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The way the government debarred a general counsel and two other executives from federal healthcare programs for 12 years “raises serious constitutional due process concerns about the government’s interpretation” of the law, the Washington Legal Foundation said Wednesday. The statement came in the group’s amicus brief to the U.S. Court of Appeals in Washington, D.C. The brief supports the appeals of former Purdue Pharma executives — general counsel Howard Udell, CEO Michael Friedman, and chief medical officer Paul Goldenheim. The three were debarred after being convicted in 2007 of a criminal misdemeanor as “responsible corporate officers” of a company that misbranded the addictive prescription drug Oxycontin. Udell hasn’t returned calls for comment. He is the first known general counsel to be debarred under the responsible officer doctrine. It says, in effect, that an executive can be convicted of a criminal misdemeanor even if he personally did nothing wrong, but failed to detect and stop those who did. Richard Samp, chief counsel at the foundation and co-author of the brief, called the case a precursor of things to come. “Since this was filed, and in the last year or so, the FDA [Food and Drug Administration] has come out with guidelines that suggest they will be bringing exclusion proceedings against executives in similar situations,” Samp said. “If they have their way, this case will no longer be the outlier.” The brief says the case has great significance because the group has members and supporters who are directly threatened by the government’s use of the responsible corporate officer doctrine to impose strict criminal liability “and then impose harsh penalties such as exclusion from participation in federal programs.” The foundation offers two key arguments in asking the court to overturn the debarments. First, that exclusion is too severe a penalty for a strict liability misdemeanor and raises serious due process concerns. And second is that the government’s interpretation of a statute allowing strict liability is wrong and conflicts with the U.S. Constitution’s requirement of due process. The brief urges the court to overturn that interpretation of the statute. All briefs are due to the court by September 1, and no date for oral arguments is yet set. Since his debarment, Udell has gone into private practice at the Udell Law Office, LLC, in Westport, Connecticut. See also: “Judge Rules Against Debarred Ex-Purdue Pharma General Counsel Howard Udell ,” CorpCounsel.com, December 2010.

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