Teamsters Union v. Warner Chilcott Limited , 907 F.3d 42 ( 2018 )


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  •           United States Court of Appeals
    For the First Circuit
    No. 18-1065
    IN RE: ASACOL ANTITRUST LITIGATION
    UNITED FOOD & COMMERCIAL WORKERS UNIONS AND EMPLOYERS MIDWEST
    HEALTH BENEFITS FUND, on behalf of itself and all others
    similarly situated; MARK ADORNEY,
    Plaintiffs,
    TEAMSTERS UNION 25 HEALTH SERVICES & INSURANCE PLAN, on behalf
    of themselves and all others similarly situated; NECA-IBEW
    WELFARE TRUST FUND, on behalf of themselves and all others
    similarly situated; WISCONSIN MASONS' HEALTH CARE FUND, on
    behalf of itself and all others similarly situated; MINNESOTA
    LABORERS HEALTH AND WELFARE FUND, on behalf of itself and all
    others similarly situated; AFSCME HEALTH AND WELFARE FUND;
    PENNSYLVANIA EMPLOYEES BENEFIT TRUST FUND; AHOLD U.S.A., INC.;
    ROCHESTER DRUG CO-OPERATIVE, INC.; VALUE DRUG COMPANY; MEIJER,
    INC.; MEIJER DISTRIBUTION, INC.,
    Plaintiffs, Appellees,
    v.
    WARNER CHILCOTT LIMITED; ALLERGAN, INC., f/k/a Actavis, PLC;
    ALLERGAN USA, INC.; ALLERGAN SALES, LLC; ALLERGAN, PLC, Formerly
    known as Actavis, PLC,
    Defendants, Appellants,
    ZYDUS PHARMACEUTICALS USA INC.; CADILA HEALTHCARE LIMITED;
    WARNER CHILCOTT (US), LLC; WARNER CHILCOTT SALES (US), LLC;
    WARNER CHILCOTT COMPANY, LLC,
    Defendants.
    APPEAL FROM THE UNITED STATES DISTRICT COURT
    FOR THE DISTRICT OF MASSACHUSETTS
    [Hon. Denise J. Casper, U.S. District Judge]
    Before
    Lynch, Kayatta, and Barron,
    Circuit Judges.
    J. Mark Gidley, with whom Peter J. Carney, Dana Foster,
    Matthew S. Leddicotte, Jaclyn Phillips, Maxwell J. Hyman, Robert
    A. Milne, Jack E. Pace III, Bryan D. Gant, Kelly Newman, and White
    & Case LLP were on brief, for appellants.
    Richard A. Samp and Marc B. Robertson on brief for Washington
    Legal Foundation, amicus curiae.
    Justin N. Boley, with whom Kenneth A. Wexler, Tyler J. Story,
    Wexler Wallace LLP, Tyler W. Hudson, Eric D. Barton, David Barclay,
    Wagstaff & Cartmell, LLP, Nathaniel L. Orenstein, Todd A. Seaver,
    Berman Tabacco, Daniel E. Gustafson, Karla M. Gluek, Michelle J.
    Looby, Joshua J. Rissman, Gustafson Gluek PLLC, Jeffrey L. Kodroff,
    William G. Caldes, John A. Macoretta, Spector Roseman Kodroff &
    Willis, P.C., Peter J. Mougey, Levin, Papantonio, Thomas,
    Mitchell, Rafferty & Proctor, P.A., Jonathan D. Karmel, and Karmel
    Law Firm were on brief, for appellees.
    October 15, 2018
    KAYATTA,     Circuit     Judge.       Drug    manufacturer        Warner
    Chilcott Limited pulled one of its products -- Asacol -- from the
    market just months before the drug's patent protection expired.
    Warner    simultaneously     introduced       a   similar    but      not    exactly
    identical substitute drug called Delzicol, the patent protection
    for which ran years longer.          This coordinated withdrawal and entry
    of the two drugs allegedly precluded generic manufacturers from
    introducing a generic version of Asacol, which would have provided
    a lower-cost alternative to Warner's drugs Delzicol and Asacol HD,
    a version of Asacol that was also still under patent protection.
    Crying foul, the named plaintiffs in this case filed a class action
    alleging a violation of the consumer protection and antitrust laws
    of twenty-five states and the District of Columbia. On plaintiffs'
    motion,    the   district    court    certified    a     class   of    all   Asacol
    purchasers who subsequently purchased Delzicol or Asacol HD in one
    of those twenty-six jurisdictions.            In so doing, the court found
    that approximately ten percent of the class had not suffered any
    injury    attributable      to   defendants'      allegedly      anticompetitive
    behavior.    Nevertheless, the district court determined that those
    uninjured class members could be removed in a proceeding conducted
    by a claims administrator.         We find this approach to certifying a
    class at odds with both Supreme Court precedent and the law of our
    circuit.    We therefore reverse.
    - 3 -
    I.
    Asacol is a pharmaceutical drug that treats mild to
    moderate     ulcerative   colitis,     a   chronic   inflammatory    bowel
    disorder.    Developed and first manufactured by Procter and Gamble
    Pharmaceuticals, Asacol debuted on the market in 1992 and received
    the protection of two patents.       Those patents expired on July 30,
    2013.     In 2008, Procter and Gamble brought a new variation of
    Asacol to market, dubbed Asacol HD, which treated moderate, but
    not mild, ulcerative colitis.        This new drug differed from Asacol
    in two key ways: it included twice the dosage, and it replaced
    Asacol's single-layer coating with a dual-layer coating.            Asacol
    HD's patent protection extended years beyond that of Asacol.           In
    2009,      Warner   Chilcott   purchased       Procter    and    Gamble's
    pharmaceutical portfolio, which included both Asacol and Asacol
    HD.
    On March 18, 2013, only a few months shy of the end of
    Asacol's patent protection, Warner stopped selling and marketing
    Asacol.    On the same day, Warner introduced a new drug:       Delzicol.
    Delzicol, like Asacol, treats ulcerative colitis.          The two drugs
    contain the same active ingredient and dosage, and sold for the
    same price.    Unlike Asacol, Delzicol comes in a capsule that does
    not contain dibutyl phthalate ("DBP").        DBP is a plasticizer, the
    safety of which appears to have been the subject of a dialogue
    between the FDA and Asacol's manufacturers.
    - 4 -
    On   June 22,     2015,   several        plaintiffs      (collectively
    "plaintiffs,"       "named    plaintiffs,"      or     "class    representatives")
    filed suit on their own behalf and on behalf of a putative class.
    These plaintiffs are all union-sponsored benefit plans that paid
    for the purchases of Asacol HD and Delzicol.                    In their operative
    complaint,         plaintiffs     allege        that     Warner        harbored    an
    anticompetitive motivation for its conduct.                      According to the
    complaint, Warner's aim in pulling Asacol from the market and
    introducing Delzicol was to preclude the possibility of market
    entry of generic drugs, which would have cut into Warner's profits.
    State law provides the mechanism for this preclusion.                     Under most
    state substitution laws, pharmacists can fill a prescription by
    substituting a generic drug for the prescribed brand drug, but
    only if the brand drug is listed as a "reference" drug for the
    generic.      This automatic substitution, plaintiffs say, provides
    the   "only    viable    cost-efficient         means"    for    new    generics   to
    "compet[e] with brand drugs."           But even a small alteration to the
    brand drug, such as substituting a tablet form for a capsule form,
    can prevent a generic equivalent from using the discontinued form
    as a reference drug.         Thus, by pulling Asacol, Warner effectively
    prevented generic drugs that would have used Asacol as a reference
    drug from entering the market after the expiration of Asacol's
    - 5 -
    patents.1      And the introduction of a similar, but not wholly
    equivalent, drug -- Delzicol -- with the potential for longer-
    lasting patent protection, allowed Warner to substantially retain
    its   market    share.     Thus,    plaintiffs    contend,     Warner   forced
    consumers into a "hard switch" and maintained its monopoly power
    unencumbered     by   competition   from    generic   entry.        Plaintiffs'
    theory of liability rests on a Second Circuit decision that
    condemns similar such conduct.        See New York ex rel. Schneiderman
    v. Actavis PLC, 
    787 F.3d 638
    (2d Cir. 2015).
    The named plaintiffs and the putative class members
    purchased Warner's products not from Warner directly, but from
    third party intermediaries. That means that they cannot sue Warner
    for damages under the federal antitrust law.            Illinois Brick Co.
    v. Illinois, 
    431 U.S. 720
    , 736 (1977).           Plaintiffs therefore seek
    recovery under the laws of twenty-five states and the District of
    Columbia       that   allow    indirect       purchasers       to    challenge
    anticompetitive conduct by manufacturers whose products consumers
    acquire through intermediaries.2            All twenty-six jurisdictions,
    1 A number of our recent opinions provide comprehensive overviews
    of the regulatory framework that governs the introduction of
    generic drugs. See In re Nexium (Esomeprazole) Antitrust Litig.,
    
    842 F.3d 34
    , 40-42 (1st Cir. 2016); In re Loestrin 24 Fe Antitrust
    Litig., 
    814 F.3d 538
    , 542-43 (1st Cir. 2016);         In re Nexium
    Antitrust Litig., 
    777 F.3d 9
    , 15-16 (1st Cir. 2015).
    2 Like the district court and the parties, we will use "states"
    informally in the remainder of this opinion to refer to both states
    and the District of Columbia.
    - 6 -
    according to plaintiffs, generally interpret state law restraints
    on anticompetitive activity consistently with federal courts'
    interpretation of federal antitrust law, but have "Illinois Brick
    repealer"   laws   allowing   antitrust   damage   actions   by   indirect
    purchasers against manufacturers.
    Plaintiffs moved for class certification on behalf of a
    class of all similarly situated indirect purchasers, including any
    individual consumers who purchased the relevant Warner products
    from drug retailers in the twenty-six jurisdictions.          Plaintiffs
    designed the class to include only those persons or entities that
    both purchased Asacol prior to July 31, 2013 -- the approximate
    date on which Asacol's patent protection expired -- and also
    purchased either Asacol HD or Delzicol after July 31, 2013.          Both
    sides introduced expert evidence regarding the propriety of class
    certification.
    The district court granted plaintiffs' motion for class
    certification.     Rejecting Warner's argument to the contrary, the
    district court concluded that the named plaintiffs had standing to
    prosecute claims on behalf of class members under various state
    laws even if the named plaintiffs themselves had not made purchases
    in all those states.      Any difference between the claims of the
    named plaintiffs and those of unnamed class members was a matter
    for consideration under Rule 23, and not a matter of Article III
    standing, the court ruled.
    - 7 -
    Moving to the Rule 23 analysis, the district court first
    found that plaintiffs' proposed class satisfied the four elements
    of Rule 23(a):       numerosity, commonality, typicality, and adequacy.
    See Fed. R. Civ. P. 23(a).            The district court also concluded that
    the   proposed      class    passed     muster   under     Rule 23(b)(3)    because
    common questions predominated over individual questions and a
    class action presented a superior method for resolving plaintiffs'
    claims.
    In     making    those    determinations,        the    district   court
    grappled with a problem that has been the source of much debate
    among the circuits:          the presence of uninjured class members.            The
    district court presumed that approximately ten percent of class
    members had not been injured by Warner's allegedly anticompetitive
    conduct because, even had a lower-priced generic alternative been
    available, these consumers would not have switched to it.3                        The
    court based this conclusion on the reports of both sides' experts.
    Those     experts    used    the   experiences        of   similar   pharmaceutical
    products as benchmarks from which to infer likely market dynamics
    had   a    lower-priced       generic    form    of    Asacol   been    introduced.
    Defendants' expert, Dr. Bruce Strombom, pointed to a benchmark
    product in which the prevalence of consumers who stuck with the
    3 Plaintiffs make no explicit claim that the price of Delzicol and
    Asacol HD would have been lower had generic versions of Asacol
    been available.
    - 8 -
    higher-priced brand decreased to 10.6% within approximately three
    years after generic entry.     Dr. Rena Conti, plaintiffs' expert,
    looked to different benchmark products, from which she concluded
    that the market share of generic Asacol would have grown to
    approximately 88.8% within a year of generic entry, and would then
    have risen to about 91.4% thirty-one months after generic entry.
    From these two reports, the district court presumed that "by the
    end of the relevant period, somewhere around 10% of the class
    members would have opted for Asacol HD or Delzicol even in the
    presence of generic Asacol."       In re Asacol Antitrust Litig., 
    323 F.R.D. 451
    , 482 (D. Mass. 2017).
    The   district   court    nevertheless   concluded   that   the
    number of these uninjured class members was "de minimis."             The
    district court also accepted plaintiffs' contention that they
    could remove these uninjured persons from the class with the
    assistance of a so-called claims administrator.         Our opinion in
    Nexium, plaintiffs argue, permitted such a process.            See In re
    Nexium Antitrust Litig., 
    777 F.3d 9
    (1st Cir. 2015).
    The district court's order certifying the class raises
    issues on which circuits are split and that are likely to arise in
    other cases in this circuit before an appeal from a final judgment
    would -- if ever -- ripen in this case.        A panel of this court
    therefore found "special circumstances" justifying the grant of
    leave to pursue an interlocutory appeal under Rule 23(f).             See
    - 9 -
    Fed. R. Civ. P. 23(f); Waste Mgmt. Holdings, Inc. v. Mowbray, 
    208 F.3d 288
    , 293-94 (1st Cir. 2000).     In accord with this grant,
    Warner presents two primary challenges.   First, it argues that,
    because the named plaintiffs only made purchases in four states,
    they lack Article III standing to assert claims under the laws of
    states in which they did not make purchases.   Second, Warner takes
    issue with the district court's decision to certify a class
    containing uninjured class members.
    II.
    We review de novo the existence of Article III standing
    required to invoke the jurisdiction of a federal court.        See
    Anderson ex rel. Dowd v. City of Boston, 
    375 F.3d 71
    , 92 (1st Cir.
    2004).   The named plaintiffs in this case indisputably have
    standing to litigate their own claims against Warner.         They
    plausibly allege an injury in the form of lost money fairly
    traceable to an allegedly unlawful supra-competitive price, and
    seek classic redress in the form of a damage award.   See generally
    Lujan v. Defs. of Wildlife, 
    504 U.S. 555
    , 560-61 (1992).   Nor does
    the standing requirement of Article III erect any impediment to
    the named plaintiffs' ability to litigate as class representatives
    materially identical claims by other persons under the same laws
    - 10 -
    under   which    the   named       plaintiffs'    claims   arise.       Gratz     v.
    Bollinger, 
    539 U.S. 244
    , 267 (2003).
    Warner     challenges,       instead,    the   named      plaintiffs'
    standing to bring claims on behalf of class members whose claims
    arise under the laws of the twenty-two states within which no named
    plaintiff has either resided or purchased the relevant Warner
    products during the class period.             These states, apparently, apply
    their relevant law only to claims that arise out of purchases made
    within the state or by state residents.              Therefore, says Warner,
    because no named plaintiff can successfully bring a claim under
    the laws of any of those twenty-two states, they necessarily lack
    standing to bring such claims as representatives of persons who
    might sue successfully in those states.
    One might think that we could reject this argument merely
    by observing that whether a plaintiff may represent persons who
    themselves have standing to bring the claims alleged is a question
    to be addressed under Rule 23, rather than a question of standing.
    After all, that is how one would presumably proceed in seemingly
    analogous situations outside of Rule 23.             For example, in deciding
    whether a fiduciary, a parent, a personal representative, or a
    partner may prosecute a claim on behalf of another person, courts
    generally    focus     not    on    whether    the   putative    representative
    independently     satisfies        Article III    standing,     but   rather      on
    whether   that   party       qualifies   under    the   applicable     law   as    a
    - 11 -
    representative of the one who does have standing.          See, e.g., Sam
    M. ex rel. Elliot v. Carcieri, 
    608 F.3d 77
    , 83 n.5 (1st Cir. 2010);
    Goodwin v. C.N.J., Inc., 
    436 F.3d 44
    , 49 (1st Cir. 2006); Pérez v.
    Clinica Dr. Perea, 
    915 F.2d 1556
    , 
    1990 WL 151307
    , at *3 (1st Cir.
    July 9, 1990) (unpublished); Levin v. Berley, 
    728 F.2d 551
    , 555-
    56 (1st Cir. 1984).       And sometimes the authority for such a person
    to bring a suit as a representative of another resides in the
    Federal   Rules   of   Civil   Procedure.   See,   e.g.,   Fed.   R.   Civ.
    P. 17(c)(2) (allowing a "next friend" to sue on behalf of a minor
    with no requirement that the next friend possess standing to bring
    such a claim on behalf of herself or himself).
    Precedent, though, forecloses such a simple and quick
    answer.   See Warth v. Seldin, 
    422 U.S. 490
    , 502 (1975); Blum v.
    Yaretsky, 
    457 U.S. 991
    , 1000-01 (1982); see also 1 William B.
    Rubenstein, Newberg on Class Actions § 2:5 (5th ed. 2012) ("In a
    class action suit with multiple claims, at least one named class
    representative must have standing with respect to each claim.").
    In Blum, the Supreme Court confronted an effort by two plaintiffs
    to represent a class of Medicaid patients challenging the decisions
    of a state committee to transfer them to different levels of
    nursing   home    care,    allegedly   without   sufficient    procedural
    safeguards.      The two named plaintiffs, who had been threatened
    with transfers to lower levels of nursing care, also sought to
    press the claims of persons who might object to being transferred
    - 12 -
    to facilities providing higher levels of 
    care. 457 U.S. at 1000
    -
    02.     The named plaintiffs had not been transferred or threatened
    with transfers to facilities providing higher levels of care.
    Furthermore,    the     conditions      under    which   transfers     to   such
    facilities occurred were sufficiently different from transfers to
    facilities providing lesser care "that any judicial assessment of
    their     procedural    adequacy     would      be   wholly    gratuitous     and
    advisory."     
    Id. at 1001.
        For that reason, the plaintiffs lacked
    "the necessary stake in litigating conduct . . . to which [the
    plaintiffs] ha[d] not been subject."            
    Id. at 999.
    In keeping with this precedent, we have trained our
    Article III focus in class actions on "the incentives of the named
    plaintiffs to adequately litigate issues of importance to them."
    Plumbers'    Union     Local   No. 12    Pension     Fund     v.   Nomura   Asset
    Acceptance Corp., 
    632 F.3d 762
    , 770 (1st Cir. 2011).                 This focus
    is in many respects simply an application to aggregate litigation
    of the basic Article III requirement that a plaintiff possess "such
    a personal stake in the outcome of the controversy as to assure
    . . . concrete adverseness."            Baker v. Carr, 
    369 U.S. 186
    , 204
    (1962).
    Nothing in this precedent, though, suggests that the
    claims of the named plaintiffs must in all respects be identical
    to the claims of each class member.             See 
    Gratz, 539 U.S. at 262
    -
    68.     Requiring that the claims of the class representative be in
    - 13 -
    all respects identical to those of each class member in order to
    establish     standing       would     "confuse[]       the      requirements          of
    Article III and Rule 23."            Fallick v. Nationwide Mut. Ins. Co.,
    
    162 F.3d 410
    , 421 (6th Cir. 1998).            Indeed, such an approach would
    render   superfluous        the   Rule 23     commonality     and     predominance
    requirements    because      any     case    that     survived    such     a    strict
    Article III    analysis      would    by    definition    present     only      common
    issues. So the question of standing is not: Are there differences
    between the claims of the class members and those of the class
    representative?       Rather, the pertinent question is:                       Are the
    differences    that     do    exist    the     type    that   leave       the       class
    representative       with    an    insufficient       personal     stake       in     the
    adjudication    of    the    class    members'      claims?       Here,    with       one
    exception, we think not.
    Importantly, the claims of the named plaintiffs parallel
    those of the putative class members in the sense that, assuming a
    proper class is certified, success on the claim under one state's
    law will more or less dictate success under another state's law.
    Even while arguing that there may be a few subtle differences in
    the attitudes of some state courts toward such claims, Warner
    concedes that the "parties do agree that Plaintiffs' liability
    theories as to monopolization are limited to a construction of
    state antitrust laws that parallel the federal Sherman Act." Under
    those parallel laws, all plaintiffs who were forced to pay a higher
    - 14 -
    price in the absence of generic competition have a substantial and
    shared interest in proving that the higher price was the result of
    unlawful monopolizing conduct that is redressable by an award of
    damages.   And the fact that judgments for some class members will
    nevertheless enter under the laws of states other than the states
    under which any of the class representatives' judgments will enter,
    where those laws are materially the same, has no relevant bearing
    on the personal stake of the named plaintiffs in litigating the
    case to secure such judgments.   See Morrison v. YTB Int'l, Inc.,
    
    649 F.3d 533
    , 536 (7th Cir. 2011) (holding that a state law's limit
    to in-state events is an "application of choice-of-law principles
    [that] has nothing to do with standing" (emphasis in original)).
    Indeed, the fact that the judgments will enter under different
    statutes is such a minor point of difference that in individual
    actions it might not even preclude a finding of issue preclusion.
    B&B Hardware, Inc. v. Hargis Indus., Inc., 
    135 S. Ct. 1293
    , 1306
    (2015); see also Smith v. Bayer Corp., 
    564 U.S. 299
    , 310 (2011)
    (rejecting the proposition "that the source of law is all that
    matters" in determining whether two issues differ).
    It is true that, in order to prevail on their claims,
    the named plaintiffs need not prove where a class member resides,
    or where the class member made a purchase.    But that same thing
    could be said of the named plaintiffs' need to prove that any class
    member made a purchase anywhere, even in the states under which
    - 15 -
    the   named    plaintiffs'   claims    arise.     As   we    have    previously
    observed, "[i]n a properly certified class action, the named
    plaintiffs regularly litigate . . . claims of other class members
    based on transactions in which the named plaintiffs played no
    part."   Plumbers' 
    Union, 632 F.3d at 769
    .
    Warner does argue that the applicable laws in a few
    states actually do have added substantive elements that the named
    plaintiffs will have no interest in proving:             First, the laws of
    three states require proving some effect on intrastate commerce,
    see In re Flonase Antitrust Litig., 
    610 F. Supp. 2d 409
    , 415-16
    (E.D. Pa. 2009) (Tennessee); Sun Dun, Inc. v. Coca-Cola Co., 
    740 F. Supp. 381
    , 396-97 (D. Md. 1990) (District of Columbia); In re
    Microsoft Corp. Antitrust Litig., 
    2003 WL 22070561
    , at *2 (D. Md.
    Aug. 22, 2003) (Maryland); Second, some states treble damages,
    compare, e.g., Nev. Rev. Stat. § 598A.210(2) (providing for treble
    damages);     Wis.   Stat.   § 133.18(1)(a)     (same)      with    Fla.      Stat.
    § 501.211(2) (providing only for actual damages) and Mass. Gen.
    Laws ch. 93A, § 11 (requiring proof of willful conduct as a
    predicate to trebling); and, Third, New York's consumer protection
    statute requires proof of deception, see Stutman v. Chem. Bank,
    
    731 N.E.2d 608
    (N.Y. 2000).
    Warner, though, makes no showing that an effect on
    intrastate commerce will even be a disputed issue.                 Trebling, in
    turn,    seems    irrelevant   to     our    inquiry   unless       it   is     not
    - 16 -
    automatically applied to the common surcharge that the named
    plaintiffs have ample self-interest in proving.                 So that leaves
    Warner's unopposed contentions that New York law may require proof
    of   deception,    and    that     trebling    in   Massachusetts     apparently
    requires proof of willfulness.          As to the latter, plaintiffs base
    their relatively novel common monopolization claim on a theory
    that expressly requires proof of a "specific intent to monopolize,"
    as "distinguished from growth or development as a consequence of
    a    superior   product,    business    acumen,      or    historic   accident."
    
    Actavis, 787 F.3d at 651
    (quoting Verizon Commc'ns, Inc. v. Law
    Offices of Curtis V. Trinko, LLP, 
    540 U.S. 398
    , 407 (2004)).               They
    expressly allege in pursuit of their own claims that Warner acted
    willfully.      Nor does Warner claim that plaintiffs need not prove
    an intent to monopolize.             So, whether or not such proof is
    ultimately      required,    the    named     plaintiffs    certainly   have   a
    substantial stake in proving up a case that is, as a practical
    matter, unreliably distinguishable from proving willfulness.
    That leaves only Warner's contention that, under N.Y.
    Gen. Bus. Law § 349(a), the named plaintiffs have an insufficient
    stake in the claim of New York class members because that law
    requires proof of deception.          Plaintiffs offer no response to this
    argument at all.         The complaint's list of common issues and its
    statement of its causes of action include no suggestion that they
    intend to prove deception (suggesting that they indeed see no stake
    - 17 -
    in doing so).      We therefore find that plaintiffs have waived any
    opposition to Warner's argument that plaintiffs lack standing to
    sue on behalf of those who can claim no basis for relief other
    than under New York law.         In so doing, we put off to another day
    how to apply Article III standing principles to a case in which a
    putative class representative has a personal stake in proving most
    but not all of the elements of a class member's claim.
    Finding Article III standing otherwise satisfied in this
    case is in accord with the decisions of our sister circuits that
    have considered similar issues.         See Langan v. Johnson & Johnson
    Consumer   Cos.,    
    897 F.3d 88
    ,   92-96   (2d   Cir.   2018);   see   also
    
    Morrison, 649 F.3d at 536
    .          Our conclusion is in line with our
    prior precedent, in which we required only that a plaintiff make
    a single purchase in order to satisfy standing for a claim brought
    under multiple state laws.         See 
    Nexium, 777 F.3d at 31-32
    .           It
    also accords with direction from the Supreme Court that, once the
    named plaintiff establishes injury and membership in the class,
    the inquiry should shift "from the elements of justiciability to
    the ability of the named representative to 'fairly and adequately
    protect the interests of the class.'"            Sosna v. Iowa, 
    419 U.S. 393
    , 403 (1975) (quoting Fed. R. Civ. P. 23(a)).            Therefore, it is
    to that inquiry that we now turn our focus.
    - 18 -
    III.
    Satisfied that we have subject matter jurisdiction, we
    consider    next    the    district     court's   finding   that    plaintiffs'
    proposed    class    meets       the   requirement   of   Rule 23(b)(3)          that
    "questions of law or fact common to class members predominate over
    any questions affecting only individual members."                  Fed. R. Civ.
    P. 23(b)(3).    We review that decision for abuse of discretion.                  In
    re New Motor Vehicles Canadian Exp. Antitrust Litig., 
    522 F.3d 6
    ,
    17 (1st Cir. 2008).            Within this ambit, we review pure issues of
    law de novo and "fact-dominated" issues for clear error.                   
    Id. In considering
    the propriety of class certification in
    this case, we again deal with an issue that strikes at the heart
    of the competing considerations raised by some class actions: the
    proper     treatment      of    uninjured   class    members   at    the     class
    certification stage.            Proof of injury, also called "injury-in-
    fact," is a required element of a plaintiff's case in an action
    such as this one.              New Motor 
    Vehicles, 522 F.3d at 19
    n.18.
    Plaintiffs' class nevertheless includes consumers who would have
    continued to purchase a brand drug for various reasons, even if a
    cheaper, generic version had been available.
    On appeal, both parties argue that the district court's
    estimate that approximately ten percent of the class was uninjured
    is wrong:    Plaintiffs say it is too high and Warner says it is too
    low.     The district court record suggests that many of these
    - 19 -
    specific challenges were not preserved.            See Clauson v. Smith, 
    823 F.2d 660
    , 666 (1st Cir. 1987) (stating that "points which were not
    seasonably advanced below" are waived on appeal).               In any event,
    having reviewed the parties' competing critiques, we find no clear
    material error in the district court's factual approximation.               See
    
    Nexium, 777 F.3d at 17
    (reviewing factual findings for "clear
    error").   So, the question thus becomes:          Can a class be certified
    in this case even though injury-in-fact will be an individual
    issue, the resolution of which will vary among class members?
    To answer this question, the parties agree that we must
    direct our attention to the requirement of Rule 23(b)(3) that
    common issues must predominate over individual issues in order to
    certify a class.     See Amgen, Inc. v. Connecticut Ret. Plans & Tr.
    Funds, 
    568 U.S. 455
    , 469 (2013).              The aim of the predominance
    inquiry is to test whether any dissimilarity among the claims of
    class   members    can   be    dealt   with   in   a   manner   that   is   not
    "inefficient or unfair."         
    Id. (citing Richard
    A. Nagareda, Class
    Certification in the Age of Aggregate Proof, 84 N.Y.U. L. Rev. 97,
    107 (2009)).      Inefficiency can be pictured as a line of thousands
    of class members waiting their turn to offer testimony and evidence
    on individual issues.         Unfairness is equally well pictured as an
    attempt to eliminate inefficiency by presuming to do away with the
    rights a party would customarily have to raise plausible individual
    challenges on those issues.
    - 20 -
    In assessing efficiency and fairness, we have recognized
    that   a    class   may   be   certified   notwithstanding     the   need   to
    adjudicate individual issues so long as the proposed adjudication
    will   be   both    "administratively      feasible"   and   "protective    of
    defendants' Seventh Amendment and due process rights."               
    Nexium, 777 F.3d at 19
    .        In Nexium itself, the court found a possible
    mechanism available to avoid both inefficiency and unfairness.
    The court reasoned that, "if unrebutted," a consumer's testimony
    that "given the choice, he or she would have purchased the generic"
    would be "sufficient to establish injury in an individual suit."
    
    Id. at 20.
        It therefore concluded that "similar testimony in the
    form of an affidavit or declaration would be sufficient in a class
    action" when introduced "at the liability stage."            
    Id. at 20-21.
    The district court in this case sought to track Nexium,
    finding that "prior to judgment, it will be possible to establish
    a mechanism for distinguishing the injured from the uninjured class
    members."      In re Asacol Antitrust 
    Litig., 323 F.R.D. at 481
    (quoting 
    Nexium, 777 F.3d at 19
    ).          Pointing to a proposal advanced
    by plaintiffs, the district court described the mechanism to which
    it referred as follows:          "[i]n a Court-approved notice, Class
    members will be asked to submit a claim form, along with data and
    documentation that may be deemed necessary for consideration.               The
    Claims Administrator will evaluate each claim pursuant to a formula
    proposed by Plaintiffs and approved by the Court."              
    Id. at 479.
    - 21 -
    Plaintiffs'     actual     proposed       mechanism        also    noted     that
    "[i]ndividual Class members will have an opportunity to contest
    the    calculations,     and    the    Court     will   review       the   Claims
    Administrator's      report,    making    any    changes     it   believes   are
    necessary."
    One can only guess what data and documentation may be
    deemed necessary, what the formula will be, and how the claims
    administrator will decide who suffered no injury.                 Nevertheless,
    the district court was convinced that Nexium blesses such a scheme.
    We disagree.
    Nexium held that "unrebutted testimony" contained in
    affidavits would suffice as a mechanism for identifying who was
    injured and who was not injured.          
    Id. at 21
    (emphasis added).         If
    unrebutted, such testimony in an affidavit could be used prior to
    trial to obtain summary judgment, thereby efficiently and fairly
    removing the issue of injury-in-fact from the case for trial.                See
    Fed. R. Civ. P. 56(c)(1)(A), (c)(4); see also, e.g., Kuperman v.
    Wrenn, 
    645 F.3d 69
    , 80 (1st Cir. 2011) (finding that a party
    prevailed on an issue on summary judgment on the basis of an
    unrebutted affidavit).         In Nexium itself, neither our court nor
    the district court ever learned whether the defendants would in
    fact   rebut   any   affidavits.        The    possibility    that    unrebutted
    affidavits could be used was raised sua sponte for the first time
    in the majority opinion.       By the time that opinion was issued, the
    - 22 -
    case had been tried without the benefit of our holding and, having
    won, the defendants indeed chose not to challenge the inclusion of
    any class members, by that point presumably enjoying the breadth
    of their win.      See generally In re Nexium (Esomeprazole) Antitrust
    Litig., 
    842 F.3d 34
    , 40-42 (1st Cir. 2016).
    Here, though, the record is clear that plaintiffs do not
    propose to rely on unrebutted testimony to eliminate the question
    of injury-in-fact before trial.           And, unlike in Nexium, defendants
    have expressly stated their intention to challenge any affidavits
    that might be gathered.        Nor do plaintiffs point to any basis in
    the record for deeming all such challenges to be so implausible as
    to   warrant   a    finding   that   we   can   consider   the   issue   to   be
    uncontested.       Warner has explained that some class members stopped
    taking (and will therefore have no record of purchasing) Asacol
    anywhere between 2009 and 2012, and some class members when asked
    will admit a preference for DBP-free medication such as Delzicol.
    Additionally, some class members would not have switched to a
    generic because they had no co-pay, and therefore were not price
    sensitive.     So whatever one thinks of Nexium's sua sponte positing
    in the face of the defendants' silence that unrebutted affidavits
    might be both available and sufficient, see 
    Nexium 777 F.3d at 36
    (Kayatta, J., dissenting), here we have no basis for venturing
    such a prediction (nor did the district court do so).
    - 23 -
    Our inability to fairly presume that these plaintiffs
    can rely on unrebutted testimony in affidavits to prove injury-
    in-fact is fatal to plaintiffs' motion to certify this case.
    Testimony that is genuinely challenged, certainly on an element of
    a party's affirmative case, cannot secure a favorable summary
    judgment ruling disposing of the issue.                    Fed. R. Civ. P. 56(a).
    And the affidavits would be inadmissible hearsay at trial, leaving
    a fatal gap in the evidence for all but the few class members who
    testify in person.             Nor have the plaintiffs provided any basis
    from which we could conclude that the number of affidavits to which
    the defendants will be able to mount a genuine challenge is so
    small that it will be administratively feasible to require those
    challenged affiants to testify at trial.
    We also reject any invitation to rewrite Nexium as
    sanctioning the use of inadmissible hearsay to prove injury to
    each class member at or after trial.                  The fact that plaintiffs
    seek class certification provides no occasion for jettisoning the
    rules of evidence and procedure, the Seventh Amendment, or the
    dictate of the Rules Enabling Act, 28 U.S.C. § 2072(b).                    See Tyson
    Foods, Inc. v. Bouaphakeo, 
    136 S. Ct. 1036
    , 1048 (2016) (evidence
    may    not   be   used    in    a    class   action   to    give   "plaintiffs   and
    defendants different rights in a class proceeding than they could
    have     asserted        in     an    individual      action").        A    "claims
    administrator's" review of contested forms completed by consumers
    - 24 -
    concerning an element of their claims would fail to be "protective
    of defendants' Seventh Amendment and due process rights."              
    Nexium, 777 F.3d at 19
    .        Plaintiffs' proposed claims process provides
    defendants    no    meaningful    opportunity   to    contest      whether      an
    individual would have, in fact, purchased a generic drug had one
    been available.     A "class cannot be certified on the premise that
    [the defendant] will not be entitled to litigate its statutory
    defenses to individual claims."        Wal-Mart Stores, Inc. v. Dukes,
    
    564 U.S. 338
    , 367 (2011).         Here, we have more than a statutory
    defense; rather, we have a challenge to a plaintiff's ability to
    prove an element of liability.       And although Halliburton permitted
    class certification based on a proper presumption furnished by the
    applicable law, even if the presumption might be rebutted as to
    individual plaintiffs in a few instances, Halliburton Co. v. Erica
    P. John Fund, Inc., 
    134 S. Ct. 2398
    , 2412 (2014), here we have no
    such presumption.
    Relatedly, this is not a case in which a very small
    absolute   number    of   class   members   might    be   picked    off    in    a
    manageable, individualized process at or before trial.                Rather,
    this is a case in which any class member may be uninjured, and
    there are apparently thousands who in fact suffered no injury.
    The need to identify those individuals will predominate and render
    an   adjudication     unmanageable    absent    evidence     such     as     the
    unrebutted affidavits assumed in Nexium, or some other mechanism
    - 25 -
    that can manageably remove uninjured persons from the class in a
    manner that protects the parties' rights.             See 
    Nexium, 777 F.3d at 30
    ("We thus define 'de minimis' in functional terms.").               And, as
    we have already explained, the process on which the district court
    relied is not such a mechanism.
    Plaintiffs' fallback argument, urged most prominently on
    appeal, is that, at trial, they will prove "class-wide impact"
    with the testimony of their expert, Dr. Conti, and with defendants'
    own documents and admissions. But plaintiffs point to no documents
    or admissions that would support a finding that all class members
    suffered injury.     So this argument on appeal comes down to their
    claim that they will prove class-wide impact at trial with the
    testimony of their expert, Dr. Conti.
    To support this alternative approach, plaintiffs point
    to the approval in Tyson Foods of the plaintiffs' use of an expert
    report that calculated each individual employee's average time
    spent "donning and doffing" protective equipment for the purpose
    of establishing the employees' total hours worked in an overtime
    compensation case under the Fair Labor Standards 
    Act. 136 S. Ct. at 1042-43
    .       Here,   plaintiffs        contend    that,   "[c]onsistent
    with . . . the guidance in Tyson Foods[], plaintiffs will prove
    classwide    antitrust      impact    at      trial     using    representative
    evidence."      Such evidence relies on Dr. Conti's calculation that
    a generic substitute drug would have achieved approximately ninety
    - 26 -
    percent market penetration in a but-for world, from which, in part,
    the district court estimated that about ten percent of the class
    was likely brand loyal and thus uninjured.         For several reasons,
    plaintiffs' reliance on Tyson Foods falls short of the mark.
    To begin with, using the average time it takes a person
    to don and doff clothes to estimate how long it takes a given
    individual to do so (as in Tyson Foods) is quite different than
    saying, for example, that a given person wore certain clothes
    merely because most but not all others did so.            If statistically
    valid, an average multiplied by the total number of individuals
    likely equals the actual total time spent by all.          But Dr. Conti's
    estimate that a generic drug would achieve roughly ninety percent
    market penetration, if used to prove that each individual would
    have likely purchased the generic drug and was thus injured by
    defendants' conduct, leads to the demonstrably wrong conclusion
    that one hundred percent of individuals were injured.          And that is
    a contention that Dr. Conti's opinion itself rejects.
    In Tyson Foods, the Court pointed out that under the
    controlling substantive law, the proffered representative evidence
    would   be   admissible   and   sufficient   to   prove    injury   in   any
    individual class member's individual trial.        See Tyson 
    Foods, 136 S. Ct. at 1047
    (quoting Anderson v. Mt. Clemens Pottery Co., 
    328 U.S. 680
    , 687 (1946), for the proposition that, under the Fair
    Labor Standards Act, "an employee has carried out his burden" if
    - 27 -
    he   produces   evidence   demonstrating   the    amount   of   improperly
    compensated work "as a matter of just and reasonable inference").
    Here, plaintiffs point to no such substantive law that would make
    an opinion that ninety percent of class members were injured both
    admissible and sufficient to prove that any given individual class
    member was injured.    And whether such evidence would actually be
    "sufficient to sustain a jury finding," 
    id. at 1048,
    is far from
    self-evident.    See, e.g., Guenther v. Armstrong Rubber Co., 
    406 F.2d 1315
    , 1318 (3d Cir. 1969) ("[A]s we see it there was no
    justification for allowing plaintiff's case on that so-called
    probability hypothesis to go to a jury."); see also United States
    v. Veysey, 
    334 F.3d 600
    , 604-06 (7th Cir. 2003) (reviewing the
    academic literature and case law surrounding the use of statistical
    evidence); United States v. Hannigan, 
    27 F.3d 890
    , 896-901 (3d
    Cir. 1994) (Becker, J., concurring in the judgment) (similar);
    Laurence H. Tribe, Trial by Mathematics:         Precision and Ritual in
    the Legal Process, 84 Harv. L. Rev. 1329 (1971) (discussing the
    use of statistical evidence in litigation).        Indeed, plaintiffs do
    not even grapple with the question of whether federal or state law
    provides the relevant rule of decision.          And without making such
    showings, plaintiffs cannot meet their burden to "'affirmatively
    demonstrate . . . compliance' with Rule 23."           Comcast Corp. v.
    Behrend, 
    569 U.S. 27
    , 33 (2013) (quoting Wal-Mart Stores, 
    Inc., 564 U.S. at 350
    ).
    - 28 -
    Plaintiffs argue that we should nevertheless approve of
    their   proposed     approach    because      it   protects   Warner    from   any
    practical harm that might otherwise be caused by removing questions
    of individual injury-in-fact from the jury.              Warner would only be
    found liable and forced to pay damages if the jury found that
    Warner's actions unlawfully raised the price paid by consumers by
    a specified amount, and if the jury also determined the percentage
    of sales for which that price surcharge would not have been paid
    but for the illegal conduct.            The total aggregate damages award
    would therefore in theory net out all purchases by brand loyal
    consumers as a group.        The fact that some of that money might then
    be paid to uninjured people should be of no concern to Warner, say
    plaintiffs.
    This argument confuses different types of aggregate
    damages scenarios.         See 4 William B. Rubenstein, Newberg on Class
    Actions § 12:2 (5th ed. 2012).           In some cases, the total damage
    caused by the defendant is independent of the number and identity
    of people harmed.      Newberg gives as an example a trustee's theft
    of money from a pension fund.           
    Id. Such a
    case perhaps might be
    tried as a class action without causing any harm to the defendant
    no   matter    how   the    recovered    funds     are   allocated     among   the
    beneficiaries (although there would still be the question whether
    Article III nevertheless precludes per se the knowing use of a
    civil suit to make an award to an uninjured person, see Tyson
    - 29 -
    
    Foods, 136 S. Ct. at 1053
    (Roberts, C.J., concurring).       In many
    other instances, as here, the aggregate damage amount is the sum
    of damages suffered by a number of individuals, such that proving
    that the defendant is not liable to a particular individual because
    that individual suffered no injury reduces the amount of the
    possible total damage.   Furthermore, here the district court has
    reasonably presumed that determining whether any given individual
    was injured (and therefore has a claim) turns on an assessment of
    the individual facts concerning that person.    In such a case, the
    defendant must be offered the opportunity to challenge each class
    member's proof that the defendant is liable to that class member.
    See Wal-Mart Stores, 
    Inc., 564 U.S. at 366-67
    .         Whether that
    opportunity precludes class certification turns on whether such
    challenges are reasonably plausible in a given case and whether
    the plaintiff cannot demonstrate that allowing for such challenges
    in a manner that protects the defendant's rights will be manageable
    and superior to the alternatives.   See Fed. R. Civ. P. 23(b)(3).
    Accepting   plaintiffs'   proposed   procedure   for   class
    litigation would also put us on a slippery slope, at risk of an
    escalating disregard of the difference between representative
    civil litigation and statistical observations of tendencies and
    distributions.   Once one accepts plaintiffs' "no harm, no foul"
    position there would be no logical reason to prevent a named
    plaintiff from bringing suit on behalf of a large class of people,
    - 30 -
    forty-nine percent or even ninety-nine percent of whom were not
    injured, so long as aggregate damages on behalf of "the class"
    were reduced proportionately.    Such a result would fly in the face
    of the core principle that class actions are the aggregation of
    individual claims, and do not create a class entity or re-apportion
    substantive claims.   See 1 William B. Rubenstein, Newberg on Class
    Actions   § 1:1   (5th   ed.    2012)    (stating   that   Rule 23   is
    "fundamentally a procedural device" that allows a representative
    to "litigate on behalf of many absent class members" but cannot
    "abridge, modify, or enlarge any substantive right" (emphasis in
    original)); see also Tyson 
    Foods, 136 S. Ct. at 1048
    (noting that
    a class action cannot enlarge class members' substantive rights
    and thus basing the availability of evidence in a class action on
    what would be available "in an individual action"); In re Deepwater
    Horizon, 
    739 F.3d 790
    , 828 (5th Cir. 2014) (Garza, J., dissenting)
    ("Rule 23's aggregation function cannot be used to create new
    rights and then settle claims brought under them." (internal
    quotation marks omitted)).
    We recognize that there remains the problem of how to
    deal with conduct that inflicts small amounts of damage on large
    numbers of people.    Certainly Rule 23 serves as an important tool
    to address many such situations.    See Mace v. Van Ru Credit Corp.,
    
    109 F.3d 338
    , 344 (7th Cir. 1997) ("The policy at the very core of
    the class action mechanism is to overcome the problem that small
    - 31 -
    recoveries do not provide the incentive for any individual to bring
    a solo action."); Castano v. Am. Tobacco Co., 
    84 F.3d 734
    , 748
    (5th Cir. 1996) (noting that "negative value" suits provide the
    "most compelling rationale for finding superiority in a class
    action").        But   that   fact    grants   us   no   license   to   create   a
    Rule 23(b)(3) class in every negative value case by either altering
    or reallocating substantive claims or departing from the rules of
    evidence.    Moreover, there are other tools available to address
    the problem of low-value, high-volume claims that pose individual
    issues of causation.           Regulators may sue, see, e.g., FTC v.
    Actavis, Inc., 
    570 U.S. 136
    , 141 (2013); governments may bring
    parens patriae claims, see, e.g., New Hampshire v. Purdue Pharma,
    No. 17-cv-427,         
    2018 WL 333824
    ,    at *1     (D.N.H.    Jan. 9,     2018);
    substantive laws may provide presumptions available to all class
    members, see, e.g., 
    Halliburton, 134 S. Ct. at 2411-12
    ; and private
    lawyers may marshal the threats of res judicata and fee shifting
    to induce aggregate settlements when liability is clear.
    In     reaching     our    conclusion,       we   acknowledge     the
    divergence evident in the manner in which our sister circuits have
    addressed   the    treatment     of    uninjured    putative   class     members.
    Framing the issue of uninjured class members through the lens of
    Article III, the Second Circuit opined that "no class may be
    certified that contains members lacking Article III standing," and
    required that the class "be defined in such a way that anyone
    - 32 -
    within it would have standing."              Denney v. Deutsche Bank AG, 
    443 F.3d 253
    , 264 (2d Cir. 2006).4
    In Halvorson v. Auto-Owners Insurance Co., 
    718 F.3d 773
    (8th Cir. 2013), the Eighth Circuit announced the same standing
    requirement articulated by the Second Circuit, but also seemed to
    ground   its        analysis    in   the      predominance      requirement    of
    Rule 23(b)(3).        It thus denied class certification because the
    "individual inquiries" necessary to determine which class members
    were uninjured would "overwhelm questions common to the class."
    
    Id. at 779
    (quoting Comcast 
    Corp., 569 U.S. at 34
    ); see Neale v.
    Volvo Cars of N. Am., LLC, 
    794 F.3d 353
    , 366 (3d Cir. 2015) ("[I]t
    is . . . not clear to us whether the Eighth Circuit's standing
    analysis rests on Article III or Rule 23.").
    More    clearly    viewing      the   issue   of   uninjured    class
    members through the prism of Rule 23(b)(3) predominance, the D.C.
    Circuit vacated the certification of a class because the plaintiffs
    had failed to "show that they can prove, through common evidence,
    that   all   class    members    were   in    fact   injured    by   the   alleged
    conspiracy."        See In re Rail Freight Fuel Surcharge Antitrust
    Litig.-MDL No. 1869, 
    725 F.3d 244
    , 252 (D.C. Cir. 2013) (emphasis
    added); see also 
    Nexium, 777 F.3d at 24
    n.20 (characterizing Rail
    4 In Denney, the Second Circuit found that each member of the class
    had suffered an injury-in-fact, and thus held that the class
    satisfied Article III 
    standing. 443 F.3d at 265
    .
    - 33 -
    Freight as requiring that plaintiffs "'show that they can prove'
    -- not that they have proved" -- that all class members were in
    fact injured (emphasis in original)).
    The Fifth Circuit has similarly held that "where fact of
    damage cannot be established for every class member through proof
    common to the class, the need to establish antitrust liability for
    individual    class   members   defeats    Rule 23(b)(3)   predominance."
    Bell Atl. Corp. v. AT&T Corp., 
    339 F.3d 294
    , 302 (5th Cir. 2003).
    And the Third Circuit, expressly and closely following New Motor
    Vehicles, has joined this majority view.            See In re Hydrogen
    Peroxide Antitrust Litig., 
    552 F.3d 305
    , 311 (3d Cir. 2008).5
    The Seventh Circuit does appear to have signaled a
    willingness to allow a district court to certify a damages class
    containing not "a great many" uninjured members without requiring
    that there be a mechanism for eventually culling out the uninjured.
    Messner v. Northshore Univ. HealthSystem, 
    669 F.3d 802
    , 825 (7th
    Cir. 2012); Kohen v. Pac. Inv. Mgmt. Co. LLC, 
    571 F.3d 672
    , 677-
    78 (7th Cir. 2009).     The Ninth Circuit recently arguably adopted
    5 Because our circuit precedent clearly requires that there exist
    "some means of determining that each member of the class was in
    fact injured," New Motor 
    Vehicles, 522 F.3d at 28
    , we have been
    able to finesse the question whether Article III's standing
    requirement imposes any barrier to the certification of a class
    that will at judgment have uninjured members.      See 
    Nexium, 777 F.3d at 32
    ("To the extent that it is necessary that each and every
    member of the class who secures a recovery also has standing, the
    requirement will be satisfied -- only injured class members will
    recover.").
    - 34 -
    a similar rule, although to some uncertain extent it seems to rely
    in great part on a notion that being "exposed to" injurious conduct
    can serve a proxy for common injury.    See Torres v. Mercer Canyons
    Inc., 
    835 F.3d 1125
    , 1137 (9th Cir. 2016).         Neither circuit,
    though, has explained what not "a great many" means.     See, e.g.,
    
    Messner, 669 F.3d at 825
    ("There is no precise measure for 'a great
    many.'").    And if it means only that there can be a few unusual
    class members who can be picked off by the defendant, then neither
    case rests too far outside the mainstream.     See 
    Halliburton, 134 S. Ct. at 2412
    .
    In any event, in no case cited above, nor in any case to
    which plaintiffs have directed our attention, has a federal court
    affirmed a damages judgment in a class action against a defendant
    who was precluded from raising genuine challenges at trial to the
    assertion of liability by individual members of a class that was
    known to have members who could not be presumed to be injured.
    Nor has either party drawn to our attention any federal court
    allowing, under Rule 23, a trial in which thousands of class
    members testify.    We see no reason to think that this case should
    be the first such case.
    IV.
    The rule we reiterate today, consistent with our prior
    holding in Nexium, strikes a balance that is faithful to the
    requirements of Article III and Rule 23, while remaining cognizant
    - 35 -
    of   the   practical   realities   of   class   actions.     We   have   not
    previously required every class member to demonstrate standing
    when a class is certified, nor do we do so today.          See 
    Nexium, 777 F.3d at 32
    ; see also 
    Neale, 794 F.3d at 362
    ; DG ex rel. Stricklin
    v. Devaughn, 
    594 F.3d 1188
    , 1197 (10th Cir. 2010); 
    Kohen, 571 F.3d at 676-77
    .    We also agree that it would "put the cart before the
    horse," 
    Kohen, 571 F.3d at 676
    , to read Rule 23 to require that a
    plaintiff demonstrate prior to class certification that each class
    member is injured.        But certainly where injury-in-fact is a
    required element of a claim, as it is in an antitrust action, see
    New Motor 
    Vehicles, 522 F.3d at 19
    n.18, a class cannot be
    certified based on an expectation that the defendant will have no
    opportunity to press at trial genuine challenges to allegations of
    injury-in-fact.    Cf. Wal-Mart Stores, 
    Inc., 564 U.S. at 367
    .           And
    to determine whether a class certified for litigation will be
    manageable, the district court must at the time of certification
    offer a reasonable and workable plan for how that opportunity will
    be provided in a manner that is protective of the defendant's
    constitutional rights and does not cause individual inquiries to
    overwhelm common issues. These plaintiffs have plainly not enabled
    the district court to articulate such a plan.              See New Motor
    
    Vehicles, 522 F.3d at 20
    ("Under the predominance inquiry, 'a
    district court must formulate some prediction as to how specific
    issues will play out in order to determine whether common or
    - 36 -
    individual issues predominate in a given case.'" (quoting 
    Mowbray, 208 F.3d at 298
    )).
    For the foregoing reasons, we reverse the decision of
    the district court granting class certification, and remand for
    further proceedings in accord with this opinion.
    - Concurring Opinion Follows -
    - 37 -
    BARRON, Circuit Judge (Concurring).                         The issues that
    courts must address in deciding whether to certify a proposed class
    action in a case like this are potentially vexing.                            The class is
    large.      It contains a non-trivial number of uninjured class
    members.    The nature of the injury is not easily proved through
    common evidence.         And the prospect of individualized recovery is
    unlikely, even though the aggregate wrong may be great, given the
    costs of litigation and the relatively minimal amount of loss each
    plaintiff incurred.         Should, then, such a class be certified?
    On     the    one    hand,      Rule    23    was    clearly       written    to
    facilitate large consumer class actions.                      See, e.g., Amchem Prod.,
    Inc. v. Windsor, 
    521 U.S. 591
    , 617 (1997) ("While the text of Rule
    23(b)(3)    does    not    exclude       from      certification        cases    in   which
    individual damages run high, the Advisory Committee had dominantly
    in   mind   vindication         of   'the   rights       of    groups    of    people    who
    individually would be without effective strength to bring their
    opponents into court at all.'"); In re New Motor Vehicles Canadian
    Exp. Antitrust Litig., 
    522 F.3d 6
    , 8 (1st Cir. 2008) ("[A]n
    erroneous failure to certify a class where individual claims are
    small may deprive plaintiffs of the only realistic mechanism to
    vindicate meritorious claims.").                On the other hand, Rule 23 sets
    forth requirements -- most particularly, the requirement that
    common rather than individual issues predominate -- that raise
    - 38 -
    serious questions about whether a class of the sort I have just
    described can be certified.       See Fed. R. Civ. P. 23(b)(3).
    Not   surprisingly,    appellate    courts      throughout   the
    country have struggled to develop a uniform mode of analyzing such
    cases.   In fact, our own precedent reflects a similar struggle,
    given our holding rejecting certification of a consumer antitrust
    class in New 
    Motor, 522 F.3d at 9
    , and our holding affirming the
    certification of one in In re Nexium Antitrust Litig., 
    777 F.3d 9
    ,
    14 (1st Cir. 2015).
    Of course, because Nexium is our last word on the
    subject, we are bound, as a panel, to follow it if it controls.
    But, here, I agree with the majority that it does not, even though,
    in my view, one could be forgiven for concluding -- as the District
    Court did -- that Nexium does require certification of the class
    proposed here.
    In Nexium, we upheld the certification of a class where,
    like here, the anticipated means by which plaintiffs would cull
    uninjured   class   members   would   include   the   use    of   individual
    affidavits attesting to the affiant's injury.            See 
    id. at 20-21.
    Moreover, in Nexium, like here, the affidavits would be used to
    resolve an inquiry into injury turning on whether the plaintiffs
    would have hypothetically purchased a cheaper generic had one been
    available rather than on any representations as to past purchases.
    See 
    id. at 20
    n.17.       And, finally, in Nexium, like here, the
    - 39 -
    overwhelming bulk of the class is purported to be injured, as only
    a relatively small percentage of the class members in each case
    are conceded to be uninjured.        See 
    id. at 27.
    Nonetheless, I join our opinion reversing the order
    certifying this class.         As our opinion explains, the culling
    process on which the plaintiffs rely -- and which the District
    Court found to be sufficient -- is not one that Nexium blessed or
    that we may bless, at least on this record.           I do, however, want
    to say more about my reasons for reaching that conclusion.                 In
    particular, I wish to highlight two grounds for distinguishing
    this case from Nexium.
    First,    in    Nexium,   it   was   perfectly   clear    that   the
    defendants would be able to challenge -- prior to a liability
    finding -- the sufficiency of testimony to prove injury (whether
    that testimony was offered at trial or pre-trial by affidavit) by
    any class member that she would have purchased a generic version
    of the drug had one been available.            For that reason, we were
    confident that "a mechanism would exist for establishing injury at
    the liability stage of this case, compliant with the requirements
    of the Seventh Amendment and due process."          
    Id. at 21
    .
    Here, in contrast, it is hard for me to see how the
    plaintiffs'    proposed    claims   processing    mechanism   for    culling
    uninjured class members could be deployed before there were any
    claims to process.       In fact, by the plaintiffs' own account, that
    - 40 -
    culling mechanism will be deployed only "post-judgment."              Thus,
    the reason that we gave in Nexium for concluding that there was no
    Seventh Amendment problem with the culling mechanism that we
    identified there does not appear to be one that we may rely on
    here.
    Second, insofar as the plaintiffs here, as in Nexium, do
    propose     to    submit   affidavits       concerning   class     members'
    hypothetical purchasing preferences prior to completion of the
    liability phase, there is still another ground for distinguishing
    this case from that one.        In Nexium, unlike here, the defendants
    presented   a    categorical   challenge.      They   contended   that   the
    presence, at the certification stage, of any uninjured class
    members itself defeated predominance because the plaintiffs had no
    possible means to prove injury at all.         The defendants based that
    contention on the hypothetical nature of the inquiry into injury
    presented in that case, given that the inquiry turned on what was
    necessarily      speculation     about   a    plaintiff's    hypothetical
    purchasing preference.         See 
    id. at 20
    (noting the defendants'
    argument that "the [brand-loyalist issue] presents problems that
    plaintiffs cannot overcome, for plaintiffs have no methodology to
    identify [at a later stage of litigation] those consumers who would
    have switched to a generic version" (emphasis added)).
    Nexium rejected that categorical challenge.           It did so
    by explaining that, in an individual action, a plaintiff could
    - 41 -
    prove the injury claimed through "testimony by the consumer that,
    given the choice, he or she would have purchased the generic."
    
    Id. at 20.
    And Nexium then went on to explain that because "[t]here
    cannot be a more stringent burden of proof in class actions than
    in individual actions," it followed that "similar testimony in the
    form of an affidavit or declaration would be sufficient in a class
    action."     
    Id. For that
      reason,     Nexium    concluded   that     the
    defendants had failed to show that the plaintiffs could not meet
    their burden at the certification stage to demonstrate a viable
    means of identifying injured class members.
    To be sure, Nexium did not stop there.                Nexium also
    acknowledged that proof of injury in the form of personal testimony
    may "require[] determination of the individual circumstances of
    class members" and thus may cause individual rather than common
    issues to predominate.       
    Id. at 21
    .       But, having identified that
    additional potential obstacle to establishing predominance, Nexium
    dispensed with that concern by explaining that the predominance
    requirement does not categorically preclude a class from relying
    on individualized proof of injury, at least where the number of
    uninjured class members is de minimis.          See 
    id. (refusing to
    find
    that "the need for individual determinations or inquiry for a de
    minimis    number   of   uninjured    members   at     later   stages   of   the
    litigation defeats class certification").
    - 42 -
    Unfortunately, Nexium's holding that the predominance
    requirement does not impose a categorical bar against plaintiffs
    relying on individualized means of proving injury only gets us so
    far here.         And that is because I do not read Nexium to have
    addressed the distinct issue of when, even where the number of
    uninjured class members is de minimis, plaintiffs' reliance on
    individualized means of proving injury is so great that it can no
    longer comport with the predominance requirement.                    Yet, that is
    the question that we must confront here, because the defendants
    make precisely that contention in this case.
    In considering that question, I would not rule out the
    possibility that plaintiffs who seek to prove injury in such a
    case    by   relying     on   affidavits   might   be    able   to       satisfy   the
    predominance requirement just as the plaintiffs were found to have
    satisfied it in Halliburton Co. v. Erica P. John Fund, Inc., 
    134 S. Ct. 2398
    , 2412 (2014) (upholding certification on the basis of
    a presumption of reliance even where "the defendant might attempt
    to pick off the occasional class member here or there through
    individualized rebuttal"). I note, in that regard, that one reason
    that the Halliburton Court assumed that the defendants would only
    be   able    to    engage     in   "individualized      rebuttal"    against       the
    "occasional class member" may have been that proof of reliance in
    that case involved resolution of a "'speculative state of facts,
    i.e.,    how      [the   plaintiff]    would    have    acted   .    .    .   if   the
    - 43 -
    misrepresentation had not been made.'"           
    Id. at 2407
    (quoting Basic
    Inc. v. Levinson, 
    485 U.S. 224
    , 245 (1988)).                   I suspect that
    defendants might have a similarly hard time making more than a
    speculative case that they would be able effectively to contest an
    affiant's representation that, if presented with a cheaper generic
    alternative, she would have spent less rather than more to get the
    same   drug.    See    
    Nexium, 777 F.3d at 31
      ("The   defendants'
    speculation cannot defeat the plaintiffs' showing.").                 Moreover,
    I could imagine that plaintiffs in a case not unlike this one might
    be able to establish -- perhaps through undisputed evidence from,
    say,   health   plan   purchasing      records    --    that   only    a   small
    identifiable subset of the class's members would actually need to
    rely on individualized testimony concerning their hypothetical
    purchasing preferences to show injury.
    In the event that plaintiffs made those showings, I could
    see how, in light of Nexium, a court might be able to conclude
    that the plaintiffs, at the certification stage, could succeed in
    showing that resolution of the injury issue would not require an
    impermissibly large number of individualized determinations.                See
    
    id. at 21
    (noting that Rule 23(b)(3) "does not require a plaintiff
    seeking class certification to prove that each element of her claim
    is susceptible to classwide proof" but only to show that there is
    no "reason to think that [individualized] questions will overwhelm
    common ones and render class certification inappropriate").                But,
    - 44 -
    even if that is the case, the plaintiffs before us make no showing
    that would permit us to so find.
    As our opinion explains, the plaintiffs do not argue
    that the defendants would be incapable of mounting effective
    challenges to any, let alone to most, of the plaintiffs' affidavits
    at summary judgment. Nor may we conclude that the plaintiffs would
    only need to rely on individualized proof of injury for a small
    identifiable subset of the class, such that their reliance on
    individual adjudications could be deemed both efficient and fair.
    The   plaintiffs   have   not   shown   that   the   number   of
    potentially uninjured class members could be winnowed down through
    common means of proof, even when that evidence is considered in
    combination with evidence gleaned from health plan purchasing
    records.   And we may not assume that only the plaintiffs within
    the small subset of the class conceded to be uninjured will need
    to offer an affidavit to prove what hypothetical choice they would
    have made if given the option to purchase a generic. Class members
    do not come pre-identified as brand loyal or price sensitive, after
    all, and one does not ordinarily set out to find a needle in a
    haystack by examining only ten percent of the straw.
    I thus see no basis for affirming the certification order
    on this record, because the plaintiffs have not yet shown that
    common rather than individual issues would predominate if this
    class were certified.    Accordingly, I join our opinion in full.
    - 45 -
    

Document Info

Docket Number: 18-1065P

Citation Numbers: 907 F.3d 42

Filed Date: 10/15/2018

Precedential Status: Precedential

Modified Date: 1/12/2023

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