United States ex rel. Suarez v. AbbVie Inc., Case No. 15 C 8928
| Decision Date | 30 September 2019 |
| Docket Number | Case No. 15 C 8928 |
| Parties | UNITED STATES OF AMERICA ex rel. LAZARO SUAREZ, and on behalf of the STATE OF CALIFORNIA, et al., Plaintiff-Relator, v. ABBVIE INC. and ABBOTT LABORATORIES, Defendants. |
| Court | U.S. District Court — Northern District of Illinois |
MEMORANDUM OPINION AND ORDER
Plaintiff-Relator Lazaro Suarez ("Relator"), a registered nurse, commenced this qui tam action under the False Claims Act (FCA), 31 U.S.C. §§ 3729-33, which establishes penalties for the submission of false claims for payment to federal health care programs. Under the FCA's qui tam provisions, relators—meaning private citizens acting as whistleblowers—are authorized to sue on behalf of the United States to recover damages for the submission of materially false claims. See 31 U.S.C. § 3730; Thulin v. Shopko Stores Operating Co., 771 F.3d 994, 998 (7th Cir. 2014). In this action, Relator alleges that Defendant AbbVie Inc., a pharmaceutical company with its principal place of business in Illinois, and its predecessor, Abbott Laboratories (collectively, "AbbVie"), paid kickbacks to doctors in the form of product support services for AbbVie's prescription drug Humira. AbbVie provided these support services through its "Ambassador Program", in which Relator was employed through a subcontractor. Relator alleges that the kickbacks require the conclusion that all resulting claims for government reimbursement of Humira prescriptions constitute false claims under the FCA. Relator asserts claims for violations of the FCA, § 3729(a)(1)(A), (B), (G), and conspiracy to violate the FCA, § 3729(a)(1)(C). In addition, he asserts claims for violations of analogous laws in 30 states and the District of Columbia.1
Relator filed this lawsuit on October 8, 2015. He amended his complaint on February 12, 2018, to remove a claim arising under the California Insurance Frauds Prevention Act, CAL. INS. CODE § 1871 et seq. On March 13, 2018, the United States declined to intervene in the action. (See Notice [26].) So, too, did all thirty states and the District of Columbia. (See Order [28].) Thereafter, the court ordered Relator's complaint unsealed. (See id.) AbbVie has moved to dismiss Relator's amended complaint. For the following reasons, the motion is granted, but the court will allow Plaintiff leave to amend.
The following summary is taken from Relator's amended complaint, whose factual allegations the court accepts as true for present purposes. See United States ex rel. Berkowitz v. Automation Aids, Inc., 896 F.3d 834, 839 (7th Cir. 2018).
Relator's FCA claims concern product support services that AbbVie offers in connection with its prescription drug Humira. Humira is an "injectable drug that treats various autoimmune diseases." (Am. Compl. [20] ¶ 2.) It was "the highest-grossing drug in the world in 2014." (Id. ¶ 3.)
Relator holds a bachelor's degree in nursing and has been a registered nurse since 1996. (Id. ¶ 16.) From March 2013 to October 2014, he worked in South Florida as a "nurse educator" and "patient ambassador" for AbbVie's Ambassador Program: an "education and support program" for Humira patients. (Id. ¶¶ 8, 14-15, 19.) Although Relator was hired by an AbbVie sub-contractor—Quintiles Transactional Holdings, Inc.—he "reported to and worked with personnel at AbbVie, maintained an AbbVie email address, and worked exclusively in connection with . . . Humira." (Id. ¶¶ 14-15.)
AbbVie's Ambassador Program is limited to patients for whom physicians have prescribed Humira, and whose prescriptions are for purposes that have been approved by the Food and Drug Administration. (Id. ¶¶ 40, 56.) "Ambassadors" are registered nurses who serve as representatives for AbbVie. (See id. ¶ 53.) They "are primarily tasked with going into patients' homes to discuss the patients' disease states and their treatment with Humira," and "to work with patients directly to enable payment for the drug." (Id.) More specifically, Ambassadors train patients on obtaining insurance payment for the drug, self-injecting the drug, and disposing of injection equipment. (See id. ¶ 65.) The "initial patient visit" usually takes "an average of one hour" but can take "as many as two-and-a-half" hours. (Id. ¶ 92.) Following the initial patient visit, "Ambassadors typically make two additional in-person visits" and thereafter contact patients by telephone. (Id. ¶¶ 101-02.)
Relator alleges that Ambassadors spend approximately one third of an initial patient visit "making sure the patient has access to reimbursement or, as needed, free drugs." (Id. ¶ 92.) AbbVie, for example, instructs Ambassadors that "they can (and should) be on the phone when patients call [their insurers]" and that they "can (and should) encourage patients to initiate calls to learn about coverage." (Id. ¶ 104.) For "Government Payor patients," AbbVie requires Ambassadors "to contact Medicare to determine the patients' payment status: namely, how much the patient must pay in the first couple of months of treatment . . . and at what point the patient's coverage stops during the gap period before coverage resumes." (Id. ¶ 105.)2 After obtaining this information, Ambassadors refer government payor patients to AbbVie's "Patient Assistance Foundation," which "has ample free supply to give patients during their . . . payment gap period." (Id. ¶ 107.) Relator alleges that he recalls hearing at an AbbVie national meeting that AbbVieprovided 94,000 free doses to government payor patients in 2013. (Id. ¶ 110.) Relator further alleges that "AbbVie management provides information about open enrollment periods for Medicare plans and requires Ambassadors to try to push their patients into plans that maximize reimbursement for Humira." (Id. ¶ 111.)
Ambassadors also "visit, or communicate with, doctors' offices to respond to specific questions about specific patients, including if the patient has routed an administrative question to the doctor's office rather than to the Ambassador." (Id. ¶ 75.) And Ambassadors encourage "patients to enroll on the website 'MyHumira.'" (Id. ¶ 98.) According to Relator, AbbVie uses patient data collected on the website to "target the marketing of Humira" and "focus resources to have maximal return." (Id. ¶¶ 98-100.) Similarly, AbbVie identifies "high prescribers of injectable biologics" that "might benefit from receiving visits from Ambassadors" and sends Ambassadors to "tout[] [the program's] benefits to doctors and their staff." (Id. ¶ 71-72.) Relator alleges that he himself made "at least four such calls in August 2014 alone." (Id. ¶ 72.)
According to Relator, AbbVie "launched [the Ambassador Program] around the time the sales curve for Humira appeared to be flattening." (Id. ¶ 52.) The program's true goal, Relator avers, is not patient education and support, but rather "ensur[ing] that patients start on and continue to take Humira." (Id. ¶ 8.) Initially, Ambassadors "focus[ed] on newer patients who may be wavering on whether to take the medicine, and/or for whom payment has not been set up." (Id. ¶ 61; see also id. ¶ 89 (); id. ¶ 90 (); id. ¶¶ 58-60 ().) More recently, "AbbVie launched [a] 'low touch' program for patients who already have been taking Humira for longer periods." (Id. ¶ 61.) Presumably to ensure that the patients continue to do so, Ambassadors communicated with them by telephone. (Id.) Additionally, in or around fall 2014, AbbVie "piloted'Operation Dakota'": a "program in which prospective Humira patients living in sparsely-populated areas have contact with Ambassadors by telephone or video." (Id.) By virtue of Operation Dakota, "no market is beyond the reach of the Ambassador Program." (Id.)
The Ambassador Program "has been enormously successful." (Id. ¶ 9.) At annual meetings in 2013 and 2014, high-level AbbVie employees told Ambassadors "that until the [program] was initiated, sales of Humira had begun to plateau after its ninth year on the market." (Id. ¶ 133.) A graph displayed at one such meeting "compar[ed] where sales were before the program and where the sales had gone as a direct result" of the program, and "[t]he difference amounted to billions of dollars in sales." (Id. ¶ 134-35.) "As of May 2014," approximately 10,000 Humira patients "were supported by an Ambassador." (Id. ¶ 131.)
The Anti-Kickback Statute (AKS) prohibits soliciting, receiving, offering, or paying any "remuneration" in exchange for referring a patient for services that are reimbursed by a federal health care program, such as Medicare. 42 U.S.C. § 1320a-7b(b)(1), (2); see Am. Compl. ¶ 28. A claim that includes items or services resulting from a violation of the AKS constitutes a false or fraudulent claim for purposes of the False Claims Act. 42 U.S.C. § 1320a-7b(g); see Am. Compl. ¶ 33. In other words, when a claim is submitted to government health care programs such as Medicare and Medicaid, and "a kickback [was] involved in the underlying transaction," that claim is "false within the meaning of the federal False Claims Act and State analogs." (Am. Compl. ¶ 142.) To illustrate, when a health care provider submits a claim to Medicare, he or she must certify that the claim complies with all Medicare regulations, including the AKS. (Health Insurance Claim Form, Form CMS-1500, CENTERS FOR MEDICARE AND MEDICAID SERVICES (rev. Feb. 1, 2012) (https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/Downloads/ CMS1500. pdf) (last visited Sept. 30, 2019).) Accordingly, receiving or providing kickbacks to...
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