In re: Avandia Marketing v.
CourtCourt of Appeals for the Third Circuit
Date FiledJuly 21, 2026
Docket25-2278
StatusPublished
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Full Opinion
PRECEDENTIAL
UNITED STATES COURT OF APPEALS
FOR THE THIRD CIRCUIT
_____________
No. 25-2278
In re: AVANDIA MARKETING, SALES PRACTICES and
PRODUCTS LIABILITY LITIGATION,
GlaxoSmithKline LLC,
Appellant
On Appeal from the United States District Court
for the Eastern District of Pennsylvania
(D.C. Civil Action No. 2:07-md-01871)
District Judge: Honorable Cynthia M. Rufe
Argued on February 26, 2026
Before: SHWARTZ, MONTGOMERY-REEVES, and
AMBRO, Circuit Judges
(Opinion filed July 21, 2026)
Devora W. Allon (Argued)
Jay P. Lefkowitz
Kevin M. Neylan, Jr.
Kirkland & Ellis
601 Lexington Avenue
New York, NY 10022
Cole Carter
Kirkland & Ellis
333 W Wolf Point Plaza
Chicago, IL 60654
Kyle A. Dolinsky
Troutman Pepper Locke
11682 El Camino Real
Suite 400
San Diego, CA 92130
Robin P. Sumner
Troutman Pepper Locke
3000 Two Logan Square
18th and Arch Streets
Philadelphia, PA 19103
Counsel for Appellant
Hannah W. Brennan
Erin C. Burns
Thomas M. Sobol (Argued)
Hagens Berman Sobol Shapiro
One Faneuil Hall Square
5th Floor
Boston, MA 02109
2
Edwina Bullard Clarke
David Zimmer
Zimmer Citron & Clarke
711 Atlantic Avenue
Sixth Floor
Boston, MA 02111
Joseph H. Meltzer
Jonathan F. Neumann
Terence S. Ziegler
Kessler Topaz Meltzer & Check
280 King of Prussia Road
Radnor, PA 19087
Julia Solomon-Strauss
Zimmer Citron & Clarke
14 Ridge Square NW
Suite 328
Washington, DC 20016
Anne-Marie J. De Bartolomeo
Kaplan Fox & Kilsheimer
1999 Harrison Street
Suite 1501
Oakland, CA 94612
Counsel for Appellees
OPINION OF THE COURT
3
AMBRO, Circuit Judge
We do not presume in law that x caused y merely
because x happened first. The connection might be causal. But
it might be coincidental. Or some z might be responsible for x
and y alike. As statisticians emphasize, correlation alone does
not prove causation.
One method experts have developed for distinguishing
true causation from mere correlation is multiple regression
analysis. It can “define statistically the relationship between a
dependent variable (e.g., salary) and one or more independent
variables (e.g., education or work experience),” enabling us to
conclude with confidence that the latter is the reason for the
former (or is at least one reason). Weisfeld v. Sun Chem. Corp.,
84 F. App’x 257, 261 n.3 (Table) (3d Cir. 2004); see also 1
David L. Faigman et al., Mod. Sci. Evidence § 6.1 (2025-2026
ed.). It can also enable us “to control for other independent
variables” so we can rule out competing explanations (or at
least rule them unlikely). Id. And it can quantify how much of
a difference the cause makes to the effect. Thus, although it
may be that “[t]he only empirical facts . . . we can discover
about the world are facts about correlation,” regression
analysis can justify the “inference” of causation by “testing and
attempted invalidation” of other “causal hypotheses.” See
United States v. Mosley, 454 F.3d 249, 266 (3d Cir. 2006).
This appeal raises this issue and more. Third-party
payors (“TPPs”) who covered prescriptions for the diabetes
medication Avandia brought a putative class action against the
manufacturer, GlaxoSmithKline LLC (“GSK”), for
misrepresenting the drug’s cardiovascular risks and benefits.
GSK’s misrepresentations, they claim, caused more health care
4
providers (we use “physicians,” “prescribers,” and similar
terms interchangeably) to prescribe Avandia than cheaper
alternatives. That, in turn, allegedly caused these TPPs to
reimburse patients for Avandia that otherwise would not have
been prescribed.
GSK challenges the District Court’s certification of the
class. It argues the proposed class is not ascertainable because
there is not enough evidence to identify which TPPs
reimbursed members for the drug. And it contends common
issues do not predominate on causation because the plaintiffs
lack class-wide evidence GSK’s fraud caused them to cover
more Avandia prescriptions than they would have otherwise.
Their evidence, GSK contends, shows only correlation, not
causation.
Though we hold the proposed class is ascertainable, we
part with the District Court’s ruling that common issues would
predominate on causation. We join the other circuits that have
addressed this issue—the First, Second, and Ninth—and
conclude that plaintiffs in a pharmaceutical fraud RICO class
action may use statistical evidence to prove the defendant was
responsible for their injuries when the evidence can establish
causation, not merely correlation. The Plans’ statistical
evidence does not satisfy this standard yet. After laying out the
type of statistical evidence that may be used to prove causation
in a case like this one, we vacate the District Court’s
certification of the class and remand for further fact-finding on
predominance under the clarified standard.
I. BACKGROUND
5
In 1999, the Food and Drug Administration (“FDA”)
approved a new treatment for Type II diabetes: Avandia.1
GSK, its developer, sold it for a higher price than the drug’s
older rivals, like metformin. But GSK said Avandia was worth
the premium. According to the pharmaceutical company’s
marketing, Avandia would not help patients manage only their
blood sugar. It would also reduce their cardiovascular risks.
To diabetics, that mattered. Roughly two-thirds of diabetes
patients die of cardiovascular conditions. So despite Avandia’s
higher cost, health insurers added it to their formularies and
reimbursed patients. In the years following FDA approval,
Avandia prescriptions soared. In 2006 alone, GSK sold $2.2
billion of the drug in the United States.
Meanwhile, GSK’s own research began to suggest an
inconvenient truth: the drug actually posed distinctive
cardiovascular risks. In 2004, GSK began an internal meta-
analysis, that is, a study of what existing clinical trials
indicated about Avandia’s cardiovascular profile. See In re
Paoli R.R. Yard PCB Litig., 916 F.2d 829, 856 (3d Cir. 1990)
(defining as “meta-analysis” a study “combining the results of
different . . . studies done by other scientists, and re-analyzing
the combined data to see if the data, in toto, renders different
results than the individual studies done with a smaller data
sample”). That September, it completed its initial review of
those trials, the precursor to the study later dubbed ICT-37.
1
We limit our recitation of the facts, as we have recounted
them in two prior precedential opinions in this case. See In re
Avandia Mktg., Sales Practices & Prod. Liab. Litig., 804 F.3d
633 (3d Cir. 2015); In re Avandia Mktg., Sales Practices &
Prod. Liab. Litig., 945 F.3d 749 (3d Cir. 2019), cert. denied,
141 S. Ct. 265 (Mem).
6
GSK did not complete the meta-analysis and present the results
to its safety board as ICT-37 until a year later, September 2005.
The conclusion: Avandia was associated with a statistically
significant increase of serious ischemic events (compromises
of the blood flow to the heart causing heart attack, disability,
or death). GSK nonetheless did not immediately update the
drug’s label or ask the FDA for permission to do so.
In February 2006, GSK completed a new meta-analysis,
reexamining the results of the clinical trials it examined in ICT-
37 and evaluating five additional ones. This study, ICT-42,
reached the same conclusion: Avandia posed serious
cardiovascular risks. In August the same year, the company
asked the FDA for permission to add a warning to Avandia’s
label, notifying patients that ICT-42 found the drug caused a
statistically significant risk of an increase in myocardial
ischemic events. In May 2007, GSK also asked to make that
warning clearer and more prominent.
Then—before the FDA had ruled on either of these
requests—the truth reached the public. The New England
Journal of Medicine published a study of Avandia by Dr. Steve
Nissen (the “Nissen study”). It found Avandia “was associated
with a significant increase in the risk of myocardial infarction
and with an increase in the risk of death from cardiovascular
causes that had borderline significance.” JA 443. The FDA
denied GSK’s requests to change the label, then demanded that
it make more dramatic changes to address the Nissen study and
other emerging research. By the end of 2007, the FDA had
directed GSK to add a “black-box warning”2 conveying that
2
Though officially called a “boxed warning,” the term refers
to the FDA’s most stringent safety alert communicated through
7
Avandia could cause or exacerbate congestive heart failure and
increase the risk of myocardial ischemic events.
Prescriptions plummeted. Between 2004 and 2006,
doctors prescribed Avandia about 1.2 million times per month.
By the end of 2007, that number was below 500,000
prescriptions per month. After over 50 additional clinical trials,
the FDA enhanced the black-box warning and restricted
distribution of Avandia.3
Consequences followed. In 2012, GSK pled guilty to
one count of failing to report clinical data to the FDA and
agreed to pay a criminal fine of nearly $250 million. GSK also
reached a civil settlement for misrepresenting Avandia’s
cardiac risks in violation of the False Claims Act, 31 U.S.C. §
3729, and agreed to pay the federal Government over $500
million.
United Food and Commercial Workers Local 1776 and
Participating Employers Health and Welfare Fund (“UFCW”),
along with J.B. Hunt Transport Services, Inc. (“J.B. Hunt”),
provide prescription drug coverage to their members or
employees. In 2010, they sued GSK on behalf of a proposed
a bold, black-bordered notice atop a drug’s label or package
insert. See generally 21 C.F.R. § 201.57(c)(1) (explaining that
black-box warnings reveal “[c]ertain contraindications or
serious warnings, particularly those that may lead to death or
serious injury”).
3
In 2013, the FDA relaxed these restrictions and removed the
black-box warning for myocardial ischemic events (blocked
blood vessels), but it retained the one for myocardial infarction
(heart attack).
8
class of TPPs (the “Plans”) that paid for Avandia, alleging
violations of the Racketeer Influenced and Corrupt
Organizations Act (“RICO”), 18 U.S.C. § 1962(c), and a host
of state laws. Their cases were combined into the In re Avandia
Marketing, Sales Practices and Products Liability multi-
district litigation.
The Plans alleged GSK fraudulently misrepresented
Avandia’s true cardiovascular profile, marketing the drug for
its supposed cardiovascular benefits while failing to disclose
its real cardiovascular risks. In reliance on GSK’s
misrepresentations, they included Avandia on their formularies
even though the drug cost more than the alternatives and
covered more Avandia prescriptions than they would have
absent the fraud.
GSK moved to dismiss the complaint for failure to state
a claim, contending in relevant part that the Plans had failed to
allege plausibly they suffered an economic injury and that
GSK’s alleged fraud was its proximate cause. In re Avandia
Mktg., Sales Practices & Prod. Liab. Litig., 804 F.3d 633, 637
(3d Cir. 2015) (“Avandia I”). The District Court denied the
motion as to the RICO claim, holding the plaintiffs plausibly
alleged GSK’s misrepresentations about Avandia’s cardiac
benefits deprived them of “the substantial savings they would
have experienced had they covered cheaper alternatives to
Avandia.” Id. We affirmed. Id. at 634.
In 2016, GSK moved for summary judgment on the
grounds the federal Food, Drug, and Cosmetic Act, 21 U.S.C.
Ch. 9, preempted the remaining state law claims and that the
Plans had failed to create a genuine dispute of material fact
about the existence of a RICO enterprise. In re Avandia Mktg.,
9
Sales Practices & Prod. Liab. Litig., 945 F.3d 749, 756 (3d
Cir. 2019), cert. denied, 141 S. Ct. 265 (Mem). The District
Court granted summary judgment for GSK. Id. We reversed
the Court’s order on the state law claims and vacated its order
on the RICO claims, holding the Plans were entitled to
discovery on the latter. Id. at 752–53.
In May 2023, the Plans moved to certify the following
class:
All entities in the United States of America and
its territories, which indirectly purchased, and/or
provided reimbursement for some or all of the
purchase price for the drugs Avandia,
Avandamet, and/or Avandaryl from May 25,
1999 until August 14, 2007.4
Included in the Class are self-insured non-
governmental entities and third-party payers that
offer insured plans to private individuals and
groups. Likewise third-party payers that offer
insured plans to government entities including
the Federal Employee Program, Managed
Medicaid, and Medicare Part D are class
members.
They also proposed five exclusions:
(i) governmental entities other than
municipalities and/or local governments with
self-funded prescription drug plans; (ii) fully
4
We use Avandia throughout to refer to all three drugs.
10
insured health plans, i.e., plans for which the
insurer bears 100% of the risk for the
reimbursement obligations to members; (iii)
pharmacy benefit managers; (iv) natural person
consumers; and (v) employees of [GSK],
including its officers or directors, and
subsidiaries and affiliates.
And they later agreed to narrow the class period to January 1,
2005 to August 14, 2007.
In support of their motion for class certification, the
Plans moved to introduce two expert reports. The first, from
Dr. Meredith Rosenthal, sought to prove causation. She offered
two main opinions: (a) GSK’s misrepresentations of Avandia’s
health benefits were responsible for a significant portion of the
prescriptions the Plans covered; and (b) 41% of prescriptions
in the class period would not have happened but for the fraud.
Dr. Rosenthal based these conclusions on a multiple regression
analysis performed to isolate the causal significance of GSK’s
misrepresentations on prescription volume.
The Plans introduced the second report, from Dr.
Thomas McGuire, to prove damages. Using several models, he
estimated damages totaling between $500 million and over $2
billion. As relevant here, one model—the Scenario 1 Step
Down Adjustment—assumed the earlier publication of ICT-37
would have caused a similar decline in prescriptions as did the
actual publication of the Nissen study. On that assumption,
Dr. McGuire calculated damages by applying the percentage
decline in prescriptions after that study to the earlier time
period and estimated damages of around $1 billion.
11
GSK moved to exclude both reports. In October 2024,
after a Daubert hearing, the District Court granted GSK’s
motion to exclude the Rosenthal report and granted in part and
denied in part its motion to exclude the McGuire report. The
Court found Dr. Rosenthal’s opinions unreliable because her
regression model deviated from the standards of her field and
the deviations were consequential. The model appeared
“results-oriented” and particularly susceptible to false
positives. In re Avandia Mktg., Sales Pracs. & Prods. Liab.
Litig., No. 07-MD-1871, 2024 WL 4582876, at *10–11 (E.D.
Pa. Oct. 25, 2024). For instance, not only did it show a
statistically significant positive causal relationship between
prescription volume and GSK’s promotion of Avandia, it also
indicated a statistically significant positive causal relationship
between prescription volume and obviously irrelevant
variables, like U.S. carbon emissions. So the District Court
granted the motion to exclude it. The Court found one of Dr.
McGuire’s models unreliable because it depended on Dr.
Rosenthal’s opinions and rejected others as unreliable on their
own merits. The Court nonetheless left one standing: the
Scenario 1 Step Down Adjustment, explained above. The Plans
did not appeal the District Court’s evidentiary rulings.
In May 2025, the District Court granted the Plans’
motion to certify the class. First, it held the proposed class
satisfied the elements of Federal Rule of Civil Procedure 23(a):
numerosity, commonality, typicality, and adequacy of
representation. GSK did not contest any of the Rule 23(a)
issues. Second, the Court ruled that the proposed class satisfied
Rule 23(b)(3); in relevant part, it held the Plans established that
common questions would predominate and that the proposed
class was ascertainable.
12
GSK argued the Plans had not proven common
questions would predominate on one element of their RICO
claim: causation. The Plans advanced a quantity-effect theory
of causation: that GSK’s misrepresentations about Avandia’s
cardiac profile led doctors to issue more Avandia prescriptions,
which in turn led the Plans to reimburse more prescriptions for
this expensive drug. GSK claimed that individualized issues
would predominate over common ones. It offered two
arguments on this point.
First, GSK insisted, questions of reliance are typically
individual questions: they turn on why particular doctors
issued particular prescriptions to particular patients. Matters
like that, it said, are not susceptible to proof by class-wide
evidence. The District Court rejected GSK’s argument. It held
that the Plans had introduced enough common evidence to
justify an inference of “class-wide reliance,” emphasizing two
forms of evidence. In re Avandia Mktg., Sales Pracs. & Prods.
Liab. Litig., No. 07-MD-1871, 2025 WL 1479618, at *7 (E.D.
Pa. May 22, 2025). They had common evidence of the alleged
uniform scheme to cover up the drug’s dangers, like marketing
materials touting Avandia’s cardiac benefits and testimony
from GSK employees about the success of that marketing. And
they also had, the District Court found, statistical evidence that
GSK’s marketing mattered: internal GSK studies showed that
some of its marketing campaigns increased prescriptions.
Together, the Court determined, these two forms of common
evidence could prove causation.5
5
Along the way, it rejected GSK’s argument that the
individualized nature of providers’ decision-making precluded
an inference of reliance. As the Court saw the matter, “even
though the decision to prescribe Avandia is not ‘one-
13
Second, GSK argued, even if causation could be proven
on a class-wide basis by these two forms of common evidence,
the evidence here was insufficient. Specifically, according to
GSK, its internal studies played a key role in the Plans’
common evidence. But those studies did not isolate causation.
And, without causation isolated, they could not serve as class-
wide evidence capable of proving it. While the District Court
acknowledged GSK’s second argument, it did not articulate the
reasons for rejecting it.
On ascertainability, the Plans proposed to identify
members of the class through a combination of drug purchase
records for GSK, a data publisher’s list of entities that paid for
Avandia, and a pharmaceutical database, supplemented by
affidavits to confirm membership. GSK argued there would not
be enough reliable evidence to determine which prospective
class members had actually covered Avandia prescriptions.
After a careful review of the record, the District Court rejected
these concerns. So it held the class was ascertainable and
granted the motion to certify.
dimensional,’ it is not so subjective that a provider’s reliance
cannot be inferred.” Avandia, 2025 WL 1479618, at *8. It
acknowledged “there are many factors that impact a provider’s
decision to prescribe one medication over another.” Id. Yet it
perceived “every provider’s goal when considering whether to
prescribe Avandia is largely the same—to treat a patient’s
diabetes without otherwise causing harm to their health.” Id.
And it thought “providers generally consider the same set of
factors” with minimal patient-by-patient variation. Id.
14
In June 2025, GSK petitioned us for permission to
appeal under Federal Rule of Civil Procedure 23(f). We
granted it, and this appeal followed.
II. JURISDICTION AND STANDARDS OF REVIEW
The District Court had jurisdiction under 28 U.S.C. §
1331. We have jurisdiction under 28 U.S.C. § 1292(e) and
Federal Rule of Civil Procedure 23(f). We review the
certification of a class for abuse of discretion, “which occurs if
the district court’s decision rests upon a clearly erroneous
finding of fact, an errant conclusion of law, or an improper
application of law to fact.” In re Hydrogen Peroxide Antitrust
Litig., 552 F.3d 305, 312 (3d Cir. 2008) (cleaned up).
III. DISCUSSION
GSK challenges the District Court’s holdings that the
class is ascertainable and that common issues would
predominate on causation. We asked the parties to brief a third,
threshold issue: the scope of our review of a Rule 23(f) appeal.
That is where we begin.
A. We may limit the scope of our review under Rule 23(f).
Rule 23(f) provides that a “court of appeals may permit
an appeal from an order granting or denying class-action
certification under this rule.” Fed. R. Civ. P. 23(f). The text
does not expressly address whether a motions or merits panel
may limit review to specific questions. No precedent of ours
directly answers this question either. However, since Rule
23(f)’s inception, we have analogized it to another
interlocutory appeal provision, 28 U.S.C. § 1292(b). Under that
15
subsection, we may choose which issues we review when we
accept and decide an appeal. For this reason, we now hold we
have the same discretion under Rule 23(f).
Rule 23(f) models § 1292(b). Newton v. Merrill Lynch,
Pierce, Fenner & Smith, Inc., 259 F.3d 154, 163 (3d Cir. 2001)
(citing 7B Charles Alan Wright, Arthur R. Miller & Mary Kay
Kane, Fed. Prac. & Proc. § 1802 (West Supp. 2000)). The
statute authorizes us to permit an interlocutory appeal of a non-
final order that “involves a controlling question of law as to
which there is substantial ground for difference of opinion”
where “an immediate appeal from the order may materially
advance the ultimate termination of the litigation.” 28 U.S.C. §
1292(b). As the Supreme Court has explained, “[c]ourts of
appeals wield ‘unfettered discretion’ under Rule 23(f), akin to
the discretion afforded circuit courts under § 1292(b). But Rule
23(f) otherwise ‘departs from the § 1292(b) model,’ for it
requires neither district court certification nor adherence to §
1292(b)’s other ‘limiting requirements.’” Microsoft Corp. v.
Baker, 582 U.S. 23, 31 (2017) (quoting Comm. Note on Rule
23(f)). In short, Rule 23(f) is the class-action version of §
1292(b), save that it confers on courts of appeals even greater
discretion.
Under § 1292(b), we may choose which issues to
review. The Supreme Court has taken care to use permissive
rather than mandatory language in characterizing appellate
courts’ power over the scope of our review in § 1292(b)
appeals. Yamaha Motor Corp., U.S.A. v. Calhoun held that a
court of appeals has appellate jurisdiction over the entire order
certified for appeal because “it is the order that is appealable,”
not the certified question. 516 U.S. 199, 205 (1996) (emphasis
omitted) (quoting 9 J. Moore & B. Ward, Moore’s Federal
16
Practice ¶ 110.25[1], p. 300 (2d ed. 1995). The Court could
have said a court of appeals must consider every question the
parties raise. It did not. Instead, it consistently said that appeals
courts may do that. See, e.g., id. at 205.
We too have taken care to use permissive words like
“may” and “can,” rather than mandatory language like “must”
or “shall,” in the § 1292(b) context. See, e.g., Lundeen v. 10 W.
Ferry St. Operations LLC, 156 F.4th 332, 337 (3d Cir. 2025)
(“Although the District Court certified a single question, our
review may reach any matter ‘fairly included within the
certified order.’” (emphasis added) (quoting Barbato v.
Greystone All., LLC, 916 F.3d 260, 264 (3d Cir. 2019)));
Gruber v. Price Waterhouse, 911 F.2d 960, 963 (3d Cir. 1990)
(“[S]ince we review orders and not isolated legal questions, we
may consider all grounds that might require reversal of the
order.” (emphasis added) (citation omitted)); see also McMunn
v. Babcock & Wilcox Power Generation Grp., 869 F.3d 246,
266 (3d Cir. 2017) (noting “may” is permissive).
This permissive language is no accident. It reflects the
position we adopted around the same time we started writing
on these discretionary terms: on a § 1292(b) appeal, “we are
free to consider ‘all grounds advanced in support of [reversal]
and all grounds suggested for [affirmance].’” See Miller v.
Bolger, 802 F.2d 660, 666 (3d Cir. 1986) (quoting Struble v.
N.J. Brewery Emps.’ Welfare Tr. Fund, 732 F.2d 325, 336 n.10
(3d Cir. 1984)). “In deciding whether to exercise that power,
we are guided by prudential considerations”—not by any
obligation to consider every challenge the appellant raises. Id.
Were there any doubt, in 1988 our full Court adopted
these expressly permissive terms for § 1292(b) appeals,
17
providing that we “may consider all grounds that might require
reversal of the order appealed from.” In re Data Access Sys.
Sec. Litig., 843 F.2d 1537, 1539 (3d Cir. 1988) (en banc)
(emphasis added) (citing Merican, Inc. v. Caterpillar Tractor
Co., 713 F.2d 958, 962 n.7 (3d Cir. 1983)), superseded on other
grounds by statute as stated in In re Exxon Mobil Corp. Sec.
Litig., 500 F.3d 189, 198 (3d Cir. 2007).
We have refused to consider a ground for reversal on a
§ 1292(b) appeal at least three times: in Miller, 802 F.2d at
666–67; Resol. Tr. Corp. v. Cityfed Fin. Corp., 57 F.3d 1231,
1236 & n.6 (3d Cir. 1995), vacated on other grounds sub nom.
Atherton v. FDIC, 519 U.S. 213 (1997); and most recently in
this very case. A decade ago, we heard an appeal from the
District Court’s denial of GSK’s motion to dismiss for failure
to state a claim. See Avandia I, 804 F.3d at 637. GSK had
moved to dismiss all of the Plans’ claims, federal and state. See
id. at 636–37 & n.9. The District Court certified for appeal
three questions about its denial of the motion to dismiss the
federal-law claims. Id. at 637. Even though GSK asked us to
reverse on the state-law claims as well, we refused to consider
them. Id. at 637 n.11.
The lesson of our § 1292(b) practice: we may
circumscribe the scope of our review, refusing to consider
asserted grounds for reversal. See 16 Charles Alan Wright,
Arthur R. Miller & Edward H. Cooper, Fed. Prac. & Proc. §
3931.1 (3d. ed. 2026).
To be sure, in the more distant past we declared that
“[o]n a Section 1292(b) appeal we consider all grounds which
might require a reversal of the order appealed from.” Murphy
v. Heppenstall Co., 635 F.2d 233, 235 n.1 (3d Cir. 1980); see
18
also Merican, 713 F.2d at 962 n.7 (same); In re Sch. Asbestos
Litig., 789 F.2d 996, 1002 & n.5 (3d Cir. 1986) (same). But
these cases predate our 1988 en banc decision in Data Access.
Since then, we have never repeated the arguably mandatory
language. Instead, we have used the permissive version. See,
e.g., Howard Hess Dental Lab’ys Inc. v. Dentsply Int’l, Inc.,
424 F.3d 363, 368–69 (3d Cir. 2005) (“We may ‘consider all
grounds which might require a reversal of the order appealed
from.’” (emphasis added) (quoting Merican, 713 F.2d at 962
n.7)).6
There are two caveats. First, we cannot set aside
challenges to our subject matter jurisdiction. See Fox v.
Saginaw Cnty., 67 F.4th 284, 292 (6th Cir. 2023). Even if a
motions panel purported to refuse review of a jurisdictional
question, the merits panel not only may, but must, address it.
Cf. Council Tree Commc’ns, Inc. v. FCC, 503 F.3d 284, 292
6
There is also some language in Katz v. Carte Blanche
Corporation, 496 F.2d 747 (3d Cir. 1974) (en banc), cert.
denied, 419 U.S. 885 (1974), that one could read as requiring
us to consider any argument that a district court erroneously
certified a class, see id. at 756. Even if that were the right
reading of Katz, it would not survive our decision in Link v.
Mercedes-Benz of North America, Inc., 550 F.2d 860 (3d Cir.
1977) (en banc). The case presented two questions: whether
the District Court erred in certifying a class and whether it
could bifurcate the trial and use separate juries for the liability
phase and damages phase were liability found. Id. at 861–62.
Even though a motions panel had granted permission to appeal
these matters, id. at 862, the full Court declined to rule on either
one, id. at 861, 864–65; see also Sperling v. Hoffman-La Roche
Inc., 862 F.2d 439, 443–44 (3d Cir. 1988).
19
(3d Cir. 2007). Second, as the history we have recounted
reveals, although a motions panel is free to specify the issues
for the merits panel to review, the merits panel may refuse to
answer them. See, e.g., Link v. Mercedes-Benz of North
America, Inc., 550 F.2d 860, 861, 864–65 (3d Cir. 1977) (en
banc).
In sum, Rule 23(f) essentially mirrors § 1292(b). To the
extent they differ, Rule 23(f) provides more discretion, not
less. Under § 1292(b), we may limit the scope of our review of
an order to select issues. We have exercised this discretion for
decades. There is no reason to think we may not do the same
on a Rule 23(f) appeal. Accordingly, we hold we may
circumscribe review of a Rule 23(f) appeal to the issues we
choose.
B. The proposed class is ascertainable.
Class certification is warranted when the putative class
meets the requirements of Rule 23(a) and Rule 23(b)(1), (2), or
(3). See Reyes v. Netdeposit, LLC, 802 F.3d 469, 482 (3d Cir.
2015). Here, there is no dispute the Plans satisfied Rule 23(a).
What is disputed is whether they satisfy two requirements of
Rule 23(b)(3): predominance and ascertainability. Although
we do not believe the ascertainability issue presented in this
case merits review, we briefly address it out of respect for the
parties.
To establish ascertainability, the plaintiffs must prove
that “(1) the class is defined with reference to objective
criteria” and “(2) there is a reliable and administratively
feasible mechanism for determining whether putative class
members fall within the class definition.” In re Niaspan
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Antitrust Litig., 67 F.4th 118, 130 (3d Cir. 2023) (quoting
Hargrove v. Sleepy’s LLC, 974 F.3d 467, 469–70 (3d Cir.
2020)). That happens when membership can be determined
from a combination of objective records and verifiable
affidavits from potential members. See Byrd v. Aaron’s Inc.,
784 F.3d 154, 171 (3d Cir. 2015); Hargrove, 974 F.3d at 480;
City Select Auto Sales Inc. v. BMW Bank of N. Am. Inc., 867
F.3d 434, 441 (3d Cir. 2017). The Plans intend to determine
membership using this very combination of evidence:
identifying potential members with Avandia purchase and
reimbursement records, then confirming actual membership
with an affidavit and proof of purchase.
GSK nonetheless advances two arguments that the
Plans failed to prove there is a reliable and feasible mechanism
for identifying class members. First, it contends there are no
records of which putative members reimbursed Avandia
prescriptions in the class period. Second, it asserts that even if
those records existed, they would not indicate whether a
putative member was an end-payor (thus eligible for class
membership) or was fully insured (hence ineligible for class
membership).
The District Court’s finding that there are objective
records of the Plans’ reimbursements for Avandia prescriptions
has no clear error. We note that two named plaintiffs—Allied
Services Division Welfare Fund and United Benefit Fund
(“UBF”)—dropped out of the case when they could not obtain
purchase records from their pharmaceutical benefit managers
(“PBMs”). But, after receiving a subpoena, UBF’s PBM
provided the data, showing it has (or at least had) the records
after all. Even if PBMs could not provide the requisite data, the
District Court’s finding that class members would be able to
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corroborate their claims was not clearly erroneous because a
potential class member’s affidavit can be corroborated using
multiple forms of documentation.
The District Court’s finding the Plans will be able to
distinguish end-payors from fully insured plans did not clearly
err either. GSK claims that most TPPs will rely on PBM
purchase records to establish their membership in the class.
Generally, those documents do not identify whether a
purchaser was an end-payor. See Niaspan, 67 F.4th at 136. The
Plans, however, do not propose to rely on PBM data alone; the
record contained ample evidence they would be able to use
other resources to distinguish end-payors from fully insured
TPPs.
In a final bid to prevent class certification, GSK frames
the Plans’ proposal as a dilemma. In its view, the proposal
permits potential class members to identify themselves—
violating our admonition that ascertainability cannot rest on
mere say-so—or it depends on individualized evidence, risking
the very mini-trials the ascertainability requirement exists to
prevent. See id. at 130–31.
This dilemma is illusory. The Plans’ proposal for
distinguishing end-payors from fully insured plans does not
rely on mere say-so. Each potential class member’s payor
status would be verified with documentation like receipts,
claims data, plan documents, or public records. And using
these records to confirm a TPP is an end-payor hardly
constitutes a mini-trial. To the contrary, it is the
“straightforward ‘yes-or-no’ review of existing records to
identify class members” we have held “is administratively
feasible even if it requires review of individual records with
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cross-referencing of voluminous data from multiple sources.”
Kelly v. RealPage Inc., 47 F.4th 202, 224 (3d Cir. 2022).
The Plans’ proposal falls well within the bounds of our
precedents, leaving no abuse of discretion in holding the class
is ascertainable.
C. The record so far does not show that common issues
would predominate.
Rule 23(b)(3) requires “questions of law or fact
common to class members predominate over any questions
affecting only individual members.” Reyes, 802 F.3d at 482
(quoting Fed. R. Civ. P. 23(b)(3)). “An individual question is
one where ‘members of a proposed class will need to present
evidence that varies from member to member,’ while a
common question is one where ‘the same evidence will suffice
for each member to make a prima facie showing [or] the issue
is susceptible to generalized, class-wide proof.’” Tyson Foods,
Inc. v. Bouaphakeo, 577 U.S. 442, 453 (2016) (alteration in
original) (quoting 2 W. Rubenstein, Newberg on Class Actions
§ 4:50 196–97 (5th ed. 2012)).
“[T]he presence of individual questions does not per se
rule out a finding of predominance.” In re Prudential Ins. Co.
Am. Sales Prac. Litig. Agent Actions, 148 F.3d 283, 315 (3d
Cir. 1998). Common questions predominate so long as they
“overwhelm individual issues.” Neale v. Volvo Cars of N. Am.,
LLC, 794 F.3d 353, 371 (3d Cir. 2015) (citing Amgen Inc. v.
Conn. Ret. Plans & Tr. Funds, 568 U.S. 455, 468–69 (2013)).
In other words, “[w]hen one or more of the central issues in the
action are common to the class and can be said to predominate,
the action may be considered proper under Rule 23(b)(3) even
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though other important matters will have to be tried separately,
such as damages or some affirmative defenses peculiar to some
individual class members.” Tyson, 577 U.S. at 453–54 (cleaned
up).
“Class certification is proper only ‘if the trial court is
satisfied, after a rigorous analysis, that the prerequisites’ of
Rule 23 are met.” Hydrogen Peroxide, 552 F.3d at 309
(quoting Gen. Tel. Co. of Sw. v. Falcon, 457 U.S. 147, 161
(1982)). “Factual determinations necessary to make Rule 23
findings must be made by a preponderance of the evidence.”
Id. at 320. This requires resolving “every dispute that is
relevant to class certification” before it can be granted.
Ferreras v. Am. Airlines, 946 F.3d 178, 183 (3d Cir. 2019).
We “analyze predominance in the context of Plaintiffs’
actual claims” because “the nature of the evidence that will
suffice to resolve a question determines whether the question
is common or individual.” Neale, 794 F.3d at 371–72 (quoting,
in second passage, Hydrogen Peroxide, 552 F.3d at 311). That
means class-wide evidence of each element of the cause of
action must predominate over evidence particular to individual
class members. See Reyes, 802 F.3d at 482–83, 489; see also
Hydrogen Peroxide, 552 F.3d at 311 (“If proof of the essential
elements of the cause of action requires individual treatment,
then class certification is unsuitable.” (cleaned up)).
Accordingly, here predominance is “satisfied if each element
of the alleged RICO violation involves common questions of
law and fact capable of proof by evidence common to the
class.” Reyes, 802 F.3d at 489 (emphasis omitted).
“Establishing liability under [§ 1962(c)] of the RICO
statute requires (1) conduct (2) of an enterprise (3) through a
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pattern (4) of racketeering activity, plus an injury to business
or property.” Id. (alteration in original) (quoting In re Ins.
Brokerage Antitrust Litig., 579 F.3d 241, 269 (3d Cir. 2009)).
Implicit is a requirement that the racketeering activity was the
but-for cause of the alleged injury. Id. “The simplest statement
of the concept of but-for causation is that event A is a but-for
cause of event B if event B could not happen without event A
happening first.” Mosley, 454 F.3d at 266.
“Although reliance on the defendant’s alleged
misrepresentation is not an element of a RICO mail-fraud
claim, the plaintiffs’ theory of injury in most RICO mail-fraud
cases will nevertheless depend on establishing that someone—
whether the plaintiffs themselves or third parties—relied on the
defendant’s misrepresentation.” Sergeants Benevolent Ass’n
Health & Welfare Fund v. Sanofi-Aventis U.S. LLP, 806 F.3d
71, 87 (2d Cir. 2015) cert. denied, 580 U.S. 825 (2016).
That is because reliance will typically be a
necessary step in the causal chain linking the
defendant’s alleged misrepresentation to the
plaintiffs’ injury: if the person who was allegedly
deceived by the misrepresentation (plaintiff or
not) would have acted in the same way regardless
of the misrepresentation, then the
misrepresentation cannot be a but-for, much less
proximate, cause of the plaintiffs’ injury.
Id.
Because “reliance is nearly always an individualized
question,” Harnish v. Widener Univ. Sch. of L., 833 F.3d 298,
309 (3d Cir. 2016), establishing predominance on causation in
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a putat