Gardasil HPV Vaccine Lawsuit, 220+ Cases Dismissed After Federal Judge Rules Preemption Bars Failure-to-Warn Claims—Appeals Pending, Trial Delayed Due To RFK Jr. HHS Confirmation

More than 220 Gardasil HPV vaccine lawsuits alleging the vaccine causes autoimmune disorders like POTS and premature ovarian failure face significant legal hurdles after U.S. District Judge Kenneth Bell granted Merck’s summary judgment motion on March 11, 2025, dismissing the majority of failure-to-warn claims. The Fourth Circuit upheld these dismissals on September 4, 2025, ruling that federal preemption bars state-law claims when FDA-approved warning labels already exist.

The first state court trial in California was postponed from early 2025 to September 2025 due to concerns that Robert F. Kennedy Jr.’s confirmation as HHS Secretary might bias jurors, given his history of vaccine criticism and financial ties to vaccine litigation.

Federal multidistrict litigation (MDL No. 3036) in Charlotte, North Carolina now faces appeals, while a handful of California state cases proceed separately.

What the Gardasil Lawsuits Allege

Claimed Injuries and Side Effects

The lawsuits claim Merck failed to adequately warn consumers about serious health risks associated with Gardasil and Gardasil-9. The most common allegations involve autoimmune disorders and neurological complications.

Postural Orthostatic Tachycardia Syndrome (POTS): A condition causing rapid heart rate increases when standing, leading to dizziness, fainting, and chronic fatigue. Many plaintiffs report POTS symptoms developing weeks or months after vaccination, leaving them disabled and unable to work or attend school.

Premature Ovarian Failure/Insufficiency (POF/POI): Plaintiffs allege the vaccine causes early menopause in girls and young women, resulting in infertility, hormonal imbalances, and need for lifelong hormone replacement therapy.

Other alleged injuries include lupus, rheumatoid arthritis, multiple sclerosis, Guillain-Barré syndrome, and severe allergic reactions.

What Plaintiffs Claim Merck Did Wrong

Lawsuits allege Merck manipulated clinical trials to fast-track FDA approval. Critics claim the company used aluminum-containing placebos instead of true saline placebos, making it impossible to accurately assess safety by comparing vaccinated groups against truly unvaccinated control groups.

Plaintiffs assert Merck overstated Gardasil’s benefits while downplaying risks, engaged in aggressive marketing campaigns targeting children as young as nine, lobbied to make HPV vaccination mandatory for school attendance, and failed to adequately warn about autoimmune and neurological risks.

The lawsuits also claim Merck withheld adverse event reports from FDA regulators during the approval process.

Current Litigation Status

Federal MDL Dismissals and Appeals

On March 11, 2025, Judge Bell granted summary judgment for Merck in the bellwether cases, ruling that federal preemption bars state-law failure-to-warn claims when FDA-approved labels already exist.

The court found plaintiffs failed to present evidence showing Gardasil causes POTS or POI. Judge Bell emphasized that adding warnings without substantial scientific evidence “would effectively make the regulatory standard meaningless.”

The Fourth Circuit Court of Appeals affirmed these dismissals on September 4, 2025, in a published opinion. The appeals court ruled that HHS Secretary’s authority to add vaccines to the Vaccine Injury Table doesn’t violate the Constitution, strengthening federal control over vaccine injury claims.

Plaintiffs have appealed, with opening briefs filed in summer 2025. The appeals outcome will determine whether remaining cases proceed or the entire MDL collapses.

Similar to challenges in BMW transfer case class action $13,000 defect lawsuit, product liability plaintiffs must overcome high evidentiary burdens to prove causation.

California State Court Trial Postponed

The first jury trial over Gardasil safety was scheduled for early 2025 in Los Angeles Superior Court involving plaintiff Jennifer Robi, who alleges the vaccine caused POTS that left her wheelchair-bound.

The trial was halted and rescheduled to September 2025 due to concerns that media coverage of RFK Jr.’s HHS Secretary confirmation might influence jurors. Kennedy has financial ties to vaccine litigation and a long history of vaccine criticism.

Merck points to vaccine court’s finding that Robi failed to prove Gardasil “actually caused” her injury and argues CDC hasn’t “detected any safety concerns related to POTS following HPV vaccination.”

Vaccine Court Requirements Create Legal Hurdles

Because Gardasil is covered by the National Vaccine Injury Compensation Program (VICP), individuals must first file claims in “Vaccine Court” before suing Merck in civil court.

Judge Bell dismissed four federal cases in July 2024, ruling his court lacks authority to overturn Vaccine Court decisions. Plaintiffs who didn’t initially file with Vaccine Court or filed too late cannot pursue civil litigation.

This requirement creates a unique legal environment where claims must pass through federal administrative process first. Vaccine Court has paid nearly $6 million in Gardasil-related injury compensation since the program’s creation, though this is modest compared to millions of doses administered worldwide.

What You Must Know

The Preemption Obstacle

Federal preemption bars state-law claims that conflict with federal regulatory decisions. Because FDA approved Gardasil’s warning label after reviewing available evidence, plaintiffs cannot argue under state law that different warnings were required—unless they can prove Merck withheld information from FDA.

This legal doctrine makes vaccine injury cases extremely difficult to win in civil court. Courts give significant deference to FDA’s scientific determinations about vaccine safety and labeling.

What Scientific Evidence Shows

More than 135 million Gardasil doses have been administered in the United States and 500 million worldwide. The FDA approved the original Gardasil in 2006 and Gardasil-9 in 2014 after clinical trials.

CDC and FDA continue to monitor vaccine safety through the Vaccine Adverse Event Reporting System (VAERS) and other surveillance programs. Health authorities maintain that scientific evidence supports Gardasil’s safety and effectiveness in preventing HPV-related cancers.

Merck emphasizes “an overwhelming body of scientific evidence continues to support the safety and efficacy of our HPV vaccines.”

However, plaintiffs point to case reports, temporal associations between vaccination and symptom onset, and VAERS reports as evidence of causation. A 2025 National Cancer Institute study suggested a single Gardasil dose may be 97% effective, raising questions about Merck’s multi-dose protocol.

The legal battle centers on whether plaintiffs can prove causation through admissible scientific evidence—not just temporal correlation or individual case reports.

Statute of Limitations Concerns

State statutes of limitations for product liability claims vary, typically ranging from 1-4 years from injury discovery. Many potential claimants may already be time-barred from filing.

The Vaccine Court has its own strict filing requirements: claims must generally be filed within three years of the first symptom of the injury. Missing these deadlines permanently bars recovery.

Similar to issues in Rheem water heater defective drain valve class action settlement, product defect plaintiffs must act quickly before limitations periods expire.

What to Do Next

If You Received Gardasil and Experienced Adverse Effects

Preserve all medical records documenting your vaccination dates, symptom timeline, diagnoses, treatments, and healthcare provider statements linking symptoms to vaccination timing.

Save vaccination cards, appointment records, and any correspondence with healthcare providers or Merck about reported side effects.

Document your symptoms in detail, including when they started relative to vaccination, how they’ve progressed, and how they’ve impacted your life.

Understanding Your Legal Options

Given the federal MDL dismissals and Fourth Circuit ruling, new federal lawsuits face significant obstacles. However, state court options may still exist depending on jurisdiction and specific facts.

Consult a qualified attorney specializing in vaccine injury litigation or pharmaceutical product liability to evaluate your case. Most work on contingency and offer free consultations.

Consider whether Vaccine Court may be a better option. While payouts may be lower than potential civil verdicts, the process is faster, easier, and doesn’t require proving manufacturer fault—only causation between vaccine and injury.

Filing Requirements and Deadlines

Vaccine Court: Must file within three years of first symptom. This is a hard deadline with limited exceptions.

Civil Court: Must exhaust Vaccine Court remedies first (file petition, receive judgment or wait statutory period). State statutes of limitations then apply from injury discovery.

Federal Court: Given current preemption rulings, federal litigation prospects are extremely limited unless plaintiffs can show Merck withheld information from FDA.

Act quickly. Statutes of limitations are running, and the longer you wait, the harder it becomes to gather evidence and build a case.

Official Resources for Gardasil Information

FDA Gardasil Safety Information: FDA.gov provides official vaccine prescribing information, clinical trial data, and safety communications.

CDC HPV Vaccine Safety: CDC.gov maintains current vaccine safety monitoring data, recommendations, and adverse event analysis.

VAERS Database: Vaccine Adverse Event Reporting System allows searching reported adverse events following vaccination.

National Vaccine Injury Compensation Program: HRSA.gov/VICP provides information about filing vaccine injury claims, covered vaccines, and compensation process.

Court Dockets: PACER.gov allows searching federal court dockets for MDL No. 3036 (Western District of North Carolina) to monitor case developments.

Frequently Asked Questions

What are the Gardasil lawsuits claiming?

Lawsuits allege Merck failed to adequately warn about risks of autoimmune disorders (primarily POTS and premature ovarian failure) and manipulated clinical trials to fast-track FDA approval. Plaintiffs claim the vaccine caused serious health complications including chronic fatigue, infertility, and disability.

What is the current status of Gardasil litigation?

The federal MDL involving 220+ cases hit major setbacks after Judge Bell granted summary judgment for Merck in March 2025, with the Fourth Circuit upholding dismissals in September 2025. Plaintiffs are appealing, but preemption rulings make success unlikely. The first California state trial was postponed to September 2025 due to RFK Jr. HHS confirmation concerns.

Can I still file a Gardasil lawsuit?

It depends. You must first file with Vaccine Court within three years of symptom onset. After exhausting that process, you may pursue civil litigation if state statutes of limitations haven’t expired. However, recent federal court rulings create significant legal obstacles through preemption doctrine.

Do I need to prove the vaccine caused my injury?

Yes. You must establish causation through medical evidence and expert testimony showing Gardasil more likely than not caused your specific injury. Temporal correlation alone (symptoms appearing after vaccination) is insufficient. This is a high evidentiary burden that has proven difficult for plaintiffs to meet.

Is there a settlement or compensation available?

No settlement exists. The Vaccine Court has paid approximately $6 million total in Gardasil injury compensation since the program began, but each claim must be individually proven. The federal MDL has not settled, and given recent dismissals, settlement prospects appear unlikely.

What is the statute of limitations for Gardasil claims?

Vaccine Court: 3 years from first symptom (hard deadline). Civil court: Varies by state (typically 1-4 years from injury discovery), but you must exhaust Vaccine Court remedies first. Federal preemption may bar civil claims entirely regardless of timing.

Should I join the class action or file individually?

There is no Gardasil class action. The federal MDL consolidates individual lawsuits for efficiency, but each plaintiff maintains their own case. Given current legal obstacles, consult an experienced vaccine injury attorney to evaluate whether Vaccine Court or civil litigation makes sense for your situation.

Last Updated: January 24, 2026

Disclaimer: This article provides general information only and does not constitute legal or medical advice; individuals should consult qualified attorneys and healthcare providers for case-specific guidance.

If you received Gardasil and experienced serious health complications, act quickly—statutes of limitations are running and legal deadlines are strict.

Stay informed, stay protected. — AllAboutLawyer.com

About the Author

Sarah Klein, JD, is a licensed attorney and legal content strategist with over 12 years of experience across civil, criminal, family, and regulatory law. At All About Lawyer, she covers a wide range of legal topics — from high-profile lawsuits and courtroom stories to state traffic laws and everyday legal questions — all with a focus on accuracy, clarity, and public understanding.
Her writing blends real legal insight with plain-English explanations, helping readers stay informed and legally aware.
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