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  • Enforcement

    • Limitations Imposed on Use of FDA Warning LettersMarch 25th, 2014

      By Anne K. Walsh – The Supreme Court of Arkansas recently overturned (here and here) a lower court’s $1.2 billion award to the State of Arkansas, and also reversed and remanded the decision granting over $200 million in attorney’s fees and costs to the state.  Putting …

    • Court Rules that FTC’s Substantiation Requirements Are Applicable to Claims for Medical FoodsMarch 12th, 2014

      By Riëtte van Laack – Defendants Wellness Support Network, and co-owners Robert and Robyn Held, marketed two diabetes products – Diabetic Pack and Insulin Resistance – as medical foods.  In 2005 and 2006, FDA issued two Warning letters to them (here and here), claiming the products …

    • Endo Pharmaceuticals – Not Your Typical Off-Label SettlementMarch 6th, 2014

      By Anne K. Walsh – Yes, this post relates to yet another off-label settlement between a pharmaceutical company and the federal government.  But some aspects of this recent settlement, coupled with other recent cases, might indicate noteworthy trends in how these cases are being resolved.  The …

    • Every Breath You Take . . . FDA is Watching You!March 5th, 2014

      By Robert A. Dormer – Every breath you takeEvery move you makeEvery bond you breakEvery step you takeI'll be watching you Every single dayEvery word you sayEvery game you playEvery night you stayI'll be watching you Our apologies to Sting and The Police, but we were reminded of the …

    • Government Says Supreme Court Should Not Take Up False Claims Act Case Alleging Off-Label PromotionFebruary 27th, 2014

      By JP Ellison – On February 25th, the Solicitor General’s Office weighed in on whether the Supreme Court should take up a case involving False Claims Act allegations arising out of alleged off-label promotion of a drug.  The case is Nathan v. Takeda, and the United States …

    • Is the Government Entitled to Deference in FDA Criminal Cases?February 27th, 2014

      By John R. Fleder – In litigation brought by or against FDA, the agency frequently seeks to avoid a “jump-ball” by arguing that FDA’s position is entitled to deference by the court.  That argument is consistently made in civil cases and has been made in some …

    • We’ll Say It Again: Regulatory Noncompliance Does Not an FCA Case MakeFebruary 24th, 2014

      By Jennifer M. Thomas – The writers of this blog have often noted with dismay Relators’ attempts to enforce the FDCA and FDA regulations through the False Claims Act.  Here, and here, for example.  Last week, the Fourth Circuit confirmed that this is a losing strategy …

    • Speech by High-Level DOJ Official Claims Shared Interests of Prosecutors and Regulated IndustryJanuary 30th, 2014

      By JP Ellison – In a speech on January 29th at the CBI Pharmaceutical Compliance Congress that DOJ posted on its own website, U.S. Department of Justice Assistant Attorney General Stuart Delery set forth his views of the three ways that the government’s enforcement interests align with …

    • An Old Fashioned Park Criminal Prosecution With Some Twists – Part IIJanuary 30th, 2014

      By John R. Fleder – On October 2, 2013, HP&M posted the following on this blog: On September 26, 2013, the United States Attorney for the District of Colorado announced that he had filed a six count criminal Information against Eric and Ryan Jensen.  The government alleges …

    • Increase in Enforcement Actions against Medical Foods; FDA Sends Two Warning LettersJanuary 29th, 2014

      By Riëtte van Laack – On December 26, FDA sent Warning Letters (here and here) to Accera, Inc. and NVN Therapeutics.  Accera Inc. markets a product, Axona, as a medical food “for the clinical dietary management of the metabolic processes associated with mild to moderate Alzheimer’s …

    • Tenth Circuit Affirms False Statement Conviction: Lesson LearnedJanuary 23rd, 2014

      By Anne K. Walsh – While the mid-Atlantic region was paralyzed under 4 to 8 inches of snow, it was business as usual for the Tenth Circuit Court of Appeals in Colorado.  On January 21, 2014, the court issued an opinion affirming the felony conviction of John …

    • DC Circuit Reinstates KV Lawsuit Over MAKENA and Compounded 17p in Light of Cook Decision and DQSAJanuary 9th, 2014

      By Kurt R. Karst –       With primary briefing over (briefs here, here, and here), and a December 13, 2013 Oral Argument before Judges Griffith, Kavanaugh and Randolph concluded, we were waiting with bated breath for the U.S. Court of Appeals for the District of Columbia Circuit …

    • The Federal Circuit Wades into FDC Act Preemption and Intended Use in RevitaLash DecisionJanuary 2nd, 2014

      By Kurt R. Karst –       Last week, in an unusual move, the U.S. Court of Appeals for the Federal Circuit waded into non-patent territory when the Court issued its decision in Allergan, Inc. v. Athena Cosmetics, Inc. (Case No. 2013-1286), a consolidated appeal of several decisions …

    • Harkonen’s Supreme Court Petition DeniedDecember 20th, 2013

      By Anne K. Walsh – With no fanfare, the U.S. Supreme Court on Monday denied a writ of certiorari in a case watched closely by the drug and device industry.  As reported earlier, the former CEO of InterMune Inc., Scott Harkonen, had filed a petition asking the …

    • First Circuit Skirts the Issue of the Scope of the False Claims Act Regarding FDC Act ViolationsDecember 9th, 2013

      By John R. Fleder – On August 8, 2013, we reported on a brief filed by the Department of Justice in United States ex rel. Ge v. Takeda Pharmaceutical Company Limited.  The case involves the defendants’ alleged failure to timely report to FDA adverse drug events …