Timeliness Determinations Under the Vaccine Act Are Binding in Subsequent Tort Suits; Gardasil’s Addition to the Vaccine Injury Table Upheld Under the Presentment Clause

Introduction

This published decision from the Fourth Circuit—authored by Chief Judge Diaz and joined by Judges Niemeyer and Berner—resolves two recurring, high-stakes questions in vaccine litigation:

Whether the Secretary of Health and Human Services’ addition of the HPV vaccine Gardasil to the Vaccine Injury Table comports with the Constitution’s Presentment Clause; and
Whether a plaintiff who wishes to pursue state-law tort claims must not only file a Vaccine Act petition first, but also file it on time—and, crucially, whether a special master’s adverse timeliness ruling can be revisited in the subsequent civil action.

The court answers both in Merck’s favor: (1) Gardasil’s addition to the Table via 42 U.S.C. § 300aa-14(e) is constitutional; and (2) timely participation in the Vaccine Act compensation program is a prerequisite to suit, and once a special master determines a petition is untimely (and that ruling is not overturned in the Court of Federal Claims or the Federal Circuit), trial courts in later tort suits may not relitigate timeliness. The judgment affirms dismissals in three representative actions within the Gardasil MDL and sustains a district-wide ruling rejecting a Presentment Clause challenge.

Background and Key Issues

Congress enacted Title XXI of the Public Health Service Act (the “Vaccine Act”) to stabilize vaccine supply and create a swift, no-fault compensation scheme for covered vaccine injuries. Claimants must first petition the Court of Federal Claims, where special masters adjudicate entitlement. Only after exhausting the program—either by rejecting a final judgment or withdrawing due to defined delays—may a claimant sue a manufacturer, and only if the petition was filed “in accordance with” the Act’s statute of limitations.

The three appellants (Needham, Walker, and Roman) received Gardasil and later experienced symptoms they allege were vaccine-related. All filed Vaccine Act petitions more than 36 months after their first symptoms. They conceded untimeliness but sought equitable tolling. The special masters denied tolling and dismissed. Plaintiffs then sued Merck in the Western District of North Carolina MDL; the district court dismissed for failure to timely exhaust the Vaccine Act remedy. In managing the MDL docket, the district court also rejected a sweeping Presentment Clause challenge to the procedure for adding vaccines to the Vaccine Injury Table and entered a bellwether Rule 12(c) order on preemption (not reached on this appeal).

On appeal, Plaintiffs posed three issues:

Whether Gardasil’s addition to the Table via § 300aa-14(e) violates the Presentment Clause;
Whether district courts may independently decide Vaccine Act timeliness in subsequent tort suits (including equitable tolling); and
Whether the Vaccine Act’s “de novo” civil action language allows relitigation of timeliness determinations.

Summary of the Judgment

Presentment Clause: The court holds that Gardasil’s addition to the Vaccine Injury Table under 42 U.S.C. § 300aa-14(e) complies with the Presentment Clause. The statute directs the Secretary to add a vaccine upon the occurrence of specified conditions—CDC’s routine childhood recommendation and enactment of a vaccine excise tax—making the executive’s action a permissible execution of legislative policy rather than an unauthorized amendment of statutory text.
Forfeiture of broader constitutional challenge: Plaintiffs’ separate attack on § 300aa-14(c) (which lets the Secretary prospectively adjust listed injuries and onset windows) was forfeited because it was not raised in the district court. The court thus does not reach its merits or the Vaccine Act’s non-severability clause.
Exhaustion and timeliness as a prerequisite: Filing a Vaccine Act petition “in accordance with” § 300aa-16—including the 36-month limitations period, subject to equitable tolling—is a mandatory prerequisite to bringing a tort suit. A special master’s adverse timeliness ruling must be reviewed (if at all) in the Court of Federal Claims and the Federal Circuit, not relitigated later. The subsequent tort action is “de novo” only in the sense that Vaccine Act findings cannot be used to prove liability or damages; it does not authorize collateral reconsideration of the exhaustion prerequisite.
Issue preclusion: Ordinary issue preclusion bars relitigation of timeliness where a special master has already decided the issue and the claimant had a full and fair opportunity to litigate, and did not pursue statutorily prescribed review.
Disposition: The Fourth Circuit affirms the dismissals. It does not reach the district court’s alternative, merits-based equitable tolling analysis, nor the MDL-wide Rule 12(c) preemption order.

Analysis

1) Precedents Cited and How They Shaped the Decision

Bruesewitz v. Wyeth LLC, 562 U.S. 223 (2011) and Shalala v. Whitecotton, 514 U.S. 268 (1995)
- These decisions articulate the Vaccine Act’s channeling design: a no-fault compensation program that claimants must pursue before filing tort suits. The Fourth Circuit relies on these cases to underscore that claimants must “exhaust” the Vaccine Program before any “de novo” civil action is available.
Cloer v. Sec’y of HHS, 654 F.3d 1322 (Fed. Cir. 2011)
- Cloer confirms that the Vaccine Act’s statute of limitations is subject to equitable tolling. Plaintiffs invoked tolling; special masters rejected it. The Fourth Circuit accepts that tolling is available but stresses the proper forum to litigate it is the Vaccine Program (and its reviewing courts), not a later tort suit.
Clinton v. City of New York, 524 U.S. 417 (1998) and Marshall Field & Co. v. Clark, 143 U.S. 649 (1892)
- These bookend the Presentment Clause analysis. Clinton invalidated the Line Item Veto because it enabled the President to rewrite statutes. Clark approved “conditional legislation,” where Congress made future executive action contingent on factual predicates.
- The Fourth Circuit characterizes § 300aa-14(e) as Clark-style conditional legislation: when CDC recommends a vaccine for routine pediatric use and Congress enacts an excise tax on it, the Secretary must add the vaccine to the Table. The Secretary executes Congress’s policy; he does not amend statutory text. Clinton’s concerns (same conditions, unconstrained discretion, and executive pursuit of independent policy) are absent.
Terran ex rel. Terran v. Sec’y of HHS, 195 F.3d 1302 (Fed. Cir. 1999)
- While the Fourth Circuit finds the plaintiffs’ § 300aa-14(c) challenge forfeited and does not adopt Terran, it notes Terran’s reasoning: prospective regulatory updates to injury listings do not erase Congress’s initial table; they operate prospectively.
Montana v. United States, 440 U.S. 147 (1979) and B&B Hardware, Inc. v. Hargis Industries, Inc., 575 U.S. 138 (2015)
- These cases anchor the application of issue preclusion beyond traditional courts. The Fourth Circuit draws on them to hold that special master timeliness rulings, rendered in adversarial proceedings of competent jurisdiction, preclude relitigation in later tort suits, provided the party had a full and fair opportunity to litigate.
In re Microsoft Corp. Antitrust Litig., 355 F.3d 322 (4th Cir. 2004)
- Supplies the Fourth Circuit’s familiar five-part test for issue preclusion, which the court finds satisfied by special master timeliness determinations.
Rohrbough v. Wyeth Labs., Inc., 916 F.2d 970 (4th Cir. 1990)
- Recognizes the Vaccine Act’s evidentiary prohibition (42 U.S.C. § 300aa-23(e)) in civil actions. The Fourth Circuit harmonizes this with its holding: “de novo” applies to liability and damages stages; it does not disable courts from enforcing the Act’s exhaustion/timeliness gatekeeping function.
Gelboim v. Bank of Am. Corp., 574 U.S. 405 (2015)
- Confirms immediate appealability of dispositive rulings on individual cases within MDL proceedings. It explains the procedural posture enabling this appeal.
Riley v. Bondi, 145 S. Ct. 2190 (2025)
- Invoked for the proposition that “court-directed” statutory language often signals jurisdictional rules. The Fourth Circuit hints that § 300aa‑11(a)(2)(B)’s “court shall dismiss” may be jurisdictional, though it does not decide the point.
Schafer v. American Cyanamid Co., 20 F.3d 1 (1st Cir. 1994) (Breyer, C.J.)
- Reinforces that the Vaccine Act requires first filing in the compensation program.

2) The Court’s Legal Reasoning

A. Presentment Clause and the Addition of Gardasil

The court upholds § 300aa-14(e) as a constitutional instance of conditional legislation:

Statutory conditions: The Secretary must add a vaccine to the Table when (i) the CDC recommends routine pediatric administration, and (ii) Congress enacts an excise tax on doses to fund the program. Both conditions were met for HPV vaccines in 2006–2007.
Execution, not amendment: The Secretary’s role is to ascertain that conditions are satisfied and then to memorialize that fact in the Table. This does not rewrite the Act; it executes a policy choice Congress already made, echoing Clark.
Forfeiture of § 300aa-14(c) challenge: Plaintiffs’ late pivot to attack the Secretary’s separate power to modify injury listings and onset windows (§ 300aa-14(c)) came too late; it was not raised below. The court therefore does not address whether that delegation violates the Presentment Clause or whether the Act’s non-severability clause would magnify the consequences of any constitutional defect.

B. Exhaustion, Timeliness, and the Meaning of “De Novo”

Timely petition is a prerequisite: A tort suit “shall” be dismissed unless the plaintiff first filed a Vaccine Act petition “in accordance with” § 300aa‑16 (i.e., within 36 months of first symptom/onset or significant aggravation, subject to equitable tolling). This timeliness requirement is part of the Act’s exhaustion scheme.
Who decides timeliness: Congress vested special masters (and their reviewing courts) with jurisdiction to decide entitlement, which necessarily includes timeliness and tolling. Challenges to those determinations must be addressed within the Vaccine Program’s appellate path—the Court of Federal Claims and the Federal Circuit—not collaterally in later tort suits.
“De novo” is limited: The Act’s “de novo civil action” language, coupled with § 300aa-23(e), means Vaccine Program findings are inadmissible to prove liability or damages in the civil case. But that evidentiary bar—carefully keyed to the “stages” of liability and damages described in § 300aa-23(b)-(d)—does not erase the threshold duty of civil courts to enforce the Act’s exhaustion/timeliness gate.

C. Issue Preclusion Locks In Timeliness Determinations

Even apart from the statutory structure, ordinary issue-preclusion principles bar relitigation of timeliness:

Identity and actual resolution: Whether the petition was time-barred is the same issue plaintiffs later sought to litigate; it was explicitly decided by special masters.
Necessity: Timeliness was critical to the Vaccine Program dismissals.
Finality and validity: Plaintiffs did not seek review; the special masters’ rulings stand as final within the Program.
Full and fair opportunity: Plaintiffs conceded untimeliness but argued equitable tolling before the special masters; the Program afforded a meaningful opportunity to litigate.

The Fourth Circuit adds a narrow caveat: if a petitioner withdraws because the special master did not decide within the statutory time (generally 240 days), a civil court may need to decide timeliness in the first instance. That scenario is not present here because the special masters ruled within the window, and plaintiffs did not withdraw.

D. Equitable Tolling Lives in the Vaccine Program, Not the Later Tort Suit

The court’s framework relegates equitable tolling disputes to the Vaccine Program. Plaintiffs cannot leverage civil discovery to build a tolling record after losing before the special masters. The court does not reach the district court’s alternative, merits-based tolling analysis because the statutory channeling and preclusion holdings resolve the case.

3) Impact and Forward-Looking Consequences

Binding within the Fourth Circuit: District courts in the Fourth Circuit must dismiss tort suits where Vaccine Act petitions were untimely, as determined by special masters (unless that ruling was overturned within the Vaccine Program). “De novo” no longer functions as an invitation to relitigate exhaustion.
National significance for MDLs: In large vaccine MDLs (like Gardasil), defendants will invoke this decision to streamline dockets by moving to dismiss plaintiffs who either never petitioned under the Vaccine Act or did so untimely and lost on tolling before special masters.
Practice pointer for plaintiffs’ counsel:
- File in the Vaccine Program within 36 months of first symptom/onset or significant aggravation—or be prepared to prove equitable tolling there.
- If you lose, promptly seek review in the Court of Federal Claims (and if necessary the Federal Circuit) to preserve timeliness issues; failure to do so will preclude relitigation in civil court.
- Do not rely on civil discovery to “rebuild” a tolling record; the Fourth Circuit’s preclusion holding forecloses that path.
Constitutional doctrine stabilized: The decision affirms that adding vaccines under § 300aa-14(e) is constitutional “conditional legislation” in the Clark tradition. The CDC recommendation plus Congress’s excise tax enactment are the dual triggers; the Secretary’s role is ministerial-executive, not legislative.
Jurisdictional undertones: The panel notes that the “court shall dismiss” language likely makes the exhaustion/timeliness rule jurisdictional. Whether jurisdictional or a mandatory claim-processing rule, the practical result is the same here: dismissal when the Vaccine Program timeliness requirement is not satisfied.

Complex Concepts Simplified

Vaccine Injury Table: A statutory table listing covered vaccines and presumptively compensable injuries with onset windows. If your injury matches a listed injury within its time window, causation is presumed; otherwise, you can still prove actual causation.
Special Masters: Adjudicators at the Court of Federal Claims who decide Vaccine Act petitions. They determine timeliness, entitlement, and compensation under expedited, informal procedures.
Exhaustion Under the Vaccine Act: Before suing a manufacturer, you must first file a Vaccine Act petition “in accordance with” the statute (including timeliness), then either (a) reject a final judgment, or (b) withdraw if statutory time limits for a decision are exceeded.
Equitable Tolling: A doctrine that pauses a limitations period in extraordinary circumstances despite diligence by the claimant. It is available under the Vaccine Act (per Cloer), but you must litigate tolling in the Vaccine Program—not in a later civil suit.
“De Novo” Civil Action: After exhausting the Vaccine Act remedy, you may bring a fresh tort action. “De novo” means Vaccine Program findings cannot be used as evidence to prove liability/damages. It does not mean you can ignore or relitigate the prerequisite of timely exhaustion.
Issue Preclusion (Collateral Estoppel): If an issue (like timeliness) was actually litigated and necessarily decided in a prior proceeding of competent jurisdiction, and you had a full and fair chance to litigate it, you cannot contest it again in a later suit.
Presentment Clause: The Constitution requires laws to pass both Houses and be presented to the President. Congress can, however, enact laws that direct the executive to act upon future facts (conditional legislation), so long as the executive is executing Congress’s policy rather than rewriting statutes.

Practical Checklists

For Claimants and Counsel

Identify the first symptom or significant aggravation date; diary it.
File the Vaccine Act petition within 36 months, or develop a robust record for equitable tolling within the Vaccine Program.
If timeliness or tolling is denied, seek review in the Court of Federal Claims (and potentially the Federal Circuit) to avoid preclusion.
Consider strategic withdrawal only if the program’s decision deadlines are missed; if a special master decides timeliness within 240 days, withdrawal won’t restore de novo timeliness adjudication in civil court.
When moving to civil court, do not assume Vaccine Program findings can be imported to prove liability or causation; build a fresh liability case.

For Defendants

Audit whether each plaintiff filed a Vaccine Act petition, whether it was timely, and the status of any special master ruling.
Move early to dismiss untimely petitioners based on exhaustion and issue preclusion; emphasize the “court shall dismiss” directive in § 300aa‑11(a)(2)(B).
Invoke § 300aa‑23(e) to exclude Vaccine Program findings on liability/damages, while relying on the Fourth Circuit’s clarification that courts must still enforce the exhaustion gate.

Notable Limits and Open Questions

Unreached issues: The court did not review the MDL’s Rule 12(c) preemption ruling or the district court’s alternative equitable tolling merits analysis.
Jurisdictionality unresolved: The court suggested—but did not decide—that § 300aa‑11(a)(2)(B)’s dismissal command is jurisdictional.
§ 300aa‑14(c) challenge: The constitutionality of prospective injury/onset-window updates by regulation remains unaddressed here due to forfeiture.
Timing gap scenario: If a petitioner withdraws because the special master does not rule within statutory time limits, a civil court may have to decide timeliness in the first instance.

Conclusion

This decision cements two consequential propositions for vaccine litigation in the Fourth Circuit. First, Congress’s mechanism for adding vaccines to the Vaccine Injury Table—CDC recommendation plus Congress’s excise tax—passes Presentment Clause muster; Gardasil’s inclusion is valid. Second, a timely Vaccine Act petition is not merely a procedural nicety; it is a precondition to suit. Once a special master determines a petition is untimely and that ruling stands within the Vaccine Program, civil courts are not free to revisit timeliness under the banner of “de novo” review. The Act’s evidentiary bar preserves fresh litigation on liability and damages, but it does not displace the exhaustion gate.

For plaintiffs and counsel, the message is clear: litigate timeliness and tolling fully and promptly in the Vaccine Program, and preserve issues through the Program’s appellate path. For courts and litigants managing vaccine MDLs, this opinion provides a clean, administrable rule that channels threshold timeliness disputes to the specialized forum Congress designed, preventing collateral relitigation and promoting the Act’s twin goals of market stability and prompt compensation.