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United States ex rel Kennedy v. Aventis Pharmaceuticals

December 10, 2008


The opinion of the court was delivered by: Matthew F. Kennelly, District Judge


Relators Katy Kennedy and Frank Matos have brought qui tam claims*fn1 on behalf of the United States and the State of Illinois under the False Claims Act, 31 U.S.C. § 3730(b) (FCA), and the Illinois Whistleblower Reward and Protection Act, 740 ILCS 175/4(b)(IWRPA), against Aventis Pharmaceuticals, Inc. Kennedy has also brought a claim on her own behalf against Aventis, claiming retaliation in violation of the Illinois Whistleblower Act, 740 ILCS 174/20 (IWA). Aventis has moved to dismiss the qui tam claims in relators' third amended complaint (Counts 1-6) pursuant to Federal Rules of Civil Procedure 9(b) and 12(b)(6). For the following reasons, the Court grants Aventis's motion.


When considering a motion to dismiss a complaint, the Court accepts all the facts stated in the complaint as true and draws all reasonable inferences in favor of the plaintiff. Newell Operating Co. v. Int'l Union of United Auto., Aerospace, and Agr. Implement Workers of Am., 538 F.3d 583, 587 (7th Cir. 2008).

Relators are former Aventis sales representatives. While at Aventis, relators promoted the prescription drug Lovenox, an anticoagulant used almost exclusively for inpatient hospital care. The Food and Drug Administration (FDA) approved Lovenox for seven indications. See United States ex rel. Kennedy v. Aventis Pharms., Inc., 512 F. Supp. 2d 1158, 1162 (N.D. Ill. 2007).

Relators allege that Aventis marketed Lovenox for off-label uses and thereby induced doctors and hospitals to submit fraudulent Medicare reimbursement claims to the government. Relators allege that this marketing strategy caused doctors to prescribe Lovenox for atrial fribillation, acute myocardial infarction, mechanical heart valve replacement, coronary artery bypass graft surgery, ST-elevation myocardial infarction, bariatric surgery, arthroscopic-assisted surgery, hemodialysis patients, hip fracture surgery, trauma, lower or upper extremity fractures, neurosurgery, spinal cord injuries, acute ischemic stroke, stroke, percutaneous coronary intervention, general surgery, heparin-induced thrombocytopenia, IV dosing, and cardiac catheterization. Lovenox is not approved by the FDA for any of these indications.

Relators allege that Aventis provided things of value to doctors and hospitals to induce them to prescribe Lovenox for off-label indications. Specifically, they allege Aventis paid $34,000 to Ben Muoghalu, a pharmacist, for several speaking engagements. Relators contend that Aventis hired Muoghalu to induce him to keep Lovenox on hospital formularies under his control. In addition, Aventis gave various organizations grants ranging from $5,000 to $30,000. Relators contend that Aventis made the grants intending to induce those organizations to use or promote Lovenox for off-label indications.

In August 2000, Aventis entered into an agreement with PharmaNetics (PharmaNetics was previously a defendant in this case but was dismissed by stipulation with relators). According to the agreement, PharmaNetics developed a test, called the ENOX test, to detect the anticoagulant effects of Lovenox on patients with unstable angina. Relators contend that the purpose of the test was to convince unwilling doctors to perform interventional procedures on patients with unstable angina who receive Lovenox. Because the FDA did not approve Lovenox for use in such invasive procedures, relators contend that the development of the test was part of a scheme to create a new marketing tool designed to market Lovenox for an unapproved use.

Relators allege that Aventis purposely ordered its personnel to mislead doctors regarding the approved and safe uses of Lovenox. As a result, prescriptions for Lovenox increased, including prescriptions reimbursed through government health programs.

Relators identify two specific instances in which a hospital prescribed Lovenox for allegedly off-label indications due to Aventis' marketing tactics and then billed the government for reimbursement. First, relators contend that Lutheran General Hospital made a false claim to the government when, on January 5, 2002, it submitted a claim for Lovenox as a covered expense for atrial fribillation, an off-label use. Second, relators contend that Alexian Brothers Hospital made a false claim to the government in 2002 when it submitted a claim for Lovenox as a covered expense for atrial fribillation. Relators also attached two charts to their third amended complaint detailing other allegedly off-label uses of Lovenox in connection with which hospitals submitted claims to the government for payment. Finally, relators allege that the hospitals used false records or statements to get false or fraudulent claims paid or approved by the government when they included Lovenox, as prescribed for the off-label uses, in "cost report[s] and/or Medicare Cost Reconciliation[s]." 3d Am. Comp. ¶¶ 56, 58.

Relators filed their first complaint, under seal pursuant to the FCA, on April 24, 2003. The government declined to intervene in December 2006. After the Court unsealed the complaint, relators served it on Aventis and PharmaNetics.

Aventis has twice moved the Court to dismiss relators' claims. First, in March 2007, Aventis moved the Court to dismiss relators' first amended complaint on multiple grounds. The Court granted Aventis's motion in part, dismissing Kennedy's whistleblower retaliation claims, but declining to dismiss relators' qui tam claims. Aventis Pharms., 512 F. Supp. 2d at 1169. Kennedy amended her retaliation claims, and Aventis again moved to dismiss. On February 11, 2008, the Court granted Aventis's motion as to Kennedy's FFA and IWPRA claims but declined to dismiss Kennedy's IWA claim. United States ex rel. Kennedy v. Aventis Pharms. Inc., No. 03 C 2750, 2008 WL 4371323 (N.D. Ill. Feb. 11, 2008).

On November 13, 2007, the Court bifurcated discovery into two phases and set deadlines for the completion of each. The purpose of the first phase was to allow relators to attempt to identify specific allegedly false claims. The deadline for completing that phase was extended by approximately three months at relators' ...

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