> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# 3rd Circuit Remands Hundreds of Fosamax Cases
- URL: https://www.fdaweb.com/3rd-circuit-remands-hundreds-of-fosamax-cases/
- Published: 2019-12-03T12:00:00.000Z
- Updated: 2026-09-14T15:55:01.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145634

Citing a May Supreme Court ruling outlining the standard for a federal preemption defense in drug warning claims, the 3rd Circuit Court of Appeals has remanded to a New Jersey federal court hundreds of Fosamax bone fracture lawsuits, asking that court to decide whether the failure-to-warn cases are preempted by federal law. An AboutLawsuits online [post](https://www.aboutlawsuits.com/fosamax-lawsuits-remanded-165012/?ref=fdaweb.com) says that in its ruling, the high court had said that a judge, and not a jury, should determine there is “clear evidence” that federal regulators were fully informed about the justifications for adding a warning to a drug’s labeling and that the agency had informed the drug company that it would not approve a label change to add the warning.

In the Fosamax cases, plaintiffs have argued that Merck knew about the bone fracture risk but withheld information from consumers and the medical community until FDA required a label change in 2010.

The company said the cases were subject to federal preemption and that FDA would not have allowed an earlier label update, since it had rejected a proposed label update on the risk of stress fractures.

A New Jersey federal court granted the company’s motion for summary judgment in 2014 but was overruled by the 3rd Circuit in 2017, after which Merck appealed to the Supreme Court. The high court sent the case back to the 3rd Circuit after outlining its standard for federal preemption.