WILKINS v. GENZYME CORPORATION

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