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Home » Constitutional challenge to National Childhood Vaccine Injury Act rejected in Gardasil lawsuits

Constitutional challenge to National Childhood Vaccine Injury Act rejected in Gardasil lawsuits

This article, about a constitutional challenge to the National Childhood Vaccine Injury Act during Gardasil lawsuits, was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Law San Francisco, who is a frequent contributor to this and many other websites, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.

In law journals, Professor Reiss writes extensively about vaccination’s social and legal policies. Reiss is also a member of the Parent Advisory Board of Voices for Vaccines. This parent-led organization supports and advocates for on-time vaccination and the reduction of vaccine-preventable diseases. She is also a member of the Vaccines Working Group on Ethics and Policy.

On June 27, 2024, the district court hearing over 200 cases claiming damages from Merck’s Gardasil vaccine, the vaccine to prevent HPV, ruled against the plaintiffs’ constitutional challenge to the National Childhood Vaccine Injury Act (NCVIA), finding the act constitutional. While I expect the plaintiffs to appeal (I do not know that they will, but I suspect they will), the court’s decision is very well-founded, and the plaintiffs’ claims here are weak. 

pile of folders Gardasil lawsuits
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The Gardasil lawsuits and claims

I discussed this litigation before in my post about the judge’s decision limiting the claims in these cases. As the court states in this decision, “[s]ince August 2022, this Court has been the forum for a multi-district litigation (“MDL”) in which nearly two hundred cases asserting vaccine injury claims against Merck have been consolidated.” In my previous post, I said: 

Since 2020, one law firm has been bringing claims against Merck over its HPV vaccine, Gardasil. The law firm has worked closely with anti-vaccine leader Robert F. Kennedy Jr. in preparing these claims, and the claims largely echo the claims in a highly misleading anti-vaccine book I have reviewed before

Since there are many cases, they have been consolidated in one court, under one judge, in what is called multi-district litigation. All these cases are now heard in the federal district court for the Western District of North Carolina, Charlotte Division, before Judge Kenneth D. Bell. In the decision discussed here, Judge Bell put the number of cases at “nearly two hundred,” and mentioned (in footnote 2) that “Plaintiffs’ counsel informed the Court that the number of consolidated cases could increase by hundreds more over time.”

On March 20, 2024, Judge Bell ruled that most of the claims in the litigation could not proceed. The judge found that the design, negligence, manufacturing, and direct warning defects in the claims are barred by the NCVIA. The judge also found that the plaintiffs’ fraud claims were too general, and not well-pled. I covered that decision in more detail, again, in my previous post.

The only two claims allowed to go forward in these Gardasil lawsuits were claims that Merck did not warn the doctors who gave the plaintiffs their HPV vaccines of certain risks and that Merck fraudulently concealed those risks. Neither of those claims is easy, but they are not, at present, barred. 

The judge decided in the context of two “bellwether” cases and allowed other plaintiffs to claim that the decision should not be applied to them. Instead, all the other plaintiffs filed a motion arguing that the NCVIA is unconstitutional and that therefore, it cannot bar any claims. 

close up photo of a wooden gavel
Photo by Sora Shimazaki on

The Constitutional claim and why the court rejected it

The plaintiffs’ constitutional claim in the Gardasil lawsuits was, essentially, based on the fact that the NCVIA allows the Secretary to revise the table of injuries. As a reminder, the acts, among other things, created a compensation system for vaccine harms, the National Vaccine Injury Compensation Program (NVICP). Among other things, the act also created the Vaccine Injury Table.

Essentially, if a claimant can show that an injury in the table happened after the vaccine within the period set in the table, the vaccine is presumed to cause the harm, unless the government proves it did not. The act included an initial table, reflecting the vaccines then (in 1986) in use for children and what science showed they may cause. However, Congress realized that there may be new vaccines, and the science can change and show different things on causation. So Congress created a mechanism for the Secretary to add vaccines to the table and revise the table. 

The plaintiffs argued that this mechanism is unconstitutional because it authorizes the Secretary of Health and Human Services to change the law without the change in the law going through Congress and the President through the legislative process. Specifically, since HPV vaccines were not on the original table (since the vaccines were first licensed in 2006, they could not be on the 1986 table), the addition is an unconstitutional change in the law.

This is a creative legal argument since it builds on several real features of our constitutional law, but at the end of the day, it fails, and Judge Bell was right to reject it. The strength of the argument is that under our law, legislation is done by Congress, and the executive is the junior partner in legislation.

In 1998, in Clinton v. City of New York, the Supreme Court clarified that the President cannot be given the power to strike down specific items in the budget – the so-called “line item veto” – because that would give the President the power to change Congressional acts without going through Congress, and the executive cannot have that power. This is a constitutional limit: Congress can’t waive it and give the executive this power, even if it wants to.

However, it was always clear that the executive has the power to fill gaps in legislation and has some use of discretion, and Congress can give the executive power to act, within limits. The court here cites to a very old case, Field v. Clark from 1892, in which the Supreme Court (then) upheld the Tariff Act of 1890, which allowed the President to suspend certain exemptions tariffs to countries that imposed “unequal and unreasonable tariffs. So from early on, the executive was allowed to make some decisions – and the question is whether the decisions under the NCVIA are more like changing the statute (which is unconstitutional, and is what the plaintiffs claimed) or like exercising executive discretion or making rules, which is permitted.

The plaintiffs even found a case from 1999, Terran ex rel. Terran v. Secretary of Health and Human Services, which directly addressed this issue in the context of the Vaccine Act. The problem for the plaintiffs is that the majority in Terran went against them — the court found that the act was constitutional, seeing the table as “sunsetting” – becoming invalid – when the Secretary created a new table, and seeing the new table as an exercise of administrative discretion. But like the competent lawyers they are, plaintiffs’ lawyers pointed to the dissent in the case. The dissent would not be binding – the case generally, being from another circuit, would not be binding on this district court – but it could be used persuasively, with plaintiffs arguing that the dissent got it right.

The judge rejected that claim, for several reasons, and I think the judge is right.

  1. The judge pointed out that no court has ever accepted the plaintiffs’ position – that their only support is a “25-year-old case cited only for its dissent.” That alone would not be determinative – that dissent could be right and other wrongs – but it makes the claim a far-reaching one, which works against it, making it valid only if it is very strong. In the court’s words, “Agreeing with this contention (which no court has ever accepted), would result in the effective removal from the Vaccine Act of all of the childhood vaccines developed in the nearly 4 years since its enactment in 1986,” a big change. It would also go against the clear intent of Congress to allow for adding new vaccines to the table – another reason not to interpret the situation this way.
  2. The court found changing the table was constitutional under the test in Field v. Clark, which was then used in Clinton v. City of New York, cited above. Under this test, it’s okay to let the executive act when Congress itself decided to delegate specific power to act in the future. The Field v Clark test had three parts: 1. Using the power dependent on conditions that did not exist when the act Congress allowed the executive to revise was passed; 2. When the conditions arise, the executive actor has to act – it’s not purely discretionary (note: more modern cases do allow discretionary actions, but that discussion is beyond this case). 3. Acting carries out the policy Congress put in the act. Concerning adding new vaccines to the NCVIA table, new vaccines did not exist when the act was passed, filling the first requirement. Further, adding new vaccines is not discretionary – the act “requires the Secretary to add all vaccines recommended by the CDC for routine administration to children “within 2 years of such recommendation.” Finally, this is following Congress’ defined policy choices.  
  3. Adding vaccines to the table can only be done after Congress passes an act creating an excise tax for these vaccines, so Congress in essence ratifies the addition through a full legislative process, and that was done for HPV vaccines – Congress passed a law creating an excise tax for them, and that law passed both houses and was signed by the President. So the Secretary was not acting alone in adding them to the table, and Congress essentially approved it.
  4. Terran does not help plaintiffs anyway (and remember the plaintiffs only drew on the dissent there – the majority rejected their position), since it was about an existing vaccine – DTP – and changing the table to change the injuries associated with it, which is a different analysis – even the dissent there, Judge Bell says, might agree that for new vaccines, the Secretary’s actions are constitutional. 

For these reasons, Judge Bell rejected the constitutional challenge to NCVIA in these Gardasil lawsuits.


Judge Bell, in a strong decision in the Gardasil lawsuits, rejected the plaintiffs’ challenge to the constitutionality of the National Childhood Vaccine Injury Act, finding that the secretary’s addition of HPV vaccines to the table was an executive action, not a change in the legislation and that Congress also ratified that addition by legislating an excise tax on HPV vaccines’ manufacturers.

What this means is that the judge’s previous decision that barred most of the claims plaintiffs made stands, for now, leaving their 200 cases with only two claims that can go forward –  both claims that Merck did not warn plaintiffs’ doctors about certain side effects. These are hard claims since plaintiffs would have to prove that the vaccines cause the side effects (a tall order, given the extensive data against it), that Merck knew of the link before plaintiffs got the vaccines (for the fraud by concealment claims) or should have known about it (for the warning defect claims), and did not warn, even though some of these claims are mentioned in the vaccine’s label. Plaintiffs would much prefer to have their other claims go forward.

Because this leaves plaintiffs’ cases with very limited claims, I suspect plaintiffs (through their lawyers) will appeal their ruling. I think their chances are not very good because the judge’s decision is strong, but you can never be sure.

We will continue to track these Gardasil lawsuits. 

Dorit Rubinstein Reiss
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