cross-appellant actavis's reply brief in third circuit (endo v actavis) false advertising case

5/19/2018 Cross-appellant Actavis's Reply Brief in Third Circuit (Endo v Actavis) false advertising case

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Case Nos. 13-3981; 13-4096

United States Court of Appealsfor 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 Courtfor 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 SpitalHOLLAND &KNIGHT LLP

31 West 52nd StreetNew York, New York 10019

(212) 513-3200

Attorneys for Defendants-Appellees

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


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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 IMPROPERLYREQUIRE ADJUDICATION OF ISSUES RESERVED TO THE

FDA UNDER THE FOOD, DRUG & COSMETIC ACT, AND BEAN END-RUN AROUND THE ABSENCE OF A PRIVATERIGHT OF ACTION UNDER THAT STATUTE, GOES TO THE

MERITS AND THUS SHOULD RESULT IN DISMISSAL OF

ENDOS CLAIMS WITH PREJUDICE, AS ACTAVIS MADECLEAR IN BOTH THE DISTRICT COURT AND THIS COURT .............. 2

II. ACTAVISS ALTERNATIVE ARGUMENTS, WHICH ACTAVISALSO RAISED IN THE DISTRICT COURT, GO TO THE

MERITS AND WOULD REQUIRE (IF ACCEPTED) DISMISSALWITH PREJUDICE ......................................................................................... 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 .................................. 8C. Endos Failure to Present Competent Summary Judgment

Evidence that Actavis Used the Challenged Advertisements AfterMay 2012 ............................................................................................... 8

D. This Court Should Reach Actaviss Alternative Arguments if ItConcludes that a Sandoz Dismissal Is Without Prejudice................... 13

III. CONCLUSION .............................................................................................. 15



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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 Craftsmenv. Gallante,

912 F. Supp. 695 (S.D.N.Y. 1996) ....................................................................... 9

Jones v. Hashagen,512 F. Appx 179 (3d Cir. 2013) ........................................................................ 11

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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

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RULES

FED.R.CIV.P. 12 ......................................................................................... 4,6, 8,14

Fed. R. Civ. P. 56 ............................................................................................... 11,12

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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.

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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 ThusShould 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.

Sandozheld 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 Sandozand

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 Sandozbecause 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

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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 Sandozis 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

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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

1Contrary 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 aclaim 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 notcognizable 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 . . . )

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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 resolveEndos claims.).

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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).

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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

OpanaER 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.

2In its reply brief, Endo does not dispute that it waived any argument that the

advertisements are misleading.

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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.

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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 movingparty: A motion for summary judgment searches the record, and it is

well settled that if such a search reveals that there are no genuineissues of material fact, but that the law is on the side of the non-

movingparty, 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 Craftsmenv. 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) (citingProcter & Gamble Indep. Union v. Procter & Gamble Mfg.

Co., 312 F.2d 181, 190 (2d Cir. 1962)).3

3Endos 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, YellowBr. at 31, based on arguments and evidence never addressed by the (contd . . .)

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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 Jersey 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 theirclaim, 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 Appealslack this authority.

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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

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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) (quotingBradley 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) (citingBradley, 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.

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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).

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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 suprapp. 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 suprapp. 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

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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. ConclusionFor 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 LLP31 West 52nd Street

New York, New York 10019(212) 513-3200

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

By: s/Charles A. Weiss

CHARLES A. WEISS(N.J. Bar # 039791991)

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CERTIFICATIONS PURSUANT TO

FED. R. APP. P. 32(A)(7)(C) AND L.A.R. 31.1

This brief complies with the type-volume limitation of Fed. R. App. P.

28.1(e)(2)(C) because it contains 3,604 words, excluding the parts of the brief

exempted by Fed. R. App. P. 32(a)(7)(B)(iii). This brief complies with the

typeface requirements of Fed. R. App. P. 32(a)(5) and typestyle requirements of

Fed. R. App. P. 32(a)(6). This brief has been prepared in a proportionally spaced

typeface using Microsoft Word 2013, in 14-point Times New Roman font.

This brief complies with L.A.R. 31.1 because the electronic and paper copies

of the brief contain identical text, and a virus check of the brief using the Symantec

Program was performed and no virus was detected.

s/ Charles A. Weiss

Charles A. Weiss



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CERTIFICATE OF SERVICE

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

filed with the Clerk of Court using the CM/ECF system, which will send a notice

of such filing to the following registered CM/ECF users:

Martin J. BlackEmail: [email protected]

Daniel B. Epstein

Email: [email protected]

Robert D. Rhoad

Email: [email protected]

Counsel for Appellant

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

the United States Court of Appeals for the Third Circuit via federal express

overnight delivery.

s/ Charles A. Weiss

Charles A. Weiss

#33212165_v1


cross-appellant actavis's reply brief in third circuit (endo v actavis) false advertising case

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