Leo Parrino v. United States

655 F. App'x 399
CourtCourt of Appeals for the Sixth Circuit
DecidedJuly 12, 2016
DocketNo 15-5921
StatusUnpublished
Cited by11 cases

This text of 655 F. App'x 399 (Leo Parrino v. United States) is published on Counsel Stack Legal Research, covering Court of Appeals for the Sixth Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Leo Parrino v. United States, 655 F. App'x 399 (6th Cir. 2016).

Opinion

KETHLEDGE, Circuit Judge.

Pharmacist Leo Parrino pled guilty to a federal misdemeanor for introducing and delivering" misbranded inhalation drugs into interstate commerce. As a result of his conviction, he cannot participate in any federal healthcare program for five years. Parrino petitioned the district court to set aside his conviction, arguing that he would not have pled guilty had he known that his conviction would effectively prevent him from working as a pharmacist. The district court denied Parrino’s petition and we affirm.

I.

Parrino began working as a pharmacist in 1974. In 2002, he went to work for National Respiratory Services, where he was responsible for preparing and mixing pharmaceutical ingredients to create respiratory medications. In 2008, an FDA investigator audited National Respiratory and found that it was distributing extremely subpotent doses of budesonide, a steroid suspension used in inhalers to treat asthma and chronic obstructive pulmonary disease. The FDA investigator found company records showing that in 2005, National Respiratory had tested samples of its bu-desonide and found that much of it was subpotent and that some of it was superpo-tent. National Respiratory had shipped this defective (and thus misbranded) bude-sonide to patients in over a dozen states. Many of the misbranded budesonide doses were billed to Medicare.

In 2009, federal investigators contacted Parrino, who in 2006 had moved on to work as a pharmacist for K-Mart. According to the investigators, they specifically asked Parrino whether National Respiratory had shipped any subpotent or super-potent batches. Parrino said that any such batches had been destroyed before they were shipped to patients. The investigators returned later in the year. They asked him again whether National Respiratory had shipped any defective batches of budeso-nide, and again Parrino denied that he had. They then showed Parrino the company’s own lab reports indicating that its budesonide was defective. Parrino then changed his story: he admitted that he knew National Respiratory had shipped some defective budesonide and that he had told National Respiratory’s COO about the problem. At the end of the interview, he prepared and signed a handwritten state *401 ment acknowledging that, while he worked as National Respiratory’s pharmacist, he was aware that he had prepared defective (misbranded) budesonide that the company later shipped to patients.

In making that concession, Parrino had admitted to participation in a federal crime under 21 U.S.C. § 331(a), which prohibits the delivery of misbranded drugs into interstate commerce. Violations are punishable by up to a year in prison, or three years if the act is committed with the “intent to defraud and mislead[.]” 21 U.S.C. § 333(a)(l)-(2). In May 2010, lawyers from the U.S. Attorney’s office in Louisville met with Parrino and his lawyer, Kenneth Plotnik. They told Parrino that they hoped to secure his cooperation in a criminal case against National Respiratory’s COO. If Parrino cooperated, the government would charge him with a misdemeanor violation of the law against mis-branding; if Parrino refused, he would face a felony prosecution and could be held liable for over $2 million in restitution.

The next day, according to Plotnik, he and Parrino met to discuss Parrino’s options. Again according to Plotnik, Parrino was “extremely distraught ... and he was unwilling to really even discuss [possible] defenses very much. He was going to plead guilty to the misdemeanor, and if there were consequences, we would deal with them later.” Parrino, according to Plotnik, was well aware that there would be collateral consequences if he pled guilty to the misdemeanor charge, including the possible revocation of his pharmacist’s license by the Kentucky Board of Pharmacy.

He knew that coming in. He also knew that there was some—there was another thing called this statute that would expel him from prescribing. He knew there was a statute out there. He knew there was some federal—he had either done some research between the year after he had been contacted by the agents and he contacted me, or maybe he [knew] it from his continuing pharmaceutical education, but he knew that there was this exclusion statute associated with a fraud conviction and most—but we definitely knew about this.

Plotnik thereafter researched the federal statute in question, 42 U.S.C. § 1320a-7, which instructs the Secretary of Health and Human Services to exclude (for five years) certain individuals and entities from participation in any federal health-care program on a mandatory or permissive basis, depending on certain conditions, such as whether the excluded person has been convicted of certain crimes or has had his license suspended by a state licensing authority. See 42 U.S.C. § 1320a-7. Plotnik became convinced that Parrino would fit within the terms of the “permissive” portion of the statute, so that it would be up to the Secretary’s discretion whether Parrino was barred from participating in federal health-care programs. About one month after Parrino and Plotnik met with the U.S. Attorney’s office, Plot-nik advised Parrino that Parrino “was going to be in this permissive section and not in this mandatory exclusion section ... of course, I couldn’t guarantee that they wouldn’t exclude him because even under the permissive section, exclusion was still a possibility.”

Thus, according to Plotnik, Parrino and Plotnik had discussed the possibility that “[Parrino] could lose his license. He could lose the ability to prescribe medication. But [Parrino] was adamant that he would not ... face trial [for] the felony. He would not do it.” Plotnik was interested in exploring defenses for Parrino: “I wanted to take it to trial. I thought there were problems—constitutional problems with [the case].” But “Parrino was very unwill *402 ing to discuss defenses.” Plotnik thereafter went about negotiating a plea that would downplay Parrino’s role in the criminal conduct at National Respiratory, as part of a “strategy ... both for the purpose of the Board of Pharmacy and for the exclusion statute, to minimize [Parrino’s] activities or behaviors.” Parrino eventually pled guilty to the misdemeanor misbranding charge in September 2011. The date of his sentencing was dragged out by continuances, and Plotnik wrote in emails to Par-rino that this was a good thing: “this is going to postpone the day when you are going to face any discipline from the Board of Pharmacy.”

In 2013, the district court sentenced Parrino to one year of probation and ordered him to pay $14,000 in restitution. The Office of the Inspector General at the Department of Health and Human Services later determined that Parrino’s five-year exclusion from federal programs was mandatory. The Kentucky Board of Pharmacy also began investigating the possible revocation of Parrino’s license. Parrino thereafter lost his job as a pharmacist at K-Mart.

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Bluebook (online)
655 F. App'x 399, Counsel Stack Legal Research, https://law.counselstack.com/opinion/leo-parrino-v-united-states-ca6-2016.