Case 2:22-cv-00223-Z Document 137 Filed 04/07/23 Page 24 of 67 PageID 4446
to meet new situations that demand equitable intervention, and to accord all the relief necessary to correct particular injustices.”) (cleaned up).
Equitable tolling is appropriate here in large part because of FDA’s unreasonable delay in responding to Plaintiff’s 2002 and 2019 Petitions. See WildEarth Guardians v. U.S. Dep’t of Just., 181 F. Supp. 3d 651, 670 (D. Ariz. 2015) (it is “grossly inappropriate” to apply a statute of limitations where the agency unreasonably delayed a claim because the agency “could immunize its allegedly unreasonable delay from judicial review simply by extending that delay for six years”) (internal marks omitted). It took FDA 13 years, 7 months, and 9 days to respond to the 2002 Petition. FDA then moved the goalposts by substantially changing the regulatory scheme on the same day it issued its Response. And it took FDA 2 years, 8 months, and 17 days to respond to the 2019 Petition which challenged those changes. Thus, in the 20 years between the 2002 Petition and the filing of this suit, Plaintiffs were waiting on FDA for over 16 of those years. See Hill Dermaceuticals, Inc. v. U.S. Food & Drug Admin., 524 F. Supp. 2d 5, 9 (D.D.C. 2007) (“Once citizen petitions are submitted, the FDA Commissioner is required to respond in one of three manners ‘within 180 days of receipt of the petition.’”) (quoting 21 C.F.R. § 10.30(e)(2)).[1]
Additionally, statutes of limitations “are primarily designed to assure fairness to defendants,” and “to promote justice by preventing surprises through the revival of claims that have been allowed to slumber until evidence is lost, memories have faded, and witnesses have disappeared.” Clymore v. United States, 217 F.3d 370, 376 (5th Cir. 2000), as corrected on reh’g (Aug. 24, 2000) (internal marks omitted). But it “has not been argued, and cannot seriously be, that the government was unfairly surprised” when Plaintiffs filed this suit. Id. Plaintiffs have been
- ↑ Incidentally, the delayed FDA Response is extreme but not unprecedented. See, e.g., Bayer HealthCare, LLC v. U.S. Food & Drug Admin., 942 F. Supp. 2d 17, 22 (D.D.C. 2013) (FDA had yet to respond to a 2006 petition when it approved a related ANDA in 2013).
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