In Re: Gardasil Products Liability Litigation

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IN THE UNITED STATES DISTRICT COURT
FOR THE WESTERN DISTRICT OF NORTH CAROLINA
CHARLOTTE DIVISION
CIVIL ACTION NO. 3:22-MD-03036-KDB
IN RE: GARDASIL PRODUCTS LIABILITY ) MDL No. 3036
LITIGATION )
) THIS DOCUMENT RELATES TO
) ALL CASES
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ORDER
THIS MATTER is before the Court on Plaintiffs’ “Motion to Limit Application of the
Court’s Order on Defendant’s Motion for Partial Judgment on the Pleadings to Plaintiffs Bergin
and America” and “Motion to Find that Subjecting Gardasil Personal Injury Claims to the Vaccine
Act Violates the Presentment Clause of the United States Constitution.” (Doc. No. 136). While the
first motion is nominally related to the application of the Court’s previous Order, (Doc. No. 132),
the substance of these motions is more accurately reflected by the Plaintiffs’ second motion, both
of which are asserted in the same document. Although the broad constitutional question now raised
by Plaintiffs is not the type of argument that the Court intended to invite in allowing other plaintiffs
to raise individual issues after the resolution of Plaintiffs Bergin and America’s bellwether
motions, the Court will consider the merits of Plaintiffs’ constitutional challenge so as to put it to
rest for all Plaintiffs. For the reasons discussed below, the Court concludes that there is no
constitutional violation of the “Presentment Clause” in applying the National Childhood Vaccine
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Injury Act (“Vaccine Act” or “Act”), 42 U.S.C. § 300aa-1 et seq., to Plaintiffs’ personal injury
claims related to the Gardasil vaccine.
I. FACTS AND PROCEDURAL HISTORY
Since 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. (Doc. No. 2). Each Plaintiff alleges that he or she has suffered harm caused by
vaccination with Gardasil, a Human Papillomavirus (“HPV”) vaccine which seeks to prevent
cervical and other cancers believed to be associated with HPV.
Prior to the creation of the MDL, several motions to dismiss pursuant to Federal Rule
of Civil Procedure 12 were either decided or pending in cases which then became
consolidated in the MDL. All pending motions were stayed by this Court’s First Pretrial
Order. However, the Court permitted Merck to file proposed “bellwether” Rule 12 motions in
two cases, Bergin v. Merck & Co., Inc. et al., No. 3:22-CV-00117, and America v. Merck &
Co., Inc. et al., No. 3:22-CV-00585. (See Doc. Nos. 35 at pp. 2-4; Doc. No. 58 at 7). In
February 2023, Merck filed a Motion for Partial Judgment on the Pleadings in Bergin and
America (Doc. No. 68) seeking dismissal of Plaintiffs’ alleged “design defect” and “direct
warning” claims based on the argument they are preempted by the National Childhood Vaccine
Injury Act, 42 U.S.C. § 300aa-1, et seq. (the “Vaccine Act”) and their “manufacturing defect”
and fraud claims for allegedly inadequate pleading.
After full briefing and oral argument, the Court ruled on the motion on March 20, 2024,
in part granting and in part denying the motion. (Doc. No. 132). Consistent with the “bellwether”
nature of the motion, the Court applied the ruling to “all substantially similar allegations/claims
asserted in the cases subject to the MDL.” (Id. at 26). However, the Court allowed “Parties who
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believe they have good cause (as discussed in the Order) to avoid the application of [the] ruling”
to file a motion seeking relief from the Order. On April 19, 2024, all the then-remaining
Plaintiffs (other than Bergin and America) filed the present motions, arguing that they should
not be bound by the Court’s March 20 Order to the extent it relates to the Vaccine Act because,
as a matter of constitutional law, the Vaccine Act does not apply to Gardasil, which was not
included in the Act’s original table of covered vaccines. (See Doc. 136 at 9). Plaintiffs’ motions
rest only on their constitutional claim (which was not asserted in the bellwether motions), and
none argue that they have made allegations that are materially different from Plaintiffs Bergin
or America. (See Doc. No. 132 at 9, fn. 9).
The Court later granted the Parties’ joint motion to extend the time for briefing the
motions, and briefing concluded on June 5, 2024. No party requested that the Court hold oral
argument (and the Court does not believe that oral argument would assist it in deciding these
motions). Therefore, the motions are ripe for the Court’s ruling.
II. DISCUSSION
Plaintiffs’ constitutional challenge to the Vaccine Act rests on their argument that “the
Act’s purported delegation of authority to allow the Secretary of Health and Human Services
(“Secretary”) to amend the text of the Act to add vaccines like Gardasil” violates the Presentment
Clause of the United States Constitution. U.S. Const. art. I, § 7, cl. 2. 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 40 years since its enactment in 1986,
notwithstanding decades of vaccine table additions and the routine enforcement of the Act with
respect to those “new” vaccines. Indeed, the only authority cited by Plaintiffs in support of this
position is the dissenting opinion in Terran ex rel. Terran v. Secretary of Health and Human
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Services, 195 F.3d 1302, 1312-1314 (Fed. Cir. 1999) (Plager, J. dissenting). The Court declines to
so drastically curtail the application of the Vaccine Act.
A. The Vaccine Act and Gardasil’s Inclusion in the Vaccine Injury Table
In Terran, the authority cited by Plaintiffs, the Court described the purpose, history and
overall structure of the Vaccine Act:1
Childhood vaccinations, though an important part of the public health
program, are not without risk. Because vaccines often contain either killed bacteria
or live but weakened viruses, they can cause serious adverse effects. See O'Connell
v. Shalala, 79 F.3d 170, 172 (1st Cir. 1996) (citing Committee to Review the
Adverse Consequences of Pertussis and Rubella Vaccines, Institute of Medicine,
Adverse Effects of Pertussis and Rubella Vaccines 1 (1991)). Despite the relatively
rare occurrence of such problems, Congress became concerned that tort liability
and related costs might drive up the prices of vaccines and discourage vaccine
manufacturers from staying in this market, and that normal tort litigation might
leave many sufferers of vaccine-caused injuries uncompensated. See H.R.Rep. No.
99–908, at 1, 4, 6–7 (1986), reprinted in 1986 U.S.C.C.A.N. 6287, 6344, 6345,
6347–48; see also O'Connell, 79 F.3d at 172–73.
Accordingly, in 1986, Congress passed the National Childhood Vaccine
Injury Act of 1986, Pub.L. No. 99–660, 1986 U.S.C.C.A.N. (100 Stat.) 3755
(codified as amended at 42 U.S.C. §§ 300aa–1 to –34 (1994)), which established a
program administered by the Secretary of Health and Human Services
(“Secretary”) to increase the safety and availability of vaccines. See 42 U.S.C. §
300aa–1 (1994). As part of this program, Congress established a Vaccine Injury
Compensation Program through which claimants could petition to receive
compensation for vaccine-related injuries or death. See id. § 300aa–10(a). To
receive compensation, a claimant must petition the Court of Federal Claims and
demonstrate by a preponderance of the evidence either that (i) the vaccinated child
suffered an injury listed on a table, or a complication or “sequela” thereof; or (ii)
that the vaccine caused or significantly aggravated the child's injury or condition.
See id. §§ 300aa–11, –13 to –14; 42 C.F.R. § 100.3 (1996). Thus, the Vaccine Act
provides two possible ways for a claimant to receive compensation: first, by
showing that she suffered a “table injury,” or second, by proving causation in fact.
The Vaccine Act establishes an Office of Special Masters within the United States
Court of Federal Claims to decide petitions for compensation, provides for review
of a Special Master's decision by the Court of Federal Claims, and allows appeal of
the Court of Federal Claims' rulings to this court. See 42 U.S.C. § 300aa–12 (1994).
1 This Court has also previously discussed the goals and general operation of the Vaccine Act. See
Doc. No. 132 at 11-12.
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To aid the Vaccine Program's goal of providing efficient compensation for
vaccine injuries, Congress provided, in the form of a table, a list of vaccines, a
parallel list of adverse medical conditions commonly associated with the use of
each vaccine, and, for certain medical conditions, a time period in which the first
symptoms should become apparent following vaccination. See id. § 300aa–14(a).
These listings comprise the initial Vaccine Injury Table (the “Initial Table”), and
are to be read in conjunction with a separate subsection, the “Qualifications and
aids to interpretation” (the “QAIs”), that provides explanations and definitions for
terms used in the Initial Table. Id. § 300aa–14(b). To demonstrate a table injury, a
claimant must prove that within the prescribed time period following a vaccination,
she suffered one of the disorders set forth on the Vaccine Injury Table
corresponding to the vaccine administered. If she cannot make this showing, she
must instead prove causation in fact.
Terran, 195 F.3d at 1306–07. Looking beyond the “initial table,” which includes only four types
of vaccines (DTP; measles, mumps and rubella; polio and inactivated polio), Congress understood
that “Additional vaccines” would be developed and enacted a statutory process for their future
inclusion. See § 300aa–14(a), § 300aa–14(e). The Act provides that when “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” include the vaccine and
related table information in the Vaccine Injury Table. See § 300aa–14(e)(2) (for vaccines
recommended after August 1, 1993). The Secretary makes these additions to the Table through
regulations enacted through the agency’s rulemaking authority. See § 300aa–14(c)
Also, for the inclusion of a vaccine on the “Table” to actually take effect, Congress needed
to extend the excise taxes that supported the initial vaccines to each newly included vaccine. Thus,
the 1993 revision to the Act provided that any addition to the Table “by the Secretary under . . .
42 U.S.C. 300aa-14(e)) . . . shall take effect upon the effective date of a tax enacted to provide
funds for compensation paid with respect to the vaccine to be added to the vaccine injury table.”
Pub.L. 103-66, Title XIII, § 13632(a)(3), Aug. 10, 1993, 107 Stat. 646. In other words, vaccines
recommended by the CDC can be effectively added to the Table only if Congress, by separate
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legislation, enacts a separate excise tax on that vaccine to pay for compensation from the vaccine
program.
After the Food and Drug Administration approved Gardasil, the CDC’s Advisory
Committee on Immunization Practices (“ACIP”) voted in 2006 to recommend routine use of HPV
vaccines in children. See Mortality and Morbidity Weekly Report at 3 (Mar. 23, 2007) (noting
approval of the vaccine in June 2006). Also in 2006, Congress expressly added “human
papillomavirus vaccines to the list of taxable vaccines” in the Tax Relief and Health Care Act of
2006. Pub. L. 109–432, § 408(b); see 26 U.S.C. § 4132(a)(1)(P). The Secretary then added HPV
vaccines to the Vaccine Injury Table as of February 1, 2007. See 42 C.F.R. § 100.3(c)(7) (“HPV[]
vaccines . . . are included on the Table as of February 1, 2007”). Since Gardasil has been included
in the Table, courts have recognized it as a vaccine covered by the Vaccine Act. See, e.g.,
Cottingham on Behalf of K.C. v. Sec’y of Health & Hum. Servs., 971 F.3d 1337, 1340 (Fed. Cir.
2020) (“HPV Vaccines are included on the Vaccine Act’s vaccine injury table as of February 1,
2007.”).
B. The Presentment Clause and the Vaccine Act
The Presentment Clause of the United States Constitution requires, in relevant part, that
“[e]very Bill which shall have passed the House of Representatives and the Senate, shall, before it
becomes a Law, be presented to the President of the United States; If he approve he shall sign it,
but if not he shall return it,” U.S. Const. art. I, § 7, cl. 2. The Constitution thus does not authorize
members of the executive branch to enact, amend, or repeal statutes. See Clinton v. New York, 524
U.S. 417 (1998) (holding that the Line Item Veto Act violates the Presentment Clause); INS v.
Chadha, 462 U.S. 919, 954–59 (1983) (striking down a legislative veto provision). Instead, this
legislative power is vested exclusively in Congress, and the exercise of such legislative power
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must follow the procedures set forth in the Constitution. See Chadha, 462 U.S. at 954
(“Amendment and repeal of statutes, no less than enactment, must conform with Art[icle] I.”).
However, the Presentment Clause is inapplicable to administrative rulemaking in general because
rulemaking is by definition not a legislative act, but rather an exercise of executive function
properly entrusted to administrative agencies. See, e.g., American Trucking Assns., Inc. v. United
States, 344 U.S. 298, 310–13 (1953).2
In Clinton and Field v. Clark, 143 U.S. 649 (1892), the Supreme Court discussed the
circumstances in which the Presentment Clause bars the exercise of “legislative power” by the
Executive branch. In Field v. Clark, the Court upheld the constitutionality of the Tariff Act of
1890, Act of Oct. 1, 1890, 26 Stat. 567. That statute contained a list of goods that were exempted
from import duties, but a separate provision of the Act directed the President to suspend that
exemption for sugar, molasses, coffee, tea, and hides “whenever, and so often” as he should be
satisfied that any country producing and exporting those products imposed duties on the
agricultural products of the United States that he deemed to be “reciprocally unequal and
unreasonable ...” Id., at 612, quoted in Field, 143 U.S., at 680; see Clinton, 524 U.S. at 442. In
rejecting the Presentment Clause challenge, the Supreme Court found that Congress itself made
the decision to take the challenged action (imposition of tariffs) based on the occurrence of
particular events subsequent to enactment, even though the determination of when and whether
such events occurred was up to the President. Specifically, as later emphasized in Clinton, 1) the
2 The scope and exercise of the permissible “delegation” of decision-making authority to federal
agencies is not directly at issue here. See Gundy v. United States, 588 U.S. 128, 135 (2019) (“a
statutory delegation is constitutional as long as Congress ‘lay[s] down by legislative act an
intelligible principle to which the person or body authorized to [exercise the delegated authority]
is directed to conform.’”); Nat'l Fed'n of Indep. Bus. v. Dep't of Lab., Occupational Safety &
Health Admin., 595 U.S. 109, 117 (2022) (Administrative agencies are creatures of statute. They
accordingly possess only the authority that Congress has provided.)
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exercise of the suspension power was contingent upon a condition that did not exist when the Tariff
Act was passed; 2) when the President determined that the contingency had arisen, he had a duty
to suspend; and 3) whenever the President suspended an exemption under the Tariff Act, he was
executing the policy that Congress had embodied in the statute. See Clinton, 524 U.S. at 443–44.
In contrast, the Supreme Court in Clinton concluded that the Line Item Veto was
unconstitutional because it authorized the President himself to effect the repeal of laws, for his
own policy reasons, without observing the procedures set out in Article I, § 7.
Applying the factors described above, the Supreme Court held that 1) the exercise of the
President’s cancellation power was based on the same conditions that Congress evaluated when it
passed those statutes, not some new occurrence; 2) the President had discretion whether or not to
exercise the line item veto; and 3) whenever the President canceled an item of new direct spending
or a limited tax benefit he would be rejecting the policy judgment made by Congress and relying
on his own policy judgment. Id.
The addition of new vaccines to the Vaccine Injury Table satisfies the Field v. Clark
criteria. In the Vaccine Act, as in the Tariff Act, Congress anticipated that future circumstances
might be different (here, new vaccines would be developed) and made plans for that in the Act.
Therefore, adding new vaccines is contingent upon a condition that did not exist when the Vaccine
Act was first passed. Second, the addition of new vaccines to the Table 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.” See § 300aa–14(e)(2). Third, unlike in
Clinton, the Secretary is plainly following, rather than contravening, Congress's policy under the
Vaccine Act by adding newly developed vaccines to the Table. Moreover, as discussed below,
because additions of newly developed vaccines must effectively be ratified by Congress through
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tax legislation, the scope of Congress’s “delegation” is further limited. Therefore, the Secretary’s
inclusion of “Additional vaccines” in accordance with the specific directions in the statute does
not violate the Presentment Clause of the Constitution.
As noted, Plaintiffs’ position has never been accepted by any court. Further, even putting
aside that it is a 25-year old case cited only for its dissent, Plaintiffs’ reliance on Terran is
misplaced. In Terran, the plaintiff argued that changes that had been made by the Secretary to the
compensable table injuries for DTP, one of the initial table vaccines, were unconstitutional.
Whatever the constitutionality of changes to an existing portion of the Act might be (and the Court
does not express any view as to that issue except to note that it has never been contradicted by the
Federal Circuit or any other), that does not address the issue here, which is the addition to the
Table of vaccines that did not exist when the statute was enacted (but which were specifically
contemplated by the 1993 amendments to the Act). Indeed, even the Terran dissent suggests that
situation might be different.3 Terran, 195 F.3d at 1321. (“If Congress in the Vaccine Act had
specified certain external events upon the happening of which the enacted table became no longer
effective, and at which time the Secretary was to create a revised injury table, and left to the
Secretary the determination of when the specified events in fact occurred, the analysis might be
different.”). Accordingly, the Court does not find Plaintiffs’ cited authority persuasive.
Finally, even if the Presentment Clause was applicable to the addition of new vaccines to
the Vaccine Injury Table, the inclusion of HPV vaccines (including Gardasil) in the Vaccine Act
program has been favorably voted on by Congress and signed by the President. As discussed
above, for a vaccine to become an effective part of the Vaccine Act, an excise tax on that vaccine
3 The Terran dissent also notes that Congress could properly direct the Secretary to create/revise
a Vaccine Injury Table through administrative rulemaking authority, which is indeed the process
by which new vaccines are added to the Table. See Terran, 195 F.3d at 1321
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must be approved by Congress and the President to fund the compensation required by the Act.
This was done in the Tax Relief and Health Care Act of 2006 when Congress expressly added
“human papillomavirus vaccines to the list of taxable vaccines.” Pub. L. 109–432, § 408(b). The
only reason to create this excise tax was to further the vaccine’s effective inclusion in the Table as
part of the Vaccine Act program. Accordingly, the constitutional separation of powers has been
fully satisfied with respect to Gardasil’s inclusion into the Vaccine Act.
C. Other Issues
Merck has raised other issues – judicial estoppel, administrative exhaustion and waiver –
that the Court need not and does not reach. However, as discussed above, the Court finds that even
though the Court did not have generally applicable constitutional arguments in mind when it
granted leave for other plaintiffs to raise individual circumstances that might lead to a different
result on the issues presented in the Motion for Judgment on the Pleadings, it is most efficient and
in the broader interest of the MDL that the Court resolve Plaintiffs’ constitutional challenge on the
merits in this Order.
III. ORDER
NOW THEREFORE IT IS ORDERED THAT:
1. Plaintiffs’ Motion to Limit Application of the Court’s Order on Defendant’s Motion
for Partial Judgment on the Pleadings to Plaintiffs Bergin and America and Motion
to Find that Subjecting Gardasil Personal Injury Claims to the Vaccine Act Violates
the Presentment Clause of the United States Constitution, (Doc. No. 136), are
DENIED; and
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2. This matter case shall proceed in the course set by the Court’s operative case
management orders in the absence of a voluntary resolution of the dispute among
the parties.
SO ORDERED ADJUDGED AND DECREED.
Signed: June 27, 2024
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