Eleventh Circuit Re-Affirms a “Rigorous Identity” Comparator Standard for Class-of-One Equal Protection Claims in Complex Regulatory Contexts

Introduction

In Hybrid Pharma LLC v. Matthew Knispel, No. 24-13095 (11th Cir. June 24, 2025), the United States Court of Appeals for the Eleventh Circuit clarified, if not tightened, the evidentiary burden a plaintiff must satisfy when advancing a “class-of-one” claim under the Equal Protection Clause. Hybrid Pharma alleged that Florida health regulators selectively enforced pharmaceutical outsourcing laws against it while sparing two competitors—Olympia Pharmacy Services (“OPS”) and KRS Global Biotechnology (“KRS”). The district court granted summary judgment to the regulators, holding that Hybrid failed to identify any “similarly situated” comparators. The Eleventh Circuit affirmed, emphasizing that, in a complex, multi-factor regulatory regime, a plaintiff’s proffered comparators must be “prima facie identical in all relevant respects.”

The opinion does not create wholly new doctrine but consolidates and applies existing precedent in a nuanced setting—state/federal dual regulation of pharmaceutical compounding facilities—thereby carving out a practical guide for future litigants facing the same argument.

Summary of the Judgment

1. Holding. The appellate panel (Jordan, Abudu & Kidd, JJ., per curiam) affirmed summary judgment for the defendants because Hybrid failed to present evidence that OPS or KRS were “similarly situated in all relevant respects,” a prerequisite to a viable class-of-one claim.

2. Key Findings.

  • Merely operating in the same industry, under the same statutes, and subject to the same inspectors is insufficient to establish comparator status.
  • When challenging “complex, multi-factored government decision-making processes,” the comparator’s conduct must mirror the plaintiff’s challenged conduct (same deficiencies, same factual posture, same temporal frame).
  • The record showed Hybrid accumulated multiple, distinct deficiencies (e.g., uncertified anteroom, instrument calibration lapses) that were not shown to exist at OPS or KRS; accordingly, Hybrid could not prove unequal treatment.

Analysis

Precedents Cited

  • PBT Real Estate, LLC v. Town of Palm Beach, 988 F.3d 1274 (11th Cir. 2021) – requires comparator entities to be “prima facie identical in all relevant respects.” Hybrid is essentially an application of PBT to the pharmaceutical-regulation context.
  • Griffin Industries, Inc. v. Irvin, 496 F.3d 1189 (11th Cir. 2007) – coined the “apply with rigor” directive when evaluating similarity; quoted repeatedly by the panel.
  • Campbell v. Rainbow City, 434 F.3d 1306 (11th Cir. 2006) – established that different treatment of dissimilarly-situated parties does not offend equal protection.
  • City of Cleburne v. Cleburne Living Ctr., 473 U.S. 432 (1985) – foundational equal protection authority, cited for the overarching principle of treating like cases alike.
  • Douglas Asphalt Co. v. Qore, Inc., 541 F.3d 1269 (11th Cir. 2008) – comparator analysis in a public-contract dispute; supplies the “objectively reasonable governmental decision-maker” test quoted here.
  • Title VII employment cases (Lewis v. City of Union City, 918 F.3d 1213 (11th Cir. 2019) (en banc)) are invoked analogously to illustrate rigorous comparator scrutiny.

Legal Reasoning

The opinion unfolds in three logical steps:

  1. Restatement of the Comparator Standard. Drawing from PBT Real Estate and Griffin, the court reiterates that “similarly situated” is a strict threshold issue. Unless the plaintiff clears it, the rational-basis strand of a class-of-one claim never activates.
  2. Record-Specific Application. The panel parses each enforcement episode: anteroom certification (2013), personnel training, special sterile compounding permit (SSCP) revocation (2014-15), repeated deficiencies (2017-23). In each instance Hybrid produced no admissible evidence showing OPS or KRS committed the same violation yet avoided sanction. Thus, no genuine dispute of material fact existed.
  3. Rejection of Hybrid’s “Industry-wide” Theory. Hybrid argued that all Section 503B outsourcing facilities are, by definition, similarly situated. The court calls this “too broad,” warning that such a construction would swallow the comparator requirement and convert every regulatory variance into a constitutional tort.

Impact

The decision’s practical consequences are multi-layered:

  • Regulatory Enforcement Space. Agencies administering complex, technical regulations (pharmaceuticals, environmental, financial) can rely on Hybrid to resist equal-protection challenges predicated merely on uneven inspection frequency or sanction counts. Plaintiffs must produce “mirror-image” comparators.
  • Pleading & Discovery Strategy. Litigants eyeing a class-of-one claim should marshal detailed, side-by-side evidentiary charts early—FOIA/State-public-records requests, 483 inspection reports, deficiency letters—to survive summary judgment.
  • Attorney’s Fees Exposure. The district court here (in a separate order) awarded fees to the State, branding the suit “frivolous.” That outcome, unreviewed in this appeal, signals increased financial risk for plaintiffs proceeding on thin comparator showings.
  • Precedential Weight. Although “DO NOT PUBLISH” designations limit formal precedential value under 11th Cir. R. 36-2, the opinion is citable for its persuasive reasoning and harmonizes published circuit law—expect district courts within the circuit to quote it liberally.

Complex Concepts Simplified

  • Class-of-One Claim. A lawsuit where the plaintiff says, “I am not a member of a protected class, but the government singled me out arbitrarily.” Think of it as a “Why only me?” theory of equal protection.
  • Comparator. Another person or entity that is just like the plaintiff in every way that matters to the government decision at issue. In employment cases, it might be a co-worker with the same job and disciplinary history; in Hybrid, it would require another pharmacy with the same deficiencies.
  • Section 503B Outsourcing Facility. Under the Federal Food, Drug & Cosmetic Act, a pharmacy that compounds large-scale sterile drugs for hospitals and clinics under a special registration, subject to FDA “Good Manufacturing Practices” and state licensing.
  • Deficiency / 483 Observation. A citation by regulators during an inspection identifying a potential violation; severity ranges from paperwork missteps to critical sterile-compounding failures.
  • SSCP (Special Sterile Compounding Permit). Florida’s extra layer of authorization required to manufacture high-risk sterile preparations; losing it can cripple a compounding business.

Conclusion

Hybrid Pharma LLC v. Knispel reinforces that a plaintiff cannot short-circuit the “similarly situated” inquiry by invoking industry-wide commonalities. In the Eleventh Circuit, especially where the government exercise involves “complex, multi-factored” judgment, the comparator must be “very similar indeed.” Absent concrete, side-by-side proof of identical misconduct treated differently, a class-of-one claim will not survive summary judgment—and may even invite fee shifting.

Practitioners should therefore invest early in fact-intensive comparator discovery, or, alternatively, evaluate other constitutional or statutory theories (e.g., First-Amendment retaliation, substantive due process, or state-law selective enforcement) that do not erect so formidable a gateway. The Eleventh Circuit’s message is clear: equal protection litigants must bring more than “we are in the same business.” They must show: “We broke the same rules in the same way, but only we were punished.”