Public Citizen Health Research Group v. Dr. Frank Young, Commissioner, Food and Drug Administration

909 F.2d 546, 285 U.S. App. D.C. 307, 1990 U.S. App. LEXIS 12584, 1990 WL 106792
CourtCourt of Appeals for the D.C. Circuit
DecidedJuly 31, 1990
Docket89-5055
StatusPublished
Cited by51 cases

This text of 909 F.2d 546 (Public Citizen Health Research Group v. Dr. Frank Young, Commissioner, Food and Drug Administration) is published on Counsel Stack Legal Research, covering Court of Appeals for the D.C. Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Public Citizen Health Research Group v. Dr. Frank Young, Commissioner, Food and Drug Administration, 909 F.2d 546, 285 U.S. App. D.C. 307, 1990 U.S. App. LEXIS 12584, 1990 WL 106792 (D.C. Cir. 1990).

Opinion

Opinion for the Court filed by Circuit Judge WILLIAMS.

STEPHEN F. WILLIAMS, Circuit Judge:

We review here an award of attorneys’ fees incurred by Public Citizen Health Research Group in an effort to force the Food & Drug Administration to require a warning of Reye’s Syndrome on aspirin labels. The FDA eventually imposed the requirement, and the district court found that even though the lawsuit was never decided on the merits, it was enough of a “catalyst” for Public Citizen to be considered a “prevailing party” under EAJA, the Equal Access to Justice Act, 28 U.S.C. § 2412 (1988). We affirm that finding, but must reverse his award of fees on two other points. First, in finding the government’s position *548 not “substantially justified” after 1984, the district court used a less generous standard (to the government) than is demanded by the Supreme Court’s decision in Pierce v. Underwood, 487 U.S. 552, 108 S.Ct. 2541, 101 L.Ed.2d 490 (1988). Second, even though the court found that the government’s position was substantially justified before 1985, it awarded fees incurred in that period.

I

Reye’s Syndrome is a rare illness that usually afflicts children and teenagers recovering from viral infections. It causes death in 20-30 percent of all cases, and permanent brain damage in many others. See Public Citizen Health Research Group v. Commissioner, Food & Drug Admin., 740 F.2d 21, 24 (D.C.Cir.1984). In March 1982 Public Citizen filed a “citizen’s petition” with the FDA (a branch of the Department of Health and Human Services) demanding that it require warning labels. Public Citizen relied on three state studies finding that a class of chemicals called salicylates (which are contained in aspirin) might tend to cause the disease. See id. Unhappy with the FDA’s pace in dealing with the petition, Public Citizen filed suit in May 1982, seeking a court order compelling the FDA to require the warning. Its substantive theory was that unlabeled aspirin containers were “mis-branded” under the Food, Drug & Cosmetic Act, 21 U.S.C. § 352(f) (1988), for want of “adequate warnings against use ... by children where its use may be dangerous to health,” id. In the alternative, Public Citizen sought an injunction requiring the FDA to respond to its petition within 30 days.

A good deal of backing and filling ensued. Three months after Public Citizen brought suit, the Secretary of HHS issued a press release indicating that he would propose requiring a warning label on products with salicylates. Public Citizen then moved for summary judgment. A month later, the Secretary announced that he was initiating the process of requiring a warning by submitting an appropriate regulation to OMB for review. A little later, however, while the summary judgment motion was still pending, the Secretary reversed field on the basis of a switch by the American Academy of Pediatrics, which dropped its earlier support for a mandatory warning label and instead suggested that more evidence was needed. At this point the FDA decided to commission a comprehensive study.

The district court proceeded to dismiss the suit for want of both ripeness and finality in the FDA’s actions. The court of appeals affirmed the dismissal on the “mis-branding” claim but remanded for the district court to consider Public Citizen’s claim of unreasonable delay. See Public Citizen, 740 F.2d at 27, 35-36.

In January 1985 the FDA released the results of a pilot study designed as the first phase of the comprehensive inquiry. Although the pilot was on a small scale and suffered from other methodological frailties, a committee of the Institute of Medicine (an offshoot of the National Academy of Sciences) found that the data showed a “strong association” between Reye’s Syndrome and the use of aspirin. The Secretary renewed his decision to wait for the results of the final study, but asked the aspirin industry to label its aspirin products voluntarily in the meantime.

Two months later Public Citizen filed a new motion for summary judgment, and the FDA countered with its own. The court heard oral argument in September 1985, and in December, while the motions were still undecided, the FDA proposed a warning requirement. It adopted the regulation in March 1986 (effective June 5, 1986), and Public Citizen moved to have its complaint dismissed, reserving only the issue of attorneys’ fees.

The study initiated in 1982 was completed in November 1986. It confirmed the pilot study, finding a “large, statistically significant association between Reye’s syndrome in children and teenagers and the ingestion of aspirin during previous illnesses.” See Labeling for Oral and Rectal Over-the-Counter Aspirin and Aspirin-Containing Drug Products; Reye Syn *549 drome Warning, 53 Fed.Reg. 21,633 (June 9, 1988).

II

The Equal Access to Justice Act allows a limited class of “prevailing” parties-ones that aren’t too wealthy-to recover attorneys’ fees in suits against the United States unless the United States’s position was “substantially justified." 28 U.S.C. § 2412(d)(1)(A) (1988). We first address the conclusion that plaintiff prevailed, then the issues revolving around the court’s finding that the government was “substantially justified” until the end of 1984 but not thereafter.

A. Prevailing party

A party need not procure a final judgment on the merits in order to be considered a “prevailing party” for fee-shifting purposes. It is enough that the lawsuit was a “causal, necessary, or substantial factor in obtaining the result” plaintiff sought. Commissioners Court of Medina County, Texas v. United States, 683 F.2d 435, 442 (D.C.Cir.1982); see also Hewitt v. Helms, 482 U.S. 755, 760-61, 107 S.Ct. 2672, 2675-76, 96 L.Ed.2d 654 (1987). (dictum) (citing Maher v. Gagne, 448 U.S. 122, 129, 100 S.Ct. 2570, 2574-75, 65 L.Ed.2d 653 (1980) (involving consent decree)). This construction of “prevailing party” is consistent with one of Congress’s purposes in enacting EAJA: to compensate plaintiffs who cause the government to conform to the law. See H.Rep. No. 1418, 96th Cong., 2d Sess. 10, reprinted in 1980 U.S. Code Cong. & Admin.News 4953, 4984, 4988-89. Of course there is a limit; the Fourth Circuit has held that a plaintiff who filed suit in a court without jurisdiction cannot recover no matter how effective the suit might have been in changing agency conduct, Finn v. U.S.,

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Bluebook (online)
909 F.2d 546, 285 U.S. App. D.C. 307, 1990 U.S. App. LEXIS 12584, 1990 WL 106792, Counsel Stack Legal Research, https://law.counselstack.com/opinion/public-citizen-health-research-group-v-dr-frank-young-commissioner-food-cadc-1990.