Take the Fifth

Designated for publication

• Wages and White Lion Investments, L.L.C. v. Food & Drug Administration, 21-60766, c/w 21-60800, petitions for review of FDA Orders
  • Oldham, J. (joined by Richman, Jones, Smith, Elrod, Willett, Ho, Duncan, Engelhardt, Wilson, JJ.); Haynes, J., dissenting (joined by Stewart, Southwick, Higginson, Douglas, JJ.); Graves, J., joining dissent in part; administrative law
  • Granting petition for review of FDA marketing denial orders regarding flavored e-cigarettes, setting orders aside, and remanding to the FDA for reconsideration of the e-cigarette manufacturers’ premarket tobacco applications (“PMTAs”).
  • The en banc majority held that the FDA’s denial of the petitioners’ PMTAs was arbitrary and capricious for four reasons:
    • First, the Court held that the denials violated the prohibition on post hoc rationalizations. The Court noted that the FDA in providing guidance and clarifications as to the PMTA application process for flavored e-cigarettes had emphasized the “critical” nature of the applicants’ marketing plans, while disclaiming the need to conduct new long-term studies. “In the MDOs, however, FDA explicitly stated that its instructions were all for naught. First, FDA determined that the mere existence of flavor was sufficient to justify denial of a PMTA because flavor standing alone was enough to prove that youth would use the proposed product and that youth use would outweigh any countervailing benefit to adults. Gone was any suggestion that a manufacturer could do anything to limit youth access to its products. And second, FDA stated that it did not even read the marketing plans it previously said were critical.” The Court then noted that, at oral argument, FDA’s counsel had changed this position and argued that the FDA had looked at summaries of the marketing plans, which the Court characterized as a post hoc rationalization.
    • Second, the Court invoked the fair notice doctrine. “At its core, the doctrine requires administrative agencies to give the public fair notice of their rules before finding a violation of them.” The Court held that the difference between the FDA’s pre-decision guidance and its across-the-board denial of all flavored e-cigarette PMTAs was “stark.” “Then FDA flip-flopped. FDA turned around and denied petitioners’ applications because they did not perform ‘a randomized controlled trial and/or longitudinal cohort study’ or other comparably robust evidence that directly measured the behaviors of those who use their flavored products. See A.57, A.85 & n.vi. And when petitioners submitted voluminous, robust scientific studies to show e-cigarettes induce adults to switch from smoking (and thus save lives), FDA categorically rejected that data as irrelevant because it did not show flavored e-cigarettes promote more switching than unflavored ones. See A.57. And FDA ignored as irrelevant petitioners’ observational cross-section studies without any acknowledgement that the agency previously invited them.”
    • Third, the Court looked to the change-in-position doctrine, which prohibits an agency from changing position without acknowledging the changed position and explaining the rationale for it. “If an agency is arbitrary and capricious when it (1) acknowledges changing its position from (2) a policy reflected in a solitary OIG report, see PSR, 956 F.3d at 645–48, how much more arbitrary and capricious is the agency when it (1) refuses to acknowledge the change in its position from (2) its own voluminous guidance documents, PowerPoint decks, and enforcement memoranda promulgated over years and reiterated in numerous different ways?”
    • Finally, the Court examined the good faith reliance doctrine, under which, “even when an agency lawfully changes its position, it cannot fault a party for relying in good faith on the prior one.”
  • The majority also discounted the FDA’s argument that five other Circuits have sided with the FDA, while only the Eleventh Circuit (and now the Fifth) had found against it. “[L]aw is not a nose-counting exercise. … Rather, the relevant question is whether our sister circuits have spotted a defect in petitioners’ arguments that we have missed. With deepest respect for our colleagues who have seen this case the other way, we think not.”
  • The Court then rejected FDA’s argument that any arbitrary and capricious action was harmless error because the agency would likely deny the petitioners’ applications on remand. The Court explained that the administrative harmless error rule is “quite narrow.” “[T]he Administrative Procedure Act requires agencies to follow procedures, and those procedures are what give agency decisions legitimacy. A court cannot forgive procedural violations simply because the court thinks they did not matter. … APA errors are only harmless where the agency would be required to take the same action no matter what. In all other cases, an agency cannot avoid remand.”
  • Judge Haynes dissented, joined by Judges Stewart, Southwick, Higginson, and Douglas. She summarized her position: “As I discuss more fully below, the e-cigarettes are not safe. Just as being shot in the stomach might be less likely to cause death than being shot in the head, but neither one is wanted, neither e-cigarettes nor cigarettes are safe. As such, the focus on e-cigarettes has been to assist those already addicted, not to create a whole new group of youth becoming addicted. Thus, while this dissenting opinion is long, a short sentence could sum it up: the Petitioners here did not establish that their products would so sufficiently assist adults that it would overcome the harm to youth.” She conducted an APA review cognizant that the Court’s reviewing role under the APA is narrow and does not allow the Court to review the agency’s evaluation of relevant evidence.
  • Judge Graves separately dissented, joining Judge Haynes’ conclusion that the FDA had not acted arbitrarily and capriciously, but disagreeing only as to Judge Haynes’ conclusion that the FDA had reviewed the applicants’ marketing plans; Judge Graves agreed with the majority’s conclusion that the FDA in fact had not reviewed those marketing plans, but opined that there was no error in that failure.

• U.S. v. Diaz, 22-50951, c/w U.S. v. Marrufo, 22-50956, appeal from W.D. Tex.
  • Englehardt, J. (Clement, Engelhardt, Oldham), criminal, sentencing
  • Affirming convictions for conspiracy to commit murder in a foreign country; affirming sentence enhancement for obstruction of justice; affirming conviction of one co-defendant for aiding and abetting the murders; but vacating imposition of three consecutive life sentences on one of the co-defendants; and remanding for resentencing.
  • The Court held that, viewing the evidence in the record in a light favorable to the jury’s verdict, there was sufficient evidence to support the conviction for conspiracy to commit murder in a foreign country.
  • The Court held that there was sufficient evidence to support imposition of the “sentencing enhancement for obstructing or impeding the administration of justice based on the destruction of the vehicle Perez Marrufo used in the Consulate Murders.”
  • The Court held that there was sufficient evidence of one co-defendant’s conviction of aiding and abetting because the evidence shows that he was encouraging and enabling the murders by running the communications between the hit squads on the day of the murders.
  • The Court held, however, that there was plain error in the sentencing of that co-defendant to three consecutive life sentences. “The record indicates that the district court believed the consecutive life sentences on these three counts were mandatory. However, while this case was pending, the Supreme Court held that section 924(c)(1)(D)(ii)’s bar on concurrent sentences does not extend to a sentence imposed under section 924(j). Lora v. United States, 599 U.S. 453, 455, 458 (2023).”

• Mejia-Alvarenga v. Garland, 22-60554, petition for review of BIA order
  • Elrod, J. (Higginbotham, Smith, Elrod), immigration
  • Denying in part and dismissing in part Salvadoran citizen’s petition for review of BIA order denying application for asylum.
  • The Court held that the BIA did not err in finding that the Salvadoran government would be unable to protect her from private persecution by a man who had previously raped her and threatened her based on her report of him to the authorities and his subsequent arrest. The Court held that the BIA appropriately applied the “complete helplessness” standard in evaluating the ability/willingness of the government to protect her.
  • The Court held that the BIA did not show bias when it ruled against her on various issues without first requiring briefing by DHS.
  • The Court rejected the petitioner’s due process claim based on the BIA’s decision by a single ALJ rather than a three-ALJ panel.

• Banks v. Herbrich, 23-20107, appeal from S.D. Tex.
  • Douglas, J. (Wiener, Willett, Douglas), Wiener, J., dissenting in part; § 1983, qualified immunity
  • Affirming in part and reversing in part denial of qualified immunity summary judgment to the Texas department of Family and Protective Services on plaintiff’s claims of violation of the Fourth and Fourteenth Amendment based on DFPS’s removal of the plaintiff’s son from her custody.
  • The Court held that there was no evidence in the record supporting DFPS’s allegations that there were exigent circumstances requiring the immediate removal of the child from the home, and that it was a clearly established violation of the Fourth Amendment for the DFPS investigators to remove him. However, the Court held that there was not a clearly established violation by the Investigation Supervisor.
  • Judge Wiener dissented in part, as he would find that none of the DFPS defendants, including the Investigation Supervisor, should be entitled to qualified immunity.

Unpublished

• Securities and Exchange Commission v. Barton, 23-10046, appeal from N.D. Tex.
  • per curiam (Stewart, Dennis, Wilson), receivership, mootness
  • Dismissing as moot appeal from receivership order, after issuance of new receivership order.

• U.S. v. Ordonez-Dominguez, 23-10486, c/w 23-10496, appeal from N.D. Tex.
  • per curiam (Willett, Duncan, Wilson), criminal, sentencing
  • Affirming conviction and 37-month sentence for illegal reentry.

• Keyes v. BP Exploration & Production, Inc., 23-30365, appeal from E.D. La.
  • per curiam (Jones, Southwick, Graves), toxic tort
  • Affirming summary judgment in favor of BP on toxic tort case brought by plaintiff pro se on behalf of his mother, and issuing sanctions warning to plaintiff for including derogatory comments about the district court judge.

• U.S. v. Olvera-Rodriguez, 23-40431, appeal from S.D. Tex.
  • per curiam (King, Haynes, Graves), criminal
  • Granting Anders motion to withdraw, and dismissing appeal.