A Rock and a Hard Place: Court Rejects Drug Manufacturer’s Defense that Changes to the Label Required FDA Approval and Were Preempted

This week, a Florida federal court denied a drug manufacturer’s motion in limine to preclude a plaintiff’s alternative warning theory on the basis that any changes to the label required FDA approval and were preempted. Dopson-Trout v. Novartis Pharma. Corp., 2013 U.S. Dist. LEXIS 135834 (M.D.Fla. Sept. 23, 2013). During her treatment for breast cancer that had metastasized to her bones, the plaintiff was infused with Aredia and then Zometa. She then had her tooth extracted, after which she began experiencing jaw pain caused…
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Florida Federal Court Allows Claim that Novartis Should Have Issued “Black Box” Warning on Zometa

A United States District Court Judge, sitting in the Middle District of Florida, has rejected arguments by Novartis Pharmaceutical Corporation (“Novartis”) that federal law would prohibit claims that the company should have added “Black Box” warnings regarding potential side effects of Zometa, including potential bone loss.  As a result, plaintiffs will be allowed to proceed with their claims notwithstanding the company’s arguments (1) that all of the failure-to-warn claims were controlled by the Supreme Court’s 2009 decision in Wyeth vs. Levine; and (2) that…
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