# WILKINS v. GENZYME CORPORATION

> District Court, D. Massachusetts · September 14, 2022

URL: https://www.frixlaw.com/law-library/cases/10200535

## Case

- **Court:** District Court, D. Massachusetts
- **Decided:** September 14, 2022
- **Opinion:** 100trialcourt
- **Cited by:** 0 later opinions in the Frix Law Library

## Citator (automated)

- No negative treatment found by the automated citator. That is not the same as a confirmation that the case is good law; read the citing cases.
- Full citator and citing cases: https://www.frixlaw.com/law-library/cases/10200535

## How later opinions describe it (automated extraction)

- explaining that loss of consortium “is a derivative right and [wife] may recover only if her husband has a cause of action against the same defendant”
- observing, in deciding to recognize exception to privity rule involving an express warranty, that the most recent Kentucky Supreme Court decision not to find an exception involved an implied warranty
- explaining that Indiana law does not require proof of an alternative design, though it “can be relevant to design-defect liability”

## Opinion text

UNITED STATES DISTRICT COURT
DISTRICT OF MASSACHUSETTS

TRINA WILKINS, ET AL, )
)
) CIVIL ACTION NO.
Plaintiffs, ) 21-10023-DPW
)
v. )
)
)
GENZYME CORPORATION, )
)
Defendant. )

MEMORANDUM AND ORDER
September 14, 2022
Table of Contents
I. BACKGROUND.................................................. 4
A. The Parties ............................................. 4
B. Fabry Disease, Fabrazyme, and the 2009 Shortage ......... 5
C. Prior Litigation ........................................ 6
1. Hochendoner I: Consolidation in the District of
Massachusetts .............................................. 7
2. Hochendoner II: In the Court of Appeals for the First
Circuit .................................................... 8
D. The Instant Litigation ................................. 10
1. Hochendoner III – Before Transfer: In the Southern
District of Indiana ....................................... 10
2. Hochendoner IV: After Transfer in the District of
Massachusetts ............................................. 11
a. Operative Second Amended Complaint .................. 11
b. Proposed Third Amended Complaint .................... 14
E. Genzyme’s Asserted Grounds for Dismissal ............... 14
II. THRESHOLD CONSIDERATIONS.................................. 15
A. Choosing the Law ....................................... 16
B. Amending the Complaint ................................. 16
III. MOTION TO DISMISS........................................ 17
A. Subject Matter Jurisdiction ............................ 19
1. Expiration of Claims .................................. 20
a. Claims Related to Product Liability Under Indiana Law 21
b. Claims Subsumed by Products Liability ............... 22
Under Indiana Law........................................ 22
c. Loss of Consortium Claims Under Indiana Law ......... 24
d. Other State Statutes ................................ 25
2. Accrual of Claims ..................................... 26
a. Harm Caused by Law Dosing and Contamination ......... 30
b. Harm Caused by Sensitization ........................ 31
c. Harm Caused by Fraud ................................ 31
d. Summary ............................................. 32
3. American Pipe Tolling ................................. 35
4. Tolling Agreement ..................................... 38
5. Indiana Journey’s Account Statute ..................... 42
6. What Is Preserved ..................................... 47
B. Standing ............................................... 48
1. Theories of Harm ...................................... 50
a. Acceleration Theory ................................. 50
b. Sensitization Theory ................................ 51
c. Vesivirus Theory .................................... 51
d. Life Expectancy Theory .............................. 52
e. Financial Theory .................................... 52
2. Success of the Five Theories of Harm .................. 52
IV. CLASS ACTION STATUS....................................... 56
V. MERITS..................................................... 57
A. Rule 9(b) Heightened Pleading Standards ................ 58
B. Negligence ............................................. 59
1. Negligent Design Theory ............................... 61
2. Negligent Manufacture Theory .......................... 62
3. Failure to Warn Theory ................................ 62
C. Negligence Per Se ...................................... 64
D. Strict Liability ....................................... 65
E. Breach of Warranty ..................................... 65
1. Claims for Breach of Implied Warranties ............... 65
2. Claims for Breach of Expressed Warranty ............... 68
F. Florida Deceptive and Unfair Trade Practices ........... 69
G. Indiana Product Liability Act and Kentucky Product
Liability Act ............................................... 70
H. Kentucky Consumer Protection Act ....................... 72
I. Virginia Consumer Protection Act ....................... 74
J. Virginia False Advertising Act ......................... 75
K. Fraud and Fraudulent Concealment ....................... 75
L. Breach of Fiduciary Duty ............................... 78
M. Unjust Enrichment ...................................... 80
N. Loss of Consortium ..................................... 82
VI. THIRD AMENDED COMPLAINT................................... 82
VII. CONCLUSION............................................... 83
Fabrazyme is a drug prescribed to treat a rare genetic
disorder, Fabry disease. A shortage of the drug several years
ago led numerous Fabry patients – among them Plaintiffs in this
case - to sue Genzyme, Fabrazyme’s manufacturer. The First
Circuit rejected Plaintiffs’ claims in that litigation for lack
of standing. I now consider new litigation begun thereafter by

Plaintiffs – in another federal district court outside the First
Circuit - that seeks to improve on the pleadings the First
Circuit rejected. Most Plaintiffs now before me as a result of
transfer of the litigation to this district again fail to
establish standing. But there are four who manage to do so on a
basis recognized in the prior litigation. Nevertheless, those
Plaintiffs otherwise plead their claims inadequately as to the
merits. Accordingly, in the end I have determined to dismiss
this action in its entirety with respect to all Plaintiffs.
I. BACKGROUND
A. The Parties
Plaintiffs are twenty-six named individuals who either

suffer from Fabry disease and have taken Fabrazyme or are
relatives of such individuals according to the now-operative
complaint. Second Amended Complaint (“SAC”) at ¶¶1-26, ECF No.
67. Among named Plaintiffs are citizens of California, Florida,
Indiana, Massachusetts, Michigan, Nevada, New York, North
Carolina, Pennsylvania, Washington, Tennessee, and Virginia.
Defendant Genzyme Corporation (“Genzyme”) is a
Massachusetts corporation with a principal place of business in
Cambridge, Massachusetts; the company markets and sells
Fabrazyme throughout the United States. Id. at ¶27.
B. Fabry Disease, Fabrazyme, and the 2009 Shortage
Fabry disease arises in roughly 1 in 3,000 births. SAC at

¶31. The condition results from a missing or mutated gene for
the enzyme alpha-galactosidase, which is needed to metabolize
the fat globotriaosylceramide (“GL-3”). Id. at ¶32. Without
the enzyme, GL-3 builds up in cells, blood vessels, and organs,
causing inflammation and death, typically from strokes, kidney
failure, or heart enlargement. Id.
Fabrazyme is a synthetic version of alpha-galactosidase.
Id. at ¶33-34. It cannot undo prior harm from Fabry disease but
it mitigates the condition. Id. at ¶35. Because Fabrazyme
metabolizes quickly, the standard regimen is to receive
injections every two weeks. Id. at ¶36. Although at all
relevant times Fabrazyme was the only medication for Fabry

patients available in the United States; a competitor drug
called Replagal® was sold in other countries. Id. at ¶140.
A Fabrazyme shortage arose in June 2009 when Genzyme’s
production stalled due to various problems at its manufacturing
facility. Hochendoner v. Genzyme Corp., 95 F. Supp. 3d 15, 18
(D. Mass. 2015) (“Hochendoner I”), aff’d in part, vacated in
part, remanded, 823 F.3d 724 (1st Cir. 2016) (“Hochendoner II”).
These problems included a contamination of Genzyme’s bioreactors
with vesivirus. SAC at ¶¶42-87. “During this shortage, Genzyme
adopted a rationing plan under which United States Fabry
sufferers would be allocated less than the recommended dose, and
newly diagnosed Fabry patients would not be prescribed the

drug.” Hochendoner I, 95 F. Supp. 3d at 18.
C. Prior Litigation
Following the shortage, patients filed lawsuits against
Genzyme in the Western District of Pennsylvania (“the
Hochendoner action”)1 and in this Court (“the Adamo action”); I
sometimes refer in this Memorandum to these actions collectively
as the Hochendoner/Adamo actions.2 See Hochendoner I, 95 F.

1 Certain of the plaintiffs now again before me — Amber Britton,
George Demko, Michael Masula, Erin Masula, Thomas Olszewski,
Darlene Cookingham, Thomas Stanziano, and Wendy Stanziano — were
plaintiffs in the Hochendoner action originally filed in the
United States District Court for the Western District of
Pennsylvania on March 9, 2011. See Hochendoner v. Genzyme Corp.,
No. 2:11-cv-00313-CB (filed Mar. 9, 2011, W.D. Pa.), ECF No. 1;
No. 1:11-cv-10739-DPW (filed June 30, 2011, D. Mass.), ECF No.
29.
2 The following plaintiffs now again before me — Trina Wilkins,
James Bishop, Lisa Bishop, Toni Cordova, John Cortina, Jill
Cortina, Mary Helton, Donovan Helton, D.J., Sydney Johnson,
Damon LaForce, James Matthews, Eddie Viers, and Jeanne Wallace —
were plaintiffs in the Adamo action originally filed in this
Court on June 3, 2013. See Adamo v. Genzyme Corp., 1:13-cv-
11336-DPW (filed June 3, 2013, D. Mass.), ECF No. 1.
Additionally, several new Plaintiffs now before me are relatives
of Adamo plaintiffs. They include William McNew (surviving son
of Teresa Viers), SAC ¶23, James and Samuel Wallace (surviving
Supp. 3d at 20-21; see also Schubert v. Genzyme Corp., No.
2:12CV587DAK, 2013 WL 4776286, at *1 (D. Utah Sept. 4, 2013).3
Upon transfer by the Western District of Pennsylvania to this
Court in Hochendoner I, I consolidated the two actions and ruled
on motions to dismiss in both matters. 95 F. Supp. 3d at 21. I
granted the motions to dismiss, finding that the complaint

failed under Rules 8 and 12(b)(6) of the Federal Rules of Civil
Procedure. Id. The First Circuit affirmed — “with one small
exception,” discussed below — based on standing, an issue not
raised until appeal. Hochendoner II, 823 F.3d at 728, 730 (1st
Cir. 2016).
1. Hochendoner I: Consolidation in the District of
Massachusetts

I found the Hochendoner/Adamo complaints broadly described
“three possible types of causation leading to three possible
types of injury suffered by [p]laintiffs.” Hochendoner I, 95 F.
Supp. 3d at 23. The first causal chain posited that lower doses
of Fabrazyme reduced the drug’s effectiveness, leading to “a

sons of Joseph Wallace), id. ¶¶25-26, and Nate Brooks (spouse of
Mary Helton), id. ¶10.
3 An individual plaintiff, separate from the Plaintiffs here,
sued Genzyme in Schubert. Throughout their Second Amended
Complaint, Plaintiffs cite extensively to the Proposed Fourth
Amended Complaint in Schubert, which described internal
communications at Genzyme concerning the Fabrazyme shortage.
Schubert ended in June 2015 with a stipulated motion to dismiss
with prejudice all claims and causes of action against Genzyme.
Schubert v. Genzyme Corp., 2:12-cv-00587-DAK (D. Utah dismissed
June 24, 2015), ECF No. 195.
return of symptoms in Fabry patients.” Id. The second causal
chain posited that lower doses of Fabrazyme accelerated the
course of the disease. Id. The third causal chain posited that
Genzyme’s Fabrazyme vials were contaminated with particulate
steel, glass, and rubber. Id.
For the latter two alleged causal chains — acceleration and

contaminants — I found the pleading insufficient to provide fair
notice as required by Fed. R. Civ. P.8 as to which of the
plaintiffs suffered injury under those theories. Id. at 24.
For the first causal chain — effectiveness reduction — I
dismissed the counts for failure to state a claim under Fed. R.
Civ. P.12(b)(6). As a result, numerous state common law claims
of negligence, negligence per se, strict liability, breach of
warranty, loss of consortium, and claims under state consumer
protection acts and state product liability acts were dismissed.
Id. at 29-35.
2. Hochendoner II: In the Court of Appeals for the First
Circuit

On appeal, the Hochendoner I plaintiffs only pursued the
acceleration and contaminant theories. The First Circuit found
these claims failed the Article III standing requirement.
Standing, the First Circuit explained on appeal, requires a
“plaintiff-by-plaintiff and claim-by-claim analysis” that
“demands allegations linking each plaintiff to each of [the
alleged] injuries.” Hochendoner II, 823 F.3d at 733 (emphasis
added). The Court of Appeals observed that the complaints’
allegations did not show a particularized injury because no
specific information was referenced regarding the harm
experienced by each individual plaintiff. Id. The Court of
Appeals determined that the Hochendoner I plaintiffs made “no

assertion at any point in the complaints that any specific
plaintiff took or received a dose contaminated with particulate
matter”; they simply alleged broadly that Genzyme produced
contaminated Fabrazyme. Id. at 732.
However, the First Circuit reversed my order with respect
to a somewhat different causation theory — the “increased risk”
theory — which it found successfully alleged as to one
plaintiff, James Mooney (not a plaintiff here). That theory, a
variant of the “reduced effectiveness” theory, posited that, by
forcing patients to forego Fabrazyme doses, Genzyme caused an
“increased risk and severity of acute adverse reactions due to
inconsistent infusion schedules,” the complaint adequately

alleged that Mr. Mooney suffered “an allergic reaction
attributable to his exposure to a reduced dose of Fabrazyme.”
Id. at 733-35. The First Circuit further found the Mooney
claims on that theory might satisfy Fed. R. Civ. P. 12(b)(6) and
thus vacated the dismissal of those claims and remanded to
evaluate the pleading further to see whether the pleading was
adequate. Id. at 735.
Because it chose to affirm dismissal of plaintiffs’ claims
for lack of standing — that is, a dismissal for lack of subject
matter jurisdiction, which “normally operates without prejudice”
— the First Circuit directed on remand clarification that “the

judgment is to operate without prejudice as to claims based on
the acceleration and contaminant injuries.” Id. at 736.
D. The Instant Litigation
1. Hochendoner III – Before Transfer: In the Southern
District of Indiana

Plaintiffs now before me were unsuccessful in settling
their claims in the wake of remand. Nearly four years later, on
February 29, 2020, they filed the present action in the United
States District Court for the Southern District of Indiana.
Wilkins v. Genzyme Corp., 20-cv-00051-TWP-DML (S.D. Ind. filed
Feb. 29, 2020) (“Hochendoner III”).4 On May 6, 2020, they filed
a First Amended Complaint changing identification of the entity
or entities alleged to be the defendant. First Amended
Complaint (“FAC”), id. (S.D. Ind. May 6, 2020), ECF No. 10. On

4 Although the first named plaintiff in Hochendoner I and
Hochendoner II is not a plaintiff in the litigation transferred
to my docket from the Southern District of Indiana, I will
continue to refer to the case — before transfer as Hochendoner
III and after transfer as Hochendoner IV — to emphasize its
status as a descendant in the Hochendoner family of litigation.
October 5, 2020, Plaintiffs filed the now-operative Second
Amended Complaint, naming Genzyme as the sole defendant. SAC,
id. (S.D. Ind. Oct. 5, 2020), ECF No. 67.
2. Hochendoner IV: After Transfer in the District of
Massachusetts

In the wake of remand, the plaintiffs entered into
settlement negotiations with Genzyme. During these
negotiations, the plaintiffs and Genzyme struck an agreement on
May 17, 2017 that tolled “[a]ny applicable statutes of
limitations pertaining to any matters asserted” during the
Hochendoner I and Adamo lawsuits. [ECF No. 105-1 at ¶1]
Plaintiffs now before me were unsuccessful in settling their
claims. I came to preside over this matter, now Hochendoner IV,
following transfer pursuant to 28 U.S.C. § 1404(a). Transfer
Order, id. (S.D. Ind. Dec. 30, 2020), ECF No. 78. Meanwhile, in
response to the pending motion to dismiss the Second Amended
Complaint in this litigation again in this Court, Plaintiffs
moved, ECF No. 105, to file a Third Amended Complaint, ECF No.
105-2.
a. Operative Second Amended Complaint
The operative Second Amended Complaint makes class
allegations as to payments for defective and/or ineffective
Fabrazyme, in addition to twenty-four individual counts.5 The

5 Although these counts are labeled “individual” counts, they are
class allegations are under Fed. R. Civ. P. 23 on behalf of five
representative plaintiffs,6 the other plaintiffs named in the
complaint, and “all others similarly situated,” defined to
include “any and all individuals residing in the United States
of America and who have been diagnosed with Fabry disease,
received Fabrazyme at any time from July 1, 2009 through March

2012 in a reduced dose amount, and who paid for the reduced dose
Fabrazyme, either directly or through an insurance plan and the
spouses of any such person.” ECF No. 67 at ¶342. Plaintiffs
say that I have subject matter jurisdiction under the Class
Action Fairness Act (“CAFA”), 28 U.S.C. § 1332(d).
The individual claims include nine counts under common law
(Counts 1-4, 20-24) and several under state statutes concerned
with deceptive and unfair trade practices (Counts 5, 9, 11-14,
and 18), product liability (Counts 6-7, 10, and 19), consumer
protection (Counts 8 and 15), false advertising (Count 16), and
wrongful death/survival (Count 17).
The individual claims, stated in the order presented in the

Second Amended Complaint, are as follows:
1. Negligence
2. Negligence per se
3. Strict Liability

still apparently pled in support of the class claims and each
includes reference to “all others similarly situated.”
6 These five co-representative plaintiffs are Trina Wilkins,
George Demko, Michael Masula, Thomas Olszewski, and Tom
Stanziano. SAC at ¶342.
4. Breach of Warranty
5. Florida Deceptive and Unfair Trade Practices Act Violation
6. Indiana Products Liability Action Violation
7. Product Liability Act of Kentucky Violation
8. Kentucky Consumer Protection Act Violation
9. Massachusetts Unfair and Deceptive Trade Practices Act
Violation
10. Michigan State Product Liability Act Violation
11. Michigan State Law Deceptive Trade Practice Violation
12. Nevada State Law Deceptive Trade Practice Violation
13. North Carolina Unfair and Deceptive Trade Practices Act
Violation
14. Pennsylvania Unfair Trade Practices Consumer Protection
Law Violation
15. Virginia Consumer Protection Act Violation
16. Virginia Prohibition of False Advertising Violation
17. Virginia Wrongful Death or in the alternative Survival
Action Claims
18. Washington Uniform Deceptive Trade Practices Act
19. Washington Product Liability Act Violation
20. Fraud
21. Fraudulent Concealment
22. Breach of Fiduciary Duty
23. Unjust Enrichment
24. Loss of Consortium

It is worth noting that Plaintiffs flag three ways in which
the current lawsuit seeks to fix problems identified with their
claims in Hochendoner I and Hochendoner II. First, they say
their injuries “are discussed individually and not in the
aggregate.” Opposition to MTD at 6, ECF No. 108. Second, they
say Plaintiffs “who received ‘low doses’ plead ‘acceleration’ of
their disease,” an allegation they contend “is vetted pleading
language as a cause of action” under the First Circuit’s
decision in Hochendoner II. Id. Third, they say they “plead
anaphylactic reactions to ‘low dose’ Fabrazyme,” which they
contend is also vetted language under Hochendoner II. Id. I
observe also that Plaintiffs newly allege in the Second Amended
Complaint extensive contamination of Fabrazyme dosages with
vesivirus, the pathogen found in Genzyme’s bioreactors that led
to the Fabrazyme shortage. See SAC at ¶¶42-87.
b. Proposed Third Amended Complaint

Although the Second Amended Complaint remains the operative
pleading before me, Plaintiffs seek to file a Third Amended
Complaint, (“TAC”) ECF No. 105, which they say is appropriate in
response to Genzyme’s Motion to Dismiss (described below). The
Third Amended Complaint would bring four small changes. First,
it would attach a tolling agreement the parties entered into
after the decision in Hochendoner II. Id. ¶18. Second, it
would add allegations based on a draft of a letter that Genzyme
included with its Motion to Dismiss. Id. ¶20. Third, it would
drop causes of action under the Massachusetts Deceptive Trade
Practices Act, Washington Uniform Deceptive Trade Practices Act,
and Washington Product Liability Act.7 Id. ¶24. Fourth, it

would drop claims related to 2013 and 2015 contaminations at the
Framingham Plant. Id. ¶25.
E. Genzyme’s Asserted Grounds for Dismissal
Defendant presents four grounds for dismissal of this case.

7 Plaintiffs only directly reference dropping the Massachusetts
claim, but the Washington claims are apparently withdrawn as
well, since they do not appear in the proposed Third Amended
Complaint.
First, Genzyme says the litigation should be dismissed pursuant
to Fed. R. Civ. P. 12(b)(1) for lack of subject matter
jurisdiction, because all putative class claims that support
federal jurisdiction are untimely and complete diversity is
lacking between the parties. In any event, Genzyme contends I
should decline to exercise supplemental jurisdiction over any

remaining state law claims. Second, Genzyme contends each
Plaintiff lacks standing as another reason to dismiss under Fed.
R. Civ. P.12(b)(1). Third, Genzyme contends Plaintiffs’ claims
all essentially sound in fraud and fail to meet the Fed. R. Civ.
P.9(b) particularity standard. Fourth, Genzyme contends
Plaintiffs have failed to state a claim under Fed. R. Civ. P.8
and Fed. R. Civ. P.12(b)(6).
As to the proposed Third Amended Complaint, Genzyme says I
should deny this request outright, because presenting another
complaint at this point in the litigation would be prejudicial
and is futile, since the proposed Third Amended Complaint will
not overcome the inadequacies of the Second Amended Complaint

that provide the basis for dismissal.
II. THRESHOLD CONSIDERATIONS
I must identify at the outset two basic threshold
considerations — choice of law and whether and how to treat a
proposed amended complaint — that shape my approach to
consideration of Genzyme’s motion to dismiss contentions.
A. Choosing the Law
As alleged, this is a diversity case upon transfer from the
United States District Court for the Southern District of
Indiana, albeit said to have been raised under the Federal Class
Action Fairness Act. In these circumstances, “a federal court
sitting in diversity or exercising supplemental jurisdiction

over state law claims must apply state substantive law, but a
federal court applies federal rules of procedure to its
proceedings.” Hoyos v. Telecorp Commc’ns, Inc., 488 F.3d 1, 5
(1st Cir. 2007) (citing Gasperini v. Ctr. For Humanities, Inc.,
518 U.S. 415, 427 (1996)). For questions of state law, I follow
Indiana choice-of-law rules, as would an Indiana federal court
sitting in diversity. See AER Advisors, Inc. v. Fidelity
Brokerage Servs., LLC, 921 F.3d 282, 289 (1st Cir. 2019) (“[T]he
transferee court applies the state law that the transferor court
would have applied to any questions of state law.”); Gre-Ter
Enter., Inc. v. Mgmt. Recruiters Int’l, Inc., 329 F. Supp. 3d
667, 675 (S.D. Ind. 2018) (citing Klaxon Co. v. Stentor Elec.

Mfg. Co., 313 U.S. 487, 496 (1941)). For questions of federal
law, I apply federal law as interpreted by the First Circuit.
AER Advisors, 921 F.3d at 289-91.
B. Amending the Complaint
Fed. R. Civ. P.15(a)(2) provides that “a party may amend
its pleading only with the opposing party’s written consent or
the court’s leave,” and that the court “should freely give leave
when justice so requires.” Fed. R. Civ. P.15(a)(2). That said,
“amendments may be denied for several reasons, including ‘undue
delay, bad faith, dilatory motive of the requesting party,
repeated failure to cure deficiencies, and futility of
amendment.’” Hagerty ex rel. United States v. Cyberonics, Inc.,

844 F.3d 26, 34 (1st Cir. 2016) (quoting United States ex rel.
Rost v. Pfizer, Inc., 507 F.3d 720, 733-34 (1st Cir. 2007),
overruled on other grounds by Allison Engine v. United States ex
rel. Sanders, 553 U.S. 662 (2008)). In this posture,
“‘[f]utility’ means that the complaint, as amended, would fail
to state a claim upon which relief could be granted.” Glassman
v. Computervision Corp., 90 F.3d 617, 623 (1st Cir. 1996). In
canvassing Genzyme’s contentions in support of the operative
Second Amended Complaint, I am alert to the implications for
allowing a proposed Third Amended Complaint to become the
operative pleading in the litigation.

III. MOTION TO DISMISS
I address first the standard for a Rule 12(b)(6) motion,
the standard integral to other issues before me. I “assume that
well-pleaded facts are true and ask whether such facts and
inferences reasonably drawn from those facts plausibly state a
claim.” Doe v. Pawtucket Sch. Dep’t, 969 F.3d 1, 7 (1st Cir.
2020) (citing Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009)).
However, I do not accept “legal conclusions clothed as factual
allegations.” Thompson v. JPMorgan Chase Bank, N.A., 982 F.3d
809, 811 (1st Cir. 2020) (citing Bell Atlantic Corp. v. Twombly,
550 U.S. 544, 555-56 (2007)). “Threadbare recitals of the
elements of a cause of action, supported by mere conclusory
statements, do not suffice.” Ashcroft, 556 U.S. at 678. The

well-pleaded facts must permit me to “infer more than the mere
possibility of misconduct.” Id. at 679. Plaintiffs must
“nudge[] their claims across the line from conceivable to
plausible.” Twombly, 550 U.S. at 570.
I employ this Rule 12(b)(6) standard as well for Rule
12(b)(1) motions. “Rule 12(b)(1) motions challenging subject-
matter jurisdiction are divided into two categories: facial
challenges and factual challenges.” Cebollero-Bertran v. Puerto
Rico, 4 F.4th 63, 69 (1st Cir. 2021). In the posture of
Genzyme’s motion to dismiss, with its “facial challenges
[Genzyme] raises a question of law without contesting the
facts.” Id. Accordingly, “[t]he analysis is essentially the

same as a Rule 12(b)(6) analysis: [I] accept the well-pleaded
facts alleged in the complaint as true and ask whether the
plaintiff has stated a plausible claim that the court has
subject matter jurisdiction.” Id.
Similarly, the standing analysis under Rule 12(b)(1)
mirrors Rule 12(b)(6) analysis. “[A]t 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.” Hochendoner II, 823 F.3d at
731.
With recognition that Genzyme suggests the proposed Third

Amended Complaint is futile, I turn first to Genzyme’s Motion to
Dismiss as applied to the currently operative Second Amended
Complaint. See supra Section II.B. But I reference points that
would be added by the proposed Third Amended Complaint, when
relevant.8 In addressing the Motion to Dismiss, I start with the
arguments about subject matter jurisdiction. This is because
“federal courts are required to determine whether Article III
jurisdiction exists prior to proceeding to the merits of the
case.” See United Seniors Ass’n, Inc. v. Philip Morris USA, 500
F.3d 19, 23 (1st Cir. 2007).
A. Subject Matter Jurisdiction
Genzyme contends I lack subject matter jurisdiction because

the claims underlying the CAFA class claims — the only aspect of
this litigation that could support federal jurisdiction in the

8 For purposes of this analysis, I ignore the 2013 and 2015
claims concerning the Framingham plant and the Massachusetts and
Washington claims, all of which the plaintiffs have abandoned in
the Third Amended Complaint. See supra note 7 and accompanying
text.
first place — are all time-barred. For their part, Plaintiffs
say tolling under American Pipe & Const. Co. v. Utah, 414 U.S.
538 (1974), Indiana’s Journey Account Statute,9 and a May 2017
tolling agreement10 between the parties’ work to preserve their
claims.
I begin my analysis by identifying the relevant statutes of

limitations and when Plaintiffs’ claims accrued, in order to
assess if and when any of the claims have expired. I then
address American Pipe tolling, the tolling agreement, and
Indiana’s Journey’s Account Statute.
1. Expiration of Claims
Because statutes of limitations are substantive law under
federal direction, see Guaranty Trust Co. of New York v. York,

9 Plaintiffs also reference the Massachusetts Savings Statute,
but Massachusetts law does not apply in this circumstance,
because I am directed by Massachusetts law to apply Indiana law.
See Hemric v. Reed & Price Mfg. Co., 739 F.2d 1, 3 (1st Cir.
1984) (“[W]e are aware of no case suggesting that Massachusetts
would abandon the traditional rule that local law of the forum
determines whether an action is barred by a statute of
limitations.”).
10 A copy of this agreement is attached to the Third Amended
Complaint and undisputed by the parties. Although I have yet to
rule on allowing the Third Amended Complaint, I consider its
contents here. “While, ordinarily, a district court’s review
under Rule 12(b)(6) is limited to consideration of the facts set
forth in the complaint and the documents attached thereto, an
exception exists for ‘documents the authenticity of which are
not disputed by the parties . . . .” Town of Acton v. W.R.
Grace & Co. Conn. Techs., Inc., No. 13-12376-DPW, 2014 WL
7721850, at *5 (D. Mass. Sep. 22, 2014) (quoting Watterson v.
Page, 987 F.2d 1, 3 (1st Cir. 1993)).
326 U.S. 99, 110-12 (1945), I rely on Indiana choice-of-law
principles. Under those principles, statutes of limitations are
treated as procedural, so Indiana’s statutes of limitations
apply. Autocephalous Greek-Orthodox Church of Cyprus v.
Goldberg & Feldman Fine Arts Inc., 717 F. Supp. 1374, 1385 (S.D.
Ind. 1989), aff’d, 917 F.2d 278 (7th Cir. 1990). But there is

an exception. For statutory claims arising under the law of
another state, that state’s relevant statute of limitations
applies. Shearer v. Thor Motor Coach, Inc., 470 F. Supp. 3d
874, 879 (N.D. Ind. 2020). And there is an exception to this
exception: If the statutory claim originated at common law, then
Indiana’s statutes of limitations still apply. Id. at 879-880;
see also Big Rivers Elec. Corp. v. Gen. Elec. Co., 820 F. Supp.
1123, 1125–26 (S.D. Ind. 1992).
a. Claims Related to Product Liability Under Indiana
Law

Indiana’s statutes of limitations apply for all the common
law claims here — as well as the claim under the Indiana Product
Liability Act. The common law claims are for negligence,
negligence per se, strict liability, breach of warranty, fraud,
fraudulent concealment, breach of fiduciary duty, unjust
enrichment, and loss of consortium.
A two-year statute of limitations applies for the common
law claims. A two-year statute of limitations for claims
related to products liability, as alleged here, negligence,
negligence per se, and strict liability, arises from the Indiana
Products Liability Act. See Ind. Code § 34-20-3-1. Likewise,
the statute of limitations is set at two years for breach of
fiduciary duty under Indiana law. See Ind. Code § 34-11-2-4;
Shriner v. Sheehan, 773 N.E. 2d 833, 846 (Ind. Ct. App. 2002).

b. Claims Subsumed by Products Liability
Under Indiana Law

In Count Four, Plaintiffs allege various breaches of
express and implied warranties under common law. [Dkt. No. 67
¶¶ 361–64.] These claims are subsumed under the Indiana Product
Liability Act for two reasons, and accordingly a two-year
statute of limitations applies. First, where a breach of
warranty claim is “tort-based,” “several federal district courts
and other panels of the [Indiana] Court of Appeals” have found
the claim “subsumed into the [Indiana Product Liability Act].”
Kovach v. Caligor Midwest, 913 N.E.2d 193, 197 (Ind. 2009); see
Cavender v. Medtronic, Inc., No. 3:16-CV-232, 2017 WL 1365354,
at *7 (N.D. Ind. Apr. 14, 2017) (“[I]f it walks like a duck and
quacks like a duck, it's a tort—not a breach of warranty claim—
and it is subsumed by the [Indiana Product Liability Act].”).
Although Plaintiffs pleaded that low-dose Fabrazyme “is not fit
for the ordinary purpose for which it is customarily or
foreseeably used” [Dkt. No. 67 ¶362(d)] — language framing
Plaintiffs’ claim in warranty — Plaintiffs did not provide
additional facts that set the claim outside of tort. [See
generally Dkt. No. 67 ¶¶362–64.] See Lyons v. Leatt Corp., No.
4:15-CV-17-TLS, 2015 WL 7016469, at *3 (N.D. Ind. Nov. 10, 2015)
(using language that framed plaintiff’s claim as a breach of
warranty did not shield it from being subsumed under the Indiana

Product Liability Act where it sounded in tort). Second,
Plaintiffs did not bring their claim for breach of warranty
under the Indiana adoption of the Uniform Commercial Code, which
is “independent” from the Indiana Products Liability Act and
provides for different damages. Atkinson v. P & G-Clairol,
Inc., 813 F. Supp. 2d 1021, 1024–25 (N.D. Ind. 2011).
Similarly, the claims sounding in fraud and in unjust
enrichment are subject to the two-year statute of limitations,
since this litigation continues to present a products liability
case and the fraud and unjust enrichment claims arise out of
that framework. In Indiana, it is “the nature or substance of
the cause of action, rather than the form of the action, which

determines the applicability of the statute of limitations.”
Shideler v. Dwyer, 417 N.E.2d 281, 285 (Ind. 1981) (quoting
Koehring Co. v. Nat’l Automatic Tool Co., 257 F. Supp. 282, 292
(S. D. Ind. 1966), aff’d, 385 F.2d 414 (7th Cir. 1967) (per
curiam)).11 “Where an unjust enrichment claim arises out of a
tort-based products liability claim as occurred here, Indiana
would apply a two-year limitations period.” Juday v. Merck &
Co., No. CV 16-1547, 2017 WL 1374527, at *3 (E.D. Pa. Apr. 17,
2017) (citing Knutson v. UGS, 2007 WL 2122192 at *5 (S.D. Ind.
July 19, 2007) and Schwindt v. Hologic, Inc., 2011 WL 3806511 at

*7 (S.D. Ind. Aug. 26, 2011)), aff’d, Juday v. Merck & Co Inc,
730 F. App’x 107 (3d Cir. 2018). The same is true for the fraud
claims. See In re Vioxx Prods. Liab. Litig., MDL No. 1657, 2007
WL 3334339, at *6 (E.D. La. Nov. 8, 2007) (finding under Indiana
law that two-year statute of limitations applied to fraud claims
in product liability suit).
c. Loss of Consortium Claims Under Indiana Law
Loss of consortium is a derivative claim, and thus tied to
the relevant statute of limitations for the loved one’s claim;
consequently, it does not have a set statute of limitations but

11 I recognize there is some debate about how far the Indiana
Supreme Court will ultimately take this doctrine in claims as
presented to be subsumed by other statutes of limitations based
on “form.” See Lewis v. Methodist Hosp., Inc., 326 F.3d 851,
854-56 (7th Cir. 2003). The crux of this debate is that there
are provisions in the Indiana code providing state statutes of
limitations — including for fraud — and that such provisions may
become meaningless if every claim is always read to be subsumed
by another relevant statute of limitations. Here, the framing
of the litigation has firmly and consistently been in essence as
a product liability case. Cf. In re Vioxx Prods. Liab. Litig.,
MDL No. 1657, 2007 WL 3334339, at *6 (E.D. La. Nov. 8, 2007).
will rely upon that of the claim from which it is derived. See
Palmer v. Gorecki, 844 N.E.2d 149, 157 (Ind. Ct. App. 2006).
d. Other State Statutes
All other claims brought are under statutes of other
states. I find it unnecessary to scrutinize whether Indiana
courts would identify these claims as originating separately at

common law, because the claims in all events have expired for
purposes of Indiana law or the law of the other states, as I
will explain momentarily. To frame that explanation, I observe
that the various state statutes of limitations are as follows:
• Three years for the Florida Deceptive and Unfair Trade
Practices Act. Fla. Stat. § 95.11(3)(f); Koski v. Carrier
Corp., 347 F. Supp. 3d 1185, 1192 (S.D. Fla. 2017).
• One year for the Kentucky Products Liability Act. Ky. Rev.
Stat. Ann. § 413.140(1)(a). Bosch v. Bayer Healthcare
Pharms., Inc., 13 F. Supp. 3d 730, 737 (W.D. Ky. 2014).

• Two years for the Kentucky Consumer Protection Act. Ky.
Rev. Stat. Ann. § 367.220(5). Arnold v. Liberty Mut. Ins.
Co., 392 F. Supp. 3d 747, 766-67 (E.D. Ky. 2019).
• Three years for the Michigan Product Liability Act. Mich.
Comp. Laws § 600.5805(12); McMan v. C.S. Bard, Inc., No.
19-12670, 2021 WL 3079894, at *3 (E.D. Mich. July 21,
2021).
• Six years for the Michigan Consumer Protection Act.12 Mich.
Comp. Laws § 445.911(9).
• Four years for the Nevada Deceptive Trade Practices Act.
Nev. Rev. Stat. § 11.190(2)(d).

• Four years for the North Carolina Deceptive Trade Practices
Act. N.C. Gen. Stat. § 75-16.2; Dreamstreet Invs., Inc. v.
MidCountry Bank., 842 F.3d 825, 830 (4th Cir. 2016).
• Six years for the Pennsylvania Consumer Protection Act. 42
Pa. Cons. Stat. § 5527(b); Rodgers v. Lincoln Benefit Life
Co., No. 19-cv-350, 2019 WL 4750193, at *2 (W.D. Pa. Sept.
30, 2019).
• Two years for the Virginia Consumer Protection Act. Va.
Code Ann. § 59.1-204.1.

• Two years for the Virginia False Advertising Act. Parker-
Smith v. Sto Corp., 551 S.E.2d 615, 619 (Va. 2001).
• Two years for Virginia Wrongful Death/Survival Actions.
Va. Code Ann. § 8.01-244.
2. Accrual of Claims
With the expiration framework in place, I turn to the issue

12 In Count 11, Plaintiffs allege a violation of the “Michigan
State Law Deceptive Trade Practice” and cite to Mich. Comp. Laws
§ 445.903 et seq. Plaintiffs’ citation is actually to the
Michigan Consumer Protection Act, and finding no “Michigan State
Law Deceptive Trade Practice” Act, I have applied the Michigan
Consumer Protection Act statute of limitations.
of when Plaintiffs’ claims accrued. “The determination of when
a cause of action accrues is generally a question of law.”
Cooper Indus., LLC v. City of S. Bend, 899 N.E.2d 1274, 1280
(Ind. 2009). I note that Indiana courts are inclined to
construe limitation provisions as “enacted upon the presumption
that one having a well-founded claim will not delay enforcing

it.” Shideler, 417 N.E.2d at 283. “They are practical and
pragmatic devices to spare the courts from litigation of stale
claims, and the citizen from being put to his defense after
memories have faded, witnesses have died or disappeared, and
evidence has been lost.” Havens v. Ritchey, 582 N.E.2d 792, 794
(Ind. 1991) (quoting Rohrabaugh v. Wagoner, 413 N.E.2d 891, 893
(Ind. 1980)).
Under Indiana’s discovery rule, a cause of action accrues
“when a party knows, or in the exercise of ordinary diligence
could discover, that . . . an injury had been sustained as a
result of the tortious act of another.” Strauser v. Westfield
Ins. Co., 827 N.E.2d 1181, 1185 (Ind. Ct. App. 2005). The rule

“does not mandate that plaintiffs know with precision the legal
injury that has been suffered, but merely anticipates that a
plaintiff be possessed of sufficient information to cause him to
inquire further in order to determine whether a legal wrong has
occurred.” Perryman v. Motorist Mut. Ins. Co., 846 N.E.2d 683,
689 (Ind. Ct. App. 2006). The question is whether “the acts and
circumstances of an injury would put a person of common
knowledge and experience on notice that some right of his has
been invaded or that some claim against another party might
exist.” Id. (quoting Mitchell v. Holler, 429 S.E.2d 793, 795
(S.C. 1993)). “Stated more succinctly, the law does not require
a smoking gun in order for the statute of limitations to

commence.” Id.
To be sure, the doctrine of fraudulent concealment may toll
the statute of limitations in certain circumstances. But “the
affirmative acts of concealment must be calculated to mislead
and hinder a plaintiff from obtaining information by the use of
ordinary diligence, or to prevent inquiry or elude
investigation.” Study v. State, 24 N.E.3d 947, 956 (Ind. 2015)
(quoting Olcott Int’l. & Co., Inc., v. Micro Data Base Sys.,
Inc., 793 N.E.2d 1063, 1072 (Ind. Ct. App. 2003)).
Examining the operative Second Amended Complaint, I can
identify three types of harm alleged for purposes of accrual of
claims. I consider at what point in time claims would have

accrued in Indiana, using Indiana standards. Of course,
statutes from Florida, Kentucky, Michigan, Nevada, North
Carolina, Pennsylvania, and Virginia are still theoretically in
play, since I have left to the side the question of whether any
of these statutes cover claims originating at common law.
However, none of these states would apply a discovery rule
substantially more plaintiff-friendly than Indiana’s.13

13 Florida law is at most no more generous to Plaintiffs than
Indiana law. The Florida Supreme Court has said the delayed
discovery doctrine “generally provides that a cause of action
does not accrue until the plaintiff either knows or reasonably
should know of the tortious act giving rise to the cause of
action.” R.R. v. New Life Cmty. Church of CMA, Inc., 303 So. 3d
916, 921 (Fla. 2020) (citation omitted). The Florida discovery
rule only has a statutory basis for claims of fraud, products
liability, professional and medical malpractice, and intentional
torts based on abuse. Id.
Kentucky’s discovery rule mirrors Indiana’s. Fluke Corp. v.
LeMaster, 306 S.W.3d 55, 60 (Ky. 2010) (“[A] cause of action
will not accrue until the plaintiff discovers (or in the
exercise of reasonable diligence should have discovered) not
only that he has been injured, but also that this injury may
have been caused by the defendant’s conduct.”)
The Michigan Consumer Protection Act is no more generous than
Indiana in terms of discovery; it provides that an action “must
not be brought more than 6 years after the occurrence of the
method, act, or practice that is the subject of the action or
more than 1 year after the last payment in a transaction
involving the method, act, or practice that is the subject of
the action, whichever period of time ends at a later date.”
Mich. Comp. Laws § 445.911(9).
The Nevada Deceptive Trade Practices Act mirrors Indiana’s
discovery rule by providing that “the cause of action shall be
deemed to accrue when the aggrieved party discovers, or by the
exercise of due diligence should have discovered, the facts
constituting the deceptive trade practice.” Nev. Rev. Stat. §
11.190(2)(d).
The North Carolina Deceptive Trade Practices Act provides
simply that claims must be brought within four years of accrual.
N.C. Gen. Stat. § 75-16.2. In general, “this statute commences
when the violations actually occur.” Wood v. S. Carolina Bank &
Trust Co. of the Piedmont, N.A., No. 3:11-CV-00300, 2012 WL
395318, at *2 (W.D.N.C. Feb. 7, 2012). “However, when the
violation of the statute arises out of fraud, the statute of
limitations does not accrue until the unfair or deceptive act is
discovered or should have been discovered,” which mirrors the
Indiana discovery rule. Id.
Pennsylvania’s discovery rule is comparable to Indiana’s. The
limitations period may not begin “until the discovery of the
a. Harm Caused by Law Dosing and Contamination
The first type of harm is said to be caused by some
combination of low dosing and contamination. Both low dosing
and contaminated doses are alleged to have begun in 2009. See
SAC at ¶¶1, 2, 6, 8, 9, 11–15, 17, 18, 20, 22, 24. The
allegations describe news coverage in 2009 about the viral

contamination, SAC at ¶55, Genzyme’s public communications about
the shortage, id. at ¶207, ¶239, ¶273, and communications about
non-viral contaminants, id. at ¶171. Thus, Plaintiffs’ claims
accrued by the end of 2009. This is well before the filing of
the Hochendoner case in the Western District of Pennsylvania on

injury is reasonably possible.” Miller v. Ginsberg, 874 A.2d
93, 97 (Pa. 2005) (quoting Dalrymple v. Brown, 701 A.2d 164, 167
(Pa. 1997)).
The Virginia Consumer Protection Act is no more generous than
Indiana law; it provides that “the right of action shall be
deemed to accrue and the prescribed limitation period shall
begin to run from the date the injury is sustained in the case
of injury to the person or damage to property.” Va. Code Ann.
§ 8.01-230; see Va. Code Ann. § 59.1-204.1. However, “claims
for violation of the Consumer Protection Act that are based upon
any misrepresentation, deception, or fraud shall be deemed to
accrue when such fraud is discovered or by the exercise of due
diligence reasonably should have been discovered.” Skibinski v.
Lunger, No. 06-152, 2006 WL 1571820, at *3 (Va. Cir. Ct. June 7,
2006); see Va. Code. Ann. § 8.01-249. Wrongful death/survival
actions must come within two years after death of the injured
person. Va. Code Ann. § 8.01-244(B). The limitations period
for false advertising is based on the “catch-all” provision and
does not specify a discovery rule. See Parker-Smith v. Sto
Corp., 551 S.E.2d 615, 619 (Va. 2001); Va. Code Ann.
§ 8.01-248.
March 9, 2011, when a subset of plaintiffs asserted claims based
on low dosing and contamination.
b. Harm Caused by Sensitization
The second type of harm is that identified by the Court of
Appeals in Hochendoner II, 823 F.3d at 733-35; the sensitization
harm asserted by Mr. Mooney. That harm is alleged to have

arisen for some plaintiffs upon return to a full dose. It
applies for three named Plaintiffs: Trina Wilkins, Tom
Stanziano, and Damon LaForce (and also Mr. Stanziano’s wife, who
brings a derivative action for loss of consortium). Id. at ¶¶1,
14, 20, 118–19. Their return to full dosage was in 2012, so
accrual would have been by no later than the end of that year.
c. Harm Caused by Fraud
The third type of harm concerns fraud. These allegations
derived from the 2009 contamination. SAC at ¶128–340, 441–71.
Thus, there is a fair argument that plaintiffs should have been
aware of this injury by the end of 2009.14 I acknowledge that,

14 I note here that plaintiffs include in their complaint
internal communications from Genzyme that are quite damning and
show efforts to conceal information. See, e.g., SAC ¶220, ¶229
(showing Genzyme executive wrote to employee “Did we lie to the
[Fabry Stakeholders Working Group?],” a group of physicians and
patient advocates from which Genzyme sought endorsement). The
information being actively concealed, however, was not about
contaminants or vesivirus — or even the limited effectiveness of
low-dose Fabrazyme. Rather, the information being actively
concealed was the likelihood of an extended delay before full
doses would be available. The studies discussed in the
complaint were publicly available, and it would have been
with fraud as alleged, Plaintiffs may have had a more difficult
time recognizing the harm. Nevertheless, even allowing
Plaintiffs the benefit of a generous reading of the doctrine of
fraudulent concealment, their claims would have accrued by the
time the Hochendoner complaint was filed in the Western District
of Pennsylvania on March 9, 2011. In that complaint it was

alleged that Genzyme “expressly or impliedly misrepresent[ed]
that the reduced dose of Fabrazyme® was in accordance with
statutory mandates and efficacious for use,” and “instructed
and/or through knowledge and consent reduced the dose of
Fabrazyme® to dangerous, sub-efficacious and unapproved levels.”
Compl. ¶¶ 71(f), 83(k), Hochendoner v. Genzyme Corp., No. 2:11-
cv-00313 (W.D. Pa. Mar. 9, 2011), ECF No. 1.
d. Summary
To synthesize these conclusions, for purposes of Indiana
law, the low-dose/contaminant-based claims and fraud-based

obvious that a lower dose was sub-optimal. Plaintiffs make only
passing mention of harm coming from this concealment. They say
in the body of their complaint that “[h]ad the true information
about the supply situation been provided to [them] and their
doctors, they would have acted with great urgency in September,
2009 to seek alternative treatment, such as Replagal®, through a
compassionate use exemption or additional Fabrazyme through
private arrangements with other patients and doctors.” SAC
¶299. But they do not otherwise substantiate this point beyond
that conclusory allegation. They do not describe advice from
their doctors or any efforts to obtain a compassionate use
exemption that were reconsidered because of Genzyme’s
statements.
claims likely expired by the end of 2011 and certainly by March
2013. The sensitization claims appear to have expired by the
end of 2014. The fraud claims conceivably expired by the end of
2011 and certainly by March 2013.
Turning to consider statutes of other states, any low-
dose/contaminant-based claims or fraud-based claims under:

• The Florida Deceptive and Unfair Trade Practices Act likely
expired by the end of 2013 and certainly by March 2015.
• The Kentucky Products Liability Act likely expired by the
end of 2012 and certainly by March 2013.
• The Kentucky Consumer Protection Act likely expired by the
end of 2011 and certainly by March 2013.
• The Michigan Product Liability Act likely expired by the
end of 2012 and certainly by March 2014.

• The Michigan Consumer Protection Act likely expired by the
end of 2015 and certainly by March 2017.
• The Nevada Deceptive Trade Practices Act likely expired by
the end of 2013 and certainly by March 2015.
• The Pennsylvania Consumer Protection Act likely expired by
the end of 2015 and certainly by the end of March 2017.
• The Virginia Consumer Protection Act likely expired by the

end of 2011 and certainly by the end of March 2013.
• The Virginia False Advertising Act likely expired by the
end of 2011 and certainly by the end of March 2013.
As for sensitization, I observe Ms. Wilkins is alleged to
be a resident of both Kentucky as well as Indiana. Her Kentucky
Product Liability claim expired by the end of 2013. And her

Kentucky Consumer Protection claim expired by the end of 2014.
The other relevant individuals are Mr. LaForce, who was a
Virginia resident during low-dose treatment, and Mr. Stanziano
and his wife, who are both Florida residents. SAC at ¶¶ 14, 20,
21. Mr. LaForce’s claims under the Virginia Consumer Protection
Act and the Virginia False Advertising Act would have expired by
the end of 2014. Mr. Stanziano’s claim under the Florida
Deceptive and Unfair Trade Practices Act would have expired by
the end of 2016. And any derivative claim for loss of
consortium by his wife, Wendy Stanziano, would have expired by
the end of 2016 as well.
Lastly, the Virginia Wrongful Death/Survival actions raised

by Eddie Viers and Jeanne Wallace do not fit neatly into the
paradigm just employed for the other claims. See SAC at ¶¶ 22,
24. As noted, these claims must be raised within two years of
the deceased’s death. The complaint specifies that Mr. Viers
lost his wife Teresa Viers in September 2019. There is no
information about when Ms. Wallace’s husband Joseph Wallace
died. Based on this information, the complaint is insufficient
as to Ms. Wallace’s claim. However, Mr. Viers’ claim would have
accrued in September 2019 and he would have until September 2021
to bring a claim – a deadline he met, since this lawsuit was
filed in February 2020. Thus, Mr. Viers has the only claim for
Wrongful Death Survival not barred under a statute of limitation
enforced by Indiana.

3. American Pipe Tolling
On a different front, Plaintiffs and Genzyme debate the
applicability of the Supreme Court’s American Pipe tolling
doctrine, which preserves the claims of putative class members
when a class action is filed in court. See generally American
Pipe & Const. Co. v. Utah, 414 U.S. 538 (1974). Although this
debate is interesting, the parties overlook an important
consideration. American Pipe does not by its terms apply where
a court sits in diversity, presiding over state law claims, as I
do now. See Casey v. Merck & Co., 653 F.3d 95, 100 (2d Cir.
2011), certified question answered, 283 Va. 411, 722 S.E.2d 842
(2012). Accordingly, to determine the applicability of American

Pipe tolling, I must consider whether the relevant state courts
have adopted this doctrine, in addition to whether the doctrine
itself fits with the facts. Moreover, I must consider whether
the relevant states would be likely to adopt cross-
jurisdictional tolling – that is, whether they would recognize
any relevant tolling for a class action filed outside of the
state’s courts. Id.
At the outset, I am of the view that American Pipe tolling
is a poor fit for the facts of this case, even assuming the
doctrine applies. The doctrine has continued to introduce
questions as different issues arise in class action litigation.

The First Circuit has acknowledged relatively recent Supreme
Court clarification that “[w]hile a putative class member may
join an existing suit or file an individual action upon denial
of class certification, a putative class member may not commence
a class action anew beyond the time allowed by the untolled
statute of limitations.” In re Celexa & Lexapro Mktg. & Sales
Pracs. Litig., 915 F.3d 1, 16 (1st Cir. 2019) (citing China
Agritech, Inc. v. Resh, 138 S. Ct. 1800, 1807 (2018)). The
First Circuit has even more recently extended this reasoning,
holding that the Supreme Court in China Agritech “effectively
ruled that the tolling effect of a motion to certify a class
applies only to individual claims, no matter how the motion is

ultimately resolved.” Id. at 17. At least one district court
outside the First Circuit has found this reasoning compelling.
See Torres v. Wells Fargo Bank, N.A., No. CV 17-9305 DMG (RAOx),
2019 WL 7169790, at *8 (C.D. Cal. Sept. 27, 2019).
In this case, Plaintiffs argue the class claims have been
tolled. But that is directly at odds with In re Celexa. I am,
of course, not directly bound by the First Circuit on this
issue, but I have no reason to believe Indiana’s courts would
employ American Pipe tolling here.
The state law component to this equation gives all the more
reason to doubt that Plaintiffs can rely on American Pipe. It
appears that “[m]ost states, following the Supreme Court’s

reasoning in American Pipe, have adopted a rule allowing tolling
during the pendency of a class action filed in their own
courts.” In re Fosamax Prod. Liab. Litig., 694 F. Supp. 2d 253,
258 (S.D.N.Y. 2010), aff’d sub nom. Casey v. Merck & Co., 678
F.3d 134 (2d Cir. 2012). But “[o]nly a small fraction of states
have addressed the cross-jurisdictional tolling issue . . . and
there is no clear consensus among them.” Id. “Recognizing the
lack of consensus on the issue and the frequently articulated
concern of forum shopping, federal courts generally have been
disinclined to import cross-jurisdictional tolling into the law
of a state that has not ruled on the issue.” Id.
Although the lower Indiana appellate court has adopted

American Pipe-style tolling as a matter of state law, Ling v.
Webb, 834 N.E.2d 1137, 1141-42 (Ind. Ct. App. 2005), Indiana
courts have not explicitly adopted cross-jurisdictional tolling,
see In re Vioxx Prod. Liab. Litig., 2007 WL 3334339, at *6. For
that reason, federal courts have been wary of assuming Indiana
would recognize such tolling. See id.; see also Shea v. Gen.
Motors LLC, 567 F. Supp. 3d 1011, 1022 (N.D. Ind. 2021); In re
Urethane Antitrust Litig., 663 F. Supp. 2d 1067, 1082 (D. Kan.
2009). But see In re Linerboard Antitrust Litig., 223 F.R.D.
335, 349 (E.D. Pa. 2004) (holding Indiana courts likely would
observe cross-jurisdictional tolling for an antitrust claim).
Given this context and the fact that the doctrine seems

inappropriate in this circumstance, in any event, I find
American Pipe tolling unavailable for plaintiffs.
4. Tolling Agreement
Plaintiffs also contend their claims are preserved by a
tolling agreement. The parties entered into an agreement on May
17, 201715 that provides:
[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 beginning on [May 17, 2017], and Genzyme
agrees it will not assert any defense of statute of
limitations, laches or any similar defense based upon
the passage of time during the term of this Agreement
against the Plaintiffs or members of the putative
class alleged in the Lawsuits.

Tolling Agreement, Mot. for Third Amended Compl., ECF No. 105-1,
Ex. A.
Plaintiffs say this language saves them, but Genzyme points
to the next sentence, which says that “[n]otwithstanding the
foregoing, Genzyme does not waive and expressly reserves the

15 Notably, this date falls after the expiration of all the
claims as found above, except for a wrongful death claim.
right to assert any such defense based upon the passage of time
prior to the effective date of this Agreement or the passage of
time after the termination of this Agreement.” Id. (emphasis
supplied).
This contention presents me with a question of contract
interpretation, as to which I turn to Indiana choice-of-law

principles. In Indiana, “[t]he court will consider all acts of
the parties touching the transaction in relation to the several
states involved and will apply as the law governing the
transaction the law of that state with which the facts are in
most intimate contact.” Nat’l Union Fire Ins. Co. of
Pittsburgh, PA v. Standard Fusee Corp., 940 N.E.2d 810, 814
(Ind. 2010) (emphasis in original) (quoting W.H. Barber Co. v.
Hughes, 63 N.E.2d 417, 423 (Ind. 1945)). There are five types
of contact Indiana courts consider: “(1) the place of
contracting; (2) the place of negotiation of the contract; (3)
the place of performance; (4) the location of the subject matter
of the contract; and (5) the domicile, residence, nationality,

place of incorporation and place of business of the parties.”
Id. Because none of these contacts applies here, and indeed
there is no apparent state with the “most intimate contact” –
this dispute being one that involves plaintiffs from many
different states – I apply Indiana law.
Under Indiana law, “[c]onstruction of the terms of a
written contract is a pure question of law for the court.”
Peoples Bank & Tr. Co. v. Price, 714 N.E.2d 712, 716 (Ind. Ct.
App. 1999). “If the language of the instrument is unambiguous,
the intent of the parties is determined from the four corners of
that instrument,” but if “a contract is ambiguous or uncertain,

its meaning is to be determined by extrinsic evidence and its
construction is a matter for the fact finder.” Id. In general,
“it is . . . appropriate to construe an ambiguous agreement
against its drafter.” Trinity Homes, LLC v. Fang, 848 N.E.2d
1065, 1068 (Ind. 2006). Further, I “should attempt to determine
the intent of the parties at the time the contract was made as
discovered by the language used to express their rights and
duties.” Price, 714 N.E.2d at 717. “The contract is to be read
as a whole when trying to ascertain the intent of the parties.”
Id. I “must accept an interpretation of the contract which
harmonizes its provisions as opposed to one which causes the
provisions to be conflicting.” Id.

I find as an initial matter the tolling agreement
unambiguously preserves the claims that Plaintiffs made in the
Hochendoner I litigation. The contract plainly says 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.” On its face I take this
language to preserve Plaintiff’s claims.
True, the next sentence says that “notwithstanding the
foregoing” Genzyme still has “the right to assert any
[timeliness] defense based upon passage of time prior to the
[May 17, 2017].”

But I must read the contract as a whole. The agreement
also says 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 the agreement recites that the parties’ agreement is in part
“to facilitate the orderly settlement and resolution of the
Plaintiffs’ claims.” Id.
For these provisions to exist in harmony, it would make no
sense for the sentence that Genzyme highlights to drain the
prior sentence of all meaning. Genzyme’s emphasized sentence
makes sense as a clarification that the agreement does not save
any claims not already made. But by the same token the sentence

reads naturally as a preservation of the claims that Plaintiffs
already made in litigation, since that meaning is the one that
would facilitate negotiations between the parties.
Accordingly, I find the tolling agreement preserves
Plaintiffs’ claims. It is then an open question the exact
extent of what is preserved and what Plaintiffs are allowed to
argue in a new action reliant on this tolling agreement. I
address this issue infra in subsection IV.B.6.
5. Indiana Journey’s Account Statute
I turn meanwhile to Indiana’s Journey’s Account statute,
which Plaintiffs say is of further help in saving their claims.
This statute preserves claims after a lawsuit is dismissed in

certain circumstances. The lawsuit cannot have been dismissed
for “negligence in the prosecution of the action,” Ind. Code §
34-11-8-1(a)(1), and the new lawsuit must be filed within three
years after the prior action failed, id. § 34-11-8-1(b)(1). “It
is well settled that in order for the saving power of the
[Journey’s Account Statute] to apply, the decision ending the
previous suit must not have been a decision on the merits.”
Allen v. State, 30 N.E.3d 1280, 1283 (Ind. Ct. App. 2015).
Overall, “[t]he Journey’s Account Statute is designed to ensure
that the diligent suitor retains the right to a hearing in court
until he receives a judgment on the merits. Its broad and
liberal purpose is not to be frittered away by narrow

construction.” Vesolowski v. Repay, 520 N.E.2d 433, 434 (Ind.
1988).
Genzyme argues that statute cannot apply because American
Pipe tolling doctrine makes clear that the right to file a new
class action cannot be tolled. But American Pipe tolling is
irrelevant to the current question. Indiana’s statute is its
own independent method by which claims might be preserved.
Indeed, the statute has been used by a federal court in Indiana
to preserve class claims. Leathermon v. Grandview Mem’l
Gardens, Inc., No. 4:07-CV-137-SEB-WGH, 2011 WL 2445980, at *10
(S.D. Ind. June 15, 2011).
Thus, I move forward and inquire whether Plaintiffs’ suit

would satisfy these requirements. Plaintiffs do not seem to
argue that the statute operated independently to allow for them
to file this suit; they acknowledge that they “had three years
to file a new action” and that the tolling agreement was signed
not long before the statute would have lapsed. [See Opposition
to Motion to Dismiss at 9, ECF No. 108] Specifically, the
Hochendoner/Adamo suit was dismissed with respect to the current
Plaintiffs on May 23, 2016, when the First Circuit released its
ruling in Hochendoner II. See 823 F.3d at 724. The tolling
agreement was signed on May 17, 2017. The window for the
Journey’s Account Statute to operate on its own closed on May
23, 2019. And the lawsuit now before me was filed on February

29, 2020.
The exact role then of the Journey’s Account Statute in
Plaintiffs’ argument is unclear. Plaintiffs argue that Genzyme
seeks for me to deprive them of “the protection of Indiana’s
savings statute and the parties’ tolling agreement.” Their best
theory is seemingly that the statute helped to keep their claims
alive after the dismissal and the tolling agreement locked them
in. I see no Indiana caselaw on the interaction between tolling
agreements and this statute, so I am reluctant to wade into
uncharted, state-patrolled legal waters. I note that Indiana
courts have said the 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.” Hayes v.
Westminster Village N., Inc., 953 N.E.2d 114, 118 (Ind. Ct. App.
2011). This characterization makes the statute seem less like a
broad tolling device and more like a specific mechanism to allow
claims to move forward when a suit has been filed.
Even so, to evaluate Plaintiffs’ arguments thoroughly, I
now will consider how the new complaint maps onto the prior
action and whether it would seem like a permissible extension,
timing aside. First, I address the requirement that there be no
negligence in the prosecution of the action. “Examples of
conduct which would likely be deemed negligence in prosecuting a
case presumably include dismissal for failure to prosecute,

dismissal for failure to comply with the discovery rules,
failure to pay filing fees, and naming the wrong party.”
Dempsey v. Belanger, 959 N.E.2d 861, 866 (Ind. Ct. App. 2011).
“The Journey’s Account Statute’s typical use is to save an
action filed in the wrong court by allowing the plaintiff enough
time to refile the same claim in the correct forum.” Al-Challah
v. Barger Packaging, 820 N.E.2d 670, 672 (Ind. Ct. App. 2005).
Next, I consider the nexus needed between the prior claim
and the new one. The Indiana Supreme Court has emphasized that
“[a] plaintiff invoking the benefit of the [Journey’s Account
Statute] is not required to prove the second complaint is a

‘continuation’ of the first.” Eads v. Cmty. Hosp., 932 N.E.2d
1239, 1245 (Ind. 2010). “The two must assert fundamentally the
same claim, but whether one suit is a ‘continuation’ of another
is the result of meeting the test of subsections, (a) and (b),
not the cause.”16 Id. (emphasis added).
In Eads, the plaintiff sought to bring a medical
malpractice claim after previously bringing a general negligence
claim. Id. In finding the two were “fundamentally the same
claim,” the court noted that “[b]oth complaints allege[d]
identical historical facts and assert[ed]” the same basis for a
claim, specifically the hospital’s failure to ensure the
plaintiff had “a safe means of egress.” Id. The court also

observed that “the source of a medical malpractice claim” was
also “basic tort law” and “[t]here [were] no more legal elements

16 As I have earlier observed in this memorandum, part (a) of the
statute establishes the requirement that the plaintiff was
unsuccessful in the earlier action on the basis of a cause other
than negligence in the prosecution. Ind. Code § 34-11-8-1.
Part (b) establishes when the new action may be brought.
to [the malpractice claim] than there [were] to other negligence
torts.” Id. at 1246 (quoting Burke v. Capello, 520 N.E.2d 439,
441 (Ind. 1988), overruled in part by Vergara v. Doan, 593
N.E.2d 185 (Ind. 1992)); see also Land v. Int’l Bus. Machs.
Corp., 108 F. Supp. 3d 632, 648–49 (S.D. Ind. 2015) (finding
continuation permissible where complaint was “altered” only to

name state entities as defendants, a procedural requirement).
The scenario in Eads may be contrasted with another case in
which the parties changed and elements of the different claims –
a 42 U.S.C. § 1983 claim versus gross negligence – were
demonstrably distinct. Eads, 932 N.E.2d at 1246 (citing McGill
v. Ling, 801 N.E.2d 678 (Ind. Ct. App. 2004)); see also Sutton
v. Scott, 732 F. App’x 482, 483 (7th Cir. 2018) (Mem.) (finding
“suit against the United States [that] sought to rescind [a]
forfeiture” was “not remotely the ‘same claim’” as “a tort
action against one’s lawyers,” who were being sued for their
representation earlier concerning the forfeiture).
I find that the operative Second Amended Complaint before

me is close to satisfying the requirements of the Journey’s
Account Statute (except for the timing component), but I also
find that it differs from that statute’s customary function. On
the one hand, most of the claims are the same and use the same
elements. But on the other hand, entirely new causes of action
have been added (wrongful death/survival; fraud; fraudulent
concealment; breach of fiduciary duty; unjust enrichment), and
the facts have been substantially enhanced.
6. What Is Preserved
As a general proposition, I have found preserved by the
Tolling Agreement Plaintiffs’ claims from the Hochendoner I
litigation — with a possible assist from Indiana’s Journey’s

Account Statute. Thus the question becomes what claims were
actually preserved. Unfortunately, this issue was not addressed
in the briefing.
The key phrase is in the tolling agreement: “[a]ny
applicable statutes of limitations pertaining to any matters
asserted in” the prior lawsuits. The narrowest reading of this
phrase is that precisely the same claims can be brought as were
asserted in the prior action. A slightly more expansive
interpretation — one consonant, to my mind, with the type of
continuation envisioned by Indiana’s Journey’s Account Statute —
is that the same fundamental claims can be brought, with
modifications that address flaws in the earlier action. A more

liberal reading than these initial two interpretations may be
possible, also. The phrase reads “any matters asserted” in the
prior lawsuit. “Matters” could refer not simply to specific
claims but more broadly to the conduct discussed. This
interpretation could open the door to new causes of action that
still focus on the same issues as in the earlier suit.
Given this array of possible meanings, I draw again on
Indiana’s principles for contract interpretation and find that
the meaning on this point is ambiguous. Thus, I am to consider
extrinsic evidence that would shed light on the parties’
agreement, but the current pleadings do not provide any
extrinsic evidence. I conclude then that the meaning of this

part of the tolling agreement would be a factual issue in
dispute, to be resolved at a later stage in this litigation,
with implications for the claims that may be ultimately
successful. See Banknorth, N.A. v. BJ’s Wholesale Club, Inc.,
394 F. Supp. 2d 283, 285-86 (D. Me. 2005) (explaining that
although the defendant may raise meritorious arguments, “they
require factual determinations more appropriately made at
summary judgment or trial” and not on a motion to dismiss).
B. Standing
As the First Circuit advised in an earlier stage of this
litigation, “[t]he heartland of constitutional standing is
composed of the familiar amalgam of injury in fact, causation,

and redressability.” Hochendoner II, 823 F.3d at 731. For this
case, injury and causation are most pertinent.
The injury must be “concrete and particularized and actual
or imminent, not conjectural or hypothetical.” Susan B. Anthony
List v. Driehaus, 513 U.S. 149, 158 (2014) (citations and
quotations omitted). As the First Circuit explained in
addressing Plaintiffs’ prior action, “concrete” means the injury
“actually exist[s]” and “particularized” means a plaintiff has
experienced harm “in a personal and individual way.”
Hochendoner II, 823 F.3d at 731 (quoting Spokeo, Inc. v. Robins,
578 U.S. 330, 339 (2016)). Where, as here, plaintiffs allege a
variety of injuries and “causal chains,” the standing doctrine

requires specific allegations “linking each plaintiff to each of
these injuries.” Id. at 733. Although all alleged injuries may
flow from the same set of facts, “a plaintiff who has been
subject to injurious conduct of one kind” does not “by virtue of
that injury” hold “the necessary stake in litigating conduct of
another kind, although similar, to which he has not been
subject.” Blum v. Yaretsky, 457 U.S. 991, 999 (1982).
For causation, a plaintiff must show that her injury is
“fairly traceable to the challenged conduct of the defendant.”
Sopkeo, 578 U.S. at 338. This “requires the plaintiff to show a
sufficiently direct causal connection between the challenged
action and the identified harm.” Katz v. Pershing, LLC, 672

F.3d 64, 71 (1st Cir. 2012). The connection “cannot be overly
attenuated.” Donahue v. City of Boston, 304 F.3d 110, 115 (1st
Cir. 2002). “Because the opposing party must be the source of
the harm, causation is absent if the injury stems from the
independent action of a third party.” Katz, 672 F.3d at 71-72.
Although Plaintiffs embellish their pleadings from their
initial suit in an attempt to establish standing, they are
unsuccessful, with the exception of four Plaintiffs. Overall,
Plaintiffs improve on showing particularized harm compared with
Hochendoner/Adamo, but none of the harm they successfully show
is fairly traceable to misconduct by Genzyme (again with the

exception of four Plaintiffs). And other harm they allege fails
because it is speculative or insufficiently alleged.
1. Theories of Harm
I can discern five theories of injury in the Second Amended
Complaint:
a. Acceleration Theory
The first is an acceleration theory. This theory posits
that patients received defective Fabrazyme that caused
Plaintiffs’ Fabry symptoms to worsen at a faster pace than would
have occurred with proper Fabrazyme. This theory is analogous
to the acceleration theory in the Hochendoner/Adamo action.
This harm is alleged for almost every Plaintiff. For each of

these Plaintiffs, the complaint says the Plaintiff’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 at least the
following physical injuries, symptoms, and diagnostic criteria.”
See, e.g., SAC at ¶¶1-2. What follows then is a laundry list of
ailments. These allegations do not specify what is meant by
“defective Fabrazyme.” The surrounding sentences refer both to
low dosing and vesivirus-contaminated Fabrazyme.
b. Sensitization Theory
The second is a sensitization theory. This theory posits
that some Plaintiffs (Ms. Wilkins, Mr. LaForce, and Mr.

Stanziano) became sensitized from low doses of Fabrazyme and
consequently experienced dangerous reactions upon returning to
full doses. See id. at ¶¶1, 14, 20. This theory is analogous
to the theory found successful for Mr. Mooney in the
Hochendoner/Adamo action. See Hochendoner II, 823 F.3d at 734-
36.
c. Vesivirus Theory
The third is a vesivirus theory. This theory posits that
the presence of vesivirus in the Fabrazyme doses given to
Plaintiffs caused “vesivirus-induced vesiculating non-
anaphylactic rashes,” as well as an increased “risk of
developing fulminating vesivirus infection, and vesivirus

induced hematological cancer.” See, e.g., SAC at ¶1-2. This
theory is applied to almost every Plaintiff. Plaintiffs allege
generally that Genzyme contaminated its bioreactors – containers
similar to fermentation tanks that are used to produce Fabrazyme
– with vesivirus at some point before July 2009. Id. at ¶42.
Genzyme named the particular strain of vesivirus “2117
(Allston)” for the manufacturing facility where it was detected
(Allston, Massachusetts). Id. at ¶47.
d. Life Expectancy Theory
The fourth is a life expectancy theory. This theory posits
that low doses of Fabrazyme decreased Plaintiffs’ life
expectancy. See, e.g., id. at ¶¶1-2. This theory is also

applied to almost every Plaintiff.
e. Financial Theory
The fifth is a financial theory. This theory posits that
Plaintiffs spent money on medically worthless medication,
worthless “because it was ineffective for treating Fabry disease
and unsafe to administer at the dosage and purity which it was
sold.” See, e.g., id. at ¶¶1-2. This theory is also applied to
almost every plaintiff.
2. Success of the Five Theories of Harm
I now address whether any of the five theories of harm
satisfy the requirements of constitutional standing. Like the
Court of Appeals in Hochendoner II, I find that only the

sensitization theory succeeds.
The acceleration theory fails for insufficiently showing
causation. Plaintiffs’ allegations repeatedly refer to
“defective” Fabrazyme without specifying whether the problem was
dosage or contaminants, a failure which undermines Plaintiffs’
claims. Plaintiffs’ open-ended pleading fails to make
meaningful allegations of causal ties.
Moreover, there is no information to corroborate that any
Plaintiff received a dose contaminated with vesivirus; the link
to be drawn is apparently that Genzyme reported vesivirus at its
plant and Plaintiffs experienced symptoms they claim — with no

particularized allegation — resulted from contamination.
Although the Second Amended Complaint describes distressing
ailments suffered by numerous patients and attempts to connect
them to “defective” doses of Fabrazyme, it does not for any
Plaintiff provide information to show that the symptoms
experienced were the result of “defective” dosing and not simply
the progression of Fabry disease as would have occurred without
the drug and perhaps even at a faster pace. There is no
information from a physician about symptoms or a comparison with
symptom progression before “defective” doses.
The Second Amended Complaint does reference research from
Europe showing that acceleration can occur and that “Europe

banned ‘low-dosing’ entirely and required Genzyme Corporation to
change the label to warn patients of possible acceleration of
the Fabry-disease process.” SAC ¶98-99. And the Second Amended
Complaint states for various Plaintiffs that they have
experienced an acceleration of symptoms due to “defective”
doses. But a study showing that acceleration can occur says
nothing of whether Plaintiffs themselves suffered acceleration.
As the First Circuit made clear in the prior iteration of this
suit, “[n]either conclusory assertions nor unfounded speculation
can supply the necessary heft” to establish standing.
Hochendoner II, 823 F.3d at 731. As pleaded, Plaintiffs only
speculate regarding the cause of their injuries.

The vesisvirus theory fails as well for insufficiently
showing causation. I have explained the weak basis plaintiffs
provide for vesivirus being in a dose they received.
Additionally, the specific symptom they describe for this injury
theory — vesivirus-induced vesiculating non-anaphylactic rashes
— is consistent with known side effects of Fabrazyme.
Plaintiffs simply provide their say-so that these rashes are
from vesivirus. No plaintiff provides any particularized
allegation of a vesivirus diagnosis or of the virus being
detected in their body.
The vesivirus theory also fails for being too speculative,
and the life expectancy theory fails for this reason, too. With

the vesivirus theory, the complaint states baldly that vesivirus
exposure has increased the risk of certain health problems for
Plaintiffs. And with the life expectancy theory, the complaint
states simply that low doses have resulted in a lower life
expectancy. But Article III standing requires showing harm that
is “actual or imminent, not conjectural or hypothetical.” Susan
B. Anthony List, 573 U.S. at 158 (quoting Lujan v. Defens. of
Wildlife, 504 U.S. 555, 560 (1992)). These vague
prognostications in the operative complaint now before me also
are insufficient.
Finally, the financial theory also fails because it is
insufficiently pled to show injury. Plaintiffs spent money on a

medication that they knew would come in a lesser quantity than
what they usually purchased. Their only arguments to show the
medication was worthless are based on conclusory statements that
the doses harmed them in some way. See, e.g., SAC ¶1. But
again, Plaintiffs do not offer any particularized allegation to
show that low doses or a highly speculative contamination of
vesivirus caused them harm. The harm they describe is
consistent with the progression of Fabry disease.
Nevertheless, the sensitization theory of standing
succeeds, as it did before the First Circuit in Hochendoner II.
Plaintiffs plausibly allege that “‘[l]ow dosing’ a protein like
Fabrazyme increases the likelihood that Fabrazyme will induce an

immune response against Fabrazyme itself because the immune
system is more likely to interpret low-dose protein as a
pathogen and become hypersensitive to subsequent injections.”
SAC ¶104. As a result, Mr. LaForce, Mr. Stanziano,17 and Ms.
Wilkins all say they experienced anaphylactic response upon
returning to a full dose. Id. at ¶¶1, 14, 20. The allegations
here mirror the allegations in the prior suit but with some
specificity. And Genzyme does not dispute the success of this
theory for the four remaining plaintiffs in their motion to

dismiss.
IV. CLASS ACTION STATUS
To this point, I have found that the May 2017 tolling
agreement between the parties preserved Plaintiffs’ claims – at
least in some form – but that only four Plaintiffs succeed in
establishing standing, and then on a narrow, idiosyncratic basis
(with one of these Plaintiffs doing so with a derivative loss-
of-consortium claim). To maintain this action as a class action
under Rule 23 requires that the class be “so numerous that
joinder of all members is impracticable.” Fed. R. Civ.
P.23(a)(1). Genzyme has not challenged whether Plaintiffs
satisfy the numerosity requirements. But with only four

Plaintiffs who experienced a very specific type of injury, I
have doubts about whether this suit may proceed on a class

17 Mr. Stanziano’s wife, Ms. Stanziano, also sues through a
derivative loss-of-consortium claim on a surviving sensitization
claim by Mr. Stanziano.
action basis.18 At this point, I will evaluate the claims of
these plaintiffs only on an individual basis.
V. MERITS
I now must address the claims made by Ms. Wilkins, as a
resident of Indiana and Kentucky, Mr. and Ms. Stanziano, as

18 In Rovinelli v. Trans World Entertainment Corporation I
had occasion to address a similar, though not identical,
issue: How and whether to proceed as to state law claims where
“the pleaded matters [were not] properly dealt with through a
class action in federal court.” See No. 19-11304-DPW, 2021 WL
752822, at *1 (D. Mass. Feb. 2, 2021). There I found that the
plaintiffs’ allegations did not provide facts demonstrating
“commonality and predominance that are required to adjudicate
claims as a class action under Fed. R. Civ. [P.] 23.” Id. I
explained that the plaintiffs never had proper jurisdiction in
federal court pursuant to the CAFA, and I struck the class
allegations. Id. at *13. I then considered whether I had
subject matter jurisdiction to proceed with respect to
plaintiffs remaining claims, all brought under state law. Id.
I concluded that I would not exercise supplemental jurisdiction
over the state law claims because the “jurisdictional hook” of
the CAFA was improper, and the amount in controversy was
insufficient for the “ordinary diversity of citizenship
analysis.” Id. at *16.
The current matter presents different circumstances. Genzyme
is a citizen of Massachusetts, whereas the four remaining
Plaintiffs are variously citizens of Indiana, Kentucky, Florida,
and Virginia. In most Counts, Plaintiffs “demand[ed] judgment
against [Genzyme] in an amount in excess of $75,000.00,” and
pleaded both “individually and on behalf of all others similarly
situated.” SAC ¶457 (emphasis added). Although most of
Plaintiffs’ allegations containing injuries have been dismissed
for standing, the remaining allegations, if proven, would likely
have damages that could exceed $75,000.00. Plainly, I cannot
say to a legal certainty that the claim is for less. See
Stewart v. Tupperware Corp., 356 F.3d 335, 338 (1st Cir. 2004)
(explaining that a plaintiff’s allegation of damages “controls”
if it is “made in good faith,” since “[i]t must appear to a
legal certainty that the claim is really for less . . . to
justify dismissal” when challenged (quoting St. Paul Mercury
Indem. Co. v. Red Cab Co., 303 U.S. 283, 288-89 (1938))).
Florida residents, and Mr. LaForce, as a Virginia resident.
Notably, several of these claims — for fraud, fraudulent
concealment, breach of fiduciary duty, and unjust enrichment –
were not brought in the Hochedoner I & II litigation. I
nevertheless address them here. As I explained above, however,
whether these claims can be brought is a matter of factual

dispute involving the meaning of the tolling agreement.
I address first whether the heightened pleading standards
of Fed. R. Civ. P. 9(b) should apply and then examine each claim
through the lens fashioned in that manner. The standing theory
I have found viable – the sensitization theory – is the one
standing theory accepted in Hochendoner II.
A. Rule 9(b) Heightened Pleading Standards
Genzyme contends that all claims in the Second Amended
Complaint “are grounded in allegations of fraudulent,
misleading, or deceptive conduct,” and so they must satisfy Rule
9(b)’s heightened pleading standards.
Genzyme also contends that Plaintiffs’ “fraud claims are

grounded in the same core theory as the rest of their product
liability claims,” and so the fraud claims should be subject to
the two-year statute of applications relevant for product
liability in Indiana.
Plaintiffs apparently agree with Genzyme’s Rule 9(b)
contention and point to the First Circuit’s instruction that
“Rule 9(b)’s heightened pleading requirements apply not only to
claims of fraud simpliciter but also to related claims as long
as the central allegations of those claims ‘effectively charge
fraud.’” Foisie v. Worcester Polytechnic Inst., 967 F.3d 27, 49
(1st Cir. 2020) (quoting Mulder v. Kohl’s Dep’t Stores, Inc.,
865 F.3d 17, 21-22 (1st Cir. 2017)).

Considering the theory of harm before me and how it
interacts with the causes of action, I find Rule 9(b)’s pleading
standards applicable to the denominated fraud claim. At bottom,
though Plaintiffs make many allegations of Genzyme concealing
information in their other claims, those claims are
fundamentally about product liability and Rule 9(b) does not
apply. I will return to a discussion of the fraud denominated
claims in Section V.K. infra.
B. Negligence
The negligence claims asserted by Mr. LaForce and Mr.
Stanziano (and derivatively Ms. Stanziano) fail. See SAC at
¶¶350-352. The negligence claims are brought under theories of

products liability. See, e.g., West v. Caterpillar Tractor Co.,
Inc., 336 So. 2d 80, 84 (Fla. 1976) (“Products liability deals
with recourse for personal injury . . .resulting from the use of
a product and, in the past, has covered actions for negligence.
. . .”). Florida and Virginia both recognize three theories of
negligence for products liability cases: negligent design,
negligent manufacture, and negligent failure to warn.19 Powell
v. Diehl Woodworking Mach., Inc., 198 F. Supp. 3d 628, 633 (E.D.
Va. 2016) (“Virginia law only recognizes three products
liability claims: negligent assembly or manufacture, negligent
design, and failure to warn.”); Ugaz v. Am. Airlines, Inc., 576
F. Supp. 2d 1354, 1374–75 (S.D. Fla. 2008) (“In Florida, a

product may be defective by virtue of a design defect, a
manufacturing defect, or an inadequate warning.”).
“To prove any products liability claim sounding in
negligence, whether negligent design, negligent manufacture, or

19 Plaintiffs seem to allege that Genzyme acted negligently
by “fail[ing] to test or require the testing of the effects of
reducing the dosage of Fabrazyme to unapproved levels.” SAC ¶
351(j.). Florida and Virginia law do not recognize an
independent negligence theory for failure to test a
product. See Horton v. Hoosier Racing Tire Corp., No. 8:15-cv-
1453-T-17TGW, 2015 WL 12859316, at *4 (M.D. Fla. Dec. 15, 2015)
(“Florida courts have refused to recognize an independent claim
for negligent failure to test.”); Powell v. Diehl Woodworking
Mach., Inc., 198 F. Supp. 3d 628, 633–34 (E.D. Va. 2016)
(explaining the same). Rather, failure to test allegations
must “fit [] into one of the traditional theories, or [be]
dismiss[ed] [] altogether.” Powell, 198 F. Supp. 3d at
634. Plaintiffs do not plead this claim as a part of a
recognized negligence claim. Moreover, Plaintiffs do not show
that they received a defective product or that Genzyme did not
test the Fabrazyme they received. Accordingly, this claim
fails.
Additionally, Plaintiffs seem to allege negligence on the
basis of “negligent[] monitor[ing]” and “negligent[]
marketing.” SAC ¶ 351(l.);(o.). Setting aside whether Florida
and Virginia law would recognize these theories of liability in
a negligence products liability claim, Plaintiffs have not
stated a claim based on these allegations because Plaintiffs
fail to show causation.
the negligent failure to provide adequate warnings or
instructions, a plaintiff must establish (1) that the defendant
owed a duty of care toward the plaintiff, (2) that the defendant
breached that duty, (3) that the breach was the proximate cause
of the plaintiff's injury, and (4) that the product was
defective or unreasonably dangerous.” Cooper v. Old

Williamsburg Candle Corp., 653 F. Supp. 2d 1220, 1226 (M.D. Fla.
2009). Plaintiffs cannot meet this burden.
1. Negligent Design Theory

A claim for negligent design requires showing a defect in
the product caused Plaintiffs’ injuries. Wolicki-Gables v.
Arrow Int’l, Inc., 641 F. Supp. 2d 1270, 1287 (M.D. Fla. 2009);
see Dodson v. C.R. Bard, Inc., No. 3:20cv596 (DJN), 2020 WL
7647631, at *5 (E.D. Va. Dec. 23, 2020) (“At minimum,
[p]laintiff must provide some allegation that a design defect
existed and that such a defect proximately caused [p]laintiff’s
injuries.”). Plaintiffs have not clearly alleged a defect. As
I have explained, Plaintiffs seem to allege that the Fabrazyme
was defective due to contaminants or low dosage, supra Section
III.B.1.a.; [SAC ¶¶ 2, 8, 351], but the pleadings are unclear
and such “[a] bare allegation of a ‘defect’ is no more than a
legal conclusion” that is insufficient to state a claim. Ball
v. Takeda Pharms. Am., Inc., 963 F. Supp. 2d 497, 505 (E.D. Va.
2013), aff’d 587 F. App’x 78 (4th Cir. 2014) (per curiam)
(Mem.). Plaintiffs also fail to plead causation. Plaintiffs do
not demonstrate that they ever took “defective Fabrazyme,” and,
as a result, cannot show that “defective Fabrazyme” caused their
alleged injuries.
2. Negligent Manufacture Theory
The negligent manufacture theory fails along the same lines

as the negligent design theory — Plaintiffs do not show a causal
connection between the manufacturing defects they allege
(contamination) and their relevant injuries (sensitization).
Cooper, 653 F. Supp. 2d at 1226; Va. Prac. Tort and Personal
Injury Law § 15:15 (“[A] plaintiff may not recover for damages
in a product liability action absent a legally sufficient causal
link between the alleged wrong and the plaintiff's resulting
damages.”).
3. Failure to Warn Theory
In general, “a manufacturer has a duty to warn its
customers of risks posed by its products.” Higgins v. Forest
Lab’ys, 48 F. Supp. 3d 878, 884 (W.D. Va. 2014). The failure-

to-warn theory, however, fails in the face of the learned
intermediary doctrine, which instructs that a drug
manufacturer’s duty to warn extends to a patient’s physician,
but not to the patient, based on the proposition that a
physician has the expertise to read warning labels and advise
patients. See id. (describing this doctrine in Virginia
courts); Small v. Amgen, Inc., 723 F. App’x 722, 724-25 (11th
Cir. 2018) (per curiam) (explaining the same under Florida law).
Accordingly, a “[p]laintiff must show [it is] more likely than
not the warning to the physician was inadequate and the warning
did not sufficiently inform the prescribing physician about the
risks involved in prescribing the drug.” Chase v. Novartis

Pharm. Corp., 740 F. Supp. 2d 1295, 1297 (M.D. Fla. 2006)
(internal quotations omitted) (applying Florida law); see also
Higgins, 48 F. Supp. 3d at 884-87 (describing doctrine in
similar terms for Virginia).
If a physician is independently aware of a risk associated
with a medication, then the patient has no claim against the
manufacturer, regardless of any warnings provided. See Higgins,
48 F. Supp. 3d at 893 (granting summary judgment on failure-to-
warn claim on these grounds); see also Tillman v. C.R. Bard,
Inc., 96 F. Supp. 3d 1307, 1335 (M.D. Fla. 2015) (“[T]he failure
of the manufacturer to provide the physician with an adequate
warning is not the proximate cause of a patient’s injury if the

prescribing physician had independent knowledge of the risk that
an adequate warning should have communicated.”).
Plaintiffs’ allegations in this matter are thus
insufficient to support a failure-to-warn claim. Although
Plaintiffs allege that Genzyme “failed to provide adequate
warnings, cautions, and directions concerning the dangers and
limitations of the ‘low dose’ of Fabrazyme” and “expressly and
impliedly misrepresent[ed] that injection with Vesivirus-
containing Fabrazyme is harmless,” SAC ¶¶351(k.), they have not
provided any allegation about what their doctors knew or what
they advised, let alone the warnings that Genzyme provided.
C. Negligence Per Se

Mr. LaForce and Mr. Stanziano (and derivatively Ms.
Stanziano) also make claims for negligence per se. Mr.
LaForce’s claim fails because the relevant provision of Virginia
law he cites, Va. Code Ann. § 54.1-3461 et seq., applies to
adulterated products, while the viable standing theory
identified in Hochendoner II is not based on adulteration. See
823 F.3d at 732-33. The Stanzianos’ claims fail because they do
not identify what portions, if any, of Florida law Genzyme
violated. See SAC at ¶352 n.10. In Plaintiffs’ narrative
Opposition to Genzyme’s Motion to Dismiss, Mr. Stanziano says
his claim is “based on the violations of the Florida Pure Food
and Drug Acts,” but he does so without specifying what provision

of the Florida law Genzyme violated. Accordingly, the
Stanzianos fail to state a claim because they do not specify
that there was a “violation of a statute which establishes a
duty upon a party to take precautions to protect a particular
class of persons from a particular injury or type of injury.”
Hesterly v. Royal Caribbean Cruises, Ltd., 515 F. Supp. 2d 1278,
1287 n.6 (S.D. Fla. 2007).
D. Strict Liability
Mr. LaForce’s claim for strict liability stumbles at the
threshold because, as he admits, Virginia does not permit strict
product liability claims. See Harris v. T.I. Inc., 413 S.E. 2d

605, 609-10 (Va. 1992).
The Stanzianos’ strict liability claims fail more
particularly because any claim based on failure to warn cannot
avoid the learned intermediary doctrine, as described above, and
they do not demonstrate a causal connection between any alleged
defect in the Fabrazyme Mr. Stanziano actually received and his
injury. In Florida, to make a claim against a manufacturer “on
the theory of strict liability tort, the user must establish the
manufacturer’s relationship to the product in question, the
defect and unreasonably dangerous condition of the product, and
the existence of a proximate causal connection between such
condition and the user’s injuries or damage.” Siemens Energy &

Automation, Inc. v. Medina, 719 So.2d 312, 315 (Fla. Dist. Ct.
App. 1998) (emphasis added) (quoting West v. Caterpillar Tractor
Co., 336 So.2d 80, 87 (Fla. 1976)).
E. Breach of Warranty
1. Claims for Breach of Implied Warranties
Mr. LaForce and the Stanzianos bring claims for breach of
implied warranties of merchantability or fitness. SAC ¶362.
The claims for breach of implied warranty of merchantability
fail because Mr. LaForce and the Stanzianos show no defect in
the Fabrazyme actually received. See Fla. Stat. § 672.314
(defining in relevant part that merchantable good is “fit for
the ordinary purposes for which such goods are used”); Va. Code

Ann. § 8.2-314 (same); see also Egbebike v. Wal-Mart Stores E.,
LP, No. 3:13-cv-865-J-34MCR, 2014 WL 3053184, at *6 (M.D. Fla.
July 7, 2014) (requiring plaintiff to prove that there is a
defect in the product to sustain a claim for breach of implied
warranty of merchantability for defective product under Florida
law).
The Stanzianos’ claims for breach of implied warranty of
merchantability and fitness also fail because they do not
adequately allege how Mr. Stanziano was in privity with Genzyme.
See Cruz v. Mylan, Inc., No. 8:09-CV-1106T17-EAJ, 2010 WL
598688, at *2 (M.D. Fla. Feb. 17, 2010). Although the complaint
states Mr. Stanziano “was in privity with Genzyme throughout his

treatment with his Genzyme case coordinator as well as being
registered in the Genzyme sponsored Fabry Registry,” the
complaint does not allege that he and Genzyme had a buyer-seller
relationship. See id. (“A plaintiff who purchases a product,
but does not buy it directly from the defendant, is not in
privity with that defendant” (quoting T.W.M. v. Am. Med. Sys.,
Inc., 886 F. Supp. 842, 844 (N.D. Fla. 1995).); cf. id.
(recognizing exceptions to this rule for express warranties, but
not implied warranties, where a buyer has an extensive
relationship with a manufacturer).
Mr. LaForce’s claim for breach of implied warranty of
fitness also fails. First, Virginia’s statute refers

specifically to a “buyer” and a “seller,” but Genzyme did not
sell directly to Mr. LaForce. I do recognize that it is not
completely clear from Virginia caselaw if these facts on their
own bar Mr. LaForce from bringing this claim. See Bayliner
Marine Corp. v. Crow, 509 S.E.2d 499, 503 (Va. 1999) (seemingly
not barring on this ground a claim brought by a buyer against a
manufacturer, where purchase was made through an exclusive
dealer). But second, if the claim is not barred for lack of
direct sales relation, it still would fail because Plaintiffs
must prove that Genzyme “at the time of contracting [had] reason
to know” a “particular purpose for which the goods [were]
required and that [the plaintiffs] [] rel[ied] on [Genzyme’s]

skill or judgment to select or furnish” the Fabrazyme. See Va.
Code Ann. § 8.2-315. Neither Mr. LaForce nor the Stanzianos
have pled this sufficiently because they do not explain how
Genzyme would have perceived their reliance when Genzyme would
necessarily have understood that Fabrazyme patients made
decisions under the care of a physician.
2. Claims for Breach of Expressed Warranty
The claims for breach of express warranty fail because
neither Mr. LaForce nor the Stanzianos trace their injuries to
any specified breaches of an express warranty. The complaint
alleges:
[1] [Genzyme] expressly warranted in the Fabrazyme
product insert that Fabrazyme reduces
globotriaosylceramide deposition in capillary
endothelium of the kidney and certain other cell
types, despite never having tested whether the product
at these doses was efficacious and having observed
that such dosing does not reduce such deposition; . .
.

[2] [Genzyme] expressly warranted in the Fabrazyme
product insert that Fabrazyme is indicated for use to
treat Fabry disease, despite never having obtained FDA
approval for using ‘low dose’ for such an indication;
. . .

[3] in affirmatively representing that the drug given
at full dosage would be sold to citizens at various
dates, but breached such promises repeatedly since
June 2009; . . .

[4] in expressly and impliedly warranting that a “low
dose” of Fabrazyme was approved for use by the FDA and
efficacious for use in the treatment of Fabry disease;
. . .

[5] in expressly and impliedly misrepresenting that
injection with vesivirus-containing Fabrazyme is
harmless, non-immunogenic, without impact on the
efficacious treatment of Fabry disease with Fabrazyme,
even though no medical testing had ever been
undertaken to establish the objective truth of such
material medical claims and further concealing
previously published medical literature rendering such
statements regarding medical safety of vesivirus
injection as false.

SAC at ¶¶362(a), 362(b), 362(m), 362(n), 362(q).
Causation is an essential element for a breach of warranty
claim. See 77A C.J.S. Sales § 484. But the plaintiffs do not
show how the breach of any such warranties led to their
anaphylactic reactions upon returning to a full dose.
Additionally, with the exception of the third and fifth
enumerated items, Plaintiffs do not sufficiently establish that

Genzyme made these warranties. I addressed similar allegations
in Hochendoner I and noted that the language that Plaintiffs
cited from the package insert contained “dosing directions,
indicating the dosage at which the FDA [had] approved Fabrazyme®
and in the context of which the ‘Indications and Usage’
statement must be read.” Hochendoner I, 95 F. Supp. 3d at 32.
“Nowhere does the package insert state that a lower dosage would
be as efficacious for use in the treatment of Fabry disease as
the dose recommended on the packaging and by the FDA. Nowhere
does the package insert state that a lower dosage is FDA-
approved.” Id.

F. Florida Deceptive and Unfair Trade Practices
Despite Mr. Stanziano claiming financial injury in addition
to personal injury, I have only found viable his standing theory
based on personal injury. Thus, the Stanzianos’ claims under
the Florida Deceptive and Unfair Trade Practices Act fails
because the law “expressly states that it ‘does not apply to . .
. [a] claim for personal injury.” Echols v. RJ Reynolds Tobacco
Co., No. 13-cv-14215, 2014 WL 5305633, at *5 (S.D. Fla. Oct. 15,
2014) (quoting Fla. Stat. § 501.212(3)) (dismissing claim
because damages sought for personal injury).
G. Indiana Product Liability Act and Kentucky Product
Liability Act

Ms. Wilkins’ claims under the Indiana Product Liability Act
and the Kentucky Product Liability Act fail for reasons similar
to those that render the negligence product liability claims of
the Stanzianos and Mr. LaForce inadequate.
Like Florida and Virginia, Indiana and Kentucky recognize
product liability claims based on manufacturing defects, design
defects, and failures to warn. See Brewer v. PACCAR, Inc., 124
N.E.3d 616, 621 (Ind. 2019); Clark v. Hauck Mfg. Co., 910 S.W.2d
247, 251 (Ky. 1995) (Barker, J.), overruled on other grounds by
Martin v. Ohio Cnty. Hosp. Corp., 295 S.W.3d 104 (Ky. 2009).
A manufacturing defect claim will fail for lack of
causation. Jarrett v. Wright Med. Tech., Inc., No. 1:12-cv-
00064-SEB-DML, 2021 WL 4307026, at *8 (S.D. Ind. Sept. 22,
2021); Red Hed Oil, Inc. v. H.T. Hackney Co., 292 F. Supp. 3d
764, 773 (E.D. Ky. 2017) (“Regardless of the theory a plaintiff
pursues, he must show causation in a products liability case.”).
As for a design defect claim, like Mr. LaForce and the
Stanzianos, Ms. Wilkins does not specify in the Second Amended
Complaint a theory of design defect under either Indiana law or
Kentucky law. Under Indiana law, plaintiffs bringing a products
liability claim based on an alleged design defect “must
establish that the manufacturer or seller failed to exercise
reasonable care under the circumstances of designing the
product.” TRW Vehicle Safety Sys., Inc. v. Moore, 936 N.E.2d
201, 209 (Ind. 2010) (emphasis added) (quoting Ind. Code § 34-

20-2-2). Kentucky law requires “establish[ing] existence of an
alternative, safer design that is practical under the relevant
circumstances.” Primal Vantage Co., Inc. v. O’Bryan,
__S.W.3d__, 2022 WL 3641122, at *12 (Ky. Aug. 18, 2022) (Minton,
C.J.). But see Kaiser v. Johnson & Johnson, 947 F.3d 996, 1014
(7th Cir. 2020) (explaining that Indiana law does not require
proof of an alternative design, though it “can be relevant to
design-defect liability”).
In her narrative opposition to Genzyme’s motion to dismiss
her Kentucky claim, Ms. Wilkins does say that she shows a design
defect “in that Fabrazyme is a pharmaceutical and therefore
Genzyme is strictly liable for the effects of vesivirus and

particulates on [her] vesivirus infection and her inflammation
and her accelerated disease process.” And she says further
“[t]he product was defectively designed in that it was
administered at ‘low’ dose which makes it impossible to treat
Fabry disease.” These allegations do not state a claim under
either Indiana or Kentucky law. The first point she makes is
off the mark because what she really alleges is a manufacturing
defect, and in any event that claim fails for causation. The
second point fails as well because although low-dose Fabrazyme
may be less effective than full dose – as was certainly known to
patients and their doctors – the complaint does not show that
low-dose Fabrazyme “makes it impossible to treat Fabry disease.”

The failure-to-warn claims fail because of the learned
intermediary doctrine in both Kentucky and Indiana, in the same
way the claims brought by Mr. LaForce and Mr. Stanziano fail
under Florida and Virginia law. See Larkin v. Pfizer, Inc., 153
S.W.3d 758, 762-770 (Ky. 2004) (describing and adopting the
doctrine); Ortho Pharm. Corp. v. Chapman, 388 N.E.2d 541, 548
(Ind. Ct. App. 1979) (“[A] manufacturers [sic] duty to warn
extends only to the medical profession, and not the ultimate
users.”).
H. Kentucky Consumer Protection Act
The Kentucky Consumer Protection Act prohibits “[u]nfair,
false, misleading, or deceptive acts or practices in the conduct

of any trade or commerce.” Ky. Rev. Stat. Ann. § 367.170. To
prove a violation of the Act, a plaintiff must show that they
“(1) purchase[d] or lease[d] goods or services (2) for personal,
family or household purposes and (3) [was] injured as a result
of a seller’s prohibited practice or act.” Simpson v. Champion
Petfoods USA, Inc., 397 F. Supp. 3d 952, 961 (E.D. Ky. 2019)
(Bertelsman, J.).
Genzyme says that Ms. Wilkins’s claim under the Kentucky
Consumer Protection Act “fails as a matter of law because [she]
has not sufficiently alleged that she purchased Fabrazyme
directly from Genzyme such that she was in privity with

Genzyme.” Genzyme also says that, even if she did show she was
in privity, her claim would fail because it is inadequately
alleged.
As to the first argument, the Second Amended Complaint says
that Ms. Wilkins “was in privity with Genzyme throughout her
treatment with her Genzyme case care coordinator as well as
being registered in the Genzyme sponsored Fabry Registry.” SAC
at ¶1. While the complaint does not show explicitly a buyer-
seller relationship, Kentucky allows an exception where
“‘express warranties were clearly intended for the product’s
consumers,’ even if the warranties did not ‘expressly state that
they run directly to the intended consumers.’” Yonts v. Easton

Tech. Prods., Inc., 676 F. App’x 413, 420 (6th Cir. 2017)
(quoting Naiser v. Unilever U.S., Inc., 975 F. Supp. 2d 727,
739-40 (W.D. Ky. 2013)). However, this exception does not
extend to implied warranties. See Naiser, 975 F. Supp. 2d at
739 (observing, in deciding to recognize exception to privity
rule involving an express warranty, that the most recent
Kentucky Supreme Court decision not to find an exception
involved an implied warranty).
Thus, to the extent this exception applies, Ms. Wilkins
might be able to make an argument based on express warranties.
But this argument fails based on causation, for the same reasons
identified in discussing the warranty claims brought by Mr.

LaForce and the Stanzianos. “The breach of the express warranty
must have caused the injury,” Ky. Prod. Liab. L. § 6:2, which
Ms. Wilkins does not demonstrate.
I. Virginia Consumer Protection Act
Mr. LaForce may not bring a claim under the Virginia
Consumer Protection Act, because sales of Fabrazyme are
regulated by the U.S. Food and Drug Administration. The Act
does not apply to “[a]ny aspect of a consumer transaction which
aspect is authorized under laws or regulations of this
Commonwealth or the United States, or the formal advisory
opinions of any regulatory body or official of this Commonwealth
or the United States.” Va. Code Ann. § 59.1-199(A). Thus, for

example, a federal court has found that plaintiffs could not sue
a company for representations made “in advertisements and other
marketing materials concerning the safety and effectiveness” of
a medical device, because regulations about the device were
“authorized and regulated by the FDA under federal law.” Ali v.
Allergan USA, Inc., No. 12-cv-115, 2012 WL 3692396, at *19 (E.D.
Va. Aug. 23, 2012).
J. Virginia False Advertising Act
Mr. LaForce’s claim under the Virginia False Advertising
Act fails for the same reason I found inadequate a claim under
the Act in Hochendoner I. As I explained there, “[u]nder Va.

Code § 59.1–68.3, a plaintiff may bring a claim for losses
resulting from an ‘untrue, deceptive or misleading’ ‘promise,
assertion, representation, or statement of fact’ in an
advertisement.” Hochendoner I, 95 F. Supp. 3d at 33 n.13
(quoting Va. Code Ann. § 18.2–216). But Mr. LaForce has not
sufficiently “alleged that Genzyme made any untrue or deceptive
statements regarding the efficacy of Fabrazyme® at a lower
dosage.” See id.
K. Fraud and Fraudulent Concealment
The fraud claims asserted by Mr. LaForce and the Stanzianos
fail because they cannot trace the harm they experienced to
information that Genzyme is alleged to have withheld

intentionally. I note that here Rule 9(b)’s heightened pleading
requirements apply in full force. See supra Section V.A.
The elements of fraud in Florida are: “(1) a false
statement concerning a material fact; (2) the representor’s
knowledge that the representation is false; (3) an intention
that the representation induce another to act on it; and (4)
consequent injury by the party acting in reliance on the
representation.” Butler v. Yusem, 44 So. 3d 102, 105 (Fla.
2010) (per curiam) (emphasis added) (quoting Johnson v. Davis,
480 So.2d 625, 627 (Fla. 1985)). The elements in Florida for
fraudulent concealment are similar.20
In Virginia, a plaintiff bringing a fraud action “bears the

burden of proving by clear and convincing evidence” these
elements: “(1) a false representation, (2) of a material fact,
(3) made intentionally and knowingly, (4) with intent to
mislead, (5) reliance by the party misled, and (6) resulting
damage to the party misled.” Richmond Metro. Auth. v. McDevitt
St. Bovis, Inc., 507 S.E.2d 344, 346 (Va. 1998) (emphasis added)
(quoting Evaluation Rsch. Corp. v. Alequin, 439 S.E.2d 387, 390
(Va. 1994)). Virginia does not have a separate cause of action
for fraudulent concealment, though “[c]oncealment of a material
fact by one who knows that the other party is acting upon the
assumption that the fact does not exist constitutes actionable

20 A claim for fraudulent concealment in Florida must show (1)
the defendant “concealed or failed to disclose a material fact”;
(2) the defendant “knew or should have known the material fact
should be disclosed”; (3) the defendant “knew [its] concealment
of or failure to disclose the material fact would induce the
plaintiffs to act”; (4) the defendant “had a duty to disclose
the material fact”; and (5) “the plaintiffs detrimentally relied
on the misinformation.” Hess v. Philip Morris USA, Inc., 175
So. 3d 687, 691 (Fla. 2015) (emphasis added) (quoting R.J.
Reynolds Tobacco Co. v. Martin, 53 So.3d 1060, 1068 (Fla. Dist.
Ct. App. 2010)).
fraud.” Bank of Montreal v. Signet Bank, 193 F.3d 818,827 (4th
Cir. 1999) (quoting Allen Realty Corp. v. Holbert, 318 S.E.3d
592, 597 (Va. 1984)). “In all cases of fraud [under Virginia
law] the plaintiff must prove that it acted to its detriment in
actual and justifiable reliance on the defendant’s
misrepresentation (or on the assumption that the concealed fact

does not exist).” Id.
Thus, Plaintiffs must allege some form of injury that
resulted from them relying on Genzyme’s alleged false statements
or concealment. They do not do so. The only information that
Plaintiffs can plausibly show Genzyme concealed was that the
Fabrazyme shortage would last longer than initially forecast.
As I observed earlier at footnote 14 in this Memorandum,
Plaintiffs say at paragraph 299 of the complaint that “[h]ad the
true information about the supply situation been provided to
[them] and their doctors, they would have acted with great
urgency in September, 2009 to seek alternative treatment, such
as Replagal®, through a compassionate use exemption or

additional Fabrazyme through private arrangements with other
patients and doctors.” SAC ¶299. But Plaintiffs do not plead
with any particularity how they relied on Genzyme’s statements
in deciding not to pursue alternative treatment, arrangements,
or a compassionate use exemption. They do not allege, for
example, any communications involving their medical providers
that they actually reconsidered due to Genzyme’s statements.
L. Breach of Fiduciary Duty
The claims brought by Mr. LaForce and the Stanzianos for
breach of fiduciary duty fail because they do not establish a
fiduciary duty between Genzyme and customers taking Fabrazyme.

In Florida, “[c]ourts have found a fiduciary relation
implied in law when ‘confidence is reposed by one party and a
trust accepted by the other.’” Cap. Bank v. MVB, Inc., 644 So.
2d 515, 518 (Fla. Dist. Ct. App. 1994) (quoting Dale v.
Jennings, 107 So. 175, 179 (Fla. 1925)). “A fiduciary
relationship must be established by competent evidence, and the
burden of proving such a relationship is on the party asserting
it.” Orlinsky v. Patraka, 971 So.2d 796, 800 (Fla. Dist. Ct.
App. 2007). “[A] party must allege some degree of dependency on
one side and some degree of undertaking on the other side to
advise, counsel, and protect the weaker party.” Orlinsky, 971
So. at 800 (Fla. Dist. Ct. App. 2007) (quoting Watkins v. NCNB

Nat’l Bank of Fla., N.A., 622 So.2d 1063, 1065 (Fla. Dist. Ct.
App. 1993)).
In Virginia, “there is a fiduciary relationship ‘when
special confidence has been reposed in one who in equity and
good conscience is bound to act in good faith and with due
regard for the interests of the one reposing the confidence.’”
Allen Realty Corp. v. Holbert, 318 S.E.2d 592, 595 (Va. 1984)
(quoting H–B P’ship v. Wimmer, 257 S.E.2d 770, 773 (Va. 1979)).
“[T]o establish breach of a fiduciary duty, a plaintiff must
show that (1) the defendant owed a fiduciary duty (2) the
defendant breached that duty and (3) damages resulted from the
breach.” Tech Sys., Inc. v. Pyles, 630 F. App’x 184, 187 (4th

Cir. 2015) (per curiam).
Plaintiffs mention a few features of their relationship
with Genzyme to show the company owed them a fiduciary duty.
First, they say Genzyme “maintained and still maintains a close
personal relationship with Plaintiffs, including monitoring
their health both through individual case managers and through
the Fabry registry clinical trial.” SAC at ¶474. Second,
“[w]hen a shortage of Fabrazyme was imminent, Genzyme undertook
to create a body of experts for reviewing the effectiveness and
safety of ‘low-dose’ Fabrazyme which included doctors and
employees of Genzyme.” Id. at ¶475. Third, Genzyme “created
further fiduciary duties by affirmatively undertaking to

‘protect the most vulnerable patients’ who were the American
Fabry patients and then telling each individual plaintiff that
it would protect them even though Genzyme knew that Americans
did not have free-market access to Replagal.” Id. at ¶477.
The relationship between Genzyme and Fabry patients may
appear closer than a standard relationship between a
manufacturer and a consumer, but I do not find that Florida or
Virginia would recognize this to be a fiduciary relationship.
The complaint does not say where the statements attributed to
Genzyme about protecting vulnerable patients come from. More
importantly, patients still saw their own doctors and would
necessarily have known they were dealing with a private company.

As discussed above, Florida and Virginia both follow the
doctrine of the learned intermediary. The assumption in these
states appears to be that a patient relies on her doctor when
making medical decisions, not the manufacturer.
M. Unjust Enrichment
The unjust enrichment claims that Mr. LaForce and the
Stanzianos bring against Genzyme also fail.
In Florida, the elements for an unjust enrichment action
are: “(1) plaintiff has conferred a benefit on the defendant,
who has knowledge thereof; (2) defendant voluntarily accepts and
retains the benefit conferred; and (3) the circumstances are
such that it would be inequitable for the defendant to retain

the benefit without first paying the value thereof to the
plaintiff.” Agritrade, LP v. Quercia, 253 So.3d 28, 33 (Fla.
Dist. Ct. App. 2017) (quoting Peoples Nat’l Bank of Com. v.
First Union Nat’l Bank of Fla., 667 So.2d 876, 879 (Fla. Dist.
Ct. App. 1996)). “Equitable” is meant to reference the idea of
fairness “and does not mandate that unjust enrichment be
construed as seeking only an equitable, as opposed to a legal,
remedy.” Duty Free World, Inc. v. Miami Perfume Junction, Inc.,
253 So.3d 689, 694 (Fla. Dist. Ct. App. 2018).
In Virginia, the elements of an unjust enrichment claim
are: “(1) [the plaintiff] conferred a benefit on [the
defendant]; (2) [the defendant] knew of the benefit and should

reasonably have expected to repay [the plaintiff]; and (3) [the
defendant] accepted or retained the benefit without paying for
its value.” Schmidt v. Household Fin. Corp., II, 661 S.E.2d
834, 838 (Va. 2008). The doctrine “effects a ‘contract implied
in law’ requiring one who accepts and receives goods, services,
or money from another to make reasonable compensation for those
services.” James G. Davis Constr. Corp. v. FTJ, Inc., 841
S.E.2d 642, 647 (Va. 2020). “Typical examples of unjust
enrichment involve a payment or overpayment under a mistake of
fact . . . or the acceptance of services without a contract for
those services.” Id. (internal citation omitted).
Mr. LaForce and the Stanzianos say this doctrine applies

because “it would be unjust to allow Genzyme to retain the
monies it charged” for low-dose Fabrazyme, when it knew the low
doses sold were “ineffective and dangerous.” SAC at ¶484. They
say “[t]he scale and level of deception is so unconscionable
that restitution to the individual Plaintiffs and disgorgement
of the entire monies derived from the sale of ‘low-dose’ and
[v]esivirus contaminated Fabrazyme is required in equity.” Id.
at ¶485.
This argument is unpersuasive. As I discussed in relation
to the financial standing issue, Plaintiffs have not shown that
what they received from Genzyme was something of lesser value
than what they intended to purchase or that they were operating

“under a mistake of fact” as to what they would receive. Cf.
Hochendoner I, 95 F. Supp. 3d at 32 (observing, in discussing an
argument on warranties, “[a] shop owner does not warrant that
one cup of sugar (the only cup in stock) will make as sweet a
cake as the two cups of sugar for which the recipe calls”).
Under the sensitization theory, Plaintiffs may have been harmed
by the product, but that is an issue for tort law.
N. Loss of Consortium
Ms. Stanziano’s loss of consortium claim fails because it
is derivative of Mr. Stanziano’s claims, which as indicated in
this general discussion I will dismiss. See Gates v. Foley, 247
So.2d 40, 45 (Fla. 1971) (explaining that loss of consortium “is

a derivative right and [wife] may recover only if her husband
has a cause of action against the same defendant”).
VI. THIRD AMENDED COMPLAINT
Having found Plaintiffs’ Second Amended Complaint
inadequate, even incorporating the new information asserted in
the proposed Third Amended Complaint, I will deny the request to
file a Third Amended Complaint because doing so would be futile
in light of the shortcomings identified for dismissing the
Second Amended Complaint.
VII. CONCLUSION
For the reasons set forth above, Genzyme’s Motion [ECF No.
102] to Dismiss is GRANTED with respect to all claims made by

Plaintiffs. All claims are dismissed without prejudice, except
for the claims I address on the merits, which are claims
asserted by Mr. LaForce, Mr. Stanziano, Ms. Stanziano, and Ms.
Wilkins concerning harm they experienced due to sensitization to
Fabrazyme. I DENY as futile the Motion [ECF No. 105] to file a
Third Amended Complaint.

/s/ Douglas P. Woodlock_______
DOUGLAS P. WOODLOCK
UNITED STATES DISTRICT JUDGE

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Source: Frix Law Library, https://www.frixlaw.com/law-library/cases/10200535. Public record. Not legal advice.