## Facts

- The United States brought a civil enforcement action seeking civil penalties and injunctive relief for alleged violations of the Controlled Substances Act (CSA) and related regulations.
- Ridley’s Family Markets, Inc. owned and operated a pharmacy located in a grocery store in Morgan, Utah.
- The government alleged the pharmacy filled 160 invalid controlled-substance prescriptions totaling 16,270 pills for two married individuals.
- The prescriptions allegedly included carisoprodol, hydrocodone, and oxycodone.
- The government alleged numerous “red flags” indicating potential invalidity, including cash payments, unusual prescribing patterns, high doses and long durations, early refills, dangerous combinations, same-household patients with similar prescriptions, and facial irregularities (e.g., misspellings or suspicious signatures).
- The pharmacy maintained a controlled-substance dispensing checklist designed to identify red flags, but employees allegedly did not fully complete it and allegedly dispensed without resolving the red flags.

## Issues

1. Whether the amended complaint plausibly alleged that the pharmacy unlawfully dispensed controlled substances by filling prescriptions lacking a legitimate medical purpose or outside the usual course of professional practice, given the alleged red flags.
2. Whether the pleadings sufficiently supported civil penalties and injunctive relief under 21 U.S.C. § 842(a)(1) based on alleged violations of the CSA and implementing regulations.
3. Whether certain asserted statutory or regulatory theories failed as a matter of law or were inadequately pled and therefore required dismissal at the Rule 12(b)(6) stage.

## Decision

- The court granted the motion to dismiss in part and denied it in part.
- Applying the Twombly/Iqbal plausibility standard, the court held that the government alleged enough factual matter to proceed on claims tied to dispensing controlled substances despite unresolved red flags.
- The court concluded that allegations of repeated red flags, noncompletion of the checklist, and failure to take steps to resolve concerns plausibly supported violations grounded in the pharmacist’s “corresponding responsibility” for valid prescriptions.
- The court dismissed certain aspects of the government’s case to the extent particular counts or theories were not supported by the statutory/regulatory scheme or were inadequately pleaded.

## Legal Principles

- On a Rule 12(b)(6) motion, the court accepts well-pleaded factual allegations as true and asks whether they plausibly state a claim for relief.
- Under the CSA framework, dispensing controlled substances must comply with statutory prescription requirements and implementing regulations, including the requirement that prescriptions be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice.
- Pharmacists have a “corresponding responsibility” not to fill controlled-substance prescriptions that show indicia of invalidity; allegations of multiple unresolved “red flags” can plausibly state a violation at the pleading stage.
- In CSA civil enforcement actions, courts may narrow claims where a pleaded theory does not fit the authorizing statute or regulation, even if other related theories are adequately alleged.

## Conclusion

The court allowed the government’s CSA case to proceed insofar as it plausibly alleged that the pharmacy dispensed controlled substances despite numerous unresolved red flags implicating pharmacists’ corresponding responsibility, while dismissing discrete claims or theories that were not legally supported or sufficiently pleaded.


United States v. Ridley’s Family Markets, Inc., 525 F. Supp. 3d 1355 (D. Utah 2021)