Fosamax Lawsuit Update: 2025 Settlement and Preemption Ruling

The Fosamax lawsuit update most people are looking for comes down to two events roughly a month apart in 2025: on June 16, the U.S. Supreme Court refused to hear Merck’s appeal on federal preemption, and on July 28, Organon and Merck signed a confidential master settlement with attorneys representing femur fracture plaintiffs.¹² Together they ended a decade-long legal stalemate and started a fast-moving resolution phase that is still playing out in New Jersey state court in 2026.

Where the Fosamax Litigation Stands Now

For most of the last ten years, the nearly 1,000 femur fracture lawsuits against Merck went nowhere because of a single legal question: whether federal drug-labeling rules preempted state-law failure-to-warn claims. Merck argued they did. If the argument had held, every case would have been dismissed before trial.

The Third Circuit rejected that argument in September 2024, reviving more than 500 dismissed cases.³ Merck asked the Supreme Court to intervene. On June 16, 2025, the Court denied certiorari without noted dissent, closing off Merck’s last appellate option on preemption.⁴

Six weeks later, on July 28, 2025, Organon, which took over responsibility for certain Merck legacy products, signed a Master Settlement Agreement with plaintiffs’ counsel covering femur fracture claimants in the federal MDL and the New Jersey state consolidated litigation.²

What the July 2025 Settlement Covers

The financial terms are confidential. Organon’s SEC filing describes the settlement amount as a “confidential, but non-material, sum,” which is the company’s own characterization for accounting purposes.²

Two conditions define the deal. First, at least 95% of participating attorneys’ eligible clients must sign releases of Organon and Merck for the agreement to take full effect.² Second, plaintiffs had until November 30, 2025 to opt in.⁵

The settlement covers femur fracture claims only. Osteonecrosis of the jaw (ONJ) claims followed a separate track and were largely resolved years earlier, including a $27.7 million settlement in 2013 that covered roughly 1,200 ONJ cases.⁶ A New Jersey state ONJ multicounty litigation was reportedly close to closing as of mid-2024.⁷

What Happens to Plaintiffs Who Did Not Settle

Plaintiffs who did not sign a release by the November 30, 2025 deadline were reclassified as “Litigating Plaintiffs” and put on a structured case management track in New Jersey state court.⁵

Under the case management order, each remaining plaintiff must produce medical records documenting the atypical femoral fracture, proof of Fosamax use, and a causation theory. Plaintiffs whose injuries occurred after the January 2011 label change face additional scrutiny on causation. If a plaintiff fails to comply and does not cure the deficiency within 14 days of a motion to dismiss, the case is dismissed with prejudice.⁵

That process is already producing dismissals. Court records from the first half of 2026 show 17 cases dismissed with prejudice in March 2026 and additional cases dismissed without prejudice in May 2026, while at least one motion to dismiss was denied in March.⁸ An Amended Case Management Order was issued in May 2026, with expert report deadlines to be set case by case after discovery.⁵

Why the Preemption Ruling Mattered

The core of every femur fracture claim is that Merck should have warned patients and doctors about the fracture risk earlier than it did. Merck’s defense was that it tried, but the FDA said no, so it was legally impossible to comply with both federal labeling rules and any state duty to warn.

In March 2008, Merck asked the FDA to add fracture warning language to the “Precautions” section of the Fosamax label. In May 2009, the FDA issued a Complete Response Letter rejecting the proposed language on the ground that the scientific support was insufficient. Merck then added a narrower note in the “Adverse Reactions” section.³ Not until October 2010 did the FDA formally recognize the bisphosphonate-fracture link and require a “Warnings and Precautions” update for all bisphosphonate manufacturers.⁹ Merck updated the Fosamax label with the mandated language in January 2011.

In Merck Sharp & Dohme Corp. v. Albrecht, decided May 20, 2019, the Supreme Court held that preemption is a question for the judge, and that a manufacturer must show “clear evidence” that the FDA would have rejected the warning to win on impossibility preemption.¹⁰ On remand, the district court ruled for Merck in March 2022. The Third Circuit reversed on September 20, 2024, finding that the 2009 FDA letter was ambiguous, that ambiguity had to be read against preemption, and that Merck therefore had not shown clear evidence the FDA would have rejected any adequate fracture warning.³ The Supreme Court’s June 2025 denial of certiorari let that reversal stand.

The Injuries Behind the Cases

Fosamax (alendronate) is a bisphosphonate approved by the FDA in 1995 for osteoporosis.¹¹ It reduces the risk of common fractures by as much as 50% by suppressing the cells that break down bone. Plaintiffs allege that long-term use suppresses bone turnover so thoroughly that bones become brittle, producing atypical femoral fractures: low-energy breaks in the thigh bone that can occur during ordinary activity, often preceded by weeks or months of dull thigh or groin pain.¹² The risk is concentrated in patients who took bisphosphonates for more than five years.¹³

In February 2026, the FDA expanded the Fosamax label further, noting that atypical fractures can occur in bones other than the femur and that pain in other locations should prompt evaluation.¹⁴

Trial and Settlement History

Before the 2025 master settlement, no femur fracture case had produced a plaintiff verdict. The first federal bellwether, Glynn v. Merck in 2013, ended in a defense verdict after the jury found Fosamax did not cause the plaintiff’s broken leg. An earlier femur bellwether ended in a mistrial.¹⁵ The first California state femur trial, Galper v. Merck in 2015, also produced a defense verdict.¹⁶

The ONJ track produced a mixed record: five federal bellwether trials with Merck winning three and plaintiffs winning two, followed by the $27.7 million settlement in 2013 covering about 1,200 cases.⁷⁶ Federal MDL No. 1789, which handled ONJ claims, closed in 2018.

Fosamax Litigation Timeline

1995: FDA approves Fosamax.
2006: ONJ claims consolidated into MDL No. 1789 (S.D.N.Y.).
2008: Merck asks FDA to add femur fracture warning to “Precautions.”
2009: FDA rejects the proposed language; Merck adds a note in “Adverse Reactions.”
2010: FDA recognizes the bisphosphonate-fracture link and mandates a label update.
2011: Merck updates the label with FDA-mandated language. Femur fracture MDL No. 2243 opens in the District of New Jersey.
2013: Merck settles about 1,200 ONJ cases for $27.7 million. Merck wins Glynn, the first femur bellwether.
2019: Supreme Court decides Merck v. Albrecht, setting the “clear evidence” standard.
2022: District court again grants Merck summary judgment on preemption.
September 2024: Third Circuit reverses, reviving 500-plus cases.
June 16, 2025: Supreme Court denies Merck’s certiorari petition.
July 28, 2025: Organon and Merck sign the Master Settlement Agreement for femur fracture claims.
November 30, 2025: Deadline for plaintiffs to opt into the settlement.
February 2026: FDA expands label to atypical fractures beyond the femur.
March–May 2026: Dismissals and case management orders continue in New Jersey state court.

1
NJ Law Journal. Hundreds of Revived Fosamax Lawsuits Allowed to Move Forward as US High Court Denies Merck’s Bid for Appeal
2
SEC. Organon SEC Filing – Fosamax Femur Fracture Litigation
3
U.S. Court of Appeals for the Third Circuit. In re Fosamax (Alendronate Sodium) Products Liability Litigation, No. 22-3412
4
SCOTUSblog. Merck Sharp and Dohme Corporation v. Albrecht
5
NJ Courts. Fosamax Case Management Order
6
FindLaw. Fosamax Settlement: Proposed $27.7M for 1,200 Plaintiffs
7
Drugwatch. Fosamax Lawsuits
8
NJ Courts. Fosamax Orders and Decisions
9
Medscape. FDA Announces New Bisphosphonate Warnings
10
U.S. Supreme Court. Merck Sharp and Dohme Corp. v. Albrecht, 587 U.S. 299
11
NJ Courts. Fosamax Case Information
12
Cleveland Clinic Journal of Medicine. Atypical Femoral Fractures
13
PMC. Alendronate and Atypical Femoral Fractures
14
FDA. Fosamax Prescribing Information, Revised February 2026
15
Merck. Merck Wins Fosamax Federal Bellwether Trial Involving Atypical Femur Fracture Claims
16
Goldman Ismail. Goldman Ismail Wins Fosamax Bellwether Trial in California for Merck