Hochendoner v. Genzyme Corporation , 823 F.3d 724 ( 2016 )


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  •           United States Court of Appeals
    For the First Circuit
    No. 15-1446
    ANITA HOCHENDONER ET AL.,
    Plaintiffs, Appellants,
    v.
    GENZYME CORPORATION,
    Defendant, Appellee.
    No. 15-1447
    PHILIP ADAMO ET AL.,
    Plaintiffs, Appellants,
    v.
    GENZYME CORPORATION,
    Defendant, Appellee.
    ____________________
    APPEALS FROM THE UNITED STATES DISTRICT COURT
    FOR THE DISTRICT OF MASSACHUSETTS
    [Hon. Douglas P. Woodlock, U.S. District Judge]
    Before
    Howard, Chief Judge,
    Selya and Lipez, Circuit Judges.
    Matthew L. Kurzweg, with whom Kurzweg Law Offices was on
    brief, for appellants.
    Robert G. Jones, with whom Justin Florence, Mark S. Gaioni,
    Cassandra Bolaños, and Ropes & Gray LLP were on brief, for
    appellee.
    May 23, 2016
    SELYA, Circuit Judge.    These consolidated actions stand
    on the cutting edge of modern medicine.        In the end, however, they
    reduce mainly to a question of standing.           Though we affirm the
    order of dismissal (with one small exception), our reasoning
    differs from that of the district court: we dismiss for lack of
    Article III standing.       Because a dismissal for lack of standing is
    functionally equivalent to a dismissal for lack of jurisdiction,
    the resulting judgment will (unlike a judgment on the merits)
    operate without prejudice.       The tale follows.
    I.   BACKGROUND
    Because these appeals follow the granting of a motion to
    dismiss, we rehearse the facts as they appear in the plaintiffs'
    complaints     (including     documents     incorporated   by   reference
    therein).     See Katz v. Pershing, LLC, 
    672 F.3d 64
    , 69 (1st Cir.
    2012).
    Fabry Disease (Fabry) is a rare genetic disorder that
    leaves afflicted persons unable to synthesize a key enzyme that
    helps the body break down fats.           Left untreated, Fabry patients
    will suffer a variety of progressively more severe symptoms,
    including pain in their extremities, gastrointestinal issues,
    vision and hearing losses, stroke, and heart and kidney failure,
    eventually leading to premature death.           Researchers at the Mt.
    Sinai School of Medicine (Mt. Sinai) developed a method for
    producing a replacement enzyme, which effectively treats (but does
    - 3 -
    not cure) Fabry.     After patenting this method, Mt. Sinai granted
    an exclusive license to defendant-appellee Genzyme Corporation
    (Genzyme).       Genzyme    thus   became      the    sole     producer   of    the
    replacement enzyme.        Dubbed "Fabrazyme," it is the only enzyme
    replacement     therapy    approved    by     the    federal    Food   and     Drug
    Administration (FDA) for the treatment of Fabry.
    Fabrazyme received FDA approval in April of 2003.                 That
    approval was based on a dose of one milligram of Fabrazyme for
    each kilogram of body weight taken intravenously every two weeks.
    Genzyme provided the drug steadily to Fabry patients until June of
    2009, after a virus was discovered in improperly cleaned equipment
    at the company's Allston, Massachusetts manufacturing facility.
    This discovery compelled Genzyme to reduce production, leading to
    a shortage of Fabrazyme.
    In response, the company initiated a rationing plan,
    providing Fabry patients with a reduced dose of Fabrazyme in order
    to stretch the available supply during the shortage.                      It also
    organized a group of doctors and other stakeholders to work on
    supply management guidance.
    In November of 2009, Genzyme's efforts to restore a full
    supply of Fabrazyme met a roadblock in the form of the discovery
    of particulate steel, glass, and rubber in a recently produced
    batch of Fabrazyme.        Later, another adulterated lot of Fabrazyme
    was spotted and destroyed prior to any distribution.                         A bad
    - 4 -
    situation     grew      worse:     shortages     in    the   United     States   were
    exacerbated in 2011 when Genzyme diverted some Fabrazyme to the
    European market.         The complaints aver that this diversion was part
    of a pattern of favoring European patients due to competition
    Genzyme   faced        from   an   alternative      enzyme   replacement    therapy
    approved only in Europe.
    Although the company had been able, beginning in January
    of 2010, to provide Fabry patients with 50% of their FDA-approved
    doses,    even    this    reduced     supply     was   subject     to   intermittent
    interruptions.         The supply dried up entirely in August of 2011,
    leaving Fabry patients in the United States unable to obtain
    Fabrazyme at all for a brief period.                  It was not until some time
    in 2012 that Genzyme succeeded in restoring fully supplies of
    Fabrazyme.
    This      sustained     shortage      sparked   a   proliferation     of
    lawsuits, including the two actions that are before us.                    The first
    of these actions (Hochendoner) was filed in the United States
    District Court for the Western District of Pennsylvania in March
    of 2011 on behalf of the named plaintiffs and a putative class
    comprising       all    Fabry      patients   in    the   United    States.       The
    Hochendoner complaint was amended the following month and, shortly
    thereafter, the district court transferred the case to the District
    of Massachusetts.             After the defendants moved to dismiss, the
    - 5 -
    Hochendoner plaintiffs obtained leave of court and filed a second
    amended complaint (the operative pleading for present purposes).
    The   second   of   the   two     actions   (Adamo)   was   brought
    directly in the District of Massachusetts.               That action was filed
    in June of 2013 by another group of Fabry patients on behalf of
    themselves and a putative class.               After motions to dismiss were
    served, the Adamo complaint was amended as of right in September
    of 2013.     That amended complaint is the operative pleading for
    present purposes.      The district court thereafter consolidated the
    two cases.
    Each complaint named Genzyme and Mt. Sinai as defendants
    and laid out a laundry list of claims.               Those claims rest on a
    variety of theories, implicating alleged statutory violations
    (federal and state), torts, breaches of warranty, breaches of
    contract, and losses of consortium (brought by spouses of Fabry
    patients).    By stipulation, Mt. Sinai has been dropped as a party,
    and the cases are proceeding against Genzyme alone.
    After a hearing on Genzyme's motions to dismiss for
    failure to state any actionable claims, see Fed. R. Civ. P.
    12(b)(6), the court below dismissed both actions, see Hochendoner
    v. Genzyme Corp., 
    95 F. Supp. 3d 15
    , 35 (D. Mass. 2015).                    The
    court's reasoning warrants some elaboration.
    Faced with a matched set of rambling complaints, the
    court identified three potential injuries, bound up with three
    - 6 -
    potential causal chains.      The first such cause and effect pairing
    involved the return of Fabry symptoms and the progression of the
    disease previously prevented by full doses of Fabrazyme.            See id.
    at 24.   The second pairing drew upon assertions in the complaints
    that patients "not only had a return of life threatening symptoms
    but also an accelerated course of deterioration on the lowered
    dose" (emphasis in original).     On this second theory, the reduced
    Fabrazyme    doses   caused   affirmative   harm    rather   than    merely
    permitting the return of the normal progression of Fabry symptoms.
    See id. at 24-25.      The final pairing involved the plaintiffs'
    claims of harm attributable to the receipt of Fabrazyme tainted
    with particulate matter.      See id. at 25-26.
    After titrating the complaints into these three types of
    claims — the progression claims, the acceleration claims, and the
    contaminant claims — the court rejected them all.         See id. at 35.
    The court concluded that the acceleration and contaminant claims
    did not comport with the requirements of Federal Rule of Civil
    Procedure 8(a) because they did not provide sufficient notice to
    Genzyme of which plaintiffs, if any, suffered the harms alleged
    under those theories.     See id. at 25-26.        While the court found
    that the progression claims did provide sufficient notice — after
    all, the complaints alleged that every plaintiff had suffered
    disease progression as a result of the Fabrazyme shortage — it
    nonetheless found the panorama of common-law and statutory causes
    - 7 -
    of action underlying the progression claims to be impuissant. Many
    of them were ineffective due to reliance on the notion, debunked
    by the district court, that Genzyme had a duty to supply the market
    with Fabrazyme.    See, e.g., id. at 30-31.
    On appeal, the parties embrace the district court's
    tripartite taxonomy as a means of channeling the plaintiffs'
    claims. The progression claims need not concern us: the plaintiffs
    do not challenge the district court's thorough evaluation and
    ultimate dismissal of those claims.          Nor do they challenge the
    court's conclusion that Genzyme had no free-standing duty to supply
    the market with Fabrazyme.        Their appeals challenge only the
    district court's disposition of the acceleration and contaminant
    claims.
    II.   ANALYSIS
    Federal courts are courts of limited jurisdiction and,
    thus, we must begin by ensuring that we have jurisdiction to reach
    the questions presented by these appeals.         This brings front and
    center Genzyme's asseveration that the plaintiffs lack standing to
    advance claims based on either the acceleration or contaminant
    theories.     Though   Genzyme   did   not   challenge   the   plaintiffs'
    standing below, we nonetheless must address its asseveration here:
    because standing is a prerequisite to a federal court's subject
    matter jurisdiction, the absence of standing may be raised at any
    stage of a case.   See P.R. Tel. Co. v. T-Mobile P.R. LLC, 678 F.3d
    - 8 -
    49, 57 (1st Cir. 2012).          Since no class was certified below, we
    focus   on    the     standing    vel     non   of    the   named    plaintiffs,
    individually.       See Katz, 672 F.3d at 71.
    Although review of a Rule 12(b)(6) dismissal for failure
    to state a claim and review to ensure the existence of standing
    are conceptually distinct, the same basic principles apply in both
    situations.        See id. at 70-71.      Appellate review is de novo, see
    P.R. Tel., 678 F.3d at 57, and the court of appeals must take the
    complaint's well-pleaded facts as true and indulge all reasonable
    inferences in the pleader's favor, see Kerin v. Titeflex Corp.,
    
    770 F.3d 978
    , 981 (1st Cir. 2014).                We are not wedded to the
    district court's reasoning but, rather, may affirm the order of
    dismissal on any basis that is apparent from the record.                See 
    id.
    The    parallelism    between      the   threshold     requirements
    needed to satisfy Rule 12(b)(6) and the threshold showing necessary
    for standing extends beyond the standard of review.                 Just as the
    plaintiff bears the burden of plausibly alleging a viable cause of
    action, see, e.g., Ashcroft v. Iqbal, 
    556 U.S. 662
    , 678 (2009), so
    too the plaintiff bears the burden of pleading facts necessary to
    demonstrate standing, see FW/PBS, Inc. v. City of Dallas, 
    493 U.S. 215
    , 231 (1990).        Each element of standing "must be supported in
    the same way as any other matter on which the plaintiff bears the
    burden of proof, i.e., with the manner and degree of evidence
    required at the successive stages of the litigation."                  Lujan v.
    - 9 -
    Defs. of Wildlife, 
    504 U.S. 555
    , 561 (1992).             Taking this cue, we
    — like the majority of our sister circuits — have applied the
    plausibility standard applicable under Rule 12(b)(6) to standing
    determinations at the pleading stage.             See Van Wagner Bos., LLC v.
    Davey, 
    770 F.3d 33
    , 40 (1st Cir. 2014); Katz, 672 F.3d at 77-78;
    see also Silha v. ACT, Inc., 
    807 F.3d 169
    , 173-74 (7th Cir. 2015);
    In re Schering Plough Corp. Intron/Temodar Consumer Class Action,
    
    678 F.3d 235
    , 243-44 (3d Cir. 2012); Amidax Trading Grp. v.
    S.W.I.F.T. SCRL, 
    671 F.3d 140
    , 145 (2d Cir. 2011) (per curiam);
    White v. United States, 
    601 F.3d 545
    , 551-52 (6th Cir. 2010).
    In the interest of clarity, we make explicit today what
    our cases have implied and what the near-uniform precedent in other
    circuits has established: at the pleading stage, the plaintiff
    bears the burden of establishing sufficient factual matter to
    plausibly demonstrate his standing to bring the action.               Neither
    conclusory assertions nor unfounded speculation can supply the
    necessary heft.         See Iqbal, 
    556 U.S. at 678-79
    ; Blum v. Holder,
    
    744 F.3d 790
    , 795 (1st Cir.), cert. denied, 
    135 S. Ct. 477
     (2014).
    With this backdrop in place, we divide our ensuing
    discussion into four segments.            First, we turn to the allegations
    made       by   the   plaintiffs   in   support   of   the   acceleration   and
    contaminant claims.1         Second, we discuss the unique situation of
    1
    From this point forward, we use the term "the plaintiffs" to
    refer to all of the named plaintiffs except for James Mooney and
    - 10 -
    two of the named plaintiffs — James Mooney and his wife, Laura
    Kurtz-Mooney — whose allegations do satisfy the prerequisites for
    standing.     Third, we address the plaintiffs' contention that the
    district court should have permitted further amendment of the
    complaints. Finally, we explain why the district court must modify
    the dismissal of the acceleration and contaminant claims to operate
    without prejudice.
    A.   Standing.
    Standing doctrine assures respect for the Constitution's
    limitation      of   "[t]he   judicial       Power"   to    "Cases"   and
    "Controversies."     U.S. Const. art. III, § 2, cl. 1.         At bottom,
    that doctrine reflects "concern about the proper — and properly
    limited — role of the courts in a democratic society."           Warth v.
    Seldin, 
    422 U.S. 490
    , 498 (1975).      The heartland of constitutional
    standing is composed of the familiar amalgam of injury in fact,
    causation, and redressability.       See Lujan, 
    504 U.S. at 560-61
    .
    In our view, the case at hand hinges on the presence or
    absence of a plausibly pleaded injury in fact.             Such an injury
    "must be both 'concrete and particularized and actual or imminent,
    not conjectural or hypothetical.'"          Van Wagner Bos., 770 F.3d at
    his wife, Laura Kurtz-Mooney. For reasons to which we shall
    return, see infra Part II(B), we treat the Mooney claims
    separately.
    - 11 -
    37 (quoting Susan B. Anthony List v. Driehaus, 
    134 S. Ct. 2334
    ,
    2341 (2014)).
    The   Supreme    Court    recently     has     emphasized    that
    concreteness and particularization are distinct requirements.              An
    injury is concrete only if it "actually exist[s]."             Spokeo, Inc.
    v. Robins, ___ S. Ct. ___, ___ (2016) [No. 13-1339, slip op. at
    8].   For example, when an alleged injury is nothing more than "a
    bare procedural violation," there may be no cognizable harm to the
    plaintiff and thus no concreteness.       
    Id.
     at ___ [slip op. at 9].
    The   particularization    requirement   is   a   different      matter:   it
    necessitates that a plaintiff has been affected "in a personal and
    individual way" by the injurious conduct.         
    Id.
     at ___ [slip op. at
    7] (quoting Lujan, 
    504 U.S. at
    560 n.1).
    The   particularization    element     of    the   injury-in-fact
    inquiry reflects the commonsense notion that the party asserting
    standing must not only allege injurious conduct attributable to
    the defendant but also must allege that he, himself, is among the
    persons injured by that conduct.      See Lujan, 
    504 U.S. at 563
    .          The
    requirement that a plaintiff must adduce facts demonstrating that
    he himself is adversely affected guarantees that "the decision as
    to whether review will be sought [is] in the hands of those who
    have a direct stake in the outcome," Sierra Club v. Morton, 
    405 U.S. 727
    , 740 (1972), and ensures that disputes are settled "in a
    concrete factual context conducive to a realistic appreciation of
    - 12 -
    the consequences of judicial action," Valley Forge Christian Coll.
    v. Ams. United for Separation of Church & State, Inc., 
    454 U.S. 464
    , 472 (1982).
    With respect to both the acceleration and contaminant
    claims, the plaintiffs here have failed to satisfy this abecedarian
    requirement.        The sum total of the relevant portions of the
    complaints     is    easily   summarized.   The   complaints,   taken
    collectively, list each plaintiff's name and place of residence
    and proceed to allege that each plaintiff is a Fabry sufferer (or
    the spouse of a Fabry sufferer).       The complaints proceed to set
    forth general information about each plaintiff's history of taking
    Fabrazyme, typically in the form of an assertion that, prior to
    2009, the particular plaintiff received a full dose of Fabrazyme
    but thereafter was limited to a reduced dose (due to the shortage).2
    The Adamo complaint further avers that many plaintiffs were "forced
    to be injected with non FDA-approved doses of Fabrazyme under
    Defendants' threat to place [each such] Plaintiff at the end of a
    secret waiting list for access to Fabrazyme during its shortage if
    the unapproved and untested dose was refused."
    2 Our generalized description masks some idiosyncrasies among
    Fabrazyme recipients that are not relevant to the standing inquiry.
    For example, some plaintiffs are alleged not to have begun taking
    Fabrazyme until after the shortage began, while at least one other
    plaintiff alleges that she stopped taking Fabrazyme during the
    shortage.
    - 13 -
    Tellingly, no specific information is provided regarding
    the harm, if any, that has befallen each individual plaintiff.
    Instead,    the   complaints    offer    only    scattered    descriptions    of
    generalized harms.        They state, in nearly identical language, that
    "[a]s a direct result" of Fabrazyme rationing, "denial of access,"
    "dilution," "change in dosing schedules," and "sale of adulterated
    [Fabrazyme]," Fabry patients in the United States "have had a
    return of symptoms, accelerated disease development, injury, and
    otherwise preventable disease progression" or "have died from
    these injuries." Under the heading of the first substantive count,
    each complaint alleges that the "Plaintiffs have sustained, or are
    at imminent risk of sustaining, the following serious injuries."
    A list of horribles then appears, including heart and kidney
    failure,    pain,    vision   and   hearing     impairments,     and   premature
    death.     Utterly absent, however, is any allegation linking the
    alleged acceleration and contaminant injuries to any specific
    plaintiff.
    This gap is most apparent with respect to the contaminant
    theory.      There   is    simply   no   assertion   at    any   point   in   the
    complaints that any specific plaintiff took or received a dose
    contaminated with particulate matter.             Rather, the allegation is
    only that Genzyme produced a batch of Fabrazyme contaminated with
    particulate matter — not that contaminated doses were ever shipped
    or administered to any named Fabry patients.              Upon close scrutiny,
    - 14 -
    the same gap is evident in the acceleration claims: there is no
    allegation    that   any   named   plaintiff   has   suffered   accelerated
    disease progression (as opposed to the natural progression of the
    disease) as a result of taking a reduced dose of Fabrazyme.3
    The plaintiffs rail against this characterization.        They
    say that the complaints allege that every named Fabry patient has
    been injured.     Specifically, the plaintiffs say that they "have
    unambiguously averred that Genzyme produced a defective drug, the
    [plaintiffs] took that drug, and as a result they have sustained,
    or are at imminent risk of sustaining, enumerated specific harms."
    But this gloss on the complaints is insupportable.         It ignores the
    settled rule that "standing is not dispensed in gross."           Lewis v.
    Casey, 
    518 U.S. 343
    , 358 n.6 (1996).        The appropriate inquiry must
    be "whether each particular plaintiff is entitled to have a federal
    court adjudicate each particular claim that he asserts."           Pagán v.
    3 On this point, the plaintiffs rely heavily on a report from
    the European Medicines Agency, attached to the complaints. This
    report includes a statement that the observed "pattern of adverse
    events" in Fabry patients who received reduced dosages of Fabrazyme
    during   the   shortage  period   "resembles   the   natural,   but
    accelerated, course of Fabry's disease" (emphasis omitted). Even
    accepting arguendo the plaintiffs' assertion that this report
    bolsters the theory behind the acceleration claims, the report
    provides no basis for concluding that every Fabry patient on the
    reduced dose suffered an acceleration. Thus, the report does not
    justify the conclusion that every Fabry patient in the plaintiffs'
    shoes has standing to assert acceleration-theory claims.        See
    Hochendoner, 95 F. Supp. 3d at 25.
    - 15 -
    Calderón, 
    448 F.3d 16
    , 26 (1st Cir. 2006); accord DaimlerChrysler
    Corp. v. Cuno, 
    547 U.S. 332
    , 352 (2006).
    Here, the progression, acceleration, and contaminant
    theories   allege     different     injuries   and     causal   chains.
    Consequently,   the   plaintiff-by-plaintiff     and    claim-by-claim
    analysis required by standing doctrine demands allegations linking
    each plaintiff to each of these injuries.      Suffering one species
    of injury does not confer standing on a plaintiff to press claims
    based on another species of injury, even if the injuries share a
    common genus. See Blum v. Yaretsky, 
    457 U.S. 991
    , 999 (1982) ("Nor
    does a plaintiff who has been subject to injurious conduct of one
    kind possess by virtue of that injury the necessary stake in
    litigating conduct of another kind, although similar, to which he
    has not been subject.").
    It follows that, even assuming for argument's sake that
    the complaints make out a showing of harm sufficient to ground the
    progression claims, that showing does not confer standing with
    respect to either the acceleration or contaminant claims.          The
    progression claims may be characterized as sufficient to plead an
    injury because the complaints (read in the most forgiving manner)
    allege that every named Fabry patient suffered a progression of
    his or her disease due to a lack of Fabrazyme during the period of
    the shortage. However, no comparable allegation pertains to either
    - 16 -
    the acceleration or contaminant claims,4 and the complaints are
    wholly lacking in assertions that any named plaintiff suffered
    either an acceleration or contaminant injury in fact.
    The plaintiffs have one last string to their bow.        In
    support of their professed standing, they point to the complaints'
    generalized assertion that Genzyme forced patients in the United
    States to forgo doses, resulting "in an increased risk and severity
    of   acute      adverse   reactions    due   to   inconsistent   infusion
    schedules."      Though this injury does not fall neatly into either
    the progression or acceleration category, it need not detain us:
    what matters is that none of the plaintiffs (other than Mooney,
    see supra note 1) is alleged actually to have suffered an adverse
    reaction as a result of taking a diminished dose.            Nor is any
    ongoing risk of harm apparent: the plaintiffs concede, and the
    incorporated documents show, that the Fabrazyme shortage has long
    since ended and that all Fabry patients are now able to receive
    full doses of the drug.           The plaintiffs thus lack standing to
    advance claims based on their averments concerning reactions to
    the drug.
    We add a coda.       Although the same pleading standards
    apply    both     to   standing    determinations   and   Rule   12(b)(6)
    4At least with respect to the Adamo complaint, any such
    allegation would fly in the face of specifically pleaded facts.
    That complaint asserts that one of the named plaintiffs, Adam
    Dible, never took Fabrazyme during the period of the shortage.
    - 17 -
    determinations, the two inquiries remain fundamentally distinct:
    "standing in no way depends on the merits of the plaintiff's
    contention that particular conduct is illegal."                  Warth, 
    422 U.S. at 500
    ;   accord    Ariz.     State    Legislature       v.      Ariz.     Indep.
    Redistricting    Comm'n,      
    135 S. Ct. 2652
    ,     2663     (2015).       An
    individual's    plausible     allegations      of   a   personal    injury    will
    generally suffice to plead an injury in fact, even if the claim is
    ultimately lacking on the merits.         See, e.g., Chaudhry v. City of
    Los Angeles, 
    751 F.3d 1096
    , 1109 (9th Cir.), cert. denied, 
    135 S. Ct. 295
     (2014); Katz, 672 F.3d at 72; Carver v. City of New York,
    
    621 F.3d 221
    , 225-26 (2d Cir. 2010); Muir v. Navy Fed. Credit
    Union, 
    529 F.3d 1100
    , 1105-07 (D.C. Cir. 2008).              It follows that,
    in conducting our inquiry into standing, we have not considered
    the validity of any of the plaintiffs' claims as a matter of law
    or the adequacy of their pleading to state a claim under Rule
    12(b)(6).   Mindful of the bedrock proposition that a plaintiff
    must "be himself among the injured," Lujan, 
    504 U.S. at 563
    (quoting Sierra Club, 
    405 U.S. at 735
    ), we conclude that the utter
    failure of any plaintiff (other than Mooney) to plausibly allege
    that he or she suffered an injury in fact as a result of accelerated
    disease progression or receipt of a contaminated drug means that
    none of the plaintiffs has standing to assert claims based on those
    theories of injury.
    - 18 -
    B.   The Mooney Claims.
    This leaves only the excepted claims, which relate to
    James Mooney (one of the named plaintiffs in Adamo).5    The district
    court did not single out these claims in any way.       Mooney argues
    that his claims were overlooked and, in all events, stand on a
    different footing.   Genzyme, though, suggests that the differences
    do not matter and that separate consideration was unnecessary.
    In Genzyme's view, Mooney's alleged injury is that he is
    no longer able to take Fabrazyme after experiencing a severe
    reaction to the drug and, thus, his untreated Fabry is progressing.
    Genzyme sees this as old wine in a new bottle: the notion that
    Genzyme had a duty to supply the market with Fabrazyme, thus
    preventing the progression of untreated Fabry, was rejected by the
    district court and is not pursued on appeal.
    Genzyme's analysis misreads the gravamen of Mooney's
    claims.   To be sure, the Adamo complaint states that Mooney, like
    other Fabry patients, was placed on a reduced Fabrazyme regimen
    beginning in June of 2009.   But the complaint goes on to provide
    5  Under this rubric, we include, albeit without further
    reference, the allegations and claims of Mooney's wife, Laura
    Kurtz-Mooney (who is also a named plaintiff in Adamo). For the
    reasons given as to Mooney himself, we hold that Kurtz-Mooney's
    allegations, like her husband's, are sufficient to plead an injury
    in fact and, thus, are adequate to ground standing for her
    derivative loss-of-consortium claims. See generally Bowen v. Kil-
    Kare, Inc., 
    585 N.E.2d 384
    , 391-92 (Ohio 1992) (discussing
    derivative spousal consortium claims under Ohio law).
    - 19 -
    specific and unique details about Mooney's alleged injury: "In
    March 2012, when Genzyme finally permitted Mr. Mooney to resume
    receiving FDA approved doses . . . he experienced anaphylactic
    treatment reactions from the development of antibodies to the
    diluted Fabrazyme" that he earlier had received.   This statement,
    combined with the other information in the complaint, establishes
    Mooney's standing: he alleges that he was injured through an
    allergic reaction attributable to his exposure to a reduced dose
    of Fabrazyme at Genzyme's behest.   Monetary damages would redress
    this injury, even if imperfectly.
    Properly understood, Mooney's alleged injury is the
    anaphylactic reaction suffered when he returned to a full dose of
    Fabrazyme, not his inability to receive full doses of Fabrazyme.
    Although Genzyme may have had no duty to provide Mooney with a
    drug to treat his Fabry, it may still be responsible for taking
    care to make sure that any drug it did supply was safe for use.
    Mooney's central contention — that a reduced Fabrazyme dose led to
    his anaphylactic reaction when the full dose was resumed — does
    not depend in any way on a duty to supply the market.
    As a fallback, Genzyme suggests that alternative grounds
    exist for affirming the dismissal of the Mooney claims.   It argues
    that the claims fail to adumbrate causes of action under the law
    of Ohio (the jurisdiction in which Mooney resides) and are bereft
    - 20 -
    of the full complement of plausible factual allegations necessary
    to state actionable claims under that law.
    As a general matter, federal courts of appeals, engaged
    in appellate review, are understandably reluctant to consider
    issues that were not passed upon below.            See Singleton v. Wulff,
    
    428 U.S. 106
    ,    120   (1976).    While   this   reluctance    is   not    a
    straitjacket — we have loosened it, for example, when the result
    is obvious or when failure to address the issue immediately would
    work an injustice, see 
    id. at 121
    ; Town of Barnstable v. O'Connor,
    
    786 F.3d 130
    , 141 (1st Cir. 2015) — there is no reason to loosen
    it here. This is especially so since the district court's rescript
    passes over the Mooney claims without any discussion, and the
    viability of those claims under Ohio law is neither well-briefed
    nor readily discernable.          We conclude, therefore, that we should
    adhere to the usual praxis, vacate the dismissal of the Mooney
    claims, and remand them for consideration by the district court in
    the first instance.
    C.   Leave to Amend.
    The    plaintiffs    insist   that   their   claims   should     be
    returned to the district court to allow amendment.                 We do not
    agree.
    Some further background is helpful to put this aspect of
    the appeals into perspective.          After the last set of motions to
    dismiss was filed, the plaintiffs did not move for leave to amend.
    - 21 -
    But at the hearing on the motions to dismiss, they suggested that
    they could provide information about the specific harms suffered
    by each plaintiff.      Even then, however, no motion to amend was
    made.
    In the absence of exceptional circumstances, a district
    court is under no obligation to offer a party leave to amend when
    such leave has not been requested by motion.           See United States ex
    rel. Karvelas v. Melrose-Wakefield Hosp., 
    360 F.3d 220
    , 241-42,
    241 n.30 (1st Cir. 2004); Emerito Estrada Rivera-Isuzu de P.R.,
    Inc. v. Consumer's Union of U.S., Inc., 
    233 F.3d 24
    , 30-31 (1st
    Cir. 2000). Although the standard of review for a district court's
    failure to offer a sua sponte opportunity to amend is uncertain,
    see   Karvelas,   
    360 F.3d at
       242     n.32   (collecting   cases   and
    identifying abuse of discretion, plain error, and interests of
    justice as three standards this circuit has applied), we discern
    no infirmity on this record under any standard.            The short of it
    is that there is a complete absence of exceptional circumstances.
    The plaintiffs had (and used) several previous opportunities to
    amend.   Moreover, the concern that the injuries to the plaintiffs
    were insufficiently pleaded was apparent from the outset: that
    concern was thoroughly briefed and argued by the parties, and the
    district court pointedly observed that it had given the plaintiffs
    "an extended opportunity to draft a complaint" that would survive
    a Rule 12(b)(6) motion.
    - 22 -
    The plaintiffs' importuning that they "reasonably and
    strategically opted not to amend their Complaints in an effort to
    cure deficiencies that they believed non-existent" does not tip
    the scale.      The liberal disposition of the Civil Rules toward
    amendments, see Fed. R. Civ. P. 15(a), cannot be exploited to avoid
    the predictable consequences of a litigant's strategic choices,
    see Fisher v. Kadant, Inc., 
    589 F.3d 505
    , 510 (1st Cir. 2009).            We
    thus find no fault with the district court's failure to invite the
    plaintiffs, sua sponte, to further amend their complaints.               See
    Emerito Estrada, 
    233 F.3d at 30-31
    .
    D.     Effect of Dismissal for Lack of Standing.
    There is one loose end.     The plaintiffs rail against the
    prejudicial effect of the district court's order of dismissal.
    There is good reason for this concern: although the district
    court's order does not specify whether it is to operate with or
    without prejudice, the normal presumption is that a Rule 12(b)(6)
    dismissal is with prejudice.     See Fed. R. Civ. P. 41(b); Karvelas,
    
    360 F.3d at 241
    .     After all, such a judgment constitutes "a final
    decision on the merits."     Karvelas, 
    360 F.3d at 241
    .
    By contrast, a dismissal for lack of subject matter
    jurisdiction normally operates without prejudice.             See Torres-
    Fuentes v. Motorambar, Inc., 
    396 F.3d 474
    , 475 (1st Cir. 2005).
    This   approach    makes   eminently   good   sense   since   a   want    of
    jurisdiction deprives a court of the authority to enter a judgment
    - 23 -
    on the merits of the claims sub judice.      See Mills v. Harmon Law
    Offices, P.C., 
    344 F.3d 42
    , 45-46 (1st Cir. 2003); Christopher v.
    Stanley-Bostitch, Inc., 
    240 F.3d 95
    , 100 (1st Cir. 2001) (per
    curiam).   Courts routinely apply this principle to dismissals for
    lack of Article III standing.       See, e.g., S. Walk at Broadlands
    Homeowner's Ass'n, Inc. v. OpenBand at Broadlands, LLC, 
    713 F.3d 175
    , 185 (4th Cir. 2013); Stalley ex rel. United States v. Orlando
    Reg'l Healthcare Sys., Inc., 
    524 F.3d 1229
    , 1232, 1234-35 (11th
    Cir. 2008) (per curiam); Brereton v. Bountiful City Corp., 
    434 F.3d 1213
    , 1216 (10th Cir. 2006); County of Mille Lacs v. Benjamin,
    
    361 F.3d 460
    , 464-65 (8th Cir. 2004).        Following this line of
    authority, we hold that a dismissal for lack of Article III
    standing must operate without prejudice.
    Consequently, we will direct the district court, on
    remand, to clarify its judgment to reflect that the judgment is to
    operate without prejudice as to claims based on the acceleration
    and contaminant injuries.   The judgment shall continue to operate
    with prejudice, however, as to claims based on the progression
    theory.    Those claims were disposed of below under Rule 12(b)(6)
    and are not pursued on appeal.
    III.   CONCLUSION
    We need go no further.    The Mooneys alone have plausibly
    alleged facts sufficient to demonstrate Article III standing.     We
    thus affirm the dismissal of the complaints as to all the other
    - 24 -
    plaintiffs based on their lack of Article III standing.   However,
    we direct the district court, on remand, to clarify the judgment
    so that it will operate without prejudice as to claims based on
    the alleged acceleration and contaminant injuries.   At the same
    time, we vacate the dismissal of the Mooneys' claims and remand
    the Adamo action for further proceedings consistent with this
    opinion.   All parties shall bear their own costs.
    So Ordered.
    - 25 -
    

Document Info

Docket Number: 15-1446P

Citation Numbers: 823 F.3d 724

Filed Date: 5/23/2016

Precedential Status: Precedential

Modified Date: 1/12/2023

Authorities (24)

Torres-Fuentes v. KIA Motors, Inc. , 396 F.3d 474 ( 2005 )

United States Ex Rel. Karvelas v. Melrose-Wakefield Hospital , 360 F.3d 220 ( 2004 )

Mills v. Harmon Law Offices, P.C. , 344 F.3d 42 ( 2003 )

Emerito Estrada Rivera-Isuzu De P.R., Inc. v. Consumers ... , 233 F.3d 24 ( 2000 )

Christopher v. Stanley-Bostitch, Inc. , 240 F.3d 95 ( 2001 )

Pagan v. Calderon , 448 F.3d 16 ( 2006 )

Carver v. City of New York , 621 F.3d 221 ( 2010 )

White v. United States , 601 F.3d 545 ( 2010 )

Muir v. Navy Federal Credit Union , 529 F.3d 1100 ( 2008 )

In Re Schering Plough Corp. Intron/Temodar Consumer Class ... , 678 F.3d 235 ( 2012 )

Brereton v. Bountiful City Corp. , 434 F.3d 1213 ( 2006 )

Stalley Ex Rel. United States v. Orlando Regional ... , 524 F.3d 1229 ( 2008 )

FW/PBS, Inc. v. City of Dallas , 110 S. Ct. 596 ( 1990 )

Warth v. Seldin , 95 S. Ct. 2197 ( 1975 )

Valley Forge Christian College v. Americans United for ... , 102 S. Ct. 752 ( 1982 )

Singleton v. Wulff , 96 S. Ct. 2868 ( 1976 )

Blum v. Yaretsky , 102 S. Ct. 2777 ( 1982 )

Sierra Club v. Morton , 92 S. Ct. 1361 ( 1972 )

Lujan v. Defenders of Wildlife , 112 S. Ct. 2130 ( 1992 )

Lewis v. Casey , 116 S. Ct. 2174 ( 1996 )

View All Authorities »