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    Anne K. Walsh

    • DOJ Lays Out Arguments Opposing APA Challenges to Vacate RulesSeptember 19th, 2018

      In a memo issued by the Attorney General to all civil litigators throughout the country, AG Sessions set forth the DOJ position that it would seek to limit courts from applying “overbroad injunctive relief” in cases involving “nationwide injunctions.”  A “nationwide injunction” is one in …

    • Oh, How the Tables Have Turned: Court Requires FDA to Follow Law Requiring Graphic Warnings on CigarettesSeptember 11th, 2018

      A district court in Massachusetts scolded FDA for failing to meet a two-year deadline for issuing a final rule mandating color graphic warnings on cigarettes. This decision is important for the public health interests associated with the graphic warnings, but interesting for the loss dealt …

    • New DOJ Policy Purports to Prevent Piling-On of PenaltiesJuly 9th, 2018

      Rather than rolling out the red carpet, DOJ has been highlighting with little fanfare a policy that could prove to be a powerful negotiating tool for companies in the government’s crosshairs. First announced by Deputy Attorney General Rod Rosenstein here, and later reinforced by Acting …

    • DePuy Petitions Supreme Court to Weigh in on FCA Pleading StandardsMarch 22nd, 2018

      Last year, the First Circuit reversed the dismissal of a False Claim Act (FCA) case brought against DePuy Orthopaedics, Inc., holding that the district court had wrongly dismissed the relators’ complaint for failing to plead with particularity under Federal Rule of Civil Procedure 9(b) (see …

    • Guidance on Guidance on GuidanceMarch 16th, 2018

      As one of her final acts before leaving DOJ, Associate Attorney General Rachel Brand announced that DOJ would no longer permit its lawyers to use guidance documents issued by its “client” agencies as a basis for civil enforcement. The “Brand Memo” provides guidance about DOJ’s use …

    • Will the Supreme Court Take on the False Claims Act Materiality Standard?March 14th, 2018

      The saga continues in United States ex rel. Campie v. Gilead Sciences, Inc., 862 F.3d 890 (9th Cir. 2017), a False Claims Act case alleging that Gilead concealed information from FDA regarding the contamination of certain drugs, leading to false claims being paid by the …

    • Guidance on Guidance: Enforcement to be CurtailedJanuary 31st, 2018

      We have seen the stock language in every guidance document FDA issues claiming its guidance is non-binding: This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is …

    • New DOJ Memo Discusses Factors for Dismissing FCA CasesJanuary 25th, 2018

      The Department of Justice recently issued a memo to all attorneys in the Commercial Litigation Branch, Fraud Section, and any Assistant U.S. Attorneys handling False Claims Act (FCA) cases, directing those attorneys to seek dismissal of FCA cases under certain circumstances. While the government’s ability …

    • How to Lose $350 millionJanuary 12th, 2018

      In a thorough and thoughtful 23-page opinion, Judge Steven Merryday of the Middle District of Florida dismissed a $350 million judgment against the defendants, owners and operators of specialized nursing facilities. The court detailed the rigorous materiality and scienter requirements for liability under the False …

    • Court May Confirm the Rigorous Materiality Standard Required by the False Claims ActJanuary 9th, 2018

      To prevail on an allegation under the False Claims Act (FCA), a plaintiff must allege that the misrepresentation by defendant was “material to the Government’s payment decision.” Universal Health Services, Inc. v. United States ex rel. Escobar, 136 S. Ct. 1989 (2016).  The U.S. Supreme …

    • Litigation Briefing: HP&M Issues Report Summarizing Leading Cases and Settlements of 2017January 8th, 2018

      Hyman, Phelps & McNamara, P.C. is pleased to present this report summarizing leading cases and settlements from 2017 affecting the FDA-regulated industry. Our goal was to provide a concise summary of issues that most impact our clients, many of whom are drug and medical device …

    • FDLI’s Enforcement, Litigation, and Compliance Conference 2017November 22nd, 2017

      The Food and Drug Law Institute’s (“FDLI”) Enforcement, Litigation, and Compliance Conference is just a few weeks away, and spaces are going fast!  The two-day conference will be held on December 6-7, 2017, in Washington, D.C.  Hear from new government officials, including Rebecca Wood, the …

    • Court Deals Blow to Mysteriously Named Whistleblower, and Blows off PrecedentSeptember 27th, 2017

      Earlier this month, the U.S. District Court for the Central District of California dismissed a qui tam complaint filed against Medtronic and its subsidiaries alleging violations of the False Claims Act (FCA).  The relator (an LLC named “The Dan Abrams Company LLC” formed by a former …

    • Rehearing Urged for Bad Ninth Circuit DecisionSeptember 10th, 2017

      In July, as reported here, the Ninth Circuit reversed the lower court’s decision to dismiss a False Claims Act (FCA) case against Gilead Sciences, Inc.  Not surprisingly, Gilead timely filed a petition for rehearing or rehearing en banc with the Ninth Circuit, and several groups submitted …

    • REMS Program Violations Result in Disgorgement and False Claims Act LiabilitySeptember 6th, 2017

      In a settlement noteworthy to any company with a drug subject to a Risk Evaluation and Mitigation Strategy (“REMS”), on September 5, 2017, the U.S. announced a multi-million dollar civil settlement with Novo Nordisk for an alleged violation of REMS requirements for its drug Victoza …

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