195 F. Supp. 3d 243
D.D.C.2016Background
- Plaintiffs (individuals and advocacy organizations opposing mercury in dental amalgam) challenged the FDA’s 2009 Final Rule classifying dental amalgam as a Class II device and the agency’s January 2015 denials/partial grants of citizen petitions seeking stricter regulation or a ban.
- Dental amalgam consists of dental mercury (Class I) and amalgam alloy (Class II); the FDA treated the combined device as Class II and declined to prepare an EA/EIS under NEPA, invoking categorical exclusion 21 C.F.R. § 25.34.
- Plaintiffs filed citizen petitions (2009 and later) asking for a ban, Class III classification, warnings, restrictions for subpopulations, and environmental assessments; FDA issued final responses in Jan. 2015 denying most relief and declining NEPA review.
- The suit asserts: unreasonable delay/agency error under the APA, seeks regulatory relief (ban, reclassification, warnings, restrictions) and an EA/EIS; defendants moved to dismiss for lack of Article III standing.
- The district court dismissed for lack of standing, finding (a) many named plaintiffs failed to make any standing showing, (b) organizational spending on advocacy/studies did not constitute cognizable injury, (c) the individual plaintiff’s injury (inmate Waller) was not traceable or redressable, and (d) IAOMT’s claimed NEPA informational injury was not fairly traceable to the underlying agency action.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Organizational standing (IAOMT, CoMeD) | Organizations spent resources researching, publishing, educating, and defending members because FDA’s Rule impaired their mission and forced diversion of resources | Expenditures are routine advocacy, litigation preparation, or self-inflicted and do not show operational impairment beyond normal activities | Dismissed — advocacy and litigation-oriented expenditures do not establish Article III injury; no cognizable organizational injury proven |
| Individual standing (Roger Waller) | Waller (incarcerated) alleges mercury poisoning and that ODRC denied filling removal citing FDA’s Rule, so FDA action caused his inability to obtain removal | ODRC’s denial was based on medical findings showing no mercury poisoning; any reference to FDA was not a determinative, coercive cause; redress (agency reclassification or ban) would likely not change ODRC’s decision | Dismissed — causation and redressability lacking; injury attributed to independent third-party (ODRC) and speculative to be redressed by court relief against FDA |
| Representational standing (IAOMT, DAMS) | Organizations sue on behalf of members who allegedly face occupational exposure or discipline; at least one member has standing (Hunt test) | Plaintiffs failed to identify specific members with concrete, imminent injury; claims are speculative or generalized | Dismissed — no identified member with standing; generic or probabilistic risks insufficient for representational standing |
| NEPA/Environmental/informational standing (IAOMT) | FDA’s failure to prepare EA/EIS deprived IAOMT (and members) of environmental information about mercury discharge and its environmental harms | IAOMT’s asserted informational injury is not fairly traceable to the agency act requiring an EIS (the injury must stem from the underlying major federal action), and speculative environmental risk allegations inadequate | Dismissed — procedural/informational injury alone not traceable to the challenged agency action; IAOMT lacks NEPA standing |
Key Cases Cited
- Lujan v. Defenders of Wildlife, 504 U.S. 555 (1992) (Article III standing requirements: injury in fact, causation, redressability)
- Food & Water Watch, Inc. v. Vilsack, 808 F.3d 905 (D.C. Cir. 2015) (organizational standing: advocacy expenditures ordinarily insufficient; need diversion that perceptibly impairs operations)
- People for the Ethical Treatment of Animals v. U.S. Dep’t of Agric., 797 F.3d 1087 (D.C. Cir. 2015) (organizational injury where agency inaction forced diversion of resources to replace agency functions)
- Moms Against Mercury v. FDA, 483 F.3d 824 (D.C. Cir. 2007) (background on FDA’s regulation history of dental amalgam)
- Summers v. Earth Island Institute, 555 U.S. 488 (2009) (associational standing requires at least one identified member who has standing in his own right)
- Florida Audubon Soc. v. Bentsen, 94 F.3d 658 (D.C. Cir. 1996) (NEPA standing requires a particularized environmental interest that will suffer a demonstrably increased risk traceable to the challenged federal action)
- Abigail Alliance v. Eschenbach, 469 F.3d 129 (D.C. Cir. 2006) (organizational diversion-of-resources analysis in pharmaceutical/FDA context)