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New FDA Commissioner Hits the Ground Running

USA - May 30 2017 Fresh off his noticeably smooth confirmation, the new Commissioner of Food and Drugs, Dr. Scott Gottlieb, appeared before Congress last Thursday and…

David L. Rosen, Judith A. Waltz

Seventh Circuit Applies Escobar’s Materiality Standard to (Again) Reject False Certification Claim

USA - October 31 2016 This summer, the United States Supreme Court undertook to resolve the long-running circuit split over the validity and scope of the implied false…

Lisa M. Noller

Supreme Court Implied False Certification Case Reargued to First Circuit

USA - October 27 2016 On Tuesday, October 25, 2016, a three-judge panel of the United States Court of Appeals for the First Circuit heard argument in United States ex rel…

Lawrence M. Kraus

Three Dozen States Sue Makers of Opioid Addiction Treatment Medications for Antitrust

USA - October 12 2016 With opioid abuse continuing to dominate national headlines, manufacturers of opioid overdose medications are facing intense scrutiny over pricing…

Katy E. Koski, James W. Matthews, Judith A. Waltz

The EpiPen Controversy Signals Intensifying Scrutiny of Drug Classification Under Medicaid Rebate Program

USA - September 7 2016 Price increases threatening the availability of EpiPen® and EpiPen Jr® Auto-Injectors (“EpiPen”) have touched off the latest firestorm over drug…

Katy E. Koski, James W. Matthews, David L. Rosen