{"id":54,"date":"2018-11-13T14:15:34","date_gmt":"2018-11-13T18:15:34","guid":{"rendered":"http:\/\/blogs.duanemorris.com\/productsliability\/?p=54"},"modified":"2019-04-23T14:23:06","modified_gmt":"2019-04-23T18:23:06","slug":"should-juries-try-to-predict-fda-drug-labeling-decisions","status":"publish","type":"post","link":"https:\/\/blogs.duanemorris.com\/productsliability\/2018\/11\/13\/should-juries-try-to-predict-fda-drug-labeling-decisions\/","title":{"rendered":"Should Juries Try To Predict FDA Drug Labeling Decisions?"},"content":{"rendered":"
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On June 28, 2018, the Supreme Court of the United States accepted for review Merck Sharp & Dohme Corp. v. Albrecht<\/em>, an appeal from the Third Circuit Court of Appeals\u2019 decision in\u00a0In re Fosamax (Alendronate Sodium) Products Liability Litigation<\/em>.[1<\/a>] At the marrow of the high court\u2019s review lie the thorny questions of whether a state law failure-to-warn claim is preempted where the\u00a0U.S. Food and Drug Administration\u00a0has rejected a drug manufacturer\u2019s proposed label warning about the health risks at issue, and, in making this determination, whether a jury, as opposed to the trial court, may be asked to look beyond the FDA\u2019s rejection and decide if the FDA would have approved a differently worded warning had it been proposed by the manufacturer.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n

While the issue is a relatively narrow one, the Supreme Court\u2019s analysis promises to shape the way courts around the country decide whether and how the decisions of regulatory agencies should be interpreted \u2015 and here, predicted \u2015 by juries.<\/p>\n

How Did We Get Here?<\/h3>\n

The Fosamax litigation began in 2011, when the Judicial Panel on Multidistrict Litigation consolidated several thousand lawsuits in the United States District Court for the District of New Jersey. The common question raised by the plaintiffs was whether their use of Fosamax, a drug developed and manufactured by Merck for the treatment and prevention of osteoporosis, led to femur fractures and similar bone injuries, and further, whether Merck had properly warned of these potential risks.<\/p>\n

To read the full text of this article by Duane Morris attorneys Alan Klein<\/a> and Matthew Decker<\/a>, please visit the Duane Morris website<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"

On June 28, 2018, the Supreme Court of the United States accepted for review Merck Sharp & Dohme Corp. v. Albrecht, an appeal from the Third Circuit Court of Appeals\u2019 decision in\u00a0In re Fosamax (Alendronate Sodium) Products Liability Litigation.[1] At the marrow of the high court\u2019s review lie the thorny questions of whether a state … <\/p>\n

Continue reading “Should Juries Try To Predict FDA Drug Labeling Decisions?”<\/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":[10,12,11,6],"ppma_author":[110],"class_list":["post-54","post","type-post","status-publish","format-standard","hentry","category-general","tag-alan-klein","tag-fda","tag-matthew-decker","tag-products-liability"],"authors":[{"term_id":110,"user_id":6,"is_guest":0,"slug":"duanemorris3","display_name":"Duane Morris","avatar_url":"https:\/\/secure.gravatar.com\/avatar\/843ff6e7a8fe5fc92109b47a45f34b6cf0ea499e6e788db23456c838b0ae6747?s=96&d=blank&r=g","0":null,"1":"","2":"","3":"","4":"","5":"","6":"","7":"","8":""}],"_links":{"self":[{"href":"https:\/\/blogs.duanemorris.com\/productsliability\/wp-json\/wp\/v2\/posts\/54","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.duanemorris.com\/productsliability\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.duanemorris.com\/productsliability\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/productsliability\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/productsliability\/wp-json\/wp\/v2\/comments?post=54"}],"version-history":[{"count":0,"href":"https:\/\/blogs.duanemorris.com\/productsliability\/wp-json\/wp\/v2\/posts\/54\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.duanemorris.com\/productsliability\/wp-json\/wp\/v2\/media?parent=54"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/productsliability\/wp-json\/wp\/v2\/categories?post=54"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/productsliability\/wp-json\/wp\/v2\/tags?post=54"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/productsliability\/wp-json\/wp\/v2\/ppma_author?post=54"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}