Merck Lawsuits: Vioxx, Gardasil, Propecia, and Fosamax

Merck & Co. has been a defendant in some of the largest pharmaceutical lawsuits of the past 25 years, and the company continues to face active litigation on multiple fronts. The best-known Merck lawsuits involve the painkiller Vioxx, which produced a $4.85 billion settlement in 2007, and the HPV vaccine Gardasil, which Merck agreed in June 2026 to settle for more than $50 million. Beyond those, the company faces securities fraud claims tied to Gardasil sales in China, product liability suits over Propecia and Januvia, talc-related mesothelioma cases involving Dr. Scholl’s and Lotrimin products, and a wrongful death suit tied to a former Georgia plant. Since 2000, Merck has incurred more than $10.7 billion in cumulative penalties, fines, and settlements according to the Violation Tracker database.¹

Vioxx: The $4.85 Billion Settlement and Criminal Plea

Vioxx remains the defining episode in Merck’s litigation history. The arthritis and pain drug was approved by the FDA in 1999 and generated $2.5 billion in annual sales at its peak.² Merck pulled it from the market in September 2004 after company-funded research showed patients taking Vioxx faced roughly twice the risk of heart attack and stroke.³

Thousands of lawsuits followed. The first trial, in Texas in 2005, produced a $253.4 million jury award to the widow of a man who died after taking the drug; the amount was later reduced to approximately $26 million. Other trials went both ways. In November 2007, Merck announced a $4.85 billion settlement covering 26,600 lawsuits, roughly 47,000 plaintiffs, and 265 potential class actions. The deal required at least 85% of plaintiffs to drop their claims and set eligibility rules tied to proof of a heart attack or stroke and documented Vioxx use.³

The case also produced criminal exposure. In December 2011, Merck Sharp & Dohme pleaded guilty to a federal misdemeanor for introducing a misbranded drug into interstate commerce, based on promotion of Vioxx for rheumatoid arthritis for nearly three years before the FDA approved that use in April 2002.⁴ The company was sentenced to pay a criminal fine of approximately $321.6 million.⁵ A broader $950 million resolution that year covered the criminal fine plus civil penalties for off-label promotion.

Gardasil Product Liability

Gardasil, Merck’s HPV vaccine first approved in 2006, drew hundreds of lawsuits from people who said the vaccine caused serious autoimmune and neurological conditions, including postural orthostatic tachycardia syndrome (POTS), primary ovarian insufficiency (POI), chronic fatigue syndrome, lupus, and nerve damage. Plaintiffs generally alleged Merck failed to warn about these risks.

Federal cases were consolidated into multidistrict litigation (MDL No. 3036) in the Western District of North Carolina before Judge Kenneth D. Bell.⁶ In March 2025, Judge Bell granted summary judgment for Merck and dismissed more than 200 lawsuits, ruling that federal law preempted the state-law failure-to-warn claims because Merck could not unilaterally change the Gardasil label without FDA approval.⁷ The Fourth Circuit affirmed in September 2025, holding that participation in the National Childhood Vaccine Injury Act’s compensation program is a prerequisite to bringing a tort suit and rejecting a constitutional challenge to how Gardasil was added to the federal Vaccine Injury Table.⁸

Merck settled anyway. In June 2026, the company agreed to pay more than $50 million to resolve over 200 Gardasil cases across multiple jurisdictions, including the dismissed North Carolina suits and a long-running Los Angeles state court case.⁹ Merck said the deal was meant to “end the litigation in its entirety” except for one remaining case, and that the settlement was “considerably less than Merck’s anticipated costs” of continued litigation.¹⁰ The company did not admit liability and continued to maintain that Gardasil is safe and effective.¹¹ The Los Angeles case, Jennifer Robi v. Merck, was dismissed with prejudice in late May 2026 after what Merck described as a “tentative accord” reached in February.¹²

Securities Fraud Class Action Over Gardasil in China

A separate line of Gardasil litigation targets what Merck told investors. In February 2025, shareholders filed a class action in the District of New Jersey, In re Merck & Co., Inc. Securities Litigation (No. 2:25-cv-01208), alleging the company misled investors about Gardasil demand in China.¹³ The suit alleges Merck repeatedly assured investors that Gardasil was on track to hit $11 billion in annual sales by 2030 while concealing that its Chinese distributor, Chongqing Zhifei Biological Products, had accumulated unsold inventory far beyond what it could move.¹⁴

In February 2025, Merck halted Gardasil shipments to China through at least mid-2025 and withdrew the $11 billion sales target. CEO Robert Davis acknowledged that Zhifei’s inventory had exceeded its ability to sell the product.¹⁵ Warning signs had surfaced earlier: Merck first reported flattening China sales in July 2024, then disclosed an 11% decline in third-quarter sales that October. Full-year 2024 global Gardasil sales fell 3% to $8.6 billion, and fourth-quarter sales dropped 18% year over year.¹⁶

The class period runs from February 3, 2022 through February 3, 2025, and a Swedish pension fund, AMF Tjanstepension AB, was appointed lead plaintiff.¹⁴ As of mid-2026, the defendants’ motion to dismiss the amended complaint was being briefed.¹⁷ A related derivative action, Collins v. Davis, was filed in July 2025 against Merck officers and directors alleging breach of fiduciary duty over the same conduct.¹⁸

Propecia

More than 1,100 Propecia lawsuits were consolidated in federal court in Brooklyn, alleging Merck’s hair-loss drug caused persistent sexual dysfunction and depression that continued after patients stopped taking it. Plaintiffs cited internal Merck communications and alleged the company understated how often and how long side effects occurred in clinical trials.¹⁹

In April 2018, Merck settled hundreds of cases for a total of $4.3 million, with plaintiffs agreeing to confidentiality provisions covering court documents. Between 2009 and 2018, the FDA received roughly 5,000 reports of sexual or mental health side effects linked to Propecia, including about 350 involving suicidal thoughts and about 50 involving suicide. The FDA approved a label change in 2012 acknowledging that sexual problems could persist after patients stopped the drug.¹⁹ Some wrongful-death suits alleging suicide have been filed in the years since. Merck has said it acted responsibly and that the drug’s safety profile is supported by its clinical data.²⁰

Fosamax

Merck’s osteoporosis drug Fosamax generated two separate waves of lawsuits: one over osteonecrosis of the jaw and another over unusual femur fractures. Merck won five of seven jaw-related cases that went to trial between 2005 and 2013 and, in December 2013, settled about 1,200 remaining jaw claims for $27.7 million.²¹ A separate MDL for femur fracture claims was consolidated in New Jersey, with more than 560 cases pending as of 2018 and no reported settlements or trials in that track since.²²

Other Active Cases

Dr. Scholl’s and Lotrimin Talc

Merck faces more than 600 pending lawsuits alleging that talcum powder products sold under the Dr. Scholl’s and Lotrimin brands contained asbestos that caused mesothelioma. The products were part of a portfolio Merck acquired in 2009 and sold in 2014. In April 2026, an Illinois jury returned a defense verdict in the first case to go to trial, deliberating less than two hours before finding for Merck.²³

Januvia Pancreatic Cancer

Nearly 950 lawsuits alleging the diabetes drug Januvia causes pancreatic cancer remain pending in federal court in San Diego as MDL No. 2452. A trial judge dismissed all of them in 2015, but the Ninth Circuit reversed in 2017, finding the lower court had improperly limited discovery and wrongly excluded a plaintiffs’ expert.²⁴ No trials or settlements have been reported since the cases were reinstated.

Flint River Plant Wrongful Death

In October 2025, the family of Saville Sullivan filed a wrongful death lawsuit in the Middle District of Georgia, alleging that Merck’s former Flint River Plant in Albany, Georgia released a “toxic cocktail” of hazardous chemicals, including methylene chloride, and that exposure caused rare brain cancer in the daughters of a former employee.²⁵ Saville Sullivan died in October 2023 at age 26.²⁶ Merck moved to dismiss in late October 2025, arguing the claim is time-barred and that the parent company did not own or operate the plant. As of early 2026, the court had not ruled.²⁷

Keytruda Patent Dispute

Merck is in a patent ownership dispute with Johns Hopkins University over research underlying certain uses of its cancer drug Keytruda. The case, filed in the District of Maryland, is stayed while Merck challenges nine Johns Hopkins patents before the Patent Trial and Appeal Board. As of October 2025, five of those patents had been found unpatentable.¹⁸

The Cumulative Total

Across all categories since 2000, Merck has incurred more than $10.7 billion in cumulative regulatory penalties, fines, and legal settlements according to the Violation Tracker database.¹ The biggest items are the $4.85 billion Vioxx settlement in 2007, a $2.3 billion IRS tax settlement the same year, and the $950 million Vioxx criminal and civil resolution in 2011. Merck has also paid hundreds of millions to resolve Medicaid overbilling allegations, False Claims Act cases, and state-level deceptive marketing charges.

1
Good Jobs First Violation Tracker. Merck Parent Company Summary
2
Chemical & Engineering News. Merck Settles Vioxx Claims
3
National Center for Biotechnology Information. Vioxx Litigation and Settlement
4
U.S. Department of Justice. U.S. Pharmaceutical Company Merck Sharp & Dohme Sentenced in Connection With Unlawful Promotion of Vioxx
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FBI. Merck Sharp & Dohme Pleads Guilty to Misbranding Vioxx
6
CourtListener. In Re Gardasil Products Liability Litigation
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Fierce Pharma. Merck Emerges Victorious in Gardasil Safety Litigation
8
Fourth Circuit Court of Appeals. In Re Gardasil Products Liability Litigation, Nos. 24-1828, 24-1831, 24-1832
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Insurance Journal. Merck to Settle Gardasil Lawsuits
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Claims Journal. Merck Agrees to Settle Gardasil Lawsuits
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Yahoo Finance. Merck Gardasil Settlement Eases Legal Concerns
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Pasadena Now. Pasadena Woman Drops Suit vs Merck Over Gardasil HPV Vaccine
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Stanford Law School Securities Class Action Clearinghouse. Merck & Co., Inc. Securities Litigation
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Labaton Keller Sucharow. In Re Merck & Co., Inc. Securities Litigation
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STAT News. Merck Gardasil Keytruda China
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Fierce Pharma. Merck Puts Temporary Kibosh on Gardasil Shipments to China
17
Kessler Topaz Meltzer & Check. Merck & Co., Inc.
18
U.S. Securities and Exchange Commission. Merck & Co. SEC Filing
19
Reuters. Special Report: Propecia
20
PFS Foundation. Propecia Litigation Library
21
Merck. Merck Favorably Resolves Fosamax Alendronate Sodium ONJ Litigation
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FindLaw. Fosamax Settlement Proposed
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Law.com. Merck Wins First Trial Over Cosmetic Talc Products
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Drugwatch. Januvia Lawsuits
25
Beasley Allen. Wrongful Death Lawsuit Filed Against Merck
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Beasley Allen. Sullivan v. Merck Filing
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WALB News. Merck Moves to Dismiss Flint River Plant Cancer Lawsuit