> ## 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.

# 3 Lessons Learned from Fosamax ‘Failure-to-Warn’ Case
- URL: https://www.fdaweb.com/3-lessons-learned-from-fosamax-failure-to-warn-case/
- Published: 2022-07-28T12:00:00.000Z
- Updated: 2026-09-14T17:53:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152392

Attorney **Daniel Feith** (Sidley Austin) says a recent New Jersey federal court decision in a failure-to-warn case involving Merck’s Fosamax (alendronate sodium) helps industry broaden preemption of such claims. Writing in a Washington Legal Foundation *Legal Backgrounder*, Feith [says](ttps://www.wlf.org/2022/07/22/publishing/in-re-fosamax-advances-trend-toward-broader-preemption-of-pharmaceutical-failure-to-warn-claims/) the case was returned to the New Jersey federal court on remand from the Supreme Court and the district court granted summary judgment to Merck, ruling that all the plaintiffs’ claims were preempted. In the process, it answered many questions that were raised by the Supreme Court decision.

“This decision builds on a growing body of case law taking a broader view of how drug makers can establish preemption and offers drug makers valuable insight into how effective FDA engagement can preempt liability down the road,” Feith writes.

After describing the case’s progression through the courts, Feith lists three areas of significance:

- highlighting the importance for manufacturers of diligent engagement with FDA regarding risk-related information to be sure that the agency has been “fully informed” by the company of justifications for a proposed warning;
- a broader view of the types of evidence that can establish preemption, reinforcing the value of putting all relevant information before FDA as courts will assume that the agency considered whatever information was before it, even if it did not expressly act on or discuss that information; and
- establishing that a manufacturer need not submit a changes-being-effected supplement simply to preserve a preemption defense.