On July 27, 2012, in Friedman et al. v. Sebelius, the United States Court of Appeals for the D.C. Circuit held that the Department of Health & Human Services may exclude from participation in federal health care programs three former Purdue Pharma executives who pleaded guilty to misdemeanor misbranding of Oxycontin. Friedman is the first appellate decision to address whether a misdemeanor conviction under the Food, Drug, and Cosmetic Act can expose a defendant to permissive exclusion under 42 U.S.C. § 1320a-7(b). Friedman holds that an individual will be subject to permissive exclusion “if the conduct underlying the conviction is factually related to fraud.” The Friedman decision — a full copy of which can be found here —underscores the value of obtaining, if possible, some type of assurance from the government that HHS will not seek exclusion if a corporate or individual client agrees to plead guilty to a misdemeanor FDCA offense.
On May 10, 2007, Purdue Pharma pleaded guilty to felony misbranding, admitting to allegations that it falsely marketed Oxycontin as posing a lower risk of abuse and addiction than non-time released painkillers. On that same day, three of the company’s top executives — Michael Friedman (president), Howard Udell (general counsel), and Dr. Paul Goldenheim (medical director) — pleaded guilty, under the so-called “Responsible Corporate Officer doctrine,” to “misdemeanor misbranding . . . for their admitted failure to prevent Purdue’s fraudulent marketing of Oxycontin.” In their plea agreements, the executives disclaimed any knowledge of the fraudulent marketing of Oxycontin; they admitted only that they failed to discharge their “‘responsibility and authority to prevent in the first instance or to promptly correct’ the misrepresentations certain unnamed Purdue employees made regarding Oxycontin.”
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