White Coat Waste Project, Inc. v. National Institutes of Health

CourtDistrict Court, District of Columbia
DecidedAugust 2, 2023
DocketCivil Action No. 2022-0006
StatusPublished

This text of White Coat Waste Project, Inc. v. National Institutes of Health (White Coat Waste Project, Inc. v. National Institutes of Health) is published on Counsel Stack Legal Research, covering District Court, District of Columbia primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
White Coat Waste Project, Inc. v. National Institutes of Health, (D.D.C. 2023).

Opinion

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

WHITE COAT WASTE PROJECT, INC.,

Plaintiff,

v. Civil Action No. 1:22-cv-00006 (CJN)

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, et al.,

Defendants.

MEMORANDUM OPINION

The National Institutes of Health (“NIH”) funds biomedical and behavioral research on

animals by approving grants to foreign and domestic research entities. To ensure proper care of

animals used in that research, Section 495 of the Public Health Services Act (“Services Act”), 42

U.S.C. § 289d, requires the Secretary of Health and Human Services, acting through the Director

of NIH, to set guidelines for grant recipients to follow. In this suit, a watchdog group called White

Coat Waste Project, Inc. (“White Coat”) claims that NIH violated the Services Act by exempting

foreign grant recipients from some of those guidelines. NIH moves to dismiss the complaint, on

grounds that White Coat lacks standing and fails to assert an interest protected by the Services Act.

The Court disagrees—at this stage in the proceedings, White Coat has adequately established that

it has organizational standing and that its interests arguably fall within the zone of interests

protected by the statute. The Court will thus deny NIH’s motion to dismiss.

1 I. Background

A. Legal Framework

Each year, the federal government spends around $20 billion on animal research by

providing grants, contracts, and additional funding to research entities. Am. Compl. ¶ 1, ECF No.

17. Both foreign and domestic entities are eligible to receive NIH funding for this research—

indeed, about a quarter of eligible grantees are foreign laboratories. Declaration of Daniel Eduardo

López Breña (“López Decl.”) ¶ 28, ECF No. 24-3. Whether foreign or domestic, any institution

that uses animals in NIH-funded research must comply with certain animal welfare requirements.

These requirements flow from the Services Act. The Act requires the Secretary to establish

guidelines for the proper care of animals used in NIH-funded biomedical and behavioral research.

42 U.S.C. § 289d(a). Applicants for funding must, in turn, provide “assurances” that they comply

with these guidelines. Id. § 289d(c)(1). No entity may receive funding for research involving

animals unless NIH approves its animal welfare assurance. Id. § 289d(c)–(d).

As relevant here, NIH provides alternative ways for entities to obtain approval of their

assurances. Domestic institutions must, among other things, set up an Institutional Animal Care

and Use Committee (“animal care committee”) to monitor the institution’s compliance with

applicable guidelines. See Public Health Service Policy on the Humane Care and Use of

Laboratory Animals (“Humane Care Policy”), Secs. II, IV.A.3, Ex. 3, ECF No. 24-2. Animal care

committees must keep certain records and file reports of violations with NIH. § 289d(b)(3).

Foreign institutions, by contrast, have a choice: They can either set up an animal care committee,

or they can submit evidence to NIH proving “that acceptable standards for the humane care and

use of the animals in [NIH-funded] activities will be met.” Humane Care Policy, Sec. II. This suit

is (in part) about whether the Services Act permits that choice.

2 B. This Lawsuit

White Coat “is a bipartisan taxpayer watchdog organization.” Am. Compl. ¶ 6. Its mission

is to “unite animal-lovers and liberty-lovers to find, expose, and defund wasteful and cruel

taxpayer-funded animal experimentation.” Id. That mission, White Coat says, is frustrated by

NIH’s decision to exempt foreign grantees from the same requirements applicable to domestic

grantees. And that exemption, White Coat continues, violates the plain text of the Services Act.

Specifically, White Coat contends that the Services Act requires all entities—foreign and

domestic—receiving funds for animal research to “maintain an animal care committee to review,

approve, and monitor animal experiments, and to ensure proper care for animals.” Id. ¶ 1. Yet

NIH has, according to White Coat, “enacted multiple contradictory and binding agency rules

exempting foreign grant recipients of taxpayer money for animal experiments from maintaining

an animal care committee.” Id. As a result, White Coat has had to alter its operations and “redirect

its limited resources to counteract and offset [NIH’s] unlawful actions and omissions.” Id. ¶ 7.

For example, because the challenged exemption appears to relieve foreign entities from certain

statutory record keeping and reporting obligations, White Coat allegedly cannot monitor

compliance with animal welfare guidelines—and thereby expose animal mistreatment—through

its regular practice of obtaining records from NIH through the Freedom of Information Act

(“FOIA”). See, e.g., id. ¶ 93; López Decl. ¶¶ 6–10. White Coat instead has had to track down

relevant information through other, more time-consuming methods. See, e.g., López Decl. ¶¶ 44–

45.

White Coat alleges that NIH violated the Administrative Procedure Act by exempting

foreign entities from certain statutory requirements. Alternatively, White Coat alleges that the

guidance at issue constitutes rulemaking under the APA and that NIH disregarded notice-and-

3 comment requirements. NIH moves to dismiss for lack of standing and failure to assert an interest

protected by the Services Act.

II. Legal Standards

To survive a motion to dismiss under Rule 12(b)(1), a plaintiff must establish subject-

matter jurisdiction. Lujan v. Defs. of Wildlife, 504 U.S. 555, 561 (1992). At this stage, a plaintiff’s

burden is not heavy—the court must “assume the truth of all material factual allegations in the

complaint and construe the complaint liberally, granting plaintiff the benefit of all inferences that

can be derived from the facts alleged.” Am. Nat’l Ins. Co. v. FDIC, 642 F.3d 1137, 1139 (D.C.

Cir. 2011) (quotations omitted). The court may also “consider materials outside the pleadings in

deciding whether to grant a motion to dismiss for lack of jurisdiction.” Jerome Stevens Pharms.

v. FDA, 402 F.3d 1249, 1253 (D.C. Cir. 2005).

Standing is a predicate to subject-matter jurisdiction and requires a plaintiff to “show injury

in fact that was caused by the conduct of the defendant[] and that can be redressed by judicial

relief.” Pub. Citizen, Inc. v. Nat’l Highway Traffic Safety Admin., 489 F.3d 1279, 1289 (D.C. Cir.

2007). These elements—injury-in-fact, causation, and redressability—“must be supported in the

same way as any other matter on which the plaintiff bears the burden of proof, i.e., with the manner

and degree of evidence required at the successive stages of the litigation.” Lujan, 504 U.S. at 561.

In other words, a “plaintiff’s burden to demonstrate standing grows heavier at each stage of the

litigation.” Osborn v. Visa Inc., 797 F.3d 1057, 1063 (D.C. Cir. 2015). At the dismissal stage, all

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