WILKINS v. Genzyme Corp.

Decision Date14 September 2022
Docket NumberCivil Action 21-10023-DPW
PartiesTRINA WILKINS, ET AL, Plaintiffs, v. GENZYME CORPORATION, Defendant.
CourtUnited States District Courts. 1st Circuit. United States District Courts. 1st Circuit. District of Massachusetts
MEMORANDUM AND ORDER

DOUGLAS P. WOODLOCK, UNITED STATES DISTRICT JUDGE.

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.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 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,...

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