• Perdue v. Wyeth Pharmaceuticals, Inc.: A Triple Knockout on Pre-Emption and Innovator Liability Grounds
  • September 27, 2016 | Authors: Vincent R. Lodato; Beth S. Rose
  • Law Firm: Sills Cummis & Gross P.C. - Newark Office
  • Pharmaceutical companies recently achieved a significant legal victory in a product liability suit involving amiodarone (brand name Cordarone®) that plaintiff filed in the United States District Court for the Eastern District of North Carolina. See Sara Perdue, as Executor of the Estate of Marjorie Newton v. Wyeth Pharmaceuticals, Inc., et al., Civil Action No. 4:15-cv-00208-FL, 2016 U.S. Dist. LEXIS 94636 (E.D.N.C. Jul. 20, 2016). Amiodarone/Cordarone® is a prescription medication approved by the FDA as a treatment of last resort for life-threatening recurrent ventricular arrhythmias. The FDA approved Cordarone® in December 1985 when it granted Wyeth Pharmaceuticals, Inc.’s (“Wyeth”) New Drug Application. Amiodarone has been cleared for marketing in generic form since the late 1990s. In December 2004, the FDA mandated that amiodarone be accompanied by a medication guide pursuant to 21 C.F.R. § 208.1.