PRECEDENTIAL

UNITED STATES COURT OF APPEALS

FOR THE THIRD CIRCUIT

_____________

No. 18-1010

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IN RE: AVANDIA MARKETING, SALES 

AND PRODUCTS LIABILITY LITIGATION

UFCW Local 1776 and Participating Employers Health

and Welfare Fund; J.B. Hunt Transport Services, Inc.,

Appellants

______________

On Appeal from the United States District Court

for the Eastern District of Pennsylvania

(District Court Nos. 2-07-md-01871, 2-10-cv-02475, 2-11-cv04013)

District Judge: Hon. Cynthia M. Rufe

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Argued: March 6, 2019

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Before: SMITH, Chief Judge, AMBRO and RESTREPO, 

Circuit Judges.

(Filed: December 17, 2019)
2

Thomas M. Sobol [ARGUED]

Hannah W. Brennan

Edward Notargiacomo

Kiersten A. Taylor

Hagens Berman Sobol Shapiro

55 Cambridge Parkway

Suite 301

Cambridge, MA 02142

James R. Dugan, II

Douglas R. Plymale

The Dugan Law Firm

365 Canal Street

Suite 1000

New Orleans, LA 70130

Eric L. Young

McEldrew Young

123 South Broad Street

Suite 2250

Philadelphia, PA 19109

Eric H. Gibbs

Anne-Marie J. de Bartolomeo

Gibbs Law Group

505 14th Street

Suite 1110

Oakland, CA 94612

Counsel for Appellants

Jay P. Lefkowitz [ARGUED]

Thomas S. Burnett

Kirkland & Ellis LLP
3

601 Lexington Avenue

New York, NY 10022

Nina M. Gussack

Anthony C. Vale

Sean P. Fahey

Kyle A. Dolinsky

Hedya Aryani

Jeremy D. Heep

Yvonne M. McKenzie

Pepper Hamilton LLP

3000 Two Logan Square

18th and Arch Streets

Philadelphia, PA 19103

Counsel for Appellee
4

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OPINION OF THE COURT

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RESTREPO, Circuit Judge.

Plaintiffs, two health benefit plans (“Plans”), appeal the 

District Court’s grant of summary judgment in favor of 

Defendant, GlaxoSmithKline LLC (“GSK”), the manufacturer 

of the prescription drug Avandia. The Plans brought suit 

against GSK under various state consumer-protection laws and 

the Racketeer Influenced and Corrupt Organizations Act, 18 

U.S.C. ch. 96 (“RICO”), based on, among other things, GSK’s 

marketing of Avandia. The District Court granted summary 

judgment in favor of GSK on the Plans’ claims, finding, in 

relevant part, that (i) the Plans’ state-law consumer-protection 

claims were preempted by the Federal Food, Drug, and 

Cosmetic Act, 21 U.S.C. ch. 9 (“FDCA”); (ii) the Plans had 

failed to identify a sufficient “enterprise” for purposes of 

RICO; and (iii) the Plans’ arguments related to GSK’s alleged 

attempts to market Avandia as providing cardiovascular 

“benefits” were “belated.” The Plans assert that the District 

Court erred in granting summary judgment, and we agree.

Applying the guidance recently provided by the

Supreme Court in Merck Sharp & Dohme Corp. v. Albrecht, 

139 S. Ct. 1668 (2019), we hold that the Plans’ state-law 

consumer-protection claims are not preempted by the FDCA. 

With respect to their RICO claims, the Plans should have been 

given the opportunity to seek discovery prior to the District 

Court’s granting summary judgment on such claims. Further, 

from the inception of this litigation, the Plans’ claims have 

centered on GSK’s marketing of Avandia as providing superior 
5

cardiovascular outcomes—in other words, cardiovascular 

benefits—as compared to other forms of treatment, and 

therefore, the District Court’s refusal to consider the Plans’ 

“benefits” arguments was in error because those arguments

were timely raised.

Therefore, for the reasons that follow, we will reverse 

in part and vacate in part the order of the District Court granting 

summary judgment in favor of GSK, and we will remand to the 

District Court for further proceedings consistent with this 

opinion.

I.

In May 1999, the Food and Drug Administration 

(“FDA”) approved Avandia (Rosiglitazone), a drug developed 

by GSK, for the treatment of type-2 diabetes. Prior to the 

development of Avandia and similar drugs, physicians 

primarily treated type-2 diabetes by prescribing metformin 

and/or sulfonylureas. GSK, however, marketed Avandia at a 

much higher price point than metformin and sulfonylureas: a 

one-month supply of Avandia cost approximately $220, 

approximately $140 of which typically was covered by 

patients’ health benefit plans, whereas a one-month supply of 

metformin or sulfonylureas cost approximately $50, about $45 

of which typically was covered by patients’ health benefit 

plans.

Despite this cost differential, health benefit plans—

including the Plans—placed Avandia on their formularies as a 

“covered” drug. The Plans, for example, determined that it was 

advantageous to cover the cost of Avandia because GSK 

allegedly marketed Avandia as being capable of both 

controlling a patient’s blood sugar levels and reducing 
6

cardiovascular risk, the latter of which is particularly pertinent 

to type-2 diabetes patients, 65% of whom suffer fatal

cardiovascular-related illnesses or complications. Metformin 

and sulfonylureas—the drugs that constituted the “standard of 

care” for type-2 diabetes prior to Avandia’s development—did 

not decrease cardiovascular risk, and therefore, according to 

the Plans, GSK presented Avandia as a cost-effective 

alternative to those drugs. As a result, health benefit plans 

covered a large portion of the expenses related to patients’ 

prescriptions for Avandia, resulting in approximately $2.2 

billion in U.S. sales in 2006 alone.

In 2006, however, concerns arose that Avandia may in 

fact increase certain cardiac risks. In August of that year, GSK 

submitted a Prior Approval Supplement to the FDA, in which 

GSK sought approval to add information to Avandia’s label

regarding the results of a recent meta-analysis of various 

clinical trials. The meta-analysis, “ICT-42,” demonstrated that 

use of Avandia was associated with a statistically significant 

increase in myocardial ischemic events—events during which 

the heart does not receive adequate oxygen because blood flow 

to it is reduced. In May 2007, GSK submitted an update to its 

Prior Approval Supplement, offering a new formulation of its 

proposed warning with respect to myocardial ischemic events 

that would, among other things, make the warning more 

prominent and clear.

Three days after GSK submitted the update to its Prior 

Approval Supplement, the New England Journal of Medicine

published a study authored by Dr. Steve Nissen regarding 

Avandia (“Nissen Study”), in which Dr. Nissen concluded that 

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 
7

significance.” J. App. 1064. Following the release of the 

Nissen Study, a representative of GSK held a telephone 

conversation with an official at the FDA regarding progress on 

the FDA’s review of the Prior Approval Supplement. 

According to GSK’s representative, who wrote a memo 

memorializing the details of the conversation, the FDA official 

advised that another official within the FDA was “calling for 

withdrawal of [the] approval” of Avandia, and thus, it was 

difficult for FDA officials to agree on labeling language for 

Avandia. Sealed App. 655–56. GSK’s representative then 

proposed implementing the labelling changes with respect to 

myocardial ischemic events through the Changes Being 

Effected (“CBE”) process, which permits a drug manufacturer 

to implement a change to its label prior to approval of such 

label by the FDA. The FDA official “strongly advised against 

proceeding” through the CBE process, stating that doing so 

“may give legitimacy to Dr. Nissen’s data” and “will make 

people think that GSK must have other information.” Id. at 

656. The FDA official concluded the conversation by 

reminding the GSK representative that he “knew the 

regulations,” which state that the drug manufacturer is 

ultimately responsible for making the decision to pursue a 

labelling change through the CBE process. Id.

On June 8, 2007, the FDA sent a letter (“Letter”) to 

GSK regarding the Prior Approval Supplement. In the Letter, 

the FDA stated that it had “reviewed the data provided [by 

GSK in its Prior Approval Supplement] and f[ou]nd [that] the 

information presented [was] inadequate” and that, therefore, 

the Prior Approval Supplement was “not approvable.” Id. at 

660. The FDA stated that it had “concluded that the pooled 

data require[d] further analysis to adequately convey the 

potential risk for increased cardiac ischemia associated” with 
8

use of Avandia. In particular, the FDA stated that it had 

“identified certain subgroups of patients . . . that may be 

particularly vulnerable to experiencing an ischemic event” 

while using Avandia. Id. The FDA then directed GSK to 

provide additional information “to address the deficiency” in 

the Prior Approval Supplement, including “[d]ata from studies 

included in a meta-analysis performed by Dr. Steven Nissen 

published in the New England Journal of Medicine that were 

not included in [GSK’s] pooled analysis,” as well as data from 

various other clinical trials. Id. at 661.

The FDA expressed its view that the “potential risk of 

increased cardiac ischemia [was] a significant finding that may 

impact a large proportion of patients with type[-]2 diabetes,” 

and as a result, the FDA scheduled a joint meeting of two FDA 

advisory committees (“Joint Meeting”) “to discuss the findings 

from th[e Prior Approval Supplement] submission, additional 

data recently requested, and accruing information from 

ongoing clinical trials” of Avandia. Id. The FDA stated that 

the “outcome of th[e Joint M]eeting w[ould] be particularly 

germane to any labeling or other regulatory action needed for 

[Avandia] and should be factored into any resubmission to 

address the above deficiencies.” Id.

Later in 2007, the FDA required GSK to implement 

various changes to Avandia’s label. Subsequent to issuing the 

Letter, the FDA directed GSK to add a black-box warning to 

Avandia’s label with respect to the risk of congestive heart 

failure that (i) advised physicians and patients that Avandia 

“cause[s] or exacerbate[s] congestive heart failure in some 

patients,” (ii) instructed physicians to “observe patients [taking 

Avandia] carefully for signs and symptoms of heart failure,” 

and (iii) warned patients with certain heart conditions not to 

take Avandia. J. App. 708. Following the Joint Meeting, the 
9

FDA additionally directed GSK to add a black-box warning to 

Avandia’s label with respect to the risk of myocardial ischemic 

events, advising physicians and patients that a “meta-analysis 

of 42 clinical studies . . . , most of which compared Avandia to 

placebo, showed Avandia to be associated with an increased 

risk of myocardial ischemic events such as angina or 

myocardial infarction” and that “[t]hree other studies . . . , 

comparing Avandia to some other approved oral antidiabetic 

agents or placebo, have not confirmed or excluded this risk.” 

Id. at 743. The FDA also required GSK to include a longer 

explanation of the data with respect to the risk of myocardial 

ischemic events elsewhere on Avandia’s label.

Approximately three years later, in 2011, the FDA again 

directed GSK to revise the warning on Avandia’s label, 

including the black-box warning, with respect to the risk of 

myocardial ischemic events. By that time, GSK had completed 

fifty-two (52) clinical trials. The FDA’s required warning 

advised physicians and patients that “[a] meta-analysis of 52 

clinical trials . . . , most of which compared Avandia to placebo, 

showed Avandia to be associated with a statistically significant

increased risk of myocardial infraction” and that “[b]ecause of 

the potential increased risk of myocardial infarction, Avandia 

[was] available only through a restricted distribution program.” 

Id. at 786. In a memorandum accompanying its direction to 

implement the labelling changes, the FDA noted that the 

“evidence pointing to a cardiovascular ischemic risk with 

[Avandia] is not robust or consistent,” but that “[n]evertheless, 

there are multiple signals of concern, from varied sources of 

data, without reliable evidence that refutes them.” Id. at 1397.

In November 2013, however, following the 

readjudication of a particular clinical trial (“RECORD Trial”), 

the FDA concluded that while “[o]ne cannot entirely discount 
10

the results of the meta-analysis” that associated Avandia with 

a statistically significant increased risk of myocardial ischemic

events, “the totality of the available evidence does not support 

a marked signal of cardiovascular harm.” Id. at 1656. The 

FDA determined that, following the readjudication of the 

RECORD Trial, Avandia “does not appear to be associated 

with an increased risk of major adverse cardiovascular events 

or death, although a small amount of residual uncertainty 

remains.” Id. at 1657. The FDA directed GSK to revise 

Avandia’s label “to reflect the current level of knowledge 

regarding [its] cardiovascular risk.” Id.

In 2014, GSK revised Avandia’s label pursuant to the 

FDA’s direction. GSK removed information regarding the 

restricted-distribution program from the label and information 

regarding the risk of myocardial ischemic events from the 

black-box warning only. The revised label, however, 

continued to warn physicians and patients elsewhere on the 

label that “[i]n a meta-analysis of 52 double-blind, 

randomized, controlled clinical trials . . . , a statistically 

significant increased risk of myocardial infarction with 

Avandia versus pooled comparators was observed”—this 

information simply was no longer included in the black-box 

warning, but this warning nonetheless appeared elsewhere on 

the label. Id. at 829. Avandia’s label continued to include a 

black-box warning that (i) advised physicians and patients that 

Avandia “cause[s] or exacerbate[s] congestive heart failure in 

some patients,” (ii) instructed physicians to “observe patients 

[taking Avandia] carefully for signs and symptoms of heart 

failure,” and (iii) warned patients with certain heart conditions 

not to take Avandia. Id. at 825. These warnings remain on 

Avandia’s label to this day.
11

II.

The Plans brought suit alleging that GSK falsely 

marketed Avandia and concealed data with respect to its 

potential cardiovascular risks and side effects, thereby 

violating RICO and various state consumer-protection laws. 

The Plans assert that they would not have placed Avandia on 

their formularies if GSK had disclosed the cardiovascular risks 

that are in fact associated with Avandia. In other words, the 

Plans would not have covered the cost of Avandia, which was 

considerably more expensive than alternatives, if they had 

known that Avandia not only did not reduce cardiovascular risk 

in type-2 diabetes patients but also increased cardiovascular 

risk as compared to those alternatives.

The Plans first filed suit in May 2010, and their cases 

subsequently were consolidated in a multi-district litigation 

case, which also included consumer and personal-injury suits 

filed by other plaintiffs. In November 2010, GSK filed a 

motion to dismiss the Plans’ complaints, arguing that the Plans 

lacked standing to bring claims under RICO. In October 2013, 

the District Court denied GSK’s motion, and, in October 2015,

we affirmed the decision of the District Court on an 

interlocutory appeal. See In re Avandia Mktg., Sales Practices 

& Prod. Liab. Litig. (Avandia I), 804 F.3d 633, 646 (3d Cir. 

2015).

In May 2016, GSK filed a motion for summary 

judgment. It argued that it was entitled to summary judgment 

because, among other things, the Plans’ state-law consumerprotection claims were preempted by the FDCA and the Plans 

had failed to identify a distinct “enterprise” for purposes of 

RICO. The Plans opposed the motion.
12

In December 2017, the District Court granted summary 

judgment in favor of GSK. First, the District Court refused to 

consider the Plans’ arguments that GSK falsely marketed 

Avandia as providing cardiovascular benefits in comparison to 

alternatives because such arguments were “belated.” Unsealed

App. 4. The District Court noted that the Plans “seemed to 

[have] shift[ed] their allegations to focus on Avandia’s 

benefits, rather than the risks,” and stated that it only would 

“address GSK’s motion for summary judgment as to [the 

Plans’] state law claims on cardiovascular risk.” Id. at 3–4. It

stated that it would not “entertain” any of the Plans’ “benefits” 

arguments “at th[at] juncture” due to their “belated” nature. Id.

at 4.

Second, the District Court found that the Plans’ statelaw consumer-protection claims were preempted by the FDCA 

under the doctrine of “impossibility” preemption. It found that 

three separate facts established “clear evidence” that the FDA 

would not have approved a change to Avandia’s label with 

respect to cardiovascular risks: (a) “the FDA rejected GSK’s 

[Prior Approval Supplement],” (b) “the FDA advised against 

using the CBE process to unilaterally change the label,” and (c) 

“the FDA ultimately concluded that there was no increased 

cardiovascular risk with Avandia use in relation to 

comparators.” Id. at 24. With respect to the Prior Approval 

Supplement, the District Court found that the “rejection of 

GSK’s proposed label on the basis of inconclusive data, 

considered with other evidence, constitutes clear evidence that 

the FDA would not have approved the label change . . . , 

particularly where . . . the FDA wanted to conduct further 

review of the data.” Id. at 24–25. Regarding the FDA’s 

advising against using the CBE process, the District Court 

found that an FDA representative’s statements—that she 
13

“strongly advised” against using the CBE process and that 

initializing that process would be “looked on with suspicion” 

and would “pull the rug out” from the FDA’s then-current 

plans for reviewing Avandia’s label—“shows that the FDA 

advised against using [the] CBE [process] to make the 

proposed label change prior to November 2007.” Id. at 25. 

Finally, the District Court placed an emphasis on the FDA’s 

“remov[al of] the black[-]box warning and restricted[-]access 

information from Avandia’s label,” as well as the FDA’s 

“current conclusion that a link between Avandia use and 

increased cardiovascular risk does not exist.” Id. at 26. In 

summary, the District Court found that the “FDA would not 

have approved of a warning for increased cardiovascular risk 

in Avandia versus competitors earlier than 2007 . . . and would 

not approve one now.” Id.

Third, the District Court concluded that the Plans failed 

to identify an “enterprise” that satisfies the “distinctiveness” 

requirement of RICO. Specifically, it determined that “GSK 

was conducting its own business in selling Avandia, and thus . 

. . GSK is both the person and the enterprise.” Id. at 16. 

Because “RICO liability ‘depends on showing that the 

defendants conducted or participated in the conduct of the 

enterprise’s affairs, not just their own affairs,’” the District 

Court found that the Plans had not adequately alleged that an 

“enterprise” existed because they merely alleged that the 

“enterprise” in this case consisted of “GSK and its agents.” Id.

(emphasis in original) (quoting Reeves v. Ernst & Young, 507 

U.S. 170, 185 (1993)).

The Plans timely appealed. They also appealed two 

orders of the District Court that maintained the vast majority 

of the summary-judgement record under seal. We considered 

that appeal in In re Avandia Mktg., Sales Practices and Prods. 
14

Liab. Litig. (Avandia II), 924 F.3d 662, 680 (3d Cir. 2019), in 

which we vacated the District Court’s sealing orders.

III.

The District Court had jurisdiction pursuant to 28 

U.S.C. §§ 1331 and 1332(d), and we have jurisdiction under 

28 U.S.C. § 1291. We exercise plenary review over a district 

court’s grant of summary judgment. Reedy v. Evanson, 615 

F.3d 197, 210 (3d Cir. 2010). When a district court grants 

summary judgment without considering a declaration filed by 

the nonmoving party under Federal Rule of Civil Procedure 

56(d), however, we review for abuse of discretion the district 

court’s decision to disregard the Rule 56(d) declaration. 

Shelton v. Bledsoe, 775 F.3d 554, 568 (3d Cir. 2015).

A.

With the benefit of the Supreme Court’s recent 

guidance in Merck, which was decided following oral 

argument in this case and well after the District Court’s 

issuance of its memorandum opinion,

1 we hold that the Plans’ 

state-law consumer-protection claims are not preempted by the 

FCDA, and we therefore will reverse the District Court’s order 

granting summary judgment in favor of GSK on such claims.

In Wyeth v. Levine, 555 U.S. 555, 570–71 (2009), the 

Supreme Court recognized that “it has remained a central 

premise of federal drug regulation that the manufacturer [of a 

pharmaceutical] bears responsibility for the content of its label 

 1 We subsequently ordered the parties to submit supplemental 

letter briefs discussing Merck’s effect, if any, on the disposition 

of this case. 
15

at all times” and that the manufacturer “is charged both with 

crafting an adequate label and with ensuring that its warnings 

remain adequate as long as the drug is on the market.” Thus, 

when it “bec[o]me[s] apparent” that a drug poses a certain risk 

to the health and safety of persons taking it, the manufacturer 

of the drug “ha[s] a duty to provide a warning that adequately 

describe[s] that risk.” Id. at 571. The manufacturer may warn 

persons of that risk by altering the drug’s label through the 

CBE process, which “permit[s] it to provide such a warning 

before receiving the FDA’s approval.” Id.

Under the FDCA, however, the FDA “retains authority 

to reject labeling changes made pursuant to the CBE regulation 

in its review of the manufacturer’s supplemental application, 

just as it retains such authority in reviewing all supplemental 

applications.” Id. Therein lies the conflict that may give rise 

to impossibility preemption: even though a drug manufacturer 

has the responsibility under state consumer-protection laws to 

accurately label a drug and may change the label pursuant to 

the CBE process prior to receiving approval from the FDA, it

may reject a label change at any time if it considers the drug to 

be “mislabeled” under the FDCA. Thus, a situation may occur

in which a drug company seeks to change its label to add a 

warning that it believes is required by state consumerprotection laws, but the FDA considers the drug “mislabeled” 

under the FDCA in light of the new warning that was added to 

the label. In that situation, it would be impossible to comply 

with both state and federal law. In resolving this conflict, the 

Supreme Court struck a balance in Wyeth, holding that the 

FDCA does not preempt state-law consumer-protection claims 

regarding the labeling of a drug “absent clear evidence that the 

FDA would not have approved a change to [the drug]’s label.” 

Id.
16

After we indicated in In re Fosamax (Alendronate 

Sodium) Prods. Liab. Litig., 852 F.3d 268, 284 (3d Cir. 2017), 

vacated, Merck, 139 S. Ct. 1668, that it would be helpful for 

the Supreme Court to “clarif[y] or buil[d] out the doctrine” 

espoused in Wyeth, the Supreme Court provided such 

interpretive guidance in Merck. “[C]lear evidence,” as used in 

Wyeth’s core holding, means “evidence that shows the court 

that the drug manufacturer fully informed the FDA of the 

justifications for the warning required by state law and that the 

FDA, in turn, informed the drug manufacturer that the FDA 

would not approve a change to the drug’s label to include that 

warning.” 139 S. Ct. at 1672. Thus, to “show[] that federal 

law prohibited [a] drug manufacturer from adding a warning 

that would satisfy state law,” the drug manufacturer must 

demonstrate that (1) “it fully informed the FDA of the 

justifications for the warning required by state law” and (2)

“the FDA, in turn, informed the drug manufacturer that the 

FDA would not approve changing the drug’s label to include 

that warning.” Id. at 1678.

GSK has failed to satisfy either prong of Merck’s twoprong test, and it therefore is not “entitled to judgment as a 

matter of law.” Fed. R. Civ. P. 56(a). First, GSK has not 

shown that “it fully informed the FDA of the justifications for 

the warning required by state law.” Merck, 139 S. Ct. at 1678. 

In the Letter, the FDA itself stated that it had “reviewed the 

data provided [by GSK] and f[ou]nd [that] the information 

presented is inadequate.” Sealed App. 660 (emphasis added). 

Further, the FDA indicated that GSK needed to submit various 

data and information “in order to address the deficiency of this 

application.” Id. at 661. Thus, GSK cannot demonstrate that 

the FDA was “fully informed . . . of the justifications for the 

warning,” Merck, 139 S. Ct. at 1678, because the FDA itself 
17

stated that it was “inadequate[ly]” informed of the 

justifications for the warning, Sealed App. 660.

GSK argues that it “fully informed” the FDA because 

GSK (1) provided all “material” information to the FDA and 

(2) did not have access to the information that the FDA 

requested until after the latter issued the Letter, but these 

arguments are unavailing. GSK concedes that the FDA 

requested additional data and information in the Letter, yet

GSK argues that none of the data and information that the FDA 

actually requested in the Letter was “material” to its proposed 

warning on cardiac risk, and that therefore, the FDA was “fully 

informed” for purposes of Merck. This argument turns the 

regulatory regime on its head. The FDA, not GSK, is the entity 

with power to approve or refuse a change to a drug’s label, and 

in making such a decision, it has the statutory authority to 

conclude that the data and tests submitted by a manufacturer 

were not “adequate” or that there is “insufficient information 

about the drug to determine whether the product is safe for use 

under the conditions prescribed, recommended, or suggested in 

its proposed labeling.” 21 C.F.R. §§ 314.125(b)(2), (4). GSK 

is not the arbiter of which data and information is or is not

“material” to the FDA’s decision to approve or reject a change 

to a drug’s label—the FDA, and only the FDA, can determine 

what information is “material” to its own decision to approve 

or reject a labelling change.

Additionally, by arguing that it did not have access to 

the FDA’s requested data and information until after the FDA’s 

issuance of the Letter, GSK undermines its own argument that 

the FDA was “fully informed.” Merck noted that “a drug 

manufacturer will not ordinarily be able to show that there is 

an actual conflict between state and federal law such that it was 

impossible to comply with both.” 139 S. Ct. at 1679. Thus we 
18

read Merck as holding that, in order to prove impossibility 

preemption, the drug manufacturer must show that the “FDA 

would not approve changing the drug’s label” and that the FDA 

was “fully informed . . . of the justifications for the [proposed] 

warning” at the time that the FDA rejected the proposed 

warning. Id. at 1678. In other words, the upshot of Merck is 

that a drug manufacturer must show that the FDA made a fully 

informed decision to reject a change to a drug’s label in order 

to establish the “demanding defense” of impossibility 

preemption. Id. at 1678. If the question of whether the FDA 

was “fully informed” was not tethered in time to the question 

of whether the FDA indeed rejected the proposed warning, the 

“fully informed” prong of the test espoused in Merck would be 

rendered superfluous.

Thus, if GSK wishes to rely on the Letter as proof that 

the FDA rejected its proposed label change, it must also 

demonstrate that the FDA possessed all the information it 

deemed necessary to decide whether to approve or reject the 

proposed warning at the time it issued the Letter. By arguing 

that it did not have the FDA’s requested data and information 

until after the FDA issued its letter, however, GSK is, in effect, 

conceding that the FDA was not “fully informed” at the time 

of the Letter’s issuance. For that reason, among the others 

outlined above, GSK cannot satisfy the first prong of the test 

espoused in Merck.

Second, GSK cannot show that the “FDA . . . informed 

[it] that the FDA would not approve changing the drug’s label 

to include [the relevant] warning.” Id. at 1678. GSK directs 

the Court’s attention to the Letter as proof that the FDA 

rejected the proposed warning. The Letter indeed stated that 

GSK’s Prior Approval Supplement for a label change was “not 

approvable,” but the FDA indicated that this was so because 
19

the “information presented [by GSK wa]s inadequate.” Sealed 

App. 660. The FDA then required GSK to “amend the 

supplemental application,” stating that “[a]ny amendment 

should respond to all the deficiencies listed” in the Letter. Id.

at 661 (emphasis added). Thus, it is clear from the very text of 

the Letter that the FDA did not consider GSK’s Prior Approval 

Supplement “not approvable” because it was unconvinced of 

the need for a strong warning on myocardial ischemic events; 

rather, the FDA considered the Prior Approval Supplement 

“not approvable” because it contained various “deficiencies” 

that the FDA required GSK to ameliorate prior to the FDA’s 

making a final determination. At most, the Letter indicates that 

it is possible that the FDA could have rejected the label change 

after receiving the various data and information it requested 

from GSK, but as the Supreme Court has reiterated, the 

“possibility of impossibility [is] not enough.” Merck, 139 S. 

Ct. at 1678 (alteration in original) (quoting PLIVA, Inc. v. 

Mensing, 564 U.S. 604, 625 n.8 (2011)). We nevertheless need 

not speculate regarding the possibility that the FDA would 

have rejected the proposed warning upon the receipt of the

requested data and information because it indeed ordered GSK 

to include various warnings regarding cardiac risks on 

Avandia’s label shorty after issuing the Letter, which alone 

undermines GSK’s position that the Letter represents a 

rejection of its proposed warning.

Finally, we are not persuaded by any of GSK’s 

arguments that the Plans’ claims are preempted because GSK 

allegedly was unable to avail itself of the CBE process for 

various reasons. GSK primarily argues that it could not use the 

CBE process to introduce a warning on ischemic risks prior to 

mid-2006, when it submitted its Prior Approval Supplement. 

GSK reasons that ICT-42 served as the basis for its belief that 
20

an ischemic-risk warning should be included on the label, and 

because that study was completed in mid-2006, it did not have 

the “newly acquired information” necessary to make a labeling 

change prior to that time. This argument, however, is 

undermined by GSK’s own admissions. For example, GSK 

itself described the results of “ICT-37,” a meta-analysis 

completed a year earlier in August 2005, as “generally similar” 

to ICT-42, and GSK stated that “[a]ny numerical differences 

[between the meta-analyses] were not clinically significant.”

Sealed App. 861. Thus, at the very least, it appears that GSK 

could have used the CBE process to add an ischemic-risk 

warning as early as August 2005 because, by GSK’s own 

admission, ICT-37 and ICT-42 indicated similar results and 

had clinically insignificant numerical differences.2 Further, 

GSK cannot rely on its informal phone conversations with an 

FDA official to claim that it could not pursue a label change 

through the CBE process, nor can GSK rely on the stock 

language at the end of the Letter, which advised GSK that 

Avandia “may be considered to be misbranded under the 

[FDCA] if it is marketed with the[ proposed] changes before 

approval of this supplemental application.” Id. at 661. An 

informal phone conversation with an FDA official is not an 

“agency action taken pursuant to the FDA’s congressionally 

delegated authority,” Merck, 139 S. Ct. at 1679, and the stock 

language at the end of the Letter is a simple statement of the 

law: if a manufacturer makes a label change pursuant to the 

CBE process (i.e., without seeking the prior approval of the 

FDA), the manufacturer always runs the risk that the FDA will 

 2 We take no position with respect to whether GSK could have 

used the CBE process, or otherwise sought to change 

Avandia’s label, to add an ischemic-risk warning prior to 

August 2005.
21

later reject the label change and consider the drug as 

“mislabeled,” see 21 C.F.R. § 314.70(c)(7). Finally, GSK’s 

argument that it could not implement a black-box warning 

through the CBE process is a red herring—the Plans are not 

arguing that GSK should have added the black box itself

through the CBE process, but rather that GSK should have 

added the content of the black-box warning anywhere on the 

label.

GSK thus has failed to demonstrate that the Plans’ statelaw consumer-protection claims are preempted by the FDCA, 

and GSK therefore is not entitled to summary judgment on 

those grounds. Therefore, we will reverse the order of the 

District Court granting summary judgment in favor of GSK on

the Plans’ state-law consumer-protection claims.

B.

The District Court erred in granting summary judgment 

on the Plans’ RICO claims without giving the Plans the benefit 

of discovery on those claims.

“[A] Court ‘is obligated to give a party opposing 

summary judgment an adequate opportunity to obtain 

discovery.’” Doe v. Abington Friends Sch., 480 F.3d 252, 257 

(3d Cir. 2007) (quoting Dowling v. City of Philadelphia, 855 

F.2d 136, 139 (3d Cir. 1988)). “If discovery is incomplete, a 

district court is rarely justified in granting summary judgment, 

unless the discovery request pertains to facts that are not 

material to the moving party’s entitlement to judgment as a 

matter of law.” Shelton, 775 F.3d at 568.

Rule 56(d) provides that “[i]f a nonmovant shows by 

affidavit or declaration that, for specified reasons, it cannot 
22

present facts essential to justify its opposition, the court may: 

(1) defer considering the motion or deny it; (2) allow time to 

obtain affidavits or declarations or to take discovery; or (3) 

issue any other appropriate order.” Fed. R. Civ. P. 56(d). 

“[D]istrict courts usually grant properly filed requests for 

discovery under Rule 56(d) ‘as a matter of course’ . . . .” 

Shelton, 775 F.3d at 568 (quoting Murphy v. Millennium Radio 

Grp. LLC, 650 F.3d 295, 309–10 (3d Cir. 2011)). “This is 

particularly true when there are discovery requests outstanding 

or where relevant facts are under control of the party moving 

for summary judgment.” Id. A district court abuses its 

discretion when it grants summary judgment in favor of the 

moving party “without even considering” a Rule 56(d)

declaration filed by the nonmoving party. See id.

The Plans never received discovery related to their 

RICO claims, including with respect to whether an “enterprise” 

existed for purposes of RICO, and thus when GSK moved for 

summary judgment on the Plans’ RICO claims, the Plans 

submitted a detailed Rule 56(d) declaration regarding the lack 

of discovery on the issues related to RICO. See J. App. 2195–

2198. They subsequently filed a supplemental Rule 56(d) 

declaration, further elaborating on their need for discovery on 

RICO-related issues. See id. at 2272–76.

The District Court granted summary judgment in favor 

of GSK on the Plans’ RICO claims without considering their 

Rule 56(d) declaration and their supplemental Rule 56(d)

declaration. This was an abuse of discretion, especially as the 

District Court granted summary judgment on the ground that 

the Plans could not prove the existence of an “enterprise,” 

information related to which is “under control of the party 
23

moving for summary judgment”—in this case, GSK.3

 Shelton, 

775 F.3d at 568. We therefore vacate the District Court’s order 

granting summary judgment in favor of GSK on the Plans’ 

RICO claims, and we remand to the District Court to give 

proper consideration to the Plans’ Rule 56(d) declarations.

IV.

Finally, we note that, on remand, the District Court must

consider the Plans’ arguments that GSK marketed Avandia as 

providing cardiovascular benefits. These arguments and 

claims are not “belated”; the Plans have pursued this line of 

argument since the outset of this litigation. In the Plans’ 

complaint itself, the Plans alleged that they “rel[ied] upon 

[GSK]’s promises of superior treatment and better 

cardiovascular outcomes compared with the older diabetes 

drugs” in determining that it was worth the increased cost to 

cover Avandia. J. App. 1273. They alleged that “better 

cardiovascular outcomes” were a crucial part of GSK’s alleged 

fraudulent marketing: “[t]he notion that Avandia would 

actually lower diabetics’ cardiovascular risk was critical to 

Avandia’s marketing” because GSK “needed justification for 

the steep price difference between Avandia and the older 

established diabetes drugs.” Id. at 1291. While a portion of 

the Plans’ claims center on the assertion that GSK should have 

disclosed on its label the true nature of the increased 

cardiovascular risk that was presented by Avandia as compared 

to cheaper alternatives, the increased risk is only relevant to the 

 3 We refuse to construe the District Court’s grant of summary 

judgment in favor of GSK on the Plans’ RICO claims as a 

dismissal on the pleadings pursuant to Rule 12(c), particularly 

because the Plans’ RICO claims previously survived a Rule 

12(b)(6) motion to dismiss. See Avandia I, 804 F.3d at 646.
24

Plans’ claims insofar as the Plans make the following 

argument: GSK failed to warn of Avandia’s true 

cardiovascular risk, and thus, GSK was continuing—by 

omission—to promote Avandia as capable of lowering

patients’ cardiovascular risk, and GSK thereby continued to 

induce the Plans to cover the cost of Avandia based on this 

perceived “benefit” of lowering cardiovascular risk. Id. at 

1316. In short, the Plans have never argued that GSK 

promoted Avandia as capable of actually improving patients’ 

cardiovascular health, but rather as capable of lowering 

cardiovascular risk when compared to cheaper alternatives, 

which indeed is a “benefit.”

Because the Plans have raised, throughout these 

proceedings, arguments that GSK marketed Avandia as 

providing cardiovascular benefits, it was error for the District 

Court to refuse to consider those arguments. See, e.g., Hillman 

v. Resolution Tr. Corp., 66 F.3d 141, 144 (7th Cir. 1995). 

Therefore, on remand, the District Court needs to give proper 

consideration to these arguments.

V.

For the reasons stated above, we will reverse the order 

of the District Court granting summary judgment in favor of 

GSK on the Plans’ state-law consumer-protection claims, 

vacate the order of the District Court granting summary 

judgment in favor of GSK on the Plans’ RICO claims, and 

remand to it for proceedings consistent with this opinion. On 

remand, the District Court shall give proper consideration to 

the Plans’ Rule 56(d) declarations, as well as their arguments 

that GSK marketed Avandia as providing cardiovascular 

benefits.