United States Ex Rel. Kennedy v. Aventis Pharmaceuticals, Inc.

512 F. Supp. 2d 1158, 2007 U.S. Dist. LEXIS 68134, 2007 WL 2681701
CourtDistrict Court, N.D. Illinois
DecidedSeptember 13, 2007
Docket03 C 2750
StatusPublished
Cited by16 cases

This text of 512 F. Supp. 2d 1158 (United States Ex Rel. Kennedy v. Aventis Pharmaceuticals, Inc.) is published on Counsel Stack Legal Research, covering District Court, N.D. Illinois primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
United States Ex Rel. Kennedy v. Aventis Pharmaceuticals, Inc., 512 F. Supp. 2d 1158, 2007 U.S. Dist. LEXIS 68134, 2007 WL 2681701 (N.D. Ill. 2007).

Opinion

*1161 MEMORANDUM OPINION AND ORDER

MATTHEW F. KENNELLY, District Judge.

Relators Katy Kennedy and Frank Ma-tos bring this qui tam 1 action on behalf of the United States and the State of Illinois under the False Claims Act, 31 U.S.C. § 3729 et seq. (FCA), and the Illinois Whistleblower Reward and Protection Act, 740 ILCS 175/1 et seq. (IWRPA), against Aventis Pharmaceuticals, Inc. and Phar-maNetics, Inc. Kennedy also brings a claim on her own behalf against Aventis, claiming retaliation under the FCA and IWRPA. Aventis and PharmaNeties have moved to dismiss relators’ amended complaint pursuant to Federal Rules of Civil Procedure 8(a), 9(b), 12(b)(1) and 12(b)(6). For the following reasons, .the Court denies PharmaNetics’s motion and grants in part and denies in part Aventis’s motion.

Facts

When considering a motion to dismiss a complaint, the Court accepts the plaintiffs allegations as true. Thompson v. Ill. Dep’t of Prof'l Reg., 300 F.3d 750, 753 (7th Cir.2002).

Kennedy and Matos are former Aventis sales representatives. While at Aventis, Kennedy and Matos promoted the prescription drug Lovenox, an anticoagulant prescribed by physicians almost exclusively for inpatient hospital care. Lovenox is approved by the Food and Drug Administration (FDA) for seven indications. These indications are prophylaxis of deep vein thrombosis in patients undergoing abdominal surgery; prophylaxis of deep vein thrombosis in patients undergoing hip replacement surgery; prophylaxis of deep vein thrombosis in patients undergoing knee replacement surgery; prophylaxis of deep vein thrombosis in patients who are at risk for thromboemobolic complications due to severely restricted mobility; prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin; inpatient treatment of acute deep vein thrombosis with or without pulmonary embolism, when administered in conjunction with warfarin sodium; and the outpatient treatment of acute deep vein thrombosis without pulmonary embolism when administered in conjunction with warfarin sodium.

Relators allege that Aventis engaged in a scheme to market Lovenox for off-label uses that resulted in doctors submitting fraudulent reimbursement claims to the government. They allege that in August 2000, Aventis entered into an agreement with PharmaNeties pursuant to which PharmaNeties developed a test, called the ENOX test, to detect the anticoagulant effects of Lovenox on patients with unstable angina. Relators allege that the purpose of the test was to overcome objections from interventional cardiologists who were unwilling to perform interventional procedures, such as cardiac catheterization, on patients with unstable angina who were receiving Lovenox. Lovenox has not been approved by the FDA for use in the cath-eterization laboratory on patients with unstable angina. Aventis informed its sales associates about the test and told them that a brochure they had been provided “should help you to discuss management of patients on [Lovenox] who may transition to the cath lab. The Enox test card is now available and can be used to help give skeptical physicians the evidence they need to feel confident using [Lovenox] in this scenario.” Amend. Compl. ¶ 46. On *1162 April 18, 2000, PharmaNetics issued a press release, approved by Aventis, which stated that “the ability to monitor [Love-nox] in potential new areas of study such as Percutaneous Coronary Intervention [PCI] ... has been an increasingly important issue. We believe that by providing access to a rapid test for [Lovenox], we will strengthen the drug’s leadership position, facilitate administration in acute-care settings and help physicians manage difficult sub-sets of patients.” Id. ¶ 44. Rela-tors allege that Lovenox is not approved for PCI or acute-care settings.

Relators allege that on August 10, 2001, Matos received a copy of an e-mail concerning renal dosing for Lovenox, which was given to a medical center in Elk Grove Village, Illinois. The FDA has not approved Lovenox for renal patients. Rela-tors further allege that in May 2002, an Aventis district manager instructed a subordinate to make a binder containing off-label information. The Aventis manager provided the binder to a sales associate to help market Lovenox for off-label uses. The binder contains eight sections: trauma, general surgery, stroke, neurosurgery, spinal cord injuries, obstetrician/gynecology/pediatrics, heparin induced thrombocy-topenia, and other. The FDA has not approved Lovenox to treat any of these conditions.

In May 2002, Matos informed senior Aventis personnel in the legal and human resources departments that unapproved and off-label clinical studies were being distributed by Aventis. Also in May 2002, another Aventis employee gave Kennedy a Lovenox dosing guideline booklet. On February 4, 2003, Kennedy visited Resurrection Hospital in Park Ridge, Illinois and saw approximately 150 of the booklets. The booklets contained dosing guidelines for special patient populations for which Lovenox had not been approved by the FDA.

At the January 2003 Lovenox national sales meeting, participants were given clinical workshop materials on the off-label use of Lovenox in the catheterization lab and unapproved intravenous dosing. The sales force also was shown a slide presentation that stated that Lovenox is “therapeutic within 30 minutes.” During a sales practice session in May 2003, however, the director of marketing for Lovenox told Kennedy and Matos that therapeutic levels are reached in sixty to ninety minutes.

In March 2003, Aventis conducted advanced training at Northwestern Memorial Hospital in Chicago. A significant amount of the training took place in the catheteri-zation lab, though Lovenox is not approved for use with catheterization procedures. Aventis also provided its Lovenox sales team with articles containing off-label indications for Lovenox. Relators contend that Aventis provided these articles to the sales force to assist them in selling Love-nox for off-label purposes.

In November 2003, PharmaNetics filed a lawsuit against Aventis arising out of their agreement to develop and market the ENOX test card. In the suit, PharmaNet-ics alleged that “although [Lovenox] is not approved for PCI[,] Aventis nonetheless has engaged in off-label promotion of its drug for PCI.” Amend. Compl. ¶ 49. PharmaNetics also alleged that Aventis engaged in false advertising regarding Lo-venox’s efficacy and whether physicians needed to routinely monitor the effects of the drug on heart patients.

Relators allege that Aventis encouraged its Lovenox sales representatives to provide items of value to physicians, pharmacists, and others in order to induce health care providers to purchase Lovenox. They also contend that Aventis paid excessive fees to speakers to encourage their continued use and promotion of Lovenox and provided unrestricted grants to

Free access — add to your briefcase to read the full text and ask questions with AI

Related

United States v. AbbVie Inc
N.D. Indiana, 2024
Singer v. Progressive Care, SC
202 F. Supp. 3d 815 (N.D. Illinois, 2016)
United States ex rel. Kroening v. Forest Pharmaceuticals, Inc.
155 F. Supp. 3d 882 (E.D. Wisconsin, 2016)
United States ex rel. Kalec v. Nuwaye Monitoring, LLC
84 F. Supp. 3d 793 (N.D. Illinois, 2015)
United States ex rel. McGee v. IBM Corp.
81 F. Supp. 3d 643 (N.D. Illinois, 2015)
Goldberg v. Rush University Medical Center
929 F. Supp. 2d 807 (N.D. Illinois, 2013)
United States ex rel. Upton v. Family Health Network, Inc.
900 F. Supp. 2d 821 (N.D. Illinois, 2012)
United States Ex Rel. Nowak v. Medtronic, Inc.
806 F. Supp. 2d 310 (D. Massachusetts, 2011)
United States Ex Rel. Radcliffe v. Purdue Pharma L.P.
582 F. Supp. 2d 766 (W.D. Virginia, 2008)
United States Ex Rel. Batty v. Amerigroup Illinois, Inc.
528 F. Supp. 2d 861 (N.D. Illinois, 2007)

Cite This Page — Counsel Stack

Bluebook (online)
512 F. Supp. 2d 1158, 2007 U.S. Dist. LEXIS 68134, 2007 WL 2681701, Counsel Stack Legal Research, https://law.counselstack.com/opinion/united-states-ex-rel-kennedy-v-aventis-pharmaceuticals-inc-ilnd-2007.