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November 17, 1988

DR. FRANK YOUNG, Commissioner, Food and Drug Administration, et al., Defendants

The opinion of the court was delivered by: PENN


 This case is before the Court on the plaintiffs' motion for award of attorney's fees pursuant to the Equal Access to Justice Act (EAJA), 28 U.S.C.A. § 2412.


 The plaintiffs filed this action in 1982 against the Food and Drug Administration (FDA) and contended that "since at least November 1981, [FDA] has been aware of strong evidence connecting the use of aspirin with Reye's Syndrome, a serious, and sometimes fatal, childhood disease." Complaint para. 1. They sought an "order directing the FDA to take necessary action to protect children against Reye's Syndrome. Id. Shortly thereafter, the plaintiffs moved for summary judgment requesting a determination that aspirin products were misbranded within the meaning of the Food, Drug and Cosmetic Act (FDC Act), 21 U.S.C.A. § 352, because their labels did not contain a warning that such products should not be used for children with chicken pox or during the flu season. In moving for summary judgment, the plaintiffs agreed that the "misbranding" of aspirin products could be cured if the manufacturers included a warning label on their products. The defendants opposed the motion and moved to dismiss or, in the alternative, for summary judgment, on the grounds of failure to exhaust and ripeness and because the agency action had not been unreasonably delayed.

 The Court dismissed the case without prejudice noting that the plaintiffs had not demonstrated that the time taken by FDA in considering whether to require aspirin manufacturers to include a label warning of Reye's Syndrome was unreasonable and that the case was not ripe for judicial decision. Memorandum filed March 14, 1983. In reaching the first determination, the Court noted that, while the American Academy of Pediatrics (AAP) had originally supported the concept of labeling, in November 1982, the Executive Board of the AAP had advised the Department of Health and Human Services (HHS) that they "believe[d] labeling should be delayed until more conclusive evidence of the association of aspirin administration and Reye's Syndrome [was] shown by further investigation. Id. at 3-4. The Court also noted that "since the issue is now before the agency charged with the responsibility of maintaining and supervising the enforcement of the laws relating to drugs, the agency should be permitted to conduct its administrative proceedings in an orderly fashion without interference by the Court." Id. at 5-6.

 After remand the plaintiffs undertook discovery on the issue of unreasonable delay. The plaintiffs note that five months after the Court of Appeals remanded the case, a Public Health Service Task Force study "showed that children with chicken pox or flu who are given aspirin are 12-25 times more likely to develop Reye's Syndrome than children with those diseases who are not given aspirin." Memorandum in Support of Plaintiffs' Motion for Award of Attorney's Fees (Plaintiffs' Memorandum) at 8-9. In January 1985, the Secretary of HHS announced that the results of the pilot study "show an association between the use of aspirin and the onset of Reye Syndrome in children and teenagers." Id. at 9. "Despite the fact that the FDA had stated in its Advance Notice of Proposed Rulemaking that it would immediately issue regulations requiring a warning label 'if warranted by new scientific information,' . . . the Secretary merely called on the industry to use a warning label 'voluntarily.'" Id. at 9. "Subsequently, on March 15, 1985, representatives of the AAP testified before a Congressional committee that in view of the results of the pilot study, there was 'more reason then ever to warn the public, and especially young adolescents, about the association between aspirin . . . and Reye's Syndrome.'" Id. at 9. "The AAP further testified that it questioned 'the effectiveness of voluntary labeling,' and that it was therefore in support of requiring aspirin manufacturers to use a warning label about Reye's Syndrome." Id. 9-10.

 The plaintiffs filed a second motion for summary judgment on the grounds that the Secretary's (of HHS) decision to seek voluntary labeling amounted to a final decision not to require a label and that therefore, the plaintiffs' challenge was then ripe for review. While the motion was pending, "more than a year and a half after the pilot study results were reported, and on the basis of no new evidence," Plaintiffs' Memorandum at 11, the FDA issued a final rule requiring the following label on aspirin products:

WARNING: Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye Syndrome, a rare but serious disease.

 51 Fed. Reg. 8180 (March 7, 1986). On March 19, 1986, the plaintiffs dismissed the action with prejudice, reserving only the issue of attorney's fees.


 The first question that must be addressed under the EAJA is whether the plaintiffs are the "prevailing parties" in this litigation. 28 U.S.C.A. § 2412(d)(1)(B). "A typical formulation is that 'plaintiffs may be considered to be "prevailing parties" for attorney's fees purposes if they succeed on any significant issue in litigation which achieves some of the benefit the parties sought in bringing suit.'" Hensley v. Eckerhart, 461 U.S. 424, 433, 103 S. Ct. 1933, 1939, 76 L. Ed. 2d 40 (1983)(citation and footnote omitted, emphasis this Court's). In order to determine whether the plaintiffs prevailed, it is necessary to consider the relief they sought and compare that with the disposition in this case.

 In their complaint the plaintiffs sought an order (1) declaring that aspirin-containing products, sold without a Reye's Syndrome warning are misbranded and (2) directing the FDA to require all manufacturers to place a warning label on aspirin products. With respect to the misbranding issue, neither this Court nor the Court of Appeals addressed the merits of that claim. Indeed, this Court held in its March 14, 1983 Memorandum that the misbranding issue was not ripe for decision in advance of a determination on that issue by the agency. The Court of Appeals agreed. Public Citizen Health Research Group v. Commissioner, ...

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