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    • HP&M Releases 2018 Litigation BriefingJanuary 9th, 2019

      Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to present its annual report highlighting the leading cases and settlements from 2018 that affect the FDA- and DEA-regulated industries. Each page provides a concise summary of the relevant facts and key takeaways for our clients. We …

    • DOJ Wants It Both Ways: Case Satisfies Materiality Standard, but Still Merits DismissalDecember 20th, 2018

      Drug and device manufacturers that sell FDA-approved products reimbursed by the federal government should stay abreast of the pending Supreme Court petition in United States ex rel. Campie v. Gilead Sciences, Inc. (the factual and procedural background is summarized here and here).  In short, the …

    • New Data Integrity Guidance Imposes Significant Burdens, Yet FDA Claims It Does Not Regulate by GuidanceDecember 17th, 2018

      FDA issued its final Guidance on Data Integrity on December 12.  The federal government has sworn off regulating by guidance (see blogpost here about Brand memo).  In fact, at the Food and Drug Law Institute (FDLI) Enforcement and Litigation Conference that was occurring simultaneously with …

    • The FTC and FDA May Face New Hurdles in Injunction ActionsDecember 13th, 2018

      On December 11, 2018, the authors of this blog post attended the oral argument in Federal Trade Commission v. Shire ViroPharma, Inc., No. 18-1807 (3d Cir. filed Apr. 12, 2018).  We have previously blogged about the case here, here, and here. In a nutshell, Shire …

    • Failure to File Adverse Event Reports Results in Criminal Pleas for Medical Device Company and Quality ManagerDecember 12th, 2018

      Duodenoscopes are flexible, lighted tubes that are threaded through the body into the top of the small intestine (duodenum) and allow doctors to see potential problems in the pancreas and bile ducts. Because duodenoscopes are reusable devices, they must be reprocessed (cleaned) after each use …

    • The Other Shoe Drops on ev3December 7th, 2018

      Hard to believe that just two years ago, ev3, Inc. scored a resounding victory after the First Circuit affirmed the dismissal of a qui tam action against it (we reported it here). This week, DOJ announced that the same company has agreed to a criminal …

    • DOJ Slackens Focus on Individual Liability to Facilitate Corporate ResolutionsDecember 5th, 2018

      Last week, DOJ announced that it had concluded a year-long review of its individual accountability policy and that it had made changes to reflect a more efficient and practical position in its investigations of companies. As you may recall, in 2015, then-Deputy Attorney General Sally …

    • HP&M’s Anne Walsh to Moderate Panel at FDLI Enforcement, Litigation and Compliance ConferenceDecember 4th, 2018

      Hyman, Phelps & McNamara, P.C. is pleased to announce that Anne Walsh will again participate in the Food and Drug Law Institute’s (“FDLI”) Enforcement, Litigation and Compliance Conference this year.  The conference will be held in Washington, DC on December 12-13, 2018.  As a member …

    • More Kryptonite for KratomNovember 13th, 2018

      Most people think of getting salt water taffy from resort beach town Myrtle Beach, SC. But, apparently, there is more activity going on in Myrtle Beach: a company there was supplying customers with kratom, a substance that the government contends is an illegal dietary supplement. …

    • 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 …

    • OPDP Issues First Efficacy-Only Enforcement Letter in Over 3 YearsSeptember 3rd, 2018

      In its fourth enforcement letter of 2018, the Office of Prescription Drug Promotion (OPDP) takes aim at a marketed drug’s sell sheet solely on the basis of misleading efficacy claims, the first letter to do so in over 3 years. The letter, issued August 16 to …

    • Third Circuit Affirms False Claims Act Dismissal Based on Reasonable InterpretationAugust 22nd, 2018

      In United States of America ex rel Streck v. Allergan Inc., a federal False Claims Act (FCA) case alleging that several pharmaceutical manufacturers knowingly calculated false Average Manufacturer Prices (AMPs) that affected their Medicaid rebate payments, the U.S. Court of Appeals for the Third Circuit …

    • 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 …

    • The Eleventh Circuit Avoids Opining on the FTC’s Authority to Police Negligent Data Security Practices in HealthcareJune 14th, 2018

      On June 6, the Eleventh Circuit vacated the Federal Trade Commission’s (“FTC’s”) data security-related cease and desist order against LabMD, Inc. (“LabMD”), a diagnostic testing company. The decision was less than satisfactory for many amici who had called on the Court to opine – one …

    • Supreme Court Denies Cert. Petition Accusing Fifth Circuit of “Sabotage of Off-Label Enforcement”May 24th, 2018

      Last September, we posted on the Fifth Circuit’s decision to uphold summary judgment and award of costs in favor of Solvay Pharmaceuticals, Inc. in a False Claims Act (FCA) case (see post here). The relators pursued an FCA theory against Solvay based on allegations of …