COALITION FOR MERCURY-FREE DRUGS v. Sebelius
399 U.S. App. D.C. 442
| D.C. Cir. | 2012Background
- Coalition for Mercury-Free Drugs (COMED) and members sue FDA to prohibit thimerosal-preserved vaccines; district court dismissed for lack of standing.
- FDA approves thimerosal as a preservative; most vaccines for children/pregnant women lack thimerosal or contain trace amounts, except some flu vaccines.
- Coalition submitted a 2007 Citizen Petition asking FDA to ban thimerosal-preserved vaccines; FDA denied the petition.
- Plaintiffs allege three injuries: (i) past mercury-related harms, (ii) reputational injury to medical professionals, (iii) difficulty in obtaining thimerosal-free vaccines.
- Court assesses standing under Article III; plaintiffs must show imminent, concrete injury likely to be redressed by court relief; here, injuries are not cognizable.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether any plaintiff has standing to sue. | COMED members have injury from FDA allowing thimerosal-preserved vaccines. | FDA action does not injure plaintiffs personally; thimerosal-free options exist. | No standing; injury not concrete or imminent. |
| Whether reputational injury to professionals is cognizable. | Physician members suffer reputational harm due to FDA actions. | FDA does not compel physicians or patients to use thimerosal-preserved vaccines. | Not cognizable; FDA’s actions do not cause reputational injury to individual doctors. |
| Whether difficulty obtaining thimerosal-free vaccines supports standing. | FDA approval makes thimerosal-free vaccines hard to obtain or costly. | Thimerosal-free vaccines are readily available and purchasable; price differences are not sufficient for standing. | No standing; thimerosal-free vaccines are available. |
| Whether association standing principles apply. | Association may sue on behalf of its members. | Only one member must have standing; the others fail. | Not applicable; no member has standing. |
Key Cases Cited
- Lujan v. Defenders of Wildlife, 504 U.S. 555 (U.S. 1992) (standing requires concrete, particularized injury and redressability)
- City of Los Angeles v. Lyons, 461 U.S. 95 (U.S. 1983) (threat of injury must be real and immediate for injunctive relief)
- Whitmore v. Arkansas, 495 U.S. 149 (U.S. 1990) (threatened injury must be certainly impending)
- Summers v. Earth Island Inst., 555 U.S. 488 (U.S. 2009) (standing as a tool to separate policy disputes from judicial review)
- Public Citizen v. NHTSA, 489 F.3d 1279 (D.C. Cir. 2007) (standing intrudes on democratic process; protects separation of powers)
- Sierra Club v. EPA, 292 F.3d 895 (D.C. Cir. 2002) (association standing requires member with standing or germane interests)
- Foreman v. Foreman, 631 F.2d 969 (D.C. Cir. 1980) (injury to consumers from product availability can confer standing)