United States Court of Appeals For the First Circuit
No. 22–1782
TRINA WILKINS; JAMES BISHOP; LISA BISHOP; AMBER BRITTON; TONI CORDOVA; JOHN CORTINA; JILL CORTINA; GEORGE DEMKO; DOVAN HELTON; MARY HELTON; NATE BROOKS; SYDNEY JOHNSON; D.J.; DAMON LAFORCE; ERIN MASULA; MICHAEL MASULA; JAMES MATTHEWS; THOMAS OLSZEWSKI; DARLENE COOKINGHAM; THOMAS STANZIANO; WENDY STANZIANO; EDDIE VIERS, individually as surviving spouse of Teresa Viers, deceased, and as personal representative of the Estate of Teresa Viers; WILLIAM MCNEW; JAMES WALLACE; JEANNE WALLACE, individually as surviving spouse of Joseph Wallace, deceased, and as personal representative of the Estate of Joseph Wallace; SAMUEL WALLACE,
Plaintiffs, Appellants,
v.
GENZYME CORPORATION,
Defendant, Appellee.
APPEAL FROM THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MASSACHUSETTS
[Hon. Douglas P. Woodlock, U.S. District Judge]
Before
Kayatta, Lynch, and Montecalvo, Circuit Judges.
Jonathan M. Gesk and C. Allen Black, Jr., with whom Law Office of C. Allen Black, Jr. and Gesk Moritz, LLC were on brief, for appellants. Robert G. Jones, with whom Renee T. Whyte, Ezra D. Geggle, and Ropes & Gray LLP were on brief, for appellees. February 15, 2024 KAYATTA, Circuit Judge. Filed in February of 2020, this
lawsuit seeks monetary recovery on behalf of more than two dozen
individuals for injuries allegedly caused by drug manufacturer
Genzyme Corporation's ("Genzyme") mishandling of a prescription
drug shortage between 2009 and 2012. Given that eight to eleven
years have passed between the events giving rise to this lawsuit
and its commencement, the applicable statutory limitations periods
would normally have rendered plaintiffs' claims fatally stale.
Plaintiffs argue, however, that two prior putative class actions,
a so-called savings statute, and a tolling agreement between the
parties all align to bridge any gap that would otherwise have
prevented this lawsuit from proceeding.
The district court agreed, at least in part, and rejected
Genzyme's contention that the delay in filing this lawsuit required
its dismissal under Rule 12(b)(6) of the Federal Rules of Civil
Procedure. See Wilkins v. Genzyme Corp., No. 21–10023, 2022 WL
4237528, at *18 (D. Mass. Sept. 14, 2022). At the same time, the
district court dismissed without prejudice the claims of all but
four plaintiffs for lack of standing, and it dismissed with
prejudice all remaining claims of those four plaintiffs on the
merits. Id. at *19–31. All plaintiffs then timely appealed. For
the reasons that follow, we vacate the district court's judgment
in part and remand for further proceedings consistent with this
opinion.
- 3 - I.
Given the number of parties, claims, and issues in this
lawsuit, a roadmap of our decision may prove helpful. The opinion
commences with two threshold questions of justiciability --
Article III standing and subject matter jurisdiction. We conclude
that all plaintiffs have standing and that this court has
jurisdiction to proceed with this case, at least with respect to
plaintiffs' individual claims.
We then turn to the district court's rejection of
Genzyme's statute-of-limitations defense. Because Genzyme has not
appealed that rejection, we can consider Genzyme's reliance on
that defense on this appeal only to the extent it might serve as
an alternative basis to affirm the judgment with respect to four
plaintiffs whose claims were dismissed with prejudice. After
unspooling plaintiffs' tolling-related arguments, we conclude that
all four plaintiffs waited far too long before filing this lawsuit.
In so concluding, we make a series of subsidiary findings that
will guide the district court's treatment of the claims advanced
by the remaining twenty-two plaintiffs.
As to the claims advanced by those plaintiffs, we
conclude that the district court incorrectly dismissed those
plaintiffs' claims for lack of standing. For that reason, we
vacate the judgment dismissing those claims and remand the case to
the district court. The district court can then decide, in
- 4 - whatever order it thinks prudent: (1) whether the claims withstand
Genzyme's limitations defense as explicated in this opinion, and
(2) whether the claims survive Genzyme's challenge to their merits
under Rule 12(b)(6).
With this roadmap in hand, we start with the facts.
II.
We previously detailed the allegations that underpin
this litigation in Hochendoner v. Genzyme Corp., 823 F.3d 724 (1st
Cir. 2016) ("Hochendoner II"), so we provide only an abbreviated
version here. Because of the preliminary procedural posture of
this case, we summarize the facts as alleged by plaintiffs, rather
than as they might otherwise be shown to be. See Germanowski v.
Harris, 854 F.3d 68, 69 (1st Cir. 2017) ("Because this appeal
follows a dismissal pursuant to Rule 12(b)(6) of the Federal Rules
of Civil Procedure, we accept as true all well-pleaded facts in
[the] complaint and draw all reasonable inferences in
[plaintiffs'] favor.").
Genzyme makes what was at relevant times the only drug
approved in the United States for treating Fabry disease, a
progressive affliction that leads to destructive inflammation,
organ failure, and premature death. Hochendoner II, 823 F.3d at
728. Genzyme's drug, called Fabrazyme, slows the progression of
Fabry disease when administered at the proper dosage every two
- 5 - weeks. Id. During the relevant time period, Fabrazyme was the
only FDA-approved treatment for Fabry disease in the United States.
From 2003 until 2009, Genzyme steadily provided the
FDA-approved dosage of Fabrazyme to U.S. patients. Id. Then, in
June 2009, upon discovering viral contamination in one of its
facility's bioreactors, Genzyme suspended bulk production of
Fabrazyme, leading to shortages. Id. at 728–29. Genzyme initiated
a rationing plan, providing U.S. patients with reduced doses in
order to prolong the drug's available supply. Id. In
November 2009, Genzyme discovered particulate contamination in
another batch of Fabrazyme, exacerbating the shortage. Id. at
728. In 2011, Genzyme worsened the shortage in the United States
by diverting some Fabrazyme to the European market. Id.
Plaintiffs aver that Genzyme did so to ward off competition from
an alternative Fabry disease treatment approved only in Europe,
while Genzyme's monopoly over the domestic market enabled the
company to continue peddling reduced doses to U.S. Fabry patients
without fear of losing market share.
It was not until after March 2012 that Genzyme succeeded
in restoring full supplies of Fabrazyme to U.S. patients. In the
meantime, U.S. patients had received reduced doses or, for a period
in August 2011, no doses at all. Id. at 728–29. Plaintiffs
variously allege that they experienced injuries as a result,
including worsening symptoms and acceleration of the disease's
- 6 - progression, sensitization to the drug upon returning to a full
dose, shortened life expectancies, and/or financial harm. They
allege that Genzyme knew that low-dose Fabrazyme would not
effectively treat Fabry disease and yet continued to sell the
reduced doses to patients. They also allege that Genzyme knowingly
misrepresented both the effectiveness of its low-dose regimen and
the expected duration of the shortage.
The Fabrazyme shortage provoked several lawsuits against
Genzyme that form the predicate for this case. In March 2011, a
group of plaintiffs, on behalf of a putative class of all U.S.
Fabry patients, brought suit in the U.S. District Court for the
Western District of Pennsylvania, which transferred the case to
the District of Massachusetts ("the Hochendoner lawsuit"). In
June 2013, another group of plaintiffs, on behalf of a similar
putative class, brought suit directly in the District of
Massachusetts ("the Adamo lawsuit"). Both lawsuits alleged an
array of common law and statutory claims against Genzyme. The
district court consolidated the two lawsuits before dismissing
both on the pleadings in March 2015. See Hochendoner v. Genzyme
Corp., 95 F. Supp. 3d 15, 21, 35 (D. Mass. 2015).
On appeal, we concluded that the complaint failed to
sufficiently allege a cognizable injury to any individual
plaintiff to establish Article III standing, save for what the
parties called a "sensitization" theory of injury as alleged by
- 7 - one of the Adamo plaintiffs named James Mooney (and his wife, Laura
Kurtz-Mooney). Hochendoner II, 823 F.3d at 734–35. As to all
plaintiffs but the Mooneys, "[u]tterly absent . . . [was] any
allegation linking the . . . injuries to any specific plaintiff."
Id. at 732. We therefore remanded the case so that the district
court could adjudicate the Mooneys' sensitization-based claims,
while dismissing without prejudice due to a lack of standing all
other claims presented for review on that appeal. Id. at 735–37.
Thereafter, the parties engaged in settlement
discussions. As part of that effort, the plaintiffs and Genzyme
agreed, effective May 17, 2017, to toll "[a]ny applicable statutes
of limitations pertaining to any matters asserted" during the
Hochendoner and Adamo lawsuits ("Tolling Agreement"). While it
seems that Genzyme ultimately reached agreement with some of the
Hochendoner and Adamo plaintiffs -- including the Mooneys -- others
remained unable to settle their claims. As a result, Genzyme
terminated the Tolling Agreement effective February 29, 2020, the
same day on which those plaintiffs filed the current lawsuit.
The twenty-six plaintiffs, almost all of whom were
plaintiffs in the Hochendoner/Adamo lawsuits, filed the present
action in the U.S. District Court for the Southern District of
Indiana. 1 The case was transferred back to the District of
1 The only new plaintiffs are relatives of the Adamo plaintiffs: William McNew (surviving son of Teresa Viers), James
- 8 - Massachusetts. The new complaint asserts twenty-four counts of
common law and statutory claims on behalf of the named plaintiffs
and "all others similarly situated." Plaintiffs allege federal
subject matter jurisdiction under the Class Action Fairness Act
("CAFA"), 28 U.S.C. § 1332(d), and supplemental jurisdiction over
related claims under 28 U.S.C. § 1367. As we will discuss, this
time each plaintiff has alleged the specific injuries that they
claim to have suffered.
In response to the new complaint, Genzyme raised
threshold challenges to the court's subject matter jurisdiction
and plaintiffs' standing. As to the court's subject matter
jurisdiction, Genzyme contended that all of the claims upon which
class certification was sought were untimely and that, once those
claims were dismissed, the court could no longer maintain subject
matter jurisdiction under CAFA. The district court rejected this
argument because it found that many of the plaintiffs' claims were
timely refiled. Wilkins, 2022 WL 4237528, at *18.
As to standing, however, Genzyme's arguments fared
better. The district court held that only four of the twenty-six
plaintiffs -- those bringing claims based on the same
"sensitization" theory of injury that we recognized in
Hochendoner II -- could establish Article III standing. See
and Samuel Wallace (surviving sons of Joseph Wallace), and Nate Brooks (spouse of Mary Helton).
- 9 - Wilkins, 2022 WL 4237528, at *18–21. It rejected plaintiffs' other
proffered theories of standing and dismissed all claims of the
other twenty-two plaintiffs on those grounds. Id. Then, the court
dismissed the four plaintiffs' outstanding sensitization-based
claims on the merits under Rule 12(b)(6) for failure to state a
claim upon which relief could be granted. Id. at *31.
Plaintiffs now appeal the district court's dismissal of
their claims for lack of standing and for failure to state a claim.
III.
In considering plaintiffs' appeal, we first turn to two
threshold questions of justiciability -- Article III standing and
subject matter jurisdiction.
A.
Plaintiffs seeking to invoke federal jurisdiction must
first establish that they have constitutional standing to sue in
federal court. See Dantzler, Inc. v. Empresas Berríos Inventory
& Operations, Inc., 958 F.3d 38, 46 (1st Cir. 2020). Because the
existence of standing for pleading purposes is a legal question,
we review it de novo on appeal. See In re Evenflo Co., Mktg.,
Sales Pracs. & Prods. Liab. Litig., 54 F.4th 28, 34 (1st Cir.
2022). "To satisfy th[e] standing requirement, a plaintiff must
sufficiently plead three elements: injury in fact, traceability,
and redressability." Id. (alteration in original) (quoting Kerin
v. Titeflex Corp., 770 F.3d 978, 981 (1st Cir. 2014)). When, as
- 10 - here, no class has been certified below, "our review is limited to
whether [the named plaintiffs have] standing." Id. (alteration in
original) (quoting Kerin, 770 F.3d at 981). Further, "standing is
not dispensed in gross." Town of Chester v. Laroe Ests., Inc.,
581 U.S. 433, 439 (2017) (quoting Davis v. Fed. Election Comm'n,
554 U.S. 724, 734 (2008)). Instead, "a plaintiff must demonstrate
standing for each claim he seeks to press and for each form of
relief that is sought." Id. (quoting Davis, 554 U.S. at 734).
We previously addressed similar questions of standing in
Hochendoner II. We found that standing in that case "hinge[d] on
the presence or absence of a plausibly pleaded injury in fact."
823 F.3d at 731. While plaintiffs had alleged three possible
theories of harm -- acceleration, contamination, and sensitization
-- we found that the complaint only alleged that one of the
identified plaintiffs, James Mooney, had suffered one of those
harms, sensitization. Id. at 734–35. Key to our holding was the
complaint's failure to provide "specific information . . .
regarding the harm, if any, that ha[d] befallen each individual
plaintiff" (with one exception). Id. at 732. We therefore ordered
that the complaint be dismissed without prejudice, except as to
Mooney and his spouse. Id. at 737. Following remand, after
plaintiffs filed an amended complaint in Adamo, the parties
ultimately settled the Mooneys' outstanding claims.
- 11 - On this appeal from the dismissal of plaintiffs' most
recent lawsuit, Genzyme contends that plaintiffs have made the
same mistake in failing to specify which alleged defect caused
which individual plaintiff to suffer which, if any, specific harm.
We disagree. The complaint that commenced this new lawsuit, unlike
the prior complaints in the Hochendoner and Adamo lawsuits, makes
specific allegations about the particular injuries suffered by
each individual plaintiff.
In support of their "acceleration" theory of injury,
plaintiffs allege that the low and/or contaminated Fabrazyme doses
caused their Fabry disease symptoms to worsen more quickly than
they would have had plaintiffs received full doses.2 Plaintiffs
allege that "[a]s a result of being subjected to multiple defects,
all of which cause and/or increase inflammation, all surviving
[p]laintiffs now have a worse clinical outcome than if they had
been given no drug at all because of the merger of the inflammatory
disease process created by the triply-inflammatory adulterated
Fabrazyme cocktail." (Emphasis added.)
2 Plaintiffs also allege that the defective Fabrazyme doses shortened their life expectancies. On appeal, plaintiffs devote one conclusory sentence to this claim and offer no explanation as to how their "reduced-life-expectancy" theory of injury differs meaningfully from their acceleration theory for purposes of Article III standing. We therefore find that plaintiffs have waived the issue on appeal. See United States v. Zannino, 895 F.2d 1, 17 (1st Cir. 1990) ("[I]ssues adverted to in a perfunctory manner, unaccompanied by some effort at developed argumentation, are deemed waived.").
- 12 - The complaint then adds further detail for each
Fabry-patient plaintiff. Typical of such individual allegations
is the claim that "[p]laintiff [Trina Wilkins's] clinical status
has deteriorated as the Fabry disease has accelerated due to the
defective Fabrazyme treatment as evidenced by the occurrence,
progression, and exacerbation of [various] physical injuries . . .
[including] anaphylactic infusion reactions, venous collapse,
vascular thrombosis" and so on.
The district court found these allegations insufficient
to show that "the symptoms experienced were the result of
'defective' dosing" as opposed to the typical progression of Fabry
disease without any treatment. Wilkins, 2022 WL 4237528, at *20.
As the foregoing allegations make clear, however, plaintiffs'
complaint includes multiple specific allegations precisely to that
effect. And despite Genzyme's argument to the contrary, at the
present stage of litigation we accept as true plaintiffs' "say-
so" that they suffered the physical injuries in question. See
Germanowski, 854 F.3d at 69. Whether a defective drug treatment
actually caused the decline in each plaintiff's health as alleged
goes to the merits of the claim itself, not to standing to seek
recovery for the harm.
In support of their "contamination" theory of harm --
which the district court labeled the "Vesivirus theory" --
twenty-one plaintiffs allege that they (or their spouses) suffered
- 13 - physical injuries as a result of receiving Fabrazyme doses
contaminated with Vesivirus and particulate matter. Plaintiffs'
complaint alleges that Genzyme contaminated Fabrazyme, then sold
contaminated lots to plaintiffs, which caused the injuries.
Plaintiffs allege that, for example, "[t]he Fabrazyme lots
[plaintiff Trina Wilkins] was injected with contained
Vesivirus 2117 which injured her by inducing Vesivirus-induced
vesiculating chronic non-anaphylactic rashes that are not
treatable with steroids." As another example, plaintiffs allege
that "[i]n 2013 and 2015, [plaintiff Michael Masula] was . . .
delivered and injected with defective Fabrazyme containing
Vesivirus . . . which injured him by inducing [injuries similar to
those alleged by Trina Wilkins]." Thirteen other Fabry-patient
plaintiffs and six spousal plaintiffs make similar specific claims
of harm from the alleged contamination. And contrary to Genzyme's
arguments on appeal, these allegations assert a direct causal
connection between the contaminated Fabrazyme and the injuries
suffered by plaintiffs and are therefore sufficient to confer
standing as to the relevant claims.
Plaintiffs finally allege a "financial" theory of harm:
that they were injured by paying for ineffective and medically
worthless doses of Fabrazyme. Economic injury is sufficient to
confer standing, so much so that, as one court noted, "where a
plaintiff alleges financial harm, standing 'is often assumed
- 14 - without discussion.'" Cottrell v. Alcon Lab'ys, 874 F.3d 154, 163
(3d Cir. 2017) (quoting Danvers Motor Co. v. Ford Motor Co., 432
F.3d 286, 293 (3d Cir. 2005)). Other courts considering similar
claims of economic injury from payment for defective medication
have found such allegations sufficient for standing purposes. See
Harris v. Pfizer Inc., 586 F. Supp. 3d 231, 239 (S.D.N.Y. 2022);
In re Zantac (Ranitidine) Prods. Liab. Litig., No. 21–10335, 2022
WL 16729170, at *3 (11th Cir. Nov. 7, 2022). We readily agree.
While Genzyme argues that plaintiffs effectively got "what they
paid for" because they knew they were purchasing a reduced dose
that had not been clinically tested, such an argument goes to the
merits of the claim, not to standing.
Taken as a whole, plaintiffs' newly pleaded, individual
claims closely resemble the types of claims routinely and
successfully asserted in classic product liability lawsuits. See,
e.g., Garside v. Osco Drug, Inc., 976 F.2d 77, 78 (1st Cir. 1992).
Genzyme is alleged to have supplied a product
(reduced/contaminated Fabrazyme doses without accurate warnings)
that injured each plaintiff by, in some instances, accelerating
the progression of their disease, causing them to experience a
rash and other symptoms of contamination, triggering a harmful
sensitization to a drug they needed to take, and making them pay
for harmful medication. These claims are at least plausible, and
an assessment of standing provides no occasion to venture further
- 15 - in adjudicating the merits of the claims. As we said in
Hochendoner II, "[a]n 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." 823 F.3d
at 734. All of which is to say that, for purposes of establishing
Article III standing, plaintiffs' allegations pass muster.
B.
Standing, though, cannot by itself sustain a lawsuit if
the court in which the suit resides otherwise lacks subject matter
jurisdiction. Genzyme argues that plaintiffs' complaint does not
establish federal jurisdiction because there is no complete
diversity of citizenship, nor is there "CAFA-based diversity
jurisdiction." But plaintiffs bring this case as a putative class
action, with respect to some, if not all, claims. On its face,
the action as pleaded fits the broad definition of a "class action"
as defined in CAFA.3 See 28 U.S.C. § 1332(d)(1)(B). It also meets
CAFA's jurisdictional requirements as a putative class action in
which the amount in controversy is over $5 million and one
plaintiff class member is a citizen of a different state than one
defendant. See id. §§ 1332(d)(2)(A), (6); see also
id. § 1332(d)(8) (noting that CAFA applies "to any class action
3 This is not to say, however, that plaintiffs' action necessarily qualifies for certification under Rule 23 of the Federal Rules of Civil Procedure.
- 16 - before or after the entry of a class certification order"). And
there is no suggestion that this action fits within any exception
listed at 28 U.S.C. § 1332(d)(4) or (5). Accordingly, the
district court certainly had subject matter jurisdiction over the
case at the time of filing.4
Still, Genzyme argues that the "CAFA claim" is doomed to
fail, and that once it fails there will remain no basis upon which
to assert subject matter jurisdiction. But Genzyme puts the cart
before the horse. Suppose that A sues B (who is arguably a citizen
of A's state) on two counts, one a federal claim and the other a
state claim, and the federal claim is vulnerable to an affirmative
defense based on the statute of limitations. No one would
reasonably say that the court lacks jurisdiction to decide the
case. At most, if the court exercised that jurisdiction to decide
the statute-of-limitations defense, and subsequently dismissed the
federal claim, then only at that point would the court be called
upon to consider whether it should decide to continue exercising
jurisdiction over the supplemental state claim. See 28 U.S.C.
§ 1367(c)(3).
4 We thus need not decide whether the alternative ground on which the district court accepted jurisdiction was proper. See Wilkins, 2022 WL 4237528, at *20 n.18 (expressing doubts about whether the lawsuit could proceed as a class action but proceeding to analyze plaintiffs' remaining claims individually).
- 17 - Moreover, federal jurisdiction may persist under CAFA
even if a traditional analysis under section 1367(a)(3) would
otherwise militate against continuing to exercise jurisdiction at
that point. Many courts have held that federal CAFA jurisdiction
survives denial of class certification, such that a federal court
retains subject matter jurisdiction over the residual individual
action even where jurisdiction is premised solely on CAFA. See,
e.g., Coba v. Ford Motor Co., 932 F.3d 114, 119 (3d Cir. 2019);
Louisiana v. Am. Nat'l Prop. & Cas. Co., 746 F.3d 633, 639 (5th
Cir. 2014). But see Coll. of Dental Surgeons of P.R. v. Conn.
Gen. Life Ins. Co., 585 F.3d 33, 42 (1st Cir. 2009) (expressing
"no opinion" on the issue). After all, CAFA was enacted in part
because some state courts were seen as exercising too little rigor
in certifying class actions under state practices. See Amoche v.
Guarantee Tr. Life Ins. Co., 556 F.3d 41, 49 (1st Cir. 2009) ("In
CAFA, Congress expressly expanded federal jurisdiction largely for
the benefit of defendants against a background of what it
considered to be abusive class action practices in state courts.").
If a federal court decision finding that a class should not be
certified meant that the case would be relegated to state court,
where it might then be reconsidered for certification under state
procedures, one of CAFA's key purposes would be frustrated. So,
for present purposes, Genzyme's CAFA-based jurisdictional argument
is, at the very least, premature.
- 18 - IV.
As an adjunct to its jurisdictional argument, Genzyme
also presses on appeal its affirmative defense that the action is
untimely. The district court considered that defense and ruled
against Genzyme, but Genzyme did not appeal (or, technically,
cross-appeal). Genzyme suggests that it need not have
cross-appealed the district court's ruling rejecting its
limitations defense because we can rely on any argument apparent
in the record to affirm a judgment. See Mass. Mut. Life Ins. v.
Ludwig, 426 U.S. 479, 481 (1976); Olsen v. Correiro, 189 F.3d 52,
58 n.3 (1st Cir. 1999). As to the four plaintiffs whose
sensitization-based claims were dismissed for failure to state a
claim, Genzyme is correct. It is entitled to press its timeliness
defense as an alternative basis for affirming the district court's
judgment dismissing the claims of those four plaintiffs with
prejudice. Cf. Delgado-Caraballo v. Hosp. Pavía Hato Rey, Inc.,
889 F.3d 30, 39 n.15 (1st Cir. 2018).
However, as to the remaining twenty-two plaintiffs whose
claims were dismissed without prejudice on standing grounds,
accepting Genzyme's statute-of-limitations defense on the merits
would transform the judgment against those plaintiffs from a
dismissal without prejudice into a dismissal with prejudice. Such
a change would leave them worse off. As a result, because Genzyme
- 19 - failed to cross-appeal, Genzyme is prohibited from now asserting
on appeal its statute-of-limitations defense against the claims of
those twenty-two plaintiffs. See id.
Against this admittedly reticulated background, we now
turn to the merits of Genzyme's argument that the dismissal with
prejudice of four plaintiffs' claims can be affirmed on the
alternative grounds that the claims are untimely. Those plaintiffs
are Trina Wilkins and Damon LaForce (both plaintiffs previously in
the Adamo lawsuit) and Thomas Stanziano and Wendy Stanziano (both
plaintiffs previously in the Hochendoner lawsuit).5
Plaintiffs argue that their claims in this lawsuit have
survived the passage of time because: (1) Some of them previously
commenced a class action lawsuit arising out of Genzyme's alleged
defalcations; (2) Indiana law granted them a three-year tolling
period from the end of those timely lawsuits within which to
reassert their claims; and, in any event, (3) the Tolling Agreement
preserved their claims. We consider each of these assertions in
turn.
1.
The parties do not dispute on appeal the district court's
finding that the limitations period on all claims save for
5 Ms. Stanziano brings a derivative loss-of-consortium claim tracking her spouse's sensitization claims.
- 20 - sensitization and fraud claims would have expired by no later than
the end of 2011, in the absence of any tolling.6 See Wilkins, 2022
WL 4237528, at *10–13. Nor do the parties dispute on appeal the
district court's finding that the limitations period on the fraud
claims expired but for possible tolling by March of 2013,7 or that
the limitations period on the sensitization claims expired but for
possible tolling by the end of 2014. Id. at *13.
The Stanzianos filed suit as named plaintiffs in
Hochendoner in March of 2011. So there is no dispute that their
claims were then timely asserted. Wilkins and LaForce, however,
did not sue until June of 2013. Had they asserted sensitization
claims at that time, those claims would have been timely. However,
Wilkins and LaForce never made any sensitization allegations in
Adamo. So, for Wilkins and LaForce, all of their claims when first
asserted were untimely, absent the benefit of some tolling effect.
6 The district court grouped plaintiffs' claims into three categories based on the type of harm alleged for purposes of ascertaining their accrual and expiration dates: low dosing/contamination, sensitization, and fraud. The parties on appeal do not dispute this aspect of the district court's method. 7 Plaintiffs do argue that the statute of limitations has not run on their breach-of-fiduciary-duty claims on the grounds that plaintiffs' fiduciary relationship with Genzyme is ongoing. However, the claim would have accrued, just like the rest of their claims, when plaintiffs knew or could have reasonably discovered their injury. See City of E. Chi. v. E. Chi. Second Century, Inc., 908 N.E.2d 611, 618 (Ind. 2009).
- 21 - To obtain such a benefit, Wilkins and LaForce rely on
the rule of American Pipe & Const. Co. v. Utah, which they claim
applies because Hochendoner was a putative class action. See 414
U.S. 538, 553 (1974); Crown, Cork & Seal Co. v. Parker, 462 U.S.
345, 350 (1983) (holding that the timely filing of a purported
class action suit tolls the statute of limitations for putative
class members who seek to either intervene in the suit or file
their own individual lawsuits after class action certification has
been denied). American Pipe, however, involved the saving of a
federal cause of action by application of a federally recognized
tolling rule. See 414 U.S. at 541. And plaintiffs concede --
indeed argue -- that in this action involving claims arising purely
under state law, we must look to Indiana law to determine whether
the claims of the Adamo plaintiffs are somehow saved
notwithstanding the passage of more than two years from their
accrual. See Casey v. Merck & Co., Inc., 653 F.3d 95, 100 (2d
Cir. 2011) ("[A] federal court evaluating the timeliness of state
law claims must look to the law of the relevant state to determine
whether, and to what extent, the statute of limitations should be
tolled by the filing of a putative class action in another
jurisdiction."); see also In re Urethane Antitrust Litig., 663 F.
Supp. 2d 1067, 1081–82 (D. Kan. 2009) (declining to apply American
Pipe tolling when sitting in diversity because of the established
- 22 - principle that "state law alone must govern the application of a
tolling principle to a state's statute of limitations").
The district court proceeded accordingly, and found that
Indiana courts would not apply American Pipe-style tolling to save
a claim where neither the putative class action nor the subsequent
individual claim was filed in an Indiana court. See Wilkins, 2022
WL 4237528, at *14 (collecting cases). Plaintiffs' briefs on
appeal offer no challenge to that conclusion. Hence, plaintiffs
lack any basis for claiming that the Hochendoner complaint tolled
the running of the limitations period for members of the putative
class who waited until after the limitations period expired to sue
in Adamo.
To summarize, we conclude that neither American Pipe
itself nor any analogue in Indiana law of American Pipe can play
any role in rendering any of plaintiffs' claims timely. And that
means that the claims of Wilkins and LaForce were untimely when
first filed in 2013. We turn next to the second part of plaintiffs'
tolling troika: the Indiana Journey's Account Statute.
2.
As we have found, all claims raised by the Stanzianos in
the Hochendoner lawsuit were timely when originally filed. Their
prior lawsuit, however, was itself dismissed without prejudice in
March 2015, as affirmed in May 2016. Hochendoner II, 823 F.3d at
737. So to reassert their claims in this new lawsuit, filed well
- 23 - after the two-year limitations period on their claims ran, the
Stanzianos need to rely on one or more tolling doctrines that will
bridge the gap between the passing of the limitations period and
the filing of this new lawsuit in 2020.
Toward that end, the Stanzianos invoke an Indiana
savings statute that, they argue, extended for three years their
ability to refile any otherwise timely Hochendoner claims
following this court's affirmance of their dismissal in 2016. See
Hochendoner II, 823 F.3d at 728 (dismissing consolidated
Hochendoner and Adamo actions). The statute in question, Indiana's
"Journey's Account Statute," provides that a party may refile an
action that was dismissed on any grounds apart from the party's
own negligence no later than three years after its dismissal, even
if the statute of limitations has run. Ind. Code § 34–11–8–1.8
8 The statute provides in relevant part: (a) This section applies if a plaintiff commences an action and: (1) the plaintiff fails in the action from any cause except negligence in the prosecution of the action; . . . (b) If subsection (a) applies, a new action may be brought not later than the later of: (1) three (3) years after the date of the determination under subsection (a); or (2) the last date an action could have been commenced under the statute of limitations governing the original action;
- 24 - Indeed, "when it applies, the [Journey's Account] Statute serves
to resuscitate actions that have otherwise expired under a statute
of limitations." Al-Challah v. Barger Packaging, 820 N.E.2d 670,
674 (Ind. Ct. App. 2005) (alteration in original) (quoting Cox v.
Am. Aggregates Corp., 684 N.E.2d 193, 195 (Ind. 1997)). However,
"[t]he Journey's Account Statute is not an exception to the statute
of limitations; it merely allows the continuation of a previous
suit filed within the statute of limitations." Vesolowski v.
Repay, 520 N.E.2d 433, 435 (Ind. 1988).
The Stanzianos argue that their 2020 complaint falls
squarely under the protection of the Journey's Account Statute
because this court's 2016 affirmance of the dismissal of the
consolidated Hochendoner/Adamo action was not due to their own
negligence, and the 2020 complaint was but a "continuation" of
that action that cured the standing deficiencies highlighted by
the district court and this court.
This attempted reliance on the Journey's Account Statute
fails. The Stanzianos' lawsuit in this case is not a continuation
of their prior Hochendoner lawsuit within the meaning of the
Journey's Account Statute, because all the claims that the
Stanzianos now assert pivot on highly material allegations of
and be considered a continuation of the original action commenced by the plaintiff. Ind. Code § 34–11–8–1 (2005).
- 25 - individual injuries and causation that they did not allege in
Hochendoner. "Generally, for an action to be considered a
continuation of the former [for purposes of the Indiana Journey's
Account Statute], the parties, the facts, and the causes of action
must be the same." Land v. Int'l Bus. Machs. Corp., 108 F. Supp.
3d 632, 637 (S.D. Ind. 2015); cf. Eads v. Cmty. Hosp., 932 N.E.2d
1239, 1246 (Ind. 2010) (holding that where the "new complaint
changed no parties, facts or elements, and altered only the
procedural requirements to assert the claim," the second action
was preserved under the Journey's Account Statute as a continuation
of the first); Kindred Nursing Ctrs. v. Est. of McGoffney, 15
N.E.3d 641, 646, 646 n.1 (Ind. Ct. App. 2014) (noting that the
second suit was a continuation of the first because it was
"essentially identical to the one previously filed" and "add[ed]
no new allegations or parties").
The Stanzianos' new 2020 complaint alleges for the first
time that the "'[l]ow dose' . . . caused antibody sensitization
to Fabrazyme making it impossible for [Mr. Stanziano] to resume
full dose treatment with Fabrazyme without steroids as he had
before the 'low dosing' began." It also newly alleges that "[i]n
2013 and 2015, [Mr. Stanziano] was . . . injected with defective
Fabrazyme containing Vesivirus[,]" that Mr. Stanziano's "Fabry
disease has accelerated due to the defective Fabrazyme treatment
as evidenced by" an enumerated list of Mr. Stanziano's physical
- 26 - injuries, and that Mr. Stanziano "was also damaged by paying over
$200,000 for medically worthless Fabrazyme." But for the addition
of these new facts particular to Mr. Stanziano, the Stanzianos
would have no standing to sue, much less successfully so. See
Hochendoner II, 823 F.3d at 732 (dismissing plaintiffs'
predecessor claims for lack of standing because "no specific
information [was] provided regarding the harm, if any, that has
befallen each individual plaintiff"). Accordingly, we agree with
the district court that the Indiana tolling statute has no
application to the Stanzianos' claims.
3.
We turn, finally, to the Tolling Agreement. The district
court read the Tolling Agreement as both pausing the clock and as
reviving otherwise expired claims. Certainly the agreement paused
any further running of the limitations clock. But we think it is
equally clear that the agreement did not revive claims for which
the limitations period had expired before the parties signed the
Tolling Agreement.
The Tolling Agreement provided that "[a]ny applicable
statutes of limitations pertaining to any matters asserted in the
[Hochendoner and Adamo lawsuits] shall be tolled during the term
of this Agreement." (Emphasis added.) Adding belt to suspenders,
the Tolling Agreement also stated that "notwithstanding the
foregoing," Genzyme still has "the right to assert any [timeliness]
- 27 - defense based upon passage of time prior to the [effective date of
the agreement]." In rejecting the clear meaning of this language,
the district court cited language stating that "[t]he parties
desire to provide for additional time to allow them to complete
the process of finalizing documentation giving effect to that
agreement in principle[,]" and that the agreement is in part "to
facilitate orderly settlement and resolution of the Plaintiffs'
claims." Wilkins, 2022 WL 4237528, at *15. The court suggested
that such language would have had no meaning unless the Tolling
Agreement revived stale claims. Id. at *16.
We disagree. The language cited by the district court
simply explained why the parties decided to pause the running of
the clock. Nothing in that language suggests that it was somehow
intended to supersede the express statement preserving Genzyme's
right to press its defense based on the passage of time prior to
the effective date of the Tolling Agreement. Consequently, as to
Wilkins, LaForce, and the Stanzianos, because the time within which
they needed to file suit expired long before the Tolling Agreement
was signed, none of their claims in this case survive Genzyme's
statute-of-limitations defense.
We take stock of where we are. First, we have subject
matter jurisdiction over this action under 28 U.S.C. §§ 1332(d)
and 1367, at least with respect to plaintiffs' individual claims.
- 28 - Second, all plaintiffs have Article III standing to pursue their
claims. Third, we have only considered Genzyme's
statutes-of-limitations defense as an alternative basis to affirm
the judgment as to the four plaintiffs whose claims were dismissed
with prejudice. Fourth, as to those plaintiffs, the limitations
periods on all their claims expired well before this lawsuit was
filed. More specifically, their claims are time-barred because
they were either untimely when first filed or rely on material new
facts rendering the Journey's Account Statute inapplicable, and
because the Tolling Agreement did not revive any otherwise expired
claims.
We have not addressed the merits of Genzyme's
Rule 12(b)(6) challenge to the complaint. Nor have we directly
addressed Genzyme's limitations defense to the claims of the
remaining twenty-two plaintiffs. With the guidance provided by
this opinion, we leave it to the district court to decide in the
first instance which of these issues to address first and how to
do so.
VI.
For the foregoing reasons, we affirm the district
court's dismissal of all claims by plaintiffs Wilkins, LaForce,
and the Stanzianos. But we otherwise reverse the district court's
judgment dismissing the claims of the other plaintiffs for lack of
standing, leave it to the district court in the first instance to
- 29 - consider the merits of those claims or their defenses, and remand
the case for further proceedings consistent with this opinion. No
costs are awarded.
- 30 -