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False Press Release Leads To Exclusion From Federal Programs

Dr. Harkonen was the CEO of InterMune, Inc, a pharmaceutical company that developed, marketed and sold drugs for lung and liver diseases, including Actimmune. In 2002, the FDA had approved Actimmune to treat only two...more

Second Circuit Vacates Pharmaceutical Misbranding Conviction on Free Speech Grounds

After two years of deliberation, the U.S. Second Circuit Court of Appeals has finally issued its decision in United States v. Caronia, holding that the government cannot prosecute pharmaceutical manufacturers or their...more

Second Circuit Declares Off-Label Promotion Ban Unconstitutional: Implications for False Claims Act Defendants

On December 3, 2012, the United States Court of Appeals for the Second Circuit held that the First Amendment protects pharmaceutical companies who truthfully promote the lawful, off-label use of prescription drugs from...more

Why Is Qui Tam Litigation Often So Difficult to Resolve?

The Current Qui Tam Environment There has been a shift in the fault patterns of qui tam litigation. More qui tam cases are being filed than ever before. The statistics demonstrate that the number has increased steadily over...more

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