Third Circuit to rehear pre-emption cases
Executive Summary
The U.S. Supreme Court's recent ruling in Wyeth v. Levine is already having repercussions for other pre-emption cases. On March 9, the Supreme Court vacated the Third Circuit U.S. Court of Appeals' ruling in Colacicco v. Apotex, which found that state tort claims alleging Apotex and GlaxoSmithKline failed to adequately warn of the risk of suicidal behavior with their antidepressants were pre-empted by FDA-approved labeling (1"The Pink Sheet" DAILY, April 10, 2008). The Supreme Court also vacated and remanded the Third Circuit's ruling in Pennsylvania Employees Benefit Trust Fund v. Zeneca, in which a third party payer claimed AstraZeneca falsely advertised Nexium (esomeprazole) as superior to Prilosec (omeprazole). The Third Circuit ruled that since the ads complied with FDA-approved labeling, they were not subject to state consumer fraud laws (2"The Pink Sheet," Sept. 3, 2007, p. 9)
You may also be interested in...
FDA Pre-emption Wins On Appeal, But Coming Supreme Court Case May Mean More For Drug Liability Risks
Third Circuit Court of Appeals tosses failure-to-warn claims against GSK and Pfizer.
Simplified Clinical Trial Transparency Rules To Go Live In The EU In June
A new version of the EU Clinical Trials Information System’s public portal will integrate the functionalities of the streamlined transparency rules.
Top-Selling Drugs 2023: Pharma’s $60bn COVID-19 Cliff
Pfizer/BioNTech’s COVID-19 vaccine Comirnaty toppled after recording the highest ever annual sales for a pharmaceutical in 2022, while Novo Nordisk’s Ozempic climbed rapidly. But Merck & Co’s immuno-oncology blockbuster Keytruda was secure in the number one spot in 2023 as COVID-19 receded.