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:1
)
) CASE NO. 3:22-CV-00117, Bergin v.
) Merck & Co., Inc. et al.
)
) AND
)
) CASE NO. 3:22-CV-00585, America
) v. Merck & Co., Inc. et al.
)
ORDER ON MOTION FOR PARTIAL JUDGMENT ON THE PLEADINGS
Since August 2022, this Court has been the forum for a multi-district litigation (“MDL”)
in which nearly two hundred cases2 asserting vaccine injury claims against Defendants Merck &
Co., Inc. and Merck, Sharp & Dohme LLC (together, “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 (“Rule”) 12 were either decided or pending in cases which then became
1 As explained further in this Order, this motion has been filed and considered by the Court as a
“bellwether” motion that will be applicable to all cases (unless an exception is made for a particular
case for good cause shown) to the extent that similar allegations and claims are asserted.
2 At the most recent case management conference, Plaintiffs’ counsel informed the Court that the
number of consolidated cases could increase by hundreds more over time.
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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. The motion has been fully briefed and the Court held oral argument on the motion on
March 11, 2024.
After careful review of the motion, the parties’ briefs and exhibits and their oral arguments,
the Court will in part GRANT and in part DENY the motion for the reasons described below.
I. LEGAL STANDARD
Merck moves for partial judgment on the pleadings under Federal Rule of Civil Procedure
12(c). Rule 12(c) provides that “[a]fter the pleadings are closed—but early enough not to delay
trial—a party may move for judgment on the pleadings.” See In re Bland Companies, Inc. Fair
Lab. Standards Act & Wage & Hour Litig., 517 F. Supp. 3d 484, 492–93 (W.D.N.C. 2021)
(quoting Burbach Broad. Co. of Del. v. Elkins Radio Corp., 278 F.3d 401, 405–06 (4th Cir. 2002)).
A motion for judgment on the pleadings is governed by the standard applicable to a motion to
dismiss under Rule 12(b)(6) of the Federal Rules of Civil Procedure. Butler v. United States, 702
F.3d 749, 751–52 (4th Cir. 2012); Shipp v. Goldade, No. 5:19-CV-00085-KDB-DCK, 2020 WL
1429248, at *1 (W.D.N.C. Mar. 19, 2020).
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A motion to dismiss under Federal Rule of Civil Procedure 12(b)(6) for “failure to state a
claim upon which relief can be granted” tests whether the complaint is legally and factually
sufficient. See Fed. R. Civ. P. 12(b)(6); Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009); Bell Atl. Corp.
v. Twombly, 550 U.S. 544, 570 (2007); Coleman v. Md. Court of Appeals, 626 F.3d 187, 190 (4th
Cir. 2010), aff'd, 566 U.S. 30 (2012). A court need not accept a complaint's “legal conclusions,
elements of a cause of action, and bare assertions devoid of further factual enhancement.” Nemet
Chevrolet, Ltd. v. Consumeraffairs.com, Inc., 591 F.3d 250, 255 (4th Cir. 2009). The court,
however, accepts all well-pled facts as true and draws all reasonable inferences in Plaintiff's favor.
See Conner v. Cleveland Cty., N. Carolina, 22 F.4th 412 (4th Cir. 2022); E.I. du Pont de Nemours
& Co. v. Kolon Indus., Inc., 637 F.3d 435, 440 (4th Cir. 2011). In so doing, the Court “must view
the facts presented in the pleadings and the inferences to be drawn therefrom in the light most
favorable to the nonmoving party.” Pa. Nat'l Mut. Cas. Ins. Co. v. Beach Mart, Inc., 932 F.3d 268,
274 (4th Cir. 2019). Construing the facts in this manner, a complaint must contain “sufficient
factual matter, accepted as true, to state a claim to relief that is plausible on its face.” Pledger v.
Lynch, 5 F.4th 511, 520 (4th Cir. 2021) (quoting Ashcroft, 556 U.S. at 678). Thus, a motion to
dismiss under Rule 12(b)(6) or Rule 12(c) determines only whether a claim is stated; “it does not
resolve contests surrounding the facts, the merits of a claim, or the applicability of defenses.”
Republican Party v. Martin, 980 F.2d 943, 952 (4th Cir. 1992).
In analyzing a Rule 12 motion, a court may consider “documents incorporated into the
complaint by reference and matters of which a court may take judicial notice.” See Tellabs, Inc. v.
Makor Issues & Rights, Ltd., 551 U.S. 308, 322 (2007). In particular, when considering a Rule
12(c) motion, “a court may consider official public records, documents central to plaintiff's claim,
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and documents sufficiently referred to in the complaint ... so long as the authenticity of these
documents is not disputed.” Chapman v. Asbury Auto. Grp., Inc., No. 3:13 cv 679, 2016 WL
4706931, at *1, 2016 U.S. Dist. LEXIS 121043 (E.D. Va. Sept. 7, 2016) (quoting Witthohn v. Fed.
Ins. Co., 164 F. App'x 395, 396-97 (4th Cir. 2006)); see also Goines v. Valley Cmty. Servs. Bd.,
822 F.3d 159 (4th Cir. 2016). “[I]n the event of conflict between the bare allegations of the
complaint and any attached exhibit, the exhibit prevails.” Slater v. Bank of Am., No. 1:10-1091,
2012 WL 2997880 at *7, 2012 U.S. Dist. LEXIS 101687 (S.D. W. Va. June 26,
2012) (citing Fayetteville Investors v. Commercial Builders, Inc., 936 F.2d 1462, 1465 (4th Cir.
1991)).
II. RELEVANT FACTS AND PROCEDURAL HISTORY
HPV is a viral infection that is passed between people through skin-to-skin contact. It is
the most common sexually transmitted disease. (See Doc. No. 76-1 (Bergin Second Amended
Complaint (“Bergin SAC”)) at ¶¶ 34-35)).3 There are numerous strains of HPV, with
approximately 18 to 24 strains believed to be associated with cervical and/or anal cancer. (Bergin
SAC at ¶ 37). Gardasil is a vaccine manufactured and sold by Merck approved by the Food and
Drug Administration (“FDA”) as protection against cervical, vulvar, vaginal, and anal cancer
and their associated precancerous lesions, as well as genital warts, caused by certain strains of
HPV. (See Bergin SAC at ¶¶ 49-52; Doc. Nos. 68-2, 68-3 and 68-4 (Gardasil Prescribing
3 The Court notes and Plaintiffs’ counsel acknowledged at oral argument that the operative Bergin
and America complaints are similar, if not identical, with respect to their general allegations and
claims against Merck. For convenience, the Court will cite only to the Bergin SAC, except as
necessary to reflect Ms. America’s allegations related to her particular circumstances.
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Information).4 An initial formulation of Gardasil targeting four HPV strains was approved in
2006 and a second version (Gardasil 9) adding five more strains associated with cervical and
anal cancer was approved in 2014. Believing it to be “safe and effective” in preventing cancer,5
the Centers for Disease Control recommends HPV vaccination for both girls and boys through
age 26 years. (Bergin SAC at ¶¶ 50, 52, Doc. Nos. 68-7, 68-10). Currently, only Gardasil 9 is
sold in the United States. (See Bergin SAC at ¶¶ 44, 46, 51, and 53).
Plaintiff Payton Bergin alleges that in June 2013 and February 2014, when she was
13 years old, she received two injected doses of Gardasil in North Carolina. (Bergin SAC at
¶¶ 344–345, 347). The vaccination was given upon her doctor’s recommendation and with
her mother’s consent. (Id.). Plaintiff alleges that her mother agreed to her receiving the
Gardasil vaccine after being exposed to direct-to-consumer marketing by Merck, including
Merck’s “ubiquitous representations concerning the safety and efficacy of Gardasil.” (Id. at ¶¶
345, 349, 502-516).
4 As noted, the Court may properly take judicial notice of and consider certain publicly available
information related to Gardasil in ruling on Defendants' motion without converting it into a motion
for summary judgment. See Zak v. Chelsea Therapeutics Int'l, Ltd., 780 F.3d 597, 607 (4th Cir.
2015); Stratton v. Merck & Co., No. CV 2:21-02211-RMG, 2021 WL 5416705, at *2 (D.S.C. Nov.
17, 2021) (considering publicly available FDA statements and Gardasil label); Proffitt v. Bristol-
Myers Squibb Co., No. 1:17-cv-04391, 2018 WL 3318893, at *4 & n.1 (S.D.W. Va. July 5, 2018)
(considering alleged defective medication's label on motion for judgment on the pleadings); Mills
v. Bristol-Myers Squibb Co., No. CV 11-968-PHX-FJM, 2011 WL 3566131, *3 n.2 (D. Ariz. Aug.
12, 2011) (“We may consider the Plavix label attached as an exhibit to defendants' motion to
dismiss ... because it is a matter of public record.”).
5 To be clear, for purposes of this motion the Court does not rely on the FDA’s statements
concerning the safety and efficacy of Gardasil, which are disputed by Plaintiffs, beyond the
existence of the statements and the notice thereby provided to medical providers and the public.
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With respect to her injuries, Ms. Bergin alleges that prior to receiving her Gardasil
injections, she had no known autoimmune diseases, and no autonomic issues. (Id. at ¶ 346).
However, following her two Gardasil vaccinations, Ms. Bergin says that she experienced a series
of physiological and neurological adverse events, including but not limited to mobility issues,
short-term memory loss, chronic fatigue, severe headaches, tiredness, dizziness, fainting,
hallucinations, chronic joint pain, amnesic spells, and encephalopathy. (Id. at ¶¶ 350-403). Thus,
she alleges that Gardasil caused a wide variety of “autoimmune, autonomic, and neurological[]
injuries” including “hypersomnia, orthostatic intolerance, autonomic dysfunction, and
postural orthostatic tachycardia syndrome (“POTS”)” (Id. at ¶ 405).6
As required by the Vaccine Act,7 Ms. Bergin filed a petition for compensation in the
United States Court of Federal Claims related to her alleged injuries, but her claim was later
dismissed at her request. (See Bergin SAC ¶ 408; see also Bergin v. Sec’y of Health & Hum.
Servs., No. 17- 241V, 2020 WL 5800718, at *3 (Fed. Cl. Sp. Mstr. Sept. 1, 2020)). She filed
her case against Merck in this Court on March 18, 2022.
Plaintiff Ashley America alleges that in October 2014 and April 2015, when she was 18
years old, she received two injected doses of Gardasil in New York. (Doc. No. 76-2 (America
6 More broadly, Plaintiffs contend there is a significant body of medical literature that shows
Gardasil can cause serious autoimmune and neurological injuries and adverse symptoms similar
to those Bergin and America allege they have suffered, a causal link which Merck (and the FDA)
deny and is currently the subject of extensive discovery among the parties. See Doc. Nos. 76 at
fn.1., 68 at 4-5; 68-17 “FDA Information on Gardasil – Presence of DNA Fragments Expected,
No Safety Risk”.
7 Pursuant to the Vaccine Act, no one may bring “a civil action for damages” against a vaccine
manufacturer “for damages arising from a vaccine-related injury” unless she has first filed and
exhausted a petition for compensation in the U.S. Court of Federal Claims. See 42 U.S.C. § 300aa-
11(a)(2)(A).
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Amended Complaint (“America AC”) at ¶¶343-345)). She asserts that in obtaining her consent,
her doctor informed her Gardasil was a safe and effective vaccine for preventing cervical cancer,
which she claims mirrored statements Merck made through its physician and consumer marketing
and advertising. (Id. ¶¶ 345 & 440-442). With respect to alleged injuries caused by her vaccination,
she claims that she experienced various adverse events, including chronic syncope (fainting),
chronic dizziness, headaches, and concentration issues. She attributes “various medical
conditions” to Gardasil, including “symptoms of POTS,” “non- epileptic seizures, related to
autoimmune dysregulation, and neurocardiogenic syncope related to dysregulation of the
autonomic nervous system.” (Id. ¶¶ 345-351).
Ms. America filed a petition in the U.S. Court of Federal Claims pursuant to the Vaccine
Act and, following that court’s ruling, elected to pursue her claims in civil court. (See id. ¶ 356;
see also America v. Sec’y of Health & Hum. Servs., No. 17-542V, 2022 WL 278151, at *35
(Fed. Cl. Sp. Mstr. Jan. 4, 2022)). On October 10, 2022, Plaintiff filed her case against Merck in
the U.S. District Court for the Northern District of New York, which was transferred to this
Court on October 26, 2022.
III. DISCUSSION
A. The Scope of the Issues Before the Court and Relevant Authority
As discussed below, this Order resolves various issues concerning Plaintiffs’ alleged
claims related to “design defects” in the Gardasil vaccine, the scope of Plaintiffs’ “failure to warn”
claims, and the sufficiency of Plaintiffs’ “manufacturing defect” and fraud claims. However, it is
also important to clarify the issues that are not before the Court in this motion. All the Plaintiffs in
the MDL, including Plaintiffs Bergin and America, allege that they were injured as a result of
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receiving the Gardasil vaccine. The most fundamental liability merits issue raised by their claims
is the medical/scientific question of whether the Plaintiffs’ various alleged injuries were caused by
their Gardasil injections. This causation issue is not now before the Court, and the Court expresses
no view at this time as to that question.
Second, with respect to Plaintiffs’ claims that Merck is liable for failure to properly warn
Plaintiffs’ prescribing doctors (which are being permitted to proceed), Merck contends that such
claims are impliedly preempted by the FDA’s approval of the vaccine’s “label,” which limits how
Merck can warn doctors without additional FDA approval – unless Merck has “newly acquired
information” as defined in the relevant regulations. See 21 C.F.R § 601.12(f)(2)(i). As with
“causation,” these issues of “implied preemption” / “newly acquired information” are hotly
contested, not yet before the Court, and the Court expresses no view as to their merits by this
Order. Rather, the Parties and the Court expect both causation and implied preemption issues to
be addressed in summary judgment motions later this year.8
Also, further clarification is important with respect to how this Order will be applied to the
MDL consolidated cases beyond Bergin and America. It has been the Court’s belief that Merck’s
Rule 12 motion would, as requested by Merck (and opposed by Plaintiffs), be considered as a
“bellwether” motion that would resolve the questions presented as to similar allegations and claims
made throughout the consolidated cases. However, the Court has not yet been explicit about that
expectation. It will do so now.
8 There are other issues that may become relevant to later proceedings, such as the issue of Vaccine
Court exhaustion mentioned above, that are not at issue in this motion.
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The Court has the authority to apply the ruling here to other consolidated cases, see Manual
of Complex Litigation § 22.632, and finds that it is both fair and efficient to do so in these
circumstances. It would be wasteful and contrary to the spirit of the MDL to require Merck to
move to dismiss essentially the same pleadings in every case. Plaintiffs have had the opportunity
to express their view that Rule 12 motions were unnecessary and “objected” to the
“characterization” of Merck’s motion as a “bellwether” motion. See Doc. No. 40 at 3. And, since
the Court’s scheduling of the motion (implicitly overruling the objection), no plaintiff has
disavowed Plaintiffs Bergin and America’s response, which of course has been prepared by the
same counsel they share with those plaintiffs. Therefore, the Court’s ruling here will apply to all
substantially similar allegations/claims asserted in the cases subject to the MDL.9
Finally, the Court notes that while it has taken an entirely fresh look at the relevant issues
and considered Merck’s motion de novo, it does not write on an blank slate. Prior to transfer, at
least four federal district courts and two California trial courts issued written decisions on motions
to dismiss Gardasil complaints. See Flores v. Merck & Co., No. 3:21-CV-00166, 2022 WL 798374,
at *3–9 (D. Nev. Mar. 16, 2022); Herlth v. Merck & Co., No. 3:21- CV-438, 2022 WL 788669, at
*5–10 (D. Conn. Mar. 15, 2022); Colbath v. Merck & Co., Inc., et al., No. 3:21-cv-120-W, 2022
WL 935195 (S.D. Cal. Mar. 29, 2022); Stratton v. Merck & Co., Inc., et al., 2021 WL 5416705
9 Nevertheless, prior to applying the result here to all current and future MDL cases, the Court will
allow any party who wants to move to avoid the application of this ruling to her or his claims to
do so within 30 days of this Order (or within 30 days of joining the MDL, whichever comes later).
In the absence of the granting of such a motion upon a showing of good cause (not to include
simply disagreeing with the Court’s ruling or a plaintiff having asserted allegations or claims that
are only immaterially different), the Court’s ruling here will apply to all substantially similar
allegations/claims asserted in the cases subject to the MDL.
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(D.S.C. Nov. 17, 2021); Shain v. Merck, Case No. 21STCV35340 (CA Superior Court, Los
Angeles County) (August 4, 2022); Brunker v. Merck, Case No. 56-2022-00563045 (CA Superior
Court, Ventura County) (September 26, 2022). Each of the federal cases granted Merck’s motion
to dismiss, at least in part, but the state courts both denied Merck’s “demurrer” under California
state procedure. As cited and discussed below, the Court generally finds the collective view of
these federal judges from across the country to be persuasive.
However, the different standard applicable to motions to dismiss (“demurrers”) under
California law undermines the applicability of those decisions here. Unlike Rule 12 motions under
the Federal Rules of Civil Procedure, in California “a general demurrer cannot be sustained as to
a portion of a cause of action.” Brunker, Doc. No. 76-3, at p.2 (citing Daniels v. Select Portfolio
Servicing Inc., 246 Cal.App.4th 1150, 1167 (2016)); Shain, Doc. No. 76-4 at 10 (“Ordinarily, a
general demurrer does not lie as to a portion of a cause of action and if any part of a cause of action
is properly pleaded, the demurrer will be overruled.”).10 Thus, for example, the California courts
were required to reject Merck’s arguments that a Plaintiff’s negligence claim contained preempted
“design defect” claims – regardless of the merits of that argument – if the cause of action also
included a permissible “failure to warn” allegation. Accordingly, in light of this fundamentally
different standard of review, although the state court decisions have been considered, the Court
has given them substantially less weight.
10 Moreover, the Court’s opinion in Shain is stated only to be a “tentative ruling,” and the Court
could not find any indication on the docket that a “final” ruling has been entered.
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B. The Vaccine Act
There is no dispute among the Parties that Gardasil is a childhood vaccine covered by the
Vaccine Act. As explained by the Supreme Court in Bruesewitz v. Wyeth LLC, 562 U.S. 223, 228–
30 (2011), Congress enacted the Vaccine Act to “[t]o stabilize the vaccine market and facilitate
compensation” to putative plaintiffs by establishing a no-fault compensation program “designed
to work faster and with greater ease than the civil tort system.” Shalala v. Whitecotton, 514 U.S.
268, 269 (1995). The program allows a person injured by a vaccine, or her legal guardian, to file
a petition for compensation against the Secretary of Health and Human Services in the United
States Court of Federal Claims, where a special master makes an informal adjudication of the
petition, subject to objections reviewed by that court. See 42 U.S.C. § 300aa–11, 12.
More specifically, claimants who show that an injury listed in a “Vaccine Injury Table”
(which lists compensable adverse side effects of approved vaccines) are prima facie entitled to
compensation without any showing of causation. A claimant may also recover for unlisted side
effects, and for listed side effects that occur at times other than those specified in the Table, but
for those the claimant must prove causation. Unlike in tort suits, claimants under the Act are not
required to show that the administered vaccine was defectively manufactured, labeled, or designed.
Successful claimants receive compensation for medical, rehabilitation, counseling, special
education, and vocational training expenses; diminished earning capacity; pain and suffering; and
$250,000 for vaccine-related deaths. Attorney's fees are provided, not only for successful cases,
but even for unsuccessful claims that are not frivolous. If the claimant is satisfied with the court’s
judgment she can accept it; if not, she can file a tort action against the vaccine manufacturer.
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Payments to successful claimants are made from a fund created by an excise tax on each vaccine
dose. See generally, Bruesewitz, 562 U.S. at 228-229.
Most significant to the pending motion, the “quid pro quo” for this no-fault compensation
system funded by vaccine manufacturers, is “the provision of significant tort-liability protections
for vaccine manufacturers,” which was “designed to stabilize the vaccine market.”11 Bruesewitz,
562 U.S. at 229. Several provisions of the Act are relevant here:
(b) Unavoidable adverse side effects; warnings
(1) No vaccine manufacturer shall be liable in a civil action for damages
arising from a vaccine-related injury or death associated with the administration of
a vaccine after October 1, 1988, if the injury or death resulted from side effects that
were unavoidable even though the vaccine was properly prepared and was
accompanied by proper directions and warnings.
(2) For purposes of paragraph (1), a vaccine shall be presumed to be
accompanied by proper directions and warnings if the vaccine manufacturer shows
that it complied in all material respects with all requirements under the Federal
Food, Drug, and Cosmetic Act and section 262 of this title (including regulations
issued under such provisions) applicable to the vaccine and related to vaccine-
related injury or death for which the civil action was brought unless the plaintiff
shows—
(A) that the manufacturer engaged in the conduct set forth in subparagraph
(A) or (B) of section 300aa-23(d)(2) of this title, or
(B) by clear and convincing evidence that the manufacturer failed to
exercise due care notwithstanding its compliance with such Act and section (and
regulations issued under such provisions).
(c) Direct warnings
11 Congress’ concerns about the stability of the vaccine market centered around vaccines against
diphtheria, tetanus, and pertussis (“DTP”), which were blamed for children's disabilities and
developmental delays. This led to a massive increase in vaccine-related tort litigation, which
destabilized the DTP vaccine market, causing two of the three domestic manufacturers to withdraw
and left the remaining manufacturer with potential tort liability that exceeded its annual sales by a
factor of 200. See Bruesewitz, 562 U.S. at 227.
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No vaccine manufacturer shall be liable in a civil action for damages arising
from a vaccine-related injury or death associated with the administration of a
vaccine after October 1, 1988, solely due to the manufacturer's failure to provide
direct warnings to the injured party (or the injured party's legal representative) of
the potential dangers resulting from the administration of the vaccine manufactured
by the manufacturer.
42 U.S.C. § 300aa–22.
Therefore, pursuant to the Act, 1) all design-defect claims against vaccine manufacturers
brought by plaintiffs who seek compensation for injury or death caused by vaccine side effects are
preempted, Bruesewitz, 562 U.S. at 243, and 2) claims alleging liability for failure to properly
warn injured plaintiffs or their parents are expressly barred. See Stratton, 2021 WL 5416705, at
*5; Flores, 2022 WL 798374 at *4; Colbath, 2022 WL 935195 at *3; G.M. v. Sanofi Pasteur
Inc., No. CV 14-9549 FMO (ASX), 2016 WL 7638186, at *4 (C.D. Cal. Mar. 22, 2016) (“To the
extent plaintiff alleges that defendant failed to warn her or the public of the risks that the Fluzone
vaccine could cause transverse myelitis, such claims are expressly preempted by the Vaccine
Act.”).
The Court will discuss how the Vaccine Act (and relevant state law) relates to Plaintiffs’
claims below.
C. The Bergin and America Complaints
Spanning more than 120 pages and nearly 550 paragraphs, many with multiple
subparagraphs, the Bergin SAC asserts claims under North Carolina law for negligence, gross
negligence, failure to warn, manufacturing defect, breach of warranty, common law fraud and
unfair trade practices. The America AC is nearly as long with 97 pages and seeks to recover for
negligence, strict liability for failure to warn and manufacturing defects, breach of warranty and
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common law fraud under New York law. Despite this length and breadth,12 it is challenging for
the Court to discern the precise nature of Plaintiff’s claims, which in many instances rely on
sprawling and conclusory allegations and lump numerous theories of liability together.
For example, in their negligence claims, both Ms. Bergin and Ms. America allege that
Merck breached its duties of care in the “research, development, manufacturing, testing,
marketing, supply, promotion, advertisement, packaging, labeling, sale, and distribution of
Gardasil.” Bergin SAC at ¶ 419; America AC at ¶ 368. Indeed, Plaintiffs could just as well have
said, “in every manner possible.” Accordingly, the Court has attempted to summarize and
categorize Plaintiff’s more specific allegations with respect to the various issues raised by this
motion both to decide the merits of the motion and to give the Parties guidance moving forward
as to the scope of the claims that the Court finds may continue.
D. “Design Defect” Claims
Merck’s first attack on Plaintiffs’ claims is that they reflect, in part, “design defect” claims
preempted by the Vaccine Act. See Bruesewitz, 562 U.S. at 243. In response, Plaintiffs do not
dispute that “design defect” claims are preempted, but rather deny that the complaints make any
such claims. While Plaintiffs are correct that the Bergin and America complaints do not explicitly
refer to, and in fact affirmatively disclaim, any “design defect” claims (and told the Court at oral
argument that they carefully scrubbed the word “design” from the complaints in response to
Merck’s earlier successful motions to dismiss), the Court must look at the true nature of the
12 Other courts have criticized similar Gardasil complaints as “lengthy, difficult to follow, and
replete with run-on sentences,” while making claims “in blunderbuss fashion.” See Flores, 2022
WL 798374 at *4; Herlth, 2022 WL 788669 at *6.
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allegations, not just how Plaintiffs have self-described their claims. See Bergin SAC at ¶ 467 (“This
is not a design defect claim.”). Viewing the complaints through that substantive lens, it is clear
that Plaintiff have asserted a number of preempted “design defect” claims within their
“negligence” and “manufacturing defect” causes of action.
1. Gardasil’s Ingredients
Plaintiffs allege that Merck includes numerous “dangerous” ingredients in Gardasil,
including HPV LI-DNA fragments, sodium borate (borax), polysorbate 80 and yeast. See, e.g.,
Bergin SAC at ¶¶ 136-162, 422(u); 469-470 (Gardasil vaccine is “defective and unreasonably
dangerous” because it contains “dangerous and undisclosed” “ingredients and toxins”). The FDA
is aware of all these components in Gardasil;13 therefore, an attack on the ingredients of Gardasil
is an attack on the design of Gardasil itself. See Stratton, 2021 WL 5416705, at *2. In other words,
in challenging what is included in Gardasil – the Gardasil “recipe” – Plaintiffs are simply
complaining about how Gardasil is designed. Therefore, such claims are preempted by the Vaccine
Act.
2. Gardasil’s Development (Including Clinical Trials)
A second set of “design defect” allegations included in Plaintiffs’ negligence claims is that
Merck failed to properly “develop” the Gardasil vaccine, including inadequate or negligently
designed clinical trials. See, e.g., Bergin SAC at ¶¶ 422 (a), (c), (d), (e), (f), (g), (h), (i), and (j). As
with their challenge to Gardasil’s ingredients, Plaintiffs’ allegations that Gardasil – as a complete
13 Plaintiffs’ allegations that these ingredients were not disclosed is contradicted by publicly
available documents that show the FDA is aware of the presence of such substances. Doc. Nos.
68-17 (“FDA Information on Gardasil – Presence of DNA Fragments Expected, No Safety Risk”);
68-4 (Gardasil Prescribing Information) (listing other ingredients).
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product – was improperly developed is in substance a claim that the vaccine is defectively
designed.
This “design defect” claim includes Plaintiffs’ attacks on Merck’s clinical trials. An
allegation of “inadequate testing” is not an independent wrong; that is, it is not harmful in and of
itself, but rather it allegedly leads to a failure to include the best/safest ingredients in the vaccine.14
As such, it relates to the design of the vaccine. Plaintiffs suggest that “inadequate” testing is part
of its “failure to warn” claim. To be sure, a failure to warn doctors about risks discovered in clinical
trials (like risks discovered post approval) could be the subject of a negligence claim not prohibited
by the Vaccine Act. See § 300aa-22(b)(2)(B).15 However, claims that Merck simply did not do
“enough testing” or did the “wrong kind of testing” yet a vaccine was still approved is an attack
on the design of the approved vaccine, not a failure to warn claim.
In sum, Plaintiffs’ claims that Merck was negligent in its “development” of the vaccine,
including claims related to clinical trials, are design defect claims barred by the Vaccine Act.
3. Gardasil’s Overall Safety and Efficacy
Finally, Plaintiffs include several allegations in their negligence claims to the effect that
Merck is liable for failing to adequately disclose the “lack of efficacy and risk of serious harm”
and failure to use care in the “research, manufacturing, labeling, development, etc.” of Gardasil
“so as to avoid the risk of serious harm.” See, e.g., Bergin SAC at ¶¶ 414, 422 (b) and (k). As with
14 To the extent Plaintiffs are claiming that Merck committed a fraud on the FDA, such state law
claims are preempted. See Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 348 (2001)
(holding that plaintiffs' state-law fraud-on-the-FDA claims conflicted with, and are therefore
impliedly pre-empted by, federal law).
15 Again, any duty to warn medical providers may be limited by the “implied preemption” defense
discussed earlier and not at issue in this motion.
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their allegations related to ingredients and development, Plaintiffs’ broad claims that Gardasil is
not “safe and effective” is effectively an allegation that the entire design of the vaccine is defective.
Therefore, such claims are prohibited by the Vaccine Act, and Merck is entitled to have them
dismissed.
E. “Failure to Warn” Claims
Plaintiffs include in their negligence claims numerous allegations that Merck failed to
disclose certain important information or warn “Plaintiff, Plaintiff’s parent(s), Plaintiff’s medical
providers and the general public” about Gardasil’s risks, etc. See, e.g., Bergin SAC at ¶¶ 421, 422
(l)-(t), (v)-(w), 429. Under the Vaccine Act, whether or not these claims state a valid cause of
action turns on the identity of the person whom Plaintiffs contend that Merck failed to properly
warn. In short, Plaintiffs may purse claims against Merck for failure to warn Plaintiffs’ medical
providers, but may not assert similar claims related to the failure to warn Plaintiffs, their parents
or the general public.16
As discussed above, the Vaccine Act bars liability claims against vaccine manufacturers
for failing to provide “direct warnings” to Plaintiffs and their legal representatives (including their
parents). The Act provides that “[n]o vaccine manufacturer shall be liable in a civil action for
damages arising from a vaccine-related injury . . . solely due to the manufacturer’s failure to
provide direct warnings to the injured party (or the injured party’s legal representative).” 42
U.S.C. § 300aa- 22(c) (emphasis added). The Vaccine Act “eliminat[es] liability for not providing
16 At oral argument, when asked to explain under what authority Plaintiffs had standing to assert
claims on behalf of the “general public,” Plaintiffs acknowledged that those allegations are not
intended to assert a separate claim, but rather are intended only to provide support for their claim
for punitive damages related to their own claims.
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direct warnings to a claimant.” Holmes v. Merck & Co., Inc., 697 F.3d 1080, 1083 (9th Cir. 2012);
see also, e.g., Blackmon v. Am. Home Prods. Corp., 328 F. Supp. 2d 659, 666 (S.D. Tex. 2004)
(“the Vaccine Act clearly bars claims based on a manufacturer’s failure to provide warnings
to the public or to consumers”). Accordingly, the courts in the earlier Gardasil motions dismissed
similar claims based on the alleged failure to warn the Plaintiffs or their parents. See, e.g., Flores,
2022 WL 798374, at *4 (dismissing “the part[s] of [plaintiff’s] claim[s] that [were] premised on
Merck’s failure to warn Flores and her mother” directly); Stratton, 2021 WL 5416705, at *5
(“The Court finds that, as to Defendants[’] alleged failure to warn Plaintiff directly, the Vaccine
Act bars Plaintiff’s claim.”).17
Plaintiffs urge the Court to read the Vaccine Act’s prohibition on “direct warning” claims
narrowly, arguing that the statute’s use of the word “solely” in Section 22(c) should be interpreted
as allowing Plaintiffs’ “direct warning” claims to proceed because they also alleged Merck failed
to give sufficient warnings to Plaintiffs’ medical providers. The Court declines the invitation to
reach such an absurd result, which Plaintiffs conceded at the hearing no court considering the
Vaccine Act has ever adopted. Permitting a claim for failing to warn plaintiffs or their parents that
is expressly barred by the statute simply because they have similarly alleged that the vaccine
manufacturer failed to adequately warn someone else – a critical exception found nowhere in the
17 Those courts also found plaintiffs’ direct warning claims barred by the learned intermediary
doctrines under Nevada and South Carolina law. Flores, 2022 WL 798374, at *5; Stratton, 2021
WL 5416705, at *4. New York and North Carolina both recognize the learned intermediary
doctrine—which holds that a drug manufacturer’s duty to warn is fulfilled by warning the
prescribing physician, not the patient directly—and similarly bar Plaintiffs’ direct warning claims
here. See, e.g., Martin v. Hacker, 83 N.Y.2d 1, 9, 628 N.E.2d 1308 (1993); N.C. Gen. Stat. § 99B-
5(c).
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statute – would as a practical matter nullify the prohibition. A better reading, consistent with the
clear intent of the Act, is that the word “solely” was included just to emphasize that despite the
prohibition on “direct warning” claims, a Plaintiff would still be able to assert a claim for failure
to warn the medical providers to whom warnings must be given under the “learned intermediary”
doctrine. Simply put, the statute “solely” (i.e. “only”) bars direct warning claims while claims for
failing to provide warnings to others are permitted. Holding that the statutory prohibition on direct
warning claims is nullified by a claim against medical providers, which the statute intends to allow,
would thus turn the use of “solely” in the statute on its head.18
Therefore, the Court will enforce the Vaccine Act’s bar of “direct warning” claims as
written and grant Merck’s motion to dismiss Plaintiffs’ claims that Merck failed to properly warn
Plaintiffs and their parent(s).
F. “Manufacturing Defect” Claims
Plaintiffs assert a separate claim for “manufacturing defect” in both Bergin and America.
See Bergin SAC at ¶¶ 466-479, America AC at ¶¶ 402-415. They allege generally and only
“upon information and belief” that the Gardasil vaccine was “defective and unreasonably
dangerous because [Merck] failed to comply with manufacturing specifications required by the
governing manufacturing protocols and also required by the regulatory agencies,” claiming that
18 Plaintiffs’ additional argument that a vaccine manufacturer should not be permitted to mislead
consumers, including Plaintiffs, if it chooses to advertise also must be rejected. First, Plaintiffs
have cited to nothing in the Vaccine Act or relevant authority that suggests that Congress intended
to eliminate the Act’s protections for vaccine manufacturers as soon as they advertise an approved
childhood vaccine (which are vaccinations that public policy would presumably want to encourage
through advertising). Further, other federal regulations prevent vaccine manufacturers from
dishonest advertising. See 21 C.F.R. § 202.1 et seq.
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the vaccines contained “ingredients and toxins that were not disclosed in the FDA-approved
specifications and/or otherwise not disclosed in the package insert.” Bergin SAC at ¶ 469;
America AC at ¶ 405.
“In manufacturing defect cases, the plaintiff proves that the product is defective by
… showing that it does not conform to the manufacturer’s specifications” for products of that
type. Singleton v. Int’l Harvester Co., 685 F.2d 112, 115 (4th Cir. 1981). The gravamen of the
tort is not defective design but defective execution of the design. Wankier v. Crown Equip.
Corp., 353 F.3d 862, 867 (10th Cir. 2003); see Stratton, 2021 WL 5416705 at *3. Both North
Carolina and New York law describe the claim similarly. See, e.g., Boudreau v. Baughman, 368
S.E.2d 849, 860 (N.C. 1988) (“A design defect is an injury-producing hazard accompanying
normal use of a product that was intentionally manufactured according to design. A
manufacturing defect, on the other hand, is caused by a miscarriage in the manufacturing
process that produces an unintended result.” (citations omitted)); Dunham v. Covidien, LP, 498
F. Supp. 3d 549, 556 (S.D.N.Y. 2020) (“To state a claim for strict products liability under a
manufacturing defect theory, a plaintiff must plead that a specific product unit was defective as
a result of some mishap in the manufacturing process itself, improper workmanship, or because
defective materials were used in construction, and that the defect was the cause of plaintiff’s
injury.” (quotation marks omitted)).
Specifically, “the claim of selection of improper materials is a design defect claim, not a
manufacturing defect claim.” Edwards v. ATRO SpA, 891 F. Supp. 1074, 1078 (E.D.N.C. 1995),
supplemented, 891 F. Supp. 1085 (E.D.N.C. 1995). Thus, in the vaccine context, a
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manufacturing defect claim alleges that the manufacturer did not follow the vaccine formula or
recipe, with the result being a harmful and different version of the vaccine. Here, Plaintiffs allege
that the vaccine recipe itself, not any specific instances of improper manufacturing, is the
problem. See America AC at ¶¶ 389, 408; Bergin SAC at ¶¶ 453, 472 (Gardasil reached Plaintiffs
“in its intended or reasonably foreseeable manner.”). That is, the alleged failings in the
ingredients used in the manufacturing process are, according to Plaintiffs, always dangerous.
Indeed, at oral argument, Plaintiff argued that “everybody” who received the Gardasil vaccine
is the victim of a manufacturing defect. See Bergin SAC at ¶ 142 (noting the presence of
challenged ingredient in “every Gardasil vial tested from all over the world.”). A claim that all
the doses of a vaccine are inherently and unreasonably dangerous when manufactured as
intended is not a “manufacturing defect” claim. Rather, it is an allegation of a “design defect,”
which is barred by the Vaccine Act as discussed above.
To the extent that Plaintiffs claim that their complaints allege a departure from
manufacturing specifications or the inclusion of “unintended” ingredients, those “upon
information and belief” allegations are contradicted both by their pleadings, which repeatedly
describe the allegedly dangerous “HPV L1-DNA fragments” as “ingredients” in Gardasil, see
Bergin SAC at ¶¶ 137, 422(u), 471, 517(e), and by publicly available documents that show the
ingredients are intended and expected. Doc. No. 68-17 (“FDA Information on Gardasil – Presence
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of DNA Fragments Expected, No Safety Risk”);19 68-4 (Gardasil Prescribing Information) (listing
other ingredients).
Therefore, the Court will grant Merck’s motion to dismiss Plaintiffs manufacturing defect
claims.20 See City of High Point, N. Carolina v. Suez Treatment Sols. Inc., 485 F. Supp. 3d 608,
631 (M.D.N.C. 2020) (dismissing claim where plaintiff offered “no allegations that the
[product] contained a defect from manufacturing and no allegations concerning the
manufacturing process”); see also Stratton, 2021 WL 5416705, at *3–4 (dismissing
manufacturing defect claim); Colbath, 2022 WL 935195, at *5 (same); Flores, 2022 WL 798374,
at *7 (same); Herlth, 2022 WL 788669, at *5–6 (same).
G. Fraud Claims
Mirroring their claims of negligence and failure to warn, Plaintiffs also assert claims
against Merck for common law fraud under North Carolina and New York law. Plaintiffs allege
that Merck made numerous fraudulent statements and omissions in its “ubiquitous” advertising to
the public and marketing to the medical community. See, e.g. Bergin SAC at ¶¶ 501-502, 510.
However, beyond an allegation that Ms. Bergin’s mother was “exposed to” Merck’s “One Less”
19 This publicly available FDA statement regarding the “DNA Fragments” challenged by Plaintiffs
was issued in October 2011, long before Plaintiffs received their Gardasil vaccine in 2013 and
2014. Therefore, Plaintiffs cannot plausibly contend that the presence of this “ingredient” was
undisclosed at the time of their vaccination.
20 Plaintiffs suggest that this Court’s decision in Lynch v. Nucor Corp., No.
323CV00029KDBDCK, 2023 WL 3874034, at *3–4 (W.D.N.C. June 7, 2023) supports their
arguments. Not so. In Lynch, applying Arizona law, the Court found that Plaintiff’s allegation that
the same steel sourced from the defendant performed differently in the front and the back of a
“bullet proof” vest that failed, resulting in plaintiff’s death. This permitted a plausible inference
that some, but not all, of the steel had been manufactured defectively. Here, Plaintiffs allege that
all doses of the vaccine contained the same allegedly dangerous ingredients, manufactured in the
same way.
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advertising campaign, Plaintiffs do not make any specific allegations as to the who, what, when,
where, and how the alleged fraud occurred.
Merck seeks to dismiss Plaintiff’s fraud claims on several grounds. First, it argues that to
the extent the claims allege a fraudulent failure to adequately warn Plaintiffs, their parents and the
public those claims are barred by the Vaccine Act’s prohibition on “direct warning” claims. The
Court agrees. As discussed above, Section 22(c) of the Act broadly provides that “no manufacturer
shall be liable in a civil action for damages…” for failure to warn an injured party or their legal
representative. Unlike in Section 22(b)(2)(A), there is no exception for claims of “fraud” or other
intentional wrongful conduct. Instead, the statute – again as part of the quid pro quo to stabilize
the vaccine markets – provides a safe haven for manufacturers in all “civil actions” for any “direct
warning” claims. Accepting Plaintiffs’ arguments that intentional tort claims, which of course
include the possibility of punitive damages, are not included in the statutory prohibition would
significantly undermine, if not fully eliminate, the protection intended by the statute. Therefore,
Plaintiffs’ fraud claims will be dismissed to the extent they assert claims based on any fraud against
Plaintiffs, their parents or the public.
With respect to Plaintiffs claims of fraud on medical providers, Merck argues that those
claims should be dismissed because they fail to satisfy the heightened pleading requirements of
Fed. R. Civ. P. 9(b) that the circumstances of fraud must be plead with particularity. “The Rule
9(b) standard requires a party to, at a minimum, describe the time, place, and contents of the false
representations, as well as the identity of the person making the misrepresentation and what he
obtained thereby. These facts are often referred to as the who, what, when, where, and how of the
alleged fraud.” Bakery & Confectionary Union & Indus. Int’l Pension Fund v. Just Born II, Inc.,
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888 F.3d 696, 705 (4th Cir. 2018); see Corder v. Antero Res. Corp., 57 F.4th 384, 401 (4th Cir.
2023). If the required specific allegations of fraud are not pled then the claim must be dismissed.
See Stratton, 2021 WL 5416705, at *6 (dismissing Gardasil fraud claim); see also Flores, 2022
WL 798374, at *7 (dismissing identical fraud claim); Herlth, 2022 WL 788669, at *10 (same).
Plaintiffs have admittedly failed to plead the specific time, place and contents of any of
Merck’s allegedly fraudulent statements, especially as to medical providers. At oral argument,
Plaintiffs acknowledged the absence of allegations of the circumstances of fraud in the complaints,
saying that they had not spoken to Plaintiffs’ doctors (who they said “didn’t like to talk to
Plaintiffs’ lawyers”). Regardless of the reasons that Plaintiffs have failed to plead their alleged
claims of fraudulent misrepresentation with particularity, their clear failure to do so dooms their
claims. Accordingly, the Court will dismiss Plaintiffs’ fraud claims based on fraudulent
misrepresentations to “medical providers” as well as “plaintiffs, parents and the general public”
for whom Plaintiffs have also not plead their fraud claims with particularity.
The remaining fraud claims asserted by Plaintiffs allege “fraudulent concealment,” that is,
the concealment by omission of material facts that were reasonably calculated and intended to
deceive and did in fact deceive a person, resulting in damages to the injured party. See Forbis v.
Neal, 361 N.C. 519, 527 (2007); Azure Dolphin v. Barton, 821 S.E.2d 711, 726-28 (N.C. 2018);
Bermuda Container Line Ltd. v. Int'l Longshoremen's Ass'n, AFL-CIO, 192 F.3d 250, 258 (2d Cir.
1999) (discussing New York law). While the absence of any particularized allegations regarding
Merck’s alleged fraudulent concealment with respect to medical providers makes this a close
decision, the Court will allow Plaintiffs’ fraudulent concealment claims – which are held to a more
lenient standard with respect to the pleading of particularized circumstances – to proceed at this
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stage. See Colbath, 2022 WL 935195, at *7 (“Because this allegation concerns fraudulent
concealment, Plaintiff’s failure to specify the time and place of the omissions will not bar his
claim.”); Corder, 57 F.4th at 401 (endorsing “relaxed” Rule 9(b) standard for allegations of fraud
by omission or concealment, but not eliminating the particularity requirement). Also, in practical
effect, discovery on this claim will overlap with Plaintiffs’ already permitted claims that Merck
failed to properly warn medical providers and the impact of the differences in proof of this claim
of intentional conduct and potential damages will not arise until after Merck has an opportunity to
renew its challenge at summary judgment. Accordingly, the Court will deny Merck’s motion to
dismiss Plaintiffs’ claims of fraudulent concealment with respect to medical providers without
prejudice.
H. Alleged “Shotgun” Claims
Merck asks the Court to dismiss all of Plaintiff’s claims as improper “shotgun” pleadings.
A “shotgun pleading” is one that “fails to articulate claims with sufficient clarity to allow the
defendant to frame a responsive pleading” or one in which “it is virtually impossible to know
which allegations of fact are intended to support which claims for relief.” Wilkinson v. Wells Fargo
Bank, N.A., No. 3:19-CV-00580, 2020 WL 2542867, at *3 (W.D.N.C. May 19, 2020). As noted
above, the Court questions whether the Complaint is unnecessarily long, repetitive and, in parts,
vague, overly general and conclusory in its allegations and claims. Plaintiffs’ counsel candidly
acknowledged his regret at the length of the Complaints, but claimed it reflected Plaintiffs’ effort
to avoid an argument that their claims had not been sufficiently plead. In any event,
notwithstanding the flaws in the Complaint, the Court finds that even to the extent Plaintiffs are
on a fishing expedition, Merck is plainly aware of where Plaintiffs’ boat is headed and what they
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are trying to catch (as evidenced by the course and detail of the MDL proceedings to date). So, the
Court declines to dismiss any portion of Plaintiffs’ complaints as a “shotgun pleading.”
I. Leave to Amend the Plaintiffs’ Complaints
To varying degrees, the earlier courts that ruled on motions to dismiss Gardasil complaints
allowed Plaintiffs an opportunity to amend their complaints to replead their claims. Two years
later, this MDL litigation stands in a different posture. At oral argument, Plaintiffs recognized that
at this late stage of discovery it would be inefficient and likely unproductive to request additional
amended pleadings and they declined to do so. The Court agrees that further amended pleading
would not be constructive. Therefore, Plaintiffs are not permitted to amend their complaints in
response to this Order, other than with Merck’s written consent or leave of Court granted for good
cause following a separate motion under Fed. R. Civ. P. 15.21
IV. ORDER
NOW THEREFORE IT IS ORDERED THAT:
1. Defendants’ Motion for Partial Judgment on the Pleadings (Doc. No. 68) is
GRANTED in part and DENIED in part;
2. The Court’s ruling shall apply to all substantially similar allegations/claims asserted
in the cases subject to the MDL; however, Parties who believe they have good cause
(as discussed in the Order) to avoid the application of this ruling to her or his claims
21 This ruling with respect to amended pleading is unrelated to the opportunity discussed above for
MDL Plaintiffs other than Ms. Bergin and Ms. America to move that this ruling should not be
applied to their complaints.
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may, within 30 days of this Order (or within 30 days of joining the MDL, whichever
comes later), file a motion seeking relief from this Order; and
3. Except as ordered here, this case shall move forward to further proceedings in
accordance with the Court’s current case management orders and the Parties’
agreements.
SO ORDERED ADJUDGED AND DECREED.
Signed: March 20, 2024
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