Court Opinion

ID: 3205974
Source: CourtListenerOpinion
Date Created: 2016-05-23 21:00:25.407246+00
Date Added: 2024-06-11T14:28:59.421062
License: Public Domain

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.

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           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.

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