In Emerson v. Novartis Pharm. Corp., No. 09-6273, 2011 WL 3701835 (6th Cir. Aug. 23, 2011), the Sixth Circuit affirmed a grant of summary judgment based upon a statutory presumption created by Florida law.  Florida has enacted a government rules defense, which meant that Novartis Pharmaceuticals Corporation (NPC) was entitled to a rebuttable presumption that Aredia and Zometa were not defectively dangerous because they were FDA approved.

The parties agreed that the presumption applied, and the primary argument raised by the plaintiff to overcome this presumption was that NPC had defrauded the FDA.  The appeals court held that such an assertion was, however, preempted, citing Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001).  The other assertions that plaintiff made to overcome this presumption were made without particularity and incorporated a massive volume of documents.  The Sixth Circuit held that the district court was not required to do the work of plaintiff’s counsel and perform a detailed review of the record.