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Sixth Circuit affirms grant of summary judgment in favor of Firm client Novartis in three cases based on Michigan law.

news | November 24, 2009

On November 24, 2009, the United State Court of Appeals for the Sixth Circuit affirmed the grant of summary judgment in favor of firm client Novartis Pharmaceuticals Corporation in three cases brought by residents of Michigan based on Michigan’s statute immunizing manufacturers of FDA-approved drugs from liability.  The Court also affirmed the denial of plaintiffs’ motion for additional discovery.  In re: Aredia and Zometa Products Liability Litigation, Nos. 08-5573, 08-5574 & 08-5575 (6th Cir. November 24, 2009).

The Court of Appeals found that the applicable state law immunized drug manufacturers from liability for FDA-approved drugs unless a federal agency had previously found that the manufacturer intentionally withheld or misrepresented information to the FDA.  The court held that plaintiffs’ efforts to invoke the “fraud-on-the-FDA” exception to the statute were preempted pursuant to its prior holding in Garcia v. Wyeth-Ayerst Laboratories, 385 F.3d 961, 966 (6th Cir. 2004).  The court further affirmed the rejection of plaintiffs’ motion to take additional discovery under Federal Rule of Civil Procedure 56(f), finding that because plaintiffs’ claims were preempted any additional discovery would be futile.

The three cases had been part of the In re Aredia and Zometa Products Liability Litigation, a multidistrict litigation centralized in the United States District Court for the Middle District of Tennessee.  The MDL was assigned to Chief Judge Campbell by the Judicial Panel on Multidistrict Litigation on April 18, 2006.  Hollingsworth LLP is counsel for Novartis Pharmaceuticals Corporation.