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United States ex rel Kennedy v. Aventis Pharmaceuticals

September 13, 2007

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,
v.
AVENTIS PHARMACEUTICALS, INC., AND PHARMANETICS, INC., DEFENDANTS.



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

MEMORANDUM OPINION AND ORDER

Relators Katy Kennedy and Frank Matos bring this qui tam*fn1 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 PharmaNetics, Inc. Kennedy also brings a claim on her own behalf against Aventis, claiming retaliation under the FCA and IWRPA. Aventis and PharmaNetics 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 plaintiff's 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 PharmaNetics pursuant to which PharmaNetics 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 catheterization 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 April 18, 2000, PharmaNetics issued a press release, approved by Aventis, which stated that "the ability to monitor [Lovenox] 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. Relators 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. Relators 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 thrombocytopenia, 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 studieswere 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 catheterization 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 Lovenox 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, PharmaNetics 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 Lovenox'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 healthcare organizations to promote the off-label use of Lovenox.

Kennedy also alleges that she suffered retaliation for reporting alleged internal financial irregularities to management. In May 2002, she received a message from her supervisor, Joe Levato, directing her to spend the remaining funds in her expense account by July 1, 2002. He advised Kennedy to spend the funds on events that would occur after July 1 and that she should create false entertainment invoices and submit them for reimbursement. Kennedy asked Levato whether the practice would violate internal company controls. Kennedy contends that Levato threatened, harassed, and in other ways discriminated against her as a result of her questions. In August 2002, Kennedy reported her concerns to the human resources department. She also informed the director of human resources of the off-label promotion and marketing of Lovenox. Kennedy contends that she was "threatened, harassed, retaliated and discriminated against" for reporting the financial irregularities and off-label marketing. Amend. Compl. ¶ 59. Kennedy contends that due to the harassment, in February 2004 she was forced to resign.

The docket reflects that relators met with representatives from the government on April 17, 2003. See United States' Motion for Extension of Time to Consider Election to Intervene, filed June 17, 2003 (docket no. 9). On April 24, 2003, relators filed their original complaint.

Relators state in their response to defendants' motions that they provided additional documents and information to the government regarding the alleged fraud on several occasions between June 2003 and July 2006. On May 14, 2004, relators filed an amended ...


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