Subscribe Subscribe   Find us on Twitter Follow POL on Twitter  



Ninth Circuit refuses to extend Caronia

| No Comments

Pharmaceutical company InterMune performed a study on an FDA-approved drug, Actimmune, to see if it could be used to treat chronic lung disease. The study results were mixed, but if one looked at a subgroup of patients with mild to moderate lung disease, the study showed a statistically significant benefit. CEO Scott Harkonen trumpeted these results in a press release—and faced criminal prosecution as a consequence. A jury agreed that the press release was fraudulent, and convicted him in 2009, though acquitted him on the government's off-label marketing charge. (One suspects this is indicative of a compromise verdict, but the press coverage doesn't say if this was raised at any point.)

On appeal, in an unpublished opinion, the Ninth Circuit refused to hold the press release protected by the First Amendment, pointing out that the jury found the communication false. Harkonen's attorney complains "Allowing the government to criminally prosecute and convict a speaker for expressing a scientific opinion with which the government disagreed represents a real sea change in the law." [Reuters]

The result confirms my fears about the narrow application of Caronia. Who is going to want to risk their freedom on whether a lay jury correctly assesses whether a statistical analysis is intellectually honest? (Most lawyers and judges aren't equipped to evaluate legitimate controversies over statistical analysis.) The effect will be disastrously chilling, and disincentivize the dissemination of scientific knowledge.

Leave a comment

Once submitted, the comment will first be reviewed by our editors and is not guaranteed to be published. Point of Law editors reserve the right to edit, delete, move, or mark as spam any and all comments. They also have the right to block access to any one or group from commenting or from the entire blog. A comment which does not add to the conversation, runs of on an inappropriate tangent, or kills the conversation may be edited, moved, or deleted.

The views and opinions of those providing comments are those of the author of the comment alone, and even if allowed onto the site do not reflect the opinions of Point of Law bloggers or the Manhattan Institute for Policy Research or any employee thereof. Comments submitted to Point of Law are the sole responsibility of their authors, and the author will take full responsibility for the comment, including any asserted liability for defamation or any other cause of action, and neither the Manhattan Institute nor its insurance carriers will assume responsibility for the comment merely because the Institute has provided the forum for its posting.

Related Entries:



Rafael Mangual
Project Manager,
Legal Policy

Manhattan Institute


Published by the Manhattan Institute

The Manhattan Insitute's Center for Legal Policy.