Have you ever heard of the “Presentment Clause” to the United States Constitution? U.S. Const. Art. I §, cl. 2. While we can’t say that we had never heard of it – we are aware of presidential vetoes, pocket vetoes, and such – we had never had occasion to consider it in the context of the legal work we do defending prescription medical product liability litigation. That changed with In re Gardasil Products Liability Litigation, ___ F.4th ___, 2025 WL 2535105 (4th Cir. Sept. 4, 2025), which we recently discussed, here.
In Gardasil the plaintiffs argued, unsuccessfully, that the Vaccine Act, specifically 42 U.S.C. §300aa-14(e), violated the Presentment Clause, because it empowered the Secretary of Health & Human Services (“HHS”), upon the recommendation of the Centers for Disease Control (“CDC”) – both part of the executive branch – to add new vaccines to the original 1986 statutory list of four covered vaccines, i.e., the list of vaccines subject to the National Vaccine Injury Compensation Program. That subsection provides:
(e) Additional Vaccines
* * * *
(2) Vaccines recommended after August 1, 1993
When after August 1, 1993, the Centers for Disease Control and Prevention recommends a vaccine to the Secretary for routine administration to children, the Secretary shall, within 2 years of such recommendation, amend the Vaccine Injury Table included in subsection (a) to include–
(A) vaccines which were recommended for routine administration to children. . . .
Id. §300aa-14(e)(2)(A).
As discussed more thoroughly in our post about the Gardasil decision, plaintiffs argued that, because HHS and CDC could effectively amend the statutory list of covered vaccines that appeared in the initial vaccine table at §300aa-14(a), that feature was unconstitutional under the Presentment Clause because gave those two executive branch agencies the power to amend a congressional statute. 2025 WL 2535105, at *6 (“The Constitution doesn’t ‘authorize the President to enact, to amend, or to repeal statutes.’”) (quoting Clinton v. City of New York, 524 U.S. 417, 438 (1998)).
It turns out there is a test for that. A “constitutional problem” arises under the Presentment Clause when: (1) the “same conditions exist” both at the time the statute was enacted and when the executive action occurred; (2) the executive branch’s “discretion is unconstrained”; and (3) the executive branch action fails to “execut[e] the policy that Congress set in the statute when taking the challenged act.” Gardasil, 2025 WL 2535105, at *6 ( quotation marks omitted) (citing Clinton).
The plaintiffs’ attempt to use the Presentment Clause argument to vandalize public health got hammered because: (1) scientific advances resulting in new vaccines advanced over time, as Congress anticipated they would, (2) executive discretion to add new vaccines was constrained by vesting the power to initiate the addition of a vaccine to an advisory commission (see §300aa-19); and (3) by adding new vaccines as they were developed, in accordance with statutorily mandated recommendations, HHS was doing precisely what Congress intended. Id. Even beyond these three criteria, it was plain from the structure of the Vaccine Act that Congress blessed the addition of these new vaccines. For every vaccine, “Congress passed an excise tax on the vaccine to fund the compensation system.” Id.
“Perhaps recognizing the weakness of their argument,” the Gardasil plaintiffs invented a new fallback argument on appeal. They claimed that a different Vaccine Act provision, §300aa-14(c), also violated the Presentment Clause because it authorized the Secretary of HHS unilaterally to to “add” or “delete” items from “the list of compensable injuries and their onset periods that Congress enacted.” Gardasil, 2025 WL 2535105, at *7. Grasping at straws, plaintiffs argued under the Vaccine Act’s non-severability clause, the purported unconstitutionality of that provision brought down the entire statute. Id.
Our other post addresses plaintiffs’ blatant waiver of that argument, as well as the profound harm to the public health that plaintiffs were seeking, solely for their own private gain. As far as this post is concerned, that waived argument is important because it prompted us to study both the Presentment Clause precedent and §300aa-14(c) for the first time. Our review of the Presentment Clause gave us the three-part test that we just described. Our review of subsection 14(c) gave us this subpart:
(3) A modification of the Vaccine Injury Table under paragraph (1) may add to, or delete from, the list of injuries, disabilities, illnesses, conditions, and deaths for which compensation may be provided or may change the time periods for the first symptom or manifestation of the onset or the significant aggravation of any such injury, disability, illness, condition, or death.
What did Congress omit from this list of permissible HHS modifications of the vaccine table? It did not give HHS (or anyone) authority to delete any vaccine entirely, even by the formal notice-and-comment rulemaking that the statute mandates for other changes. See §300aa-14(c)(1). Similarly, the other statutory section at issue in Gardasil, §300aa-14(a), concerning “additional vaccines,” doesn’t authorize either CDC or HHS to remove vaccines from the vaccine table – only to add them. That section mandates that the HHS secretary “shall” add new vaccines recommended by the CDC with a set two-year time period, along with the relevant injuries and time periods, but does not provide a similar mechanism for removing any vaccine from the table. The congressional intent behind this section was discussed in O’Connell v. Shalala, 79 F.3d 170, 173 (1st Cir. 1996):
The Table is not intended to be static. Congress gave the [HHS] Secretary express power to promulgate regulations adding to or subtracting from the tabular list of conditions, and changing the delineated time periods. This is a rather odd approach because it authorizes the Secretary, in effect, to amend the statutorily enacted Table by way of administrative rulemaking.
Id. at 173 (footnote mentioning the Presentment Clause issue omitted). The reason for the unusual congressional process was the desire to get vaccines added quickly:
This grant of power probably reflected a congressional consensus that . . . the Table was not perfect. Driven by a sense of urgency to put something into place, the solons knowingly used incomplete data. . . . Mindful of its haste, Congress directed the Secretary to have the Institute of Medicine (IOM) . . . conduct an extensive review of all available information . . ., and thereafter to publish findings and revise the Table.
Id. (citations omitted). From what authority subsections 14(a) and 14(c) conferred – and did not confer – on the HHS secretary, it is readily apparent that, under the Presentment Clause, Congress necessarily retained for itself the power to ”repeal” the addition of vaccines to the vaccine table – and withheld that power from HHS. “[T]he statutory grant of a greater power typically includes the grant of a lesser power,” O’Connell, 79 F.3d at 177, and only the lesser power to amend risks and time periods was granted to HHS.
Returning to the Presentment Clause, Gardasil and O’Connell have viewed the addition of new vaccines as the equivalent of Congressional action, provided that the statutory prerequisites of CDC recommendation, HHS amendment, and Congressional extension of the Vaccine Act excise tax to the new vaccine are met. Thus, should the HHS secretary – hypothetically, of course – ever seek to remove a vaccine from the vaccine table, that action itself would have to pass the same Presentment Clause test that Gardasil employed. The Presentment Clause demands that “repeal of statutes, no less than enactment, must conform with Art. I.” Clinton, 524 U.S. at 438 (citation and quotation marks omitted). The executive branch has no “unilateral power to change the text of duly enacted statutes.” Id. at 447.
Using the three-part test that Gardasil derived from Clinton, a Presentment Clause “constitutional problem” would very likely be presented by any HHS attempt to remove a vaccine from the Vaccine Act’s table. First, the “same conditions” would most likely “exist” regarding the safety and effectiveness of the vaccine, unless HHS were to present substantial evidence of new and adverse data concerning a Vaccine Act table vaccine. We know of no such scientific evidence. E.g., In re Gardasil Products Liability Litigation, 770 F. Supp.3d 893, 901 n.2 (W.D.N.C. 2025) (finding “substantial evidence that the FDA does not agree with Plaintiffs’ allegations” because “[t]he FDA has approved numerous Gardasil labels without any POTS or POI warnings from 2006 to the present,” HHS “consistently opposed allegations of a causal connection in the ‘Vaccine Court’”, and both HHS and FDA have “publicly stated its view that Gardasil does not cause POTS or POI in general communications and the federal register”).
Second, since the Vaccine Act does not provide for administrative removal of vaccines from the vaccine table, a fortiori it does not set forth any standards for any non-existent removal process. Thus, as in Clinton and contrary to Gardasil, any purported removal would be an unconstitutional exercise of “unconstrained” administrative discretion. The Court of Claims discussed the limits imposed in the context of the table amendments that Congress allowed in the Presentment Clause context in Terran v. Secretary of HHS, 195 F.3d 1302 (Fed. Cir. 1999):
We have little doubt that the Vaccine Act sets forth such an intelligible principle to guide the Secretary’s actions. Again with reference to the statute, Congress has provided the Secretary with both substantive guideposts and procedural requirements that must be observed. . . . [A]lthough the Secretary could in theory delete all entries in the table or, conversely, sweep in all possible illnesses or conditions, the Act constrains the Secretary’s discretion. First, the Vaccine Act requires the Secretary to consult with the Advisory Commission on Childhood Vaccines before proposing rules to revise the injury table. . . . More generally, the Vaccine Act establishes a broad program to study and reduce the risk of childhood vaccines. Congress clearly intended the Secretary to be guided by the findings from such studies when she decides to promulgate regulations to revise the injury table.
Id. at 1314-14 (citations omitted). None of these guardrails exist as to any attempt to remove a vaccine from the table.
Third, given the purpose of the Vaccine Act’s unusual process for amending the vaccine table, see Terran, 195 F.3d at 1313, and Congress’ failure to include any similar administrative means of removing table vaccines in the Act, it appears that any unilateral HHS removal of any vaccine that was added to the vaccine table through congressionally sanctioned actions would be contrary to the “policy” Congress pursued in enacting the Vaccine Act. “Congress intended the Vaccine Act to encourage vaccine improvements while providing immunity for [preempted] claims.” Bruesewitz v. Wyeth Inc., 561 F.3d 233, 240 (3d Cir. 2009), aff’d, 562 U.S. 223 (2011); see id. at 248 (Congress “repeatedly stressed the importance of vaccine development and availability”). Thus, “the lack of any statutory provision” in the Vaccine Act allowing expansion of manufacturer liability “is conclusive proof that Congress did not intend to provide” for that. W.J. v. Secretary of HHS, 93 F.4th 1228, 1241 (Fed. Cir. 2024) (rejecting minority tolling as not provided in the Vaccine Act).
Thus, we have to acknowledge the Gardasil plaintiffs, at least backhandedly, for pursuing their baseless Presentment Clause attack on the Vaccine Act and then for belatedly doubling down on appeal. We have been worried that the current arbitrary and capricious management at HHS might seek to deprive accepted childhood vaccines of Vaccine Act preemption (indeed, we still worry), but without the Fourth Circuit’s Gardasil decision we probably would not have figured out that the Presentment Clause creates a solid constitutional obstacle to any such attempt.