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Doe v. Rumsfeld

August 21, 2007


The opinion of the court was delivered by: Emmet G. Sullivan United States District Judge


Six plaintiffs, known as John Doe #1 through #4 and Jane Doe #1 and #2, brought this action to challenge the lawfulness of the defendants' Anthrax Vaccination Immunization Program ("AVIP"). Currently pending before the Court is plaintiffs' motion for attorneys' fees and costs. Upon consideration of the motion, the response and reply thereto, the applicable law, and the entire record, the Court determines that plaintiffs are entitled to attorneys' fees, but that their pending request is flawed in several, significant aspects. Therefore, for the reasons stated herein, plaintiffs' motion for attorneys' fees and costs is DENIED without prejudice.


This Court set forth a detailed description of the case's regulatory and procedural background in its 2004 opinion, see Doe v. Rumsfeld, 341 F. Supp. 2d 1, 3-8 (D.D.C. 2004), so it need only be summarized here. Pursuant to a process established for drugs whose regulation was transferred from the National Institutes of Health to the FDA, the FDA issued a proposed order concerning AVA in 1985. Id. at 4-6. The FDA panel, whose report was incorporated into the proposed order, concluded that AVA was safe and effective "under the limited circumstances for which it is employed." Id. at 4-5. The panel did so after examining the "Brachman study," which investigated AVA's effectiveness against cutaneous anthrax and inhalation anthrax. Id. at 5. The proposed order recommended that AVA be placed in "Category I," which encompassed drugs that are safe, effective, and not misbranded. Id. Pursuant to its regulations, the FDA published notice of the proposed rule and solicited comments for 90 days. Id. at 5-6. Following the receipt of comments, the FDA took no further action until this suit was filed. Id. at 6.

In March 2003, plaintiffs filed suit in this Court, alleging that the AVIP violated federal law because AVA had never been approved as a safe and effective drug for protection against inhalation anthrax. Id. On December 22, 2003, the Court issued a preliminary injunction enjoining AVIP inoculations absent consent because the FDA had never issued a final decision regarding the safety of AVA. Id. Eight days later, the FDA issued a final order classifying AVA as a Category I drug, stating that it was effective regardless of the route of exposure. Id. The final order re-analyzed the data underlying the 1985 proposed order and also relied upon studies conducted after 1985. Id. at 7. Both parties subsequently moved for summary judgment, with plaintiff seeking permanent injunctive relief. Id. at 8.

On two initial matters, the Court determined the plaintiffs had standing and that the FDA's December 2003 decision constituted an order, instead of a rule. Id. at 9-12. Even though the decision was an order, the Court concluded that because the FDA regulations required notice and comment for the order, the notice and comment must have been procedurally sufficient under the standards of the Administrative Procedure Act. Id. at 13. Utilizing the logical outgrowth doctrine, the Court concluded that the notice and comment for AVA was insufficient because the final order deviated too greatly from the proposed order. Id. at 15. Defendants had contended that the proposed order was substantively identical to the final order because the proposed order classified AVA as a Category I drug and did not limit its application to any particular route of exposure. Id. at 14. The Court, however, found that the scope of the proposed order's recommendation did not include inhalation anthrax because the proposed order stated that there was insufficient data concerning AVA's effectiveness against inhalation anthrax. Id. at 15. Therefore, the public was not on notice that AVA was being considered for use against inhalation anthrax specifically, and thus the FDA's procedure did not provide a meaningful opportunity for comment as required by the FDA's own regulations. Id. As a remedy, the Court vacated the final order and remanded it to the FDA for reconsideration. Id. at 16. In addition, the Court entered a permanent injunction enjoining defendants' use of AVA absent consent until the FDA properly classified AVA as safe and effective for its intended purpose. Id. at 19.

While this case was on appeal, in December 2005, the FDA issued a new final order after a notice-and-comment period, explicitly finding AVA efficacious against inhalation anthrax. See Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed, 70 Fed. Reg. 75,180 (Dec. 19, 2005). As a result, the D.C. Circuit held that this Court's permanent injunction had dissolved by its own terms, dismissed the appeal as moot, and remanded the case to this Court for further proceedings. Doe v. Rumsfeld, 172 Fed. Appx. 327 (D.C. Cir. 2006) (per curiam). On remand, the only remaining issue is plaintiffs' motion for attorneys' fees and costs under the Equal Access to Justice Act ("EAJA"), 28 U.S.C. § 2412(d).


Plaintiffs have filed an application for $508,310.44 in attorneys' fees and costs. Defendants first contend that plaintiffs are not entitled to any fees and costs because defendants' position was substantially justified. In the alternative, defendants contend that the proper award is much less than plaintiffs' request because (1) plaintiffs are not prevailing parties with regard to their appeal to the D.C. Circuit; (2) plaintiffs' requested rate for their counsel is above the statutory limit; and (3) plaintiffs' purported billable hours are too high because they improperly seek reimbursement for certain activities and their billing records are too vague.

I. Substantial Justification

The EAJA provides that a prevailing party in a non-tort suit against the United States is entitled to fees and expenses unless the government's position was "substantially justified." 28 U.S.C. § 2412(d)(1)(A). The Supreme Court has held that a position is substantially justified "if a reasonable person could think it correct, that is, if it has a reasonable basis in law and fact." Pierce v. Underwood, 487 U.S. 552, 556 (1988). The D.C. Circuit has stated that "the hallmark of the substantial justification test is reasonableness." Role Models Am., Inc. v. Brownlee, 353 F.3d 962, 967 (D.C. Cir. 2004). The government bears the burden of establishing that its position was substantially justified. F.J. Vollmer Co., Inc. v. Magaw, 102 F.3d 591, 595 (D.C. Cir. 1996). Moreover, the government must demonstrate the reasonableness of both the agency's actions as well as its litigation position. Role Models, 353 F.3d at 967.

The question of reasonableness cannot be collapsed into the antecedent evaluation on the merits; it is a distinct legal standard. F.J. Vollmer, 102 F.3d at 595. The court's reasoning on the merits, however, may be quite instructive in resolving the substantial justification issue. Id. For instance, a finding on the merits that an agency's decision lacked substantial evidence generally implies that the agency's decision was unreasonable. Id. In addition, if an agency failed "to enforce a rule where it plainly applied," it is much more likely that the agency's decision was not substantially justified. Id.

Defendants contend that their position, at both the agency level and during litigation, was reasonable because they reasonably construed the 1985 proposed order as encompassing approval of AVA for treating inhalation anthrax. In support of this position, defendants point out that the proposed order classified AVA as a Category I drug and did not limit its approval to a particular route of exposure. If this view of the proposed order was reasonable, then the agency's procedures would have been proper because the 2003 final order would have been the logical outgrowth of the proposed order.

In the 2004 opinion, the Court concluded that the proposed order did not encompasses approval of AVA against inhalation anthrax, especially in the context of a potential biological attack as AVA is used in the AVIP. Doe, 341 F. Supp. 2d at 15. The Court reached this conclusion by focusing on two key statements in the proposed order. The first is that the proposed order found AVA safe and effective for the "limited circumstances" of its usage at that time, specifically inoculating individuals in certain industrial settings who worked with animal furs and hairs. Id. The second is that the proposed order, in analyzing the Brachman study, found that the lack of data permitted no meaningful analysis of the AVA's effectiveness against inhalation anthrax. Id. Thus, the public was not on notice that AVA would be deemed safe and effective against inhalation anthrax. Id.

The question of whether defendants' litigation position was substantially justified is a close one. Even conceding that the Court's analysis was correct, defendants make the argument that their view of the proposed order was still reasonable. They argue that because the proposed order did not explicitly limit its approval of AVA to any particular route of exposure, it is at least reasonable to interpret the proposed order as covering all routes of exposure. The Court, however, finds more persuasive the argument that the proposed order could not have meant to approve AVA for inhalation anthrax when it explicitly stated that it found no evidence to prove AVA's effectiveness against inhalation anthrax. In fact, the 2003 final order had to directly contradict the scientific conclusions in the proposed order regarding the Brachman study in order to support the position that AVA was effective against inhalation anthrax. See id. at 7. Given the explicit qualifications in the proposed order and the reversal in analysis in the 2003 final order, the Court concludes that defendants' litigation position was not substantially justified under the EAJA.

In addition, for the government's position to be substantially justified, the agency's actions also must have been reasonable. Role Models, 353 F.3d at 967. Plaintiffs contend that the defendants' actions were clearly unreasonable when they instituted the AVIP program without any final FDA order approving the usage of AVA. See Doe v. Rumsfeld, 297 F. Supp. 2d 119, 133-34 (D.D.C. 2003) (concluding that AVIP program violated federal law and entering preliminary injunction because the FDA had not issued a final order and no study proved AVA's effectiveness against inhalation anthrax). Rather than appeal the Court's conclusions, the FDA abruptly altered course and issued a final order merely eight days after the Court's 2003 opinion. Such a response is indicative of the unreasonableness of the agency's initial stance. Given the unreasonableness of the agencies' initial position ...

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