As we have riffed on before, staying apolitical when discussing the science and law implicated by our posts can be harder than one might expect.  That has become increasingly true with regard to litigation over alleged injuries from vaccines, to say nothing of vaccine mandates for public health.  It was not terribly long ago that we would have said that the importance of vaccines in reducing communicable disease and mortality, helping to extend the percentage of people who survive childhood and the average lifespan of humans, was nearly universally accepted.  Similarly, we would have said that the role of the Vaccine Act in reducing the burden of litigation on vaccine manufacturers/developers while providing a no-fault compensation program for “vaccine-related injuries” was also widely accepted by people who follow such things.  The non-acceptors were largely within the plaintiffs’ bar, whose positions we generally see as motivated by profit motive more than an honest reading of the science or a genuine concern about public health.  We are not immunologists or public health experts, so the foregoing was presented as the historic views of lawyers who tend to be on the right side of the v.  Regardless of whether we viewed those who tend to be the other (wrong?) side of the v. as being equally smart and honest on the science, we would not place much stock in what lawyers who make a living advocating say about what the science shows.

Both sides should be able to agree, however, that cancer is bad and medical efforts directed at reducing the incidence of potentially fatal cancers should be supported.  According to this webpage from the CDC from July 2024, presumably from true experts in immunology and public health, in less than two decades of use, the use of vaccines for human papillomavirus (“HPV”) have been associated with a major reduction in the incidence of cervical cancer and the infections that cause most of it.  This is an indisputably good thing.  Does that mean the manufacturers of HPV vaccines have not been subject to lawsuits claiming injuries?  Of course not.  Indeed, litigation led to the creation of the first MDL for a vaccine on the Vaccine Injury Table.  Since its inception in 2022, the Gardasil MDL has produced a number of favorable rulings, one of which was recently affirmed by the Fourth Circuit.  In re: Gardasil Prods. Liab. Litig., — F. 4th –, 2025 WL 2535105 (4th Cir. Sept. 4, 2025).  One of the issues in that decision, the rarely presented Presentment Clause, got us thinking and will be the subject of a deeper dive in the coming days.  With that teaser hanging, we will discuss the whole of the In re Gardasil appellate decision here.

The appeal involved both the order dismissing three particular plaintiffs and two broader “bellwether” orders from the MDL.  Essentially, the three plaintiffs had sought compensation in the Court of Federal Claims under the Vaccine Act for unspecified (in this decision, at least) “vaccine-related injuries” from the use of the HPV vaccine, but admittedly did not do so within the statutory period.  Id. at *2.  The vaccine court’s special master rejected the claims as untimely and not entitled to equitable tolling.  Rather than pursue appeal options under the Vaccine Act, the plaintiffs pivoted to suing the vaccine manufacturer in the MDL.  The MDL dismissed the cases for failing to comply with the statutory predicates and being untimely.  Id.  The MDL had previously ruled that certain counts asserted by the bellwether plaintiffs were preempted and should be applied to all the plaintiffs.  See generally here on vaccine preemption.  Along the way, the MDL court rejected the non-bellwether plaintiffs’ argument that the addition of vaccines like the HPV vaccine to the Vaccine Injury Table provided for in the Vaccine Act violated the Presentment Clause, even though Congress later took action to adopt the additions and impose an excise tax.  Id. at *3.  If that argument has been accepted, then the Vaccine Act would impose no requirements before a product liability lawsuit could be brought.

The Presentment Clause argument on appeal attacked both the Secretary of HHS’s addition of the Gardasil HPV vaccine to the Vaccine Injury Table in 2007 and the Secretary’s general authority to amend the specified injuries and timeframes on the Table for the covered vaccines.  The latter argument was not preserved below, so it was waived.  Id. at *7-8.  It also has no logical connection to why plaintiffs lost in the Court of Federal Claims and the MDL, other than as a backdoor way to challenge the constitutionality of the entire Vaccine Act.  The Fourth Circuit did not engage in overkill and address the merits of second argument.

The analysis of the merits of the first argument was straightforward.  The CDC had already recommended HPV for routine administration to eleven and twelve year old females and Congress had already passed an excise tax on the vaccine, so the Secretary’s addition of the vaccine to the Vaccine Injury Table was compelled by the Vaccine Act.  Id. at *6.  A case from way back, decided by largely the same Court that decided Plessy v. Ferguson four years later, made clear that an action by the executive branch that was pursuant to direction in a law passed by Congress was not a violation of the Presentment Clause.  See Marshall Field & Co. v. Clark, 143 U.S. 649, 693 (1992).  The addition of Gardasil to the Vaccine Injury Table by part of the executive branch “when conditions built into the statute [were] satisfied” did not usurp Congress’s authority to pass laws and then present them to the President for signature.

The three plaintiffs also challenged their dismissal below based on the argument that the MDL should have independently evaluated compliance with the Vaccine Act’s requirements and found their cases timely is equitably tolled.  In other words, the Fourth Circuit was urged to find that the federal court entertaining a tort suit against the vaccine manufacturer can ignore the procedural requirements of the Vaccine Act when it chooses simply because the civil suit—as opposed to the claim against the Secretary of HHS pursuant to the compensation program—is characterized in the Vaccine Act as “de novo.”  This is a creative, if not fanciful, argument given the actual language of the Vaccine Act.  The Vaccine Act imposes both statute of limitations and exhaustion requirements before the manufacturer can be sued.  The Vaccine Act also empowers special masters to decide timeliness and other requirements for compensation.  Moreover, it provides for review of a special master’s decisions by the Court of Federal Claims and later the Federal Circuit, not by other courts.  Id. at *9.  “If a special master finds a petition untimely, the claimant can only seek relief from that decision in the Court of Federal claims and, subsequently, the Federal Circuit.”  Id.  The characterization of a suit against the manufacturer as de novo means any “findings of fact and conclusions of law” from the proceeding against the Secretary of HHS are not admissible in the civil lawsuit against the manufacturer, “[b]ut it doesn’t require courts facing tort suits to disregard Vaccine Act proceedings.”  Id.

In addition to a district court—even a mighty MDL—having no authority to second-guess the special master’s decision on timeliness, the plaintiffs would be precluded from relitigating the issue they lost in the vaccine program and elected not to challenge within its confines.  Id. at *10. 

The special master who decided Plaintiffs’ Vaccine Act petitions concluded that their petitions were untimely. Plaintiffs didn’t pursue review of that determination in the Court of Federal Claims and, therefore, that ruling stands. Thus, Plaintiffs can’t sue Merck. It also means that Plaintiffs aren’t entitled to discovery in this case to allow them to establish equitable tolling with respect to their petitions.

Id. at *11.  All in all, this was a firm rejection of attempts to moot the requirement of the Vaccine Act so that the plaintiffs could proceed unfettered.  This decision was consistent with the clear intent of Congress that there should be protections for the manufacturers of important childhood vaccines and a no-fault option for compensation for claimants.  We know the plaintiff lawyers play games within the vaccine compensation program.  In an appeal from an MDL where the basis for plaintiffs’ claims has been lacking, it is good to see the continuing gamesmanship fail again.