Lisa Hill Leonard v. The Alabama State Board of Pharmacy

61 F.4th 902
CourtCourt of Appeals for the Eleventh Circuit
DecidedMarch 2, 2023
Docket22-11124
StatusPublished
Cited by27 cases

This text of 61 F.4th 902 (Lisa Hill Leonard v. The Alabama State Board of Pharmacy) is published on Counsel Stack Legal Research, covering Court of Appeals for the Eleventh Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Lisa Hill Leonard v. The Alabama State Board of Pharmacy, 61 F.4th 902 (11th Cir. 2023).

Opinion

USCA11 Case: 22-11124 Document: 46-1 Date Filed: 03/02/2023 Page: 1 of 25

[PUBLISH] In the United States Court of Appeals For the Eleventh Circuit

____________________

No. 22-11124 ____________________

LISA HILL LEONARD, An individual, LEONARD DRUGS INC, An Alabama Corporation d.b.a. The Drug Store, Plaintiffs-Appellants, versus THE ALABAMA STATE BOARD OF PHARMACY, A State Licensing Board, BRENDA DENSON, CHRIS PHUNG, ROBERT COLBURN, CHRISTY K. GARMON, GARY MOUNT, Individually and in their official capacities as Members USCA11 Case: 22-11124 Document: 46-1 Date Filed: 03/02/2023 Page: 2 of 25

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of the Alabama State Board of Pharmacy,

Defendants-Appellees.

Appeal from the United States District Court for the Middle District of Alabama D.C. Docket No. 3:21-cv-00596-ECM-SMD ____________________

Before WILSON, JILL PRYOR, Circuit Judges, and RUIZ, * District Judge. WILSON, Circuit Judge: In the early days of the Covid-19 pandemic, both State and Federal governments partnered with private citizens and busi- nesses to “Stop the Spread” of the virus. The government invested billions of dollars in the research, development, and production of tests to detect existing infections and vaccines to arrest the preva- lence of future infections. Thousands of businesses, schools, hos- pitals, and community organizations across the nation mobilized to distribute tests and vaccines to millions of people. To encourage voluntary participation in the distribution of these

*Honorable Rodolfo A. Ruiz II, United States District Judge for the Southern District of Florida, sitting by designation. USCA11 Case: 22-11124 Document: 46-1 Date Filed: 03/02/2023 Page: 3 of 25

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countermeasures, the Secretary of Health and Human Services (HHS) invoked the Public Readiness and Emergency Preparedness Act (PREP Act), to provide legal immunity for the individuals and organizations who provided these countermeasures to the public. Based in Auburn, Alabama, Lisa Leonard and her pharmacy were one of the thousands of businesses who answered the call to provide Covid-19 tests to the public. However, the Alabama Board of Pharmacy (the Board) concluded that Leonard’s administration of these tests fell short of the medical safety standards required un- der Alabama law. When the Board instituted an administrative en- forcement proceeding against Leonard, she sought to avail herself of the legal immunity provided by the Secretary’s PREP Act Dec- laration. Leonard filed this federal suit, seeking to enjoin the Board from even considering the charges against her. The district court exercised its discretion to abstain under Younger v. Harris, 401 U.S. 37 (1971) and declined to intervene in the Board’s proceedings. This appeal followed. After careful review of the record, and with the benefit of oral argument, we affirm the district court’s decision to abstain un- der Younger. Leonard and her business have an adequate oppor- tunity to raise their federal immunity argument before the Board, and none of the exceptions to Younger abstention apply in this case. USCA11 Case: 22-11124 Document: 46-1 Date Filed: 03/02/2023 Page: 4 of 25

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I. Background A.

On January 31, 2020, the Secretary of HHS declared a public health emergency in the United States following the outbreak of the Covid-19 pandemic. Two months later, on March 17, 2020, the Secretary issued a declaration pursuant to the PREP Act in order “to provide liability immunity for activities related to medical countermeasures against COVID-19.” Declaration Under the Pub- lic Readiness and Emergency Preparedness Act for Medical Coun- termeasures Against COVID-19, 85 Fed. Reg. 15,198 (Mar. 17, 2020) (the Declaration). Under the Declaration, “covered persons” receive PREP Act immunity for administering “covered countermeasures.” Covered countermeasures include “any diagnostic [test] . . . used to treat, di- agnose, cure, prevent, or mitigate COVID-19.” Id. at 15,202. On April 8, 2020, HHS issued guidance advising that pharmacists were covered persons for purposes of the Declaration and thus entitled to PREP Act immunity. U.S. Dep’t of Health and Hum. Servs., Guidance for Licensed Pharmacists, COVID-19 Testing, and Im- munity under the PREP Act (Apr. 8, 2020) [hereinafter, Pharmacist Guidance], https://www.phe.gov/Preparedness/legal/pre- pact/Documents/pharmacist-guidance-COVID19-PREP-Act.pdf. B. Lisa Leonard and her husband, Craig, are licensed pharma- cists in Auburn, Alabama. Together they owned and operated USCA11 Case: 22-11124 Document: 46-1 Date Filed: 03/02/2023 Page: 5 of 25

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“The Drug Store” pharmacy. The Drug Store began administering antibody tests at the end of April 2020, and between April and Sep- tember of 2020 it administered more than 5,900. Leonard’s trouble with the Board began during the summer of 2020. Board investigator Sean Malloy first visited The Drug Store on June 14, 2020, to address alleged customer privacy com- plaints. Later, on July 27, 2020, Chuck Beams, a competing phar- macist at a local hospital, contacted the Board with concerns about testing practices at The Drug Store. Malloy began corresponding with Beams about his complaint and, at Malloy’s request, Beams provided a written statement to Malloy on July 29. Later, after Beams requested an update on his complaint, Malloy responded on August 7, 2020, stating that they would be meeting with Leonard soon and “[i]f all goes the way we plan then I believe we will stop any further issues from The Drug Store.” Meanwhile, investigator Glenn Wells called Leonard to dis- cuss Beams’s complaint. This was not the first time that Wells and Leonard had crossed paths. In 2005, Leonard accused Wells of brandishing a gun at her, though Wells denies this. On August 26, 2020, Malloy and Wells visited The Drug Store in person and spoke with Leonard about the administration of antibody tests at the pharmacy. A month later, a third investigator named Mark Delk visited the pharmacy. He requested that Leonard and her husband provide a written statement about the 2005 incident with Wells. Following these interactions, Leonard and her pharmacy voluntarily stopped providing antibody tests without any Board USCA11 Case: 22-11124 Document: 46-1 Date Filed: 03/02/2023 Page: 6 of 25

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action. Nearly seven months later, the Board filed a Statement of Charges against Leonard and The Drug Store. The charges alleged that the way the pharmacy administered the antibody tests violated Alabama’s pharmacy regulations and the Board’s ethics rules. Among other things, the Charges alleged that the pharmacy mis- represented the nature of the antibody tests to its customers, failed to safely dispose of lancets 1 used to administer the tests, and used alcohol swabs improperly when administering the tests. Leonard filed this suit in the Middle District of Alabama. Her complaint, as amended, alleged that the Board’s charges were violations of antitrust laws, ultra vires, preempted, and unconstitu- tional. Leonard requested a preliminary injunction to restrain the Board from proceeding on its Statement of Charges. In particular, Leonard argued that the PREP Act’s “Targeted [L]iability [P]rotec- tions,” 42 U.S.C. § 247d-6d, immunized her. The Board moved to dismiss the complaint for failure to state a claim, and the district court agreed as to all but the PREP Act claims. Regarding these, the district court abstained from federal jurisdiction pursuant to Younger v. Harris,

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61 F.4th 902, Counsel Stack Legal Research, https://law.counselstack.com/opinion/lisa-hill-leonard-v-the-alabama-state-board-of-pharmacy-ca11-2023.