

                                        - 13 -
misconduct investigations mandated exhaustion.                           See id. at 32.

Alternatively,       the     court     held    that     common-law         principles     of

administrative exhaustion militated in favor of dismissal.                                See

id. at 34.     This timely appeal followed.

IV.   ANALYSIS

             Given the structure of the district court's disposition,

an issue of jurisdictional priority looms.                              Even though the

doctrines of statutory and administrative exhaustion have a common

objective     —    delaying        a    plaintiff's          day      in     court    while

administrative proceedings run their course — the two doctrines

rest on different foundations.                The question whether a statutory

scheme   requires          the     channeling         of        claims      through       the

administrative process implicates the jurisdiction of the district

court.      See,     e.g.,    Free     Enter.    Fund      v.    Pub.      Co.   Accounting

Oversight Bd., 561 U.S. 477, 489-91 (2010); Thunder Basin Coal Co.

v. Reich, 510 U.S. 200, 207-09 (1994). By contrast, administrative

exhaustion    applies        "where     Congress      has       not   clearly      required

exhaustion," and cedes discretion to a district court to decline

the   exercise       of    jurisdiction        and      await      the     conclusion      of

administrative proceedings.              See McCarthy v. Madigan, 503 U.S.
140, 144 (1992).

             Here,    the     district        court's      ruling     consists       of   two

alternative holdings.            Taken together, these holdings amount to a

double-barreled conclusion that the statutory structure forbade

                                         - 14 -
the district court's exercise of jurisdiction over the action and

— even if it had jurisdiction — it would decline to exercise that

jurisdiction for prudential reasons.

                 In the ordinary course, questions about the existence of

subject matter jurisdiction take precedence in our analysis of a

case.5      See Acosta-Ramírez v. Banco Popular de P.R., 712 F.3d 14,

18 (1st Cir. 2013).              This approach is consistent with the Supreme

Court's admonition that a court "may not rule on the merits of a

case without first determining that it has jurisdiction over the

category of claim in suit."              Sinochem Int'l Co. v. Malaysia Int'l

Shipping         Corp.,    549 U.S. 422,   430-31   (2007).     But   the   two

exhaustion doctrines at issue here do not implicate this principle:

they       are    simply    alternative     "threshold     grounds   for   denying

       5
      The parties have not contested the existence of Article III
jurisdiction, and the district court did not consider that
question. Nevertheless, we have an obligation to assure ourselves
of our own jurisdiction. See Watchtower Bible & Tract Soc'y of
N.Y., Inc. v. Colombani, 712 F.3d 6, 10 (1st Cir. 2013).         In
keeping with that obligation, we note that Article III jurisdiction
exists in this case notwithstanding that the controversy is between
non-diverse parties and asserts exclusively state-law claims.
Federal question jurisdiction under 28 U.S.C. § 1331 encompasses
a narrow swath of cases in which "a state-law claim necessarily
raise[s]   a   stated   federal  issue,   actually   disputed   and
substantial, which a federal forum may entertain without
disturbing any congressionally approved balance of federal and
state judicial responsibilities."     Grable & Sons Metal Prods.,
Inc. v. Darue Eng'g & Mfg., 545 U.S. 308, 314 (2005). Given that
all of the plaintiffs' claims turn on the interpretation of the
federal regulations governing research misconduct investigations
and the importance of those regulations to the Congressional
scheme, this case plainly falls within the narrow swath of cases
described in Grable.

                                          - 15 -
audience to a case on the merits."             Ruhrgas AG v. Marathon Oil

Co., 526 U.S. 574, 585 (1999).             In comparable situations, the

Supreme Court has made pellucid that a nonjurisdictional threshold

reason for pretermitting a merits determination — such as a

decision   not   to    exercise   pendent     jurisdiction    over   state-law

claims, dismissal on the basis of forum non conveniens, or Younger

abstention — may be applied without first resolving a difficult

jurisdictional question.        See Sinochem Int'l, 549 U.S. at 431-32.

            Such an approach — bypassing the jurisdictional inquiry

— is preferable here. The statutory exhaustion analysis is complex

and uncertain, and its outcome would have no bearing on the

ultimate result: as we explain below, the district court acted

well   within    its   discretion    in    insisting   upon   administrative

exhaustion.      Thus, we proceed directly to the merits of the

district court's administrative exhaustion ruling.

            Administrative exhaustion is governed by "sound judicial

discretion."      McCarthy, 503 U.S. at 144.             Consequently, the

customary practice among the circuits has been to review a district

court's    decision    to   compel   the    exhaustion   of   administrative

remedies, in the absence of a statute directing exhaustion, for

abuse of discretion.        See, e.g., Koch v. White, 744 F.3d 162, 164-

65 (D.C. Cir. 2014); Thermal Sci., Inc. v. U.S. Nuclear Regulatory

Comm'n, 184 F.3d 803, 805 n.3 (8th Cir. 1999) (per curiam).

Although we have never explicitly stated the standard in this

                                     - 16 -
manner, we have recognized that application of the administrative

exhaustion doctrine is a matter of discretion, guided by the

factors identified in McCarthy.      See Portela-Gonzalez v. Sec'y of

the Navy, 109 F.3d 74, 77 (1st Cir. 1997).         We hold, therefore,

that appellate review of a district court's decision to require

administrative exhaustion should be for abuse of discretion.

             Generally, aggrieved parties are required to exhaust

available federal administrative remedies before bringing suit in

federal court.      See Myers v. Bethlehem Shipbuilding Corp., 303
U.S. 41, 50-51, 51 n.9 (1938); Portela-Gonzalez, 109 F.3d at 77.

This principle rests on solid foundations: exhaustion normally

"serves the twin purposes of protecting administrative agency

authority and promoting judicial efficiency."          McCarthy, 503 U.S.

at 145.      Preserving agency authority is particularly important

insofar as "the action under review involves exercise of the

agency's discretionary power or when the agency proceedings in

question allow the agency to apply its special expertise."            Id.

Insisting upon exhaustion not only gives an agency the first

opportunity to apply that expertise and correct possible errors,

but   also    respects   congressional   prerogative    by   "prevent[ing]

litigants from bypassing Congress' carefully crafted remedial

scheme."      Irizarry v. United States, 427 F.3d 76, 79 (1st Cir.

2005).       So, too, insisting upon exhaustion promotes judicial

efficiency both by obviating the need for review in cases in which

                                  - 17 -
the agency provides appropriate redress, see Portela-Gonzalez, 109
F.3d at 79, and by creating "a useful record for subsequent

judicial   consideration,           especially   in    a   complex   or   technical

factual context," McCarthy, 503 U.S. at 145.

             Where, as here, Congress has not mandated exhaustion,

federal courts have some leeway to relax this requirement.                      See

Swirsky v. Nat'l Ass'n of Sec. Dealers, 124 F.3d 59, 63 (1st Cir.

1997).     That leeway is built into the common-law doctrine of

administrative exhaustion.            In considering whether to exercise it,

"courts must balance the interest of the individual in retaining

prompt access to a federal judicial forum against countervailing

institutional interests favoring exhaustion."                 McCarthy, 503 U.S.

at 146. This analysis is "'intensely practical,' because attention

is directed to both the nature of the claim presented and the

characteristics        of     the    particular       administrative      procedure

provided."     Id. (internal citations omitted) (quoting Bowen v.

City of New York, 476 U.S. 467, 484 (1986)).

             In discussing how to construct this balance, the Supreme

Court described three "sets of circumstances in which the interests

of the individual weigh heavily against requiring administrative

exhaustion."     Id.        These situations arise when "requiring resort

to the administrative remedy may occasion undue prejudice to

subsequent assertion of a court action," id. at 146-47; when an

administrative remedy may be insufficient because the agency is

                                        - 18 -
powerless to grant effective relief or incompetent to adjudicate

the claims at issue, see id. at 147-48; or when the administrative

body is clearly biased, see id. at 148-49.

             The plaintiffs asseverate that their case falls within

two of these categories. In their view, the administrative process

cannot grant them appropriate relief and, moreover, they face an

indefinite        (and,     therefore,     unreasonable)         timeline.        These

drawbacks, they say, more than outweigh whatever may be gained by

exhaustion because — in this instance — exhaustion will neither

preserve agency authority nor promote judicial economy.

             We     start     our    inquiry      into    the     district   court's

application of administrative exhaustion with the plaintiffs'

suggestion that completion of the administrative process in this

case will not advance the interests that exhaustion exists to

protect.      We do not agree.             To begin, the plaintiffs vastly

understate    the     ongoing       importance    of     ORI's   expertise   to    the

administrative proceedings.            They similarly understate the degree

to which ORI's expertise already has played a valuable role in the

institutional investigation.             The issues raised by the plaintiffs'

suit are in many respects the very kind of issues that call for

the exercise of ORI's special insights.                  We explain briefly.

             The enabling statute requires that ORI be led by a

professional experienced in research misconduct investigations,

and   the    regulations        envision     that      ORI's     oversight   of     the

                                         - 19 -
institutional investigation process will allow it to apply that

expertise.       This know-how is reflected, for example, in ORI's

ability to grant extensions to an institution to complete an

investigation       and       to   conduct     a   review   of    the   institution's

investigation before issuing findings of research misconduct.

What is more, ORI — in the course of its review — may well comment

on   the   interpretation           of   key    components      of    the   regulations

undergirding       the    plaintiffs'         claims,    such    as   the   appropriate

standard     for     initiating          an     investigation,        the      scope   of

confidentiality obligations, and the qualifications needed for

panel members.

            Permitting the agency to apply its expertise in the first

instance    is     especially        important      because      it   protects     ORI's

authority    even        if   the   plaintiffs'         state-law     claims    are    not

themselves adjudicated in the agency-supervised proceeding.                            The

statutory structure contemplates that the first tier of review in

research misconduct cases will take place at the institutional

level with ORI oversight.            Respect for Congress's judgment in this

area counsels in favor of allowing the agency to exercise that

oversight authority before a federal court intervenes.                             ORI's

authority would be severely undermined if, for example, we were to

permit a jury to decide whether an ongoing investigation, with

extension requests reviewed and approved by ORI, had dragged on so

                                          - 20 -
long as to amount to a breach of contract based on the very rules

that ORI is tasked with administering.

             The plaintiffs' countervailing interests in immediate

review do not outweigh these substantial advantages to exhaustion.

Arguing to the contrary, they assert that the administrative

process cannot provide them with appropriate relief.                 In support,

they note that ORI lacks any mechanism to review state-law claims

and has no authority to award money damages (the primary form of

relief demanded in their suit).           Although they acknowledge ORI's

oversight role, they observe that they will not be parties to any

enforcement     action    taken   by     ORI    against    the    institutions.

Furthermore, even if they were to challenge a hypothetical future

finding of research misconduct before an ALJ, the ALJ would not

have the authority to consider the institution's conduct of either

the inquiry or the investigation.          There is some truth in what the

plaintiffs say — but we conclude that neither the unavailability

of a monetary remedy in agency proceedings nor the agency's lack

of   capacity   to   adjudicate    the    state-law      claims   at   issue    is

dispositive.

             With respect to the unavailability of money damages, the

plaintiffs    rely   on   the   McCarthy       Court's   statement     that   "the

uncertainty of the administrative agency's authority to award

[monetary] relief counsels against requiring exhaustion."                 Id. at

155.   But the McCarthy Court mentioned the unavailability of a

                                   - 21 -
specific form of relief merely as one factor in the exhaustion

calculus.        Other circumstances (such as the agency's lack of

interest in exhaustion, the fact that the claim at issue did not

call for the application of agency expertise, and the fact that

record development before the agency would provide only minimal

assistance to future judicial review) combined to make exhaustion

unnecessary.       See id. at 155-56.       Because no comparable mix of

factors is present here, the unavailability of monetary relief

through ORI does not relieve us of the duty to carry out the

intensely practical analysis required by McCarthy.               See Munsell v.

Dep't of Agric., 509 F.3d 572, 592 (D.C. Cir. 2007) ("The rationale

for requiring exhaustion does not depend on the existence of money

damages as a remedy.      So long as the administrative process offers

the possibility of some redress . . . the administrative process

can serve its proper function.").

            We     add,   moreover,     that    there      are     significant

institutional       advantages     in   compelling        exhaustion        here.

Addressing a similar claim in an analogous context, we recognized

that   "[e]xhaustion      is   beneficial    regardless    of     whether    the

administrative process offers the specific form of remediation

sought by a particular plaintiff" because "the administrative

process facilitates the compilation of a fully developed record,"

which "is an invaluable resource for a state or federal court

required to adjudicate a subsequent civil action covering the same

                                   - 22 -
terrain."       Frazier v. Fairhaven Sch. Comm., 276 F.3d 52, 61 (1st

Cir. 2002).

               So it is here.        Although ORI will not adjudicate the

plaintiffs'       state-law       claims   as    such,    the    district   court's

eventual disposition of those claims would benefit greatly from

any legal interpretations or factual findings made by ORI in the

course of its review.6        Indeed, the shape of the plaintiffs' claims

may    well    change     based    on   the     outcome   of    the   institutional

investigation.       The regulations specifically require institutions

to make "[a]ll reasonable and practical efforts, if requested and

as appropriate, to protect or restore the reputation of persons

alleged to have engaged in research misconduct but against whom no

finding of research misconduct is made."                  42 C.F.R. § 93.304(k).

Insofar as the complaint seeks to remedy "[l]ong-term injury to

[the       plaintiffs']   professional        reputations       and   careers,"   the

outcome of the institutional investigation and any subsequent

action under this provision may reconfigure the contours of the

       6
       It is worth noting that this is not a case in which self-
sufficient state-law claims merely run parallel to administrative
regulations. Rather, the plaintiffs invoke the federal court's
subject matter jurisdiction only by advancing claims that turn on
the answers to embedded federal questions concerning the meaning
and application of the very federal regulations that ORI exists to
enforce. To allow the case to proceed to judgment and run the
risk of having ORI's ongoing oversight thereafter arrive at
conclusions that conflict with that judgment makes little
practical sense.

                                        - 23 -
controversy         by    the    time     it     is   ripe   for   district     court

consideration.

              Our review of the record persuades us that the district

court made the "intensely practical" assessment that the McCarthy

Court required.          We think that the totality of the circumstances

—    particularly        the    unique   characteristics      of   this    two-tiered

investigatory system, Congress's manifest desire to ensure that

ORI is able to use its expertise to guide and evaluate an initial

round    of    investigation        at    the    institutional     level,    and   the

significant advantages that exhaustion could bring — warrants a

finding that the district court did not abuse its discretion in

applying      the    doctrine      of    administrative      exhaustion.      In   the

circumstances at hand, neither the unavailability of a monetary

remedy in the administrative proceeding nor the agency's inability

to adjudicate state-law claims demands a different result.

              The plaintiffs have a fallback position.                They press the

notion that forcing them to delay their suit will cause undue

prejudice to its subsequent prosecution because they face an

indefinite timeframe for administrative action.                       They emphasize

the length of the inquiry to date and the several extensions to

the investigation (which has entered its third year). This problem

is   exacerbated,        they    say,    by     the   institutions'    lackadaisical

approach to the matter and by the repeated widening of the scope

of the investigation.            In their view, these developments show that

                                          - 24 -
the time limits in the regulations are effectively meaningless and

that ORI has abdicated its responsibility to superintend the

investigation.

           Although we understand the plaintiffs' frustration with

the pace of the proceedings, we do not believe that matters have

reached   the   tipping   point.     The     duration   of   administrative

proceedings, without more, cannot suffice to demonstrate that an

agency's actions are unreasonable.          Rather, determining whether a

timeframe for agency action is unreasonable involves more than a

matter of simple arithmetic.         Cf. Telecomms. Research & Action

Ctr. v. FCC, 750 F.2d 70, 80 (D.C. Cir. 1984) (limning range of

factors for evaluating the reasonableness of agency delay).             An

inquiring court must pay close attention to the specific regulatory

framework and its relationship to the claims presented.                 See

McCarthy, 503 U.S. at 146.

           Here, the district court fulfilled that responsibility.

The features of the ongoing process are every bit as consistent

with a conclusion that the investigation is proceeding apace

through a complex area of medical research as with an inference of

indefiniteness.    Virtually by definition, research misconduct is

a complicated area; and the regulations specifically envision that

research misconduct inquiries and investigations may take longer

than the time limits spelled out in the regulations.              Both the

inquiry process and (with ORI's consent) the investigatory process

                                   - 25 -
can   be   extended    when   circumstances   warrant.          See    42    C.F.R.

§§ 93.307(g), 93.311(b).        Such flexibility is crucial, given the

regulatory imperative that institutions must "[p]ursue diligently

all significant issues and leads discovered that are determined

relevant to the investigation."       Id. § 93.310(h).

            In the case at hand, all indications are that the

investigation     is   being    actively    pursued,      and    the    repeated

expansions of its scope suggest compliance with the mandate to

explore "any evidence of additional instances of possible research

misconduct" that comes to light during the investigation.                       Id.

Against this backdrop, we discern no principled basis for viewing

this timeframe, at present, as unreasonable.

            The   plaintiffs     advance    one   other     strain      of     this

argument.    They submit that the duration of the investigation and

subsequent ORI review could cause the statute of limitations to

expire on some or all of their state-law claims.            See, e.g., Mass.

Gen. Laws ch. 260, § 2A (establishing three-year statute of

limitations for tort claims).        This is a legitimate concern: the

running of the statute of limitations could well "occasion undue

prejudice to subsequent assertion" of the plaintiffs' claims.

McCarthy, 503 U.S. at 146. At least some of the plaintiffs' claims

already may have accrued, and the district court's order of

dismissal without prejudice will be of little consolation should

those claims become time-barred.

                                   - 26 -
              This concern, however, does not demand the solution that

the   plaintiffs     urge.      In   light    of   the   strong      interests   in

exhaustion that are extant here, permitting this action to go

forward in parallel to the administrative proceedings is not the

most salutary way to guard against a potential limitations problem.

In the context of state habeas proceedings (which present similar

temporal snares), federal appellate courts have acknowledged that

district courts may stay a petition filed within the statute of

limitations until state remedies have been exhausted.                  See, e.g.,

Pace v. DiGuglielmo, 544 U.S. 408, 416 (2005); Rhines v. Weber,

544 U.S. 269, 274-78 (2005); Neverson v. Bissonnette, 261 F.3d
120, 126 n.3 (1st Cir. 2001); see also Dolis v. Chambers, 454 F.3d
721, 725 (7th Cir. 2006) (collecting cases).                 Such a prophylactic

approach is well-suited to administrative exhaustion cases because

it protects agency authority while administrative proceedings are

ongoing yet ensures that limitations concerns will not bar the

ultimate consideration of the plaintiffs' claims.

              For these reasons, we hold that, as a matter of practice,

a district court ordinarily should stay, rather than dismiss, an

action when it finds that principles of administrative exhaustion

require it to act.           We apply that prescription here: though

upholding the district court's determination that administrative

exhaustion is warranted, we think it appropriate to direct that

its   order    of   dismissal   be   converted      to   a    stay   of   judicial

                                     - 27 -
proceedings pending the timely resolution of the administrative

proceedings.

V.   CONCLUSION

           The    defendants   have   raised   a   gallimaufry   of   other

grounds for dismissing this action, but we need go no further.

Thus, we take no view of these other grounds.          Suffice it to say

that we affirm the district court's decision, based on the common-

law doctrine of administrative exhaustion, and the plaintiffs must

exhaust their administrative remedies before proceeding with their

suit.   However, we direct that the district court, on remand,

convert its order of dismissal to an order staying the case pending

the timely resolution of administrative proceedings.

Affirmed as modified.     All parties shall bear their own costs.

                                 - 28 -