Janssen’s Appeal of Off-Label Award Challenges False Claims Act

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Janssen’s Appeal of $1.64B Off-Label Judgment Includes Constitutional Challenge to False Claims Act

Dennis Tosh

July 23, 2025 at 05:10 PM EST

In appealing a $1.64 billion judgment against it, a pharmaceutical manufacturer told a federal appeals court that liability under the federal False Claims Act (FCA) cannot be established simply on the basis of a finding that the company engaged in off-label marketing of its products (United States ex rel. Penelow v. Janssen Products, L.P., No. 25-1818 (3d Cir.)). Janssen Prod... Read More

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Janssen’s Appeal of $1.64B Off-Label Judgment Includes Constitutional Challenge to False Claims Act

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