Cross-Appellant Actavis's Reply Brief in Third Circuit (Endo V Actavis) False Advertising Case

Case Nos.
13-3981; 13-4096

United States Court of Appeals
for the
Third Circuit

ENDO PHARMACEUTICALS INC.,
Plaintiff-Appellant/Cross-Appellee,
v.
ACTAVIS, INC. and
ACTAVIS SOUTH ATLANTIC LLC,
Defendants-Appellees/Cross-Appellants.
____________________________________________________________________________________________________________________________________________________________
____________________________________________________________________________________________________________________________________________________________
Appeal from the United States District Court
for the District of New Jersey in case no. 12-cv-7591
____________________________________________________________________________________________________________________________________________________________
____________________________________________________________________________________________________________________________________________________________

REPLY BRIEF OF DEFENDANTS-APPELLEES
ACTAVIS, INC., AND ACTAVIS SOUTH ATLANTIC LLC

Charles A. Weiss
Samuel Spital
HOLLAND & KNIGHT LLP
31 West 52nd Street
New York, New York 10019
(212) 513-3200

Attorneys for Defendants-Appellees

Case: 13-3981 Document: 003111752207 Page: 1 Date Filed: 09/30/2014
TABLE OF CONTENTS

Page

TABLE OF AUTHORITIES .................................................................................... ii
I. ACTAVISS ARGUMENT THAT ENDOS LANHAM ACT
CLAIM WAS PRECLUDED UNDER SANDOZ BECAUSE A
DETERMINATION OF FALSITY WOULD IMPROPERLY
REQUIRE ADJ UDICATION OF ISSUES RESERVED TO THE
FDA UNDER THE FOOD, DRUG & COSMETIC ACT, AND BE
AN END-RUN AROUND THE ABSENCE OF A PRIVATE
RIGHT OF ACTION UNDER THAT STATUTE, GOES TO THE
MERITS AND THUS SHOULD RESULT IN DISMISSAL OF
ENDOS CLAIMS WITH PREJ UDICE, AS ACTAVIS MADE
CLEAR IN BOTH THE DISTRICT COURT AND THIS COURT .............. 2
II. ACTAVISS ALTERNATIVE ARGUMENTS, WHICH ACTAVIS
ALSO RAISED IN THE DISTRICT COURT, GO TO THE
MERITS AND WOULD REQUIRE (IF ACCEPTED) DISMISSAL
WITH PREJ UDICE ......................................................................................... 5
A. Endos Failure to Allege a False Statement .......................................... 5
B. Endos Failure to Make a Plausible Allegation that Actavis Used
the Challenged Advertisements After May 2012 .................................. 8
C. Endos Failure to Present Competent Summary J udgment
Evidence that Actavis Used the Challenged Advertisements After
May 2012 ............................................................................................... 8
D. This Court Should Reach Actaviss Alternative Arguments if It
Concludes that a Sandoz Dismissal Is Without Prejudice................... 13
III. CONCLUSION .............................................................................................. 15


TABLE OF AUTHORITIES
Page(s)
CASES
Brown v. U.S. Steel Corp.,
462 F. Appx 152 (3d Cir. 2011) ........................................................................ 12
Burella v. City of Philadelphia,
501 F.3d 134 (3d Cir. 2007) ............................................................................... 13
Chase Manhattan Bank, N.A. v. American Natl Bank & Trust Co. of
Chicago,
93 F.3d 1064 (2d Cir. 1996) ............................................................................... 14
Dial-A-Car, Inc. v. Transportation, Inc.,
82 F.3d 484 (D.C. Cir. 1996) ................................................................................ 2
Fullman v. Potter,
480 F. Supp. 2d 782 (E.D. Pa. 2007) .................................................................... 9
Howard Johnson Intl v. Cupola Enters., LLC,
117 F. Appx 820 (3d Cir. 2004) ....................................................................... 11
Hudson United Bank v. LiTenda Mortgage Corp.,
142 F.3d 151 (3d Cir. 1998) ......................................................................... 13, 14
In re Ben Franklin Hotel Assocs.,
186 F.3d 301 (3d Cir. 1999) ............................................................................... 13
In re Mercedes-Benz Anti-Trust Litigation,
364 F. Supp. 2d 468 (D.N.J . 2005) ..................................................................... 10
Intl Union of Bricklayers & Allied Craftsmen v. Gallante,
912 F. Supp. 695 (S.D.N.Y. 1996) ....................................................................... 9
Jones v. Hashagen,
512 F. Appx 179 (3d Cir. 2013) ........................................................................ 11
ii

Kingman Park Civic Assn v. Williams,
No. 01-02675, 2002 U.S. Dist. LEXIS 15254 (D.D.C. Aug. 16,
2002) ................................................................................................................... 10
Kingman Park Civic Assn v. Williams,
348 F.3d 1033 (D.C. Cir. 2003) ...................................................................... 9, 10
Lunderstadt v. Colafella,
885 F.2d 66 (3d Cir. 1989) ................................................................................. 12
Montrose Med. Group Participating Savings Plan v. Bulger,
243 F.3d 773 (3d Cir. 2001) ......................................................................... 13, 14
Morrow v. Balaski,
719 F.3d 160 (3d Cir. 2013) ............................................................................. 6, 7
New Eng. Health Care Employees Union v. Mount Sinai Hospital,
65 F.3d 1024 (2d Cir. 1995) ................................................................................. 9
Old Bridge Owners Cooperative Corp. v. Township of Old Bridge,
981 F. Supp. 884 (D.N.J . 1997) .......................................................................... 10
Pernod Ricard USA, LLC v. Bacardi U.S.A., Inc.,
653 F.3d 241 (3d Cir. 2011) ................................................................................. 7
Ramsgate Court Townhome Assn v. West Chester Borough,
313 F.3d 157 (3d Cir. 2002) ............................................................................... 14
San Lucio, S.R.L. v. Import & Storage Servs., LLC,
No. 07-3031, 2009 WL 1010981 (D.N.J . Apr. 20, 2009) .................................. 10
Sandoz Pharmaceuticals Corp. v. Richardson-Vicks, Inc.,
902 F.2d 222 (3d Cir. 1990) ........................................................................passim
Serbin v. Consolidated Rail Corp.,
140 F. Appx 336 (3d Cir. 2005) ........................................................................ 12
Unger v. Natl Residents Matching Program,
928 F.2d 1392 (3d Cir. 1991) ............................................................................... 4
United States v. Davis,
41 F. Appx 566 (3d Cir. 2002) ............................................................................ 6
iii

RULES
FED. R. CIV. P. 12 ......................................................................................... 4, 6, 8, 14
Fed. R. Civ. P. 56 ............................................................................................... 11, 12

iv

Endo recognizes that claims which fail on the merits should be dismissed
with prejudice. See Yellow Br. at 36. That is precisely the situation here, and the
reason for Actaviss cross-appeal. Because Endo did not state a claim for relief
under the Lanham Act, its case failed on the merits and should have been
dismissed with prejudice. In the alternative, the case should be dismissed with
prejudice because Actavis is entitled to summary judgment.
Contrary to Endos assertions, a with-prejudice dismissal is fully consistent
with Actaviss substantive arguments on the merits of Endos appeal, and with
Actaviss position throughout these proceedings. Id. Actavis has consistently
argued that it is entitled to judgment on the merits. Again, contrary to Endos
assertions, Actavis did not argue (and does not argue) that the district court lacked
the authority to even make a decision on the merits. Id.
As set forth below, Actaviss grounds for dismissal under Sandoz
Pharmaceuticals Corp. v. Richardson-Vicks, Inc., 902 F.2d 222 (3d Cir. 1990), and
its three alternative grounds for dismissal, are all arguments on the merits, which if
accepted, require dismissal with prejudice. Actavis disagrees with Endos
response concerning the substance of those arguments, but recognizes that
engaging on the substance is beyond the scope of this reply brief.

1

I. Actaviss Argument that Endos Lanham Act Claim Was Precluded
Under Sandoz Because a Determination of Falsity Would Improperly
Require Adjudication of Issues Reserved to the FDA Under the Food,
Drug & Cosmetic Act, and Be an End-Run Around the Absence of a
Private Right of Action Under that Statute, Goes to the Merits and Thus
Should Result in Dismissal of Endos Claims with Prejudice, as Actavis
Made Clear in both the District Court and this Court
Actavis has demonstrated that Endos suit is barred by Sandoz and its
progeny. See Red Br. at 21-39. If this Court agrees, Endos claims fail on the
merits because Sandoz makes it impossible for Endo to prove its case.
Sandoz held that a plaintiff does not state a claim for false advertising when
adjudicating the question of falsity would require a court to usurp the FDAs
authority to interpret its own rules or standards. See Sandoz, 902 F.2d at 231.
Under these circumstances, the plaintiff cannot prove its claim that the defendants
advertising violated the Lanham Act. Id. at 231-32; see also Dial-A-Car, Inc. v.
Transportation, Inc., 82 F.3d 484, 489-90 (D.C. Cir. 1996) (applying Sandoz and
affirming district courts with-prejudice dismissal of plaintiffs Lanham Act
claim), affg, 884 F. Supp. 584, 593 (D.D.C. 1995).
Actaviss position is that this case falls squarely within Sandoz because it
presents an issue at the core of the FDAs responsibility to determine the meaning
and effect of the agencys own regulatory activities. The FDA approved Actaviss
tablets as AB rated to Opana ER. Endo later voluntarily withdrew Opana ER and
replaced it with a bioequivalent formulation it calls Opana ER with Intac. Endo
2

then tried but failed to have the FDA determine that Endo had withdrawn Opana
ER for lack of safety, and to rescind existing generic approvals such as the
approval held by Actavis. Now, Endo claims that Actaviss tablets are not AB
rated to Opana ER because Endo withdrew it in favor of Opana ER with Intac. See
Yellow Br. at 13-14. Actaviss argument under Sandoz is that Endos suit fails on
the merits because it asks the judiciary to usurp the FDAs authority to determine
the regulatory status of the Actavis product by ruling on the effect (if any) on a
generics AB rating when the manufacturer of the reference listed drug voluntary
discontinues that drug (for reasons unrelated to safety or efficacy) in favor of a
new formulation that is itself bioequivalent. See Red Br. at 21, 30-34. This might
be an extra-credit exam question in an advanced class on food and drug law, but it
is not a matter to be decided by the courts.
To be sure, if the FDA were to some day rescind the AB rating of the
Actavis product, whether on Endos theory or some other rationale, and Actavis
again asserted that its tablets were AB rated to Opana ER, then Endo could file a
new Lanham Act suit that would not be barred by res judicata. See Red Br. at 51
n.11. But unless and until that happens, Sandoz makes clear that Endos suit fails
on the merits as the facts exist today. The hypothetical possibility that (i) the FDA
may in the future rescind the AB rating of the Actavis product, and (ii) Actavis will
thereafter resume use of old advertisements with the AB rated statement in the
3

teeth of the FDAs action, is not reason to dismiss the current case without
prejudice.
This has been Actaviss position throughout these proceedings. As Endo
previously acknowledged, Actavis did not argue that the district court should
dismiss based on the primary jurisdiction doctrine. See Blue Br. at 14, 19-20.
Rather, Actavis argued that under Sandoz, Lanham Act claims are prohibited if
(as here) adjudication would be bound-up with matters under the authority and
expertise of FDA, and that, [u]nder such circumstances, the Lanham Act claims
are precluded as a matter of law. A301. Plainly, a claim that is precluded as a
matter of law fails on the meritsand should be dismissed with prejudice
because the facts alleged by the plaintiff do not give rise to a legally cognizable
cause of action. See, e.g., Unger v. Natl Residents Matching Program, 928 F.2d
1392, 1401 (3d Cir. 1991) (affirming with-prejudice dismissal of a claim that was
not cognizable under the law).
1

1
Contrary to Endos assertions on reply, see Yellow Br. at 31, 36, a claim that is
not cognizable fails on the merits and should be dismissed with prejudice. Endo
appeared in its opening brief to recognize the distinction between dismissing a
claim as not cognizable and dismissing it under the primary jurisdiction doctrine
when it presented them as different grounds for dismissal. See Blue Br. at 19-20
([I]t is unclear whether the district court dismissed the Complaint (a) based on
FED.R.CIV.P. 12(b)(6), because it agreed with Actavis that Endo[s] claims are not
cognizable under the Lanham Act (or related state law claims) because they are
bound up with determinations that can only be made by FDA under the Food,
Drug & Cosmetic Act, which does not authorize a private right of (contd . . . )
4

II. Actaviss Alternative Arguments, Which Actavis Also Raised in the
District Court, Go to the Merits and Would (if Accepted) Require
Dismissal with Prejudice
Actaviss alternative grounds for dismissal are indisputably merits-based.
Actavis raised them in both the district court and this Court, contrary to Endos
spurious assertion that a with-prejudice dismissal would be inconsistent with
Actaviss position throughout these proceedings, Yellow Br. at 36.
A. Endos Failure to Allege a False Statement
Endo acknowledges that an adjudication that Actavis had not engaged in
any false advertising, would constitute a merits-based determination warranting
dismissal with prejudice. Yellow Br. at 36. But Endo simply ignores Actaviss
showing that it did not engage in false advertising. As Actavis explained, the FDA
approved its product as AB rated to Opana ER, and (despite Endos efforts) has not
revoked its approval or changed the therapeutic equivalence rating of Actaviss
product. Therefore, the statement in Actaviss advertisements challenged by
Endothat Actaviss tablets are AB rated to Opana ERis true. See Red Br. at
40-41.
(. . . contd) action (A3), or (b) based on a determination that, under the doctrine
of primary jurisdiction, it was declining to exercise the authority it had to resolve
Endos claims.).
5

Actavis made this argument in both the district court and this Court. See id.;
A308. Indeed, Endo acknowledged below that one of the grounds Actavis relied
on in moving to dismiss was that its advertising is true. A516.
It is Endo, not Actavis, that is changing its theory. In its reply brief, Endo
argues that this Court must accept as true, inter alia, Endos position that the
statement in Actaviss advertisements would be understood as a representation
that Actaviss Tablets are FDA-approved as being therapeutically equivalent to,
and listed by the FDA as having an AB therapeutic code/rating with respect to
Opana ER with Intac. Yellow Br. at 1; see also id. at 11, 13-14. But Endo only
argued in its opening brief that the advertisements would be understood in this
manner, not that this was a well-pled factual allegation that must be accepted as
true. See Blue Br. at 25. This Court should thus disregard and strike those
portions of Endos reply brief which make that argument for the first time. See
United States v. Davis, 41 F. Appx 566, 573 n.9 (3d Cir. 2002) (unpublished)
(citing Kost v. Kozakiewicz, 1 F.3d 176, 182 n.3 (3d Cir. 1993)).
In any event, Endos contention about how the advertisements would be
understood is not a factual allegation that must be accepted as true. On a Rule
12(b)(6) motion, a court is not required to accept unsupported conclusions and
unwarranted inferences, or a legal conclusion couched as a factual allegation.
Morrow v. Balaski, 719 F.3d 160, 165 (3d Cir. 2013) (en banc) (citation omitted).
6

Endo now argues that the Court must accept Endos interpretation of the
advertisements. Endo claims it is self-evident that . . . physicians, pharmacists,
and others would understand Actaviss statement that its Tablets are AB rated to
Opana
ER as referring to Opana ER with Intac, Yellow Br. at 8, even though

Actaviss advertisements do not say that. This is an unwarranted inference[] or
a legal conclusion couched as a factual allegation, that need not be accepted as
true. Morrow, 719 F.3d at 165; see also Red Br. at 35, 40-41.
At bottom, Endos position is that it has stated a claim under the Lanham
Act because it interprets Actaviss advertisements to be false. That position is
foreclosed by precedent holding that, even when a party brings a Lanham Act
claim on the theory that an advertisement is misleading, it is for a court to
determine, as a matter of law, whether the words in the advertisements could
mislead a reasonable consumer. See Pernod Ricard USA, LLC v. Bacardi U.S.A.,
Inc., 653 F.3d 241, 250-53 (3d Cir. 2011); Red Br. at 37-38. Endo waived any
argument that Actaviss advertisements are misleading, see Red Br. at 36-37, and
thus Endos burden is much higher.
2
Unless Actaviss statement that its tablets are
AB rated to Opana ER is unambiguously false, Endo has not stated a claim for
literal falsity under the Lanham Act. See Red Br. at 41.
2
In its reply brief, Endo does not dispute that it waived any argument that the
advertisements are misleading.
7

B. Endos Failure to Make a Plausible Allegation that Actavis Used
the Challenged Advertisements After May 2012
Actaviss second alternative argument is that Endo did not plausibly allege
that Actavis made the statement at issue after Endo stopped marketing the original
formulation of Opana ER in May 2012. It is undisputed the statement was true
before that date. See Red Br. at 43-45. Contrary to Endos assertion, see Yellow
Br. at 21, 25, Actavis raised this merits-based challenge to the adequacy of Endos
complaint in the district court, noting that it warranted dismissal with prejudice.
See A549-A551; see also Red Br. at 3.
C. Endos Failure to Present Competent Summary Judgment
Evidence that Actavis Used the Challenged Advertisements After
May 2012
Finally, Actavis has shown (in the alternative) that it is entitled to summary
judgment because Endo failed to present any admissible evidence that Actavis
made the challenged statement after May 2012. Red Br. at 45-49. Endo cannot
and does not dispute that this goes to the merits and would, if accepted, warrant
dismissal with prejudice. Instead, Endo claims that this issue is not properly before
the Court because Actavis did not move for summary judgment below. See
Yellow Br. at 27-31. Endo is incorrect.
In the district court, Endo opposed Actaviss Rule 12(b)(6) motion to
dismiss and filed a cross-motion for partial summary judgment, seeking a
determination that Actaviss advertising was literally false under the Lanham Act.
8

See Yellow Br. at 29; A506, A524. Endo made clear its view that the
advertisements had not always been false, but rather became false after May 2012,
when Endo stopped selling the original formulation of Opana ER. See A510-
A511, A514.
Endos summary judgment motion, in and of itself, put at issue whether
either Endo or Actavis was entitled to summary judgment. As one court has stated:
Moving for summary judgment entails some risk for the moving
party: A motion for summary judgment searches the record, and it is
well settled that if such a search reveals that there are no genuine
issues of material fact, but that the law is on the side of the non-
moving party, then summary judgment may be rendered in favor of
the opposing party even though he has made no formal cross-motion
under Rule 56.

Intl Union of Bricklayers & Allied Craftsmen v. Gallante, 912 F. Supp. 695, 700
(S.D.N.Y. 1996) (citations and formatting omitted); accord Fullman v. Potter, 480
F. Supp. 2d 782, 795 (E.D. Pa. 2007). And summary judgment may be granted to
a non-moving party by either the district court or the Court of Appeals. See New
Eng. Health Care Employees Union v. Mount Sinai Hospital, 65 F.3d 1024, 1030
(2d Cir. 1995) (citing Procter & Gamble Indep. Union v. Procter & Gamble Mfg.
Co., 312 F.2d 181, 190 (2d Cir. 1962)).
3

3
Endos characterization of a similar case, Kingman Park Civic Association v.
Williams, 348 F.3d 1033 (D.C. Cir. 2003), is misleading at best. In Kingman Park,
the Court of Appeals did enter[] summary judgment in the first instance, Yellow
Br. at 31, based on arguments and evidence never addressed by the (contd . . .)
9

Moreover, Actavis had sought summary judgment based on a point Endo
itself had put at issue in its own motion for summary judgment: namely, the
timing of Actaviss advertisements. Actavis explained that there was no competent
evidence that Actavis used the challenged advertisements after May 2012. Actavis
discussed this point extensively, and repeatedly stated that the lack of such
evidence entitled it to summary judgment. A571, A572-A573, A578-A580, A585.
Endo asserts, without analysis, that Actaviss request for summary judgment
did not follow the district courts Local Rules. Yellow Br. at 30. But what matters
is whether Actaviss papers put Endo on notice that Actavis was seeking judgment
in its favor. Indeed, the District of New J ersey has repeatedly granted summary
judgment to non-moving parties that (unlike Actavis) did not formally request
summary judgment, as long as their opposition papers (like Actaviss) provided
adequate notice of the substance of relief sought. See San Lucio, S.R.L. v. Import
& Storage Servs., LLC, No. 07-3031, 2009 WL 1010981, at *2, *4 n.4 (D.N.J . Apr.
20, 2009); In re Mercedes-Benz Anti-Trust Litigation, 364 F. Supp. 2d 468, 482 n.4
(D.N.J . 2005); Old Bridge Owners Cooperative Corp. v. Township of Old Bridge,
(. . . contd) district court. See 348 F.3d at 1041-43 (granting summary judgment
because plaintiffs failed to establish a triable issue of fact on two elements of their
claim, after concluding the district court erred in granting defendants motion to
dismiss on other grounds); see also Kingman Park Civic Assn v. Williams, No. 01-
02675, 2002 U.S. Dist. LEXIS 15254 (D.D.C. Aug. 16, 2002) (district court
decision). Nor has Endo pointed to any case law suggesting the Courts of Appeals
lack this authority.
10

981 F. Supp. 884, 888 (D.N.J . 1997). Similarly, this Court has recognized that a
party had adequate notice that its opponent was requesting summary judgment in a
case (cited by Endo) where the opponents motion was styled a motion to dismiss,
and in another case where the opponents motion was styled a motion in limine.
See Jones v. Hashagen, 512 F. Appx 179, 181 n.1 (3d Cir. 2013) (unpublished);
Howard Johnson Intl v. Cupola Enters., LLC, 117 F. Appx 820, 822-23 (3d Cir.
2004) (unpublished); see also Yellow Br. at 32.
Actavis put Endo on notice that it was seeking summary judgment by
expressly and repeatedly requesting summary judgment based on its detailed
discussion of the absence of evidence that Actavis used the challenged
advertisements after May 2012. A571, A572-A573, A578-A580, A585. As a
result, Endo was cognizant of the need to marshal all of [its] evidence in support
of [its] claims. Howard Johnson, 117 F. Appx at 823. Endo attempted to do just
that, submitting an additional affidavit (from its salesperson Danielle Overly),
which Endo characterized as a response to Actaviss challenge to the competence
of the evidence Endo presented. A767; see also A759; A779-A780. This new
affidavit, however, itself failed to present admissible evidence that Actavis used
the challenged advertisements after May 2012. See Red Br. at 46-49.
Endo now claims that it did not have an opportunity to take discovery on this
issue, but Endo did not file a Rule 56(d) request for additional discovery to oppose
11

Actaviss request for summary judgment. That is fatal to [Endos] claim of
insufficient discovery on appeal. Serbin v. Consolidated Rail Corp., 140 F.
Appx 336, 337 n.1 (3d Cir. 2005) (unpublished) (quoting Bradley v. United States,
299 F.3d 197, 207 (3d Cir. 2002)) (referring to Rule 56(d)s predecessor, Rule
56(f)).
There is an important difference between the procedural formality Endo
claims (without explanation) Actavis failed to meet, and Endos failure to comply
substantively with Rule 56(d). It is not simply that Endo failed to file a Rule 56(d)
declaration, although that by itself would be a sufficient basis to reject Endos
argument that it needed discovery. See Brown v. U.S. Steel Corp., 462 F. Appx
152, 155-56 (3d Cir. 2011) (unpublished) (citing Bradley, 299 F.3d at 207).
Rather, Endo did not address the substance of what Rule 56(d) requires. Endo
never addressed, even in its briefs to the district court, Rule 56(d)s substantive
requirements under this Courts case law: Endo did not identify with specificity
what particular information [Endo] sought; how, if uncovered, it would preclude
summary judgment; and why it has not previously been obtained. Lunderstadt v.
Colafella, 885 F.2d 66, 71 (3d Cir. 1989) (citation omitted). Indeed, Endo did not
even assert that Acatviss request for summary judgment was premature because
Endo needed more discovery.
12

It would have been entirely proper for the district court to resolve this case
by granting Actavis summary judgment based on the existing record. It is equally
proper for this Court to do the same.
D. This Court Should Reach Actaviss Alternative Arguments if It
Concludes that a Sandoz Dismissal Is Without Prejudice
Although the district court did not reach any of Actaviss alternative
arguments, this Court should do so in the interest of judicial economy if it
concludes that Sandoz does not require dismissal with prejudice. This Court does
not ordinarily resolve issues not decided by the district court, see Yellow Br. at 26,
but it has the power to do so and may appropriately exercise that power when the
record is developed and the issues raise purely legal questions. See, e.g., Montrose
Med. Group Participating Savings Plan v. Bulger, 243 F.3d 773, 786 & n.12 (3d
Cir. 2001). In such a case, an appellate tribunal can act just as a trial court would,
so nothing is lost by having the reviewing court address the disputed issue in the
first instance. Hudson United Bank v. LiTenda Mortgage Corp., 142 F.3d 151,
159 (3d Cir. 1998); see also In re Ben Franklin Hotel Assocs., 186 F.3d 301, 306
(3d Cir. 1999) (Because the record has been sufficiently developed for us to
resolve this legal issue, we need not remand to the District Court to consider it in
the first instance.); Burella v. City of Philadelphia, 501 F.3d 134, 146 n.16 (3d
Cir. 2007) (similar).
13

Actaviss alternative arguments meet this standard. Actavis argued, both in
the district court and here, that Endos complaint must be dismissed under Rule
12(b)(6) because: first, the statement in Actaviss advertisements is not false
regardless of when those advertisements were last used; and second, Endo failed to
make a plausible allegation that Actavis used the advertisements after May 2012.
See supra pp. 5-8. These arguments raise purely legal questions to be decided
based on the existing record. See, e.g., Ramsgate Court Townhome Assn v. West
Chester Borough, 313 F.3d 157, 158-59 (3d Cir. 2002).
Actaviss third alternative argumentthat it is entitled to summary
judgment because Endo failed to present admissible evidence that Actavis made
the challenged statement after May 2012likewise raises a purely legal issue
based on an adequately developed record. See supra pp. 8-13. As the Second
Circuit explained in granting summary judgment in a case the district court had
dismissed for lack of jurisdiction, a remand is unnecessary when the record as a
whole presents no genuine issue of any material fact. Chase Manhattan Bank,
N.A. v. American Natl Bank & Trust Co. of Chicago, 93 F.3d 1064, 1072 (2d Cir.
1996) (citation omitted); see also Hudson, 142 F.3d at 159 (citing Chase
Manhattan with approval); Montrose Medical Group, 243 F.3d at 786 & n.12
(addressing a ground for summary judgment not considered by the district court
14

and noting: whether a genuine issue of material fact exists presents a purely legal
question that does not require or allow a district court to exercise discretion).
III. Conclusion
For the reasons discussed above and in Actaviss opening brief, the Court
should affirm the district courts dismissal of Endos complaint, but convert the
district courts without-prejudice dismissal into a dismissal with prejudice.

Dated: September 30, 2014 Respectfully submitted,

HOLLAND & KNIGHT LLP
31 West 52nd Street
New York, New York 10019
(212) 513-3200

Attorneys for Defendants-Appellees
Actavis, Inc., and Actavis South Atlantic LLC

By: s/Charles A. Weiss
CHARLES A. WEISS
(N.J . Bar #039791991)

15

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Charles A. Weiss


CERTIFICATE OF SERVICE

On September 30, 2014, I caused the foregoing brief to be electronically
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Counsel for Appellant

I also caused ten (10) copies of the foregoing brief to be sent to the Clerk of
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#33212165_v1


Cross-Appellant Actavis's Reply Brief in Third Circuit (Endo V Actavis) False Advertising Case

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Cross-Appellant Actavis's Reply Brief in Third Circuit (Endo V Actavis) False Advertising Case

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Case Nos.

ER as referring to Opana ER with Intac, Yellow Br. at 8, even though

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