Yes, you can sue the FDA—but the path is narrow, expensive, and rarely successful. The primary obstacle is sovereign immunity, a legal doctrine rooted in the Administrative Procedure Act (5 U.S.C. § 702) that protects federal agencies from most lawsuits. To overcome this barrier, plaintiffs must prove that the FDA acted “arbitrarily and capriciously,” exceeded its statutory authority, or violated specific procedural requirements.
A 2024 analysis found the FDA denies or refuses over 99% of applications for flavored e-cigarette products, triggering a wave of litigation from manufacturers claiming the agency changed its standards without notice. Despite this surge in lawsuits, most plaintiffs face dismissal before reaching the merits of their case.
Here’s what you’ll learn in this article:
📋 The legal pathways available to challenge FDA decisions and their specific requirements
⚖️ Real case examples showing when lawsuits against the FDA succeed or fail
🚫 Common mistakes that cause courts to dismiss FDA-related lawsuits
💡 Alternatives to litigation that may resolve your issue faster and cheaper
🗺️ State-specific considerations that affect your legal options
What Is Sovereign Immunity and Why Does It Matter?
Sovereign immunity is the legal principle that prevents citizens from suing the federal government without its consent. This doctrine traces back to English common law and the idea that “the king can do no wrong.” In the United States, Congress must waive this protection for citizens to sue federal agencies like the FDA.
The Administrative Procedure Act provides the primary waiver that allows FDA lawsuits. Section 702 states that “[a] person suffering legal wrong because of agency action, or adversely affected or aggrieved by agency action” may seek judicial review. This waiver has limits—plaintiffs cannot seek monetary damages through the APA.
The Federal Tort Claims Act (FTCA) provides a separate waiver that allows some tort claims against the government. Under the FTCA, individuals can sue for negligence if government employees acted within the scope of their employment and caused injury. The FDA itself advises claimants to submit Form SF-95 to initiate administrative tort claims.
The Three Main Legal Pathways to Sue the FDA
Pathway 1: Administrative Procedure Act (APA) Claims
The APA is the most common vehicle for challenging FDA decisions. Under 5 U.S.C. § 706, courts can set aside agency actions that are:
| Ground for Challenge | What It Means |
|---|---|
| Arbitrary and capricious | The FDA failed to consider relevant factors or made a clear error in judgment |
| Contrary to constitutional right | The action violates the Constitution |
| In excess of statutory authority | The FDA acted beyond what Congress authorized |
| Without observance of required procedure | The FDA skipped mandatory procedural steps |
Real Example—The Ivermectin Case: Three doctors who prescribed ivermectin for COVID-19 sued the FDA in 2022, claiming the agency’s social media posts—including one stating “You are not a horse”—exceeded its authority. The Fifth Circuit Court of Appeals ruled in August 2023 that the doctors had valid claims because “FDA is not a physician” and has authority “to inform, announce, and apprise—but not to endorse, denounce or advise.” The FDA settled the case in March 2024.
Pathway 2: Federal Tort Claims Act (FTCA)
The FTCA allows tort claims against the government, but the discretionary function exception shields most FDA regulatory activities. This exception protects government employees when their actions involve an “element of judgment or choice” and are “grounded in policy considerations.”
The Berkovitz Exception: In Berkovitz v. United States (1988), the Supreme Court held that the government can be liable when FDA employees violate mandatory duties imposed by statute or regulation. In that case, a child contracted polio from a vaccine that the FDA approved despite knowing it failed safety standards. The Court ruled the discretionary function exception did not apply because the FDA had no discretion to approve a vaccine that violated specific regulatory requirements.
Pathway 3: Ultra Vires Claims
Ultra vires claims allege that the FDA acted completely outside its legal authority—so far beyond its power that sovereign immunity does not apply. These claims bypass the APA’s normal requirements and can proceed even when the agency’s action is not “final.”
Key Requirements for Ultra Vires Claims:
| Requirement | Explanation |
|---|---|
| Action exceeds statutory authority | The FDA did something Congress never authorized |
| No colorable basis for authority | The FDA cannot point to any reasonable interpretation supporting its action |
| Violation is clear and obvious | Courts apply a heightened standard requiring a strong merits argument |
Who Has Successfully Sued the FDA? Three Real Scenarios
Scenario 1: Challenging FDA Rulemaking
The Laboratory Developed Tests Case (2024)
The FDA issued a Final Rule in 2024 requiring laboratory developed tests (LDTs) to comply with medical device regulations. The American Clinical Laboratory Association and the Association for Molecular Pathology filed lawsuits alleging the FDA exceeded its statutory authority.
| Plaintiff Action | FDA Response |
|---|---|
| Filed for summary judgment | Argued LDTs have always been medical devices |
| Claimed FDCA does not authorize LDT regulation | Cited Congressional silence as implicit approval |
| Argued LDTs already regulated under CLIA | Maintained FDA oversight is necessary for safety |
The plaintiffs argued that Congress specifically distinguished between mass-produced medical devices and customized LDTs developed by healthcare professionals in licensed facilities. As of January 2026, this case remains pending.
Scenario 2: Challenging FDA Drug Approval Decisions
The Mifepristone Case (2024)
Anti-abortion groups challenged the FDA’s 2000 approval of mifepristone, a medication abortion drug, in the Northern District of Texas in 2022. Judge Matthew Kacsmaryk ruled in favor of the plaintiffs, effectively ordering mifepristone off the market.
The Supreme Court unanimously reversed this decision in June 2024 in FDA v. Alliance for Hippocratic Medicine. The Court held that the doctors challenging the drug lacked standing because they “do not prescribe or use mifepristone” and the FDA was “not requiring them to do or refrain from doing anything.”
Key Takeaway: Even when a plaintiff wins at the district court level, the Supreme Court can dismiss the case if the plaintiff cannot demonstrate a concrete injury caused by the FDA’s action.
Scenario 3: Challenging FDA Enforcement Actions
The E-Cigarette PMTA Litigation
E-cigarette manufacturers have filed hundreds of lawsuits challenging FDA denials of their Premarket Tobacco Product Applications (PMTAs). The Fifth Circuit ruled en banc in January 2024 that the FDA acted “arbitrarily and capriciously” by changing its evidentiary requirements after manufacturers submitted their applications.
The court found that the FDA:
- Failed to provide fair notice of requirements
- Ignored manufacturers’ marketing plans despite calling them “critical”
- Attempted to justify its actions through post hoc rationalizations
However, the Supreme Court reversed this ruling in April 2025 in FDA v. Wages and White Lion Investments, holding the FDA’s denial orders were “sufficiently consistent” with prior guidance.
Why You Usually Cannot Sue the FDA Directly for Product Injuries
When an FDA-approved drug or medical device injures you, your instinct may be to sue the agency that approved it. This strategy almost never works. Courts consistently apply the discretionary function exception to shield FDA approval decisions from liability.
The Better Strategy: Sue the Manufacturer
The Supreme Court’s landmark decision in Wyeth v. Levine (2009) established that FDA approval does not shield drug manufacturers from state tort claims. Diana Levine sued Wyeth after a medication injection caused gangrene and amputation of her arm. Wyeth argued that FDA approval of its warning label preempted state law claims.
The Supreme Court disagreed, holding that FDA approval establishes a minimum safety standard, not a maximum. States remain free to hold drug companies to higher standards through tort law.
| Type of Lawsuit | Sue the FDA? | Sue the Manufacturer? |
|---|---|---|
| Design defect | No (discretionary function) | Yes (state tort law) |
| Manufacturing defect | No | Yes |
| Failure to warn | No | Yes for brand-name drugs |
| Generic drug failure to warn | No | No (preempted) |
The Generic Drug Exception: The Supreme Court ruled in PLIVA v. Mensing (2011) that generic drug manufacturers cannot be sued for inadequate warnings because federal law requires them to use the same labels as brand-name drugs. This creates what courts call “impossibility preemption”—state law demands safer labels, but federal law prohibits changing them.
Alternatives to Suing the FDA
Alternative 1: File a Citizen Petition
The citizen petition process allows any person to request that the FDA “issue, amend, or revoke a regulation or order.” This administrative remedy is often required before you can file a lawsuit.
Citizen Petition Requirements Under 21 CFR § 10.30:
| Component | Description |
|---|---|
| Action requested | Specific regulatory action you want the FDA to take |
| Statement of grounds | Factual and legal support, including unfavorable information |
| Environmental impact | Assessment or exclusion claim |
| Certification | Signed statement verifying accuracy |
The FDA receives approximately 200 citizen petitions annually. The agency must respond within 180 days, though this deadline is frequently missed. The Post-Finasteride Syndrome Foundation sued the FDA in 2021 after waiting over three years for a response to its petition.
Strategic Consideration: Brand-name drug companies file 92% of citizen petitions targeting generic applications, and the FDA rejects 92% of these petitions. However, filing a petition preserves your right to seek judicial review if denied.
Alternative 2: Use the FDA’s Internal Appeal Process
The FDA offers formal dispute resolution for companies challenging drug, biologic, or device application decisions. Under 21 CFR 10.75, stakeholders can request internal review through the FDA’s chain of supervision.
FDA Appeal Timeline for Significant Decisions:
| Step | Timeframe |
|---|---|
| Submit appeal request | Within 30 days of decision |
| FDA schedules review | Within 30 days of request |
| FDA issues decision | Within 20-30 calendar days of review |
Alternative 3: National Vaccine Injury Compensation Program
If you suffered a vaccine injury, you likely cannot sue the FDA or the manufacturer. The National Childhood Vaccine Injury Act of 1986 created the Vaccine Injury Compensation Program (VICP) as a “no-fault alternative” to the tort system.
Key VICP Features:
- Claims filed in the U.S. Court of Federal Claims
- Over $5.2 billion paid to nearly 10,000 claimants
- Attorney fees paid separately (not from your award)
- Three-year statute of limitations from first symptom
COVID-19 Vaccine Exception: COVID-19 vaccines are not covered by the VICP. Instead, claims go through the Countermeasures Injury Compensation Program (CICP). As of December 2025, only 72 of 14,636 COVID-19 vaccine injury claims have received compensation.
Do’s and Don’ts When Suing the FDA
Do’s
1. Exhaust Administrative Remedies First
Courts routinely dismiss FDA lawsuits when plaintiffs skip the citizen petition process. The exhaustion requirement under 21 CFR § 10.45 mandates that you await the FDA’s decision before filing suit.
Why it matters: The Fifth Circuit found that plaintiffs who waited 14 years for an FDA response could argue “futility” to waive the exhaustion requirement.
2. Demonstrate Concrete Injury
Article III standing requires proof that you suffered or will suffer an “injury in fact” that is “concrete and particularized.” The Supreme Court dismissed the mifepristone challenge because doctors who never prescribed the drug showed no concrete injury.
Why it matters: Moral, ideological, or policy objections are insufficient to establish standing.
3. Challenge Agency Procedure, Not Substance
Courts more readily overturn FDA actions based on procedural failures than substantive policy disagreements. The Fifth Circuit reversed e-cigarette denials because the FDA failed to follow its own guidance documents.
Why it matters: Under the post-Chevron framework, courts no longer defer to FDA interpretations of ambiguous statutes.
4. File Within the Statute of Limitations
The six-year statute of limitations for APA claims runs from when the plaintiff is injured—not when the rule was issued. The Supreme Court’s 2024 decision in Corner Post v. Federal Reserve confirmed that new businesses can challenge decades-old regulations.
Why it matters: This ruling opens FDA regulations to renewed litigation from parties who entered the market after the rules were finalized.
5. Consider Venue Carefully
Strategic forum selection can affect outcomes. The mifepristone plaintiffs filed in Amarillo, Texas specifically to appear before Judge Kacsmaryk. The Fifth Circuit has been particularly receptive to FDA challenges.
Why it matters: The Supreme Court ruled in June 2025 that retailers “adversely affected” by FDA denials can join manufacturers in filing petitions, expanding venue options.
Don’ts
1. Don’t Sue for Monetary Damages Under the APA
The APA waives sovereign immunity only for injunctive and declaratory relief—not money damages. For monetary claims, you must use the Tucker Act (in the Court of Federal Claims) or the FTCA.
Consequence: Your case will be dismissed for lack of jurisdiction.
2. Don’t Allege “Fraud on the FDA”
State law claims alleging that a manufacturer made fraudulent statements to the FDA are impliedly preempted by the Federal Food, Drug, and Cosmetic Act (FDCA). The Supreme Court held in Buckman Co. v. Plaintiffs’ Legal Committee (2001) that “policing fraud against federal agencies” is not a field states have traditionally occupied.
Consequence: Your case will be dismissed as preempted.
3. Don’t Challenge Warning Letters in Court
FDA warning letters are not considered “final agency action” and are therefore not reviewable under the APA. The D.C. Circuit affirmed this principle in Holistic Candlers v. FDA (2012).
Consequence: Your case will be dismissed as unripe.
4. Don’t Expect Quick Resolution
FDA litigation routinely takes years. The mifepristone case took over two years to reach the Supreme Court. The ivermectin case took 18 months from filing to settlement.
Consequence: Extended litigation costs and regulatory uncertainty.
5. Don’t Ignore the Post-Chevron Landscape
The Supreme Court’s overturning of Chevron deference in June 2024 means courts no longer defer to FDA interpretations of ambiguous statutes. This changes litigation strategy—arguments that would have failed under Chevron may now succeed.
Consequence: Failing to update your legal strategy wastes opportunities.
Common Mistakes That Get FDA Lawsuits Dismissed
Mistake 1: Lacking Standing
The most common fatal flaw is failing to demonstrate Article III standing. Courts have dismissed lawsuits challenging:
- FDA approval of vaccines by activist groups with no concrete injury
- FDA regulation of mercury in dental amalgam by dental groups
- FDA emergency use authorization revocations by medical associations lacking “associational standing”
How to Avoid It: Document specific, concrete harms—lost revenue, disciplinary actions, inability to practice—that are traceable to the FDA action and redressable by a court order.
Mistake 2: Filing Before Exhausting Administrative Remedies
The FDA’s exhaustion regulation (21 CFR § 10.45) requires plaintiffs to file a citizen petition and await the Commissioner’s decision before suing. Courts call this the “exhaustion trap”—you cannot sue until the FDA responds, but the FDA may take years to respond.
How to Avoid It: File your citizen petition early, document the FDA’s delay, and argue “futility” if the agency fails to meet its 180-day deadline.
Mistake 3: Challenging Non-Final Agency Action
Only “final agency action” is reviewable under the APA. Actions that lack finality include:
| Non-Final Action | Why Not Reviewable |
|---|---|
| Warning letters | Advisory only, no legal consequences |
| Guidance documents | Non-binding recommendations |
| Investigational decisions | Subject to change during review |
How to Avoid It: Wait for the FDA to issue a formal denial, approval, or regulatory action before filing suit.
Mistake 4: Seeking the Wrong Relief
The APA limits remedies to setting aside unlawful agency action—it does not authorize money damages. Plaintiffs seeking compensation for injuries must pursue separate claims under the FTCA or state tort law.
How to Avoid It: Structure your complaint to seek injunctive or declaratory relief under the APA, and file separate tort claims where appropriate.
Mistake 5: Missing the Statute of Limitations
While Corner Post extended the limitations period for APA claims, other deadlines remain strict:
| Claim Type | Limitation Period |
|---|---|
| APA challenge | 6 years from injury |
| FTCA tort claim | 2 years from injury, must file administrative claim first |
| VICP vaccine claim | 3 years from first symptom |
| CICP COVID vaccine claim | 1 year from injury |
How to Avoid It: Consult an attorney immediately after identifying a potential claim to preserve your deadlines.
State Law Considerations
Preemption Varies by Product Type
| Product | State Tort Claims Preempted? |
|---|---|
| Brand-name drugs | No (under Wyeth v. Levine) |
| Generic drugs | Yes for failure to warn (under Mensing) |
| Class III medical devices | Yes for most claims (under Riegel v. Medtronic) |
| Class I/II medical devices | Varies by claim type |
State-Specific Immunity Statutes
Some states provide additional immunity for manufacturers of FDA-approved products. Michigan’s drug immunity statute shields manufacturers unless the plaintiff proves “fraud on the FDA” by clear and convincing evidence. However, federal preemption bars most fraud-on-the-FDA claims.
Parallel State Law Claims
Courts allow state tort claims that “parallel” federal requirements. For example, claims that a manufacturer violated state law by violating FDA reporting requirements may survive preemption. The Fifth, Seventh, and Ninth Circuits have sustained such claims against preemption challenges.
The Impact of Loper Bright on FDA Litigation
The Supreme Court’s June 2024 decision in Loper Bright Enterprises v. Raimondo overturned 40 years of Chevron deference. This means courts no longer defer to the FDA’s interpretation of ambiguous statutes—judges decide what the law means.
Implications for FDA Challengers:
| Before Loper Bright | After Loper Bright |
|---|---|
| Courts accepted reasonable FDA interpretations | Courts interpret statutes independently |
| FDA expertise carried significant weight | Agency expertise is one factor among many |
| Challenges to established interpretations rarely succeeded | Decades-old FDA positions are now vulnerable |
Industry stakeholders expect increased litigation challenging FDA classifications, approval standards, and enforcement practices. Areas likely to see challenges include the boundary between drugs and biologics (as in Eli Lilly’s lawsuit over retatrutide) and the scope of FDA authority over laboratory developed tests.
FAQs
Can I sue the FDA if an approved drug injured me?
No. The discretionary function exception shields FDA approval decisions. Sue the drug manufacturer under state tort law instead.
How long do I have to file an APA lawsuit against the FDA?
Yes, you have six years. The statute of limitations runs from when the FDA action injures you, not when the rule was issued.
Do I need a lawyer to file a citizen petition?
No. Any person can file a petition. However, petitions require specific format and content under 21 CFR § 10.30.
Can I sue the FDA for denying my drug application?
Yes. Drug sponsors can challenge denials under the APA as arbitrary and capricious. Exhaust internal appeals first.
Is the FDA liable for vaccine injuries?
No. File claims with the Vaccine Injury Compensation Program (VICP) for covered vaccines or the CICP for COVID-19 vaccines.
Can I sue both the FDA and the drug manufacturer?
Yes, but they require different legal theories. APA claims against the FDA seek injunctive relief. Tort claims against manufacturers seek damages.
What happens if I win my lawsuit against the FDA?
The court may set aside the FDA action, remand for reconsideration, or declare the action unlawful. You cannot recover money damages under the APA.
Can I sue the FDA over its social media posts?
Yes, if the posts exceed the FDA’s statutory authority. The ivermectin doctors successfully argued the FDA crossed the line from informing to advising.
Does the FDA have to respond to my citizen petition?
Yes. The FDA must respond within 180 days, though delays are common. You may argue futility to waive exhaustion after extended delays.
Can retailers sue the FDA over tobacco product denials?
Yes. The Supreme Court ruled in 2025 that retailers “adversely affected” by denial orders can seek judicial review.