FROM THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF
MASSACHUSETTS [Hon. Douglas P. Woodlock, U.S. District Judge]
Matthew L. Kurzweg, with whom Kurzweg Law Offices was on
brief, for appellants.
G. Jones, with whom Justin Florence, Mark S. Gaioni,
Cassandra Bolaños, and Ropes & Gray LLP were on
brief, for appellee.
Howard, Chief Judge, Selya and Lipez, Circuit Judges.
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.
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).
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 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.
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.
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.
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 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
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.
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
Hochendoner plaintiffs obtained leave of court and
filed a second amended complaint (the operative pleading for
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.
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
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
with a matched set of rambling complaints, the court
identified three potential injuries, bound up with three
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.
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 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.
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 ...