Lakeland Regional Medical Cent v. Astellas US, LLC, et al

Filing

Opinion issued by court as to Appellant Lakeland Regional Medical Center, Inc.. Decision: Affirmed. Opinion type: Published. Opinion method: Signed.

Case: 13-12709

Date Filed: 08/15/2014

Page: 1 of 23

[PUBLISH]
IN THE UNITED STATES COURT OF APPEALS
FOR THE ELEVENTH CIRCUIT
_________________________
No. 13-12709
_________________________
D.C. Docket No. 8:10-cv-02008-VMC-TGW
LAKELAND REGIONAL MEDICAL CENTER, INC., on behalf of itself and all
others similarly situated,
Plaintiff – Appellant,
versus
ASTELLAS US, LLC and ASTELLAS PHARMA US, INC.,
Defendants – Appellees.
__________________________
Appeal from the United States District Court
for the Middle District of Florida
__________________________
(August 15, 2014)
Before ANDERSON, Circuit Judge, and EBEL, * Circuit Judge, and UNGARO, **
District Judge.
*

Honorable David M. Ebel, United States Circuit Judge for the Tenth Circuit, sitting by
designation.
**

Honorable Ursula Ungaro, United States District Judge for the Southern District of Florida,
sitting by designation.

Case: 13-12709

Date Filed: 08/15/2014

Page: 2 of 23

EBEL, Circuit Judge:
Defendants-Appellees Astellas US, LLC and Astellas Pharma US, Inc.
(collectively “Astellas”) holds patents on a cardiac test and sells its unpatented
pharmaceutical product, Adenoscan, for use during that test. Plaintiff-Appellant
Lakeland Regional Medical Center, Inc. (the “Medical Center”), which conducts
these cardiac tests, alleges that Astellas is able to overcharge the Medical Center
for the Adenoscan product by unlawfully tying the patented right to perform the
patented cardiac test to the purchase of the unpatented Adenoscan in violation of
Section 1 of the Sherman Act, 15 U.S.C. § 1. At issue in this appeal is the district
court’s refusal to certify the Medical Center’s tying claim as a class action. We
AFFIRM.
BACKGROUND
Healthcare providers often test for coronary artery disease using a procedure
called myocardial perfusion imaging (“MPI”). This test is most accurate when
carried out while the heart is stressed by, for example, administering adenosine to
the patient during the procedure. Adenosine is a naturally occurring chemical
compound that causes selective blood vessels to dilate. Astellas has held two
patents for performing an MPI using adenosine; the first patent expired in March
2009 and the second will expire in March 2015. Astellas does not offer healthcare
2

Case: 13-12709

Date Filed: 08/15/2014

Page: 3 of 23

providers a freestanding license to perform its patented MPI procedure. Instead,
healthcare providers obtain an implied license to perform the MPI procedure by
purchasing Astellas’s unpatented adenosine product, Adenoscan, for use during the
procedure.
When this litigation began, Adenoscan was the only adenosine product that
the Food and Drug Administration (“FDA”) had approved for use during an MPI.
There are other adenosine products available in the market, however, and
healthcare providers are not bound by the FDA’s approval ruling, but can, instead,
use any adenosine product during an MPI that the healthcare providers, in their
medical judgment, deem appropriate. Exercising that prerogative, the Medical
Center began using chemically-identical adenosine products that were cheaper than
Adenoscan during MPIs performed at the Medical Center. Astellas responded by
threatening to sue the Medical Center for performing Astellas’s patented MPI
procedure without a license.
The Medical Center sued Astellas first for, among other claims, violating
federal antitrust laws by illegally tying the implied license to perform MPIs
involving adenosine to the purchase of Adenoscan. See 15 U.S.C. § 1.1 According
1

Section 1, United States Code Title 15, provides in pertinent part that “[e]very contract,
combination in the form of trust or otherwise, or conspiracy, in restraint of trade or commerce
among the several States, or with foreign nations, is declared to be illegal.” A tying
arrangement—“an agreement by a party to sell one product but only on the condition that the
3

Case: 13-12709

Date Filed: 08/15/2014

Page: 4 of 23

to the Medical Center, this unlawful tying arrangement enabled Astellas to charge
450% more for Adenoscan than the price for other, chemically-identical adenosine
products. As relief, the Medical Center sought 1) treble damages for the amount
Astellas had overcharged the Medical Center for Adenoscan, and 2) injunctive and
declaratory relief. See 15 U.S.C. §§ 15(a), 26.
The Medical Center brought its case as a class action on behalf of all
healthcare providers who had purchased Adenoscan during a four-year period,
from September 2006 through September 2010. But the district court refused to
certify the class, ruling, among other things, that the Medical Center was not a
viable class representative because 1) the direct purchaser rule, see Illinois Brick
Co. v. Illinois, 431 U.S. 720, 729, 736 (1977), precluded the Medical Center’s own
treble damages claim since the Medical Center had purchased Adenoscan, not
directly from Astellas, but instead from several independent pharmaceutical
distributors; and 2) the Medical Center’s requests for declaratory and injunctive
relief were, or soon would be, moot because, after the initiation of this suit, the
FDA had approved a generic version of Adenoscan for use during MPIs and
because the Medical Center insufficiently articulated the class-wide injunctive

buyer also purchases a different (or tied) product”—may be unlawful under § 1. Eastman Kodak
Co. v. Image Technical Servs., Inc., 504 U.S. 451, 461-62 (1992) (internal quotation marks
omitted). In this case, the Medical Center alleges that the tying product is the implied license to
perform MPIs involving adenosine, and the tied product is the Adenoscan.
4

Case: 13-12709

Date Filed: 08/15/2014

Page: 5 of 23

relief that it reasonably could obtain.
Although the district court’s denial of class certification was not a final,
appealable order, see Coopers & Lybrand v. Livesay, 437 U.S. 463, 464-65 (1978),
the ruling effectively foreclosed the Medical Center’s tying claim. The Medical
Center thus stipulated to the entry of final judgment against it on all of its claims
while preserving its right to appeal the district court’s denial of class certification.
See Dorse v. Armstrong World Indus., Inc., 798 F.2d 1372, 1376-77 (11th Cir.
1986). Exercising jurisdiction under 28 U.S.C. § 1291, we AFFIRM.
DISCUSSION
I. Because the direct purchaser rule precludes the Medical Center’s own
treble damages claim, the district court did not abuse its discretion in refusing
the Medical Center’s request to certify a class seeking damages against
Astellas for unlawful tying
A. Relevant legal principles
This appeal involves the interaction between law governing claims for
unlawful tying and antitrust standing principles. The Medical Center has claimed a
classic tying arrangement. 2 Its allegations are as follows: Astellas is the source of
two products. First, Astellas has a patent on performing MPIs that use adenosine
2

See Eastman Kodak, 504 U.S. at 460-61 (“A tying arrangement is an agreement by a party to
sell one product but only on the condition that the buyer also purchases a different (or tied)
product,” which violates antitrust laws “if the seller has appreciable economic power in the tying
product market and if the arrangement affects a substantial volume of commerce in the tied
market.”) (internal quotation marks omitted); see also Phillip Areeda & Herbert Hovenkamp, IX
Antitrust Law § 1700a (3d ed. 2011).
5

Case: 13-12709

Date Filed: 08/15/2014

Page: 6 of 23

to stress the patient’s heart during the procedure. Healthcare providers wanting to
perform that procedure, therefore, need a license from Astellas to do so. Second,
Astellas sells Adenoscan which, at the time this litigation began, was the only
adenosine product that the FDA had approved for use during the patented MPI
procedure, although there were other adenosine products available on the market
that could perform the same function as Adenoscan. According to the Medical
Center’s allegations, Astellas leveraged its power in the testing market to
overcharge for Adenoscan. The Medical Center contends that it was injured by
this tying arrangement because the only way it could obtain the tying product that
it needed—a license from Astellas to perform MPIs involving adenosine—was to
overpay for Adenoscan. The Medical Center further contends that, by requiring it
to buy the overpriced Adenoscan in order to get the process license it wanted,
Astellas foreclosed the Medical Center from purchasing other adenosine products
at much lower prices for use during the MPIs. The Medical Center measures its
tying damages, then, by the amount it overpaid for Adenoscan when compared
with the amount it could have paid to purchase another adenosine product.3

3

The appropriate measure of damages in a tying case is the amount the purchaser overpaid for
the unlawfully tied bundle of products or services when compared to the amount the purchaser
would have paid to purchase those products or services separately. See Kypta v. McDonald’s
Corp., 671 F.2d 1282, 1285 (11th Cir. 1982). Here, however, the Medical Center alleges that
Astellas charged nothing for the implied use license it tied to the sale of Adenoscan, and further
alleges that, even if Astellas had offered a stand-alone license separate from the Adenoscan,
6

Case: 13-12709

Date Filed: 08/15/2014

Page: 7 of 23

But it is well-settled that not everyone who is injured by an antitrust
violation can recover (treble) damages. 4 Under the direct purchaser rule, only the
customer who purchased the goods or services at issue directly from the alleged
antitrust violator can recover damages. See Illinois Brick, 431 U.S. at 729, 736;
see also Kansas v. UtiliCorp United, Inc., 497 U.S. 199, 203-04 (1990). In other
words, even if Astellas’s alleged tying arrangement injured purchasers all along the
distribution chain for either the tying (implied process license) or the tied
(Adenoscan) product, the direct purchaser rule only permits the first purchaser to
recover damages from Astellas for any unlawful overcharge. The reasons for this
rule are threefold, see UtiliCorp, 497 U.S. at 208-16: permitting only the direct
purchaser to recover damages 1) “eliminate[s] the complications of apportioning
overcharges between direct and indirect purchasers,” id. at 208; 2) eliminates the
possibility that direct and indirect purchasers could seek duplicative recoveries
against the antitrust violator, id. at 212; and 3) best “promote[s] the vigorous
enforcement of the antitrust laws” by permitting only the best-situated purchaser to
sue for damages, id. at 214.

Astellas would have charged nothing for that license. In this tying case, then, the Medical Center
is measuring its damages by the amount Astellas was able to overcharge the Medical Center for
the Adenoscan, by tying it to the implied license, as compared to the price at which the Medical
Center could have obtained other, comparable adenosine products.
4

Because this tying claim is before us on standing, we do not reach its merits and so we
do not express any opinion regarding the claim’s merits.
7

Case: 13-12709

Date Filed: 08/15/2014

Page: 8 of 23

B. The district court correctly determined that the direct purchaser
rule bars the Medical Center’s damages claim
We review de novo the district court’s application of the direct purchaser
rule to the Medical Center’s damages claim. See Sunbeam Television Corp. v.
Nielsen Media Research, Inc., 711 F.3d 1264, 1270 (11th Cir. 2013). Applying
that rule here, there is no doubt that the distributors who purchased Adenoscan
from Astellas and then resold it to the Medical Center are the direct purchasers
and, therefore, the only parties under Illinois Brick that can recover tying damages
from Astellas. Because, according to the Medical Center, neither the distributors
nor the Medical Center ever paid Astellas anything for the implied license to
perform the patented MPI procedure, it was the distributors who first bore all the
damages from the alleged unlawful tying, which was the overcharged price of
Adenoscan.
Although the distributors may have passed on to the Medical Center some or
all of the overcharge that they paid to Astellas, the Medical Center cannot recover
damages from Astellas for that overcharge because it was the second purchaser of
that tied product. Indeed, to allow the Medical Center to maintain a damages claim
for this particular tying arrangement would give rise to the very problems that the
direct purchaser rule seeks to avoid. It would complicate the calculation of
damages resulting from any overcharge by Astellas by requiring an apportionment
8

Case: 13-12709

Date Filed: 08/15/2014

Page: 9 of 23

of that overcharge throughout the Adenoscan distribution chain, between the direct
purchasers (the distributors) and the indirect purchasers (like the Medical Center);
it would create the possibility that both the distributors and the indirect Adenoscan
purchasers like the Medical Center could recover from Astellas for the same
allegedly unlawful tying arrangement; and it would discourage vigorous privatecitizen enforcement of the antitrust laws by making it more difficult for the bestsuited plaintiffs, the distributors, to bring an unlawful tying claim. 5 See UtiliCorp,
497 U.S. at 208-16. For these reasons, then, only the distributors, as the direct
purchasers of Adenoscan who first paid the inflated tied price for that product, can
recover damages from Astellas for that alleged overcharge resulting from
Astellas’s alleged tying behavior.
C. The Medical Center’s argument to the contrary is unavailing
The Medical Center’s primary argument against applying the direct
purchaser rule to preclude its damages claim is that the distributors are not the best
plaintiffs to assert the tying claim at issue here because they have no use for the
tying product, which is the implied license to perform an MPI using adenosine;
5

Applying the direct purchaser rule here serves all of the purposes underlying that rule. See
UtiliCorp, 497 U.S. at 208-16. But even if the rule’s application in this particular case did not
serve the rule’s underlying purposes, the Supreme Court has directed courts to apply the rule
nonetheless: “even assuming that any economic assumptions underlying the Illinois Brick rule
might be disproved in a specific case, we think it an unwarranted and counterproductive exercise
to litigate a series of exceptions.” Id. at 216.
9

Case: 13-12709

Date Filed: 08/15/2014

Page: 10 of 23

indeed, according to the Medical Center, the distributors never even receive that
license.6 According to the Medical Center, in other words, Astellas does not exert
tying pressure on the distributors, coercing them to buy the tied product
(Adenoscan) in order to get the tying product (the implied license) because the
distributors have no use for the implied license. And if there is no pressure on the
distributors to buy the tied product, so argues the Medical Center, the distributors
have no incentive to bring the tying claim.
We are unpersuaded. While admittedly the distributors have no need for a
license that permits them to perform MPIs, that license has economic value for the
distributors who seek to resell Adenoscan to their healthcare customers, who do
need that license. In fact, because the distributors could only market and sell
Adenoscan for its FDA-approved use—that is, in conjunction with an MPI
involving adenosine—the distributors needed to be able to assure their

6

No one questions that Astellas tied the implied process license to the purchase of Adenoscan.
But there are two ways to view that arrangement. One way is to suppose that the implied license
came directly from the purchase of Adenoscan and thus flowed down the Adenoscan distribution
chain, from Astellas to the distributor to the Medical Center. This is what Astellas contends, and
that is consistent with its, Astellas’s, own assertions in letters it sent to healthcare providers,
including the Medical Center. The other way to view the arrangement is that Astellas linked the
right to obtain an implied license to the purchase of Adenoscan, even though healthcare
providers like the Medical Center, in exercising that right, actually obtained the implied license
directly from Astellas. That is the Medical Center’s contention. As we see it, it does not matter
because, either way, Astellas undoubtedly conditioned its granting of the implied license on the
purchase of Adenoscan, and here the entire tying damages came from the enhanced price of
Adenoscan, the tied product, which was first paid by the distributors to Astellas.
10

Case: 13-12709

Date Filed: 08/15/2014

Page: 11 of 23

customers—the hospitals—that they could use the Adenoscan that the distributors
were selling. Thus, Adenoscan, tied to the implied license, had a greater resale
value for the distributors than other adenosine products which Astellas would not
allow to be used with its patented MPI process. Therefore, regardless of whether
or not the distributors themselves actually received or used the implied license,
they were still susceptible to the coercion of the tying arrangement and were still
injured by any unlawful overcharge that Astellas was able to command for
Adenoscan. To conclude otherwise would be to ignore the economic realities of
the transactions at issue here. See United States v. Concentrated Phosphate Export
Ass’n, 393 U.S. 199, 208 (1968) (“In interpreting the antitrust laws, . . . [w]e must
look at the economic reality of the relevant transactions.”); see also Eastman
Kodak, 504 U.S. at 466-67 (“Legal presumptions that rest on formalistic
distinctions rather than actual market realities are generally disfavored in antitrust
law.”).
Our conclusion is bolstered by several cases from other circuits which,
although not controlling here, are helpful. Though not a tying case, Kloth v.
Microsoft Corp., 444 F.3d 312 (4th Cir. 2006), is perhaps most helpful. In Kloth,
Microsoft sold computer manufacturers a license to “pre-install” Microsoft
software onto the manufacturers’ computers and the right to charge consumers for
11

Case: 13-12709

Date Filed: 08/15/2014

Page: 12 of 23

the option to purchase licenses to use the software from Microsoft. Id. at 318-19,
321-22. After consumers bought the computers from the manufacturer or a
retailer, the consumers had the option of either accepting Microsoft’s license to use
the software already installed on the computer or rejecting the license and
receiving a refund directly from Microsoft. Id. at 318, 320. Applying Illinois
Brick, the Fourth Circuit held that the consumers were indirect purchasers of
Microsoft’s software licenses, even if the consumers actually acquired the software
licenses directly from Microsoft, because the consumers paid the computer
manufacturers or retailers (and not Microsoft) for the licenses as part of the
computer’s purchase price. Id. at 320-21. In reaching that conclusion, the Fourth
Circuit rejected the consumers’ contrary suggestion that they were direct
purchasers, stating that they
fail[ed] to recognize both the role of the [computer manufacturer] or
the retailer in the licensing chain and the economic realities of the
transaction. Although Microsoft does not sell title to its software, it
does sell licenses to use its software, and plaintiffs [consumers] could
have acquired licenses directly from Microsoft. . . . But the plaintiffs
in this case acquired their licenses by purchases from [computer
manufacturers] and retailers, paying them, not Microsoft, for their
licenses at prices set by the [manufacturers] and retailers. Because the
plaintiffs purchased their products from intermediaries and not
Microsoft, they are indirect purchasers within the meaning of that
term as defined in Illinois Brick and UtiliCorp, and the recoveries they
would have from Microsoft would present the very problems that
those cases sought to avoid.
12

Case: 13-12709

Date Filed: 08/15/2014

Page: 13 of 23

Id.
The situation in Kloth is analogous to the circumstances presented here and
supports our conclusion that the direct purchaser rule precludes the Medical
Center’s damages claim. 7 As in Kloth, here the distributor paid Astellas for the
Adenoscan and the license (or the right to obtain the license); and the Medical
Center then, in turn, paid the distributor (and not Astellas) for both the Adenoscan
and the license (or the right to obtain the license). The Medical Center, therefore,
was only an indirect purchaser of both from the alleged antitrust violator, Astellas. 8
In a second case supporting our decision, Warren General Hospital v.
Amgen Inc., 643 F.3d 77 (3d Cir. 2011), the Third Circuit applied the direct
purchaser rule to preclude a hospital’s tying claim against a pharmaceutical
company. There, the hospital claimed that the drug manufacturer, Amgen, was
unlawfully tying the sale of two drugs over which Amgen had a monopoly (the
“tying” products) to the sale of a third, more expensive Amgen drug (the “tied”
product). Id. at 80-81. The alleged tying scheme specifically involved Amgen

7

The Medical Center attempts to distinguish Kloth because, in that case, 1) both the computer
hardware and software came together from the computer manufacturers to the consumer; and
2) Microsoft leveraged its power in the computer operating system market to compel the
manufacturers to install its software onto the computers. But those facts do not meaningfully
distinguish Kloth from the circumstances presented here.
8

Recall that under the Medical Center’s theory, no one actually paid anything for the implied
license.
13

Case: 13-12709

Date Filed: 08/15/2014

Page: 14 of 23

offering healthcare providers price rebates on the tying drugs based upon the
volume of purchases that healthcare providers made of the tied drug. Id. Even
though Warren General Hospital bought all three drugs through independent
distributors, the plaintiff hospital claimed that it had directly purchased the drugs
from Amgen because it contracted with Amgen directly for the rebates and it
received those rebates directly from Amgen. Id. at 87-88. The Third Circuit
rejected that argument, concluding that the hospital was still only an indirect
purchaser of Amgen’s drugs because the hospital ordered the drugs from
independent distributors and paid those distributors for the drugs at a price set by
the distributors. Id. at 88-89. According to the court, it was irrelevant that the
rebates came directly from Amgen: while there “were some direct interactions
between Amgen and the hospital relating to the rebate program and the volume of
Amgen drugs the hospital required,” those interactions were insufficient to make
the hospital a direct purchaser of the drugs from Amgen when the drugs
themselves were in fact purchased from the independent distributors. Id. at 88.
The same could be said about the products here: even if the license might be
viewed as coming directly from Astellas, see supra n. 4, that does not change the
fact that the Medical Center purchased Adenoscan, which carried the right to
obtain permission to use it in MPIs and which constituted the entire overcharge
14

Case: 13-12709

Date Filed: 08/15/2014

Page: 15 of 23

forming the basis of the treble damages claim, directly from the distributors, not
Astellas.
Finally, the Tenth Circuit’s decision in Sports Racing Services, Inc. v. Sports
Car Club of America, Inc., 131 F.3d 874 (10th Cir. 1997) lends further support to
our decision. In Sports Racing Services, an amateur car racer, Freeman, sued
Sports Car Club of America, alleging that Sports Car Club illegally tied its sale of
the right to race in Club-sponsored races to the purchase of cars and parts for the
races from Sports Car Club. 131 F.3d at 878-79, 886. Although Freeman bought
the tying product, the right to race, directly from Sports Car Club, he had to buy
the tied products, Sports Car Club’s cars and parts, from an independent
distributor. Id. at 878, 883, 887. The Tenth Circuit held that the direct purchaser
rule may not bar Freeman’s tying claim against Sports Car Club, 9 even though he
was only an indirect purchaser of the tied products (the cars and parts), because
Freeman was the first party in either distribution chain (of the tied and tying
products) that was “the direct victim of the anticompetitive activity [the tying
arrangement] and the first person with a cause of action” for tying. Id. at 889.
That reasoning is consistent with our conclusion here: the distributors were the first
entities in the Adenoscan distribution chain subjected to the tying arrangement’s
9

The case came to the Tenth Circuit on a summary judgment decision. See Sports Racing
Servs., 131 F.3d at 878. Ultimately the court remanded the case to the district court for further
factual finding. Id. at 890-91.
15

Case: 13-12709

Date Filed: 08/15/2014

Page: 16 of 23

coercive force because they were compelled to pay the overcharge for Adenoscan,
which was the source of the alleged tying damages claim and the Medical Center
was downstream of that tying damage.
The Tenth Circuit, in Sports Racing Services, concluded that the cars/parts
distributor in that case did not have a tying claim because the distributor was not
subjected to the coercive effect of the tying arrangement since it had no connection
to, and no use for, the tying product—the right to race in Club-sponsored races. 10
While the distributor in Sports Racing Services paid for the tied products, the cars
and parts it resold to the racers, the distributor did not pay for the tying product, the
right to race. Because it was the racer who first paid for both, therefore, he was the
only party who could claim tying damages, measured as the difference between the
price the racer paid for the bundled products and services against the price he
would have paid for them separately, had Sports Car Club not unlawfully tied them
together.
Here, on the other hand, the Adenoscan distributors, as we have already
explained, were subject to the coercive effect of Astellas’s allegedly unlawful tying
arrangement because both the tying product, the implied license, and the tied
10

The distributor was not itself buying the cars to race them and, when it resold the cars, it did
not do so with a license that the buyer could race them in a Club-sponsored race. The buyer
independently had to qualify and pay directly to Sports Car Club for the right to race in a
sponsored race. There was no suggestion that when the distributor bought the car from Sports
Car Club, that it was also buying an implied right to race that car in a Club-sponsored race.
16

Case: 13-12709

Date Filed: 08/15/2014

Page: 17 of 23

product, Adenoscan, were valuable to the distributors and useful to them on resale.
Moreover, the purchase of the Adenoscan automatically conveyed an implied
license to perform the patented MPI procedure using adenosine. Furthermore,
according to the Medical Center, neither it nor the distributors paid anything for
the automatically conveyed implied license. Unlike in Sports Racing Services,
then, the distributors in this case bore the full brunt of the tying arrangement and
they were the first entities who suffered the full amount of the tying damages,
measured in this case as the overcharge Astellas was able to demand for
Adenoscan. Unlike in Sports Racing Services, then, it follows that the distributors
in this case were injured by the tying arrangement in the same manner as the
Medical Center and they, rather than the Medical Center, are the first entities in the
Adenoscan distribution chain to have a tying damages claim against Astellas. It
follows, therefore, that only the distributors, as the direct purchasers of Adenoscan,
can recover damages from Astellas; the Medical Center cannot.
D. Conclusion as to the district court’s refusal to certify a class for
purposes of the Medical Center’s damages claim
For these reasons, then, we agree with the district court that the direct
purchaser rule precludes the Medical Center, as an indirect purchaser of
Adenoscan, from recovering damages from Astellas for its allegedly unlawful
tying arrangement. As such, the Medical Center would not be an adequate
17

Case: 13-12709

Date Filed: 08/15/2014

Page: 18 of 23

representative for a class seeking damages for the alleged unlawful tying and the
district court, therefore, did not abuse its discretion in denying the Medical
Center’s request to certify a class for the damages claim, see Ault v. Walt Disney
World Co., 692 F.3d 1212, 1216 (11th Cir. 2012), cert denied, 133 S. Ct. 1806
(2013).
II. The district court also did not abuse its discretion in refusing to certify the
class for purposes of seeking injunctive and declaratory relief
The direct purchaser rule does not apply to claims for injunctive and
declaratory relief. See In re Beef Indus. Antitrust Litig., 600 F.2d 1148, 1167 (5th
Cir. 1979).11 Nevertheless, the district court also declined to certify the class for
purposes of seeking injunctive and declaratory relief against Astellas because
1) such relief in this case would soon be moot; and 2) the Medical Center did “not
sufficiently brief[] the Court as to the substance of its claims for declaratory or
injunctive relief to justify class certification pursuant to [Fed. R. Civ. P.] 23(b)(2).”
(Doc. 150 at 13.) We disagree with the first reason, but affirm on the second.
A. The Medical Center’s claims are not moot
We review questions of mootness de novo. See Doe v. Wooten, 747 F.3d
1317, 1321-22 (11th Cir. 2014). It was Astellas’s burden, as the party asserting
11

This court, in Bonner v. City of Prichard, 661 F.2d 1206, 1207 (11th Cir. 1981) (en banc)
adopted as binding precedent all decisions of the former Fifth Circuit issued prior to October 1,
1981.
18

Case: 13-12709

Date Filed: 08/15/2014

Page: 19 of 23

that the Medical Center’s claims would soon be moot, to come forward with
information to support that assertion. See Cardinal Chem. Co. v. Morton Int’l,
Inc., 508 U.S. 83, 98 (1993) (addressing mootness on appeal).
Astellas grounded its mootness argument on its prediction that a generic
version of Adenoscan would be available in October 2012, just a week after the
district court denied class certification. But that prediction proved wrong, and
generic Adenoscan did not become available during the time this case remained
pending in the district court.12 Moreover, the record does not indicate what effect,
if any, the presence of this single generic might have on the Adenoscan market.
We cannot conclude, therefore, that the controversy at issue here is at an end, see
Atheists of Fla., Inc. v. City of Lakeland, 713 F.3d 577, 593-94 (11th Cir. 2013), or
that it is currently impossible to provide the Medical Center with meaningful
injunctive or declaratory relief, see Rich v. Sec’y, Fla. Dep’t of Corr., 716 F.3d
525, 531 (11th Cir. 2013). Indeed, on appeal, Astellas does not argue to the
contrary. The district court thus erred in denying class certification on the ground
that the Medical Center’s declaratory and injunctive claims might soon become

12

Astellas now asserts that the FDA approved a generic form of Adenoscan a year later, in
August 2013, after the Medical Center initiated this appeal, but that information is not part of the
appellate record.
19

Case: 13-12709

Date Filed: 08/15/2014

Page: 20 of 23

moot. 13
B. The district court did not abuse its discretion in refusing to certify
the class because the Medical Center failed to justify certification
In addition to mootness, the district court also refused to certify the class for
purposes of declaratory and injunctive relief because the Medical Center failed to
justify certification. We review that determination for an abuse of discretion. See
Ault, 692 F.3d at 1216. “As long as the district court’s reasoning stays within the
parameters of Rule 23’s requirements for the certification of a class, the district
court decision will not be disturbed.” Heffner v. Blue Cross & Blue Shield of Ala.,
Inc., 443 F.3d 1330, 1337 (11th Cir. 2006) (internal quotation marks omitted).
Rule 23(b)(2) provides that a class can be certified for purposes of seeking
injunctive or declaratory relief if “the party opposing the class has acted or refused
to act on grounds that apply generally to the class, so that final injunctive relief or
corresponding declaratory relief is appropriate respecting the class as a whole.”
“The key to the (b)(2) class is the indivisible nature of the injunctive or declaratory
remedy warranted.” Wal-Mart Stores, Inc. v. Dukes, 131 S. Ct. 2541, 2557 (2011)
(internal quotation marks omitted). Thus, “Rule 23(b)(2) applies only when a
single injunction or declaratory judgment would provide relief to each member of
13

It may be that the district court did not conclude as a jurisdictional matter that the Medical
Center’s claims were, or soon would be, moot. Instead, the district court may have decided not
to exercise its discretion to certify the class under these circumstances. If so, the denial of class
certification was an abuse of discretion, for the same reasons stated above.
20

Case: 13-12709

Date Filed: 08/15/2014

Page: 21 of 23

the class.” Id. It was the Medical Center’s burden to “affirmatively demonstrate”
that class certification was appropriate under Rule 23(b)(2). Id. at 2551. The
Medical Center failed to meet that burden, in two ways.
First, it never identified exactly what injunctive or declaratory relief it was
seeking. In its complaint, the Medical Center requested only “such declaratory and
injunctive relief as appropriate in order to compel and ensure defendant Astellas’
future compliance with law.” (Doc. 11 at 19.) In the twenty-two months between
the time the Medical Center filed its complaint and the time it moved for class
certification, Astellas tried unsuccessfully to pin the Medical Center down as to
exactly what declaratory and injunctive relief it was seeking. Specifically, Astellas
wanted to know whether the Medical Center was seeking an order requiring it to
offer healthcare providers a stand-alone license to perform MPIs involving
adenosine. When the Medical Center moved for class certification, it suggested
only that the district court “could” order Astellas to provide access to and use of its
patent without threat of litigation and without requiring the purchase of a product
from Astellas. (Doc. 115 at 13.) This statement was insufficient to permit the
district court to assess adequately whether the injunctive and declaratory relief the
Medical Center was seeking could provide relief to each member of the class, see
Wal-Mart Stores, 131 S. Ct. at 2557.
21

Case: 13-12709

Date Filed: 08/15/2014

Page: 22 of 23

Second, even if the Medical Center adequately explained the injunctive and
declaratory relief it sought, and assuming that relief included an injunction
requiring Astellas to offer healthcare providers a stand-alone license to perform
MPIs involving adenosine, the Medical Center failed to prove that such an order
would provide relief to each class member. See id. at 2551, 2557. Astellas
asserted that no other member of the putative class had ever asked for a standalone license; that, according to Astellas, it was likely a stand-alone license
combined with generic adenosine would cost class members at least as much, if not
more, than the implied license currently bundled with Adenoscan; and that, even if
it would be less expensive to purchase a stand-alone license and generic adenosine,
healthcare providers might still choose to use Adenoscan because the FDA had
approved only Adenoscan for use during MPIs and Medicare would reimburse
providers only for using Adenoscan but not for using the generic version of
adenosine. The Medical Center failed to offer any evidence to counter Astellas’s
assertions. The district court, therefore, did not abuse its discretion in refusing to
certify the class for purposes of seeking declaratory and injunctive relief against
Astellas.
CONCLUSION
For the foregoing reasons, we AFFIRM the district court’s decision denying
22

Case: 13-12709

Date Filed: 08/15/2014

Page: 23 of 23

the Medical Center class certification on its claims seeking treble damages and
injunctive and declaratory relief.

23