Gardasil Lawsuits: What MDL 3036 Actually Decided

Gardasil is the Merck vaccine against human papillomavirus (HPV). The federal lawsuits collected in MDL No. 3036, In re: Gardasil Products Liability Litigation, alleged that the vaccine caused postural orthostatic tachycardia syndrome (POTS), primary ovarian insufficiency (POI) and other injuries through an autoimmune reaction. The docket is now close to empty: the Judicial Panel on Multidistrict Litigation’s report dated October 1, 2026 lists 6 actions pending against 258 total actions reported.

The main claims did not end in a trial verdict. They were dismissed on legal grounds. The Vaccine Act bars design defect claims against vaccine manufacturers, and the district court held that Merck could not have added the POTS and POI warnings the plaintiffs demanded without prior FDA approval. That was a preemption ruling; the court did not decide whether Gardasil causes either condition.

The compensation program that comes first

Vaccine injury claims do not begin in an ordinary products liability court. The National Childhood Vaccine Injury Act of 1986 created the National Vaccine Injury Compensation Program, which HRSA describes as “a no-fault alternative to the traditional legal system for resolving vaccine injury petitions.”

A person who received a covered vaccine and believes it caused an injury files a petition in the U.S. Court of Federal Claims. HHS medical staff review it, the Department of Justice submits a report, and a court-appointed special master decides whether compensation is owed. A petitioner who rejects the decision, or withdraws within certain timelines, may then sue the manufacturer or the health care provider who administered the vaccine. HRSA’s covered vaccines list includes human papillomavirus (HPV), so that is the program the Gardasil claims passed through before federal court.

A separate Countermeasures Injury Compensation Program covers serious injuries or deaths from certain covered countermeasures, which HRSA defines as a vaccine, medication, device or other item used against a public health emergency or security threat. Its filing deadline is one year.

What the FDA label and CDC say

The Gardasil 9 prescribing information published by DailyMed is the version revised March 2025. Its warnings and precautions section has two entries: 5.1, Syncope, and 5.2, Managing Allergic Reactions. A full-text search of the label finds no occurrence of “POTS,” “postural orthostatic tachycardia,” “POI” or “primary ovarian insufficiency.”

The CDC’s HPV vaccine safety page states that monitoring and studies by CDC, FDA and other organizations have “documented a reassuring safety record” since 2006. It also describes 2019 post-licensure analyses of Gardasil 9 in Pediatrics that “did not identify any unexpected safety problems.”

Those are statements by regulators and public health agencies about the vaccine and its label, not court findings, and they do not resolve the causation question in the litigation.

What is established vs. what is alleged

Established by the documents reviewed: the identity of MDL No. 3036 and its judges; the August 4, 2022 transfer order; the Panel’s account of the claims; the March 20, 2024 ruling on design defect and direct warning claims; the March 11, 2025 ruling on implied preemption; the 2025 judgments; the Fourth Circuit’s September 4, 2025 opinion; and the October 1, 2026 pending count.

Alleged, and not decided: that Gardasil causes POTS, POI or another injury; that Merck knew or should have known of such a link; and that its warnings were inadequate. The Panel recorded those as allegations. The March 2025 order granted judgment on preemption and expressly declined to decide Merck’s separate general causation motion.

What the MDL alleged

The transfer order described “personal injury actions” presenting common questions of fact “arising from allegations that plaintiffs, or their minor children, developed postural orthostatic tachycardia syndrome (POTS) and various other injuries as the result of an autoimmune reaction to the Gardasil vaccine.” It said the plaintiffs brought products liability, breach of warranty, fraud and negligence claims.

The order listed 31 actions in 22 districts and noted nine potential tag-alongs in six more districts. By the decision date, the Panel referred to “forty involved actions pending in twenty-eight districts.” It assigned the litigation to Judge Robert J. Conrad, Jr. A Panel order signed February 2, 2024 reassigned it to Judge Kenneth D. Bell, whom the October 2026 report lists as transferee judge.

What the courts decided

On March 20, 2024, the court granted in part Merck’s motion for partial judgment on the pleadings. It held that the plaintiffs’ design defect theories were preempted by the Vaccine Act, citing Bruesewitz v. Wyeth LLC, and that the Act bars claims that Merck failed to warn patients, parents or the public directly. Claims that Merck failed to warn medical providers, and claims of fraudulent concealment, proceeded. The ruling applied to substantially similar claims across the MDL.

On March 11, 2025, the court granted Merck summary judgment on implied preemption. The question was whether federal law permitted Merck to add POTS and POI warnings without prior FDA approval. The court found that by 2013 there had been one published, verified case of POTS and four published case reports of POI, plus scattered unverified reports. It concluded that “no scientist could reasonably conclude there is a causal association between POTS and POI and Gardasil based on this paucity of evidence.”

The order applied to the other MDL plaintiffs under prior orders and the parties’ agreement. Final judgment for the bellwether plaintiffs was entered April 10, 2025, and judgment for additional plaintiffs followed on June 24, 2025.

Two sets of appeals followed. In the first, the Fourth Circuit affirmed dismissal of three plaintiffs whose Vaccine Act petitions were untimely. Its September 4, 2025 published opinion held that “the Act requires a claimant to file a timely Vaccine Act petition to later be able to bring a tort suit,” and that once the Vaccine Act forums decide timeliness, “their answer can’t ordinarily be relitigated in a later tort suit.”

In the second, the plaintiffs appealed the March 2025 summary judgment. The Fourth Circuit consolidated those appeals in July 2025 and referred them to mediation in October 2025. The docket records further orders in 2026, but their text is not in the public archive used here. The record reviewed contains no opinion or mandate deciding the preemption appeal on the merits.

Key dates

• August 4, 2022: the Panel creates MDL No. 3036, covering 31 actions in 22 districts, before Judge Robert J. Conrad, Jr.
• February 2, 2024: the Panel reassigns the litigation to Judge Kenneth D. Bell.
• March 20, 2024: the court dismisses design defect and direct warning claims and allows medical-provider warning and concealment claims to proceed.
• March 11, 2025: the court grants Merck summary judgment on implied preemption and applies the ruling across the MDL.
• April 10 and June 24, 2025: judgments are entered for the bellwether plaintiffs and for additional plaintiffs.
• July 31, 2025: the Fourth Circuit consolidates the summary judgment appeals.
• September 4, 2025: the Fourth Circuit affirms dismissal of three plaintiffs who filed untimely Vaccine Act petitions. Its mandate issues September 26, 2025.
• October 14, 2025: the consolidated summary judgment appeals are referred to mediation.
• October 1, 2026: the Panel lists 6 actions pending and 258 total actions reported.

What this does not establish

Nothing in the documents reviewed shows a court finding that Gardasil caused any person’s POTS, POI or other injury. The March 2025 order was a preemption ruling. It did not decide general causation, and it did not find that the vaccine is safe. The CDC statements and the FDA-approved label are regulatory and public health materials, not judicial findings.

The absence of a POTS or POI warning is not a finding that the vaccine cannot cause either condition, and the plaintiffs’ allegations are not a finding that it does. The record contains no verdict, no settlement, no admission of liability and no determination of what any individual claim may be worth.

The six pending actions are a docket count. The documents reviewed do not show what those actions assert or whether they will survive the earlier rulings.

Frequently asked questions

Is there a Gardasil settlement?

No settlement appears in the documents reviewed. The October 1, 2026 report still lists 6 actions pending, and the district court docket records judgments for Merck rather than a settlement.

Did a court find that Gardasil causes POTS or POI?

No. The March 11, 2025 order granted summary judgment on preemption and expressly did not decide general causation. The Fourth Circuit’s September 4, 2025 opinion addressed the timing of Vaccine Act petitions, not causation.

Does the FDA label warn about POTS or POI?

No. The March 2025 revision does not contain the terms POTS, postural orthostatic tachycardia, POI or primary ovarian insufficiency. Its warnings and precautions sections address syncope and allergic reactions.

Background on how these proceedings work appears in the pharmaceutical lawsuits hub and in MDLs compared with class actions, alongside the Depo-Provera meningioma litigation, the GLP-1 litigation and the Dupixent litigation.

Sources

1. U.S. Judicial Panel on Multidistrict Litigation: “In re: Gardasil Products Liability Litigation, MDL No. 3036, Transfer Order (August 4, 2022)” (link, accessed 2026-10-19)
2. U.S. Judicial Panel on Multidistrict Litigation: “MDL Statistics Report: Distribution of Pending MDL Dockets by Actions Pending, Report Date 10/1/2026” (link, accessed 2026-10-19)
3. U.S. Judicial Panel on Multidistrict Litigation: “MDL Statistics Report: Docket Summary Listing by MDL Number, Report Date 10/1/2026” (link, accessed 2026-10-19)
4. U.S. District Court for the Western District of North Carolina: “In re: Gardasil Products Liability Litigation, MDL No. 3036, Order on Motion for Partial Judgment on the Pleadings (Doc. 132, March 20, 2024)” (link, accessed 2026-10-19)
5. U.S. District Court for the Western District of North Carolina: “In re: Gardasil Products Liability Litigation, MDL No. 3036, Order Granting Summary Judgment Based on Implied Preemption (Doc. 305, March 11, 2025)” (link, accessed 2026-10-19)
6. U.S. Court of Appeals for the Fourth Circuit: “In re: Gardasil Products Liability Litigation, Nos. 24-1828, 24-1831, 24-1832 (4th Cir. September 4, 2025), published opinion” (link, accessed 2026-10-19)
7. Free Law Project, RECAP archive: “In re: Gardasil Products Liability Litigation, MDL No. 3036, district court docket sheet” (link, accessed 2026-10-19)
8. Health Resources and Services Administration: “National Vaccine Injury Compensation Program” (link, accessed 2026-10-19)
9. Health Resources and Services Administration: “Vaccine Injury Compensation Program: Covered Vaccines” (link, accessed 2026-10-19)
10. Health Resources and Services Administration: “Countermeasures Injury Compensation Program (CICP)” (link, accessed 2026-10-19)
11. Centers for Disease Control and Prevention: “Human Papillomavirus (HPV) Vaccine Safety” (link, accessed 2026-10-19)
12. National Library of Medicine, DailyMed: “GARDASIL 9 (human papillomavirus 9-valent vaccine, recombinant) prescribing information, revised March 2025” (link, accessed 2026-10-19)

CollectiveClaim.us publishes general legal information. This article is not legal advice and does not create an attorney–client relationship. Court records and agency actions change; verify current status with the court or agency before relying on it.