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Inside Medical Devices Updates on Developments for Medical Devices from Covington & Burling LLP

Caronia Update: Government Does Not Appeal Significant Second Circuit Decision

Posted in First Amendment, U.S. Government Investigations and Compliance

The federal government will not appeal the decision of a Second Circuit panel in United States v. Caronia.  The government did not petition for rehearing by the panel or the en banc Second Circuit before the January 16 deadline.  Further, the Wall Street Journal and others are reporting that FDA officials have confirmed that the government will not appeal the case to the U.S. Supreme Court, even though the deadline for filing that appeal does not pass until March.  Caronia remains binding in the Second Circuit, which includes federal courts in New York, Connecticut, and Vermont.

As we reported in a previous post, the Caronia panel held that the government cannot, consistent with the First Amendment, “prosecute pharmaceutical manufacturers and their representatives under the [Federal Food, Drug, and Cosmetic Act] for speech promoting the lawful, off-label use of an FDA-approved drug.”  This decision also raised substantial questions about the government’s ability to prohibit truthful, non-misleading off-label promotional speech regarding devices.

FDA apparently has taken a narrow view of the Caronia decision.  As reported by FDA Week, FDA issued the following statement about Caronia:

The government has determined not to seek further review of the Second Circuit’s decision in United States v. Caronia. FDA does not believe that the Caronia decision will significantly affect the agency’s enforcement of the drug misbranding provisions of the Food, Drug, and Cosmetic Act (FD&C Act).  The decision does not strike down any provision of the FD&C Act or its implementing regulations, nor does it find a conflict between the Act’s misbranding provisions and the First Amendment or call into question the validity of the Act’s drug approval framework.”

The government’s decision not to seek Supreme Court review is not surprising, given the risk of a potentially worse — and broadly applicable — ruling from the Supreme Court.  The current Supreme Court has proven to be protective of First Amendment rights with respect to medical product marketing.  For example, in the 2011 case of Sorrell v. IMS Health, the Court struck down a Vermont statute restricting pharmaceutical manufacturers from using prescriber-identifiable information for marketing purposes.

Although the Caronia case is apparently closed, other courts are actively considering similar issues.  For example, the Ninth Circuit recently heard oral argument in United States v. Harkonen.  The defendant, the former President and CEO of InterMune, was convicted of wire fraud based on issuance of a company press release.  The press release reported the results of a clinical trial of the company’s drug Actimmune for an off-label indication.  On appeal, he is principally arguing that his conviction is inconsistent with his First Amendment rights to scientific speech, whereas the government maintains that the First Amendment does not apply to this speech because it allegedly was fraudulent.  We will continue to monitor developments in this and other cases.