On June 3, 2022, the Civil Division of the Department of Justice filed a statement of interest in a relator\u2019s action in the Southern District of Florida, arguing that \u201c[c]onduct giving rise to a regulatory violations can also give rise to [False Claims Act] liability.\u201d Specifically, requesting \u201cthat the ruling not foreclose the possibility that, under certain circumstances, conduct giving rise to violations of the [Federal Food, Drug and Cosmetic Act] or FDA regulations could be material to the government\u2019s payment decisions and provide a basis for FCA liability assuming all necessary FCA elements are demonstrated,\u201d also known as \u201cfraud on the FDA.\u201d<\/p>\n
To read the full text of this Alert<\/em>, please visit the firm website<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":" On June 3, 2022, the Civil Division of the Department of Justice filed a statement of interest in a relator\u2019s action in the Southern District of Florida, arguing that \u201c[c]onduct giving rise to a regulatory violations can also give rise to [False Claims Act] liability.\u201d Specifically, requesting \u201cthat the ruling not foreclose the possibility that, … <\/p>\n Continue reading “Fraud-on-the-FDA Theory of False Claims Act Liability Clarified by DOJ”<\/span><\/a><\/p>\n","protected":false},"author":6,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2],"tags":[138,132,307,308,217],"ppma_author":[241],"class_list":["post-313","post","type-post","status-publish","format-standard","hentry","category-general","tag-doj","tag-false-claims-act","tag-fda","tag-fraud-on-the-fda","tag-u-s-department-of-justice"],"authors":[{"term_id":241,"user_id":6,"is_guest":0,"slug":"duanemorris3","display_name":"Duane Morris","avatar_url":"https:\/\/blogs.duanemorris.com\/whitecollarcriminallaw\/wp-content\/uploads\/sites\/11\/2014\/10\/dmlogo.jpg","author_category":"1","last_name":"Davies","first_name":"Thomas","first_name_2":"","job_title":"","user_url_2":"","user_url":"https:\/\/www.duanemorris.com","description":"Visit the Duane Morris website.<\/a>"}],"_links":{"self":[{"href":"https:\/\/blogs.duanemorris.com\/whitecollarcriminallaw\/wp-json\/wp\/v2\/posts\/313","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.duanemorris.com\/whitecollarcriminallaw\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.duanemorris.com\/whitecollarcriminallaw\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/whitecollarcriminallaw\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/whitecollarcriminallaw\/wp-json\/wp\/v2\/comments?post=313"}],"version-history":[{"count":0,"href":"https:\/\/blogs.duanemorris.com\/whitecollarcriminallaw\/wp-json\/wp\/v2\/posts\/313\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.duanemorris.com\/whitecollarcriminallaw\/wp-json\/wp\/v2\/media?parent=313"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/whitecollarcriminallaw\/wp-json\/wp\/v2\/categories?post=313"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/whitecollarcriminallaw\/wp-json\/wp\/v2\/tags?post=313"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/whitecollarcriminallaw\/wp-json\/wp\/v2\/ppma_author?post=313"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}