2014 Decisions

Opinions of the United

States Court of Appeals

for the Third Circuit

12-5-2014

Endo Pharmaceuticals v. Actavis Inc

Precedential or Non-Precedential: Non-Precedential

Docket No. 13-3981

Follow this and additional works at: http://digitalcommons.law.villanova.edu/thirdcircuit_2014

This decision is brought to you for free and open access by the Opinions of the United States Court of Appeals for the Third Circuit at Villanova

University School of Law Digital Repository. It has been accepted for inclusion in 2014 Decisions by an authorized administrator of Villanova

University School of Law Digital Repository. For more information, please contact Benjamin.Carlson@law.villanova.edu.

Recommended Citation

"Endo Pharmaceuticals v. Actavis Inc" (2014). 2014 Decisions. Paper 1217.

http://digitalcommons.law.villanova.edu/thirdcircuit_2014/1217
1

NOT PRECEDENTIAL

UNITED STATES COURT OF APPEALS

FOR THE THIRD CIRCUIT

_____________

No. 13-3981

_____________

ENDO PHARMACEUTICALS INC.,

 

Appellant

v.

ACTAVIS INC.; ACTAVIS SOUTH ATLANTIC LLC,

_____________

No. 13-4096

_____________

ENDO PHARMACEUTICALS INC.,

 

v.

ACTAVIS INC.; ACTAVIS SOUTH ATLANTIC LLC,

Appellants

______________

Appeal from the United States District Court

for the District of New Jersey

(No. 2-12-cv-07591)

District Judge: Hon. Dennis M. Cavanaugh

______________

Submitted Pursuant to Third Circuit LAR 34.1(a)

November 21, 2014

Before: CHAGARES, HARDIMAN, and SHWARTZ, Circuit Judges.

(Filed: December 5, 2014)
2

____________

OPINION

____________

CHAGARES, Circuit Judge.

Plaintiff Endo Pharmaceuticals Inc. appeals the District Court’s September 3, 2013 

order granting Defendants Actavis, Inc. and Actavis South Atlantic LLC’s (together, 

“Actavis”) motion to dismiss the Complaint pursuant to Federal Rule of Civil Procedure

12(b)(6). For the reasons that follow, we will vacate the District Court’s order and 

remand the case to the District Court.

I.

We write solely for the parties and therefore recite only the facts that are necessary 

to our disposition. Endo developed and marketed the pain reliever Opana® ER and its 

alternate, crush-resistant formula (which also bears the name Opana® ER). Appendix 

(“App.”) 26–27. Actavis sold a generic version of Opana® ER. That generic was “AB 

rated” to the original Opana® ER by the FDA, meaning the FDA approved it as 

bioequivalent to the brand-name drug. See App. 32, 573–74. Actavis’s generic was not 

AB rated to the newer, crush-resistant formula. App. 33. In May 2012, Endo voluntarily 

discontinued the original Opana® ER, leaving the crush-resistant formula the only 

Opana® ER on the market. App. 31. Actavis, however, continued to market its generic 

as “AB Rated to Opana® ER.” App. 34. In August 2012, Endo filed a petition with the 

 

 This disposition is not an opinion of the full Court and pursuant to I.O.P. 5.7 does not 

constitute binding precedent.
3

FDA seeking a determination that it had withdrawn Opana® ER from the market for 

safety reasons. App. 188. Endo requested that the FDA refuse to approve any pending 

applications for generic versions of the original Opana® ER and withdraw approval of 

any formerly-approved generics, like Actavis’s. Id. Then, in December 2012, Endo filed 

suit against Actavis in United States District Court for the District of New Jersey, 

bringing federal and state law claims for false advertising and unfair competition.

The District Court dismissed Endo’s Complaint without prejudice pursuant to Rule 

12(b)(6), citing the doctrine of primary jurisdiction. App. 4–5. It reasoned that although 

the action was otherwise within its jurisdiction, Endo’s claims required a fact 

determination — “whether Actavis’s generic is still AB equivalent to Opana® ER” —

that was best left to the FDA in the first instance. App. 4. Endo appealed.

After briefing in the District Court was complete, the FDA issued a ruling on 

Endo’s petition. It determined that the original Opana® ER was not withdrawn for 

reasons of safety or effectiveness. 78 Fed. Reg. 38053-01. Accordingly, the FDA would 

not withdraw approval of generics related to the original Opana® ER and would continue 

to approve new generics so long as they met all other legal and regulatory requirements. 

Id.

II.

The District Court had subject matter jurisdiction over the Lanham Act Claim 

pursuant to 15 U.S.C. § 1121 and 28 U.S.C. § 1331. It had supplemental jurisdiction 

over the state law claims pursuant to 28 U.S.C. § 1367. This Court has jurisdiction 

pursuant to 28 U.S.C. § 1291.
4

We review a district court’s decision to abstain on primary jurisdiction grounds for 

abuse of discretion. Baykeeper v. NL Indus., Inc., 660 F.3d 686, 690 (3d Cir. 2011); P.R. 

Mar. Shipping Auth. v. Valley Freight Sys., 856 F.2d 546, 549 (3d Cir. 1988). But the 

District Court’s analysis of the law of abstention is subject to de novo review. 

Baykeeper, 660 F.3d at 690.

III.

The doctrine of primary jurisdiction applies where a claim is originally cognizable 

in the courts1 but “enforcement of the claim requires the resolution of issues which, under 

a regulatory scheme, have been placed within the special competence of an 

administrative body.” United States v. W. Pac. R.R. Co., 352 U.S. 59, 64 (1956). “[I]n 

such a case the judicial process is suspended pending referral of such issues to the 

administrative body for its views.” Id. “No fixed formula exists for applying the 

doctrine,” id., but we have previously focused our analysis on four factors:

(1) Whether the question at issue is within the conventional experience of judges 

or whether it involves technical or policy considerations within the agency’s 

particular field of expertise; (2) Whether the question at issue is particularly within 

the agency’s discretion; (3) Whether there exists a substantial danger of 

inconsistent rulings; and (4) Whether a prior application to the agency has been 

made.

Baykeeper, 660 F.3d at 691.

The District Court applied the doctrine of primary jurisdiction because it believed 

that the FDA had special competence to determine “whether Actavis’s generic is still AB 

 

1 Actavis argues that Endo’s claims are not in fact cognizable in federal court. We need 

not decide that issue, however, because the District Court’s decision will be vacated and 

remanded on other grounds.
5

equivalent to Opana® ER.” App. 4. It noted that Endo had already made an application 

to the FDA on this issue. App. 5.

Endo argues that the District Court’s application of the primary jurisdiction

doctrine was misguided because the fact question at issue in the case was not whether 

Actavis’s generic was biochemically equivalent to Opana® ER — a determination 

committed to the FDA’s special competence — but whether it had been approved as AB 

rated to Opana® ER, a question the District Court could answer by consulting the FDA’s 

catalog of generics listed for Opana® ER. Put another way, the District Court had to 

answer the history question, not the science one. And because the FDA has approved no 

drugs as AB rated to crush-resistant Opana® ER, Endo argues the history question is a 

simple one.

In its focus on the absence of AB-rated generics to crush-resistant Opana® ER, 

Endo overlooks the possibility that the District Court would be interested in the continued 

effectiveness of an AB rating to the original, discontinued Opana® ER. But that is the 

import of the District Court’s primary jurisdiction ruling. Before considering whether 

Actavis engaged in false advertising by marketing its generic as AB rated to Opana® ER, 

the District Court sensibly wanted to know whether approval for Actavis’s generic would 

be withdrawn as a result of Endo’s petition to the FDA. This has some bearing on 

whether Actavis can fairly describe its drug as AB rated to Opana® ER. 

Now that the FDA has issued its determination, however, the District Court’s 

rationale for applying the primary jurisdiction doctrine is moot. The logical course is to 

remand for the District Court to address the remaining arguments in the first instance. 
6

See Bass v. Butler, 258 F.3d 176, 179–80 (3d Cir. 2001) (remanding to the district court 

because subsequent developments had rendered the district court’s rationale for 

abstention moot).

IV.

For the foregoing reasons, we will vacate the District Court’s September 3, 2013 

order and remand for further proceedings.