Petition for Writ of Certiorari — Chatom Primary Care, P.C., et al., Petitioners v. Merck & Co., Inc.
Supreme Court briefJul 10, 2025
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APPENDIX
TABLE OF CONTENTS
Appendix A Opinion of the United States Court
of Appeals for the Third Circuit
(Oct. 7, 2024)....................................... App. 1a
Appendix B Memorandum of the United States
District Court for the Eastern
District of Pennsylvania
(July 27, 2023) .................................. App. 39a
Appendix C Order of the United States Court
of Appeals for the Third Circuit
Denying Rehearing
(Feb. 10, 2025) .................................. App. 90a
-1aAppendix A
UNITED STATES COURT OF APPEALS
FOR THE THIRD CIRCUIT
No. 23-3089
IN RE: MERCK MUMPS VACCINE ANTITRUST
LITIGATION
MERCK & CO., INC.,
APPELLANT.
On Appeal from the United States District Court
for the Eastern District of Pennsylvania
(D.C. Civil Action No. 2-12-cv-03555)
District Judge: Honorable Chad F. Kenney
Argued July 9, 2024
Before: SHWARTZ, PHIPPS, and MONTGOMERYREEVES, Circuit Judges.
(Opinion filed: October 7, 2024)
Jessica L. Ellsworth [ARGUED]
Kristina Alekseyeva
Neal K. Katyal
Danielle D. Stempel
Michael J. West
-2aHogan Lovells US
555 Thirteenth Street NW
Columbia Square
Washington, DC 20004
Lisa C. Dykstra
R. Brendan Fee
Zachary M. Johns
Morgan Lewis & Bockius
2222 Market Street, 12th Floor
Philadelphia, PA 19103
Sally W. Bryan
Kathleen Hardway
Dino S. Sangiano
Venable LLP
750 E. Pratt Street, Suite 900
Baltimore, MD, 21202
Counsel for Appellant Merck & Co, Inc.
Jonathan Edelman
Kellie Lerner
Laura Song
Robins Kaplan
1325 Avenue of the Americas, Suite 2601
New York, NY 10019
Deepak Gupta [ARGUED]
Gupta Wessler
2001 K Street NW, Suite 850 North
Washington, DC 20006
-3aJeffrey L. Kodroff
John A. Macoretta
Dianna J. Zinser
Spector Roseman & Kodroff
2001 Market Street, Suite 3420
Philadelphia, PA 19103
Counsel for Appellees Chatom Primary Care PC,
on behalf of itself and all others similarly
situated; Dr. Andrew Klein; & John Ivan Sutter,
M.D.
OPINION*
MONTGOMERY-REEVES, Circuit Judge:
Antitrust law does not bar regulated parties from
petitioning the government. And a petition is not a sham
merely because it seeks and obtains a selfish result.
In the late 1990s, the Food & Drug Administration
(the “FDA”) approached Merck & Co., Inc. (“Merck”)
with concerns about the end-of-shelf-life potency of its
mumps vaccine, the sole licensed mumps vaccine available
in the United States. At the FDA’s suggestion, Merck
boosted the initial potency of its vaccine, presumably with
the hope that increasing beginning-of-shelf-life potency
would increase end-of-shelf-life potency too. This fix did
not work. But Merck did not reveal that failing to the FDA
because Merck was concerned that diminishing the
relevant drug-label claims could hasten the arrival of
*
This disposition is not an opinion of the full Court and pursuant
to I.O.P. 5.7 does not constitute binding precedent.
-4acompetition by lowering the regulatory bar that a
competitor would need to clear to show that its mumps
vaccine was not inferior to Merck’s, an apparent
prerequisite for FDA approval. So rather than reveal that
its vaccine might be misbranded, Merck allegedly (1)
concealed its ongoing potency problems, (2) ran a flawed
clinical trial, and (3) relied on that unreliable data to
persuade the FDA to license a less potent vaccine.
Appellees are a collection of physicians and physicians’
groups who filed a class-action lawsuit alleging that they
bought Merck’s mumps vaccines at inflated prices.
Among other things, their complaint alleges that Merck
unlawfully extended its apparent monopoly by making
false drug-label claims with the goal of thwarting
competition, in violation of § 2 of the Sherman Act, 15
U.S.C. § 2. After lengthy discovery, Merck moved for
summary judgment on a few grounds, including that the
Noerr-Pennington doctrine purportedly shielded Merck
from liability under the Sherman Act because the
asserted harm to competition flowed from Merck‘s
genuine and successful petitioning of the FDA. The
District Court rejected Merck‘s motion for summary
judgment on the antitrust claim and granted Merck‘s
request to file an interlocutory appeal under 28 U.S.C. §
1292(b). This appeal followed.
The record contains troubling evidence that Merck
sought to extend its apparent monopoly by
misrepresenting facts about its mumps vaccines on the
FDA-approved drug labeling. But those allegedly false
claims were the result of Merck‘s genuine and successful
petitioning of the FDA. And Noerr-Pennington immunity
is not vitiated “simply because [the relevant petitioning]
... ha[d] a commercial impact and involve[d] conduct that
-5acan be termed unethical.” E. R.R. Presidents Conf. v.
Noerr Motor Freight, 365 U.S. 127, 141 (1961). Thus,
there is no genuine dispute of material fact that NoerrPennington immunity attaches to Merck‘s alleged
anticompetitive scheme. And we will reverse-in-part the
District Court‘s order denying summary judgment.
I. BACKGROUND1
Because Merck moved for summary judgment, the
following recitation of the facts resolves all disputes and
draws all reasonable inferences in Appellees’ favor.
Physicians Healthsource, Inc. v. Cephalon, Inc., 954 F.3d
615, 618 (3d Cir. 2020).
A. Facts
From 1967 until 2022, Merck was the sole licensed
manufacturer of mumps vaccines in the United States.
Merck accompanied doses of its vaccine2 with FDAapproved labeling that provided information about the
drug, including its “shelf life, minimum potency
requirements, basis for licensure, and effectiveness[.]”
See App. 10,029. Merck had an ongoing duty to ensure
that its drug label was accurate. Wyeth v. Levine, 555 U.S.
555, 570–71 (2009) (“[I]t [is] ... a central premise of federal
drug regulation that the manufacturer bears
responsibility for the content of its label at all times.”).
1
We write for the benefit of the parties and recite only essential
facts. For a more detailed discussion of the factual background, see
this Court’s related decision in United States ex rel. Krahling v.
Merck & Co., No. 23-2553, 2024 WL 3664648, at *1–5 (3d Cir. Aug. 6,
2024).
2
Merck sold two branded mumps vaccines during the years
relevant to this appeal, MMR-II and ProQuad. For simplicity—and
because the vaccines used the same mumps component—we refer to
a singular “vaccine” when discussing Merck’s mumps vaccines.
-6aIn the late 1990s, the FDA raised concerns that
Merck’s mumps vaccine might be sub-potent toward the
end of its 24-month shelf life, meaning that doses might
not contain the minimum amount of live virus stated on
the drug label. Merck agreed—at the FDA’s suggestion—
to boost the initial potency of its vaccine, presumably with
the hope that overfilled doses would have enough buffer
to remain potent through the end of their shelf life.
Overfilling doses did not fix the end-of-shelf-life
potency problem with Merck’s mumps vaccine. But Merck
did not share that information with the FDA because
Merck was concerned that the FDA might—at a
minimum—order Merck to reduce the drug-label claims
about the shelf life and seroconversion of its mumps
vaccine.3 Weakening label claims was not a palatable
option to Merck because a rival pharmaceutical
manufacturer, GlaxoSmithKline (“GSK”), sold a
comparable mumps vaccine in Europe and wanted to
bring that vaccine to the United States. Merck feared that
GSK’s domestic launch was “imminent.” App. 4840. And
Merck was wary of hastening GSK’s arrival by lowering
the bar to entry, as GSK needed to show that its mumps
vaccine was not inferior to Merck’s mumps vaccine to gain
FDA approval. So rather than open the door to
competition by disclosing that its mumps vaccine might be
misbranded, Merck sought to extend its apparent
monopoly by (1) misrepresenting or concealing
information about the end-of-shelf-life potency of its
3
Seroconversion “refers to a person going from being
‘seronegative’ prior to vaccination, which generally means lacking
pathogen specific antibodies, to being ‘seropositive’ after vaccination,
which means possessing such antibodies.” In re Merck Mumps
Vaccine Antitrust Litig., 685 F. Supp. 3d 280, 293 (E.D. Pa. 2023).
-7avaccine and (2) filing a Supplemental Biologics License
Application (“sBLA”) seeking the FDA’s approval to
maintain the existing drug-label claims about shelf life
and seroconversion with a less potent vaccine.
To support its sBLA, Merck ran a new trial—called
Protocol 007—to demonstrate that Merck could reduce
the potency of its vaccine without impairing the existing
drug-label claims about seroconversion. According to
Appellees, Protocol 007 was a flawed study that did not
reliably capture immunogenicity.4 Nonetheless, Merck
leveraged the results of Protocol 007 to persuade the FDA
to approve Merck’s sBLA. As a result of the FDA’s
approval, Merck continued to make unsupported or
misleading claims about the shelf life and seroconversion
of its mumps vaccine on the drug label.
GSK could not replicate Merck’s drug-label claims
about seroconversion. And that led GSK to conclude that
the FDA would view GSK’s mumps vaccine as inferior to
Merck’s. Eventually, GSK accessed the methodology
underlying Protocol 007 and relied on the same or similar
assays5 as Merck to establish non-inferiority. The FDA—
which knew about Merck’s end-of-shelf-life potency
problems and the alleged flaws with Protocol 007, see
United States ex rel. Krahling v. Merck & Co., No. 232553, 2024 WL 3664648, at *8 (3d Cir. Aug. 6, 2024)—
accepted GSK’s clinical evidence and, in 2022, approved
4
Immunogenicity “provides information about how a subject’s
immune system responds to different stimuli, including vaccination.”
In re Merck Mumps Vaccine Antitrust Litig., 685 F. Supp. 3d at 293.
5
Assays refer to types of tests. See, e.g., Assay, Oxford English
Dictionary,
https://www.oed.com/dictionary/assay_n?tab=
meaning_and_use#37098486 (last visited Sept. 29, 2024) (“The trying
(of a person or things); trial imposed upon or endured by any object,
in order to test its virtue, fitness, etc.”).
-8aGSK’s application to sell a competing mumps vaccine in
the United States.
To date, the FDA has not asked Merck to change the
relevant drug-label claims, issued a recall, ordered
revaccinations, or taken any other action against Merck
for the purported issues with its mumps vaccine. The
Centers for Disease Control and Prevention (the “CDC”)
continues to buy mumps vaccines from Merck and GSK.
Id. at *5. And the CDC’s Advisory Committee on
Immunization Practices continues to recommend Merck’s
mumps vaccine and deems it “fully interchangeable” with
GSK’s vaccine. Id.
B. Procedural History
Appellees are a collection of physicians and physicians’
groups who claim that they bought Merck’s mumps
vaccine at an inflated price. Their operative complaint
alleges several claims against Merck, including
monopolization in violation of § 2 of the Sherman Act, 15
U.S.C. § 2. After lengthy discovery, Merck moved for
summary judgment on a few bases, including that (1)
Noerr-Pennington immunity purportedly attached to all
of Merck’s allegedly anticompetitive conduct, and (2)
Appellees purportedly failed to adduce evidence of
antitrust injury.
The District Court granted-in-part and denied-in-part
Merck’s motion for summary judgment,6 rejecting
Merck’s contentions that it was entitled to summary
judgment on Noerr-Pennington immunity and antitrust
injury. Merck sought and obtained the District Court’s
6
The District Court granted Merck’s motion for summary
judgment with respect to Appellees’ state-law claims. Appellees do
not challenge that decision on appeal, so we do not address it.
-9apermission to file an interlocutory appeal under 28 U.S.C.
§ 1292(b). This Court accepted the appeal.
II. DISCUSSION7
“[T]his case is and always has been about Merck’s
label for its [mumps vaccines] and its use of those labels
to keep GSK out of the market.” App. 264. So our analysis
begins—and ends—with the FDA-approved drug label.
A. Law
“Section 2 of the Sherman Act ‘makes it unlawful to
monopolize, attempt to monopolize, or conspire to
monopolize, interstate or international commerce.’ ”
Mylan Pharms. Inc. v. Warner Chilcott Pub. Ltd. Co., 838
F.3d 421, 433 (3d Cir. 2016) (quoting Broadcom Corp. v.
Qualcomm Inc., 501 F.3d 297, 306 (3d Cir. 2007)).
Appellees assert that Merck violated § 2 by
“implement[ing] a scheme to unlawfully protect its
monopoly” through “false and misleading claims on its
mumps-vaccine labels that GSK needed to match to enter
the U.S. market.” Response Br. 1. According to Appellees,
“Merck knew [that] neither its vaccine, nor GSK’s, could
meet those claims.” Id. But Merck did not reveal that
7
The District Court had jurisdiction under 28 U.S.C. §§ 1331 and
1367. We have jurisdiction under 28 U.S.C. § 1292(b).
We exercise plenary review over the District Court’s order
denying summary judgment. Huber v. Simon’s Agency, Inc., 84 F.4th
132, 144 (3d Cir. 2023) (“Our review of an order granting [or denying]
summary judgment is plenary, meaning we review anew the District
Court’s summary judgment decision, applying the same standard it
must apply.” (cleaned up) (quoting Ellis v. Westinghouse Elec. Co., 11
F.4th 221, 229 (3d Cir. 2021))). Summary judgment is appropriate only
if there is no genuine dispute of material fact and the movant is
entitled to judgment as a matter of law. Id. (citing Fed. R. Civ. P.
56(a)).
-10areality to the FDA or the pubxlic. As a result, “Merck’s
strategy succeeded: it delayed GSK’s entry into the U.S.
market by over a decade.” Id.
The record contains evidence that Merck sought to
extend its apparent monopoly by artificially raising the
bar that GSK had to clear to obtain FDA approval for its
competing mumps vaccine. That alleged anticompetitive
conduct might not have violated the Sherman Act,
however, because “[a] party who petitions the
government for redress generally is immune from
antitrust liability” even if their petitioning “causes an
anti-competitive effect.” Cheminor Drugs, Ltd. v. Ethyl
Corp., 168 F.3d 119, 122 (3d Cir. 1999) (collecting cases).
This petitioning immunity—named the NoerrPennington doctrine after a pair of seminal Supreme
Court decisions, see E. R.R. Presidents Conf. v. Noerr
Motor Freight, Inc., 365 U.S. 127 (1961); United Mine
Workers of Am. v. Pennington, 381 U.S. 657 (1965)—is
rooted in a few considerations, including constitutionalavoidance concerns related to the First Amendment’s
Petition Clause, Pro. Real Est. Invs., Inc. v. Columbia
Pictures Indus., Inc. (“P.R.E.”), 508 U.S. 49, 56 (1993),
and the notion that Congress did not intend to proscribe
harm to competition that “is the result of valid
government action, as opposed to private action,” Noerr,
365 U.S. at 136.8 The immunity extends to petitioning of
8
See also City of Columbia v. Omni Outdoor Advert., Inc., 499
U.S. 365, 383 (1991) (“As we have described, Parker and Noerr are
complementary expressions of the principle that the antitrust laws
regulate business, not politics; the former decision protects the States’
acts of governing, and the latter the citizens’ participation in
government.”); Edinboro Coll. Park Apartments v. Edinboro Univ.
Found., 850 F.3d 567, 572 (3d Cir. 2017) (“In Parker v. Brown, 317
-11aall three branches of government, including
administrative agencies like the FDA. Cheminor, 168
F.3d at 122 (“This immunity extends to persons who
petition all types of government entities—legislatures,
administrative agencies, and courts.” (citing Cal. Motor
Transp. Co. v. Trucking Unlimited, 404 U.S. 508, 510
(1972))).
While Noerr-Pennington immunity is broad, its scope
“is not absolute.” In re Wellbutrin XL Antitrust Litig.
Indirect Purchasers Class, 868 F.3d 132, 148 (3d Cir.
2017). And controlling precedent recognizes one
exception implicated here: petitions that are “not
genuinely aimed at procuring favorable government
action” are deemed a sham and receive no immunity.
P.R.E., 508 U.S. at 58 (quoting Allied Tube & Conduit
Corp. v. Indian Head, Inc., 486 U.S. 492, 500 n.4 (1988)).
“[E]vidence of anticompetitive intent or purpose alone
cannot transform otherwise legitimate activity into a
sham.” Id. at 59 (collecting cases). Rather, the sham
exception hinges on whether the petitioner sought to use
the invocation of governmental process—as opposed to
the result of that process—to harm competition. If the
former, the petition is a sham, and no immunity attaches.
If the latter, the petition is not a sham, and the sham
exception does not apply.
For a petition to be a sham, two things must be true.
First, the petition “must be objectively baseless in the
sense that no reasonable [petitioner] could realistically
expect success on the merits.” P.R.E., 508 U.S. at 60.
Second, the petitioner must subjectively intend to “use ...
governmental process—as opposed to the outcome of that
U.S. 341 (1943), the Supreme Court held that the Sherman Act does
not prohibit anticompetitive state action.”).
-12aprocess—as an anticompetitive weapon” “to interfere
directly with the business relationships of a competitor.”
Armstrong Surgical Ctr., Inc. v. Armstrong Cnty. Mem’l
Hosp., 185 F.3d 154, 158 n.2 (3d Cir. 1999) (cleaned up)
(quoting P.R.E., 508 U.S. at 60–61). Courts consider the
petitioner’s “subjective motivation” “[o]nly if [the]
challenged [petition] is objectively meritless.” P.R.E., 508
U.S. at 60. Thus, evidence of a petitioner’s subjective
intent cannot create a genuine dispute of material fact
about whether Noerr-Pennington immunity applies if a
petition has objective merit. See id.
When a petition contains misrepresentations, this
Court “determine[s] whether [the] petition [is] objectively
baseless under the [first step of the] Supreme Court’s test
in PRE, without regard to those [false] facts[.]”
Cheminor, 168 F.3d at 123 (emphasis omitted). Even if a
petition would be objectively meritless with the truth, the
petition is not a sham unless the plaintiff “pass[es] the
second[ ] ‘subjective test’” by showing that the petitioner’s
subjective “purpose was [not] to secure the outcome of the
[governmental] process” that they invoked. Armstrong,
185 F.3d at 158 n.2. See also Omni, 499 U.S. at 380 (“A
‘sham’ situation involves a defendant whose activities are
‘not genuinely aimed at procuring favorable government
action’ at all, not one ‘who genuinely seeks to achieve his
governmental result, but does so through improper
means.’” (quoting Allied Tube, 486 U.S. at 500 n.4, 508
n.10)).
B. Party Arguments
Merck argues that its purported anticompetitive
scheme boils down to successfully petitioning the FDA to
maintain the existing claims about seroconversion, shelf
life, and potency that Merck included on the drug label for
-13aits mumps vaccine. Noerr-Pennington immunity shields
legitimate petitions that seek to harness government
action for selfish purposes. See, e.g., P.R.E., 508 U.S. at 58
(“In short, ‘Noerr[-Pennington immunity] shields from
the Sherman Act a concerted effort to influence public
officials regardless of intent or purpose.’ ” (quoting
Pennington, 381 U.S. at 670)). Merck claims that its
alleged anticompetitive scheme fits that bill, so it is
immune from liability under the Sherman Act.
Appellees respond that there is a genuine dispute of
material fact about whether Noerr-Pennington immunity
bars their antitrust claim for three main reasons. First,
Appellees argue that “Merck’s responses to [the] FDA
[were] not petitioning actions but rather required
answers in a regulatory proceeding” and thus were a
“mere incident of regulation” not cloaked by immunity.
Response Br. 58–59 (quoting Litton Sys., Inc. v. Am. Tel.
& Tel. Co., 700 F.2d 785, 807 (2d Cir. 1983)). Second,
Appellees argue that Merck’s petitions were a sham
because “Merck knowingly misrepresented the
specifications
of
its
vaccines,”
and
those
“misrepresentations caused [the] FDA to have ‘no
negative feedback.’ ” Id. at 61–62 (quoting App. 5575,
9784). Third, Appellees appear to argue that even if
Noerr-Pennington
immunity
shields
Merck’s
communications with the FDA, summary judgment is
improper because “Merck’s misleading public label
claims” were themselves—or were the result of—private
conduct, not government action. Id. at 54, 54–58. And
Appellees claim that they can rely on “facts indisputably
outside of Noerr protection” to prove that Merck violated
the Sherman Act, like “public statements,” “internal
documents” from Merck and GSK, “and unrebutted
expert testimony.” Id. at 31.
-14aThe following analysis begins by addressing whether
Merck petitioned the FDA and then turns to the sham
exception and Merck’s non-petitioning conduct.
C. Analysis
There is no genuine dispute of material fact that
Noerr-Pennington immunity shields Merck from liability
for its alleged anticompetitive conduct. For starters, we
have no trouble concluding that Merck’s communications
with the FDA involved petitioning. Required or not, those
communications sought to persuade the FDA to approve
or refrain from changing the claims about seroconversion,
shelf life, and potency that Merck included on the drug
label for its mumps vaccine. Asking the FDA to raise the
bar for competition by confirming that Merck—and, by
extension, GSK—must meet inflated claims about
immunogenicity to sell a mumps vaccine in the United
States fell within the heartland of petitioning activity. See,
e.g., Noerr, 365 U.S. at 136 (describing petitioning as “an
attempt to persuade the legislature or the executive to
take particular action with respect to a law that would
produce a restraint or a monopoly.”). And nothing was
incidental or passive about the FDA’s continued approval
of Merck’s drug-label claims in response to petitioning
designed to elicit that exercise of governmental
discretion.9
9
See also Wyeth, 555 U.S. at 568 (“Generally speaking, a
manufacturer may only change a drug label after the FDA approves
a supplemental application.”); cf. Cont’l Ore Co. v. Union Carbide &
Carbon Corp., 370 U.S. 690, 707 (1962) (no petitioning involved
because the defendants “were engaged in private commercial activity,
no element of which involved seeking to procure the passage or
enforcement of laws”); Litton, 700 F.2d at 806–07 (“filing of ... tariffs”
with the Federal Communications Commission was “a mere incident
of regulation” not entitled to immunity because “[t]he decision to
-15aLikewise, it is apparent that Merck’s petitioning was
not a sham.10 “A winning [petition] is by definition a
reasonable effort at petitioning for redress and therefore
not a sham.” P.R.E., 508 U.S. at 60 n.5. There is no dispute
that Merck succeeded in persuading the FDA to approve
the relevant claims about seroconversion, shelf life, and
potency that Merck included on the drug label for its
mumps vaccine. So it appears at first blush that Merck’s
petitioning necessarily had objective merit because it
persuaded the FDA.
Appellees push back on this analysis by pointing to
evidence
that
Merck
allegedly
withheld
or
misrepresented information when corresponding with the
FDA. Even if we assume that Merck’s petitions would
lack objective merit without those alleged falsehoods,11
Appellees concede that they “do not allege injury from the
process at all, never mind an abuse of that process,”
Response Br. 63. Thus, Appellees’ theory of the case
impose and maintain the ... tariff was made in [the defendantcompany’s] boardroom, not at the [Commission]”); In re ZF-TRW
Airbag Control Units Prods. Liab. Litig., 601 F. Supp. 3d 625, 751
(C.D. Cal. 2022) (mandatory responses to government agency did not
involve petitioning because the responses did not “urge [the agency]
to exercise its administrative discretion by taking or refraining from
an action” (cleaned up)).
10
Because it is apparent that Merck’s petitioning was not a
sham, we need not—and do not—decide whether the sham exception
is limited to the adjudicative sphere, or whether Merck’s
communications with the FDA should be characterized as
adjudicative or legislative.
11
At least with respect to immunogenicity, that is a dubious
premise considering that the FDA has not ordered Merck to change
the relevant drug-label claims or taken any action against Merck after
learning of the alleged end-of-shelf-life potency problems and
Protocol 007. See Krahling, 2024 WL 3664648, at *7–8.
-16aseems to be that Merck intended to use the result of
petitioning the FDA to thwart competition by “ma[king]
misrepresentations that caused [the] FDA to give ‘no
negative feedback’” about Merck’s end-of-shelf-life
potency problems and the sBLA. Id. (quoting App. 5575,
9784). By definition, Merck cannot have intended to
commit a sham if it sought to use the result of petitioning
the government (i.e., FDA-approved drug label claims)—
as opposed to the petitioning itself—to harm competition.
See P.R.E., 508 U.S. at 60–61. And Appellees do not
explain how there can be a genuine dispute of material
fact about whether Merck subjectively intended to
commit a sham if there is no evidence that Merck’s
invocation of process itself harmed competition. Thus,
Appellees have failed as a matter of law to satisfy the
subjective prong of the P.R.E. test because there is no
genuine dispute of material fact that Merck did not intend
to commit a sham. And there is no need to send this case
to trial on objective merit if a reasonable jury could not
find that the subjective prong of the P.R.E. test is met. Cf.
Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986)
(“[S]ummary judgment will not lie if the dispute about a
material fact is ‘genuine,’ that is, if the evidence is such
that a reasonable jury could return a verdict for the
nonmoving party.”).12
12
Several of our sister circuits appear to recognize a standalone
exception to Noerr-Pennington immunity for petitions—made in an
adjudicative setting—containing fraudulent misrepresentations. See,
e.g., Amphastar Pharms. Inc. v. Momenta Pharms., Inc., 850 F.3d 52,
56 (1st Cir. 2017) (“Noerr-Pennington immunity ... has a wellestablished exception for knowing misrepresentations, at least in the
administrative and adjudicatory contexts.” (cleaned up)); Mercatus
Grp., LLC v. Lake Forest Hosp., 641 F.3d 834, 842 (7th Cir. 2011)
(“[T]here is little doubt that fraudulent misrepresentations may
-17arender purported petitioning activity a sham not protected from
antitrust liability.” (cleaned up)); Kottle v. Nw. Kidney Ctrs., 146 F.3d
1056, 1060 (9th Cir. 1998) (“[I]n the context of a judicial proceeding, if
the alleged anticompetitive behavior consists of making intentional
misrepresentations to the court, litigation can be deemed a sham if a
party’s knowing fraud upon, or its intentional misrepresentations to,
the court deprive the litigation of its legitimacy.” (cleaned up)). See
generally Phillip E. Areeda & Herbert Hovenkamp, Antitrust Law:
An Analysis of Antitrust Principles and Their Application, ¶ 203a–b,
d–f (last updated May 2024).
Appellees expressly disclaim reliance on a separate exception for
fraudulent misrepresentation. Response Br. 65 (arguing that the
Seventh Circuit’s opinion in Mercatus is distinguishable because it
“addressed a separate exception for fraudulent misrepresentation—
an exception the Third Circuit rejects” (first citing 641 F.3d at 845–
46; and then citing Cheminor, 168 F.3d at 124)). Thus, Appellees have
waived any argument based on that purported exception. Barna v.
Bd. of Sch. Dirs. of the Panther Valley Sch. Dist., 877 F.3d 136, 147
(3d Cir. 2017) (“Waiver ... is the intentional relinquishment or
abandonment of a known right.” (cleaned up)); Holk v. Snapple
Beverage Corp., 575 F.3d 329, 336 (3d Cir. 2009) (“[E]xplicitly
disclaim[ing]” an argument “clearly demonstrates ... that the issue is
waived”). And we may not address it on appeal. TD Bank N.A. v. Hill,
928 F.3d 259, 276 n.9 (3d Cir. 2019) (“[W]e may affirm on any ground
supported by the record as long as the appellee did not waive—as
opposed to forfeit—the issue.” (collecting cases)).
Moreover, even if we were to construe Appellees’ brief as
forfeiting—as opposed to waiving—an argument based on the
fraudulent-misrepresentation exception, but see Barna, 877 F.3d at
147 (“Forfeiture is the failure to make the timely assertion of a right,
an example of which is an inadvertent failure to raise an argument.”
(cleaned up) (quoting United States v. Olano, 507 U.S. 725, 733
(1993))), Cheminor expressly declined to adopt a standalone exception
for fraudulent misrepresentations in the adjudicative sphere. 168 F.3d
at 123 (The plaintiff “argues either that Noerr-Pennington immunity
does not apply at all to petitions containing misrepresentations or that
[the petitioner’s] alleged misrepresentations led to the conclusion”
that the relevant petition “was objectively baseless. We decline to
carve out a new exception to the broad immunity that NoerrPennington provides. Rather, we will determine whether [the]
-18apetition was objectively baseless under the Supreme Court’s test in
PRE, without regard to those facts that [the plaintiff] alleges [the
petitioner] misrepresented.” (emphasis removed)). See also id. at 131–
32 (Sloviter, J., dissenting) (“The majority’s decision to disregard the
facts that [the plaintiff] alleges [the petitioner] misrepresented is
contrary to the position of the two other courts of appeals that have
considered this issue. Both of these courts read PRE to preserve a
fraud exception to antitrust immunity, although they vary in their
interpretation of that exception.” (citations omitted); “Unlike the
majority, I conclude that the District Court erred in recognizing only
a single exception to Noerr-Pennington immunity based on ‘objective
baselessness[.]’ ”).
A few months later, this Court’s decision in Armstrong clarified
that a plaintiff still must show that the petitioner sought to use
government process itself—as opposed to the result of that process—
as an anticompetitive weapon to invoke the sham exception to NoerrPennington immunity, confining the narrow exception that Cheminor
recognized to the first prong of the P.R.E. test, objective merit. See
185 F.3d at 158 n.2. In so doing, Armstrong explained that “[w]hile
Cheminor focuse[d] on the sham exception to Noerr immunity, it also
reject[ed the plaintiff’s] more general argument that ‘NoerrPennington immunity does not apply at all to petitions containing
misrepresentations.’ ” Id. (quoting Cheminor, 168 F.3d at 123).
Armstrong then seems to have—like Cheminor—rejected a general
fraud exception to Noerr-Pennington immunity, explaining that
“[l]iability for injuries caused by ... state action is precluded even
where it is alleged that a private party urging the action did so by
bribery, deceit or other wrongful conduct that may have affected the
decision making process.” Id. at 162. See also id. at 164 (Schwartz,
D.J., dissenting) (“With its decision today, the majority holds private
parties who make misrepresentations that pervasively influence the
decision making process of public entities are entitled to immunity
under both the state action immunity doctrine and the Noerr–
Pennington immunity doctrine.”).
While reasonable minds can and do differ, see Dissenting Op. at
4–6, we read Cheminor and Armstrong to reject a standalone
exception to Noerr-Pennington immunity for petitions containing
fraudulent misrepresentations in this context. And we are bound by
those decisions even if we disagree with the result that they produce
in this appeal. United States v. Harris, 68 F.4th 140, 146 (3d Cir. 2023)
-19aFinally, Appellees’ attempt to rely on evidence of
Merck’s non-petitioning conduct to establish an antitrust
violation has a minor flaw and a major flaw. The minor
flaw is that Appellees sometimes appear to treat NoerrPennington immunity like an evidentiary privilege that
bars the use of genuine petitions to prove an antitrust
violation. But Noerr-Pennington immunity is not a rule of
evidence that prevents plaintiffs from using the contents
of a genuine petition to prove an antitrust violation.
Rather, Noerr-Pennington immunity is a substantive
principle of antitrust law—derived from the statutory text
and purpose of the Sherman Act—that shields defendants
from liability based on the notion that “[t]he federal
antitrust laws ... do not regulate the conduct of private
individuals in seeking anticompetitive action from the
government.” Omni, 499 U.S. at 379–80.13 So the question
is not whether Appellees adduced non-petition evidence
showing that Merck schemed to unlawfully extend its
apparent monopoly. Rather, the question is whether the
evidence that Appellees adduced supports a reasonable
(“[I]t is a well-established ‘tradition of this court’ that an opinion with
precedential authority ‘is binding on subsequent panels.’” (quoting 3d
Cir. I.O.P. 9.1)).
13
See also Pennington, 381 U.S. at 670 n.3 (“It would of course
still be within the province of the trial judge to admit ... evidence” of
an alleged conspiracy between private parties and a government actor
“under the established judicial rule of evidence that testimony of prior
or subsequent transactions, which for some reason are barred from
forming the basis for a suit, may nevertheless be introduced if it tends
reasonably to show the purpose and character of the particular
transactions under scrutiny.” (cleaned up) (collecting cases)); Nat.Immunogenics Corp. v. Newport Trial Grp., No. SACV 15-02034
JVS(JCGx), 2018 WL 6137597, at *3 (C.D. Cal. May 16, 2018) (“NoerrPennington insulates parties from liability for their petitioning
conduct, it is not an independent evidentiary privilege.”).
-20ainference that it was Merck’s private conduct—not the
FDA’s exercise of regulatory discretion, which Merck’s
petitioning sought to induce—that delayed the launch of
GSK’s competing vaccine.
The major flaw is that the evidence Appellees adduced
cannot link Merck’s private conduct to GSK’s delay
without passing through the drug-label claims about
seroconversion, shelf life, and potency that Merck
persuaded the FDA to approve. That regulatory approval
was an act of governmental discretion, not Merck’s
private conduct in the marketplace, and thus is shielded
by Noerr-Pennington immunity.
The crux of Appellees’ theory of antitrust injury is that
Merck “delayed the launch of [GSK’s] competing vaccine
by over a decade” by making or preserving “deceptive
statements on its mumps-vaccine labels.” Response Br.
29. Those deceptive statements caused delay, Appellees
assert, because GSK’s plan for its mumps vaccine aimed
to match the publicly available information within Merck’s
label. That was necessary, in Appellee’s view, because
GSK needed to configure its vaccine to reach the relative
effectiveness of Merck’s vaccine. Thus, “Merck’s false,
inflated labeling claims [allegedly] delayed GSK’s entry
by over a decade” by improperly exaggerating the claims
about “potency, shelf-life, and seroconversion” that GSK
had to meet to show that its vaccine “was ‘non-inferior’ to
Merck’s vaccine,” a prerequisite “[t]o gain U.S. approval.”
Id. at 5–6 (cleaned up).
The trouble for Appellees is that the heart of their
case—allegedly false or misleading claims about
seroconversion, shelf life, and potency that Merck
included on the FDA-approved label for its mumps
vaccine—was both the object and the result of Merck’s
-21asuccessful petitioning of the FDA. When the FDA
approached Merck with concerns about the end-of-shelflife potency of its mumps vaccine, Merck had two main
options: (1) reveal that its mumps vaccine might be
misbranded and then consider remedial actions, like
reducing the 24-month shelf life that Merck listed on the
drug label; or (2) persuade the FDA that overfilling doses
fixed that problem with end-of-shelf-life potency even
though Merck knew that was not true and then file an
sBLA requesting the FDA’s permission to maintain the
existing drug-label claims about seroconversion with a
less potent, and hence longer-lasting, mumps vaccine.
Merck chose the second option. That gambit worked. And
the FDA did not order Merck to change its drug label or
take any action against Merck after learning the truth
about the purported problems with its vaccine. So even if
Merck publicly admitted to misrepresenting claims on its
mumps vaccine, Appellees cannot show how their harm
flowed from Merck’s private conduct when the FDA—
government process—approved the label. That is because
GSK’s vaccine still would have lacked approval and
licensure on account of the FDA who—with knowledge of
the purported problems—allowed Merck to retain its
existing drug-label claims. Thus, there is no genuine
dispute of material fact that GSK’s delay was caused by
the FDA’s exercise of regulatory discretion in response to
Merck’s successful petitioning. And Noerr-Pennington
immunity bars Appellees’ § 2 claim against Merck as a
matter of law because the antitrust injury that Appellees
assert is the result of government action, not private
conduct. See, e.g., Omni, 499 U.S. at 379–80.14
14
Of course, had Appellees raised a genuine dispute of material
fact about whether an exception to Noerr-Pennington immunity
-22aAppellees’ brief contains some scattered arguments to
the contrary. None changes our analysis. For example,
Appellees seem to argue that Merck engaged in private
conduct every time that it printed or distributed its
allegedly deceptive drug label because it was Merck—not
the FDA—that arranged those publications. “Prospective
drug manufacturers work with the FDA to develop an
appropriate label when they apply for FDA approval of a
new drug.” Merck Sharp & Dohme Corp. v. Albrecht, 587
U.S. 299, 304 (2019) (citations omitted). The end result of
that work is a drug label that the manufacturer provides
or makes available to physicians, pharmacies, patients,
and other interested parties. See id. at 303–04 (“Although
we commonly understand a drug’s ‘label’ to refer to the
sticker affixed to a prescription bottle, in [some]
context[s] the term refers more broadly to the written
material that is sent to the physician who prescribes the
drug and the written material that comes with the
prescription bottle when the drug is handed to the patient
at the pharmacy.” (citing 21 U.S.C. § 321(m))). Thus,
Appellees appear to suggest an overbroad rule that would
vitiate Noerr-Pennington immunity whenever a
pharmaceutical manufacturer successfully petitions the
FDA to sell a new drug, as a plaintiff could evade
immunity by focusing on the contents of the FDAapproved label instead of the FDA’s discretionary
decision to approve the drug. We are reluctant to remove
Noerr-Pennington immunity root-and-stem from the
drug-approval process. And Appellees offer no controlling
authority to support that sweeping proposition.
applies, like the sham exception, Merck could be liable under the
Sherman Act even if the alleged antitrust injury flowed from Merck’s
petitioning of the FDA.
-23aMoreover, Appellees fail to explain how it was Merck’s
decision to publish the label—instead of the FDA’s
decision to approve the underlying drug-label claims—
that delayed GSK’s entry. As discussed above, Appellees’
core theory of antitrust injury is that Merck sought to
thwart competition by raising the bar that GSK had to
clear to obtain FDA approval. Merck’s allegedly false or
misleading label claims may have helped cause that
impediment. But that is because the FDA approved those
statements and thus could be expected to hold other
pharmaceutical manufacturers to the same standard
when examining non-inferiority.15 Accordingly, based on
the evidence and arguments presented here, there is no
genuine dispute of material fact that it was the FDA’s
approval of the relevant claims that Merck included on its
drug label that allegedly delayed GSK’s entry to the U.S.
market. And Appellees’ attempt to cast the content of
Merck’s FDA-approved drug label as private conduct
fails.16
15
Things might be different, for example, if a pharmaceutical
manufacturer included information on a drug label that the FDA did
not approve. And a rival manufacturer inferred that its vaccine was
inferior based on the false impression that the FDA had approved
those unapproved claims. We are not presented with that sort of
fringe circumstance here, however, as Appellees base their claim on
information that the FDA allowed Merck to include on the drug label
for its mumps vaccine.
16
The handful of cases that Appellees cite do not support their
assertion that Merck’s drug-label claims involved private conduct
because none of those cases relied on government-approved
information
heightening
a
government-imposed
licensing
requirement to show antitrust injury. Cf. Ticor Title Ins. Co. v. FTC,
998 F.2d 1129, 1138 (3d Cir. 1993) (collective rate setting approved by
insurance regulators); Barton’s Disposal Serv., Inc. v. Tiger Corp.,
886 F.2d 1430, 1436–37 (5th Cir. 1989) (suggesting that “predatory
-24aNext, Appellees cite internal documents allegedly
showing that Merck intentionally sought to thwart
competition so that Merck could keep collecting monopoly
rents. These documents support a reasonable inference
that Merck acted with anticompetitive intent. But
anticompetitive intent does not defeat Noerr-Pennington
immunity. Noerr, 365 U.S. at 140 (The “legality” of a
petition “[is] not at all affected by any anticompetitive
purpose it may have had.”). And Appellees cannot explain
how Merck’s internal machinations delayed GSK’s arrival
without passing through the FDA-approved drug-label,
which was the object and result of Merck’s genuine
petitioning—and thus involved government action, not
private conduct—for the reasons offered above.
Last, Appellees imply that Merck’s decision not to
inform the FDA about problems with Merck’s mumps
vaccine—as opposed to actively misrepresenting facts
while corresponding with the FDA—did not constitute
petitioning and thus fell under the umbrella of private
conduct. Merck’s alleged decision to omit facts from the
petitions that it filed with the FDA about the relevant
drug-label claims was “incidental” to Merck’s “valid effort
to influence governmental action,” Allied Tube, 486 U.S.
at 499 (quoting Noerr, 365 U.S. at 143), as Merck naturally
had to decide what information to include—and what
information to omit—when petitioning the FDA. Indeed,
categorizing omissions as private conduct would seem to
carve out a vast exception to Noerr-Pennington
immunity, as plaintiffs could evade the doctrine
altogether—include its exceptions, like the sham-petition
pricing” may be private conduct); In re: Lipitor Antitrust Litig., 868
F.3d 231, 264 (3d Cir. 2017) (private settlement agreement submitted
to government); Litton, 700 F.2d at 807 (unilateral tariff).
-25aexception—by focusing on omissions from petitions
instead of the petitions themselves. See, e.g., Allied Tube,
486 U.S. at 507 (explaining that Noerr-Pennington
immunity does not apply to “commercial activities simply
because they have a political impact” (citing Noerr, 365
U.S. at 141)).
Given that concern, we are satisfied that the existing
limitations on immunity, like the sham-petition exception,
suffice to preserve antitrust liability consistent with the
spirit and purpose of the Noerr-Pennington doctrine.17
We therefore reject Appellees’ argument that Merck’s
decision to omit information when corresponding with the
FDA constituted private conduct in the marketplace,
categorically
unprotected
by
Noerr-Pennington
immunity.
*
*
*
*
*
In sum, we hold that (1) Merck engaged in petitioning
activity when it sought and obtained the FDA’s approval
to make the relevant drug-label claims; (2) Merck’s
petitioning conduct was not a sham because it genuinely
sought and obtained that governmental action; and (3)
Appellees’ alleged antitrust injury flows from the FDA’s
discretionary decision to approve Merck’s drug-label
claims, not Merck’s private conduct. Accordingly, Merck
is entitled to summary judgment on the antitrust claim
because Noerr-Pennington immunity shields Merck from
liability for its alleged scheme to unlawfully raise the
17
As mentioned above, see infra note 12, other circuit courts
appear to recognize a standalone exception to Noerr-Pennington
immunity for fraudulent misrepresentation. Appellees expressly
disclaim reliance on that exception, and we read controlling precedent
to have expressly declined to adopt that exception, so we do not
address it.
-26aregulatory bar for competition by preserving false or
misleading claims on the FDA-approved drug label for
Merck’s mumps vaccine.18
III. CONCLUSION
For the reasons discussed above, we will reverse-inpart the District Court’s order and remand this case with
instructions to enter summary judgment for Merck.
SHWARTZ, Circuit Judge, dissenting.
This case presents an important question: should a
party who makes misrepresentations and material
omissions when petitioning the government be granted
antitrust immunity? I think not. As a result, I depart from
my colleagues and would affirm the District Court’s order
denying Merck summary judgment because a jury should
resolve factual disputes over whether Merck made
misrepresentations that preclude it from obtaining
Noerr-Pennington immunity for its petitioning activity. I
would also affirm because, even without considering
Merck’s petitioning activity, a reasonable jury could still
conclude that Merck engaged in anticompetitive conduct
by maintaining misrepresentations on its vaccine’s label
to protect its monopoly in the mumps vaccine market.1
18
Because we hold that Merck is shielded by Noerr-Pennington
immunity, we need not address whether there is a genuine dispute of
material fact about antitrust injury. See Ethypharm S.A. Fr. v. Abbott
Lab’ys, 707 F.3d 223, 232 n.17 (3d Cir. 2013) (antitrust standing does
not implicate Article III jurisdiction).
1
No party asserts that the vaccine is unsafe or ineffective.
-27aI
A
Under the Noerr-Pennington doctrine, “[a] party who
petitions the government for redress generally is immune
from antitrust liability.” Cheminor Drugs, Ltd. v. Ethyl
Corp., 168 F.3d 119, 122 (3d Cir. 1999). The doctrine is
rooted in the First Amendment’s right to free speech and
to petition the government for redress. See New W., L.P.
v. City of Joliet, 491 F.3d 717, 722 (7th Cir. 2007) (holding
Noerr-Pennington is “understood as an application of the
[F]irst [A]mendment’s [S]peech and [P]etitioning
[C]lauses”); see also E. R. R. Presidents Conf. v. Noerr
Motor Freight, Inc., 365 U.S. 127, 138-39 (1961) (holding
that subjecting a company’s “political activity” but “not
business activity” to the antitrust laws would be an
“unjustified” congressional invasion into the Bill of
Rights). Because, however, the First Amendment’s
Petitioning Clause does not tolerate abusing government
process, the Supreme Court has created the “sham
exception” to Noerr-Pennington Pro. Real Est. Invs., Inc.
v. Columbia Pictures Indus., Inc., 508 U.S. 49, 60-61
(1993) (“PRE”). This exception strips immunity from a
litigant whose petitioning activity is both (1) “objectively
baseless” and (2) subjectively motivated by
anticompetitive aims to abuse the governmental process.
Id.
Related to the notion that immunity should not be
conferred to disingenuous actors, some circuits have
recognized another exception to Noerr-Pennington
immunity known as the misrepresentation or fraud
-28aexception.2 This exception is based on the idea that a party
does not have a First Amendment right to misrepresent
2
Eight federal circuit courts have recognized or otherwise
suggested that a misrepresentation exception to Noerr-Pennington
exists, with some treating it as distinct from the sham exception and
others applying it as an exception within the sham exception. The
Courts of Appeal for the First, Fifth, Ninth, and Eleventh Circuits
have expressly recognized a distinct misrepresentation exception. See
Amphastar Pharms., Inc. v. Momenta Pharms., Inc., 850 F.3d 52, 56
(1st Cir. 2017) (“Noerr-Pennington immunity ... has a wellestablished exception for knowing misrepresentations, at least in the
administrative and adjudicatory contexts.” (internal quotation marks,
citation, and alteration omitted)); Kottle v. Nw. Kidney Ctrs., 146 F.3d
1056, 1062-63 (9th Cir. 1998); St. Joseph’s Hosp., Inc. v. Hosp. Corp.
of Am., 795 F.2d 948, 955 (11th Cir. 1986) (“When a governmental
agency ... is acting judicially” then “[m]isrepresentations ... do not
enjoy Noerr immunity.”); Woods Expl. & Producing Co. v.
Aluminum Co. of Am., 438 F.2d 1286, 1298 (5th Cir. 1971) (holding
that the filing of false documents related to requests to transport gas
to a state agency was not immunized because the “conduct was not
action designed to influence policy” and “abuse of the administrative
process ... does not justify antitrust immunity”). On different
occasions, the Court of Appeals for the Seventh Circuit has seemingly
treated the misrepresentation exception as both distinct from the
sham exception and incorporated therein. See U.S. Futures Exch.,
L.L.C. v. Bd. of Trade of the City of Chicago, Inc., 953 F.3d 955, 960
(7th Cir. 2020) (“Fraudulent misrepresentations made in an
adjudicative proceeding before an administrative agency are not
protected from antitrust liability.”); Mercatus Grp., LLC v. Lake
Forest Hosp., 641 F.3d 834, 843 (7th Cir. 2011) (explaining when “a
misrepresentation renders an adjudicative proceeding a sham”). The
Court of Appeals for the Sixth Circuit has applied the
misrepresentation as part of the sham exception. See Potters Med.
Ctr. v. City Hosp. Ass’n, 800 F.2d 568, 580-81 (6th Cir. 1986)
(“[K]nowing and willful submission of false facts to a government
agency falls within the sham exception to the Noerr-Pennington
doctrine. Such knowingly false submissions or intentional
misrepresentations constitute an abuse of government process[.]”
(internal citations omitted)). The Court of Appeals for the Fourth
-29amaterial facts while petitioning for government action
during an adjudicative proceeding. As the Court of
Appeals for the Ninth Circuit observed, a petitioner’s
misrepresentations to a government agency “deprive[s]
the entire [adjudicative] proceeding of its legitimacy.”
Kottle v. Nw. Kidney Ctrs., 146 F.3d 1056, 1062-63 (9th
Cir. 1998). The circuit courts that recognize the
misrepresentation exception derive it from the Supreme
Court’s suggestion in an antitrust case that
“[m]isrepresentations ... are not immunized when used in
the adjudicatory process.” Cal. Motor Transp. Co. v.
Circuit has noted that the exception may exist, but it did not reach the
issue as the plaintiff there failed to establish any material fraud or
deceit. See Balt. Scrap Corp. v. David J. Joseph Co., 237 F.3d 394, 40102 (4th Cir. 2001) (noting that whether a misrepresentation exception
to Noerr-Pennington exists is an open question, but that if one does,
“it extends only to the type of fraud that deprives [an adjudicative
proceeding] of its legitimacy”). Likewise, the Court of Appeals for the
District of Columbia Circuit, in determining whether NoerrPennington applied to certain common law tort claims outside of the
antitrust context, has suggested that the doctrine would not extend
immunity to an entity’s misrepresentations. See Whelan v. Abell, 48
F.3d 1247, 1254-55 (D.C. Cir. 1995) (“However broad the First
Amendment right to petition may be, it cannot be stretched to cover
petitions based on known falsehoods .... [A] knowing assertion of false
claims is not protected by Noerr-Pennington[.]”).
-30aTrucking Unlimited, 404 U.S. 508, 513 (1972).3, 4 For the
exception to apply, the misrepresentation must have been
(1) “intentionally made, with knowledge of its falsity[,]”
and (2) “material, in the sense that it actually altered the
outcome of the proceeding.” Mercatus Grp., LLC v. Lake
Forest Hosp., 641 F.3d 834, 843 (7th Cir. 2011) (citing,
inter alia, Cheminor, 168 F.3d at 124).
B
Although our Court has not expressly recognized a
misrepresentation exception, our precedent does not
foreclose it. Our caselaw counsels against tolerating a
party’s material misrepresentations in petitioning activity
during an adjudicative proceeding. In Cheminor, for
example, we declined to decide whether a
misrepresentation exception exists outside of the sham
exception but observed, within the confines of the sham
exception, that “a material misrepresentation that affects
the very core of a litigant’s ... case will preclude Noerr3
See also Cal. Motor Transp. Co., 404 U.S. at 513 (“There are
many [ ] forms of illegal and reprehensible practice which may corrupt
the administrative or judicial processes and which may result in
antitrust violations. Misrepresentations, condoned in the political
arena, are not immunized when used in the adjudicatory process ....
Insofar as the administrative or judicial processes are involved,
actions of that kind cannot acquire immunity by seeking refuge under
the umbrella of ‘political expression.’ ”). More than two decades later,
the Supreme Court again noted the possibility of a misrepresentation
exception. See PRE, 508 U.S. at 61 n.6 (“We need not decide here
whether and, if so, to what extent Noerr permits the imposition of
antitrust liability for a litigant’s fraud or other misrepresentations.”).
4
See supra note 1. Although Woods Explorati on & Producing
Co. was decided before California Motor, its view that NoerrPennington protects “action designed to influence policy” but not
“abuse of the administrative process” echoes California Motor. 438
F.2d at 1298.
-31aPennington immunity[.]” 168 F.3d at 124 (emphasis
omitted).
Less than four months after Cheminor, we made a
statement in Armstrong Surgical Center, Inc. v.
Armstrong County Memorial Hospital, that, read out of
context, could be viewed as foreclosing a
misrepresentation exception. See 185 F.3d 154, 162-63 (3d
Cir. 1999). Specifically, we stated that
the Sherman Act [ ] forecloses liability predicated
on anticompetitive injuries that are inflicted by
states acting as regulators. Liability for injuries
caused by such state action is precluded even
where it is alleged that a private party urging the
action did so by bribery, deceit or other wrongful
conduct that may have affected the decision
making process.
Id. Putting aside whether that dispute arose in the
legislative or adjudicative context,5 this quoted language
appears at the conclusion of the Court’s discussion of a
Supreme Court case that seemingly rejected a
misrepresentation
exception
in
legislative-type
proceedings, namely a zoning board’s enactment of an
ordinance. Id. at 161-62 (discussing City of Columbia v.
Omni Outdoor Advert., Inc., 499 U.S. 365 (1991)). Thus,
the Armstrong Court’s use of the phrase “states acting as
regulators” within its discussion of a state body acting in
a legislative context shows that it was speaking of
proceedings where an agency is engaged in promulgating
regulations, rather than where an agency enforces
regulations against a particular entity in a judicial-like
5
Armstrong involved antitrust claims that arose after the state
health department denied a medical practice a certificate of need that
was required to operate in the state. 185 F.3d at 156-57.
-32aadjudicative setting. Id. at 162. This matters because the
misrepresentation exception applies only to adjudicative,
as opposed to legislative, proceedings. See U.S. Futures
Exch., L. L.C. v. Bd. of Trade of the City of Chicago, Inc.,
953 F.3d 955, 960 (7th Cir. 2020); see also Cal. Motor
Transp. Co., 404 U.S. at 513 (distinguishing between the
“political arena” and an “adjudicatory process”).
Therefore, the above quoted language in Armstrong
reflects only the uncontroversial rule that there is no
misrepresentation exception in legislative proceedings,
which accords with our sister circuits.6
Accordingly, I would recognize a misrepresentation
exception to Noerr-Pennington the context of
adjudicative proceedings.
C
Because the misrepresentation exception applies only
in the adjudicative context, I consider next whether
Merck’s petitioning activity occurred in an adjudicative or
legislative proceeding. To determine whether a
proceeding is adjudicative or legislative for NoerrPennington immunity purposes, courts consider:
(1) the general nature of the authority exercised by
the agency; (2) the formality of the agency’s factfinding process; (3) the extent to which fact
gathering is subject to political influence; (4)
6
Moreover, a close reading of Armstrong shows that this
statement was dicta because the ultimate holding was based on the
absence of evidence to suggest that the misrepresentations there
were material, Armstrong Surgical Ctr., Inc., 185 F.3d at 163, and
thus the statement was not necessary for the Court’s holding. See
Tyler v. Cain, 533 U.S. 656, 663 n.4 (2001) (noting that dictum is “not
binding” and is different from a holding, with dictum not being
necessary to the end result (citation omitted)).
-33awhether the agency received any testimony under
oath, affirmation, or penalty of perjury; and (5)
whether the agency acted ultimately as a matter of
discretionary authority or instead acted in
accordance with more definite standards subject to
judicial review.
U.S. Futures Exch., L.L.C., 953 F.3d at 960; see also
Mercatus Grp., LLC, 641 F.3d at 844-48 (noting that
whether an agency is acting in an adjudicative or
legislative capacity is circumstance dependent).
The record here shows that Merck’s communications
with the FDA occurred in the adjudicative context.
Specifically, (1) the nature of the proceeding was similar
to a judicial proceeding in that the FDA was evaluating
the evidence to determine whether, and to what extent, to
impose sanctions on Merck; (2) the factfinding was
conducted by independent, subject-matter experts; (3) the
decision-making was made by unelected experts, not
subject to the whims of political pressure; (4) false
statements to the FDA are subject to criminal penalties,
see 18 U.S.C. § 1001; and (5) the threatened actions in the
FDA’s Warning Letter would have been subject to judicial
review, see 21 C.F.R. § 12.140 (procedures for judicial
review of the FDA Commissioner’s final decisions). See
U.S. Futures Exch., L.L.C., 953 F.3d at 960; cf. St.
Joseph’s Hosp., Inc. v. Hosp. Corp. of Am., 795 F.2d 948,
950-55 (11th Cir. 1986) (concluding that an antitrust case
based on alleged misrepresentations to a state licensing
authority could move forward because the agency acted
more judicially than legislatively).
Accordingly, because (1) there is a misrepresentation
exception to Noerr-Pennington immunity for petitioning
activity in adjudicative proceedings; (2) the exception may
-34aapply here because Merck’s communications with the
FDA occurred in an adjudicative setting; and (3) there are
factual disputes about whether Merck knowingly and
intentionally made material misrepresentations to the
FDA, I would affirm the order denying Merck summary
judgment and allow a jury to resolve those disputes and,
based upon those findings, allow the District Court to
determine whether an exception bars Merck from being
cloaked with Noerr-Pennington immunity.7 See Rock
River Commc’ns, Inc. v. Universal Music Grp., Inc., 745
F.3d 343, 352 (9th Cir. 2014) (noting that it is premature
and “not appropriate” to rule on exceptions to NoerrPennington “where the facts are disputed”
(characterizing Clipper Exxpress v. Rocky Mountain
Motor Tariff Bureau, Inc., 690 F.2d 1240, 1253-54 (9th
Cir. 1982))).
II
Separately, even if we were to ignore Merck’s
petitioning activity with respect to its Form 483, Warning
Letter, and BDPR communications with the FDA,8 the
remaining facts, viewed in Plaintiffs’ favor, provide a basis
for a reasonable jury to find that Merck engaged in
7
Although the briefing and oral argument focused on the sham
exception, the briefs mention the misrepresentation exception. Thus,
it is fairly before us, and “[w]e may affirm on any ground supported
by the record as long as the appellee did not waive – as opposed to
forfeit – the issue.” Montemuro v. Jim Thorpe Area Sch. Dist., 99
F.4th 639, 646 (3d Cir. 2024) (quotation marks, italics, and alteration
omitted). Moreover, Appellee’s suggestion that the misrepresentation
exception is not recognized in this Circuit was not a waiver as it was
not an “intentional relinquishment or abandonment of a known right”
because the statement was premised upon an incorrect understanding
of our precedent. Id. (internal quotation marks and citation omitted).
8
Merck seeks to invoke Noerr-Pennington immunity only for
these three activities.
-35aunlawful anticompetitive behavior.9 In short, the record,
viewed in Plaintiffs’ favor, shows that (1) Merck’s MMRII label was approved in the 1970s and was continually
used thereafter; (2) decades after the label was approved,
Merck learned that the public-facing label may not be
accurate with respect to the seroconversion rate10 and
potency/shelf-life claims,11 and withheld that information
from the public;12 and (3) Merck was reluctant to modify
the claims on its approved label because doing so would
make it easier for its competitor, GSK, to enter the
market and cut into Merck’s monopoly and profits.13
9
I am not treating Noerr-Pennington as an evidentiary rule, see
Majority Op. at *24, but rather, I am examining the record to
determine whether there is a basis for antitrust liability without
regard to Merck’s three FDA petitioning activities at issue in this
case.
10
Merck knew that data suggested that its mumps vaccine was
not providing the protection its label suggested against the types of
virus strains people would likely encounter.
11
Specifically, Merck’s internal documents show that it knew
that even after overfilling the vaccine, it could not guarantee that by
end-expiry its potency claims on its label would be accurate. Indeed,
Merck’s scientist who was tasked with developing the assay used to
support its label claims designed the assay with that goal in mind and
“without considering the impact on accuracy.” App. 5133-34.
Moreover, Merck acknowledged internally that there was no
correlation between the ELISA assay it designed and the results from
the more accurate PRN assay. Accordingly, there are factual disputes
about whether Merck’s label claims were supported by the science.
12
Merck was aware that the public would want to know this
information and that disclosure about sub-potent vaccine lots could
have resulted in a recall, vaccine tracing, and large numbers of
revaccinations.
13
See, e.g., App. 5031 (Merck presentation noting that “[r]elaxing
the criteria for success would lower the bar for the competition”); App.
5037 (Merck email noting “lowering the seroconversion rate in the
label would help GSK”); App. 5379 (Merck memo noting its decisions
-36aTherefore, focusing only on what Merck learned about
potential inaccuracies on its label after the label was
approved14 and its internal reaction to that data, including
about whether to pursue label and testing changes could “facilitate
licensure of Priorix”); App. 4962 (Merck report noting commercial
impacts of reducing shelf life); App. 7716 (Merck email noting
“concern if [GSK] has better sensitivity and higher seroconversion
rates – competition??”); App. 4840 (Merck Defense Action Plan noting
MMR-II was “under threat of significant change and disruption due
to” GSK); App. 4844 (Merck likewise noting MMR-II was “under
imminent threat”); App. 5195 (Merck acknowledging that Priorix'’s
licensure would “significantly increase competition”); App. 5291
(Merck noting its “defensive activity”); App. 4840-42 (Merck Defense
Action Plan Background); App. 5291-92 (Merck email regarding
strategy in light of GSK licensing efforts).
For every month that Merck maintained its monopoly by
keeping GSK out of the market, it earned an additional $10 million in
revenue. In light of Merck'’s financial interest in keeping GSK out of
the market, a reasonable jury could conclude that Merck knowingly
stood by its label'’s misrepresentations to (1) make it harder for GSK
to gain FDA approval and thus (2) thwart competition. Evidence that
GSK paused developing its MMR vaccine after it could not mirror
Merck'’s label corroborates such a conclusion. To be sure, other
factors could have contributed to the GSK vaccine'’s pause, e.g.,
budget constraints. However, a jury could reasonably conclude that
GSK'’s budget would not have been prohibitively constrained were it
not for extra-high costs of matching Merck'’s misleading label.
Accordingly,
a
jury
should
decide
whether
Merck'’s
misrepresentations or omissions, or GSK'’s own business decisions,
delayed GSK'’s entry into the market.
14
Plaintiffs do not assert that Merck made any knowing
misrepresentations in connection with its FDA communications
associated with the original approval of MMR-II. Nor do they do not
seek to hold Merck liable for any petitioning activity arising from
those communications. This is a critical distinction because Merck'’s
decision to continue to include misrepresentations on its public-facing
label is divorced from any petitioning activity associated with the
label'’s original approval as the misrepresentations and omissions at
issue here occurred only after the label was already approved.
-37awithholding information about the label’s inaccuracies
from the public to protect Merck’s monopoly,15 the record
viewed in Plaintiffs’ favor would permit a reasonable jury
to find that Merck violated the antitrust laws by engaging
in anticompetitive acts that are “on some basis other than
the merits.” LePage’s Inc. v. 3M, 324 F.3d 141, 147 (3d
Cir. 2003) (en banc).16
Therefore, the original petitioning activity is independent from
Merck'’s decision to maintain its label for the express purpose of
preventing GSK from entering into the mumps vaccine market.
15
See, e.g., App. 5506 (Merck email noting data suggested it
would “need to get [a] label change”).
16
Additionally, viewing the facts in Plaintiffs’ favor, a reasonable
jury could find that Merck’s actions caused Plaintiffs’ injuries because
(1) GSK was clearly “willing and able to supply [Priorix] but for
[Merck’s] exclusionary conduct[,]” Meijer, Inc. v. Biovail Corp., 533
F.3d 857, 862 (D.C. Cir. 2008); and (2) Plaintiffs’ injury—lack of price
erosion and therefore higher prices for the mumps vaccine—was
directly related to Merck’s successful efforts to keep GSK out of the
marketplace. Moreover, contrary to my Colleagues’ assertion, see
Maj. Op. at *27, a reasonable jury viewing the facts in Plaintiffs’ favor
could conclude that the need for the FDA to approve a license for
GSK’s vaccine before GSK could enter the market does not break the
chain of causation because (1) the FDA was not an intervening actor
because GSK put its licensing efforts on hold due in part to the
challenges it faced mirroring Merck’s allegedly misleading label even
before going through the FDA approval process; and (2) GSK’s
delayed market entry, based on the FDA’s requirement that it mirror
Merck’s label claim, was a foreseeable consequence of Merck’s alleged
label misrepresentations, see In re Flonase Antitrust Litig., 798 F.
Supp. 2d 619, 629 (E.D. Pa. 2011) (“Intervening conduct does not
sever the chain of causation [ ] where that conduct was in turn
proximately caused by the defendant’s antitrust violation.
Intervening conduct also does not sever the chain of causation where
that conduct was a foreseeable consequence of the original antitrust
violation.”); see also In re Suboxone Antitrust Litig., 622 F. Supp. 3d
22, 78 (E.D. Pa. 2022) (same). The jury may also consider whether the
actions of the FDA broke the chain of causation.
-38aIII
For the foregoing reasons, I would affirm the District
Court’s order denying Merck summary judgment and as
a result, respectfully dissent.
-39aAppendix B
___________________
IN THE UNITED STATES DISTRICT COURT
FOR THE EASTERN DISTRICT OF
PENNSYLVANIA
IN RE: MERCK
MUMPS VACCINE
ANTITRUST
LITIGATION
THIS DOCUMENT
RELATES TO:
ALL ACTIONS
:
:
:
:
:
:
:
:
:
:
CIVIL ACTION
Master File No. 12-3555
MEMORANDUM
Kenney, J.
July 27, 2023
Chatom Primary Care, P.C., Andrew Klein, M.D., and
John I. Sutter, M.D. (collectively, “Plaintiffs”) bring this
proposed class action on behalf of direct purchasers of
Defendant Merck & Co., Inc.’s (“Merck”) mumps
vaccines. Plaintiffs’ remaining claims allege that they
were overcharged for Merck’s mumps vaccines as a result
of Merck’s unlawful monopolization of the Mumps Vaccine
Market in violation of Section 2 of the Sherman Act and
New Jersey and New York state laws. Plaintiffs’ case
arises from the same underlying allegations of fraud that
spawned the related False Claims Act (“FCA”) case, U.S.
ex rel. Krahling v. Merck & Co., Inc., 10-cv-4374 (E.D.
Pa.). Presently before the Court are Merck’s Motion for
Summary Judgment (ECF No. 272) and Merck’s Motion
-40ato Exclude Evidence from Dr. Thomas Copmann
Pursuant to Federal Rule of Evidence 702 and Daubert
(ECF No. 305). These motions have been fully briefed.
For the reasons set forth below, Merck’s Motion for
Summary Judgment is granted in part and denied in part,
and Merck’s Motion to Exclude Evidence from Dr.
Thomas Copmann is denied. An appropriate Order will
follow.
I. BACKGROUND
This Section will begin by providing a brief overview of
the vaccine approval process in the United States. Then
the Court will discuss Merck’s mumps vaccines, mumps
cases in the United States following the introduction of a
vaccine, GlaxoSmithKline’s (“GSK”)1 mumps vaccines,
Merck’s alleged unlawful conduct, and finally, GSK’s path
to approval of its mumps vaccine. The facts set forth in this
Section are derived from the undisputed evidence of
record submitted by the parties and the disputed evidence
of record viewed in the light most favorable to Plaintiffs.2
1
GSK was previously known as “SmithKlineBeecham,” “SKB,”
or “SB.” See ECF 295 at 8 n.5.
2
The Court notes that in response to many of the facts Plaintiffs
put forth in their Corrected Statements of Disputed Material Facts
concerning Merck’s alleged anticompetitive conduct, Merck did not
admit or dispute the facts, but rather, claimed the facts “do not bear
on the issues material to Merck’s Motion for Summary Judgment.”
See ECF No. 301 at 1. The Court finds Merck’s position that its
purported unlawful conduct is not material to the arguments
contained in its Motion for Summary Judgment unconvincing. For
example, Merck’s first argument is that even if Merck had submitted
fraudulent information to the government, this amounts to petitioning
activity that is protected from antitrust liability under the NoerrPennington doctrine. However, Merck refused to admit or dispute
the facts relating to those submissions to the government. Given the
fact that Merck incorporated by reference its Motions for Summary
-41aA. The Vaccine Approval Process in the United
States
Bringing a vaccine to market in the United States is an
expensive, complex, and rigorous endeavor. In order to
sell a vaccine in the United States, Food and Drug
Administration (“FDA”) approval and licensure are
required. ECF No. 274 ¶ 58; ECF No. 277 ¶ 58. In deciding
whether to license a vaccine, the FDA assesses the
vaccine’s safety, efficacy, manufacturing, and product
labeling. ECF No. 274 ¶ 60; ECF No. 277 ¶ 60. As to safety
and efficacy, the FDA bases its analysis on three phases
of clinical trials. ECF No. 274 ¶ 61; ECF No. 277 ¶ 61.
However, before beginning any clinical trials, a
pharmaceutical
manufacturer
must
submit
an
Investigational New Drug application (“IND”) to the
FDA. ECF No. 274 ¶ 62; ECF No. 277 ¶ 62. An “IND
describes the vaccine, the method of manufacture, []
quality control tests for release, [and also] . . . information
about the vaccine’s safety and ability to elicit a protective
immune response (immunogenicity) in animal testing, as
well as the proposed clinical protocol for studies in
humans.” Id. Thereafter, three phases of clinical trials
proceed as follows. In Phase I, “small groups of people
receive the trial vaccine.” ECF No. 274 ¶ 61; ECF No. 277
¶ 61. “In Phase II, the clinical study is expanded and [the]
vaccine is given to people who have characteristics (such
as age and physical health) similar to those for whom the
new vaccine is intended.” Id. Finally, “[i]n Phase III, the
vaccine is given to thousands of people and tested for
Judgment in the FCA Action, many of the facts can be deemed
undisputed. See ECF No. 273 at 9 n.1. In any event, the Court must
view the evidence in the light most favorable to the nonmoving party
and it will do so as to those facts Merck did not admit or dispute.
-42aefficacy and safety.” Id. Once these three phases are
completed, manufacturers submit a Biologics License
Application (BLA) to the FDA for approval of the vaccine
for use in the United States. ECF No. 274 ¶ 73; ECF No.
277 ¶ 73.
B. Merck’s Mumps Vaccines
Merck was the first licensed mumps vaccine provider
in the United States and the sole licensed mumps vaccine
provider in the United States from 1967 until June 2022,
when the FDA licensed GSK’s mumps vaccine. ECF No.
267 ¶ 1; ECF No. 277 ¶ 1; FDA, June 3, 2022 Approval
Letter
–
PRIORIX,
https://www.fda.gov/media/158962/download (last visited
July 25, 2023). Currently, Merck sells two vaccines which
contain a mumps component: MMR-II and ProQuad. ECF
No. 267 ¶ 2; ECF No. 277 ¶ 2. MMR-II was licensed in the
United States in 1978 and is a trivalent product containing
vaccines for measles, mumps, and rubella (“MMR”). ECF
No. 267 ¶ 1; ECF No. 277 ¶ 1. ProQuad was licensed in the
United States in 2005 and is a quadrivalent product
containing vaccines for measles, mumps, rubella, and
varicella (chicken pox) (“MMRV”). Id.
C. Mumps Cases Following a Vaccine
The CDC reports that after Merck introduced the
mumps vaccine in 1967, mumps cases in the United States
decreased by more than 99%. ECF No. 274 ¶ 7; ECF No.
277 ¶ 7. Specifically, mumps cases decreased “from
152,209 in 1968 to 231 in 2003.” CDC, Mumps Cases &
Outbreaks, https://www.cdc.gov/mumps/outbreaks.html
(last visited July 25, 2023). Notably, however, “mumps
cases and outbreaks reported in the United States have
increased since 2006” with most of these cases involving
-43apeople who were vaccinated.3 Id. The CDC currently
reports that two doses of the mumps vaccine are 88%
(range 31% to 95%) effective at preventing mumps. ECF
No. 274 ¶ 6; ECF No. 277 ¶ 6. In April 2019, the director
of the FDA’s Center for Biologics Evaluation and
Research (“CBER”) issued a statement reaffirming that
the FDA “work[s] diligently to assess safety and
effectiveness of all licensed vaccines for their intended
uses [and] [t]he MMR vaccine is very effective at
protecting people against measles, mumps, and rubella.”
ECF No. 275-8 at 3.
D. GSK’s Mumps Vaccines
GSK, like Merck, manufactures two mumpscontaining vaccines. First, GSK manufactures Priorix, an
MMR (measles, mumps, rubella) vaccine, which was first
licensed for sale in Europe in 1998 and was then licensed
in the United States in 2022.4 ECF No. 274 ¶¶ 49, 52; ECF
3
According to the CDC, in 2006, 6,584 cases of mumps were
reported in the United States. In 2007, there were 800 reported cases
of mumps. In 2008, 454 cases were reported. In 2009, 1,991 cases were
reported. In 2010, 2,612 cases were reported. In 2011, 404 cases were
reported. In 2012, 229 cases were reported. In 2013, 584 cases were
reported. In 2014, 1,223 cases were reported. In 2015, 1,329 cases
were reported. In 2016, 6,366 cases were reported. In 2017, 6,109
cases were reported. In 2018, 2,251 cases were reported. In 2019,
3,780 cases were reported. In 2020, 616 cases were reported. In 2021,
154 cases were reported. In 2022, 322 cases were reported. See CDC,
Mumps
Cases
&
Outbreaks,
https://www.cdc.gov/mumps/outbreaks.html (last visited July 25,
2023); see also ECF No. 277 ¶ 7 n.3.
4
In June 2022, after the conclusion of briefing for the present
motions, but prior to oral argument, the FDA approved GSK’s Priorix
vaccine. See FDA, June 3, 2022 Approval Letter – PRIORIX,
https://www.fda.gov/media/158962/download (last visited July 25,
2023).
-44aNo. 277 ¶¶ 49, 52. Second, GSK manufactures PriorixTetra, an MMRV (measles, mumps, rubella, varicella)
vaccine, which is licensed outside the United States. ECF
No. 274 ¶¶ 50–51; ECF No. 277 ¶¶ 50–51. The mumps
strain contained in GSK’s Priorix and Priorix-Tetra
vaccines is derived from the mumps strain in Merck’s
mumps-containing vaccines. ECF No. 274 ¶ 54; ECF No.
277 ¶ 54. GSK does not view the mumps component in
Priorix as different from the mumps component in
Merck’s MMR-II, and GSK’s clinical studies show that
GSK’s mumps component is noninferior to Merck’s
mumps component. ECF No. 274 ¶ 57; ECF No. 277 ¶ 57.
In the FDA’s Summary Basis for Regulatory Approval of
Priorix, the Review Committee confirmed this, finding:
“In clinical studies, vaccine-specific antibody responses to
measles, mumps, and rubella viruses following
administration of PRIORIX were shown to be noninferior to antibody responses induced by the licensed MM-R II vaccine.” FDA, June 3, 2022 Summary Basis for
Regulatory
Action
for
PRIORIX,
https://www.fda.gov/media/159545/download (last visited
July 25, 2023).
E. Merck’s Alleged Anticompetitive Conduct
Based on the allegations in the related FCA case,
Plaintiffs contend that Merck’s submissions to the FDA
and, in turn, its labels for its mumps vaccines contain false
and misleading information related to the efficacy and
seroconversion rates of Merck’s mumps vaccines and
because of this conduct, Merck precluded GSK from
obtaining a license to sell its MMR vaccine and caused
Plaintiffs to be overcharged. See generally Amended
Complaint, ECF No. 26. Outlined below is an overview of
the specific evidence relating to Merck’s competitive
-45aintelligence regarding GSK’s potential entrance into the
Mumps Vaccine Market and Merck’s alleged false and
misleading conduct as to its mumps vaccines.
1. Merck Learns of GSK’s Potential Entrance
In the late 1990s, Merck recognized that MMR-II was
under “imminent threat of a major competitive launch” in
the United States from GSK’s Priorix. ECF No. 295-1 ¶
31; ECF No. 301 ¶ 31; see also ECF No. 286, Ex. 81.
Internal Merck documents reveal that in the face of GSK’s
impending launch, in 1996, Merck established a
“Competitive Defense Task Force for M-M-R II.” ECF
No. 295-1 ¶ 32; ECF No. 301 ¶ 32; ECF No. 286, Ex. 81.
These documents indicate that the marketing elements for
the MMR-II Competitive Defense Task Force were to: (1)
“Pursue a proactive tactical plan including initiatives to
delay and disrupt the launch of Priorix into the market”;
(2) “Launch a marketing and positioning plan to maintain
the [MMR-II] advantage by preserving share in priority
segments and emphasizing the long-term safety and
efficacy profile”; and (3) “Set the stage for a new product
platform including the use of recombinant albumin and the
introduction of MMRV.” ECF No. 286, Ex. 81 at MRKCHA00285279. In June 1999, the Competitive Defense
Task Force for MMR-II reported that since the Task
Force was created in 1996, the “team has succeeded in
‘raising the bar’ for the competition at every available
opportunity including a successful presentation to CBER
in January [and] [a]lthough, we will probably never know
whether that presentation had the effect of raising issues
for the Priorix file, we do know that [GSK] will most likely
not launch in the U.S. until 4Q99.” Id. at
MRKCHA00285278.
-46a2. Merck Mumps Vaccine Label Claim Issues
In the late 1990s, around the same time Merck learned
of GSK’s imminent threat of launch in the United States,
Merck and CBER engaged in discussions concerning the
potency figure on Merck’s mumps label. ECF No. 295-1 ¶
36; ECF No. 301 ¶ 36. At that time, the MMR-II label
specified that “the dose . . . contains not less than . . . 20,000
TCID50 of the . . . Mumps Virus” (the “Potency Claim”).
Id. TCID stands for Tissue Culture Infectious Dose and is
a measure of vaccine potency (i.e., the volume of live cells
in the vaccine), which vaccine manufacturers and the FDA
typically convert to a log10 scale. Id. Thus, the potency on
the label equated to 4.3 on a log10 scale. ECF No. 295-1 ¶
37; ECF No. 301 ¶ 37. During Merck’s communications
with CBER, it became evident that “the agency did not
agree with [Merck’s] proposal that the specifications
noted in [Merck’s] label were the minimum release
potencies for [MMR-II]. Instead, [CBER] defined these
specifications as end-expiry potencies,” meaning it wanted
the labeled potency to be the amount of live virus in the
vaccine at the end of its shelf life, which for MMR-II has
always been 24 months. ECF No. 295-1 ¶ 36; ECF No. 286,
Ex. 82 at MRK-CHA00207706. Accordingly, as an interim
measure to comply with CBER’s request, Merck
“overfilled” its mumps vaccines (i.e., put more live virus in
each dose) in order to ensure that the vaccine would
comply with the 4.3 log10 potency claim at the end of the
24-month shelf life. ECF No. 295-1 ¶ 41. Merck continues
to overfill each mumps vaccine dose to this day. Id.
In 2000, after Merck implemented the “overfill,” FDA
inspectors visited Merck’s manufacturing division and
-47aissued a Form 483,5 which cited Merck’s failures in
reporting mumps vaccines lots that fell below the potency
claim prior to the expiry of the 24-month shelf life. ECF
No. 295-1 ¶ 42. Merck submitted a response to the Form
483, but the issues identified in the Form 483 were raised
again by the FDA in a February 9, 2001, Warning Letter.
ECF No. 295-1 ¶ 42; ECF No. 295-1 ¶ 42. A Warning
Letter is issued to a manufacturer when the “FDA finds
that a manufacturer has significantly violated FDA
regulations.” FDA, About Warning and Close-Out
Letters,
https://www.fda.gov/inspections-complianceenforcement-and-criminalinvestigations/warningletters/about-warning-and-close-out-letters (last visited
July 25, 2023). The February 2001 Warning Letter
indicated that “investigators reported that the data in
[Merck’s] files showed that a number of . . . lots
manufactured before the formulation was changed during
February 2000 failed to meet the minimum potency
specification.”
ECF
No.
286,
Ex.
124
at
MRKCHA00209402. The Warning Letter directed Merck
to “submit an analysis of Mumps stability data describing
the range of potencies you would expect the various
Mumps Vaccine products to reach at the two-year
expiration date.” Id. In creating this analysis, the FDA
directed Merck to “assume the initial potency is the
minimum release potency specification that was in effect
5
“An FDA Form 483 is issued to firm management at the
conclusion of an inspection when an investigator(s) has observed any
conditions that in their judgment may constitute violations of the
Food Drug and Cosmetic (FD&C) Act and related Acts.” FDA, FDA
Form
483
Frequently
Asked
Questions,
https://www.fda.gov/inspections-compliance-enforcement-andcriminalinvestigations/inspection-references/fda-form-483frequently-asked-questions (last visited July 25, 2023).
-48abefore 2000” and “summarize the available data regarding
product efficacy at the lower end of this potency range.”
Id. In concluding, the Warning Letter stated that
“[f]ailure to promptly correct these deviations may result
in regulatory action without further notice” which could
include “license suspension and/or revocation.” Id.
In developing its response to the Warning Letter,
Merck internally identified it had, prior to increasing the
release potency, released to market 225 lots of MMR-II
that had an end-expiry potency potentially lower than 4.3
log10 minimum mumps potency specification, with 107 of
these lots being “a compliance issue,” as they were
projected to, at 24 months, fall below 4.0 log10.6 ECF No.
295-1 ¶ 43; ECF No. 286, Ex. 128. Merck instituted a “Fact
Finding” (“a prelude to a potential product recall”) to
track down all 107 lots that were a potential compliance
issue. ECF No. 286, Ex. 128. While drafts of Merck’s
Warning Letter response referenced these “sub-potent
lots,” Merck’s final version of its response did not
specifically mention these lots. ECF No. 295-1 ¶ 46; see
also ECF No. 286, Ex. 130 (draft 2001 Warning Letter
Response); ECF No. 286, Ex. 131 (draft 2001 Warning
Letter Response); ECF No. 286, Ex. 132 (Merck’s Mar. 8,
2001 Response to February 2001 Warning Letter).
Instead, Merck responded to the FDA’s Warning Letter
by explaining:
6
While Merck’s email discussing the issue and its working drafts
of its response to the February 2001 Warning Letter reference 223
lots being at risk of falling below 4.3 log10 and of those 223, 106 lots
being at risk for falling below 4.0 log10, Plaintiffs point out that the
spreadsheet attached to the email identifies 255 and 107 lots,
respectively. See ECF No. 295-1 ¶ 43 n.78.
-49a[I]f it is assumed that the initial potency is 4.3 log
TCID50/dose, the minimum release potency specification
in effect prior to February 2000, the expected average
potency at expiry is 3.6 log TCID50/dose. In order to
estimate the range of potencies around the average loss
rate, the standard deviation of the loss rate was calculated
and found to be 0.3 logs. Therefore, the 95% upper and
lower confidence limits for mumps potency at the end of a
two year expiry is estimated to be 3.9 and 3.3 log
TCID50/dose, respectively.
ECF No. 132 at MRK-CHA01537609. In March and
April of 2001, Merck sent the FDA two Biologics Product
Deviation Reports (“BPDRs”), reporting similar potency
problems, but represented that the “overfill” solved the
issue. ECF No. 295-1 ¶ 48; ECF No. 292, Ex. 269 (March
2001 BPDR), Ex. 270 (April 2001 BPDR). In April 2001,
the FDA closed its Warning Letter without requiring any
lots to be withdrawn from the market. ECF No. 302 at 15–
16.
Internal correspondence in 2002 at Merck indicates,
however, that Merck’s “corrective actions (adding more
mumps and increasing the release specification) did not
ensure [Merck met] 4.3/dose at expiry as previously
indicated.” ECF No. 295-1 ¶ 48; ECF No. 287, Ex. 137.
Instead, Merck calculated that “approx. 7% of the lots
[were] expected to be <4.3 at expiry.” Id. Merck
questioned whether the FDA would have responded
differently if it knew about the potency values below
4.3/dose. Id. Additional internal documents and
correspondence from this time indicate that if Merck’s
potency claim were to remain at 4.3 log10 at expiry, the
shelf life would need to be changed to 12 months or less,
but that such adjustment would have a commercial impact,
-50aincluding “[i]nternational loss of share due to a
competitive disadvantage ([GSK’s proposed vaccine is] at
24 months).” ECF No. 295-1 ¶ 50; see also e.g., ECF No.
287, Ex. 140.
Apart from implementing the overfill in 1999,
beginning in 1997, Merck also discussed with the FDA
conducting a clinical trial to support a label change of a
mumps end-expiry potency lower than 4.3 log10. ECF No.
295-1 ¶ 57. This clinical trial would become known as
Protocol 007, officially titled “A Study of M-M-R II at
Mumps Expiry Potency in Healthy Children 12-18
Months of Age.” ECF No. 295-1 ¶ 57. Two types of tests
were used in Protocol 007: (1) a plaque reductions
neutralization assay (“PRN”) and (2) an enzyme linked
immunosorbent assay (“ELISA”). Both of these tests are
used to measure immunogenicity, which provides
information about how a subject’s immune system
responds to different stimuli, including vaccination. ECF
No. 295-1 ¶¶ 4–6; see also, e.g., ECF No. 283 at 208. The
most common immunological response evaluated in
vaccine studies is the development of antibodies induced
by the vaccine. ECF No. 295-1 ¶ 4. One way to measure
immunogenicity is “seroconversion,” which refers to a
person going from being “seronegative” prior to
vaccination, which generally means lacking pathogen
specific antibodies, to being “seropositive” after
vaccination, which means possessing such antibodies. Id.
a) The PRN
A PRN indirectly measures antibodies based on their
capacity to neutralize the virus of interest. ECF No. 2951 ¶ 7. A PRN is considered a functional immunogenicity
assay—meaning it evaluates the functioning of the
antibodies, not merely their presence. ECF No. 283 at 210.
-51aIn a PRN, a blood serum is incubated with the virus in a
clear well (i.e., a container). ECF No. 295-1 ¶ 8. If the virus
is not neutralized, the virus causes “plaques” (or holes) in
the cells. Id.; see also ECF No. 283 at 293–94. The theory
is that if the test sample has neutralizing antibodies, they
will prevent the virus from infecting the cells, meaning
there would be fewer plaques. ECF No. 283 at 294. In the
Protocol 007 PRN, pre-vaccinated serum samples are
compared to post-vaccinated serum samples to determine
if, as a result of vaccination, the child could be said to have
seroconverted. ECF No. 295-1 ¶ 8. The PRN in Protocol
007 was designed to compare seroconversion rates across
higher and lower potencies. ECF No. 295-1 ¶ 58. CBER
set two statistical criteria that the experimental groups
had to meet in order to consider the lower potency
acceptable as compared to the existing potency. ECF No.
286, Ex. 95 at MRK-CHA00001468. First, the
seroconversion rate in the group receiving the candidate
end-expiry potency could not be more than 5% less than
the seroconversion rate in the group receiving the control,
and second, the lower limit of the confidence interval of
the seroconversion rate in the group receiving the
candidate end-expiry potency would have to be above 90%.
Id.
Initially, Merck engaged in initial testing using its
mumps virus strain (i.e., the Jeryl Lynn strain) and other
“wild-type” virus strains, meaning those naturally
occurring. ECF No. 295-1 ¶ 62. However, initial testing of
the wild-type virus resulted in seroconversion rates well
below 95%, so Merck used the Jeryl Lynn strain, which
was yielding seroconversion above 90%. Id. Additionally,
Merck included rabbit antibodies, specifically anti-human
Immunoglobin G (“antiIgG”) in the serum samples. ECF
-52aNo. 295-1 ¶ 65. This anti-IgG PRN was referred to as the
AntiIgG Enhanced Neutralization Test (“AIGENT”). Id.
After finalizing the design of the PRN, Merck
performed the AIGENT in a research lab supervised by
Dr. David Krah. ECF No. 295-1 ¶¶ 73–74. According to
the relators in the related FCA case, Dr. Krah directed his
lab staff to selectively recount pre-positive samples and
change pre-positive samples to make them pre-negative,
and also directed his staff to falsify data. Id. ¶ 74. Once the
FDA was made aware of these allegations, FDA
investigated and issued a Form 483, listing among other
observations that “raw data [was] being changed with no
justifications.” Id. ¶ 80; see also ECF No. 289, Ex. 219
(August 6, 2001 Form 483).
b) The ELISA
The second test that was performed as part of Protocol
007 was an ELISA. In an ELISA, serum samples are
added to a plastic microtiter wells coated with antigens—
which are structures that bond to particular antibodies.
ECF No. 283, Ex. 55 (Pasetti Report). If the serum
contains antigen-specific antibodies, those antibodies bind
to the antigens, triggering a secondary reaction that
changes the color of the solution. Id. This color can be
measured by a device called a spectrophotometer to
determine whether or not there has been sufficient color
change to identify a positive result. Id.
c) Merck’s MMR-II sBLA
Initially, to be allowed to support a supplemental
Biologics License Application (“sBLA”) to lower the
minimum mumps potency specification on the MMR-II
label with the Protocol 007 testing, Merck was instructed
by the FDA to demonstrate a correlation between the
-53aresults of Merck’s ELISA and AIGENT tests. ECF No.
295-1 ¶ 70. Based on the data produced in the Protocol 007
study, Merck submitted an sBLA in January 2004
requesting a lower potency figure on its label. ECF No.
283, Ex. 39 (Kessler Report) ¶ 330. In 2007, CBER
determined that “the information and data submitted are
inadequate for final approval.” Id. ¶ 333. CBER also
noted: “[h]owever, the science related to immunogenicity
of [MMR II] has substantially evolved since our initial
testing requirements [and] use of ELISA data to evaluate
the effect of difference in product potency is now
acceptable.” Id. ¶ 336. In response, Merck submitted an
amendment providing additional information, including
data from the Protocol 007 ELISA and ELISA data from
previous Merck studies. In December 2007, the FDA
approved Merck’s sBLA to change the labeled potency
from 4.3 to 4.1 log10 TCID50. Id.
d) Merck’s ProQuad BLA
In August 2004, Merck submitted its ProQuad BLA.
ECF No. 283, Ex. 39 (Kessler Report) ¶ 330. To support
this application, Merck used data from Protocol 007 and
provided information about the correlation between the
PRN and the ELISA from Protocol 007. ECF No. 288, Ex.
183 ¶ 116. In September 2005, the FDA approved Merck’s
ProQuad BLA. Id. ¶ 332.
F. GSK’s Path to FDA Approval
To obtain approval of its mumps vaccine, GSK
understood that it needed to conduct headto-head clinical
trials to study the immunogenicity and safety of MMR-II
versus Priorix and demonstrate that Priorix was noninferior to MMR-II. ECF No. 274 ¶¶ 63, 65; ECF No. 277
¶¶ 63, 65. Accordingly, as GSK’s corporate designee
testified, the clinical development plan for Priorix was
-54abased on mirroring Merck’s label. ECF No. 295-1 ¶ 131;
ECF No. 301 ¶ 131. GSK understood this process would
be very costly and time-consuming. ECF No. 274 ¶¶ 63,
65; ECF No. 277 ¶¶ 63, 65. For the Phase III clinical trials
for Priorix, the FDA required GSK to conduct five
separate studies: four non-inferiority studies and one
safety study. ECF No. 274 ¶ 66; ECF No. 277 ¶ 66. As
GSK explained, clinical trials involving children typically
cost a minimum of $10 million and involve more
burdensome documentation compared to clinical trials
with only adults. ECF No. 274 ¶ 67; ECF No. 277 ¶ 67.
GSK began this process in July 1997 when it submitted
an IND to the FDA to begin clinical trials for Priorix. ECF
No. 274 ¶ 68; ECF No. 277 ¶ 68. However, in August 1997,
the FDA put GSK’s Priorix program “on clinical hold” due
to concerns, including about GSK’s safety data, indicating
that the FDA needed additional data concerning
“neurovirulence testing, the ELISA assay used to
determine seronegativity and the reverse transcriptase
assay testing of the viral seed and viral bulk.” ECF No.
274 ¶ 69, ECF No. 277 ¶ 69; ECF No. 280-1 at 220; ECF
No. 275-19 at 2. Thereafter, in March 1998, the FDA sent
GSK a letter with fifty-two comments on GSK’s proposed
clinical development plan for Priorix. ECF No. 274 ¶ 70;
ECF No. 277 ¶ 70. GSK internally summarized the FDA’s
comments as criticisms of its proposed United States IND
study, including the proposed study’s design and the types
of assays to be used to test each vaccine component, and
criticisms concerning other studies to be submitted in its
BLA, including the quality of data derived from GSK’s
clinical testing outside the United States, the safety of the
mumps strain, and the sample sizes of those studies. Id.
Following discussions between the FDA and GSK, in June
-55a1998, the FDA lifted the clinical hold. ECF No. 274 ¶ 71;
ECF No. 277 ¶ 71; ECF No. 280-1 at 227, 233.
Nonetheless, discussions between the FDA and GSK
concerning the clinical development of Priorix continued
with the FDA requesting information on, inter alia,
vaccine lots, documentation of the measles virus strain
development, and how GSK intended to validate assays
used to test the measles, mumps, and varicella
components. ECF No. 274 ¶ 72; ECF No. 277 ¶ 72. In
March 1999, the FDA denied GSK’s request for a “preBLA meeting,” which typically occurs before a
manufacturer submits a final BLA for vaccine approval.
ECF No. 274 ¶ 73; ECF No. 277 ¶ 73. GSK believed the
FDA denied their request for the pre-BLA meeting
because the “FDA does not consider [the] safety database
as acceptable” and “FDA needs [an] additional safety
study.” ECF No. 275-23 at 5. Then, in October 1999, GSK
internally reported that the FDA’s decision to require an
additional safety study remained unchanged. ECF No.
275-13 at 11; ECF No. 274 ¶ 76; ECF No. 277 ¶ 76. GSK
estimated that this safety study requested by the FDA
would cost between $10 million to $20 million, and GSK
wanted to “avoid” conducting such a large safety study.
ECF No. 275-25 at 5–6; ECF No. 274 ¶¶ 75, 77; ECF No.
277 ¶¶ 75, 77. Comments from the FDA during this time
period also indicate that the FDA required additional
information on mumps serology. ECF No. 295-1 ¶ 137;
ECF No. 301 ¶ 137; ECF No. 295-13 at 10–11.
Thereafter, between 2000 and 2001, GSK deprioritized
development of its MMR vaccine. ECF No. 295-1 ¶ 139;
ECF No. 301 ¶ 139. The reason for this de-prioritization
was that Merck’s MMRV vaccine, ProQuad, was expected
to be on the market in 2001, and accordingly, GSK wanted
-56ato wait until the position of Merck with respect to MMRV
was clear. ECF No. 274 ¶ 78; ECF No. 277 ¶ 78. GSK
planned to follow Merck’s progress and if Merck’s MMRV
succeeded, GSK would revive its development of MMRV,
but if Merck’s MMRV failed, it would prioritize Priorix.
ECF No. 247 ¶ 80; ECF No. 277 ¶ 80. Evidence from
GSK’s documents indicates that it would cease all work
during the two-year period except it would address
outstanding MMR and Varicella IND questions, answer
FDA questions on neurovirulence, continue to work on the
level of serology in order to validate its mumps and
varicella assays for future U.S. trials, and conduct certain
neurovirulence testing. ECF No. 275-28 at 19.
In March 2002, GSK completed a risk assessment for
the development of Priorix and Priorix-Tetra in the
United States, and its marketing team recommended GSK
“[p]ursue MMRV” and “[r]e-address MMR only if MMRV
has proven not viable from a development perspective.”
ECF No. 274 ¶ 81; ECF No. 277 ¶ 81; ECF No. 275-31 at
11. GSK estimated that it would cost $33.1 million to
develop MMR, $34.8 million to develop MMRV, and a
combined $23.2 million in additional costs across both
products. ECF No. 274 ¶ 81; ECF No. 277 ¶ 81. But in
2003, GSK’s United States development of Priorix was put
on hold due to business reasons and GSK stated it would
revisit in the end of 2004 in light of study results and
competitive intelligence status. ECF No. 275-33 at 4; ECF
No. 275-34 at 7; ECF No. 274 ¶ 83; ECF No. 277 ¶ 83. One
of the business reasons for discontinuing development of
Priorix was that Merck’s MMRV vaccine was near
licensure in the United States. ECF No. 274 ¶ 84; ECF
No. 277 ¶ 84.
-57aFollowing Merck’s licensure of ProQuad in 2005, by
2006, there was a renewed interest by GSK to bring a
mumps vaccine to the United States market. ECF No.
295-1 ¶ 143; ECF No. 301 ¶ 143. After ProQuad was
approved in 2005, the CDC indicated it preferred the use
of the quadrivalent MMRV vaccine over separate
injections of MMR and varicella vaccines. ECF No. 274 ¶
87; ECF No. 277 ¶ 87.
. ECF No. 274 ¶ 89;
ECF No. 277 ¶ 89. Moreover, in 2009, the CDC updated
its recommendation to prefer separate injections of MMR
and varicella vaccines for the first dose, and MMRV,
rather than separate MMR and varicella injections, for
the second dose. ECF No. 274 ¶ 87; ECF No. 277 ¶ 87.
Accordingly, GSK shifted its focus from Priorix-Tetra
(MMRV) to Priorix (MMR), as it saw a potential
opportunity for Priorix as a first dose option. ECF No. 274
¶¶ 88–89; ECF No. 277 ¶¶ 88–89.
In 2009, Merck’s ELISA became commercially
available when Merck’s lab was purchased by an
independent research company, PPD. ECF No. 295-1 ¶
148; ECF No. 301 ¶ 148. In April 2011, GSK decided to use
Merck’s ELISA and notified the FDA of this intention in
December 2011. ECF No. 295-1 ¶ 149; ECF No. 301 ¶ 149.
In April 2012, the FDA gave GSK permission to use
Merck’s ELISA. ECF No. 295-1 ¶ 150; ECF No. 301 ¶ 150.
Accordingly, in 2012, GSK commenced five Phase III
clinical studies for Priorix, which GSK estimated would
cost between $57.1 million and $66.8 million to complete.
ECF No. 274 ¶ 91; ECF No. 277 ¶ 91.
In 2014, when GSK learned of the complaint in the
related FCA case, GSK internal correspondence
questioned whether the allegations could enable GSK to
-58abring its mumps vaccine to the United States market
sooner. ECF No. 295-1 ¶ 152; ECF No. 301 ¶ 152; see also
ECF No. 283 at 135 (email correspondence asking
whether the allegations “could have implications on our
‘non inferiority’ benchmark for the US registration??”);
see also Id. at 139 (email correspondence wondering
whether “anything will (or can) come of this??? Earlier
introduction of Priorix and Varilrix in the US????”).
Additionally, in preparing for an investor event in
2015, GSK’s Chairman of Vaccines was informed
internally that GSK’s Phase III trials started so late
because:
[D]iscussions with CBER about the Eps
[endpoints] and assays to be used in phase
III . . . proved to be protracted, since we could not
meet the serological acceptability criteria for
mumps that CBER required for Phase III success
with our mumps assay (they required “a lower
bound . . . for the response rate ≥90%”) . . . .
[U]ltimately, having access to the Merck Mumps
ELISA which they licensed to PPD facilitated
these discussions.
ECF No. 295-1 ¶ 153; ECF No. 301 ¶ 153; see also ECF
No. 283 at 56.
On January 4, 2018, GSK’s corporate designee was
deposed and explained various business and budgetary
considerations relating to GSK’s development of its
mumps vaccine in the United States. ECF No. 275-46.
Specifically, GSK explained that its leadership had
“always grappled with this vaccine for a couple of reasons;
the low sales, the impact on the portfolio is more
qualitative than quantitative, and because the schedule in
the US is such that you receive varicella the same time you
-59awould get MMR and we don’t have a varicella[.]” ECF No.
275-46 at 137:5-13. Additionally, GSK identified five
reasons why it did not yet have a mumps vaccine approved
in the United States:
1. GSK deprioritized development of mumpscontaining vaccines for business reasons, including
budgetary concerns and opportunities with other
products more in line with GSK’s business strategy
of focusing on adult vaccines;
2. GSK was concerned that Priorix sales would be
low;
3. GSK did not actively pursue Priorix prior to 2009
because it believed that the market would shift
from MMR to MMRV vaccines;
4. But then GSK did not pursue a MMRV vaccine
either, because
and
5. GSK believed a mumps-containing vaccine
would have a qualitative, but no quantitative,
impact on its overall product portfolio.
ECF No. 274 ¶ 97; ECF No. 277 ¶ 97. GSK stated that
there were no other reasons that GSK was not on the
market with a mumps-containing vaccine. ECF No. 274
¶ 98; ECF No. 277 ¶ 98. GSK also testified that it was
not aware of any statement on Merck’s product labels
for MMR-II or ProQuad that foreclosed GSK from
commercializing the mumps vaccine in the United
States. ECF No. 274 ¶¶ 100–101; ECF No. 277 ¶¶ 100–
101. However, GSK testified that the entire clinical
development plan for Priorix was based on “mirroring”
Merck’s label claims. ECF No. 295-1 ¶ 131; ECF No. 301
¶ 131.
-60aIn September 2019, a GSK executive told investors
that it had completed the Phase III studies and it was
“programming now the next step . . . submission of that
asset to the regulators.” ECF No. 295-1 ¶ 154; ECF No.
301 ¶ 154. Public approval documents from the FDA
reveal that the FDA approved GSK’s mumps vaccine
Priorix in June 2022. FDA, June 3, 2022 Approval Letter
– PRIORIX, https://www.fda.gov/media/158962/download
(last visited July 25, 2023).
II. PROCEDURAL HISTORY
On June 25, 2012, Chatom Primary Care, P.C., filed a
class action complaint against Merck based on the
allegations of fraud alleged in the qui tam action, U.S. ex
rel. Krahling v. Merck & Co., Inc., 10-cv-4374 (E.D. Pa.).
On July 9, 2012, Dr. Andrew Klein filed a class action
complaint against Merck also based on the allegations in
the qui tam action. On August 2, 2012, this Court
consolidated Chatom Primary Care, P.C. v. Merck & Co.,
Inc., No. 2:12-cv-03555 and Dr. Andrew Klein and Merck
& Co., Inc., No. 2:12-cv-03857. ECF No. 23. Thereafter, on
September 20, 2012, Plaintiffs, Chatom Primary Care,
P.C., Andrew Klein, M.D., and John I. Sutter, M.D., filed
a Consolidated Amended Class Action Complaint. ECF
No. 26. The Consolidated Amended Class Action
Complaint set forth six claims for relief: (1)
Monopolization in Violation of Section 2 of the Sherman
Act, 15 U.S.C. § 2; (2) Violation of State Consumer
Protection Laws; (3) breach of contract; (4) violation of
Pennsylvania’s Express Warranty Law, Pa. Stat. Ann. Tit.
13, § 2313; (5) violation of Pennsylvania’s Implied
Warranty Law, Pa. Stat. Ann. Tit. 13, § 2314; and (6)
unjust enrichment. Id.
-61aOn November 19, 2012, Merck filed a Motion to
Dismiss Plaintiffs’ Amended Complaint. ECF No. 40. On
September 4, 2014, the Court granted in part and denied
in part Merck’s Motion to Dismiss. ECF Nos. 63, 65. The
Court denied the motion to dismiss the antitrust claim,
granted the motion to dismiss the state law claims, except
those claims brought under the New York Deceptive Acts
and Practices Act (“NYDAPA”) and the New Jersey
Consumer Fraud Act (“NJCFA”), and granted the motion
to dismiss Count III, Count IV, Count V, and Count VI in
their entireties. United States ex rel. Krahling v. Merck &
Co., Inc., 44 F. Supp. 3d 581, 558– 59,609–610 (2014).
Years of discovery practice and accompanying motion
practice followed until January 10, 2020, when Merck filed
a Motion for Summary Judgment. ECF No. 272. Plaintiffs
filed an Opposition on February 10, 2020 (ECF No. 279)
and filed a corrected Opposition on February 20, 2020
(ECF No. 295). On March 10, 2020, Merck filed a Reply in
Support of its Summary Judgment Motion (ECF No. 302),
and Plaintiffs filed a Sur-Reply on March 17, 2020 (ECF
No. 312).
Additionally, on March 12, 2020, Merck filed a Motion
to Exclude Evidence from Dr. Thomas L. Copmann
Pursuant to Federal Rule of Evidence 702 and Daubert.
ECF No. 305. That Motion has also been fully briefed. See
ECF Nos. 319 (Plaintiffs’ Opposition); 323 (Merck’s
Reply); 324 (Plaintiffs’ Sur-Reply).
On December 5, 2022, this case was reassigned from
the Honorable C. Darnell Jones, II to the Honorable Chad
F. Kenney. ECF No. 340. This Court heard oral argument
on Defendant’s Motion for Summary Judgment on
January 24, 2023. ECF No. 342.
-62aIII. MERCK’S MOTION FOR SUMMARY
JUDGMENT
A. Legal Standard
A district court “shall grant summary judgment if the
movant shows that there is no genuine dispute as to any
material fact and the movant is entitled to judgment as a
matter of law.” Fed. R. Civ. P. 56(a). Indeed, “[s]ummary
judgment is appropriate when ‘the pleadings, depositions,
answers to interrogatories, and admissions on file,
together with the affidavits, if any, show that there is no
genuine issue as to any material fact and that the moving
party is entitled to a judgment as a matter of law.’” Wright
v. Owens Corning, 679 F.3d 101, 105 (3d Cir. 2012)
(quoting Orsatti v. New Jersey State Police, 71 F.3d 480,
482 (3d Cir. 1995)). A fact is “material” if it “might affect
the outcome of the suit under the governing law.”
Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986).
There is a genuine issue of material fact if “the evidence is
such that a reasonable jury could return a verdict for the
nonmoving party.” Id.
The party moving for summary judgment has the
initial burden “of informing the district court of the basis
for its motion, and identifying those portions of the
pleadings, depositions, answers to interrogatories, and
admissions on file, together with the affidavits, if any,
which it believes demonstrate the absence of a genuine
issue of material fact.” Celotex Corp. v. Catrett, 477 U.S.
317, 323 (1986) (internal quotation marks omitted). Once
the moving party has met this burden, the non-moving
party must counter with “specific facts showing that there
is a genuine issue for trial.” Matsushita Elec. Indus. Co. v.
Zenith Radio Corp., 475 U.S. 574, 587 (1986) (internal
-63aquotation marks and citation omitted); see also Fed. R.
Civ. P. 56(c).
The non-movant must show more than the “mere
existence of a scintilla of evidence” for elements on which
the non-movant bears the burden of production.
Anderson, 477 U.S. at 252. The non-movant opposing a
motion for summary judgment may not “rely merely upon
bare assertions, conclusory allegations or suspicions.”
Fireman’s Ins. Co. v. DuFresne, 676 F.2d 965, 969 (3d Cir.
1982). Additionally, the non-moving party “cannot rely on
unsupported allegations, but must go beyond pleadings
and provide some evidence that would show that there
exists a genuine issue for trial.” Jones v. United Parcel
Serv., 214 F.3d 402, 407 (3d Cir. 2000). Moreover,
arguments made in briefs “are not evidence and cannot by
themselves create a factual dispute sufficient to defeat a
summary judgment motion.” Jersey Cent. Power & Light
Co. v. Lacey Twp., 772 F.2d 1103, 1109–10 (3d Cir. 1985).
When determining the existence of a genuine issue of
material fact, a court must “examine the evidence of
record in the light most favorable to the party opposing
summary judgment, and resolve all reasonable inferences
in that party’s favor.” Wishkin v. Potter, 476 F.3d 180, 184
(3d Cir. 2007). The court need only decide whether “a fairminded jury could return a verdict for the plaintiff on the
evidence presented.” Anderson, 477 U.S. at 252. “Where
the record taken as a whole could not lead a rational trier
of fact to find for the non-moving party, there is no
‘genuine issue for trial’” and the court should grant
summary judgment in favor of the moving party.
Matsushita Elec. Indus. Co., 475 U.S. at 587 (citation
omitted).
-64aB. Discussion
1. Antitrust Claim
Merck argues that it is entitled to summary judgment
on Plaintiffs’ antitrust claim for the following reasons.
First, it argues that Plaintiffs’ Section 2 Sherman Act
claim is foreclosed by the Noerr-Pennington doctrine.
Second, it argues that to the extent Plaintiffs base their
Section 2 claim on any of Merck’s public statements about
its mumps-containing vaccines, those statements are not
actionable. Third, it argues that Plaintiffs cannot prove
causal antitrust injury. Lastly, it argues that Plaintiff Dr.
John I. Sutter is not a direct purchaser and therefore lacks
antitrust standing to bring a Sherman Act claim. The
Court will address each argument in turn.
a) Noerr-Pennington Doctrine
“Under the Noerr-Pennington doctrine, ‘[t]hose who
petition [the] government for redress are generally
immune from antitrust liability.’” Fed. Trade Comm’n v.
AbbVie Inc., 976 F.3d 327, 359–60 (3d Cir. 2020) (quoting
Prof’l Real Estate Inv’rs., Inc. v. Columbia Pictures
Indus., Inc. (“PRE”), 508 U.S. 49, 56 (1993)). The doctrine
applies to petitioning before “all departments of the
Government,” including the Executive Branch and its
agencies, like the FDA. A.D. Bedell Wholesale Co. v.
Philip Morris Inc., 263 F.3d 239, 250 (3d Cir. 2001)
(quoting Cal. Motor Transp. Co. v. Trucking Unlimited,
404 U.S. 508, 510 (1979)); see also In re Lipitor Antitrust
Litig., 868 F.3d 231, 273 (3d Cir. 2017) (“Petitions to
administrative agencies are consequently also immune
from antitrust liability.”). Nonetheless, this doctrine is not
absolute; rather, the “scope of Noerr Pennington
immunity depends on the ‘source, context, and nature of
the competitive restraint at issue.’” A.D. Bedell, 263 F.3d
-65aat 251 (quoting Allied Tube & Conduit Corp. v. Indian
Head, Inc., 486 U.S. 492 (1988)). “On the one hand, parties
may be immune from liability for ‘the antitrust injuries
which result from the [government] petitioning itself’ or
‘the antitrust injuries caused by government action which
results from the petitioning.’” In re Lipitor Antitrust
Litig., 868 F.3d at 264 (quoting A.D. Bedell, 263 F.3d at
251). “On the other hand, ‘[i]f the restraint directly results
from private action there is no immunity.’” Id. (quoting
A.D. Bedell, 263 F.3d at 251). This means that “immunity
will not categorically apply to private actions somehow
involving government action.” Id. “Immunity applies to
‘political activity with a commercial impact’ but not
‘commercial activity with a political impact.’” In re
Suboxone (Buprenorphine Hydrochloride & Naloxone)
Antitrust Litig., 622 F. Supp. 3d 22, 76 (E.D. Pa. 2022)
(quoting Ticor Title Ins. Co. v. FTC, 998 F.2d 1129, 1138
(3d Cir. 1993)).
Courts have found Noerr-Pennington to not apply
when the petitioning is a request to the government to
perform “a ministerial act” or the petitioning is a “mere
incident of regulation.” See, e.g., In re Buspirone Pat.
Litig., 185 F. Supp. 2d 363, 370 (S.D.N.Y. 2002); Litton
Sys., Inc. v. AT&T Co., 700 F.3d 785 (2d Cir. 1983)
(holding AT&T’s submission of its tariff rates to FCC for
publication—that FCC did not need to review or approve
prior to publication—did not warrant Noerr-Pennington
immunity because decision to impose and maintain the
interface tariff was made in the AT&T boardroom, not at
the FCC). Therefore, “it is critical to distinguish between
activities in which the government acts or renders a
decision only after an independent review of the merits of
a petition and activities in which the government acts in a
merely ministerial or nondiscretionary capacity in direct
-66areliance on the representations made by private parties.”
In re Buspirone, 185 F. Supp. 2d at 369. An example of a
ministerial act is the listing of a patent with the FDA for
publication in the Orange Book, which courts have
repeatedly found is not petitioning activity eligible for
Noerr-Pennington immunity as the FDA did not
independently confirm that the patent listing was correct.
Id. at 370; see also American Bioscience, Inc. v.
Thompson, 269 F.3d 1077, 1084 (D.C. Cir. 2001) (FDA
administers Orange Book listings in ministerial fashion).
Additionally, there is an exception to NoerrPennington immunity for “sham petitions.” Under this
exception, a “party is not entitled to immunity where the
activity ‘ostensibly directed toward influencing
governmental action [ ] is a mere sham to cover . . . an
attempt to interfere directly with the business
relationships of a competitor . . . .’” In re Flonase
Antitrust Litig., 795 F. Supp. 2d 300, 309 (E.D. Pa. 2011)
(“Flonase I”) (quoting Eastern R.R. Presidents
Conference v. Noerr Motor Freight, Inc., 365 U.S. 127, 144
(1965)). A two-step test has been established to determine
whether petitioning is a sham. PRE, 508 U.S. at 60–61.
Courts consider government petitioning a sham if: (1) it is
“objectively baseless in the sense that no reasonable
[party] could realistically expect success on the merits”
and (2) it is “an attempt to interfere directly with the
business relationships of a competitor, through the use of
the governmental process—as opposed to the outcome of
that process—as an anticompetitive weapon.” Id. (internal
quotation marks and citations omitted). And while the
Third Circuit has expressly declined to recognize a
“fraudulent misrepresentation” exception to NoerrPennington immunity, it has explained that “a material
misrepresentation that affects the very core of a litigant’s
-67acase” is relevant to the objectively baseless prong of the
sham exception. Cheminor Drugs, Ltd. V. Ethyl Corp., 168
F.3d 119, 123 (3d Cir. 1999).
In cases involving the pharmaceutical industry,
application of the two-part test has often been invoked in
the context of determining whether manufacturers’ use of
citizens petitions to the FDA are a sham and whether
bringing patent litigation to invoke the 30-month stay
under the Hatch-Waxman framework is a sham. See, e.g.,
In re DDAVP Direct Purchaser Antitrust Litig., 585 F.3d
677, 694 (2d Cir. 2009) (applying PRE to a citizen petition
filed with FDA and patent litigation and finding sham
exception adequately pled); AstraZeneca AB v. Mylan
Labs. Inc., No. 00–cv–6749, 2010 WL 2079722, at *3
(S.D.N.Y. May 19, 2010) (applying PRE to patent
infringement litigation and granting motion to dismiss as
the activity was not a sham and thus immunized by NoerrPennington); Flonase I, 795 F. Supp. 2d 300 (E.D. Pa.
2011) (denying Noerr-Pennington immunity under the
sham exception when defendant filed citizens petitions).
While administrative petitions are “less susceptible than
lawsuits to the sham exception, [they] still carry the
potential for antitrust liability.” In re DDAVP, 585 F.3d at
686; see also Flonase I, 795 F. Supp. 2d at 309–10
(“Although PRE only discussed the sham exception in the
context of litigation, the test also generally applies to
petitions to administrative agencies.”).
Additionally, “[i]t is well settled that First Amendment
rights are not immunized from regulation when they are
used as an integral part of conduct which violates a valid
statute.” Calif. Motor Transport Co. v. Trucking
Unlimited, 404 U.S. 508, 514 (1972). “Where certain
conduct is immunized from antitrust liability, a court must
-68astill ‘consider evidence of the remaining challenged
conduct in the aggregate to see if it is sufficient to support
antitrust liability.’” In re Suboxone, 622 F. Supp. 3d at 77
(quoting Mercatus Grp., LLC v. Lake Forest Hosp., 641
F.3d 834, 839 (7th Cir. 2011)).
Here, Merck asserts Noerr-Pennington immunity
applies because, even if Merck submitted fraudulent
information to the government, Plaintiffs’ alleged injuries
are caused by government action, i.e., the standard the
FDA required GSK to meet in designing clinical testing
for its mumps vaccine. ECF No. 273 at 25. Plaintiffs argue
that Merck’s conduct is not petitioning activity; rather, it
was a commercial decision to market its mumps vaccines
with a false and misleading label and that Merck’s
response to FDA enforcement is a mere incident of
regulation. See ECF No. 295 at 66–69. Merck replies by
stating that it “has never argued that statements made to
the public were immunized” by Noerr-Pennington, just
that the submissions to the FDA allegedly containing false
information that Plaintiffs’ claim resulted in the agency
holding GSK to a higher standard are immune. ECF No.
302 at 10–11.
The Court agrees that Merck’s submission to the FDA
could be considered petitioning activity. Additionally, the
submissions at issue are not requests to the government
to perform “a ministerial act” nor is the petitioning a
“mere incident of regulation.” As described above, the key
consideration for this exception is whether the
government acts in a merely ministerial or
nondiscretionary capacity in direct reliance on the
representations made by private parties’ acts or if the
government renders a decision only after an independent
review of the merits of a petition. Considering the
-69asubmissions to the FDA described in the parties’
briefing—submission of Protocol 007 data, a white paper
that Merck submitted to the FDA, a response to an FDA
Form 483, a response to an FDA Warning Letter, and
certain BPDRs—in all of these instances, the FDA is not
acting in a merely ministerial or non-discretionary
capacity based on the representations made by Merck.
Instead, the FDA is independently reviewing the merits
of each of the submissions. One does not have to look
beyond the back-and-forth between the FDA and Merck
to see that the FDA was actively reviewing Merck’s
submissions and exercising its discretion.
Turning to the sham exception, the Court must first
examine whether the submissions to the FDA had an
objective basis. However, “[t]he question of whether a
petition is a sham is generally a question of fact for the
jury” and “[a] court should only rule on the objective
baselessness prong as a matter of law [w]here there is no
dispute over the predicate facts of the underlying
petitions.” Flonase I, 795 F. Supp. 2d at 310 (internal
quotations and citations omitted). Accordingly, the Court
declines to grant summary judgment in favor of Merck on
Noerr-Pennington grounds because genuine issues of
material fact remain. Merck did not describe the
petitioning at issue in its Statement of Undisputed Facts
in Support of its Motion for Summary Judgment (ECF
No. 274), but rather, just cited to the Plaintiffs’ general
allegations in the Amended Complaint. Additionally, in its
response to the paragraphs in Plaintiffs’ Additional
Disputed Facts in Opposition to Summary Judgment that
described the facts surrounding the submissions to the
FDA, Merck stated: “The statements in this paragraph
are not material to the issues in Merck’s Motion for
Summary Judgment because they do not bear on whether
-70aPlaintiffs’ claims are barred by the Noerr-Pennington
doctrine, whether Merck’s conduct caused antitrust injury
to Plaintiffs, or any other basis upon which Merck moved
for summary judgment. Merck reserves the right to
dispute the statements in this paragraph at any trial in
this action.” See, e.g., ECF No. 301, Response to ¶ 48.
Because of this response, there remain disputes as to the
predicate facts of the underlying petitions at issue.
Finally, the Court notes that even if Merck’s
petitioning conduct is immune under Noerr-Pennington,
Plaintiffs allege that the anticompetitive business regime
centered on Merck’s false and misleading label claims, and
as such, the petitioning may be relevant to showing
Merck’s intent.
For the foregoing reasons, this Court declines to grant
summary judgment in favor of Merck on the grounds that
the Noerr-Pennington doctrine bars Plaintiffs’ antitrust
claim
b) Public Statements
In addition to arguing that its statements to the FDA
are immune from antitrust liability, Merck also argues
that to the extent Plaintiffs base their antitrust claim on
purported misstatements to the public at large, that
theory fails under the Sherman Act. Specifically, Merck
asserts that even if its statements about its own MMR
product to potential customers “may have been wrong,
misleading, or debatable,” such statements are not
actionable as antitrust violations in the absence of
coercion, and additionally, because a truthful disclosure
would not have made a difference in the competitive
process. ECF No. 273 at 42–43. In support of this
argument, Merck relies on four cases that this Court finds
distinguishable from the present case. ECF No. 273 at 42–
-71a43 (citing Santana Prods., Inc. v. Bobrick Washroom
Equip., Inc., 401 F.3d 123, 133 (3d Cir. 2005); Stearns
Airport Equip. Co. v. FMC Corp., 170 F.3d 518, 524–25
(5th Cir. 1999); Rambus v. FTC, 522 F.3d 456, 466 (D.C.
Cir. 2008); Eisai Inc. v. Sanofi-Aventis U.S., No. 08-4168,
2014 WL 1343254 (E.D. Pa. Mar. 28, 2014)).
First, Santana held that wrong, misleading, or
debatable statements by one competitor about another
competitor’s products are indicative of competition on the
merits and therefore do not constitute a “restraint of
trade” for purposes of an antitrust violation. 401 F.3d at
132. Putting aside the fact that the Third Circuit has
acknowledged that the Santana holding was phrased in
“overly broad terms,” West Penn Allegheny Health Sys.,
Inc. v. UPMC, 627 F.3d 85, 109 n.14 (3d Cir. 2010),
Santana is distinguishable on the facts as it involved
statements about a competitors’ product; whereas here,
Plaintiffs’ claims focus on the allegedly fraudulent
statements Merck made about its own product. Second,
Stearns is also factually distinct from this case as it
concerned competitors bidding on contracts to provide
airline boarding bridges to municipal airports. 170 F.3d at
524. Stearns explained that there could be no exclusionary
conduct as long as the decision on the choice of supplier
remained “in the hands of the consumer,” but the court
also noted that “bribery and threats are not competition
on the merits” and that “[s]everal cases have found
violations of section 2 when the monopolist engages in
what appears to be normal competitive behavior, but has
manipulated representatives of the consumer to the point
that the integrity of the decisional process has been
violated.” Id. at 526. Here, Plaintiffs did not have a choice
of supplier, and therefore, this case does not directly
support Merck’s argument. Third, in Rambus, the court
-72adetermined that the alleged deception did not harm the
competitive process. 522 F.3d at 466. In contrast, as will
be described infra, there is a dispute of material fact as to
whether Merck’s allegedly false and misleading label
claims were a material cause of GSK’s delayed market
entry. Lastly, Merck points to Eisai for the proposition
that “[w]hile it is theoretically possible that false
statements about a rival to potential investors and
customers can be a form of anticompetitive conduct, it
would be a rare case in which such false statements inand-of themselves would be sufficient to support an
antitrust violation.” 2014 WL 1343254, *37 (internal
quotations and citation omitted). However, as the Court is
unaware of any public statements Merck made about
GSK’s vaccine, the Court does not see how Eisai is
applicable to this case.
In conclusion, there are disputes as to material fact as
to whether Merck’s alleged deception impaired the
competitive process, and therefore, the Court declines to
grant summary judgment to Merck on the aspects of
Plaintiffs’ antitrust claim based on Merck’s statements to
the public.
c) Antitrust Injury
In antitrust actions, plaintiffs are required to
“establish antitrust standing, which is distinct from
Article III standing.” In re Wellbutrin XL Antitrust
Litig., 868 F.3d 132, 163 (3d Cir. 2017). “To establish
antitrust standing, [] plaintiff[s] must show they have
suffered an antitrust injury— that is, an ‘injury of the type
the antitrust laws were intended to prevent and that flows
from that which makes [the] defendant[‘s] acts unlawful.’”
Id. (quoting Ethypharm S.A. France v. Abbott
Laboratories, 707 F.3d 223, 233 (3d Cir. 2013)). Thus,
-73aplaintiffs must show that a defendant’s antitrust violation
was a “material cause” of their injuries. In re Flonase
Antitrust Litig., 798 F. Supp. 2d 619, 627 (E.D. Pa. 2011)
(“Flonase II”) (citations omitted). “An antitrust violation
is a ‘material cause’ of an injury if it is a proximate cause
of that injury.” Id. (citations omitted).
“That a regulatory or legislative bar can break the
chain of causation in an antitrust case is beyond fair
dispute.” In re Wellbutrin XL Antitrust Litig., 868 F.3d
at 165. However, “an antitrust violation can be the
proximate cause of a plaintiff’s injury even if there are
additional independent causes of the injury.” In re
Suboxone, 622 F. Supp. 3d at 78 (citations omitted).
Moreover, “[e]ven if an antitrust violation is not the
material cause of an injury and the only material cause is
some intervening conduct, courts have consistently found
the causation requirement satisfied and the chain of
causation intact where that intervening conduct was the
foreseeable consequence of the original antitrust
violation.” Flonase II, 798 F. Supp. 2d at 628. Ultimately,
“[w]hether conduct constitutes intervening conduct that
breaks the chain of causation and whether intervening
conduct is a foreseeable consequence of a defendant’s
actions are questions of fact to be submitted to the jury.”
Id. (citation omitted).
In order to establish antitrust injury here, Plaintiffs
must show that the harm they say they experienced—
inflated prices for mumps vaccines—was caused by
Merck’s allegedly unlawful conduct. Plaintiffs allege that
they have created a triable issue of fact as to whether
Merck’s conduct materially caused their harm because
they have put forth evidence that: (1) Merck kept GSK off
the market by maintaining false and misleading
-74astatements on the mumps vaccine labels; and (2) Merck
kept GSK off the market by failing to disclose potency
failures, staving off a massive recall. ECF No. 295 at 52–
55. Merck on the other hand argues: (1) GSK’s
independent business decisions, not Merck’s conduct,
delayed GSK’s development of Priorix; and (2) Plaintiffs’
claims that FDA would have “lowered the bar” absent
Merck’s conduct is pure speculation that does not forge
the necessary causal link. ECF No. 273 at 26–34.
The Court finds that there is sufficient evidence to
raise a genuine issue of material fact as to whether it was
Merck’s conduct that was a material cause of Plaintiffs’
injuries. Numerous pieces of evidence submitted with the
briefings establish this dispute and the Court will point to
a few herein. First, there is evidence that GSK had
protracted discussions with the FDA on the serological
acceptability criteria for mumps and it was only after
Merck licensed their mumps ELISA (the test that
Plaintiffs alleged was scientifically flawed) to PPD, and
GSK was able to use Merck’s ELISA, that GSK was
finally able to complete its Phase III clinical trials and
enter the market. See, e.g., Jan. 24, 2023 Hr’g Tr. at 19:18–
20:1. There is additional evidence contained in Merck’s
internal documents stating that they were out of
compliance, but changing their label was unacceptable
because it would allow GSK to enter the market.
Moreover, after GSK got access to Merck’s ELISA and
the approval to use Merck’s ELISA in 2012, GSK received
approval in 2022, which fits within the exact time frame,
Plaintiffs’ expert, Dr. Copmann, predicted GSK would
receive approval once it received access to Merck’s
allegedly flawed ELISA. See Id. at 20:18–20. Additionally,
the fact that GSK’s corporate designee testified as to
different reasons for GSK not obtaining approval until
-75a2022 does not, at summary judgment, break the causal
connection between the alleged antitrust violation and
Plaintiffs’ injury, as the corporate designee also testified
that GSK had to mirror Merck’s allegedly false label
claims. Moreover, the actions taken by the FDA and GSK
in response to Merck’s allegedly false label claims are
foreseeable consequences of Merck’s alleged misconduct.
Therefore, while a jury may well conclude that GSK’s
independent business reasons and the FDA decisionmaking process break the chain of causation, whether
these reasons are the proximate cause of Plaintiffs’ injury
is a question of fact for the jury. Accordingly, the Court
finds genuine issues of material fact remain as to the
question of whether Merck caused Plaintiffs’ alleged
injury.
d) Antitrust Standing
To have standing to sue for damages under the
antitrust laws, a private plaintiff must be a direct
purchaser of the product from the defendant. 15 U.S.C. §
4; Ill. Brick Co. v. Illinois, 431 U.S. 720, 746 (1977);
Warren Gen. Hosp. v. Amgen Inc., 643 F.3d 77, 79 (3d Cir.
2011). Merck argues that Dr. Sutter does not have
antitrust standing because although his practice, “John
Ivan Sutter, MD, PA”—which is a distinct corporate
entity and not a named plaintiff—made purchases of
Merck’s mumps vaccine, Dr. Sutter did not personally
make those purchases. ECF No. 273 at 44. Dr. Sutter’s
deposition testimony and his records showing payment
make it clear that it was his corporate entity, not him
personally, that purchased the mumps vaccines from
Merck. ECF No. 274 at 42; ECF No. 302 at 27. In
response, Plaintiffs point to Merck’s own sales data that
does not reveal a customer named “John Ivan Sutter, MD,
-76aPA.;” rather, the sales data contained customers “John
Ivan Sutter, MD” and “John Sutter,” both in Clifton, New
Jersey, that purchased $36,530 worth of MMRII and
ProQuad between 1998 and 2007. ECF No. 277 ¶ 42. In
reply, Merck argues that Plaintiffs’ contention that
because the sales data does not include the word “PA” to
signify the corporate entity, it is referring to Dr. Sutter in
his individual capacity, cannot defeat summary judgment
because it is pure speculation. ECF No. 302 at 27–28
(citing, inter alia, Robertson v. Allied Signal, Inc., 914
F.2d 360, 382 n.12 (3d Cir. 1990) (“speculation or
conjecture does not create a material factual dispute
sufficient to defeat entry of summary judgment”)). While
this Court agrees that Plaintiffs’ argument that Dr. Sutter
personally purchased the mumps vaccines seems
speculative in the face of Dr. Sutter’s own testimony and
his documented evidence, the Court finds this to be an
issue of fact, that it cannot resolve at summary judgment.
2. State Law Claims
Merck argues that it is entitled to summary judgment
on Plaintiffs’ New Jersey and New York consumer
protection claims. Merck argues that Dr. Sutter’s New
Jersey consumer protection claim fails “because, by his
own admission, the mumps vaccine is not sold to the public
at large and thus is not a product covered by the statute.”
ECF No. 273 at 12. Additionally, Merck argues Plaintiffs
failed to establish the essential element of causation for
their consumer protection claims. Id. For the following
reasons, the Court finds that Merck’s mumps vaccines
constitute merchandise under the NJCFA, but finds that
Plaintiffs have not created a genuine issue of material fact
that they would have acted any differently if Merck’s label
claims had said anything different.
-77aa) “Merchandise” under the NJCFA
The NJCFA prohibits sellers of “merchandise” from
engaging in any “unconscionable or abusive [commercial
practice], deception, fraud, false pretense, false promise,
misrepresentation, or the knowing, concealment,
suppression or omission of any material fact with intent
that others rely upon such concealment.” N.J. Stat. Ann.
§ 56:8-2. The NJCFA defines “merchandise” as “any
objects, wares, goods, commodities, services or anything
offered, directly or indirectly to the public for sale.” Id. §
56:8-1(c). New Jersey has interpreted “the public,” as
used in this definition of “merchandise,” to refer to the
“public at large.” Princeton Healthcare Sys. v. Netsmart
New York, Inc., 29 A.3d 361, 365 (N.J. App. Div. 2011)
(collecting cases). Notably, “it is the character of the
transaction rather than the identity of the purchaser
which determines if the Consumer Fraud Act is
applicable.” J & R Ice Cream Corp. v. California
Smoothie Licensing Corp., 31 F.3d 1259, 1273–74 (3d Cir.
1994) (citation omitted).
Accordingly, some courts have “dismissed NJCFA
claims relying on services or goods that are only offered
to a select group of individuals.” City of Atl. City v.
Zemurray St. Capital, LLC, 192 F. Supp. 3d 563, 568
(D.N.J. 2016) (citations omitted). On the other hand,
however, “at least one judge in [the district of New Jersey]
has determined that the NJCFA can encompass claims for
merchandise that is ‘expensive, uncommon, or only suited
to the needs of a limited clientele.’” Id. (citing Prescription
Counter v. AmerisourceBergen Corp., No. 04-5802, 2007
WL 3511301, at *14 (D.N.J. Nov. 14, 2007)). Courts have
summarized the distinction in this line of cases, stating
that “where courts permitted claims to go forward
-78aseemingly about goods not available to the general public,
those goods are generally standardized and did not
require individual bargaining”; “[b]ut where claims were
not permitted to proceed, those usually dealt with specific
agreements and individualized negotiations.” Id. (citing
Naporano Iron & Metal Co. v. Am. Crane Corp., 79 F.
Supp. 2d 494, 509 (D.N.J. 1999)).
Merck argues that Plaintiffs’ NJCFA claim fails
because the mumps vaccines were not available “to the
public at large,” therefore, the mumps vaccines do not
qualify as “merchandise” under the NJCFA. ECF No. 273
at 46–47. In support of this argument, Merck points to Dr.
Sutter’s deposition testimony stating that the mumps
vaccine is not available “to the public at large,” but rather,
the vaccine must be purchased by licensed medical
professionals. ECF No. 247 ¶ 43; ECF No. 277 ¶ 43.
However, looking at the character of the transaction
rather than the identity of the purchaser, the Court finds
that Merck’s mumps vaccines are standardized and not
the result of individual bargaining. As indicated by
Plaintiffs, Merck’s mumps vaccines are made under
standard formulas and conditions and are administered
uniformly to the general public. ECF No. 295 at 80. The
mumps vaccines are not customized to each patient, but
rather are sold in a uniform package and administered in
a uniform dose. Id. Additionally, Merck has not
demonstrated that the transaction was subject to
individualized negotiations.
Therefore, the Court finds that Merck’s mumps
vaccines are “merchandise” under the NJCFA and thus
will deny summary judgment on this ground.
b) Causation Elements of Plaintiffs’
State-Law Claims
-79aTo prove their claims under the NYDAPA and the
NJCFA, Plaintiffs must show causation. See Frederico v.
Home Depot, 507 F.3d 188, 202 (3d Cir. 2007) (explaining
that the NJFCA requires a causal link between the
practice and the harm); In re Currency Conversion Fee
Antitrust Litig., 230 F.R.D. 303, 310 (S.D.N.Y. 2004)
(explaining that the NYDAPA requires a plaintiff to prove
that the defendant’s material deceptive act caused the
injury). Under the NJCFA, “[c]ourts have generally found
causation to be established for [NJCFA] purposes when a
plaintiff has demonstrated a direct correlation between
the unlawful practice and the loss; they have rejected
proofs of causation that were speculative or attenuated.”
Heyert v. Taddese, 70 A.3d 680, 700 (N.J. App. Div. 2013);
see also Fleisher v. Fiber Composites, LLC, No. 12-cv1326, 2012 WL 5381381, at *10 (E.D. Pa. Nov. 2, 2012)
(explaining under the NJCFA, plaintiffs must articulate a
causal nexus between the defendant’s conduct and
plaintiffs’ ascertainable loss). “Under the [NYDAPA],
plaintiffs need not prove reliance, but at a minimum, the
complaint must allege that the plaintiffs saw the deceptive
statements prior to purchasing the defendant’s product,
and that the defendant’s deceptive act or practice caused
harm.” Fleisher, 2012 WL 5381381, at *10 (cleaned up)
(citations omitted).
Here, Plaintiffs allege in their Complaint that as “a
direct
and
proximate
result
of
Merck’s
misrepresentations and omissions, the Plaintiffs . . . were
damaged” and Plaintiffs “would not have purchased or
used Mumps Vaccine had they known the truth.” ECF No.
26 ¶¶ 167–168. But the undisputed evidence shows that
Plaintiffs would not have acted any differently if the labels
said anything different. Dr. Klein does not dispute that he
did not regularly review the package insert for Merck’s
-80aMMR-II vaccine, other than in the context of this case and
to check the dosing schedule. ECF No. 274 ¶ 33; ECF No.
277 ¶ 33. Similarly, Dr. Sutter never investigated whether
the statements in Merck’s label related to efficacy,
effectiveness, or seroconversion were false and misleading
prior to reviewing the Complaint in the related FCA
action. ECF No. 274 ¶ 44; ECF No. 277 ¶ 44. Accordingly,
Plaintiffs cannot establish the causal nexus required to
prove their state-law claims. See, e.g., Fleisher, 2012 WL
5381381, at *10 (dismissing NJCFA and NYDAPA claims
because “at the minimum” the plaintiff must have seen
“the deceptive statements prior to purchasing the
defendant’s product”); Gale v. Int’l Bus. Mach. Corp., 9
A.D.3d 446, 447 (N.Y. 2d Dep’t 2004) (“If the plaintiff did
not see any of these statements, they could not have been
the cause of his injury.”).
Plaintiffs argue that they had “no choice” but to buy
Merck’s product because there was no alternative.
However, this is beside the point, as Plaintiffs must prove
a causal nexus between the alleged false statement and
their decision to purchase, and here, Plaintiffs never
reviewed or evaluated the alleged misstatements in
connection with a purchase, making proof of a causal
nexus impossible.
Plaintiffs additionally argue that all that they need to
show is that they did not receive the benefit of the
bargain—i.e., they bought a product that was ultimately
worth less than the product that was promised. ECF No.
295 at 77–78. However, the cases Plaintiffs rely on in
support of this argument are inapposite. Smajlaj v.
Campbell Soup Co. found that a different element of the
plaintiff’s NJCFA claim, the ascertainable loss element,
was satisfied if the plaintiff did not receive the benefit of
-81athe bargain. 782 F. Supp. 2d 84, 97, 99 (D.N.J. 2011).
Additionally, Rodriquez v. It’s Just Lunch, Int’l was a
class certification decision which therefore has no bearing
on this motion. 300 F.R.D. 125, 147 (S.D.N.Y. 2014).
Accordingly, because Plaintiffs have not shown that
they would have acted any differently if the labels said
anything different, Merck is entitled to judgment as a
matter of law on Plaintiffs’ state-law claims.
3. Conclusion
For the foregoing reasons, Merck’s Motion for
Summary Judgment as to the antitrust claim will be
denied and Merck’s Motion for Summary Judgment as to
the NYDAPA and NJCFA claims will be granted.
IV. MERCK’S MOTION TO EXCLUDE EVIDENCE
FROM DR. COPMANN
A. Legal Standard
Federal Rule of Evidence 702 provides:
A witness who is qualified as an expert by
knowledge, skill, experience, training, or education
may testify in the form of an opinion or otherwise
if: (a) the expert’s scientific, technical, or other
specialized knowledge will help the trier of fact to
understand the evidence or to determine a fact in
issue; (b) the testimony is based on sufficient facts
or data; (c) the testimony is the product of reliable
principles and methods; and (d) the expert has
reliably applied the principles and methods to the
facts of the case.
Fed. R. EvId. 702. This Rule places district courts in the
role of the “gatekeeper,” requiring courts to “ensure that
any and all [expert] testimony . . . is not only relevant, but
-82areliable.” Kumho Tire Co., Ltd. v. Carmichael, 526 U.S.
137, 147 (1999) (quoting Daubert v. Merrell Dow Pharms.,
Inc., 509 U.S. 579, 589 (1993)) (internal quotations
omitted). Rule 702 has “a liberal policy of admissibility,”
Pineda v. Ford Motor Co., 520 F.3d 237, 243 (3d Cir. 2008)
(citation omitted), and accordingly, the “rejection of
expert testimony is the exception and not the rule.”
Dorman Prods. v. PACCER, Inc., 201 F. Supp. 3d 663, 689
(E.D. Pa. 2016) (quoting Fed. R. EvId. 702 Advisory
Committee Note). The Third Circuit has explained that to
survive a Daubert challenge, an expert must satisfy three
“restrictions on expert testimony: qualification, reliability,
and fit.” Schneider ex rel. Estate of Schneider v. Fried, 320
F.3d 396, 404 (3d Cir. 2003) (citations omitted). The party
offering the expert must prove each of these requirements
by a preponderance of the evidence. In re TMI Litig., 193
F.3d 613, 663 (3d Cir. 1999).
To qualify as an expert, Rule 702 requires the “expert
witness to have ‘specialized knowledge’ regarding the area
of testimony.” Betterbox Commc’ns Ltd. v. BB Techs.,
Inc., 300 F.3d 325, 327 (3d Cir. 2002). The Third Circuit
has instructed courts to interpret the qualification
requirement “‘liberally,’ recognizing that ‘a broad range of
knowledge, skills, and training qualify an expert as such.’”
Thomas v. CMI Terex Corp., No. 07-3597, 2009 WL
3068242, *5 (D.N.J. Sept. 21, 2009) (quoting In re Paoli
R.R. Yard PCB Litig., 35 F.3d 717, 741 (3d Cir. 1994)
(“Paoli II”)). “[I]t is an abuse of discretion to exclude
testimony simply because the trial court does not deem
the proposed expert to be the best qualified or because the
proposed expert does not have the specialization that the
court considers most appropriate.” Pineda, 520 F.3d at
244 (quoting Holbrook v. Lykes Bros. S.S. Co., 80 F.3d 777,
782 (3d Cir. 1996)).
-83aThe reliability requirement of Daubert “means that
the expert’s opinion must be based on the ‘methods and
procedures of science’ rather than on ‘subjective belief or
unsupported speculation’; the expert must have ‘good
grounds’ for his or her belief.” Paoli II, 35 F.3d at 742
(citation omitted). “The reliability requirement is not to be
applied ‘too strictly’ and is satisfied as long as the expert
has ‘good grounds’ for his or her opinion.” Apotex, Inc. v.
Cephalon, Inc., 321 F.R.D. 220, 228 (E.D. Pa. 2017)
(quoting Holbrook, 80 F.3d at 784). “[I]n making reliability
determinations, courts must err on the side of admission
rather than exclusion.” In re Paoli R.R. Yard PCB Litig.,
916 F.2d 829, 857 (3d Cir. 1990) (“Paoli I”).
Lastly, Rule 702 requires the expert testimony fit the
issues in the case. “Testimony ‘fits’ a case when it is
‘relevant for the purposes of the case and . . . assist[s] the
trier of fact.’” In re Flonase Antitrust Litig., 884 F. Supp.
2d 184, 190 (E.D. Pa. 2012) (“Flonase III”) (quoting
Schneider, 320 F.3d at 404). Finally, “[v]igorous crossexamination, presentation of contrary evidence, and
careful instruction on the burden of proof are the
traditional and appropriate means of attacking shaky but
admissible evidence.” Daubert, 509 U.S. at 596 (citing
Rock v. Arkansas, 483 U.S. 44, 61 (1987)).
B. Discussion
Plaintiffs proffer Dr. Thomas L. Copmann (“Dr.
Copmann”) to provide an expert opinion on the possible
effects of Merck’s conduct on GSK’s ability to obtain
regulatory approval of its own mumps vaccine, Priorix,
and to opine on when Priorix would have obtained
regulatory approval in the United States if not for Merck’s
actions. ECF No. 309 at 8. Merck’s Motion to Exclude
Evidence from Dr. Thomas L. Copmann Pursuant to
-84aFederal Rule of Evidence 702 and Daubert argues that:
(a) Dr. Copmann’s opinion about how the FDA would have
reacted to different disclosures by Merck is not
admissible; (b) Dr. Copmann’s opinions about how GSK
would have reacted to different disclosures by Merck are
not admissible; and (c) Dr. Copmann’s estimate that it
would take 8 to 10 years for GSK to secure FDA approval
for a vaccine is baseless and unreliable. ECF No. 306.
1. Dr. Copmann’s Qualifications
Dr. Copmann is qualified to offer expert testimony in
this case. Dr. Copmann holds a bachelor’s degree in
biochemistry, a master’s in endocrinology, and a doctorate
in physiology. Additionally, Dr. Copmann has thirty years
of experience helping to bring pharmaceutical products to
market and in such role, he has worked closely with the
FDA and CBER in handling NDAs, BLAs, and INDs for
dozens of drugs and biological products, many of which
involved noninferiority analyses and ELISA testing. Dr.
Copmann has authored dozens of comments to the FDA
and CBER and has met with the agencies hundreds of
times. Additionally, Dr. Copmann has written various
articles and comments about the development and
regulation of biological products. Moreover, Dr. Copmann
was nominated by a senior FDA official, Dr. Carolyn
Hardegree, to serve on the CDC’s Advisory Committee on
Immunization Practices (“ACIP”) as the liaison
representative for the Pharmaceutical Research and
Manufacturers
of
America
(“PhRMA”),
which
demonstrates the high regard FDA officials hold Dr.
Copmann’s experience and judgment.
Contrary to Merck’s assertion, the fact that Dr.
Copmann has not worked for the FDA does not disqualify
him. Experience at the FDA is not required to opine about
-85aFDA regulations. See Wolfe v. McNeil-PPC, Inc., 881 F.
Supp. 2d 650, 658–59 (E.D. Pa. 2012) (finding two experts
that did not work at the FDA qualified to testify about
FDA regulations); AstraZeneca LP v. Breath Ltd., 88 F.
Supp. 3d 326, 385 n.54 (D.N.J. 2015) (permitting testimony
of “regulatory lawyer who [] practiced before the FDA for
over 35 years, possess[ed] knowledge that [could] assist
the Court in understanding the manner in which the FDA
issues rules and regulations”). Moreover, the fact that Dr.
Copmann has never previously served as an expert, does
not undermine Dr. Copmann’s qualifications. See United
States v. Lee, 339 Fed. App’x 153, 159 (3d Cir. 2009)
(noting that the fact that it was an individual’s “first time
testimony as an expert does not undermine [his]
qualifications”).
Accordingly, the Court finds that Dr. Copmann
possesses specialized knowledge greater than the average
layman and he is therefore qualified to testify under the
Third Circuit’s liberal requirements for expert testimony.
2. Reliability and Fit of Dr. Copmann’s
Opinions
Merck first objects to Dr. Copmann’s opinion that if
Merck had revised its label, “[t]his would have likely
resulted in the FDA taking a more flexible approach in
reaching an agreement with GSK on an appropriate
serological assay to demonstrate how well Priorix
protected children from disease,” and would have allowed
GSK to demonstrate non-inferiority using tests it had
already developed and studies it had already conducted,
resulting in GSK launching Priorix sooner. ECF No. 306
at 11 (citing Dr. Copmann Report at ¶ 19). Merck argues
that this opinion is unreliable and untestable ipse dixit
and that it is unhelpful because Dr. Copmann cannot, and
-86adoes not, explain how likely the FDA would have been to
take the actions he posits. Id. at 12.
The Court finds this opinion is reliable as it is wellgrounded in Dr. Copmann’s experience and the record.
See, e.g., Center City Periodontist, P.C. v. Dentsply Int’l,
Inc., 321 F.R.D. 193, 202 (finding the “totality” of expert’s
knowledge and experience provides a reliable basis for
opining on the FDA’s regulatory and administrative
requirements but excluding the opinion because it did not
fit the facts of the case). Dr. Copmann considered over 600
documents produced in this matter; analyzed dozens of
studies and publications; and reviewed or attended
multiple depositions. Considering the intricacies of this
case, his opinion on the process by which the FDA would
review GSK’s application would be helpful to the trier of
fact.
Merck points to case law for the proposition that even
a qualified expert cannot testify to state of mind or beliefs.
ECF No. 306 at 13 (citing Wolfe, 881 F. Supp. at 660–62
(recognizing expert could not opine regarding the FDA’s
state of mind); Deutsch v. Novartis Pharms. Corp., 768 F.
Supp. 2d 420, 442 (E.D.N.Y. 2011) (noting “the opinions of
[expert] witnesses on the intent, motives, or states of
minds of corporations, regulatory agencies, and others
have no basis in any relevant body of knowledge or
expertise” (citation omitted))). However, the Court finds
that Dr. Copmann is not opining on the FDA’s state of
mind; rather his opinion is how the FDA would have likely
responded under the operative statutes and regulations to
disclosures Merck allegedly should have made, but did
not. See Flonase III, 907 F. Supp. 2d at 644 (finding
reliable expert report about how the FDA would have
responded to certain submissions). Accordingly, the Court
-87afinds that Dr. Copmann’s opinion regarding the FDA
likely taking a more flexible approach is admissible as it is
reliable and will assist the trier of fact.
The second opinion that Merck objects to is Dr.
Copmann’s opinion that if Merck revised its label and the
FDA had relaxed its standards for vaccine approval, GSK
would have launched its competing Priorix vaccine more
quickly. ECF No. 306 at 15. Again, Merck argues that this
opinion about what GSK would have done is untestable
and unreliable ipse dixit that conflicts with
uncontroverted testimony that Merck’s labels had no
effect on GSK’s development of Priorix and that the
opinion is unhelpful because Dr. Copmann cannot, and
does not, explain how likely GSK would have been to
launch Priorix any earlier. Id. at 15–16.
The Court finds this opinion reliable and that it fits the
facts of the case. As discussed supra in the discussion of
antitrust injury, the Court has found there is a dispute of
material fact as to whether the labels played a role in the
delay of Priorix coming to the market. While GSK’s
corporate designee did answer “no” when asked if Merck’s
labels stopped GSK from commercializing its mumps
vaccine, her testimony also indicated that GSK based its
development on what was publicly available on Merck’s
label. See ZF Meritor, LLC v. Eaton Corp., 696 F.3d 254,
290 (3d Cir. 2012) (affirming denial of defendant’s Daubert
motion as “amount[ing] to nothing more than a complaint
that [plaintiffs’ expert] did not adopt [defendant’s] view of
the case”). Accordingly, the Court finds this opinion
admissible as it is reliable and fits the facts of the case.
The last opinion that Merck objects to is Dr.
Copmann’s opinion that it would have taken GSK 8 to 10
years to obtain regulatory approval for Priorix once it
-88areached agreement on an appropriate endpoint for a
clinical study because Merck argues the opinion is
baseless and unreliable. ECF No. 306 at 19. Merck takes
issue with the fact that Dr. Copmann only reviewed four
Merck vaccines and four GSK vaccines for this opinion and
argues that such a review does not amount to a reliable
basis to make his conclusion. Additionally, Merck takes
issue with the fact that Dr. Copmann does not look at the
specifics of those vaccines to assess if they are relevant
comparators and his opinion does not take into account the
fact that only a small percentage of vaccine products are
actually approved by the FDA. Finally, Merck argues that
one third of the vaccines he examined took 12.75 years or
longer for approval and therefore his analysis is unreliable
as it contains no explanation as to why GSK would have
fallen within the low end of the range.
The Court finds this opinion reliable as estimating a
competitor’s entry date in the but-for world is a routine
and necessary aspect of antitrust cases. See, e.g., Apotex,
321 F.R.D. 220 (permitting expert to opine that if not for
a patent settlement, at least one of the first-filer generics
would have prevailed at summary judgment and entered
the market in 2006); In re Solodyn (Minocycline
Hydrochloride) Antitrust Litig., No. 14-md-02503, 2018
WL 563144 (D. Mass. Jan. 25, 2018) (permitting expert
testimony regarding but-for entry dates in antitrust
matter where opinion was based on “industry surveys and
[the parties] own representations”). Additionally,
according to Plaintiffs, Dr. Copmann, looked at every
clinical development start date and end date he could find
for each prophylactic vaccine licensed in the United States
to generate comparator vaccines and calculate his average
development timeline. See ECF No. 319 at 29. Moreover,
Dr. Copmann’s eight-to-ten-year estimate is reliable
-89abecause it accords with GSK’s own estimate. GSK began
its Phase III studies for Priorix in the United States in
2012 and launched in 2022. Because there is a rational
factual basis underlying Dr. Copmann’s estimate that it
would take 8 to 10 years for Priorix to come to the market,
the Court finds his opinion admissible. Additionally, the
Court finds it would be helpful to the trier of fact.
In sum, considering the fact that the Federal Rules of
Evidence illustrate a preference for admitting evidence
that might assist the trier of fact and this policy extends
to the admissibility of expert testimony, the Court finds
Dr. Copmann’s opinions admissible at this time. Cross
examination will be an appropriate means of challenging
this expert testimony. The Court will therefore deny
Merck’s Motion to Exclude Evidence from Dr. Thomas L.
Copmann (ECF No. 305).
V. CONCLUSION
For the reasons set forth above, Merck’s Motion for
Summary Judgment (ECF No. 272) is granted in part and
denied in part and Merck’s Motion to Exclude Evidence
from Dr. Thomas L. Copmann (ECF No. 305) is denied.
An appropriate Order will follow.
BY THE COURT:
/s/ Chad F. Kenney
CHAD F. KENNEY, JUDGE
-90aAppendix C
___________________
UNITED STATES COURT OF APPEALS
FOR THE THIRD CIRCUIT
No. 23-3089
IN RE: MERCK MUMPS VACCINE ANTITRUST
LITIGATION
MERCK & CO., INC.,
Appellant
(D.C. No. 2-12-cv-03555)
SUR PETITION FOR REHEARING
Present: CHAGARES, Chief Judge; HARDIMAN,
SHWARTZ, KRAUSE, BIBAS, PORTER, MATEY,
PHIPPS, FREEMAN, MONTGOMERY-REEVES, and
CHUNG, Circuit Judges
The petition for rehearing filed by Appellees in the
above-entitled case having been submitted to the judges
who participated in the decision of this Court and to all the
other available circuit judges of the circuit in regular
active service, and no judge who concurred in the decision
having asked for rehearing, and a majority of the judges
-91aof the circuit in regular service not having voted for
rehearing, the petition for rehearing by the panel and the
Court en banc, is denied. Judge Shwartz, Judge Krause,
and Judge Restrepo voted to grant the petition for
rehearing.
BY THE COURT,
s/Tamika R. Montgomery-Reeves
Circuit Judge
Dated: February 10, 2025
JK/cc: All Counsel of Record
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