California Court of Appeals Rules Plaintiffs Can Pursue Claims Against Novartis for Alleged Damages Arising From Ingestion of Generic Drug Six Years After Novartis Divested its Interest

March 15, 2016
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Damages Labeling
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On March 9, 2016, the California Court of Appeals ruled that the plaintiffs’ claims of failure to warn and misrepresentation against Novartis were legally viable. The critical dispute raised by Novartis was that it did not manufacture the prescription medication that allegedly harmed the plaintiffs. In T. H. v. Novartis Pharms. Corp., No. D067839, 2016 Cal. App. LEXIS 179 (Ct. App. Mar. 9, 2016), two minor plaintiffs alleged that Novartis was liable for neurological injuries they sustained in utero after their mother was prescribed,…
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Regulatory

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

Susan E. Van Gelder

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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Court Refuses to Scrutinize the Sufficiency of Differential Diagnosis Analysis and Permits Causation Testimony in Absence of Controlled Studies

September 25, 2013
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Daubert Medical Device Pharmaceuticals Summary Judgment
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This past week, an Ohio federal court considered under Daubert the standard by which specific causation experts in drug and device cases are to be scrutinized. While the Court precluded the opinions of certain experts who did not engage in a differential diagnosis analysis before forming specific causation opinions, it stopped short of precluding one expert who engaged in what was essentially an incomplete differential diagnosis analysis, concluding the sufficiency of the analysis goes to the weight of the evidence and not its reliability under…
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Florida Federal Court Allows Claim that Novartis Should Have Issued “Black Box” Warning on Zometa

Life Science Matters

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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Life Science Matters An inside look at the latest legal developments involving medical devices, pharmaceuticals, and more

California Court of Appeals Rules Plaintiffs Can Pursue Claims Against Novartis for Alleged Damages Arising From Ingestion of Generic Drug Six Years After Novartis Divested its Interest

This Week’s Life Science Headlines

This Week’s Life Science Headlines

This Week’s Life Science Headlines

This Week’s Life Science Headlines

This Week’s Life Science Headlines

Last Week’s Important Headlines

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

Court Refuses to Scrutinize the Sufficiency of Differential Diagnosis Analysis and Permits Causation Testimony in Absence of Controlled Studies

Florida Federal Court Allows Claim that Novartis Should Have Issued “Black Box” Warning on Zometa

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