Yesterday FDA explained why it did not seek a rehearing of the Second Circuit’s December 3, 2012 decision in United States v. Caronia. In its decision (previously discussed here), the Second Circuit overturned the conviction of a sales representative for encouraging doctors to prescribe the suppressant Xyrem for …
Is Off-Label Enforcement Off Limits?
December 7, 2012 Leave a Comment
On Monday, the Second Circuit Court of Appeals issued a split decision in U.S. v. Caronia, vacating the criminal conviction of a pharmaceutical sales representative who was found guilty of misbranding, in violation of the Food, Drug & Cosmetic Act (FDCA), because he had promoted the sleep medication Xyrem for …
Supreme Court to Review Plan Reimbursement Provisions
August 14, 2012 Leave a Comment
The Supreme Court recently agreed to rule on a case that could limit the ability of plans to recover money under their reimbursement provisions. Employee benefit plans often cover the medical bills of participants, but require full reimbursement to the plan when those participants recover from third parties. Under …
Supreme Court: Video Analysis of Affordable Care Act Decision
July 3, 2012 Leave a Comment
An innovative, in-depth, multifaceted discussion of the landmark Supreme Court ruling and its immediate and long-term impact in Washington and among American businesses. Moderated by Aaron Van Oort of Faegre Baker Daniels' Appellate Advocacy group and featuring Maureen Maly of the firm's Benefits and Compensation …
Today, the Supreme Court Issued Two Decisions, Holding That:
June 28, 2012 Leave a Comment
The two challenged provisions of the Patient Protection and Affordable Care Act, which expand the scope of Medicaid and require most Americans to buy health insurance, are valid exercises of Congress's power under the taxing and spending clauses of the Constitution. But the federal government cannot coerce States …
Day Three – The Supreme Court Hears Argument on the Severability of the Individual Mandate and State Sovereignty
March 29, 2012 Leave a Comment
On Wednesday, the U.S. Supreme Court heard oral argument on the two remaining issues involving the ACA. The morning session concerned the issue of severability–if the Court determines that the individual mandate is unconstitutional, can the mandate be severed from the rest of the ACA, or does it drag down part …