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The federal government and the Fourth Circuit have ruled that a charitable patient assistant program conceived to increase access to cancer drugs for needy patients violated the federal Anti-Kickback Statute.  In an opinion long on canons of statutory interpretation and short on compassion for sick and dying patients, the Fourth Circuit upheld an HHS advisory

When a defendant removes a case to federal court on the basis that the case presents federal questions, what happens if the plaintiff amends the complaint to remove all references to federal law, leaving only state-law claims?  The U.S. Supreme Court has ruled that once the plaintiff amends to delete all federal claims, a federal

Every time we read an order about “pre-approval” defects in prescription drugs, we stop to scratch our heads.  It is not because we are easily confused, at least not on most days.  No, we pause to ponder what exactly a “pre-approval” defect is and how a company can be held to answer for an alleged