NOT PRECEDENTIAL

UNITED STATES COURT OF APPEALS

FOR THE THIRD CIRCUIT

__________

No. 14-4261

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THE TRAVELERS INDEMNITY COMPANY, and its various property casualty 

affilliates and subsidiaries; TRAVELERS CASUALTY & SURETY COMPANY, and its 

various property casualty affilliates and subsidiaries; ST. PAUL FIRE & MARINE 

INSURANCE COMPANY, and its various property casualty affilliates and subsidiaries; 

THE STANDARD FIRE INSURANCE COMPANY, 

and its various property casualty affilliates and subsidiaries,

 Appellants

v.

CEPHALON, INC.; TEVA PHARMACEUTICALS USA, INC.; TEVA 

PHARMACEUTICAL INDUSTRIES LIMITED; ABC CORPORATIONS 1 

THROUGH 5; FICTITIOUS NAMES

______________

ON APPEAL FROM THE UNITED STATES DISTRICT COURT

FOR THE EASTERN DISTRICT OF PENNSYLVANIA

(D.C. Civ. Action No. 2-12-cv-04191)

District Judge: Honorable Mary A. McLaughlin

______________

Submitted Under Third Circuit L.A.R. 34.1(a)

July 14, 2015

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Before: SMITH, GREENAWAY, JR., and SHWARTZ, Circuit Judges.

(Opinion Filed: August 10, 2015)
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OPINION

______________

GREENAWAY, JR., Circuit Judge.

Plaintiff-Appellants (“Plaintiffs”), several workers’ compensation insurance 

providers, are Travelers Indemnity Company, Travelers Casualty & Surety Company, St. 

Paul Fire & Marine Insurance Company, and the Standard Fire Insurance Company. 

Defendant-Appellees (“Defendants”) are Cephalon, Inc., Teva Pharmaceuticals USA, 

Inc., and Teva Pharmaceutical Industries Ltd.1 Plaintiffs brought claims against 

Defendants for intentional misrepresentation, negligent misrepresentation, violations of 

state consumer protection laws, and unjust enrichment, and seek damages and an

injunction. 

The District Court dismissed Plaintiffs’ claims for lack of standing under Federal 

Rule of Civil Procedure 12(b)(1) and for failure to state a claim under Rule 12(b)(6). 

Because Plaintiffs have failed to set out their fraud claims with sufficient specificity 

under Federal Rule of Civil Procedure 9(b) and have failed to plead the necessary 

elements under Connecticut’s Unfair Trade Practices Act (“CUTPA”), Conn. Gen. Stat. 

 

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

constitute binding precedent.

1 Plaintiffs do not address the District Court’s dismissal of claims against Teva USA and 

Teva Ltd. in their opening brief. Thus, any argument with respect to those Defendants is 

waived. See In re Surrick, 338 F.3d 224, 237 (3d Cir. 2003). 
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Ann. §§ 42-110a, we will affirm the District Court’s dismissal for failure to state a claim. 

Plaintiffs also appeal the District Court’s denial of their motion to amend the judgment of 

dismissal and for leave to file an amended complaint. We will affirm that denial because 

amendment would have been futile. 

I. BACKGROUND

Actiq and Fentora are powerful painkillers approved by the Food and Drug 

Administration (“FDA”) to manage breakthrough pain in cancer patients who were 

already receiving and were tolerant to opioid pain medications. Both Actiq and Fentora 

include warning labels indicating that they are only for the treatment of persistent cancer 

pain in patients who are tolerant to opioid therapy, and that they are contraindicated for 

acute or post-operative pain management in opioid non-tolerant patients. Plaintiffs allege 

that Cephalon marketed Actiq and Fentora for off-label uses, specifically by promoting 

these medications to doctors for use in non-cancer patients for the treatment of noncancer pain. Plaintiffs allege that Cephalon’s marketing “goes beyond mere off-label 

promotion of Actiq [and Fentora] and includes untruthful, factually inaccurate, 

incomplete and/or otherwise misleading promotion of the drug[s], and the promotion of 

Actiq [and Fentora] for contraindicated uses.” (Am. Compl. ¶ 80.) Plaintiffs also allege 

that they and their claimants spent more than $18 million on Actiq and Fentora since 

2004. Plaintiffs provide illustrative examples of claimants who were prescribed Actiq 

and Fentora for off-label uses and the amount of money Plaintiffs paid for the 

medications prescribed in these examples. However, Plaintiffs do not allege that they or 
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their claimants heard or relied on fraudulent statements or misrepresentations. Rather, 

they allege that Cephalon directed its off-label marketing at doctors treating claimants 

whose claims would be reimbursed by Plaintiffs. Plaintiffs identify five doctors who 

prescribed Fentora to Plaintiffs’ claimants and who also “received payments/benefits 

from Cephalon” during the same time period. (Am. Compl. ¶ 162.) Plaintiffs also 

identify one claimant who received Actiq prescriptions from a doctor who attended “field 

rides” with Cephalon representatives, Am. Compl. ¶ 94, though Plaintiffs allege neither 

that this doctor received payments or benefits from Cephalon, nor that misleading or 

fraudulent information was provided or relied upon.

The Federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 301, et seq., 

“regulates the manufacturing, marketing and sale of prescription drugs, and provides that 

a drug cannot be sold in interstate commerce unless it is approved by the FDA for the 

specific medical use, or ‘indication,’ listed on the drug’s labeling.” In re Schering 

Plough Corp. Intron/Temodar Consumer Class Action, 678 F.3d 235, 239 (3d Cir. 2012) 

(citing 21 U.S.C. § 355(a)). Although “[p]rescription drugs frequently have therapeutic

uses other than their FDA-approved indications[,] [t]he FDCA . . . generally prohibits 

manufacturers from marketing, advertising, or otherwise promoting drugs for such 

unapproved or ‘off-label’ uses.” Id. at 239-40 (citing 21 U.S.C. § 331(a) and (d)). 

However, “[b]ecause the FDCA does not regulate the practice of medicine, physicians 

may lawfully prescribe drugs for off-label uses.” Id. at 240 (citing Buckman Co. v. 

Plaintiffs’ Legal Comm., 531 U.S. 341, 350 (2001)). Furthermore, “violations of the 
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FDCA do not create private rights of action.” Gile v. Optical Radiation Corp., 22 F.3d 

540, 544 (3d Cir. 1994).

II. ANALYSIS2

A. Plaintiffs’ Fraud Claims Are Not Pled with Sufficient Particularity Under 

Rule 9(b)

Plaintiffs’ claims are premised upon Cephalon’s allegedly fraudulent scheme to 

mislead doctors with respect to the proper use and effectiveness of Actiq and Fentora, 

thereby causing those doctors to improperly prescribe those drugs to Plaintiffs’ claimants. 

Because this theory sounds in fraud, Plaintiffs’ pleadings must satisfy the “stringent” 

Rule 9(b) requirements for particularity.3 Frederico v. Home Depot, 507 F.3d 188, 200 

(3d Cir. 2007); see Fed. R. Civ. P. 9(b) (“In alleging fraud or mistake, a party must state 

with particularity the circumstances constituting fraud or mistake.”). “In order to satisfy 

Rule 9(b), plaintiffs must plead with particularity ‘the “circumstances” of the alleged 

 

2 The District Court had jurisdiction under 28 U.S.C. § 1332. This Court has jurisdiction 

pursuant to 28 U.S.C. § 1291. “We exercise plenary review over the District Court’s 

dismissal of the Amended Complaint[],” under Federal Rule of Civil Procedure 12, 

sections (b)(1) and (b)(6). Schering Plough, 678 F.3d at 243. “We review the District 

Court’s denial of a Rule 59(e) motion to amend the complaint for abuse of discretion, but 

we review the District Court’s underlying legal determinations de novo and factual 

determinations for clear error.” Burtch v. Milberg Factors, Inc., 662 F.3d 212, 220 (3d 

Cir. 2011) (internal citations omitted). 

3 See In re Westinghouse Sec. Litig., 90 F.3d 696, 717 (3d Cir. 1996) (Even when “fraud 

is not a necessary element of a claim . . . claims that do sound in fraud must be pled with 

particularity.”). Thus, all of Plaintiffs’ claims alleging fraudulent activity—i.e., 

Plaintiffs’ claims for intentional and negligent misrepresentation, unjust enrichment and 

an injunction—must be pled with sufficient particularity under Rule 9(b). 
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fraud in order to place the defendants on notice of the precise misconduct with which 

they are charged, and to safeguard defendants against spurious charges of immoral and 

fraudulent behavior.’” Lum v. Bank of Am., 361 F.3d 217, 223-24 (3d Cir. 2004) (quoting 

Seville Indus. Mach. Corp. v. Southmost Mach. Corp., 742 F.2d 786, 791 (3d Cir. 1984)), 

abrogated in part on other grounds by Bell Atl. Corp. v. Twombly, 550 U.S. 544, 557 

(2007). “Plaintiffs also must allege who made a misrepresentation to whom and the 

general content of the misrepresentation.” Id. at 224.

Here, Plaintiffs’ conclusory allegations that Cephalon’s marketing and promotion 

of Actiq and Fentora were deceptive, improper, false or misleading do not satisfy that 

burden.4Indeed, Plaintiffs’ argument boils down to an assertion that Cephalon’s offlabel promotion of Actiq and Fentora was inherently fraudulent and created a private 

cause of action. However, Plaintiffs fail to identify any specific fraudulent statements, 

omissions, or misrepresentations that were made to doctors who prescribed Actiq and 

Fentora. We agree with the District Court that Plaintiffs fail to allege “the contents of 

these statements and materials”5and do not “specify when, where, or to whom any sales 

 

4 Plaintiffs’ argument that the Rule 9(b) particularity requirements should be relaxed here 

because certain information was exclusively within Defendants’ control fails. 

Defendants did not have exclusive control over significant information, such as the 

reasons that the doctors prescribed Actiq and Fentora, or whether Plaintiffs’ claimants 

who received those prescriptions benefitted from them. 

5 The District Court noted that one document title provided by Plaintiffs, “Actiq for 

Migraine,” suggests the content of this document. (App. 32, n. 18.) This alone is 

insufficient to satisfy the particularity requirement. 
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pitch was made.” (App. 32, n. 18.) Because Plaintiffs have not alleged the particular 

facts surrounding the alleged fraud, as required under Rule 9(b), their claims sounding in 

fraud cannot stand. Thus, we will affirm the District Court’s dismissal of those claims. 

B. Connecticut Unfair Trade Practices Act6

The District Court dismissed Plaintiffs’ claims under CUTPA on the grounds that 

Plaintiffs’ did not adequately establish a cognizable injury. However, we will not reach 

the question of injury because even assuming arguendo that Plaintiffs had established 

injury, they have failed to sufficiently plead causation, as required by CUTPA. Thus, we 

will affirm for that reason.7 See Stevenson Lumber Co.-Suffield v. Chase Assocs., 932 

A.2d 401, 406 (Conn. 2007) (“[I]n order to prevail in a CUTPA action, a plaintiff must 

establish both that the defendant has engaged in a prohibited act and that, ‘as a result of’ 

this act, the plaintiff suffered an injury. The language ‘as a result of’ requires a showing 

that the prohibited act was the proximate cause of a harm to the plaintiff.” (quoting Conn. 

Gen. Stat. Ann. § 42-110g)). “Proximate cause is an actual cause that is a substantial 

factor in the resulting harm.” Artie’s Auto Body, Inc. v. Hartford Fire Ins. Co., 947 A.2d 

320, 330 (Conn. 2008) (alterations, citations and internal quotation marks omitted). 

 

6 The District Court held that because Plaintiffs did not plead facts alleging economic 

injury in any state besides Connecticut, CUTPA is the only consumer protection law 

under which Plaintiffs have standing. On appeal, Plaintiffs have made no argument that 

their claims should have been considered under other states’ consumer protection laws,

thus this argument is waived. See Surrick, 338 F.3d at 237.

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“We may affirm the District Court on any grounds supported by the record.” Nicini v. 

Morra, 212 F.3d 798, 805 (3d Cir. 2000) (citation omitted).
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Here, the allegations in the Amended Complaint fail to establish proximate cause. 

Indeed, Plaintiffs did not allege that any doctor relied on Defendants’ alleged 

misrepresentations in prescribing Actiq or Fentora, or that these prescriptions would not 

have been written if these physicians had not received the allegedly fraudulent 

information from Cephalon. Thus, Plaintiffs have not sufficiently pleaded causation, as 

required by CUTPA, and we will affirm the District Court’s dismissal of the CUTPA 

claims.

C. Amendment

Plaintiffs also appeal the District Court’s denial of their motion to partially amend 

the judgment of dismissal pursuant to Federal Rule of Civil Procedure 59(e) and for leave 

to file a Second Amended Complaint (“SAC”). The District Court denied this motion 

because Plaintiffs had already filed one amended complaint and had discovery, the 

motion to dismiss had been pending for over a year, and the District Court had already 

heard argument on it. The District Court found that Plaintiffs strategically delayed filing 

their SAC to see if their Amended Complaint survived Defendants’ Motion to Dismiss. 

The District Court also reviewed the SAC and determined that it “fail[ed] to cure the 

deficiencies” that the District Court identified in dismissing the Amended Complaint.

(App. 47.) Thus, amendment would have been futile. See In re Burlington Coat Factory 

Sec. Litig., 114 F.3d 1410, 1434 (3d Cir. 1997) (“Among the grounds that could justify a 

denial of leave to amend . . . [is] futility.”). 

We agree that amendment would have been futile and will affirm on that ground. 
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Although Plaintiffs did include additional detail in the proposed SAC, such as 

information regarding conferences sponsored by Cephalon, and physician attendees who 

later prescribed Actiq, the SAC still fails to satisfy causation, which is a required element 

of each of Plaintiffs’ claims. See Sturm v. Harb Dev., LLC, 2 A.3d 859, 872 (Conn. 

2010) (requiring party claiming intentional misrepresentation “‘to have suffered harm as 

a result of . . . reliance [on the false representation]’” (quoting Suffield Dev. Assocs. 

P’ship v. Nat’l Loan Investors, L.P., 802 A.2d 44 (Conn. 2002)); Platinum Funding 

Servs., LLC v. Petco Insulation Co., No. 3:09-CV-1133, 2011 WL 1743417, at *10 (D. 

Conn. May 2, 2011) (“A plaintiff asserting an unjust enrichment claim must show . . . 

that the plaintiff suffered a detriment as a result of the defendant’s failure to pay the 

plaintiff.”); Stevenson, 932 A.2d at 406 (requiring a showing of proximate causation 

under CUTPA). Allegations that physicians attended presentations and interacted with 

Cephalon sales representatives do not sufficiently demonstrate that these interactions 

caused the physicians to write the prescriptions at issue. Because the facts alleged in the 

SAC do not create a sufficient causal connection between Defendants’ alleged actions 

and the alleged injury suffered by Plaintiffs, amendment would have been futile. Thus, 

we will affirm the District Court’s denial of Plaintiff’s motion to amend the judgment of 

dismissal and for leave to file an SAC. 

III. CONCLUSION 

For the foregoing reasons, we will affirm the final judgment of the District Court.