Harkonen’s Supreme Court Petition Denied

December 20, 2013

By Anne K. Walsh

With no fanfare, the U.S. Supreme Court on Monday denied a writ of certiorari in a case watched closely by the drug and device industry.  As reported earlier, the former CEO of InterMune Inc., Scott Harkonen, had filed a petition asking the Court to review his felony conviction of wire fraud related to statements he made regarding a clinical trial of the drug Actimmune.  The Pharmaceutical Research and Manufacturers of America (PhRMA) submitted an amicus brief supporting Harkonen’s position that the conviction chills commercial free speech. 

In contrast, the United States highlighted in its opposition brief the evidence establishing the fraudulent nature of Harkonen’s conduct, thus arguing that his speech was not constitutionally protected.  According to the government, the evidence presented at trial showed that Harkonen was told by multiple people on multiple occasions that the study had failed.  Harkonen allegedly also was aware that any post hoc analysis of the data was unreliable and inconclusive.  Nevertheless Harkonen’s press release allegedly touted “statistically significant survival benefit” from use of the drug, and failed to state that the positive results were based on unblended post hoc analyses that are generally considered unreliable.

Five weeks after briefing was completed, the Court included Harkonen’s case on a list of 75 other cases in which it was denying petitions for writs of certiorari.  As is common, the Court provided no explanation for its decision. 

Thus, Harkonen’s sentence stands, much if not all of which has already been served: three years of probation, 6 months home detention, community service, and a $20,000 fine.  More significant is that the felony conviction continues to support the government’s exclusion of Harkonen from participating in federal health care programs.  In October, a federal court upheld the Department of Health and Human Services Office of Inspector General’s (OIG) decision to exclude Harkonen under 42 U.S.C. §1320a-7(a)(3), which mandates exclusion following a felony conviction for fraud “in connection with the delivery of a health care item or service or with respect to any act or omission in a health care program.”  The statute mandates a minimum five-year period for exclusion. 

Categories: Enforcement