Hochendoner, et al v. Genzyme Corporation, et al

Filing

OPINION issued by Jeffrey R. Howard, Chief Appellate Judge; Bruce M. Selya, Appellate Judge and Kermit V. Lipez, Appellate Judge. Published. [15-1446, 15-1447]

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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.

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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

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SELYA, Circuit Judge.

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Entry ID: 6002025

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.
I.

The tale follows.

BACKGROUND
Because these appeals follow the granting of a motion to

dismiss, we rehearse the facts as they appear in the plaintiffs'
complaints
therein).

(including

documents

incorporated

by

reference

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

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not cure) Fabry.

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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

approved

therapy

by

the

federal

Food

and

Drug

Fabrazyme received FDA approval in April of 2003.

That

Administration (FDA) for the treatment of Fabry.

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.

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A bad

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situation

grew

worse:

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shortages

in

the

United

Entry ID: 6002025

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

interruptions.

reduced

supply

was

subject

to

intermittent

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

lawsuits, including the two actions that are before us.

of

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

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Hochendoner plaintiffs obtained leave of court and filed a second
amended complaint (the operative pleading for present purposes).
The

second

of

the

two

actions

directly in the District of Massachusetts.

(Adamo)

was

brought

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

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potential causal chains.

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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.
at 24.

See id.

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).
Fabrazyme

doses

caused

On this second theory, the reduced

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

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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

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49, 57 (1st Cir. 2012).
focus

on

the

individually.

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Since no class was certified below, we

standing

vel

non

of

the

named

plaintiffs,

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.
The

parallelism

between

the

threshold

See id.

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."

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Lujan v.

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Defs. of Wildlife, 504 U.S. 555, 561 (1992).

Entry ID: 6002025

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.
made

by

the

plaintiffs

contaminant claims.1

in

First, we turn to the allegations
support

of

the

acceleration

and

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
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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

"Controversies."

"[t]he

judicial

Power"

to

"Cases"

U.S. Const. art. III, § 2, cl. 1.

and

At bottom,

that doctrine reflects "concern about the proper — and properly
limited — role of the courts in a democratic society."
Seldin, 422 U.S. 490, 498 (1975).

Warth v.

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.

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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.
injury is concrete only if it "actually exist[s]."

An

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.
The

particularization

requirement

Id. at ___ [slip op. at 9].
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

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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.
complaints

The sum total of the relevant portions of the
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.
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Tellingly, no specific information is provided regarding
the harm, if any, that has befallen each individual plaintiff.
Instead,

the

complaints

generalized harms.

offer

only

scattered

descriptions

of

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,
death.

pain,

vision

and

hearing

impairments,

and

premature

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.

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Upon close scrutiny,

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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."
Casey, 518 U.S. 343, 358 n.6 (1996).

Lewis v.

The appropriate inquiry must

be "whether each particular plaintiff is entitled to have a federal
court adjudicate each particular claim that he asserts."

3

Pagán v.

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.
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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

Consequently,

the

different

injuries

plaintiff-by-plaintiff

and
and

causal

chains.

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

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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

schedules."

reactions

due

to

inconsistent

infusion

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.
apply

both

to

standing

Although the same pleading standards
determinations

4

and

Rule

12(b)(6)

At 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.
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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."
at

500;

accord

Redistricting
individual's

Ariz.

Comm'n,
plausible

State
135

S.

Legislature
Ct.

allegations

2652,
of

a

Warth, 422 U.S.

v.
2663

personal

Ariz.

Indep.

(2015).

An

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.

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B.

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The Mooney Claims.

This leaves only the excepted claims, which relate to
James Mooney (one of the named plaintiffs in Adamo).5
court did not single out these claims in any way.

The district
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. KilKare, Inc., 585 N.E.2d 384, 391-92 (Ohio 1992) (discussing
derivative spousal consortium claims under Ohio law).
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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

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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.
428

U.S.

106,

120

(1976).

While

See Singleton v. Wulff,

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.
The

plaintiffs

Leave to Amend.
insist

that

their

claims

returned to the district court to allow amendment.

should

be

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.

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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.
360 F.3d at 241.

See Fed. R. Civ. P. 41(b); Karvelas,

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

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on the merits of the claims sub judice.

Entry ID: 6002025

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

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plaintiffs based on their lack of Article III standing.

Entry ID: 6002025

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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