In Re Lorazepam & Clorazepate Antitrust Litigation

                  United States Court of Appeals

               FOR THE DISTRICT OF COLUMBIA CIRCUIT

          Argued March 12, 2002    Decided May 14, 2002 

                           No. 01-7163

       In Re:  Lorazepam & Clorazepate Antitrust Litigation

          Appeal from the United States District Court 
                  for the District of Columbia 
                         (No. 99ms00276)

     John G. Roberts, Jr. argued the cause for petitioners.  
With him on the briefs were Catherine E. Stetson, Michael R. 
Grynberg, Christopher K. Tahbaz, Irving Scher and David A. 
Hickerson.  James B. Weidner entered an appearance.

     Michael D. Hausfeld argued the cause for respondents.  
With him on the brief were Arthur M. Kaplan and Thomas 
Campbell.

     Before:  Ginsburg, Chief Judge, Rogers and Garland, 
Circuit Judges.

     Opinion for the Court filed by Circuit Judge Rogers.

     Rogers, Circuit Judge:  This appeal presents for the first 
time in this circuit the threshold question of when interlocu-

tory review of a class certification decision is appropriate 
under Federal Rule of Civil Procedure 23(f).  We take the 
opportunity to offer general guidance on the scope of our 
discretion under Rule 23(f) in considering the petition for 
Rule 23(f) review by Mylan Laboratories, Inc., Mylan Phar-
maceuticals, Inc., UDL Laboratories, Inc., Profarmaco S.r.l., 
Cambrex Corporation, and GYMA Laboratories of America, 
Inc. (collectively "Mylan"), of the district court's certification 
of a class of direct purchasers of the generic anti-anxiety 
drugs lorazepam and clorazepate from Mylan or UDL.  My-
lan contends that the district court erred in ruling that 
despite the Federal Trade Commission's ("FTC") procure-
ment of a settlement against Mylan on behalf of a class of 
indirect purchasers, a class of direct purchasers had antitrust 
standing under Illinois Brick Co. v. Illinois, 431 U.S. 720 
(1977), and, in the alternative that the certified class consists 
of both direct and indirect purchasers in violation of Illinois 
Brick.  We conclude that interlocutory appeal pursuant to 
Rule 23(f) typically is appropriate in three circumstances:  (1) 
when there is a death-knell situation for either the plaintiff or 
defendant that is independent of the merits of the underlying 
claims, coupled with a class certification decision by the 
district court that is questionable, taking into account the 
district court's discretion over class certification;  (2) when the 
certification decision presents an unsettled and fundamental 
issue of law relating to class actions, important both to the 
specific litigation and generally, that is likely to evade end-of-
the-case review;  and (3) when the district court's class certifi-
cation decision is manifestly erroneous.  Applying these stan-
dards we deny Mylan's petition for interlocutory review.

                                I.

     The class action now pending in the district court was 
preceded by two lawsuits brought by the FTC and several 
States' Attorneys General against Mylan that were ultimately 
consolidated and ended in a settlement.  On December 21, 
1998, the FTC filed suit, pursuant to ss 5 and 13(b) of the 
Federal Trade Commission Act ("FTC Act"), 15 U.S.C. ss 45, 
53(b), against Mylan, Cambrex, Profarmaco, and GYMA Lab-

oratories, seeking injunctive and equitable relief, including 
disgorgement of $120 million plus interest.  FTC v. Mylan 
Labs., Inc., 62 F. Supp. 2d 25, 32, 34 (D.D.C. 1999).  The 
amended complaint alleged that the defendants had engaged 
in unfair methods of competition in violation of s 5(a) of the 
FTC Act, 15 U.S.C. s 45(a), by Mylan's entering into exclu-
sive licensing agreements with the other defendants, allowing 
Mylan to control the supply of the active pharmaceutical 
ingredients ("API") for generic lorazepam and clorazepate 
tablets so that Mylan could increase the price of these generic 
drugs.  On December 22, 1998, the Attorneys General of ten 
States, later joined by an additional 22 States and the District 
of Columbia, brought suit against the same defendants and 
SST Corporation, seeking equitable relief and treble damages 
for violations of ss 1 and 2 of the Sherman Act, 15 U.S.C. 
ss 1, 2, and various State antitrust laws.  Mylan, 62 F. Supp. 
2d at 32;  see also In re Lorazepam & Clorazepate Antitrust 
Litig., 205 F.R.D. 369, 373 (D.D.C. 2002).  As to the FTC, the 
district court denied the defendants' motion to dismiss, which 
argued that the district court lacked subject matter jurisdic-
tion because the FTC was not authorized to seek either 
monetary relief or a permanent injunction in an antitrust 
case.  Mylan, 62 F. Supp. 2d at 35-37.  As to the States, the 
district court partially granted the defendants' motion to 
dismiss, inter alia, narrowing the States' federal claims to 
claims under s 4 of the Clayton Act for direct purchases and 
limiting restitution and disgorgement on behalf of indirect 
purchasers on a State-by-State basis.  Id. at 37-53;  see also 
FTC v. Mylan Labs., Inc., 99 F. Supp. 2d 1, 4-10 (D.D.C. 
1999).  Subsequently, the parties entered into a settlement 
agreement, which the district court approved on February 1, 
2002.  Mylan, 205 F.R.D. at 402.  The settlement agreement 
provided, in part, that Mylan would pay disgorgement in the 
amount of $71,782,017 to satisfy the consumer claims in the 
States' lawsuit and $28,217,983 to satisfy the States' agency 
claims.  The settlement agreement also provided that the 
FTC, States, State agencies, and consumers who did not 

exclude themselves from the settlement, would release their 
claims against the defendants.

     On August 16, 1999, the Judicial Panel on Multidistrict 
Litigation transferred to the United States District Court for 
the District of Columbia a Northern District of Illinois lawsuit 
pending against Mylan.  This lawsuit was consolidated, on 
March 9, 2000, with a lawsuit brought by St. Charles Rehabil-
itation Center against Mylan.  The named plaintiffs in the 
consolidated action were Advocate Health Care, St. Charles 
Hospital and Rehabilitation Center, Dik Drug Company, and 
Harvard Pilgrim Health Care, and they sought class certifica-
tion as direct purchasers of lorazepam and clorazepate.  The 
amended complaint alleged that Mylan had engaged in price 
fixing and monopolization in violation of ss 1 and 2 of the 
Sherman Act, and the plaintiffs sought treble damages pursu-
ant to s 4 of the Clayton Act.  Mylan moved to dismiss the 
complaint pursuant to Federal Rules of Civil Procedure 
12(b)(1) and 12(b)(6), on the ground that the plaintiffs' pro-
posed class of direct purchasers lacked antitrust standing to 
assert their claims.  In Illinois Brick, the Supreme Court 
held that, with narrow exceptions, only direct purchasers may 
recover damages for illegal overcharges under s 4 of the 
Clayton Act.  Illinois Brick, 431 U.S. at 746-47.  Essentially, 
Mylan argued that the usual direct purchaser rule of Illinois 
Brick should not apply because the FTC had won a monetary 
recovery for the benefit of a class of indirect consumer 
purchasers pursuant to s 13(b) of the FTC Act for alleged 
antitrust violations, and to allow both purchaser classes to 
obtain relief would undermine the policy rationales behind 
Illinois Brick.  In the alternative, Mylan opposed the class 
certification arguing, inter alia, that the class consisted of 
direct and indirect purchasers in violation of Illinois Brick's 
direct purchaser rule.  On July 2, 2001, the district court 
denied the motion to dismiss, and, in accord with the plain-
tiffs' request, certified the following class:

     All persons and entities in the United Sates who pur-
     chased generic lorazepam tablets and/or generic cloraze-
     pate tablets directly from Defendants Mylan and UDL 
     
     during the period January 12, 1998 through the present, 
     excluding Defendants, their respective parents, subsid-
     iaries and affiliates, any co-conspirators of Defendants, 
     and all governmental entities.
     
In re Lorazepam & Clorazepate Antitrust Litig., 202 F.R.D. 
12, 21 (D.D.C. 2001).  The district court appointed Advocate 
Health Care, St. Charles Hospital, Dik Drug, and Harvard 
Pilgrim as class representatives.

     Mylan now petitions for interlocutory review of the district 
court's denial of its Rule 12(b)(6) motion to dismiss and the 
district court's certification of a class of direct purchasers. 
Asserting that "[t]his is not the typical case," Petitioners' Br. 
at 16, Mylan contends that, in light of the flexible standards 
for review developed in the circuits, appellate review of its 
petition under Rule 23(f) is warranted:  not only does Mylan's 
petition raise the novel issue of law of "how properly to 
calibrate antitrust standing where two antitrust cases collide," 
id. at 20, the outcome of which is potentially dispositive of the 
case, but also the district court's decision is particularly 
susceptible to challenge and there may be no further opportu-
nity to review its decision.  Reviving its Rule 12(b)(6) conten-
tion, Mylan challenges the district court's certification deci-
sion by contending first that under Illinois Brick, the FTC's 
s 13(b) enforcement action on behalf of the ultimate consum-
ers of lorazepam and clorazepate precludes suit by a direct 
purchaser class.  Allowing a direct purchaser class to sue the 
same defendants for antitrust damages following the FTC's 
suit and settlement would, in Mylan's view, "topple every 
rationale" supporting Illinois Brick's rule confining potential 
antitrust plaintiffs to one level of purchasers.  Id. at 17.  In 
"these uncommon circumstances," Mylan concludes, "the di-
rect purchaser class should be denied recovery."  Id.  Sec-
ond, as to the certified class, Mylan maintains that, even if 
direct purchasers may sue for antitrust damages in addition 
to the consumer class, the district court erred in ruling that 
the class had antitrust standing under the direct purchaser 
rule and its narrow exceptions.  According to Mylan, many 
members of the class, including three of the four class 
representatives, bought lorazepam and clorazepate, not from 

Mylan, but from pharmaceutical wholesalers, who also pur-
port to be members of the direct purchaser class.  Mylan 
asserts that this purchasing chain makes these class members 
who purchased from intermediaries "quintessential indirect 
purchasers," who, under Illinois Brick, cannot sue for anti-
trust damages.  Hence, Mylan maintains, the district court 
erred in not determining, prior to certifying the class, wheth-
er the class and its representatives had antitrust standing 
under Illinois Brick.

     We first set forth the standards that we will ordinarily 
apply in exercising our discretion under Rule 23(f), and then 
we address the contentions in Mylan's petition.

                               II.

     Rule 23(f), added by amendment in 1998, provides that "[a] 
court of appeals may in its discretion permit an appeal from 
an order of a district court granting or denying class action 
certification under this rule if application is made to it within 
ten days after entry of the order."  Fed. R. Civ. P. 23(f).  
Although other circuit courts of appeals have addressed the 
scope of Rule 23(f) review, this is a question of first impres-
sion for this court.  The advisory committee's note to Rule 
23(f) states that "[a]ppeal from an order granting or denying 
class certification is permitted in the sole discretion of the 
court of appeals" and is "akin to the discretion exercised by 
the Supreme Court in acting on a petition for certiorari."  
Fed. R. Civ. P. 23(f) advisory committee's note.  The advisory 
committee's note also indicates that not all class certification 
issues warrant review, noting that "many suits with class-
action allegations present familiar and almost routine issues 
that are no more worthy of immediate appeal than many 
other interlocutory rulings" and accordingly directs the 
"courts of appeals [to] develop standards for granting review 
that reflect the changing areas of uncertainty in class litiga-
tion."  Id.  The advisory committee's note offers this further 
guidance:

          Permission to appeal may be granted or denied on the 
     basis of any consideration that the court of appeals finds 
     
     persuasive.  Permission is most likely to be granted 
     when the certification decision turns on a novel or unset-
     tled question of law, or when, as a practical matter, the 
     decision on certification is likely dispositive of the litiga-
     tion.
     
Id.  Thus, the advisory committee's note identifies two in-
stances in which Rule 23(f) review would likely be appropri-
ate:  (1) when a class certification decision as a practical 
matter terminates the litigation;  and (2) when a class certifi-
cation decision raises a novel issue of law.  Relying on this 
guidance, other circuits have examined the appropriate scope 
of Rule 23(f).

     First among the circuits to address the scope of appellate 
review pursuant to Rule 23(f), was the Seventh Circuit in 
Blair v. Equifax Check Services, Inc., 181 F.3d 832 (7th Cir. 
1999).  In Blair, the Seventh Circuit rejected the adoption of 
a bright-line rule as imprudent and, looking to the reasons for 
the addition of Rule 23(f), identified three categories of cases 
in which appellate review would be appropriate.  Id. at 834.  
First, for some cases, denial of class status would sound the 
"death knell" of the litigation because the "representative 
plaintiff's claim is too small to justify the expense of litiga-
tion."  Id.  Second, the grant of class status can put substan-
tial pressure on the defendant to settle independent of the 
merits of the plaintiffs' claims.  Id.  Third, an appeal may 
facilitate the development of the law of class actions.  Id. at 
835.  Regarding the first two categories, the Seventh Circuit 
added that the petitioner must demonstrate that the district 
court's certification decision was "questionable" and "must do 
this taking into account the discretion the district judge 
possesses in implementing Rule 23, and the correspondingly 
deferential standard of appellate review."  Id.  It explained, 
if the district court's decision is "impervious to revision," 
there is no point to an interlocutory appeal no matter how 
"dramatic the effect of the grant or denial of class status [is] 
in undercutting the plaintiff's claim or inducing the defendant 
to capitulate."  Id.  Regarding the third category of cases, 
which it noted is likely to include fundamental issues about 
class actions that have been poorly developed because so 
many class actions settle or are resolved in a manner that 

overtakes procedural matters, id., the Seventh Circuit ob-
served that it is less important to show that the district 
court's certification decision is questionable, explaining that 
law can be advanced through affirmances as well as reversals;  
rather, the more important the question under the second 
factor is and the "greater the likelihood that it will escape 
effective disposition at the end of the case," the more appro-
priate the appeal.  Id.

     The First Circuit in Waste Management Holdings, Inc. v. 
Mowbray, 208 F.3d 288 (1st Cir. 2000), agreed that Blair 
"captured the essential principles on which Rule 23(f) rests."  
Id. at 293.  However, because of the ease with which issues of 
law can be characterized as "fundamental," id. at 294, and 
because so many class certification decisions turn on "familiar 
and almost routine issues," id. (quoting Fed. R. Civ. P. 23(f) 
advisory committee's note), the First Circuit narrowed the 
third category to include only "those instances in which an 
appeal will permit the resolution of an unsettled legal issue 
that is important to the particular litigation as well as impor-
tant in itself and likely to escape effective review if left 
hanging until the end of the case."  Id.  At the same time, 
however, the First Circuit duly noted the broad discretion 
ceded to the appellate courts by the rule, and cautioned that:

     While we hope that these general comments will be 
     helpful to parties deciding whether to pursue applications 
     under Rule 23(f), we do not foreclose the possibility that 
     special circumstances may lead us either to deny leave to 
     appeal in cases that seem superficially to fit into one of 
     these three pigeonholes, or conversely, to grant leave to 
     appeal in cases that do not match any of the three 
     described categories.
     
Id.  Stating as well that it "intend[s] to exercise [its] discre-
tion judiciously," however, the First Circuit observed that 
"[b]y their nature, interlocutory appeals are disruptive, time-
consuming, and expensive," and that notwithstanding the 
access to the appellate courts provided by Rule 23(f), the 
court "should err, if at all, on the side of allowing the district 
court an opportunity to fine-tune its class certification order, 
rather than opening the door too widely to interlocutory 

appellate review."  Id. (citing Fed. R. Civ. P. 23(c)(1)).  The 
Second Circuit, in In re Sumitomo Copper Litigation, 262 
F.3d 134 (2d Cir. 2001), appears to have adopted the approach 
set forth in Mowbray.  Id. at 139-40.  It stated that Rule 
23(f) petitioners ordinarily must show either that the certifi-
cation order (1) "will effectively terminate the litigation and 
there has been a substantial showing that the district court's 
decision is questionable," or (2) "implicates a legal question 
about which there is a compelling need for immediate resolu-
tion."  Id. at 139.

     Other circuits have elaborated on the Mowbray approach.  
The Eleventh Circuit, in Prado-Steiman v. Bush, 221 F.3d 
1266 (11th Cir. 2000), adopted five guideposts for Rule 23(f) 
review:  (1) whether the certification ruling is likely to sound 
the death knell of the litigation;  (2) whether the district 
court's certification decision contains a substantial weakness, 
such that it likely was an abuse of discretion;  (3) whether the 
appeal presents an unsettled legal question that is of specific 
and general importance, e.g., issues likely to evade review, 
issues that are involved in related actions, and interests that 
affect the public interest;  (4) the nature and status of the 
litigation before the district court, e.g., the status of discov-
ery, the pendency of relevant motions, and how long the 
matter has been pending;  and (5) the likelihood that future 
events will make immediate appellate review more appropri-
ate, e.g., a change in financial status of a party or ongoing 
settlement negotiations.  Id. at 1274-76.  The second factor 
serves as a sliding scale:  the more questionable the district 
court's decision, the less the remaining four factors need 
weigh in.  Id. at 1274-75 & n.10.  The Eleventh Circuit 
recognized the possibility that when the district court's certi-
fication decision is clearly wrong, Rule 23(f) review "may be 
warranted even if none of the other factors supports granting 
the Rule 23(f) petition."  Id. at 1275.  The Fourth Circuit, in 
Lienhart v. Dryvit Systems, Inc., 255 F.3d 138 (4th Cir. 
2001), adopted the Eleventh Circuit's approach with the slid-
ing scale, but firmly stated that when a class certification 
decision is manifestly erroneous, review is warranted regard-
less of the remaining factors.  Id. at 145-46.  The court 

explained that stringent standards for review are inappropri-
ate as "Rule 23(f)'s purpose [was] to eliminate the unduly 
restrictive review practices which obtained when mandamus 
was the only available means to review a class certification 
prior to final judgment in the absence of a district court's 
decision to voluntarily certify the issue for immediate re-
view...." Id. at 145.  Hence, the Fourth Circuit observed 
that "[i]n addition to addressing 'death knell' situations and 
promoting the resolution of legal questions of general impor-
tance, a careful and sparing use of Rule 23(f) may promote 
judicial economy by enabling the correction of certain mani-
festly flawed class certifications prior to trial and final judg-
ment."  Id. at 145.  Following the Eleventh and Fourth 
Circuits' decisions, the Third Circuit, in Newton v. Merrill 
Lynch, Pierce, Fenner & Smith, 259 F.3d 154 (3d Cir. 2001), 
identified four categories of cases in which Rule 23(f) would 
be appropriate:  the three set forth by the Seventh Circuit in 
Blair and the advisory committee's note plus the Eleventh 
and Fourth Circuits' inclusion of a category of likely errone-
ous class certification decisions.  Id. at 165.

     The differences among the circuits, which are subtle, are of 
three types.  First, two circuits permit appeal if the district 
court's decision is erroneous, regardless whether the other 
factors governing appeal under Rule 23(f) are present.  Com-
pare Newton, 259 F.3d at 165;  and Lienhart, 255 F.3d at 
145-46;  with Mowbray, 208 F.3d at 293-94;  and Blair, 181 
F.3d at 834-35.  Second, two circuits allow appeal when a 
petition raises an unsettled and fundamental question of law, 
regardless whether the district court likely erred.  See Mow-
bray, 208 F.3d at 293;  Blair, 181 F.3d at 835.  Third, those 
same circuits caution that interlocutory appeal of an unsettled 
question of law is appropriate only when that question may 
evade effective appellate review at the end of the trial court 
proceedings.  See Mowbray, 208 F.3d at 293-94;  Blair, 181 
F.3d at 835.

     In our view, interlocutory appellate review under Rule 23(f) 
is properly directed by the guidance set forth in the advisory 
committee's note.  The note reflects, on balance, a reluctance 
to depart from the traditional procedure in which claimed 

errors by the district court are reviewed on appeal only upon 
the conclusion of the proceedings in the district court.  Al-
though the rule ceded broad discretion to the appellate 
courts, it is understood, if not presumed, that appellate courts 
will act with cognizance of both the concerns underlying 
interlocutory appeals generally and the specific purposes for 
the allowance of interlocutory appeals of class certification 
decisions in Rule 23(f).  Delay caused by interlocutory ap-
peals under Rule 23(f) may be less of a concern because filing 
a petition does not automatically stay the litigation, see Blair, 
181 F.3d at 835;  in the instant case, the docket indicates that 
the case proceeded until the district court granted Mylan's 
motion for a stay on April 15, 2002.  Still, interlocutory 
appeals are generally disfavored as "disruptive, time-
consuming, and expensive" for both the parties and the 
courts, Mowbray, 208 F.3d at 294, and the more so in a 
complex class action where the district court may reconsider 
and modify the class as the case progresses.  Prado- 
Steiman, 221 F.3d at 1276-77;  Fed. R. Civ. P. 23(c)(1).  As 
the Eleventh Circuit aptly commented, the exception provided 
by Rule 23(f) should be exercised in a manner that avoids 
both micromanagement of complex class actions as they 
evolve in the district court and inhibition of the district 
court's willingness to revise the class certification for fear of 
triggering another round of appellate review.  See Prado-
Steiman, 221 F.3d at 1273-74.  Thus, petitions for Rule 23(f) 
review are likely to be granted sparingly in cases that fall 
within neither the guidelines in the advisory committee's note 
nor the standards we adopt today.  Nonetheless, the circuit 
courts addressing Rule 23(f) are in agreement that restric-
tions on review should not preclude review in special circum-
stances that neither the advisory committee's note nor the 
courts foresaw.  See, e.g., Mowbray, 208 F.3d at 294;  Blair, 
181 F.3d at 834.

     With these considerations in mind, we offer the following 
guidance.  Rule 23(f) review will ordinarily be appropriate in 
three circumstances:  (1) when there is a death-knell situation 
for either the plaintiff or defendant that is independent of the 
merits of the underlying claims, coupled with a class certifica-

tion decision by the district court that is questionable, taking 
into account the district court's discretion over class certifica-
tion;  (2) when the certification decision presents an unsettled 
and fundamental issue of law relating to class actions, impor-
tant both to the specific litigation and generally, that is likely 
to evade end-of-the-case review;  and (3) when the district 
court's class certification decision is manifestly erroneous.  
Whether the district court's decision is questionable need not 
affect the appropriateness of Rule 23(f) review in the second 
category, as issues of law can be advanced through affir-
mances as well as reversals.  Blair, 181 F.3d at 835.  But we 
conclude, unlike Mowbray and Blair, that error in certifying 
a class should not entirely be ignored outside the first catego-
ry.  Where a district court class certification decision is 
manifestly erroneous, for example, Rule 23(f) review would be 
warranted even in the absence of a death-knell situation if for 
no other reason than to avoid a lengthy and costly trial that is 
for naught once the final judgment is appealed.  Although 
these standards are meant as guidance on when Rule 23(f) 
review ordinarily will be granted, we caution that the stan-
dards represent guidance, not a rigid test.

     As is true for all the circuits, we are of the view that Rule 
23(f) review should be granted rarely where a case does not 
fall within one of these three categories.  The sheer number 
of class actions, the district court's authority to modify its 
class certification decision, see Fed. R. Civ. P. 23(c)(1), and 
the ease with which litigants can characterize legal issues as 
novel, all militate in favor of narrowing the scope of Rule 23(f) 
review.  See Prado-Steiman, 221 F.3d at 1273-74;  see also 
Mowbray, 208 F.3d at 294.  At the same time, there neces-
sarily should be some hesitancy in creating a rigid test for the 
exercise of an appellate court's discretion to grant a Rule 
23(f) petition for review because circumstances may arise that 
cannot now be anticipated in which review would be appropri-
ate, and conversely, in which review would be inappropriate 
notwithstanding the fact that a petition falls within the cate-
gories of cases in which review would ordinarily be appropri-
ate.  As the advisory committee's note indicates, the circuit 
court standards should "reflect the changing areas of uncer-

tainty in class litigation."  Fed. R. Civ. P. 23(f) advisory 
committee's note.  Each circuit, thus, has reserved some 
leeway in its standards.  See, e.g., Newton, 259 F.3d at 165;  
Prado-Steinman, 221 F.3d at 1276;  Mowbray, 208 F.3d at 
294;  Blair, 181 F.3d at 834.  So do we.  That said, we 
nevertheless conclude that, absent special circumstances, this 
court's consideration of petitions for interlocutory review 
under Rule 23(f) should ordinarily fall within the three cir-
cumstances that we have identified.

                               III.

     Mylan contends in its Rule 23(f) petition for review that, 
although certification of a class of direct purchasers is consis-
tent with the direct purchaser rule of Illinois Brick, it 
conflicts with what Mylan regards as the underlying policy of 
Illinois Brick--that only one purchaser class has antitrust 
standing to sue under s 4 of the Clayton Act--when, as here, 
the FTC has brought suit and obtained a settlement on behalf 
of a class of consumer indirect purchasers.  Mylan also 
contends that the certified class consists of both direct and 
indirect purchasers in contravention of Illinois Brick and 
Rule 23's class certification requirements.  Seeking to bring 
itself within the flexible standards for Rule 23(f) adopted by 
the circuit courts, Mylan maintains that its petition for review 
should be granted because "important issues of antitrust 
standing [are] raised by the District Court's class certification 
ruling" that are novel, significant, and potentially dispositive, 
and because the class as certified is particularly suspect and 
may avoid later review given the potential liability Mylan 
faces.  We conclude that Rule 23(f) review is inappropriate 
because Mylan's arguments in support of its Rule 12(b)(6) 
motion to dismiss are unrelated to class certification, and 
because Mylan's only challenge to the class certification deci-
sion falls outside the categories for Rule 23(f) review set forth 
in Part II.

                                A.

     Rule 23(f) interlocutory review is limited to issues that 
relate to class certification.  See Fed. R. Civ. P. 23(f);  Bertul-

li v. Indep. Ass'n of Cont'l Pilots, 242 F.3d 290, 294 (5th Cir. 
2001);  Carter v. W. Publ'g Co., 225 F.3d 1258, 1262 (11th Cir. 
2000).  Thus, under Rule 23(f), this court can review the 
merits of an appeal only insofar as they bear upon the 
propriety of class certification, that is, whether the proposed 
class satisfies the prerequisites of Rule 23.  The threshold 
requirements of class certification under Rule 23(a) are:  (1) 
numerosity (a large enough class such that "joinder of all 
members is impractical");  (2) commonality ("questions of law 
or fact common to the class");  (3) typicality ("claims or 
defenses of the representative parties are typical of the 
claims or defenses of the class");  and (4) adequacy of repre-
sentation ("representative parties will fairly and adequately 
protect the interests of the class").  Fed. R. Civ. P. 23(a);  
Amchem Prods., Inc. v. Windsor, 521 U.S. 591, 613 (1997).  
The rule also limits class actions to cases where:  (1) separate 
actions would risk "establish[ing] incompatible standards of 
conduct for the party opposing the class" or individual adjudi-
cations "which would as a practical matter be dispositive of 
the interests" of nonparty members or "substantially impair 
or impede their ability to protect their interests";  (2) injunc-
tive or declaratory relief is sought and "the party opposing 
the class has acted or refused to act on grounds generally 
applicable to the class";  or (3) "the court finds that the 
questions of law or fact common to the members of the class 
predominate over any questions affecting only individual 
members, and that a class action is superior to other available 
methods for the fair and efficient adjudication of the contro-
versy."  Fed. R. Civ. P. 23(b)(1), (2), & (3);  Amchem, 521 
U.S. at 614-16.

     Although Mylan is correct that whether a class of direct 
purchasers has antitrust standing under the particular cir-
cumstances at issue is a novel question of law, the question is 
unrelated to class certification under Rule 23.  As Mylan 
styled its filing in the district court, its novel question of law 
is properly raised in a Rule 12(b)(6) motion to dismiss;  the 
denial of a motion to dismiss is generally not subject to 
interlocutory review under Rule 23(f) because whether the 
plaintiffs state a cause of action is only relevant to class 

certification to the extent the inquiry relates to the require-
ments of Rule 23.  See Gen. Tel. Co. of the Southwest v. 
Falcon, 457 U.S. 147, 160 (1982);  Eisen v. Carlisle & Jacque-
lin, 417 U.S. 156, 177-78 (1974).  Mylan's effort to recast its 
Rule 12(b)(6) arguments as a challenge to class certification 
on the ground that a class of direct purchasers lacks antitrust 
standing, is to no avail.  That Mylan's argument as to anti-
trust standing may dispose of the class as a whole and 
thereby preclude a lawsuit by direct purchasers goes well 
beyond the purpose of Rule 23(f) review because it is unrelat-
ed to the Rule 23 requirements.  The fact that Mylan's 
challenge would be dispositive of the class action is not unlike 
a variety of issues of law on the merits of a class action 
because of the very nature of commonality, see Fed. R. Civ. P. 
23(a)(2);  review of such issues would expand Rule 23(f) 
interlocutory review to include review of any question raised 
in a motion to dismiss that may potentially dispose of a 
lawsuit as to the class as a whole.  This result would inappro-
priately mix the issue of class certification with the merits of 
a case, which do not warrant interlocutory review pursuant to 
Rule 23(f).  What matters for purposes of Rule 23(f) is 
whether the issue is related to class certification itself, and 
Mylan makes no showing that its antitrust standing claim is 
so related.

     The cases on which Mylan relies do not advance its cause.  
To the extent that appellate courts have considered constitu-
tional standing pursuant to Rule 23(f), the inquiry has been 
limited to whether the court has subject matter jurisdiction to 
review the class certification issue, or whether the claims of 
the representatives of the class have the requisite typicality.  
Neither inquiry is applicable to the antitrust standing issue 
that Mylan presents.  In the first category of cases cited by 
Mylan is Bertulli v. Independent Association of Continental 
Pilots, 242 F.3d 290 (5th Cir. 2001), in which the Fifth Circuit 
explained that, because Article III standing is one element of 
the court's subject matter jurisdiction, this requirement must 
be met before the court can even examine whether the class 
has met the Rule 23 requirements.  Id. at 294;  see also 
Rivera v. Wyeth-Ayerst Labs., 283 F.3d 315, 319 (5th Cir. 

2002);  Isaacs v. Sprint Corp., 261 F.3d 679, 682-83 (7th Cir. 
2001).  Unlike constitutional standing, this court's jurisdiction 
does not turn on antitrust standing.  See Associated Gen. 
Contractors of Cal., Inc. v. Cal. State Council of Carpenters, 
459 U.S. 519, 535 n.31 (1983).  The question of constitutional 
standing, which is a prerequisite to Rule 23 class certification 
because it goes to the court's jurisdiction, is not at issue here.  
In the second category of cases cited by Mylan is Prado-
Steiman, in which the Eleventh Circuit considered, pursuant 
to Rule 23(f), whether the named representatives had consti-
tutional standing, explaining that the question of standing was 
appropriate for review under Rule 23(f) only to the extent it 
was relevant to Rule 23's typicality requirement for "[w]ith-
out individual standing to raise a legal claim, a named repre-
sentative does not have the requisite typicality to raise the 
same claim on behalf of a class."  Prado-Steiman, 221 F.3d at 
1279-80;  see also Piazza v. EBSCO Indus., Inc., 273 F.3d 
1341, 1346-55 (11th Cir. 2001);  Carter, 225 F.3d at 1262-63.  
The court thus only considered Article III standing to the 
extent that it was relevant to Rule 23 class certification.  
Unlike constitutional standing, whether the class representa-
tives have antitrust standing because they are direct purchas-
ers does not go to the typicality of the claims of the represen-
tatives of the class, which is composed entirely of direct 
purchasers.  See Fed. R. Civ. P. 23(a)(3);  Prado-Steiman, 
221 F.3d at 1279 & n.14.  Hence, the issue of antitrust 
standing is beyond the scope of the court's Rule 23(f) review.  
The only case to which Mylan points in which a court consid-
ered antitrust standing to be a necessary predicate to certify-
ing the class is In re NASDAQ Market-Makers Antitrust 
Litigation, 169 F.R.D. 493 (S.D.N.Y. 1996), but there the 
court appears to have viewed antitrust standing as being 
relevant to its subject matter jurisdiction;  it was only on this 
basis that the court considered antitrust standing to be a 
prerequisite to class certification.  See id. at 504-05.

     Although the question of whether a class of direct purchas-
ers has antitrust standing when, in Mylan's terms, "two 
antitrust cases collide" relates neither to this court's subject 

matter jurisdiction nor to any aspect of Rule 23 class certifi-
cation, there may be occasions when threshold issues (e.g., 
statute of limitations), jurisdictional issues (e.g., Article III 
constitutional standing), or issues on the merits (e.g., affirma-
tive defenses or the elements of a cause of action, see, e.g., 
West v. Prudential Securities, Inc., 282 F.3d 935, 937 (7th 
Cir. 2002);  Newton, 259 F.3d at 172;  Mowbray, 208 F.3d at 
295-99), would be appropriate for interlocutory review pursu-
ant to Rule 23(f).  In such circumstances, however, those 
issues would relate in some manner to the certification of the 
class or the court's jurisdiction.  We have no occasion to 
describe the precise contours of the relationship, for here 
there is no such relation.

                                B.

     Mylan's challenge to the composition of the certified class 
as assertedly, and improperly, consisting of both direct and 
indirect purchasers also is inappropriate for Rule 23(f) review.

     First, Mylan has not shown that certification of the class 
would sound the death knell of the litigation.  Other than 
mere assertions, Mylan makes no showing that it will be 
unduly pressured to settle because of the class's certification.  
Mylan failed to submit any evidence that the damages 
claimed would force a company of its size to settle without 
relation to the merits of the class's claims.  See Prado-
Steiman, 221 F.3d at 1274;  Mowbray, 208 F.3d at 294-95.

     Second, Mylan's challenge presents no unsettled question 
of fundamental importance to the law of class actions.  Mylan 
argues that the district court erred in applying the standards 
of Rule 23 to the facts of this case, but Mylan does not aver 
that the district court lacked established law to guide it in 
that task.  Insofar as Mylan's objection is based upon the 
district court's conclusion that the class representatives are 
direct purchasers, the law guiding that decision also is well 
settled.  See Illinois Brick, 431 U.S. at 735-36.

     Third, Mylan has not made a showing that, in light of the 
district court's discretion, see Hartman v. Duffey, 19 F.3d 

1459, 1471 (D.C. Cir. 1994), the class certification was mani-
festly erroneous.  Mylan contends the certified class does not 
meet the requirements of Rule 23(a)(2-4), namely, predomi-
nance, typicality, and adequacy of representation, because 
members of the class occupy different levels of a distribution 
relationship with Mylan.  Upon the record before us, howev-
er, we can not conclude that there is manifest error in the 
district court's determination that the class representatives 
have standing under Illinois Brick or in the findings of fact 
underlying that conclusion.  As the district court comes to 
know more about the relationships among Mylan, the phar-
maceutical wholesalers, and the class plaintiffs, it may further 
refine the class, see Fed. R. Civ. P. 23(c)(1)--a possibility that 
supports our conclusion that immediate appeal is not warrant-
ed here.

     Accordingly, we hold, upon applying the standards that we 
have outlined in defining when Rule 23(f) review is ordinarily 
appropriate, that Mylan's challenges to the class certification 
do not warrant interlocutory review pursuant to Rule 23(f).  
Although Mylan would nonetheless have the court reach the 
merits of the district court's certification decision as well as 
the merits of its Rule 12(b)(6) motion to dismiss because the 
issues have been carefully briefed, review under Rule 23(f) is 
not warranted.  Therefore, we deny the petition for review.