Carik v. United States Department of Health and Human Services, 4 F. Supp. 3d 41

Plaintiffs comprise twelve named and thirteen unnamed individuals with Fabry disease or vitamin A deficiency seeking declaratory, injunctive, and monetary relief against HHS, FDA, NIH, and Mount Sinai.
Two drugs are at issue: Fabrazyme for Fabry disease and Aquasol A for vitamin A deficiency; shortages are alleged to be caused by manufacturers Genzyme and Hospira.
Genzyme’s Fabrazyme shortage began after a viral contamination led to plant shutdowns and a consent decree with the DOJ; limited FDA oversight and a consent decree permit some manufacturing actions but not cure the shortage.
Hospira’s Aquasol A shortage arose from transferring production to another facility, with the FDA noting ongoing shortage; Hospira is not a party to the suit.
Regulatory framework discussed includes FDCA and PHSA licensing, enforcement limitations, and Bayh-Dole march-in rights, which have never been exercised by the government.
Plaintiffs’ administrative remedies include a Bayh-Dole march-in petition to NIH and a citizen petition to FDA; both were largely unavailing or informational, shaping the standing analysis.

Issue	Plaintiff's Argument	Defendant's Argument	Held
Whether plaintiffs have Article III standing.	Lacognata and others allege ongoing injury from drug shortages.	Government actions/inactions have not caused the injuries; standing fails.	Plaintiffs lack standing except Lacognata, and Lacognata lacks causation; dismissal granted.
Whether any claimed injuries are fairly traceable to defendants.	Defendants’ duties to act or to revoke licenses would causally connect to injuries.	No statutory/constitutional duty to revoke licenses; causation too weak.	Causation not shown; dismissal affirmed.
Whether alleged constitutional injuries confer standing.	National-origin discrimination and other constitutional grievances.</br>Informational injuries and state police powers claims also raised.	No cognizable injury; generalized grievances cannot confer standing; no actual discrimination or injury shown.	No standing for constitutional injuries; Lacognata only potentially, but still lacks causation.
Whether the court should address the merits notwithstanding standing.	Claims allege separation of powers, Tenth Amendment, patent clause, etc.	Without standing, court lacks subject-matter jurisdiction to reach merits.	Rule 12(b)(1) dismissal appropriate; merits not reached.
Whether physician-dosed or diluted Fabrazyme constitutes redressable harm.	diluted dosing risks harm; potential ongoing injury.	No proven injury; shortage resolved; speculative harms.	Insufficient injury in fact to support standing.

Lujan v. Defenders of Wildlife, 504 U.S. 555 (1992) (standing requires injury, causation, and redressability)
Public Citizen, Inc. v. Nat’l Highway Traffic Safety Admin., 489 F.3d 1279 (D.C. Cir. 2007) (injury must be concrete and particular, not speculative)
City of Los Angeles v. Lyons, 461 U.S. 95 (1983) (injury must be imminent for injunctive relief standing)
Bond v. United States, 131 S. Ct. 2355 (2011) (individual standing analysis; federalism context; cannot rely on Tenth Amendment alone)
Wyeth v. Levine, 555 U.S. 555 (2009) (FDCA can coexist with state remedies for injuries from drugs)
Jacobson v. Massachusetts, 197 U.S. 11 (1905) (state police power to protect health; federalism balance)
Lugar v. Edmondson Oil Co., Inc., 457 U.S. 922 (1982) (government action required to attribute private conduct to the state for § 1983)