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Medical Legal
HHS-OIG: Podcast on Improper Payments
The Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) offers a wide array of resources…
Proactive Planning for HHS-OIG-DOJ Investigations
Over the last four years, the U.S. Department of Justice (DOJ) along with the U.S. Department Health and Human Services (HHS) has…
US Court of Appeals Rules that Off Label Promotion May Be Treated as…
Earlier this month, as reported by Reuters, the U.S. Court of Appeals for the First Circuit issued an opinion that may allow…
Court Upholds InterMune Executive Conviction on Misleading Speech
In December of last year, we reported on a landmark ruling from the United States Court of Appeals for the Second Circuit (New…
Caronia and How Settlements May Not Be So Good for Public Health
In a detailed article about the Caronia decision, Scott Gottlieb, MD, a resident fellow at the American Enterprise Institute (AEI)…
The Impact of Caronia Case: What Happens Next?
Last month, in a landmark ruling, the United States Court of Appeals for the Second Circuit in United States v. Caronia, vacated…
The Supreme Court and “Pay for Delay:” The Potential Impact on…
In early December of last year, the U.S. Supreme Court agreed to hear a case to decide whether agreements between brand-name…
FDLI: Insights in Enforcement, Litigation & Compliance for…
Last week, we were fortunate enough to attend the Food and Drug Law Institute’s (FDLI) Enforcement, Litigation & Compliance…
United States v. Caronia: A Victory for Free Speech vs. Off Label Promotion
The United States Court of Appeals for the Second Circuit (New York), in a 2-1 opinion, vacated the criminal conviction of a…
Friedman vs. Sebelius: Purdue Executive Exclusion Upheld, but Terms Voided…
The U.S. Court of Appeals for the District of Columbia recently held in Friedman v. Sebelius that the Department of Health and…