UNITED STATES DISTRICT COURT 

NORTHERN DISTRICT OF ILLINOIS 

EASTERN DIVISION 

UNITED STATES OF AMERICA ex rel.

KATY KENNEDY and FRANK A. MATOS, 

THE STATE OF ILLINOIS ex rel. KATY 

KENNEDY and FRANK A. MATOS, and 

KATY KENNEDY, individually 

Plaintiffs, 

vs. 

 

AVENTIS PHARMACEUTICALS, INC., 

and PHARMANETICS, INC. 

Defendants. 

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Case No. 03-C-2750

Honorable Matthew F. Kennelly 

DEFENDANT AVENTIS PHARMACEUTICALS, INC.’s 

MEMORANDUM IN SUPPORT OF ITS MOTION TO DISMISS 

Case: 1:03-cv-02750 Document #: 64 Filed: 03/27/07 Page 1 of 31 PageID #:454
TABLE OF CONTENTS 

INTRODUCTION.................................................................................... 1 

FACTUAL BACKGROUND........................................................................ 3 

A. Lovenox........................................................................................... 3 

B. PharmaNetics’ ENOX test and ensuing litigation........................................... 4 

C. Relators’ allegations and the Government’s decision not to intervene................... 6 

ARGUMENT............................................................................................. 8 

A. The Court lacks subject-matter jurisdiction over Relators’ claims arrising from their 

off-label promotion and false statements because of the public-disclosure bar.............. 

8 

1. The facts underlying Relators’ allegations were publicly disclosed................... 8 

2. Relators’ allegations are “based upon” the publicly disclosed information.......... 9 

3. Relators are not an “original source” of their allegations............................... 10 

B. The Amended Complaint should be dismissed because it does not state any cause of 

action............................................................................................................................... 

11 

1. Relators fail to plead Aventis’s alleged “fraud” with particularity...................... 11 

2. Relators’ “off-label” allegations fail to state a claim under the False Claims Acts.. 17 

3. Relators’ “kickback” allegations fail to state a claim under the False Claims Act... 22 

C. Kennedy fails to state a retaliation claim..................................................... 24 

CONCLUSION.......................................................................................... 25 

 i 

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TABLE OF AUTHORITIES 

Cases Page(s) 

Adcock v. Brakegate Ltd., 645 N.E. 2d 888 (Ill. 1994)............................................... 17 

Bannon v. Edgewater Med. Ctr., 406 F. Supp. 2d 907 (N.D. Ill. 2005)............................ 10 

Borsellino v. Goldman Sachs Group, Inc., 477 F.3d 502 (7

th 

Cir. 2007)........................... 17 

Brandon v. Anesthesia & Pain Mgmt. Assocs., 277 F.3d 936 (7th Cir. 2002)........................ 24 

Capitol Leasing Co. v. F.D.I.C., 999 F.2d 188 (7th Cir. 1993)...................................... 3 

DiLeo v. Ernst & Young, 901 F.2d 624 (7th Cir. 1990).............................................. 12 

Durcholz v. FKW Inc., 189 F.3d 542 (7

th 

Cir. 1999).................................................. 17 

Grafon Corp. v. Hausermann, 602 F.2d 781 (7

th 

Cir. 1979)......................................... 8 

Humphrey v. Franklin-Williamson Human Svcs., Inc., 189 F. Supp. 2d 862 (S.D. Ill. 2002)... 2 

King v. F.E. Moran, Inc., 2002 WL 2003219 (N.D. Ill. 2002)...................................... 21 

Klaczak ex rel. U.S. v. Consolidated Med. Trans., 458 F. Supp. 2d 622 (N.D. Ill. 2006) 15, 23 

Luckey v. Baxter Healthcare Corp., 2 F. Supp. 2d 1034, 1050 (N.D. Ill. 1998), 

affirmed 183 F.3d 730 (7th Cir. 1999).................................................................. 

24 

Neal v. Honeywell, Inc., 942 F.Supp. 388 (N.D. Ill. 1996).......................................... 24 

Peterson v. Comm. Gen. Hosp., 2003 WL 262515 (N.D. Ill. 2003)................................ 13 

Phelps v. Sherwood Med. Indus., 836 F.2d 296 (7

th 

Cir. 1987)...................................... 20 

Scachitti v. UBS Finan. Svc., 831 N.E.2d 544 (Ill. 2005)............................................ 2 

Servpro Indus., Inc. v. Schmidt, 905 F. Supp. 475 (N.D. Ill. 1995)................................. 12 

Sharp v. Cons. Med. Trans., Inc., 2001 WL 1035720 (N.D. Ill. 2001)............................. 21 

Sprinkle v. Lowe’s Home Ctrs., Inc., 2006 WL 2038580 (S.D. Ill. 2006)......................... 25 

 ii 

Case: 1:03-cv-02750 Document #: 64 Filed: 03/27/07 Page 3 of 31 PageID #:456
Cases Page(s) 

Thompson v. Illinois Dep’t of Prof’l Reg., 300 F.3d 750 (7

th 

Cir. 2002)........................... 1 

Turner v. Michaelis Jackson & Assocs., 2007 WL 496384 (S.D. Ill. 2007)....................... 13 

U.S. ex rel. Bantsolas v. Superior Air and Ground Ambulance Trans., Inc., 2004 WL 

609793 (N.D. Ill. 2004)............................................................................................. 

12 

U.S. ex rel. Bidani v. Lewis, 2001 WL 1609377 (N.D. Ill. 2001)............................... 22 

U.S. ex rel. Burlbaw v. Orenduff, 400 F. Supp. 2d 1276 (D.N.M. 2005)........................ 18 

U.S. ex rel. Clausen v. Lab. Corp. of Am., Inc., 290 F.3d 1301(11

th 

Cir. 2002)................... 13, 14 

U.S. ex rel. Crews v. NCS Healthcare, 460 F.3d 853 (7th Cir. 2006)............................... 12 

U.S. ex rel. Drescher v. Highmark, Inc., 305 F. Supp. 2d 451 (E.D. Pa. 2004)................... 20 

U.S. ex rel. Feingold v. AdminaStar Fed., Inc., 324 F.3d 492 (7

th 

Cir. 2003)..................... 8 

U.S. ex rel. Fowler v. Caremark RX, Inc., 2006 WL 3469537 (N.D. Ill. 

2006).................... 

12 

United States ex. rel. Franklin v. Parke-Davis, 2003 WL 22048255 (D. Mass. 2003).......... 20 

U.S. ex rel. Garst v. Lockheed-Martin Corp., 328 F.3d 374 (7th Cir. 2003)........................ 12, 13, 14 

U.S. ex rel. Gear v. Emer. Med. Assocs. of IL, Inc., 436 F.3d 726 (7

th 

Cir. 2006)................ 8 

U.S. ex rel. Gross v. Aids Research Alliance-Chicago, 415 F.3d 601 (7

th 

Cir. 2006)............ 12, 14, 17 

U.S. ex rel. Hess v. Sanofi-Synthelabo Inc., 2006 WL 1064127 (E.D. Mo. 2006)............... 15, 18, 21 

U.S. ex rel. Karvelas v. Melrose-Wakefield Hosp., 360 F.3d 220 (1st Cir. 2004)................ 13 

U.S. ex rel. Kinney v. Hennepin Cty. Med. Ctr., 2001 WL 964011 (D. Minn. 2001)............ 20 

U.S. ex rel. Luckey v. Baxter Healthcare Corp., 183 F.3d 730 (7

th 

Cir. 1999)..................... 17, 21 

U.S. ex rel. Mathews v. Bank of Farmington, 166 F.3d 853 (7

th 

Cir. 1999)........................ 8, 9, 10, 11 

United States ex rel. Obert-Hong v. Advocate Health Care, 2001 WL 303692 (N.D. Ill. 

2001)..................................................................................................................... 

13, 14 

 iii 

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Cases Page(s) 

United States ex rel. Precision Co. v. Koch Indus., Inc., 971 F.2d 548 (10th Cir. 1992)........ 10 

U.S. ex rel. Rost v. Pfizer, Inc., 446 F. Supp. 2d 6 (D. Mass. 2006)................................ 19 

U.S. ex rel. Salmeron v. Eter. Recovery Sys., Inc., 2006 WL 3445579 (N.D. Ill. 2006)......... 13 

U.S. ex rel. Yannacopolous v. General Dynamics, 315 F. Supp. 2d 939 (N.D. Ill. 2004)....... 10, 13 

U.S. v. Krizek, 111 F.3d 934 (D.C. Cir. 1997)......................................................... 20 

U.S. v. Mackby, 261 F.3d 821 (9

th 

Cir. 2001).......................................................... 20 

U.S. v. Pres. and Fellows of Harvard Coll., 323 F. Supp. 2d 151 (D. Mass. 2004).............. 18, 20 

U.S. v. Rogan, 459 F. Supp. 2d 692 (N.D. Ill. 2006)................................................. 23 

Washington Legal Found. v. Friedman, 13 F. Supp. 2d 51 (D.D.C. 1998), 202 F.3d 331 

(D.C. Cir. 2000)............................................................................................ 

18 

Yesudian v. Howard Univ., 946 F. Supp. 31, 33-34 (D.D.C. 1996)................................. 25 

Statutes, Rules and Regulations Page(s) 

31 U.S.C. § 3729(a)(1), (2)............................................................................... 17 

31 U.S.C. § 3730(b)(2).................................................................................... 7 

31 U.S.C. § 3730(e)(4).................................................................................... 1, 3, 8, 9, 10

31 U.S.C. § 3730(h).............................................................................. 24 

42 U.S.C. § 1320a-7b............................................................................ 23 

42 U.S.C. § 1395x(t)(1) (Medicare)............................................................ 19, 21 

42 U.S.C. §§ 1396a(a), 1396r-8(k) and § 1396r-8(g) (Medicaid)........................ 19, 21 

63 Fed. Reg. 40,954, 40,955.................................................................... 21 

67 Fed. Reg. 49982-01, II.B.3.b................................................................ 22 

 iv 

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Statutes, Rules and Regulations Page(s) 

42 C.F.R. §§ 405, 412, 413..................................................................... 21 

42 C.F.R. § 412................................................................................... 21, 22 

42 C.F.R. § 440.120(a)........................................................................... 19 

305 ILCS 5/14-8.................................................................................. 21 

740 ILCS § 175................................................................................... 24 

740 ILCS 175/3(a)(1), (2)....................................................................... 17 

740 ILCS 175/4(b)(2)............................................................................ 7 

740 ILCS 175/4(e)(4)..................................................................................... 1, 3, 8, 9, 10

Federal Rule of Civil Procedure 

8(a)........................................................................................................... 

9(b).......................................................................................................... 

12(b)(1)..................................................................................................... 

12(b)(6)..................................................................................................... 

1, 16, 18, 23 

1, 3, 16, 22 

1, 3 

1, 22, 23 

 v 

Case: 1:03-cv-02750 Document #: 64 Filed: 03/27/07 Page 6 of 31 PageID #:459
Defendant Aventis Pharmaceuticals, Inc. respectfully moves the Court to dismiss 

Plaintiffs’ Amended Complaint with prejudice for the Court’s lack of subject matter jurisdiction 

over significant portions of the Plaintiffs’ causes of action, pursuant to 31 U.S.C. § 3730(e)(4), 

740 ILCS 175/4(e)(4), and Federal Rule of Civil Procedure 12(b)(1), and for Plaintiffs’ failure to 

plead fraud with the requisite particularity and to state any claim on which relief may be granted, 

pursuant to Federal Rules of Civil Procedure 8(a), 9(b), and 12(b)(6). 

INTRODUCTION 

 Defendant Aventis Pharmaceuticals, Inc. (“Aventis”) is a New Jersey-based 

pharmaceutical company that at all times relevant to the Amended Complaint developed and 

marketed life-saving pharmaceuticals prescribed for a range of diseases and conditions, including 

cancer, diabetes, heart attack, and deep vein thrombosis. Among the products marketed and sold 

by Aventis was the prescription drug LOVENOX® (enoxaparin sodium injection) (“Lovenox”), a 

low-molecular-weight heparin that produces an anticoagulation effect on blood. 

 Relator Katy Kennedy (“Kennedy”) worked for Aventis as a sales representative for little 

more than two years before quitting in February 2004. Amend. Compl. ¶ 7.1 At the time of 

filing of the Amended Complaint, Relator Frank Matos (“Matos”) had worked for Aventis as a 

sales representative since March 1998. Amend. Compl. ¶ 8. 

 In 2000, Aventis and defendant PharmaNetics Inc. (“PharmaNetics”) began discussions 

regarding the development of a test to measure blood clotting levels in certain Lovenox patients. 

Amend. Compl. ¶ 4. According to Relators’ own allegations, PharmaNetics and Aventis issued 

press releases in April 2000 and October 2002, in which it was announced that the test, the 

“ENOX card,” was intended for use on heart patients undergoing Percutaneous Coronary 

 

1

 The allegations of the Amended Complaint are accepted as true only where they are well-pled and solely 

for the purpose of the Court’s consideration of the instant motion to dismiss its claims. Thompson v. 

Illinois Dep’t of Prof’l Reg., 300 F.3d 750, 753 (7th Cir. 2002). 

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Intervention (“PCI”) procedures in a cardiac catheterization laboratory (“cath lab”). Amend. 

Compl. ¶¶ 44-45.2

 

 Relators Kennedy and Matos (hereinafter “Relators”), filed their original qui tam

complaint against Aventis on April 24, 2003, alleging generally that Aventis improperly 

promoted Lovenox for off-label uses and provided items of value to physicians in violation of 

the Anti-Kickback Statute. Compl. ¶¶ 3-5, 15-16. As no private right of action exists for 

Aventis’s alleged offenses, Relators cast their claims as violations of the federal False Claims 

Act, 31 U.S.C. § 3729 et seq. (“FCA”), and the Illinois Whistleblower Reward and Protection 

Act, 740 ILCS 175/3(a) (“IWRPA”) (collectively, the “False Claims Acts”).3 However, 

Relators’ original complaint did not include any specific allegations of alleged off-label 

promotion, kickbacks, or false claims. Compl. ¶¶ 3-5, 15-16. 

 While Relators’ original complaint was under seal, as required by the False Claims Acts, 

31 U.S.C. § 3730 (b)(2), 740 ILCS 175/4(b)(2), PharmaNetics filed an action against Aventis 

under the Lanham Act and state law, in which it alleged, inter alia, that Aventis “engaged in offlabel promotion of its drug for PCI.” Amend. Compl. ¶ 49 (citing PharmaNetics v. Aventis, No. 

03-cv-00817, Complaint (E.D.N.C. Nov. 3, 2003)).4

 Armed with the allegations of the 

 

2

 As explained in detail below, while Lovenox is not indicated for use during PCI procedures, Lovenox is 

approved for use in heart patients with “UA/NSTEMI” (unstable angina or a certain kind of myocardial 

infarction), without regard to whether such patients may transition to PCI procedures. Infra, p.18. As 

such, the ENOX test was not a vehicle for promoting off-label use of Lovenox, and the press releases 

relied on by Relators are not evidence to the contrary. Id. 3

 Because the IWRPA is virtually identical to the FCA, case law regarding the FCA is also applicable to 

the IWRPA. See Humphrey v. Franklin-Williamson Human Svcs., Inc., 189 F. Supp. 2d 862, 867 (S.D. 

Ill. 2002); Scachitti v. UBS Finan. Svc., 831 N.E.2d 544, 557 (Ill. 2005). 

4

 PharmaNetics’ suit, which was ultimately dismissed on summary judgment, also publicly disclosed the 

other Lovenox marketing statements that Relators allege in the Amended Complaint, well before Relators 

filed that pleading. Cf. Amend. Compl. ¶¶ 30, 34 (Aventis promoted Lovenox as “Therapeutic within 30 

minutes”); PharmaNetics Memorandum in Support of Motion for Preliminary Injunction (Dec. 18, 2003) 

(Jones Aff. Ex. 1) p. 2 (Aventis advertised Lovenox “reaches therapeutic levels within 1⁄2 Hour”); 

PharmaNetics Compl. (Jones Aff. Ex. 2) passim (Aventis promoted Lovenox as “therapeutic from dose 

one”). 

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PharmaNetics complaint that Relators’ original complaint lacked, Relators filed their Amended 

Complaint in May 2004. 

 Relators’ attempt to convert Aventis’ publicly-disclosed relationship with PharmaNetics 

and PharmaNetics’ allegations in its lawsuit into causes of action under the False Claims Acts 

fails, and Relators’ suit against Aventis must be dismissed for at least three reasons. First, this 

Court lacks subject-matter jurisdiction over Relators’ off-label promotion claims because 

Relators merely repeat allegations that were publicly disclosed prior to the dates on which 

Relators disclosed them to the United States and the State of Illinois (collectively, “the 

Government”). 31 U.S.C. §§ 3730(e)(4); 740 ILCS 175/4(e)(4). Second, Relators have failed to 

plead the alleged fraud with the particularity required by Federal Rule of Civil Procedure 9(b). 

Third, Relators’ allegations do not state any cause of action under the False Claims Acts. Thus, 

as articulated below, Relators have not pled any claim upon which relief may be granted, nor can 

they do so if granted leave to amend. Accordingly, the Court should dismiss the Amended 

Complaint with prejudice. 

FACTUAL BACKGROUND5

A. Lovenox 

 Lovenox is the most widely studied and prescribed low-molecular-weight heparin in the 

world. According to Relators, Lovenox is prescribed almost exclusively for inpatient hospital 

use. Amend. Compl. ¶ 3. At all times relevant to Relators’ claims,6

 Lovenox was approved by 

the FDA for seven clinical indications, including to prevent certain serious cardiac conditions, 

 

5

 Because Aventis’s jurisdictional challenge to Relators’ qui tam claims is brought under Fed. R. Civ. P. 

12(b)(1), the Court may examine evidence outside the four corners of the complaint to rule on that portion 

of Aventis’s motion. Capitol Leasing Co. v. F.D.I.C., 999 F.2d 188, 191 (7th Cir. 1993). In fact, much of 

the evidence necessary to establish that Relators’ claims are barred by the jurisdictional provisions of the 

False Claims Acts is set forth in the Amended Complaint. 

6

 Although the Amended Complaint does not specify the time period covered by Relators’ claims, it 

appears to include allegations related to conduct between August 2001 and February 2004. 

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i.e., “prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial 

infarction [“UA/NSTEMI”], when concurrently administered with aspirin.” Amend. Compl. ¶ 

22; Jones Aff. Ex. 3 (Lovenox Package Insert) p. 2. Patients with such conditions are often 

treated not only with pharmaceuticals such as Lovenox, but also with more invasive procedures 

requiring instrumentation in the form of PCI. As a result, many patients are transitioned to PCI 

procedures in hospital cardiac cath labs after receiving Lovenox in the emergency room. Jones 

Aff. Ex. 4, at 6 (PharmaNetics v. Aventis, Order Mar. 9, 2005). Although Lovenox is not 

approved for use by interventional cardiologists for use during PCI procedures, Lovenox is 

approved, and can be promoted, for use in UA/NSTEMI patients, regardless of whether they may 

transition to PCI procedures.7

 Jones Aff. Ex. 3; Jones Aff. Ex. 4, at 20. 

B. PharmaNetics’ ENOX test and ensuing litigation 

 In 2000, Aventis entered into a Collaborative Development Agreement with 

PharmaNetics for development of a test card to measure the anticoagulant effects of Lovenox in 

UA/NSTEMI patients who might transition to PCI procedures. From that time until Relators 

filed their original complaint on April 24, 2003, the agreement between Aventis and 

PharmaNetics and its intended purpose were well-publicized. 

• In April 2000, PharmaNetics issued a press release announcing that the 

development of the ENOX card would result in “the ability to monitor the 

drug [Lovenox] in potential new areas of study such as [PCI].” Jones Aff. 

Ex. 5 (“PharmaNetics Signs Agreement with Aventis Pharmaceuticals to 

Develop Theranostic Test for Enoxaparin,” Apr. 18, 2000); Amend. 

Compl. ¶ 44. 

• In August 2002 the FDA approved the ENOX test specifically “to detect 

the anticoagulant effects . . . of [Lovenox] in arterial citrated whole blood 

 

7

 The approved “package insert,” or product labeling, for Lovenox specifically contemplates that 

UA/NSTEMI patients who have been administered Lovenox may progress to “vascular instrumentation 

during [their] treatment” and provides instructions for physicians relating to cardiac interventional 

procedures: “[t]he vascular access sheath for [vascular] instrumentation should remain in place for 6 to 8 

hours following a dose of Lovenox injection.” 

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from patients with [UA/NSTEMI] who may transition to percutaneous 

intervention.” Jones Aff. Ex. 6 (510K pre-market approval letter). 

Following that approval, PharmaNetics issued a press release announcing 

that “[p]roviding physicians with the means to quickly and conveniently 

detect the effect of anticoagulation with [Lovenox] should facilitate its use 

in [UA/NSTEMI] patients transitioning to the cath lab.” Jones Aff. Ex. 7 

("PharmaNetics Receives FDA 510K Clearance to Market New 

Theranostic Test For Enoxaparin,” Aug. 29, 2002). 

• In October 2002, PharmaNetics issued a press release in which it stated 

the ENOX test “may provide the interventional cardiologist with the level 

of comfort they need to start a patient on [Lovenox] in the emergency 

room without the need for discontinuation of use if the patient is 

transferred to the Cath Lab.” Jones Aff. Ex. 8 (“PharmaNetics Introduces 

ENOX® Test at Transcatheter Cardiovascular Therapeutics (TCT) 

Meeting in Washington D.C.,” Oct. 17, 2002); Amend. Compl. ¶ 45. 

Similar press reports in October 2002 also announced the ENOX Test’s 

intended use by interventional cardiologists to test coagulation levels in 

patients preparing to undergo PCI procedures. Jones Aff. Ex. 9 

(“Cardiologists Now Have New Resource To Manage The Leading 

Anticoagulant Drug,” Oct. 11, 2002); Jones Aff. Ex. 10 (“PharmaNetics 

Announces Third Quarter Results; Company Recently Received FDA 

Clearance on ENOX Test,” Oct. 29, 2002). 

• Another press release, published in November 2002, described the ENOX 

test as “the missing link that cardiologists have needed to effectively and 

safely replace heparin with enoxaparin during coronary intervention.” 

Jones Aff. Ex. 11 (“PharmaNetics Announces Results of 600-Patient Elect 

Trial,” Nov. 18, 2002). 

• In December 2002 PharmaNetics and Aventis announced they had begun a 

collaborative marketing program to promote the ENOX test for use by 

interventional cardiologists. Jones Aff. Ex. 12 (“PharmaNetics Receives 

Final Milestone Payment from Aventis,” Dec. 19, 2002). 

• In a press release dated January 9, 2003, PharmaNetics stated that “much 

of the sales development expense and effort [associated with marketing 

the ENOX test] is provided by Aventis.” Jones Aff. Ex. 13 

(“Pharmanetics Announces Collaborative Sales and Marketing Program 

with Aventis for Launch of Enoxaparin Test,” Jan. 9, 2003). Specifically, 

PharmaNetics stated that the purpose of its collaboration with Aventis was 

“to address a desire by some cardiovascular interventionalists to discern 

the anticoagulant effects of [Lovenox] during invasive cardiac 

procedures.” Id. (emphasis added). 

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• In a news article published April 4, 2003—less than three weeks before 

Relators filed their original qui tam complaint against Aventis—

PharmaNetics announced “that it continued to be excited about the 

positive reception the Company’s ENOX test is receiving among 

interventional cardiologists,” with “57 hospitals currently conducting 

evaluations in cardiac catheterization labs.” Jones Aff. Ex. 14 

(“PharmaNetics Announces Filing of 510 K Application for Its Thrombin 

Inhibitor Management Test ‘TIM,’” Apr. 4, 2003) (emphasis added). 

Thus, the fact that Aventis and PharmaNetics collaborated to develop and market the ENOX test 

for use in monitoring anticoagulation levels in Lovenox patients transitioning to PCI 

procedures—precisely the alleged conspiracy and “unlawful” conduct Relators attempt to 

describe in their Amended Complaint—was publicly and thoroughly disclosed well before 

Relators even filed their original complaint (which did not yet make such allegations). 

 Ultimately, the companies disagreed over the marketing of Lovenox and the ENOX test, 

and on November 3, 2003, PharmaNetics filed suit against Aventis, asserting claims under the 

Lanham Act and contract and state law tort theories, alleging that Aventis’s marketing of 

Lovenox constituted false advertising. Specifically, PharmaNetics asserted that Aventis 

marketed Lovenox for its approved indication for treatment of UA/NSTEMI patients who 

undergo PCI procedures—the same use Relators have put at issue in the present suit. Jones Aff. 

Ex. 3 at ¶ 33. Ultimately, the court concluded that both Lovenox and the ENOX test were 

approved by the FDA for “patients with UA/NSTEMI who may transition to [PCI].” Jones Aff. 

Ex. 4 at 20. 

 C. Relators’ allegations and the Government’s decision not to intervene 

 Relators filed their original qui tam complaint under seal in April 2003, over a year and a 

half after the initial publicity surrounding PharmaNetics’ ENOX test announced that it would be 

used to monitor Lovenox in PCI procedures. In that complaint, Relators broadly alleged, without 

any detail, that Aventis caused the submission of false claims or statements to the Government 

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by disseminating unidentified “off-label information” relating to Lovenox and offering 

unspecified “things of value” to unnamed “physicians and other customers.” Compl. ¶¶ 3, 5. 

Contrary to the requirements of the Acts, only after they filed their qui tam complaint did 

Relators disclose all material evidence in their possession to the Government. 31 U.S.C. § 

3730(b)(2); 740 ILCS 175/4(b)(2); United States’ Unopposed Ex Parte Motion For An Extension 

of Time to Consider Election to Intervene, Jun. 17, 2003, at ¶ 3 (“In mid-May 2003, the relators 

provided the United States with the required material evidence.”). 

 On May 14, 2004, Relators filed their Amended Complaint. Once again, Relators failed 

to disclose all material evidence of the allegations in that complaint to the Government until well 

after its filing. See Joint Unopposed Ex Parte Motion of the United States and the State of 

Illinois for Second Extension of Time to Consider Election to Intervene, June 15, 2004, ¶ 4 

(stating “additional material evidence has come into the relators’ possession that they plan to 

disclose to the United States and the State of Illinois.”) (emphasis added). After a two and a half 

year period in which it reviewed and investigated Relators’ allegations, the Government declined 

to intervene in this action. 

 In their Amended Complaint Relators assert six qui tam claims, contending that Aventis 

violated the False Claims Acts by promoting Lovenox “off-label,” by promoting and conspiring 

with PharmaNetics to promote the ENOX test for allegedly “unlawful” purposes through the use 

of allegedly false marketing statements, and by engaging in a variety of internal training events 

relating to off-label uses of Lovenox. Relators also contend that Aventis violated the False 

Claims Acts by giving “things of value” to physicians and pharmacists in order to induce 

prescriptions of Lovenox. In addition, the Amended Complaint asserts three counts for 

retaliation under the False Claims Acts. 

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ARGUMENT 

A. The Court lacks subject-matter jurisdiction over Relators’ claims arising 

from their allegations of off-label promotion and false statements because of 

the public-disclosure bar. 

 This Court lacks subject matter jurisdiction over the Relators’ false statement- and offlabel promotion-related claims against Aventis under the “public disclosure bar,” which prohibits 

qui tam actions “based upon the public disclosure of allegations or transactions in a criminal, 

civil, or administrative hearing . . . or from the news media, unless . . . the person bringing the 

action is an original source of the information.” 31 U.S.C. § 3730(e)(4); 740 ILCS 175/4(e)(4); 

U.S. ex rel. Gear v. Emer. Med. Assocs. of IL, Inc., 436 F.3d 726, 728 (7th Cir. 2006). This 

jurisdictional bar is designed to prevent “parasitic lawsuits” brought by “persons who wish to 

capitalize on others’ discovery of frauds to the exposure of which they themselves have in no 

way contributed.” U.S. ex rel. Mathews v. Bank of Farmington, 166 F.3d 853, 858 (7th Cir. 

1999) (citations omitted). Relators bear the burden of establishing that their claims are not 

barred by the jurisdictional requirements of the False Claims Acts. Id. at 859; see also Grafon 

Corp. v. Hausermann, 602 F.2d 781, 783 (7th Cir. 1979) (holding the party invoking the court’s 

jurisdiction bears the burden of establishing jurisdiction by “competent proof.”). 

1. The facts underlying Relators’ allegations were publicly disclosed. A public 

disclosure has occurred for purposes of the False Claims Acts “when the critical elements 

exposing the transaction as fraudulent are placed in the public domain.” U.S. ex rel. Feingold v. 

AdminaStar Fed., Inc., 324 F.3d 492, 495 (7th Cir. 2003). In that event, a relator must establish 

that his claims are not based on the publicly disclosed information or that he is the original 

source of the information. Id.; Mathews, 166 F.3d at 859. In the present case, all of the facts that 

allegedly support Relators’ core off-label claims—that Aventis promoted Lovenox for use in 

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UA/NSTEMI patients who would undergo PCI procedures and conspired with PharmaNetics to 

market the ENOX test to promote that alleged off-label use—were disclosed in numerous public 

press reports about the companies’ collaboration agreement, in the FDA-approved product 

labeling for Lovenox, in the public FDA approval of the intended uses of the ENOX test, and in 

the PharmaNetics lawsuit. See supra, p. 5-6; Jones Aff. Exs. 5-14. The same is true with respect 

to Relators’ allegations regarding the allegedly false marketing statements for Lovenox. See 

supra, n. 4; Jones Aff. Exs. 1-2. Thus, Relators’ allegations of off-label promotion and false 

statements were publicly disclosed well before they were alleged in this qui tam action. 

2. Relators’ allegations are “based upon” the publicly disclosed information. 

Relators’ allegations of off-label promotion of Lovenox are “based upon” these public 

disclosures for purposes of the jurisdictional bar because they “both depend[] essentially upon 

[that] publicly disclosed information and [are] actually derived from such information.” 

Mathews, 166 F.3d at 864. Not only do Relators’ allegations parrot much of the information 

contained in the prior public disclosures, they actually rely on those disclosures—including by 

citing and quoting some of them—to support their claims. Amend. Compl. ¶¶ 44 (citing April 

18, 2000 press release), 45 (citing October 17, 2002 press release), 49 (same). Nor do Relators 

offer any allegations of off-label promotion or false marketing of Lovenox of any significance 

that are not derived from those public disclosures. Thus, Relators’ off-label allegations are 

“based upon” prior public disclosures for purposes of the jurisdictional bars of the False Claims 

Acts.8

 

8 Because Relators’ Amended Complaint contains allegations based on public disclosures, the Court 

should dismiss the entire action. See Mathews, 166 F.3d at 863 (“a qui tam plaintiff may not bring an 

action based in any part on such transactions.”) (emphasis added); United States ex rel. Precision Co. v. 

Koch Indus., Inc., 971 F.2d 548, 553 (10th Cir. 1992) (“a plaintiff whose qui tam action is based in any 

part upon publicly disclosed allegations or transactions is subject to the ‘original source’ jurisdictional 

requirement.”). 

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3. Relators are not an “original source” of their allegations. As a result, 

Relators’ claims arising from alleged off-label promotion of Lovenox and false statements are 

barred unless Relators can establish that they qualify as an “original source” of those allegations. 

Mathews, 166 F.3d at 864. An “original source” is “an individual who has direct and 

independent knowledge of the information on which the allegations are based and has voluntarily 

provided the information to the Government before filing [a qui tam] action.” 31 U.S.C. § 

3730(e)(4)(B); 740 ILCS 175/4(e)(4)(B). To be considered an original source, Relators must 

establish first that they have “direct and independent knowledge” of the information in their 

complaint, and, second, that they are a “source”—that they “voluntarily provided the information 

to the government before filing suit.” Bannon v. Edgewater Med. Ctr., 406 F. Supp. 2d 907, 922 

(N.D. Ill. 2005) (citations omitted). Relators cannot do so. 

 There can be no dispute that Relators’ original complaint was utterly devoid of any 

particular allegations of off-label promotion or false statements; Relators broadly alleged only 

that off-label promotion occurred. Compl. ¶¶ 3, 4, 15. The original complaint contains “no 

allegation from which it could be concluded that [Relators] had direct and independent 

knowledge of the fraud [they] allege[ed].” Bannon, 406 F. Supp. 2d at 923. While Relators’ 

Amended Complaint, filed over a year later, contains additional allegations regarding 

PharmaNetics and the ENOX test card, as well as one alleged marketing statement regarding 

Lovenox, those alleged facts are drawn directly from the public record in the press reports or the 

PharmaNetics litigation. Amend. Compl. ¶¶ 43-52; see U.S. ex rel. Yannacopolous v. General 

Dynamics, 315 F. Supp. 2d 939, 952-53 (N.D. Ill. 2004) (“documents filed with the court are 

‘public disclosures’ in a ‘civil hearing,’” sufficient to trigger the public disclosure bar) (citing 

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Mathews, 166 F.3d at 860). Moreover, Relators fail to allege any direct knowledge of any illegal 

act committed by Aventis or any false claim resulting from such conduct. See infra, Part B.1. 

 Finally, the record establishes that Relators did not disclose the material evidence in 

support of their Amended Complaint to the Government before filing that pleading—or for at 

least two months following that filing. See Joint Unopposed Ex Parte Motion of the United 

States and the State of Illinois for Second Extension of Time to Consider Election to Intervene, 

Docket No. 16, June 15, 2004, ¶ 4 (“On May 14, 2004, the relators filed an amended complaint. 

Relators’ counsel also recently informed the U.S. Attorney’s Office that additional material 

evidence has come into the relators’ possession that they plan to disclose to the United States and 

State of Illinois.”) (emphasis added). Because the Acts require such disclosures prior to filing a 

qui tam action, Relators cannot be an original source of the allegations in their Amended 

Complaint, and their claims must be dismissed for lack of subject-matter jurisdiction under the 

public disclosure bar. 31 U.S.C. § 3730(e)(4)(B); 740 ILCS 175/4(e)(4)(B); Bannon, 406 F. 

Supp. 2d at 924 (the public disclosure bar applies equally to an original and an amended qui tam 

complaint). 

B. The Amended Complaint should be dismissed because it does not state any 

cause of action. 

Even if Relators had properly invoked the Court’s jurisdiction, their claims against 

Aventis still should be dismissed because Relators have failed to plead their claims with the 

required particularity, and to plead facts sufficient to state any claim under the False Claims 

Acts. 

1. Relators fail to plead Aventis’s alleged “fraud” with particularity. The False 

Claims Acts are anti-fraud statutes, so causes of action under the Acts must meet the heightened 

pleading requirements of Rule 9(b). U.S. ex rel. Gross v. AIDS Research Alliance-Chicago, 415 

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F.3d 601, 604 (7th Cir. 2006). Rule 9(b) provides that “the circumstances constituting fraud . . . 

shall be stated with particularity.” Fed. R. Civ. P. 9(b). In this Circuit, Rule 9(b) has been 

construed to require the plaintiff to allege “the who, what, when, where, and how: the first 

paragraph of any newspaper story.” DiLeo v. Ernst & Young, 901 F.2d 624, 627 (7th Cir. 1990). 

In other words, a plaintiff must allege with particularity all aspects of the purported fraud 

“including the time and place of the fraud, the contents of the omissions or misrepresentations 

and the identity of the party perpetrating the fraud.” Servpro Indus., Inc. v. Schmidt, 905 F. 

Supp. 475, 479 (N.D. Ill. 1995). 

In the context of suits under the False Claims Acts, “Rule 9(b) requires a qui tam plaintiff 

to do more than merely charge that the defendants engaged in fraudulent schemes and then 

conclusively assert that fraudulent claims were submitted to the government.” U.S. ex rel. Garst 

v. Lockheed-Martin Corp., 328 F.3d 374, 378 (7th Cir. 2003) (rejecting qui tam claims where 

relator failed to connect allegations of deceit with actual claims for payment); Gross, 415 F.3d at 

604-05 (same, citing Garst). Rather, a relator must come forward with evidence “linking” the 

allegations of fraud to an actual false claim for payment. Garst, 328 F.3d at 378; U.S. ex rel. 

Crews v. NCS Healthcare, 460 F.3d 853, 857-58 (7th Cir. 2006) (upholding dismissal of relator’s 

claims where the complaint did not identify claims for government payment resulting from the 

alleged fraudulent acts); U.S. ex rel. Fowler v. Caremark RX, Inc., 2006 WL 3469537, *5 (N.D. 

Ill. 2006) (“[t]he most glaring deficiency is plaintiffs’ failure to identify any false invoices 

submitted to the government.”) (Jones Aff. Ex. 15); U.S. ex rel. Bantsolas v. Superior Air and 

Ground Ambulance Trans., Inc., 2004 WL 609793, *3 (N.D. Ill. 2004) (dismissing qui tam

action due in part to relator’s failure to identify “specific false claims”) (Jones Aff. Ex. 16); 

Peterson v. Comm. Gen. Hosp., 2003 WL 262515, *1 (N.D. Ill. 2003) (dismissing relator’s 

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claims for his failure to “identify or attach a single Medicare claim submitted by defendants for 

[the allegedly unlawful] services.”) (Jones Aff. Ex. 17); United States ex rel. Obert-Hong v. 

Advocate Health Care, 2001 WL 303692, *3 (N.D. Ill. 2001) (requiring relator to provide at least 

“representative examples” of actual false claims) (Jones Aff. Ex. 18).9

 

Thus, allegations concerning fraudulent schemes, no matter how detailed, are inadequate 

under the False Claims Acts if they are not “link[ed] to any claim for payment.” Garst, 328 F.3d 

at 378. As expressed by the Peterson court: 

[T]he whole point of relator’s case is that defendants submitted Medicare 

claims for services they provided to patients . . . in violation of the . . . law. 

But which patients? And which claims? And which claims or other 

documents show defendants falsely certified their compliance with federal 

law? These questions are absolutely essential to relator’s claim of 

fraud. . . . They must be pleaded with particularity. To be clear, the court 

does not expect relator to list every single patient, claim, or document 

involved, but he must provide at least some representative examples. 

Peterson, 2003 WL 262515 at * 2 (citing U.S. ex rel. Clausen v. Lab. Corp. of Am., Inc., 290 

F.3d 1301, 1312-13 (11th Cir. 2002)); U.S. ex rel. Karvelas v. Melrose-Wakefield Hosp., 360 

F.3d 220, 232-33 (1st Cir. 2004). Relators’ Amended Complaint does not even come close to 

satisfying the requirements of Rule 9(b). 

 Relators fail to allege any of the details regarding a single false claim that was submitted 

to the Government.10 Namely, Relators fail to allege: who submitted any improper claim to 

 

9

 The only exceptions in this Circuit, which run counter to the great weight of authority in this and other 

Circuits, appear to be U.S. ex rel. Salmeron v. Eter. Recovery Sys., Inc., 2006 WL 3445579, *2 (N.D. Ill. 

2006) and U.S. ex rel. Yannacopolous v. General Dynamics, 315 F. Supp. 2d 939, 945 (N.D. Ill. 2004), 

which did not require allegations of specific false claims. This view has been rejected by the Seventh 

Circuit, by the district courts of this Circuit, and other courts in prior and subsequent decisions. U.S. ex 

rel. Turner v. Michaelis Jackson & Assocs., 2007 WL 496384, *4 (S.D. Ill. 2007) (dismissing the view of 

Salmeron and Yannacopoulous and collecting some of the “many” cases requiring specific examples of 

false claims). 10 Relators’ failure to identify any false claim submitted to the Government for payment requires the 

dismissal of Relators’ claims that Aventis caused the presentation of false claims (Count I) and that 

Aventis made false statements to have false or fraudulent claims paid (Count II), because both causes of 

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Medicare or Medicaid; what those claims were for—which patients were treated, for which 

indication, and what amount of reimbursement was claimed; when or where those claims were 

submitted; or how those individual claims were fraudulent. Thus, Relators’ allegations regarding 

Aventis’s alleged off-label promotion and payment of illegal kickbacks are insufficient to state a 

claim under the False Claims Acts because they do not establish the next essential “link” in the 

FCA liability chain—actual reimbursement claims submitted to the Government. Garst, 328 

F.3d at 378. Instead, Relators merely make the unsupported allegation that marketing statements 

and statements regarding off-label uses of Lovenox “resulted in fraudulent claims for off-label 

uses being submitted to the Governments.” Amend. Compl. ¶¶ 5, 24, 51, 52. Such conclusory 

allegations that false claims were submitted are insufficient to allow Relators to maintain their 

action. See U.S. ex rel. Rost v. Pfizer, Inc., 446 F. Supp. 2d 6, 27-28 (D. Mass. 2006) (dismissing 

a qui tam action based on the defendant pharmaceutical manufacturers’ alleged off-label 

promotion activities where relator failed to identify how such activities caused the submission of 

false claims); Gross, 415 F.3d at 605; Clausen, 290 F.3d at 1311. Moreover, Relators make no 

attempt to connect their allegations of purported kickbacks paid by Aventis to false claims 

submitted to the Government. Amend. Compl. ¶¶ 6, 42 (alleging only that Aventis “offered 

things of value to physicians and others to induce health care program business for Lovenox.”). 

 In addition to failing to identify any actual false claims submitted to the Government, 

Relators also fail to allege the fraudulent schemes underlying their claims with sufficient 

particularity. See Obert-Hong, 2001 WL 303692, *3 (relator must also plead specific instances 

of the underlying fraud with particularity). First, Relators fail to plead any actual incident of offlabel promotion with any degree of particularity. In fact, the vast majority of Relators’ 

allegations of “off-label promotion” relate to purely internal communications between Aventis 

 

action are predicated on the submission of false claims. See Gross, 415 F.3d at 604-05.

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employees. Amend. Compl. ¶¶ 26-27, 29, 32-33, 35 (sales associates received information and 

articles on “unapproved” uses of Lovenox); 31, 33 (“clinical workshop materials” provided to 

Aventis employees).11 These allegations fail on their face because they involve internal 

dissemination of information and not “promotion” to physicians. In addition, Relators 

acknowledge that some of this information was distributed to the sales force with the caveat that 

it was “not for promotional use, is off-label, and may not be discussed by the sales associates 

with physicians.” Amend. Compl. ¶ 32. Finally, while Relators allege generally that Aventis 

encouraged its sales associates to sell Lovenox for off-label indications, Amend. Compl. ¶¶ 24, 

26, 33, 35, Relators do not allege that any sales associate actually promoted Lovenox for an offlabel indication, nor do they identify any sales associate who engaged in such activity, the date 

and place such activity occurred, the physician it involved, or the content of the off-label 

message allegedly delivered. Thus, Relators have not alleged facts to support their allegation 

that Aventis promoted Lovenox for off-label uses. 

 Relators have provided even less detail to support their general allegation that Aventis 

violated the federal Anti-Kickback Statute, 42 U.S.C. § 1320a-7b. With the exception of a 

handful of payments to one individual for speaking engagements—themselves lacking sufficient 

specificity—Relators fail to allege even the most basic facts concerning these alleged 

kickbacks—i.e., the date the alleged kickback was given or who at Aventis was involved in 

paying the alleged kickback. Relators do not even allege that the alleged payments were made 

by Aventis to induce referrals of federal healthcare business, as required under the AntiKickback Statute. See Klaczak ex rel. U.S. v. Consolidated Med. Trans., 458 F. Supp. 2d 622, 

626 (N.D. Ill. 2006). Relators’ efforts to portray reimbursement for educational programs as 

 

11 The same is true for Relators’ allegations regarding “false marketing statements” for Lovenox. Amend. 

Compl. ¶¶ 30, 34 (sales force received materials indicating Lovenox is “Therapeutic within 30 minutes”). 

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illegal “kickbacks,” without any detail necessary to support such an allegation, improperly seeks 

to tarnish the reputations of Aventis and the alleged recipients, and fails to meet the requirements 

of Rules 8(a) and 9(b). 

 Relators twice have failed to allege facts sufficient to state their claims with the 

particularity required by Rule 9(b). As a result, they are not entitled to an opportunity to further 

amend their pleading in an effort to state those facts. See U.S. ex rel. Hess v. Sanofi-Synthelabo 

Inc., 2006 WL 1064127, *12 (E.D. Mo. 2006) (the jurisdictional bar requires relator to disclose 

all material information before filing the qui tam complaint, thus relator may not amend to 

satisfy Rule 9(b)) (Jones Aff. Ex. 19). 

 2. Relators’ “off-label” allegations fail to state a claim under the False Claims 

Acts. The False Claims Acts impose liability on any person who “knowingly presents, or causes 

to be presented, to [the] Government . . . a false or fraudulent claim for payment” or who 

knowingly uses a “false record or statement, in order to get a false or fraudulent claim paid or 

approved.” 31 U.S.C. § 3729(a)(1), (2); 740 ILCS 175/3(a)(1), (2). To state a cause of action 

under the Acts, the relator must allege that: (1) the defendant made or caused to be made a claim 

to get the government to pay money; (2) the claim was false or fraudulent; (3) the defendant 

knew the claim was false or fraudulent; and (4) the underlying fraud was material to the 

government’s decision to pay money. See Gross, 415 F.3d at 604; U.S. ex rel. Luckey v. Baxter 

Healthcare Corp., 183 F.3d 730, 732-33 (7th Cir. 1999). Relators have failed to allege facts 

supporting any of these elements in connection with their “off-label” allegations. 

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No claims, no off-label promotion. First, as set forth in Part B.1., supra, Relators have 

not pled the existence of a single claim for payment submitted by any person, nor have they pled 

facts sufficient to establish that Aventis promoted Lovenox for off-label uses.12 

No falsity, no knowledge of falsity. Second, Relators have not alleged—and cannot 

establish—that Aventis knowingly caused the submission of any false claims or statements to the 

Government. The intent element of the False Claims Acts “requires that the defendant have 

actual knowledge of . . . the truth or falsity of the information presented” to the Government. 

Durcholz, 189 F.3d at 544 (emphasis added). In other words, the defendant must know that the 

claims or statements submitted are actually “false;” if the claims submitted are literally true, or if 

the defendant does not know that they are false, no cause of action lies under the Acts. See id.; 

Hess, 2006 WL 1064127 at *8-10 (dismissing qui tam claims where relator alleged defendant 

engaged in off-label promotion and did not allege any “untrue” or “false” statements or 

submissions); U.S. ex rel. Burlbaw v. Orenduff, 400 F. Supp. 2d 1276, (D.N.M. 2005) (“It cannot 

be an actionable violation of the FCA for an individual to provide truthful information to the 

government.”); U.S. v. Pres. and Fellows of Harvard Coll., 323 F. Supp. 2d 151, 181 (D. Mass. 

2004) (a False Claims Act action cannot be predicated on claims that are literally true). 

 Relators primarily rely on their broad allegations that the ENOX test was designed and 

used to market Lovenox to physicians for “unapproved” uses to support their allegations that 

 

12 Relators’ conspiracy claims against Aventis and PharmaNetics fail for the same reason. See supra, 

Parts B.1-3; Borsellino v. Goldman Sachs Group, Inc., 477 F.3d 502, 507-08 (7th Cir. 2007) (claims of 

civil conspiracy to commit fraud will be subject to the requirements of Rule 9(b)). In addition, their 

conspiracy claims fail for the separate reasons that they have not alleged any agreement by Aventis and 

PharmaNetics to get false claims paid, or any acts to do so. Supra, Parts B.1, 2; Adcock v. Brakegate Ltd., 

645 N.E. 2d 888, 894 (Ill. 1994) (to state a claim for conspiracy the plaintiff must allege (1) that the 

defendant conspired with one or more persons to get a false or fraudulent claim allowed or paid and (2) 

that one or more conspirators performed any act to effect the object of the conspiracy); U.S. ex rel. 

Durcholz v. FKW Inc., 189 F.3d 542, 545 n.3 (7th Cir. 1999) (general civil conspiracy principles are 

applied to conspiracy claims under the Acts). Thus, those claims must be dismissed pursuant to Rules 

8(a), 9(b), and 12(b)(6). 

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“false” claims and statements were submitted.13 Amend. Compl. ¶¶ 4, 23, 43-52. Relators’ 

theory fails for at least two reasons. First, Relators acknowledge that the ENOX test was used to 

monitor the anticoagulant effects of Lovenox in UA/NSTEMI patients who will transition to a 

PCI procedure. Amend. Compl. ¶¶ 4, 43-45. This simply is not an off-label use of Lovenox. 

Jones Aff. Ex. 3; Jones Aff. Ex. 4, at 20.14 

 Second, Relators allege nothing to suggest that anything other than truthful information—

even about off-label uses—was ever submitted to the Government on a claim form. Relators 

allege that Lovenox is prescribed “almost exclusively for inpatient hospital use,” and they do not 

allege that Lovenox was promoted off-label for any other use. Amend. Compl. ¶ 3. In order to 

receive Medicare or Medicaid reimbursement for inpatient hospital services, hospitals submit a 

“UB-92” claim form, which requires the hospital to indicate the patient’s age, sex, illness (such 

as UA/NSTEMI), procedures performed (such as PCI), certain drugs administered (such as 

Lovenox), and discharge status. See Aventis’s Request for Judicial Notice (“RJN”), Ex. 1. 

Thus, all the information Government decision-makers require to make their reimbursement 

decisions—even about an off-label use15—would be truthfully disclosed to the Government on 

 

13 While Relators also vaguely allege that Aventis disseminated information regarding off-label uses of 

Lovenox, including “dosing guidelines” and reprints of clinical publications, to physicians (Amend. 

Compl. ¶¶ 25, 28), these allegations are so devoid of concrete facts that they do not even pass muster 

under Rule 8(a). Moreover, pharmaceutical manufacturers are entitled under both the applicable 

regulatory framework and the First Amendment to disseminate off-label information—including certain 

“reprints of clinical publications”—to physicians in certain circumstances. See, e.g., 21 C.F.R. §99.1-

.501; Washington Legal Found. v. Friedman, 13 F. Supp. 2d 51, 74-75 (D.D.C. 1998), vacated on other 

grounds, 202 F.3d 331 (D.C. Cir. 2000) (holding manufacturers may disseminate certain scientific and 

academic materials “regardless of whether such [materials] include a significant or exclusive focus on offlabel uses.”). 

14 PharmaNetics v. Aventis Order Mar. 9, 2005 (holding both Lovenox and the ENOX test were approved 

by the FDA for “patients with UA/NSTEMI who may transition to [PCI]).” 

15 Medicare and Medicaid provide for reimbursements of off-label uses in several circumstances, such as 

when the use is “medically accepted”—including when the use is listed in certain medical compendia or 

is approved by the particular hospital in which the drug was prescribed. See 42 U.S.C. § 1395x(t)(1) 

(Medicare); 42 U.S.C. §§ 1396a(a), 1396r-8(k) and § 1396r-8(g) (Medicaid); 42 C.F.R. § 440.120(a); see 

also Medicare Benefit Policy Manual Ch. 1 §§ 30-30.2; Ch. 15 § 50.4.2 (see RJN, Ex. 2). Thus, 

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each claim form. Relators have alleged nothing to suggest otherwise, or to suggest how Aventis 

could have known about any allegedly false information included on any claim form in order to 

“knowingly cause” the submission of a false claim. 

No causation. Relators also fail to plead how, in the circumstances alleged, a 

pharmaceutical manufacturer—that clearly does not itself submit claims to the Government for 

patient care—could “cause” the submission of false claims. See Rost, 446 F. Supp. 2d at 27-28 

(D. Mass. 2006) (dismissing a qui tam action under Rule 9(b) for relator’s failure to identify how 

alleged off-label promotion activities caused the submission of false claims). In fact, many 

courts that have considered the issue of liability for a defendant that does not actually submit 

claims have held that a defendant “causes the submission” of false claims only where it plays a 

direct role in the claim submission process. See U.S. v. Mackby, 261 F.3d 821, 828 (9th Cir. 

2001) (physician instructed billing service to place his identification number on claims, thus 

causing the submission of false claims); U.S. v. Krizek, 111 F.3d 934, 942 (D.C. Cir. 1997) 

(causation element satisfied where physician delegated to his wife the authority to submit claims 

on his behalf); Harvard Fellows, 323 F. Supp. 2d at 187-89 (holding a defendant may be found 

to have caused the submission of false claims where he signed invoices indicating that the 

expenses were properly chargeable to a federally-funded entity, as distinguished from a 

defendant who did not approve any expenses or take other steps to assist in the claims 

submission process and thus could not cause such submissions); U.S. ex rel. Drescher v. 

Highmark, Inc., 305 F. Supp. 2d 451, 459-460 (E.D. Pa. 2004) (a defendant causes the 

submission of a false claim only when the submitting party is “merely a conduit to the transfer of 

government funds.”); U.S. ex rel. Kinney v. Hennepin Cty. Med. Ctr., 2001 WL 964011, *9 (D. 

 

government decision-makers need not consider only a drug’s FDA-approved label to allow 

reimbursement for a particular use, but can also consider a variety of other sources on a case-by-case 

basis.

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Minn. 2001) (dismissing a qui tam claim for lack of evidence that defendant physician had 

“control over the content of the claims” or a “right to review the claim forms being submitted.”) 

(Jones Aff. Ex. 20).16 

 Relators have not alleged any facts suggesting that Aventis was involved in any way in a 

health care provider’s claims-submission process. Indeed, physicians who may choose to 

prescribe Lovenox for an off-label use are “learned intermediar[ies],” who stand between 

Aventis and any treatment or subsequent billing decision. See Phelps v. Sherwood Med. Indus., 

836 F.2d 296, 303 (7th Cir. 1987). Physicians and hospitals make independent decisions whether 

to use Lovenox, under what circumstances, whom to bill, and what to say in their claim for 

reimbursement. Because they act on their own accord—not as Aventis’s “mere conduits”—

Aventis did not “cause” physicians to submit any claims to the Government. 

No materiality. Finally, Relators’ claims fail because they have not sufficiently alleged 

that the off-label promotion “was material to the United States’ buying position.” Luckey, 183 

F.3d at 732-33. The materiality element of an action under the False Claims Acts requires a qui 

tam relator to establish that the government would have refused to pay certain claims if it had 

known of the allegedly fraudulent acts. Id.; King v. F.E. Moran, Inc., 2002 WL 2003219, *10 

(N.D. Ill. 2002) (Jones Aff. Ex. 21); Sharp v. Cons. Med. Trans., Inc., 2001 WL 1035720, *8 

(N.D. Ill. 2001) (Jones Aff. Ex. 22). In other words, Relators must plead and prove that “but for 

[Aventis’s] allegedly fraudulent misrepresentations the doctors would not have made claims to 

Medicare [or Medicaid] for off-label uses [of Lovenox] and that but for these allegedly 

 

16 A sole district court has adopted a different view and held that, under certain circumstances, off-label 

promotion of drugs might “cause” physicians to submit fraudulent claims to the Government within the 

meaning of the False Claims Act. See United States ex. rel. Franklin v. Parke-Davis, 2003 WL 

22048255, *5 (D. Mass. 2003). Franklin is not binding on this Court, of course. More importantly, it is 

distinguishable in important ways, including that the defendant did not dispute that claims for off-label 

promotion could be false, at least with respect to certain Medicaid programs in some states. Id. at *3. 

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fraudulent misrepresentations Medicare [or Medicaid] would not have reimbursed the doctors.” 

Hess, 2006 WL 1064127, at *6. 

 In fact, Relators do not even plead the element of materiality. In general, Medicare and 

Medicaid17 reimburse inpatient hospital services through a prospective payment system (“PPS”) 

on the basis of diagnosis-related group codes (“DRGs”). 42 C.F.R. § 412. Patients are assigned 

DRGs based on their age, sex, illness, procedures performed, and discharge status, and the 

hospital receives a predetermined reimbursement amount for treating that patient. 63 Fed. Reg. 

40,954, 40,955; 42 C.F.R. §§ 405, 412, 413. DRGs 124 and 125, for example, apply to patients 

with circulatory disorders other than acute myocardial infarction whose condition requires 

cardiac catheterization. See 67 Fed. Reg. 49982-01, II.B.3.b. Hospitals are reimbursed at the 

same rates for all patients assigned to DRGs 124 and 125, regardless of the individual drugs they 

are administered, or even if they are not administered any drug at all.18 42 C.F.R. § 412. As a 

result, even if Relators had alleged that providers submitted claims for a UA/NSTEMI patient 

who required a PCI procedure and was prescribed Lovenox for an off-label use, the off-label use 

of Lovenox is immaterial to the Government’s decision to reimburse hospitals for that inpatient. 

See U.S. ex rel. Bidani v. Lewis, 2001 WL 1609377, *6 (N.D. Ill. 2001) (holding that False 

Claims Act claims may be dismissed upon “regulations or rules conclusively showing” that the 

alleged fraud was immaterial to the government’s decision to pay). 

 

17 Hospital reimbursement rates for Medicaid are determined by each state with federal approval, while 

hospital rates for Medicare are set by statute. 42 U.S.C. §§ 1395-1396. In general, state Medicaid 

programs, including the Illinois Medicaid program, reimburse for inpatient hospital services on the same 

basis as Medicare. See 305 ILCS 5/14-8. 

18 While hospitals may receive additional “outlier” reimbursements for extraordinarily costly inpatient 

services, 42 C.F.R. § 412.80, Relators have not alleged that any patients treated with Lovenox qualified 

for “outlier” reimbursement. 

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 In sum, Relators’ allegations concerning Aventis’s promotion of Lovenox for off-label 

use do not give rise to any claim for relief under the False Claims Acts. Their claims should 

therefore be dismissed pursuant to Rules 8(a), 9(b) and 12(b)(6). 

3. Relators’ “kickback” allegations fail to state a claim under the False Claims 

Acts. Relators also allege that Aventis provided “things of value” in the form of “excessive” 

speaker fees and “unrestricted grants” to physicians and entities in order to induce prescriptions 

of Lovenox. Amend. Compl. ¶¶ 36-42. Once again, Relators do not allege that any person or 

entity who received such “things of value” from Aventis ever submitted a claim for 

reimbursement to the Government. Amend. Compl. ¶¶ 36-42. Their “kickback” allegations 

must be dismissed for this reason alone. 

Moreover, Relators fail to allege any concrete facts regarding how payments by Aventis 

constitute violations of the Anti-Kickback Statute. In order to establish a violation of the AntiKickback Statute, Relators must allege and establish that Aventis knowingly and willfully 

offered or paid remuneration to a person in order to induce referrals under a federal health care 

program. 42 U.S.C. § 1320a-7b. Relators allege that one pharmacist, Ben Muoghalu, was paid 

by Aventis for various speaking engagements in 2001 and 2002. Amend. Compl. ¶¶ 38-39. 

However, among many other lacking details, Relators do not allege that Aventis made any 

payment to Muoghalu in exchange for referrals of federal healthcare business; thus, they do not 

allege a violation of the Anti-Kickback Statute. See Klaczak, 458 F. Supp. 2d at 626 (granting 

summary judgment for defendant on relators’ false claims act claims premised on alleged AntiKickback Statute violations where relators failed to establish that the defendant accepted 

something of value in return for referrals of Medicare or Medicaid business). 

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Similarly, Relators fail to allege any facts regarding how the alleged “unrestricted 

educational grants” and “tickets to sporting events, programs without educational value, grants 

and other items of value” given to various hospitals and other entities, Amend. Compl. ¶¶ 6, 40-

41, induced the referral of business under a federal healthcare program or otherwise constituted 

“kickbacks.” The mere fact that they were allegedly given to persons “in positions to prescribe 

or influence prescriptions for Lovenox” is insufficient to state a violation of the Anti-Kickback 

Statute. U.S. v. Rogan, 459 F. Supp. 2d 692, 714 (N.D. Ill. 2006) (holding “a hope, expectation 

or belief that referrals may ensue from remuneration for legitimate services is not a violation of 

the Anti-Kickback Statute.”). Thus, Relators’ “kickback” claims are insufficient to state any 

cause of action under the False Claims Acts for the reasons set forth in Part B.2., supra, and 

should be dismissed under Rules 8(a) and 12(b)(6). 

C. Kennedy fails to state a retaliation claim. 

Finally, Kennedy also has failed to state any claim for retaliation under the False Claims 

Acts, which provide private causes of action for Relators who are discharged or otherwise 

retaliated against as a result of engaging in conduct protected under the Acts. “Protected 

conduct” is limited to those “lawful acts done by the employee . . . in furtherance of an [FCA or 

IWRPA action], including investigation for, initiation of, testimony for, or assistance in an action 

filed or to be filed under this section.” 31 U.S.C. § 3730(h); 740 ILCS § 175. In order to state a 

retaliation claim under the Acts, a plaintiff must plead facts which would demonstrate that her 

employer was on notice that she was engaged in such protected conduct, and that the employer 

discriminated against the plaintiff because of the protected conduct. Brandon v. Anesthesia & 

Pain Mgmt. Assocs., 277 F.3d 936, 944 (7th Cir. 2002); Luckey v. Baxter Healthcare Corp., 2 F. 

Supp. 2d 1034, 1050 (N.D. Ill. 1998), affirmed 183 F.3d 730 (7th Cir. 1999); Neal v. Honeywell, 

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Inc., 942 F.Supp. 388, 394 (N.D. Ill. 1996). Kennedy fails to allege facts to show that Aventis 

had notice that she was engaged in protected conduct under the False Claims Acts. 

While Kennedy alleges that she complained to her superiors about practices tied to the 

“inappropriate use of company funds,” and violations of “various company internal controls,” 

Kennedy does not allege that she advised anyone at Aventis that such practices resulted in any 

fraud upon the Government. Amend. Compl. ¶¶ 53-63. Raising concerns regarding alleged 

“improprieties,” which are not connected to “alleged false claims to the government,” or 

“funds . . . fraudulently obtained from the government” are insufficient to put Aventis on notice 

that Kennedy was acting in furtherance of a False Claims Act action. Luckey, 2 F. Supp. 2d 

1054-56 (dismissing a False Claims Act retaliation action where the plaintiff alleged she 

informed her employer of “regulatory non-compliance,” but did not voice any intention to file a 

qui tam action or allege that the government had been defrauded) (citing Hopper v. Anton, 91 

F.3d 1261, 1270 (9th Cir. 1996)). Rather, in order to sustain her retaliation claim, Kennedy must 

allege that her statements to Aventis regarding the “inappropriate use[s] of company funds” and 

violations of “internal controls” indicated “the nexus between her complaints and the [False 

Claims Acts].” Id. at 1055 (citing Yesudian v. Howard Univ., 946 F. Supp. 31, 33-34 (D.D.C. 

1996). Kennedy has failed to do so, and her retaliation claims must be dismissed. 19 

 

19Count IX, brought by Kennedy under the IWRPA for retaliation for “refusing to participate in an illegal 

activity,” fails for the separate reason that Kennedy does allege that she refused to participate in any 

specific activity that she reasonably believed was illegal, or that Aventis knew of such a refusal and 

retaliated against Kennedy as a result. 740 ILCS 174/20; Sprinkle v. Lowe’s Home Ctrs., Inc., 2006 WL 

2038580, * (S.D. Ill. 2006) (holding that in order to prevail under this section, a plaintiff must show that 

“his discharge was in retaliation for his refusal to participate in an activity that he reasonably believed 

would result in a violation of a State or federal law, rule or regulation.”) (Jones Aff. Ex. 23). 

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CONCLUSION 

For the reasons discussed above, the Court should dismiss Relators’ Amended Complaint 

with prejudice. 

Dated: March 27, 2007 

 Respectfully submitted, 

By: /s/ Jaime L.M. Jones

Scott R. Lassar 

Stephen C. Payne 

Jaime L.M. Jones 

SIDLEY AUSTIN LLP

One South Dearborn Street 

Chicago, Illinois 60603 

(312) 853-7000 

Attorneys for Defendant Aventis 

Pharmaceuticals, Inc. 

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