Harkonen Again Raises First Amendment Issues

By Anne K. Walsh –

Refusing to give up his fight to overturn his felony conviction, the former CEO of InterMune Inc., Dr. Scott Harkonen, recently filed a petition asking the U.S. Supreme Court to review his case.  Harkonen asserts that the government violated his constitutional rights by prosecuting him for public statements he made to investors regarding a clinical trial of the drug Actimmune.  Without asserting outright that his statements were true and not misleading, which would receive unquestionable First Amendment protection, he argues in his petition that his conclusions were debatable, and therefore should not be the basis of a criminal conviction.

Four years ago, a jury convicted Harkonen of wire fraud.  Harkonen was sentenced to three years of probation, 6 months home detention, community service, and a $20,000 fine.  Although his sentence has been served, he remains excluded for a minimum period of five years from federal health care programs based on the felony conviction.  It is unknown whether he will apply for reinstatement once his period of exclusion expires, but if his conviction is overturned, the exclusion automatically would be lifted.  In March of this year, Harkonen lost on his appeal to the Ninth Circuit (reported here), and again on his request for a rehearing en banc. 

He now argues that the Ninth Circuit ruling creates a circuit split regarding First Amendment protection in cases involving scientific interpretation.  According to Harkonen, precedent in the Second, Sixth, and Eighth Circuits exists that prohibits fraud prosecutions if there is a “difference of opinion” between experts.  Harkonen claims that the conclusion in his press release (that the drug demonstrated survival benefit in patients) was based on accurate clinical trial data, and that, since there may be disagreement on the accuracy of that conclusion, that debate precludes a fraud conviction.  In such instances, Harkonen states, the Second, Sixth, and Eighth Circuits would have overturned his conviction.

Harkonen also claims that his conviction has created an “immediate, irreparable, and indefinite” chilling effect for all pharmaceutical companies that routinely must issue public statements regarding the latest clinical studies.  According to Harkonen, the government makes similarly debatable conclusions or “overstatements” in its press releases, and he claims these types of statements are inevitable given the exercise of judgment necessary to analyze data.  Therefore, Harkonen asks the Court to answer this “question of exceptional importance”: whether the government can convict scientists for inferences drawn from accurate data.

The government has 30 days to submit its opposition to Harkonen’s brief.