Association of Amer. Physic. v. U.S. Food and Drug

• Citation: 391 F.Supp.2d 171
• Decision Date: 27 September 2005
• Docket Number: No. CIV.A. 00-02898HHK.,CIV.A. 00-02898HHK.
• Parties: ASSOCIATION OF AMERICAN PHYSICIANS AND SURGEONS, INC., et al., Plaintiffs, v. UNITED STATES FOOD AND DRUG ADMINISTRATION, et al., Defendants.
• Court: United States District Courts. United States District Court (Columbia)

391 F.Supp.2d 171

ASSOCIATION OF AMERICAN PHYSICIANS AND SURGEONS, INC., et al., Plaintiffs, v. UNITED STATES FOOD AND DRUG ADMINISTRATION, et al., Defendants.

No. CIV.A. 00-02898HHK.

United States District Court, District of Columbia.

September 27, 2005.

COPYRIGHT MATERIAL OMITTED

Kristina Reynolds Osterhaus, Bertram Walter Rein, Daniel E. Troy, Wiley Rein & Fielding, LLP, Washington, DC, for Plaintiffs.

Drake Stephen Cutini, U.S. Department of Justice, Michael A. Humphreys, U.S. Attorney's Office, Barbara Stradling, Washington, DC, for Defendants.

MEMORANDUM OPINION AND ORDER

KENNEDY, District Judge.

This court previously ruled that a final rule promulgated by the United States Food and Drug Administration ("FDA" or "government"), which mandated pediatric testing and formulation, exceeded the FDA's statutory authority and was therefore invalid. See Ass'n of Am. Phys. & Surgeons v. FDA, 226 F.Supp.2d 204 (D.D.C.2002). Presently before the court is plaintiffs' Motion for an Award of Attorneys' Fees and Expenses pursuant to the Equal Access to Justice Act ("EAJA"), 28 U.S.C. § 2412. Upon consideration of the motion, the opposition thereto, and the record of this case, the court concludes that the motion should be granted.

I. BACKGROUND

This lawsuit arose from plaintiffs' challenge to the FDA's promulgation of "Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients" ("Pediatric Rule"), 21 C.F.R. §§ 201, 312, 314, 601, 63 Fed.Reg. 66,632 (Dec. 2, 1998).¹ The Pediatric Rule mandated that drug manufacturers evaluate the safety and effectiveness of their products on pediatric patients, absent an applicable exception. See 21 C.F.R. § 314.55.² The Pediatric Rule was applicable to all drug manufacturers, including those who disclaimed pediatric use in a product's labeling, and even, in certain circumstances, those whose products were previously approved by the FDA. Id. § 201.23(a). Failure to comply with the Pediatric Rule entitled the FDA to declare the product to be "misbranded or an unapproved new drug or unlicensed biologic." Id. § 201.23(d).

In 1999, plaintiffs filed a citizen petition with the FDA, challenging the FDA's authority to issue the Pediatric Rule and asking the agency to revoke the rule. The FDA denied the petition in 2000. This suit, brought under the judicial review provisions of the Administrative Procedure Act, 5 U.S.C. § 551 et seq., followed.

In their pleadings before this court, plaintiffs argued that the FDA had acted beyond its statutory authority in issuing the Pediatric Rule and that the Rule directly conflicted with certain provisions of both the Food and Drug Administration Modernization Act ("FDAMA"), Pub.L. No. 105-115, 111 Stat. 2296 (1997), and its successor, the Best Pharmaceuticals for Children Act ("BPCA"), Pub.L. No. 107-109, 115 Stat. 1408 (2002). Plaintiffs alleged that the FDAMA and the BPCA evidenced a clear congressional intent that pediatric testing be conducted voluntarily rather than by the Pediatric Rule's command and control approach. The government responded by asserting that the Federal Food Drug and Cosmetic Act ("FDCA"), 21 U.S.C. § 301 et seq., served as the basis for the FDA's authority to issue the Pediatric Rule.

After examining specific provisions of the FDCA as well as the Act's broader context, this court concluded that the Pediatric Rule did not have a sound statutory basis in the FDCA. Ass'n of Am. Phys. & Surgeons, 226 F.Supp.2d at 212-19. Recognizing that the FDCA's meaning "`may be affected by other Acts, particularly where Congress has spoken subsequently and more specifically to the topic at hand,'" id. at 212 (quoting FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 133, 120 S.Ct. 1291, 146 L.Ed.2d 121 (2000)), the court then looked to the FDAMA and the BPCA to determine whether Congress intended for the FDA to promulgate the Pediatric Rule and whether the Rule "`fit[ ] into the overall regulatory scheme created by Congress,'" id. at 219 (quoting Brown & Williamson Tobacco Corp. v. FDA, 153 F.3d 155, 163 (4th Cir.1998)). After a careful analysis, the court determined that the Pediatric Rule and the BPCA were incompatible. Id. at 219-22. Accordingly, the court concluded that the Pediatric Rule was beyond the FDA's statutory authority and was therefore invalid. Id. at 222.

The government opted not to appeal the court's summary judgment decision. However, the American Academy of Pediatrics and the Elizabeth Glaser Pediatric AIDS Foundation (collectively "Intervenors") requested, and were granted, leave to intervene in order to appeal. Intervenors then filed a Notice of Appeal on December 19, 2002. On December 11, 2003, after briefing on both the merits and on plaintiffs' motion to dismiss the appeal based on Intervenors' lack of standing, the court of appeals dismissed the appeal pursuant to a stipulation for voluntary dismissal signed by counsel for plaintiffs and Intervenors. The government was not a party to the appeal and did not participate in the briefings on the merits. However, the government did participate as amicus curiae, filing a brief in support of plaintiffs' motion to dismiss.

This motion for fees and expenses followed.

II. ANALYSIS

A. Legal Standard

The EAJA allows a qualified party who prevails against the United States in a civil action to recover attorneys' fees and other expenses. Specifically, the EAJA, in relevant part, provides:

[A] court shall award to a prevailing party other than the United States fees ... incurred by that party in any civil action ... including proceedings for judicial review of agency action, brought by or against the United States ... unless the court finds that the position of the United States was substantially justified or that special circumstances make an award unjust.

28 U.S.C. § 2412(d)(1)(A).

In addition to attorneys' fees, the EAJA permits a prevailing party to recover "a judgment for costs" under 28 U.S.C. § 1920, id. § 2412(a)(1), as well as "other expenses, in addition to any costs," id. § 2412(d)(1)(A). These other expenses include all "[i]tems routinely billed to a client." Nat'l Ass'n of Mfrs. v. Dept. of Labor, 962 F.Supp. 191, 199 (D.D.C.1997), aff'd, 159 F.3d 597 (D.C.Cir.1998). Thus, costs and other expenses recoverable under the EAJA include paralegal fees, computer research, and photocopying expenses. Hirschey v. FERC, 777 F.2d 1, 6 (D.C.Cir.1985) (permitting recovery of paralegal fees and computer research expenses); Chen v. Slattery, 842 F.Supp. 597, 600 (D.D.C.1994) (noting that plaintiffs' reasonable copying costs "are recoverable as a traditional element of `reasonable attorney's fees'" under the EAJA) (quoting 28 U.S.C. § 2412(d)(1)(C)(2)(A)).

Looking to the text of the EAJA, the Supreme Court has noted that eligibility for attorneys' fees, costs, and expenses under the EAJA requires the claimant to meet four conditions: (1) that the claimant be a "prevailing party"; (2) that the government's position was not "substantially justified"; (3) that no "special circumstances make an award unjust"; and, (4) that pursuant to 28 U.S.C. § 2412(d)(2)(B), plaintiffs satisfy all of the EAJA's threshold eligibility requirements. Commissioner, INS v. Jean, 496 U.S. 154, 158, 110 S.Ct. 2316, 110 L.Ed.2d 134 (1990). The government does not dispute that three of these conditions have been met here: that plaintiffs are a prevailing party, that there are no special circumstances making the award unjust,³ and that plaintiffs satisfy all threshold eligibility requirements. See Opp'n to Pls.' Mot. for an Award of Attorneys' Fees and Expenses ("Opp'n") at 1, 9-12. Accordingly, only an analysis of the "substantially justified" requirement is necessary to determine whether plaintiffs are entitled to attorneys' fees, costs, and other expenses.

The Supreme Court has held that the term "substantially justified" means "`justified in substance or in the main' — that is, justified to a degree that could satisfy a reasonable person." Jean, 496 U.S. at 158 n. 6, 110 S.Ct. 2316; Pierce v. Underwood, 487 U.S. 552, 565-66 n. 2, 108 S.Ct. 2541, 101 L.Ed.2d 490 (1988) ("[A] position can be justified even though it is not correct, and we believe it can be substantially (i.e., for the most part) justified if a reasonable person could think it correct, that is, if it has a reasonable basis in law and fact."). The government bears the burden of proving that its position was "substantially justified." Halverson v. Slater, 206 F.3d 1205, 1208 (D.C.Cir.2000).

The government's "position" for purposes of the EAJA includes both the "position taken by the United States in the civil action," as well as "the action or failure to act by the agency upon which the civil action is based." 28 U.S.C. § 2412(d)(2)(D); see also Jacobs v. Schiffer, 204 F.3d 259, 263 (D.C.Cir.2000) ("The government's `position' includes both its pre-litigation and litigation positions."). Importantly, an award of fees is appropriate "where the government's prelitigation conduct was not substantially justified even though its litigating position may have been substantially justified and vice versa." Marcus v. Shalala, 17 F.3d 1033, 1036 (7th Cir.1994); see also Role Models Am., Inc. v. Brownlee, 353 F.3d 962, 967 (D.C.Cir.2004) ("The government, however, must demonstrate the reasonableness not only of its litigation position, but also of the agency's actions.") (emphasis in original).

The court is to determine whether the Government's position was substantially justified "on the basis of the record" made in the civil action for which fees and other expenses are sought. 28 U.S.C. § 2412(d)(1)(B). The court, however, must "do more than explain, repeat, characterize, and describe the merits ... decision." Taucher v. Brown-Hruska, 396 F.3d 1168, 1174 (D.C.Cir.2005) (quoting Halverson, 206 F.3d at 1209). Instead, it must analyze "why the government's...