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Case Detail


United States v. Caputo
On February 27, 2008, the U.S. Court of Appeals for the Seventh Circuit upheld the criminal convictions of business executives alleged to have marketed an unapproved medical device. The decision was a partial setback for WLF, which had filed a brief expressing concern that the convictions could be viewed as upholding restrictions on the right of manufacturers to speak truthfully regarding off-label uses for their FDA-approved product. WLF was gratified that although the appeals court upheld the convictions, it went out of its way to make clear that it was not condoning government efforts to suppress truthful off-label speech. Rather, the court held, it did not need to reach the First Amendment issue because the trial court had made clear to the jury that it could not convict the defendants unless the jury found both that the defendants had lied to the FDA and that their medical device had never been approved by FDA.
Case Status:
Loss.
More Information and Downloads:
1/16/2007: Download the Brief

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