Fourth Circuit Clarifies: Special Masters’ Timeliness Rulings Under the Vaccine Act Are Preclusive Gatekeepers to Tort Suits; Gardasil’s Table Addition Comports with the Presentment Clause

Fourth Circuit Clarifies: Special Masters’ Timeliness Rulings Under the Vaccine Act Are Preclusive Gatekeepers to Tort Suits; Gardasil’s Table Addition Comports with the Presentment Clause

Introduction

In a published decision with sweeping implications for vaccine litigation, the U.S. Court of Appeals for the Fourth Circuit affirmed dismissals of three Gardasil cases within the In re Gardasil Products Liability multidistrict litigation (MDL) and resolved a global constitutional challenge raised across the MDL. The consolidated appeals—brought by Tessa Needham, Angela M. Walker, and Shanie D. Roman—arose after each plaintiff:

  • Received the Gardasil (HPV) vaccine;
  • Developed symptoms more than three years prior to filing a Vaccine Act petition;
  • Conceded untimeliness but sought equitable tolling before a special master in the Court of Federal Claims; and
  • Saw their petitions dismissed as untimely, with no further review sought in the Court of Federal Claims or Federal Circuit.

After turning to federal court with tort claims against Merck & Co. and Merck Sharp & Dohme LLC, plaintiffs faced dismissal on the ground that they failed to satisfy the National Vaccine Injury Compensation Program’s pre-suit requirements. On appeal, they also pressed a constitutional Presentment Clause attack on Gardasil’s inclusion in the Vaccine Injury Table.

Chief Judge Diaz, writing for a unanimous panel, held that:

  • Gardasil’s addition to the Vaccine Injury Table via 42 U.S.C. § 300aa-14(e) complies with the Constitution’s Presentment Clause; and
  • Timely participation in the Vaccine Act is a prerequisite to tort litigation, and once a special master resolves timeliness, trial courts in later tort suits may not revisit that issue. Issue preclusion bars relitigation.

Summary of the Judgment

  • Presentment Clause: The court rejected a global challenge to Gardasil’s inclusion on the Vaccine Injury Table. Section 300aa-14(e) lawfully directs the Secretary to add vaccines when Congress has enacted an excise tax and the CDC recommends routine pediatric administration—conditions built into the statute that mirror the permissible delegation upheld in Marshall Field & Co. v. Clark, not the unconstitutional “line-item veto” condemned in Clinton v. City of New York.
  • Exhaustion and Timeliness: The Vaccine Act requires filing a petition “in accordance with” the statute’s 36-month limitations period (subject to equitable tolling) before pursuing a tort suit. Special masters, the Court of Federal Claims, and the Federal Circuit have exclusive authority to decide timeliness questions; their determinations cannot be re-opened in a subsequent tort case. Ordinary issue preclusion principles bar relitigation of the timeliness issue.
  • “De novo” clarified: The Act’s “de novo civil action” feature simply means that factual and legal determinations from the Vaccine Program are not admissible on the liability and damages phases of a civil case, not that courts may ignore pre-suit gatekeeping determinations like timeliness.
  • Disposition: The Fourth Circuit affirmed the Western District of North Carolina’s dismissals. It did not reach the MDL court’s separate Rule 12(c) preemption rulings because the cases were resolved on exhaustion grounds.

Detailed Analysis

1) Precedents Cited and How They Shaped the Outcome

  • Bruesewitz v. Wyeth LLC, 562 U.S. 223 (2011) and Shalala v. Whitecotton, 514 U.S. 268 (1995): The Supreme Court’s framing of the Vaccine Act as a no-fault, streamlined compensation scheme—requiring claimants to proceed through the Program before suit—underpins the Fourth Circuit’s conclusion that timely filing is a precondition to tort litigation.
  • Cloer v. Sec’y of HHS, 654 F.3d 1322 (Fed. Cir. 2011) (en banc): Establishes that the Vaccine Act’s statute of limitations is subject to equitable tolling. The Fourth Circuit acknowledged tolling exists but emphasized it must be raised and resolved within the Vaccine Program—and reviewed through the Program’s appellate path.
  • Marshall Field & Co. v. Clark, 143 U.S. 649 (1892) vs. Clinton v. City of New York, 524 U.S. 417 (1998): The Clark/Clinton framework guided the Presentment Clause analysis. Section 300aa-14(e) directs the Executive to act upon specified conditions (CDC recommendation plus excise tax enactment), like Clark; it does not authorize unilateral policy-making akin to Clinton’s line-item veto.
  • B&B Hardware, Inc. v. Hargis Indus., Inc., 575 U.S. 138 (2015) and In re Microsoft Corp. Antitrust Litig., 355 F.3d 322 (4th Cir. 2004): These decisions supply the modern contours of issue preclusion across adjudicative forums. The court applied ordinary preclusion principles to special masters’ timeliness determinations.
  • Rohrbough v. Wyeth Labs., Inc., 916 F.2d 970 (4th Cir. 1990): Supports the interpretation of the Act’s “de novo” bar on admissibility—i.e., program determinations cannot be used to prove liability or damages; but that evidentiary bar does not erase threshold gatekeeping determinations like compliance with pre-suit requirements.
  • Schafer v. American Cyanamid Co., 20 F.3d 1 (1st Cir. 1994): Recognizes the Act’s mandatory exhaustion pathway—reinforcing the Fourth Circuit’s view that claimants must first proceed in the Program.
  • Gelboim v. Bank of Am. Corp., 574 U.S. 405 (2015): Confirms immediate appealability of dispositive orders in MDL proceedings, providing appellate jurisdiction here.
  • Riley v. Bondi, 145 S. Ct. 2190 (2025): Cited for the proposition that “shall dismiss” language often signals jurisdictional limits. The Fourth Circuit noted, but did not decide, whether the Vaccine Act’s dismissal command is jurisdictional or a claims-processing rule because Merck timely invoked it.
  • Terran ex rel. Terran v. Sec’y of HHS, 195 F.3d 1302 (Fed. Cir. 1999): While not adopted by the Fourth Circuit, it was noted in a footnote as rejecting a structurally similar Presentment challenge to § 300aa-14(c). The Fourth Circuit found the § 300aa-14(c) argument forfeited and did not opine on Terran.

2) The Court’s Legal Reasoning

A. Presentment Clause and Gardasil’s Table Addition

The Presentment Clause forbids the Executive from enacting, amending, or repealing legislation outside Article I’s bicameralism and presentment process. Plaintiffs argued that Gardasil’s addition to the Vaccine Injury Table violated this principle.

The Fourth Circuit distinguished between two separate statutory mechanisms:

  • Section 300aa-14(e): Requires the Secretary to amend the Table to add vaccines that the CDC recommends for routine pediatric use, with effectiveness conditioned on Congress having enacted an excise tax on the vaccine doses to fund compensation. The Executive’s role is ministerial—ascertaining that congressionally specified conditions occurred—akin to Marshall Field’s permissible conditional delegation.
  • Section 300aa-14(c): Authorizes the Secretary to promulgate prospective regulations modifying listed injuries and onset windows for already-listed vaccines. Plaintiffs attacked this provision by invoking the Vaccine Act’s non-severability clause to knock out the entire scheme. But they had not preserved a § 14(c) challenge in the district court; the Fourth Circuit deemed the argument forfeited and declined to consider it.

Bottom line: Gardasil’s inclusion under § 14(e) satisfies the Presentment Clause. The Executive did not unilaterally change statutory text or make free-ranging policy; it executed a conditional legislative instruction that took effect only after Congress enacted an excise tax and the CDC made a qualifying recommendation.

B. Exhaustion, Timeliness, and Who Decides

The Vaccine Act bars tort actions against vaccine manufacturers seeking more than $1,000 unless the claimant first files a petition “in accordance with” 42 U.S.C. § 300aa-16 (the Act’s limitations provision) and then rejects the Program’s outcome or withdraws after specified delays. The Act also commands that non-compliant suits “shall” be dismissed.

The court’s core holdings:

  • Timely filing is a prerequisite to suit. Congress designed the Program to be the first stop, not an optional detour. A claimant must timely pursue Vaccine Program remedies before suing (Shalala, Bruesewitz).
  • Special masters (and their reviewing courts) decide timeliness. Section 300aa-12 vests “jurisdiction” over petitions—including limitations and equitable tolling issues—with special masters, subject to review by the Court of Federal Claims and the Federal Circuit.
  • Trial courts may not re-decide timeliness in later tort suits. Plaintiffs’ argument that civil cases are “de novo” does not authorize relitigation of precondition questions. The Act’s “de novo” rule, codified in § 300aa-23(e), is an evidentiary bar aimed at the liability and damages stages; it does not erase threshold exhaustion requirements or allow a second bite at timeliness.
  • Issue preclusion applies. A special master’s final timeliness determination—especially where, as here, no Program appeal was taken—is preclusive in later litigation. The elements (identity of issue, actual litigation, necessity, finality, and full and fair opportunity) are satisfied.

The court added an important caveat for atypical cases: if a petitioner properly withdraws after the Program’s statutory time limits (e.g., no decision within 240 days), a special master may not have resolved timeliness; in that narrow scenario, a civil court might need to decide timeliness in the first instance. That was not this case.

C. The “De Novo” Misconception

Plaintiffs contended that “de novo civil action” means the district court must ignore the Program’s timeliness disposition. The Fourth Circuit rejected this reading. The “de novo” feature in § 300aa-23(e) renders Program findings and conclusions inadmissible at the liability, general damages, and punitive damages stages of a civil action. It does not grant license to bypass or re-try statutory prerequisites to suit—including whether the claimant timely and properly engaged the Program at all.

D. Practical Effect in These Appeals

Each appellant conceded untimeliness before the special master and lost on equitable tolling. Without pursuing Program appellate review, they then sued in tort. The Fourth Circuit held they could not resurrect timeliness in the MDL court; the special masters’ decisions stand and bar the suits. Because the court resolved the cases on exhaustion grounds, it did not reach the MDL court’s separate Rule 12(c) ruling that many theories were preempted as disguised design-defect or failure-to-warn claims.

3) Impact and Forward-Looking Implications

  • MDL and Case-Management Clarity: MDL courts facing vaccine cases now have authoritative guidance that special masters’ untimeliness rulings foreclose later relitigation. Expect earlier, cleaner dismissals when Program timeliness has already been resolved.
  • Strict Compliance with the Vaccine Program: Plaintiffs must:
    • File within 36 months of first symptom or significant aggravation; and
    • Litigate equitable tolling in the Program—then seek review in the Court of Federal Claims and possibly the Federal Circuit.
    Skipping Program appellate review can cement preclusion in subsequent tort suits.
  • Constitutional Stability for the Vaccine Table: The Presentment Clause attack on § 14(e) fails. Gardasil’s table status is constitutionally sound so long as the CDC recommendation and excise tax conditions are met.
  • Defense Strategy: Manufacturers should promptly:
    • Move to dismiss based on failure to file a timely Program petition;
    • Invoke issue preclusion where a special master has resolved timeliness; and
    • Highlight the Act’s “shall dismiss” command and the channeling function of § 300aa-12.
  • Narrow Window for District Court Timeliness Determinations: Only where a petitioner withdraws after statutory delay—without any special master ruling on timeliness—might a district court address timeliness in the first instance.
  • Preemption Issues Deferred: Because the court affirmed on exhaustion grounds, it did not opine on the MDL court’s preemption analysis. Those questions remain for cases that clear the Program’s timing gate.

Complex Concepts Simplified

  • Vaccine Injury Table: A schedule listing covered vaccines and certain injuries with onset windows. If your injury fits, causation is presumed; if not, you can still recover by proving actual causation.
  • Special Master: A judicial officer of the Court of Federal Claims who adjudicates Vaccine Act petitions on an expedited track with informal procedures.
  • Equitable Tolling: A doctrine allowing late filing where the petitioner diligently pursued rights but was prevented by extraordinary circumstances. Under the Vaccine Act, tolling is determined within the Program and reviewed through its appellate pathway.
  • Presentment Clause: The constitutional requirement that laws be passed by both Houses and presented to the President. It bars the Executive from unilaterally amending statutes. Conditional delegations that direct the Executive to act upon specified facts (e.g., when Congress enacts a tax and CDC issues a recommendation) are typically valid.
  • Issue Preclusion (Collateral Estoppel): Once a competent tribunal actually and necessarily decides an issue, the same parties cannot re-litigate that issue in a later case—even if the later case involves a different claim.
  • “De novo” in the Vaccine Act: Means Program findings are not admissible to prove liability or damages in a later tort trial; it does not permit courts to disregard statutory prerequisites like timely Program filing.
  • Non-Severability Clause: A provision in the Vaccine Act stating that if certain sections are held unconstitutional, the entire compensation scheme is invalid. Parties must raise such arguments in the district court; failure to do so forfeits them on appeal.
  • Withdrawal Right (240-Day Rule): If the Program does not resolve a petition within 240 days (or the Court of Federal Claims within 420 days), a petitioner may withdraw and bring a civil suit. In such cases, there may be no timeliness ruling to preclude later litigation.

Conclusion

This decision sets two important guideposts in the Fourth Circuit:

  1. Constitutional Validity of Gardasil’s Coverage: Gardasil’s addition to the Vaccine Injury Table under § 300aa-14(e) is constitutionally sound. The Executive acted within a conditional, congressionally prescribed framework—consistent with Marshall Field—not by unilaterally amending legislation as in Clinton.
  2. Preclusive Effect of Program Timeliness Rulings: Timely filing in the Vaccine Program is a mandatory predicate to tort litigation. Special masters decide timeliness subject to review within the Program. Their final determinations preclude later relitigation in civil suits, and the Act’s “de novo” rule does not alter that gatekeeping function.

For plaintiffs, the practical mandate is unmistakable: file within the 36-month window or robustly litigate equitable tolling in the Program and pursue its appellate review. For defendants and MDL courts, the opinion endorses early dismissal for noncompliance and the use of issue preclusion to prevent re-litigation of timeliness. The ruling fortifies the Vaccine Act’s central design—fast, predictable compensation coupled with limited, structured access to tort remedies—and provides clear procedural bright lines for the vast Gardasil MDL and vaccine litigation more broadly.

Case Details

Year: 2025
Court: Court of Appeals for the Fourth Circuit

Comments