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12.11.12 | Blog Posts

Does Misdemeanor Misbranding Survive Caronia?

The Insider: White Collar Defense and Securities Enforcement

The Court of Appeals for the Second Circuit sent shockwaves through the pharmaceutical industry with its decision in United States v. Caronia. Alfred Caronia was a pharmaceutical sales representative convicted of a misdemeanor conspiracy to introduce a misbranded drug. When promoting Xyrem, a prescription narcolepsy drug, Caronia made comments to a doctor about various uses of the drug that had not been approved by the Food and Drug Administration. The government did not contest at trial the truthfulness of the comments to the doctor. Though it was, and is, lawful and common for doctors to prescribe medication "off-label" [...]

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