Hochendoner v. Genzyme Corp.
95 F. Supp. 3d 15
D. Mass.2015Background
- Genzyme is sole U.S. supplier of Fabrazyme, the only FDA-approved enzyme replacement for Fabry disease; manufacturing problems beginning in 2009 caused significant shortages.
- Genzyme implemented a rationing program (initially 30% then 50% of recommended 1 mg/kg biweekly dose) and at times denied newly diagnosed patients access.
- Plaintiffs (Fabry patients and spouses from multiple states) allege harms from reduced doses: return of symptoms, accelerated disease, and injuries from alleged contaminated vials.
- Plaintiffs brought consolidated suits raising 18–35 counts across state tort, consumer-protection, product-liability, warranty, Bayh–Dole Act, and third-party-beneficiary contract theories.
- Genzyme moved to dismiss; the Court applied Rule 8 and Rule 12(b)(6) standards and dismissed all claims for failure to state a claim.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether reduced dosing / rationing claims satisfy Rule 8 notice | Plaintiffs: reduced dose diminished efficacy causing return/progression of disease (and some claim accelerated deterioration and particulate injuries) | Genzyme: Complaints are vague about which plaintiffs suffered which specific injuries | Court: Adequately pleaded only the generalized claim that reduced dosing caused return/progression of disease; claims of accelerated deterioration and particulate-caused injury dismissed for lack of notice |
| Whether Bayh–Dole Act creates a private right of action | Plaintiffs: Bayh–Dole’s purpose implies private remedy to prevent nonuse/unreasonable use of federally funded inventions | Genzyme: Statute contains no rights-creating language; provides administrative ‘march-in’ remedy instead | Court: No implied private right; Bayh–Dole’s structure and remedial scheme preclude judicially created private remedy — dismissed |
| Whether Genzyme owed tort duties to produce sufficient drug (negligence, strict liability, negligence per se) | Plaintiffs: Genzyme’s rationing harmed patients; state torts should recognize duty to supply medication | Genzyme: No precedent or state-law basis imposing a duty to meet market demand; recognizing one would improperly expand state tort law | Court: Declined to create new common-law duty to manufacture sufficient patented medication; tort claims dismissed |
| Whether consumer-protection, product-liability, and warranty statutes cover failure to produce sufficient non-defective product | Plaintiffs: Statutes and doctrines apply to Genzyme’s alleged misrepresentations, unfair practices, and product harms from rationing | Genzyme: Statutes target deceptive practices or defective products/labels/warnings; nonprovision of sufficient quantity is not covered | Court: Dismissed consumer-protection and product-liability claims; warranty claims implausible because package insert did not promise efficacy at lower doses |
| Whether plaintiffs are third-party beneficiaries of Mt. Sinai–Genzyme license | Plaintiffs: License recital indicates intent to make drug available to Fabry patients | Genzyme: Recitals cannot create enforceable third-party rights absent operative contract terms | Court: Recital alone insufficient to establish third-party-beneficiary status; contract-based claims dismissed |
| Derivative claims (loss of consortium) | Spouses: derivative harms from underlying patient claims | Genzyme: Underlying claims fail | Court: Loss of consortium dismissed because all underlying claims dismissed |
Key Cases Cited
- Ashcroft v. Iqbal, 556 U.S. 662 (2009) (pleading must state a plausible claim to relief)
- Bell Atl. Corp. v. Twombly, 550 U.S. 544 (2007) (Twombly plausibility standard for complaints)
- Swierkiewicz v. Sorema, 534 U.S. 506 (2002) (notice pleading and discovery role)
- Alexander v. Sandoval, 532 U.S. 275 (2001) (private right of action must be created by Congress)
- Gonzaga Univ. v. Doe, 536 U.S. 273 (2002) (statutory rights-creating language required for private enforcement)
- Van Dusen v. Barrack, 376 U.S. 612 (1964) (choice-of-law rules after §1404(a) transfer)
- Ferens v. John Deere Co., 494 U.S. 516 (1990) (venue-transfer choice-of-law principles)
- Hoffman v. Blaski, 363 U.S. 335 (1960) (limitations on a transferee court’s adjudicative authority when personal jurisdiction is lacking)