Case Detail

Ortho Biotech Products, L.P. v. United States ex rel. Duxbury
On June 21, 2010, the U.S. Supreme Court declined to review an appeals court decision that permits plaintiffs’ lawyers to use the federal False Claims Act (FCA) as a tool for regulating all promotional activities of drug and medical device manufacturers. The order denying review was a setback for WLF, which filed a brief warning that the appeals court decision threatens to suppress truthful speech about off-label uses of FDA-approved products. WLF argued that the FCA was intended as a means of preventing fraud against the U.S., not as a means of suppressing truthful speech and other legitimate promotional activities. In the absence of specific allegations that a pharmacy, acting at the behest of a drug manufacturer, sought payment under Medicaid or Medicare for drug costs that were not reimbursable, a complaint is subject to dismissal, WLF asserted. The appeals courts have issued conflicting decisions on this issue, so the Supreme Court will have to address it relatively soon.
Case Status:
Supreme Court Review Denied
More Information and Downloads:
1/4/2010: Download the Brief

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