Case 1:20-cv-00532-JEB Document 36 Filed 05/24/21 Page 1 of 8
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`UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF COLUMBIA
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`JEFFREY NATHAN SCHIRRIPA,
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`Plaintiff,
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`v.
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`JANET WOODCOCK,
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` Defendant.
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`Civil Action No. 20-532 (JEB)
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`MEMORANDUM OPINION
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`Like many entrepreneurs in the United States, Plaintiff Jeffrey Nathan Schirripa has
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`jumped on the marijuana trend. But unlike those who sell unregulated body lotions or dog treats
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`laced with the cannabinoids found in the popular plant, Schirripa has developed a dietary
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`supplement that requires approval from the Food and Drug Administration. After failing on his
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`first petition to the agency, Plaintiff asked for reconsideration. Following denial of this
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`reconsideration petition, he filed this pro se suit against the then-FDA commissioner, asking this
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`Court to set aside the agency’s decision. In now seeking summary judgment, FDA has identified
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`two reasons why the Court should not do so: Schirripa lacks standing and the agency decision
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`conformed to standards of rationality. Although the Court disagrees on standing, it finds ample
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`justification for the agency’s decision and will therefore grant its Motion for Summary
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`Judgment.
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`I.
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`Background
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`While the Court must at this stage view the facts in the light most favorable to Schirripa,
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`see Talavera v. Shah, 638 F.3d 303, 308 (D.C. Cir. 2011), he has made parsing such facts is no
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`Case 1:20-cv-00532-JEB Document 36 Filed 05/24/21 Page 2 of 8
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`easy matter. According to Plaintiff, he has “invented the first method of commercializing a new
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`line of dietary supplements” containing marijuana-derived cannabinoids. See ECF No. 1
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`(Compl.), ¶ 1; see also ECF No. 25 (Def. MSJ) at 1. In September of 2015, Schirripa filed a
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`citizen petition with FDA urging it to “protect and utilize” an older patent “pertain[ing] to
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`methods of using cannabinoids, specifically cannabidiols, as a class of antioxidant drugs with
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`particular application as neuroprotectants,” which is held by the Department of Health and
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`Human Services. See Def. MSJ at 5 (citation omitted). The citizen-petition process allows an
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`individual to ask the FDA commissioner “to issue, amend, or revoke a regulation or order, or to
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`take or refrain from taking any other form of administrative action.” 21 C.F.R. § 10.25(a). The
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`commissioner must then deny, approve, dismiss, or provide a tentative response to any petition
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`within 180 days of receipt. Id. § 10.30(e). After FDA did not respond within 180 days, Plaintiff
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`filed a different suit in May 2017 alleging violations of the Administrative Procedure Act that
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`were premised on such delay — violations that were cured when FDA denied the petition in July
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`of that year. See Schirripa v. Gottlieb, No. 17-1060, 2018 WL 4567163, at *1 (D.D.C. Sept. 24,
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`2018); Def. MSJ at 5–6.
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`Following his failure on the first petition, Schirripa filed a petition for reconsideration,
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`see 21 C.F.R. § 10.33, “which included gifted-samples” of his product and a “proposed . . .
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`partnership” with the agency. See Compl., ¶ 4. Defendant denied the reconsideration petition on
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`several grounds. See Def. MSJ at 7. First, FDA found it untimely under the applicable 30-day
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`deadline, see 21 C.F.R. § 10.33(b), and the agency also found “no good cause for extending that
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`deadline.” Def. MSJ at 7. Additionally, it applied the four necessary factors for reconsideration
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`outlined in 21 C.F.R. § 10.33(d): 1) “The petition demonstrates that relevant information or
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`views contained in the administrative record were not previously or adequately considered”; 2)
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`Case 1:20-cv-00532-JEB Document 36 Filed 05/24/21 Page 3 of 8
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`“The petitioner’s position is not frivolous and is being pursued in good faith”; 3) “The petitioner
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`has demonstrated sound public policy grounds supporting reconsideration”; and 4)
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`“Reconsideration is not outweighed by public health or other public interests.” Id. FDA
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`concluded that “it had carefully reviewed all relevant information” in the initial petition and “that
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`it would neither be in the public interest nor the interest of justice to grant the reconsideration
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`petition.” Def. MSJ at 7–8.
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`Schirripa took issue with the denial, prompting this suit asking the Court to set aside
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`FDA’s decision. See Compl. at 1. Plaintiff alleges that “there is substantial evidence that would
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`lead a reasonable person to conclude that there is no rational basis” for FDA’s denial. Id., ¶ 12.
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`Specifically, he asserts that Defendant neglected to consider his “gifted-sample.” Id., ¶¶ 10–11.
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`After several months of back and forth, the parties have now filed Cross-Motions for Summary
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`Judgment.
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`II.
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`Legal Standard
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`Because of the limited role federal courts play in reviewing administrative decisions, the
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`typical Federal Rule 56 summary-judgment standard does not apply to the parties’ dueling
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`Motions. Sierra Club v. Mainella, 459 F. Supp. 2d 76, 89–90 (D.D.C. 2006). Instead, “the
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`function of the district court is to determine whether or not . . . the evidence in the administrative
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`record permitted the agency to make the decision it did.” Id. at 90 (quoting Occidental Eng’g
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`Co. v. INS, 753 F.2d 766, 769 (9th Cir. 1985)). Summary judgment thus serves as the
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`mechanism for deciding, as a matter of law, whether an agency action is supported by the
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`administrative record and is otherwise consistent with the APA standard of review. Bloch v.
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`Powell, 227 F. Supp. 2d 25, 31 (D.D.C. 2002).
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`Case 1:20-cv-00532-JEB Document 36 Filed 05/24/21 Page 4 of 8
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`The APA “sets forth the full extent of judicial authority to review executive agency
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`action for procedural correctness.” FCC v. Fox Television Stations, Inc., 556 U.S. 502, 513
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`(2009). It requires courts to “hold unlawful and set aside agency action, findings, and
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`conclusions” that are “arbitrary, capricious, an abuse of discretion, or otherwise not in
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`accordance with law.” 5 U.S.C. § 706(2)(A). Agency action is arbitrary and capricious if, for
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`example, the agency “entirely failed to consider an important aspect of the problem, offered an
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`explanation for its decision that runs counter to the evidence before the agency, or is so
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`implausible that it could not be ascribed to a difference in view or the product of agency
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`expertise.” Motor Vehicle Mfrs. Ass’n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43
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`(1983). Under this “narrow” standard of review, an agency is required to “examine the relevant
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`data and articulate a satisfactory explanation for its action including a ‘rational connection
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`between the facts found and the choice made.’” Id. (quoting Burlington Truck Lines v. United
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`States, 371 U.S. 156, 168 (1962)). Put another way, the court’s role is only to “consider whether
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`the decision was based on a consideration of the relevant factors and whether there has been a
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`clear error of judgment.” Am. Oceans Campaign v. Daley, 183 F. Supp. 2d 1, 4 (D.D.C. 2000)
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`(quoting Citizens to Preserve Overton Park, Inc. v. Volpe, 401 U.S. 402, 416 (1971)).
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`It is not enough, then, that the court would have come to a different conclusion from the
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`agency. See Oceana, Inc. v. Pritzker, 24 F. Supp. 3d 49, 58 (D.D.C. 2014) (citing Steel Mfrs.
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`Ass’n v. EPA, 27 F.3d 642, 646 (D.C. Cir. 1994)). The reviewing court “does not substitute its
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`own judgment for that of the agency.” Id. A reviewing court holds an agency only to “certain
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`minimal standards of rationality.” Nat’l Env’t Dev. Ass’ns Clean Air Project v. EPA, 686 F.3d
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`803, 810 (D.C. Cir. 2012) (quoting Ethyl Corp. v. EPA, 541 F.2d 1, 36–37 (D.C. Cir. 1976) (en
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`banc)).
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`Case 1:20-cv-00532-JEB Document 36 Filed 05/24/21 Page 5 of 8
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`III. Analysis
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`Plaintiff maintains that judgment in his favor is appropriate on his APA claims, while
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`FDA counters that Schirripa both lacks standing and cannot succeed on the merits. The Court
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`will begin its analysis with the former issue. See Steel Co. v. Citizens for a Better Env’t, 523
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`U.S. 83, 94 (1998) (establishing that courts are “bound to ask and answer” the “first and
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`fundamental question” of jurisdiction) (citation omitted). Because it finds that Schirripa has
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`standing, it will then move to the central question presented — whether FDA made a clear error
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`in denying reconsideration.
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`A.
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`Standing
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`Contrary to what laypersons might believe, not every aggrieved person gets to have her
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`day in court. To properly invoke the jurisdiction of federal courts, a plaintiff must demonstrate
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`that she has a “case” or “controversy” within the parameters of Article III, a doctrine known
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`as standing. See U.S. Const. art. III, § 2, cl. 1. Standing requires, at a minimum, that a plaintiff
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`show by a “substantial probability,” Sierra Club v. EPA, 292 F.3d 895, 899 (D.C. Cir. 2002)
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`(citation omitted), that she “(1) suffered an injury in fact, (2) that is fairly traceable to the
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`challenged conduct of the defendant, and (3) that is likely to be redressed by a favorable judicial
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`decision.” Spokeo, Inc. v. Robins, 136 S. Ct. 1540, 1547 (2016). The “injury in fact” must be
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`both “(a) concrete and particularized and (b) actual or imminent, not conjectural or
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`hypothetical.” Friends of the Earth, Inc. v. Laidlaw Env’t Servs. (TOC), Inc., 528 U.S. 167, 180
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`(2000). An injury is “particularized” when it “affect[s] the plaintiff in a personal and individual
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`way,” and it is “concrete” when it is “real, and not abstract,” Spokeo, 136 S. Ct. at 1548
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`(citations and internal quotation marks omitted), although “intangible injuries can nevertheless
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`be concrete.” Id. at 1549. The Court “assume[s] for purposes of standing that [Plaintiff] will
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`Case 1:20-cv-00532-JEB Document 36 Filed 05/24/21 Page 6 of 8
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`ultimately receive the relief sought.” Fla. Audubon Soc’y v. Bentsen, 94 F.3d 658, 665 (D.C.
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`Cir. 1996) (en banc).
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`Although Plaintiff does not address standing directly, it is clear from his filings that his
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`injury stems from FDA’s denial of his reconsideration petition, foreclosing the marketing of his
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`product. See Compl., ¶¶ 14–16; ECF No. 33 (Pl. Reply) at 1–2. While Defendant contends that
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`this alleged injury is “highly speculative, if not impossible,” Def. MSJ at 11, the Court is not
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`persuaded. Schirripa has identified an agency decision that “affect[s him] in a personal and
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`individual way,” Spokeo, 136 S. Ct. at 1548: FDA has denied, in a final action, Plaintiff’s
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`request for reconsideration, leaving him with no recourse but to challenge the denial in court.
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`The agency counters, without entirely explaining the point, that Schirripa has not suffered any
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`injury because his ability to use the older patent is outside the agency’s control, as such patent is
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`assigned to HHS and expired regardless. See Def. MSJ at 6, 11–12. For purposes of standing,
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`however, the Court must assume that Schirripa will succeed on his reconsideration petition and
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`obtain the ability to market his product. See Fla. Audubon Soc., 94 F.3d at 665.
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`The final two standing elements of causation and redressability can be quickly addressed
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`together. Here, it is not hard to see that FDA directly caused the injury Schirripa has alleged: the
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`agency itself denied the reconsideration petition that is the crux of Plaintiff’s case. In that same
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`vein, a decision by this Court setting aside FDA’s denial would directly redress the injury by
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`requiring reconsideration of that petition. And, again, although the agency casts significant
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`doubt on the upshot of such reconsideration, see Def. MSJ at 12–13, that does not factor into the
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`standing analysis. See Fla. Audubon Soc., 94 F.3d at 665.
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`Because the Court finds that Schirripa has satisfied all three standing requirements, it
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`proceeds to consideration of the merits.
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`Case 1:20-cv-00532-JEB Document 36 Filed 05/24/21 Page 7 of 8
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`B.
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`Merits
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`In seeking summary judgment, FDA first points out that it correctly denied Schirripa’s
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`reconsideration petition as untimely. See Def. MSJ at 7. By regulation, requests for
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`reconsideration “must be submitted . . . no later than 30 days after the date of the decision
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`involved.” 21 C.F.R. § 10.33(b). Here, the relevant date of decision is July 27, 2017, when FDA
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`denied Plaintiff’s citizen petition. See Def. MSJ at 6. Schirripa did not file for reconsideration
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`until September 1, 2017, id. at 7, five days past his deadline. Denial was thus appropriate. It is
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`true that FDA “may, for good cause, permit a petition to be filed after 30 days,” 21 C.F.R.
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`§ 10.33(b), but Schirripa has shown no such cause. He claims only that “the parties had a
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`pending case” presenting “issues to be resolved” such that the “the deadlines for filing could not
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`reasonably be met.” Pl. Reply at 2. He is referring to his initial suit alleging that FDA failed to
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`respond to his citizen petition within the 180 days required by the APA. See Schirripa, 2018 WL
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`4567163. Yet Schirripa obtained all the relief he sought there when FDA addressed his petition
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`on July 27. He has thus not explained what further “issues” remained that would have impeded
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`his ability to file for reconsideration. FDA’s denial of his petition as untimely was thus plainly
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`reasonable.
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`Even if this Court found that Schirripa’s petition somehow did meet the statutory filing
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`deadline, FDA also denied reconsideration based on the four factors laid out in 21 C.F.R.
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`§ 10.33(d), which were described earlier. See supra Section I. The Court evaluates FDA’s
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`findings “narrow[ly],” giving significant deference to the agency’s conclusions. Motor Vehicle
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`Mfrs. Ass’n, 463 U.S. at 43. Section 10.33(d) essentially asks whether the petitioner has pointed
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`to non-frivolous, overlooked information justifying reconsideration. See 21 C.F.R. § 10.33(d).
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`Here, FDA found that “it had carefully considered all relevant information,” and that the new
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`Case 1:20-cv-00532-JEB Document 36 Filed 05/24/21 Page 8 of 8
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`information Plaintiff points to — namely, the “gifted-samples” — was “not previously
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`submitted” and was thus “outside the purview of reconsideration.” Def. MSJ at 15–16. Section
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`10.33(d) makes clear that new information must be “in the administrative record,” and the gifted
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`samples (whose value remains opaque) were not. The agency further found no “public policy
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`grounds to support reconsideration” and no “interest[s] of justice” in favor of otherwise granting
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`the petition. See Def. MSJ at 15–16. Again, given the deference owed to FDA, the Court finds
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`that its determinations contain no “clear error[s] of judgment.” Am. Oceans Campaign, 183 F.
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`Supp. 2d at 4 (quoting Overton Park, 401 U.S. at 416). The Court, accordingly, would uphold
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`the agency’s reasoning even had the petition been timely submitted.
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`IV. Conclusion
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`For the foregoing reasons, the Court will issue a contemporaneous Order granting
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`Defendant’s Motion for Summary Judgement and denying Plaintiff’s.
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`/s/ James E. Boasberg
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` JAMES E. BOASBERG
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`United States District Judge
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`Date: May 24, 2021
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