Fosamax Lawsuit Update: Master Settlement and Case Counts

The Fosamax lawsuit is nearing resolution: on July 28, 2025, Organon — which took over the drug from Merck in 2021 — signed a master settlement agreement covering the bulk of remaining femur-fracture cases in federal and New Jersey state courts, after the U.S. Supreme Court declined in June 2025 to revive Merck’s federal-preemption defense.¹² The litigation is formally active but largely on hold while claims are processed.

The July 2025 Master Settlement

Organon’s master settlement agreement was signed with plaintiffs’ attorneys representing claimants in the federal multidistrict litigation and in New Jersey state court. Under it, Organon pays a “confidential, but non-material, sum” in exchange for the release of claims against both Organon and Merck. The deal is conditioned on at least 95% of eligible clients participating.¹

Organon’s SEC filings described the settlement amount as non-material to the company. The filings also disclosed that as of mid-2025, Organon held only $8 million in general legal defense reserves across all its litigation.¹

A New Jersey state court issued an order on August 13, 2025, to aid implementation. The order established a qualified settlement fund, appointed a claims administrator and a mediator, and stayed discovery in the multicounty litigation through at least December 31, 2025.³ Organon assumed responsibility for indemnifying Merck against Fosamax-related liabilities when it was spun off in 2021, which is why the settlement releases both companies.¹

How the Cases Got to Settlement

The femur-fracture claims sat frozen for years around a single legal question: whether the FDA’s 2009 rejection of Merck’s proposed fracture warning meant federal law preempted state failure-to-warn claims. In March 2022, a federal district judge in New Jersey ruled it did and granted Merck summary judgment, dismissing roughly 500 cases.⁴

On September 20, 2024, the Third Circuit reversed. The panel found the FDA’s 2009 Complete Response Letter ambiguous — it was not clear whether the agency had rejected the science behind any fracture warning or only the specific wording Merck used. Under the Supreme Court’s 2019 decision in Merck Sharp & Dohme Corp. v. Albrecht, a drugmaker invoking preemption must show the FDA would have rejected any warning that would satisfy state law, and ambiguity in the agency’s action must be resolved against preemption.⁵⁶ The ruling revived more than 500 claims.

Merck petitioned the Supreme Court for review. On June 16, 2025, the Court denied the petition without comment, leaving the Third Circuit ruling in place.² The master settlement followed six weeks later.

What the Lawsuits Alleged

Fosamax (alendronate sodium) was approved by the FDA in September 1995 to treat and prevent osteoporosis. It belongs to a class of drugs called bisphosphonates, which slow bone loss. Plaintiffs alleged that long-term use produced atypical femoral fractures — unusual breaks in the thighbone unlike the fractures osteoporosis itself causes — and that Merck failed to warn patients and doctors of the risk. A 2010 American Society of Bone and Mineral Research task force review found that 94% of patients with atypical femoral fractures had used alendronate for more than five years.⁷

The FDA required all bisphosphonate manufacturers to add specific warning language about atypical femoral fractures in October 2010. Merck implemented the new warning in January 2011.⁵

Case Counts and Current Status

The femur-fracture claims are consolidated federally as MDL No. 2243 in the District of New Jersey, now before Judge Karen M. Williams, and in a parallel New Jersey state multicounty litigation. As of January 2026, the federal MDL had 572 pending cases out of 1,292 filed over its history.⁸

Organon’s June 2025 SEC filings reported approximately 974 federal cases, 1,714 New Jersey state cases, and 272 California state cases on the books at that point.¹ Whether the master settlement will hit the 95% participation threshold needed to close has not been publicly confirmed. No trial dates have been set for any cases that do not settle.

In May 2026, the New Jersey state court issued an amended case management order requiring remaining plaintiffs to produce detailed documentation of their drug use and injuries. Noncompliance can result in dismissal.⁹

The Earlier Jaw-Injury Settlement

The 2025 master settlement does not cover osteonecrosis of the jaw claims, which were resolved years ago on a separate track. Those cases were consolidated in 2006 as MDL No. 1789 in the Southern District of New York before Judge John F. Keenan, with a parallel New Jersey state proceeding beginning in 2008.¹⁰¹¹

Merck and the plaintiffs’ steering committee reached an agreement in principle in December 2013 to settle the remaining jaw cases for $27.7 million, formalized in a master settlement agreement in April 2014 covering roughly 1,200 claims. The deal was conditioned on 100% participation; when participation came in at about 95%, Merck proceeded at a reduced funding level. The figure was inclusive of attorney fees and medical liens.¹²¹³ MDL No. 1789 closed in 2018.¹⁰

What to Watch Next

Two things will determine how the remaining litigation closes out. The first is whether the July 2025 master settlement clears the 95% participation threshold; if it does, most of the pending femur-fracture inventory in the federal MDL and New Jersey state court will resolve without trial. The second is what happens to plaintiffs who opt out or fall short on the documentation required by the New Jersey case management order — those cases would have to proceed on the merits, now without the preemption defense that stalled the litigation for more than a decade.

1
U.S. Securities and Exchange Commission. Organon 10-Q Filing – Legal Proceedings
2
NJ Law Journal. Hundreds of Revived Fosamax Lawsuits Allowed to Move Forward as U.S. High Court Denies Merck’s Bid for Appeal
3
New Jersey Courts. Order Aiding Private Settlement
4
FindLaw. Fosamax
5
Third Circuit Court of Appeals. In Re Fosamax (Alendronate Sodium) Products Liability Litigation, No. 22-3412
6
Justia. Merck Sharp & Dohme Corp. v. Albrecht
7
PubMed Central. Atypical Femoral Fractures and Bisphosphonate Use
8
Judicial Panel on Multidistrict Litigation. Pending MDL Dockets by Actions Pending
9
New Jersey Courts. Amended Case Management Order
10
Drugwatch. Fosamax Lawsuits
11
New Jersey Courts. Fosamax Case Information
12
U.S. Securities and Exchange Commission. Merck 10-Q Filing – Fosamax Litigation
13
Robert Kreisman, Attorney at Law. $28 Million Settlement Reached Merck Fosamax Jaw Injury Claims