Opinion ID: 873494
Heading Depth: 3
Heading Rank: 2

Heading: The Heineman-Guta Complaint

Text: On November 10, 2009, while the Bennett complaint was still pending and under seal, Heineman-Guta filed a qui tam complaint under seal alleging BSC violated the FCA. Heineman-Guta amended her complaint on January 30, 2012. Like Bennett, Heineman-Guta made numerous allegations concerning BSC's kickback scheme. Heineman-Guta, a former account manager in BSC's heart failure management group from April 2003 until November 2007, claimed that over her four-year employment with BSC, it defrauded the Government by engaging in a scheme to provide kickbacks in various forms to physicians to encourage them to both implant its cardiac rhythm management devices and refer patients that would be implanted with such devices. Specifically, Heineman-Guta says that BSC instructed her to provide lavish trips and entertainment to physicians in order to encourage them to refer patients for implantation of Guidant cardiac rhythm management devices. BSC offered physicians allexpense paid trips and used expensive meals to induce them to at , . In the present case, BSC argued in its motion to dismiss that the previously dismissed George Complaint, in addition to the Bennett Complaint, served as a preclusive first-filed complaint. Agreeing with Heineman-Guta, the district court rejected the notion that the George Complaint could serve as a preclusive first-filed complaint because it did not allege a kickback scheme to promote the sale of cardiac rhythm management devices. United States ex rel. Heineman-Guta v. Guidant Corp. et al., 874 F. Supp. 2d 35, 38 (D. Mass. 2012). Since BSC does not challenge that conclusion, the George Complaint is not at issue in this appeal. -8- insist on the implantation of BSC devices or refer patients for implantation. BSC required sales representatives to prepare customer management plans on how to retain customers, grow their business or win back their support and gain market share from them. BSC paid physicians as speakers to gain their loyalty, repeatedly paying one high-volume implanting physician between $1200 and $2500 per engagement over the course of two years. A July 2005 company power point presentation on sales-representative training allegedly instructed that best practices at the company included compensating physicians by providing them with speaking opportunities. BSC used case reviews to funnel money to referring physicians and to provide a steady stream of patient referrals for implanting physicians who were loyal to BSC. Under the case review program, BSC invited an implanting physician along with several referring physicians to an expensive dinner. At the dinner, the implanting physician reviewed cases for possible referral. In addition to paying for the dinner, BSC allegedly paid each referring physician a $250 fee for each patient chart they brought to the dinner. BSC used the case review program as a means to not only funnel money to referring physicians, but also to ensure the commitment of participating implanting physicians to implant BSC cardiac rhythm management devices. -9- In addition, BSC conducted sham clinical trial programs. Heineman-Guta pointed to one specific sham program called ADVANCENT, which was an observational registry of patients with certain symptoms of cardiac failure. Through this program, BSC allegedly targeted physicians who were loyal to BSC and paid them for each patient they entered into the database who had those symptoms. BSC also assisted fellows in finding employment in practices that primarily implanted BSC devices. BSC helped place fellows in certain practices and hospitals in exchange for promises from those practices and hospitals that they would mainly use BSC devices. According to the amended complaint, these kickbacks caused certain physicians to implant or recommend the use of BSC devices. In addition to providing the initials of the specific referring and implanting physicians, the initials of the patients who received implantations due to the purported scheme and the dates and places of implantation, the amended complaint detailed the trips, meals and hotel reimbursements for physicians who implanted BSC devices. BSC, knowing that Medicare would pay for the vast majority of these implants, allegedly promoted the highly lucrative nature of implanting its devices by pointing out to implanting physicians the extent to which Medicare would provide reimbursement for implantations and the profit margins physicians -10- could make from such reimbursement. Lastly, Heineman-Guta claimed that BSC caused physicians and hospitals, who must certify compliance with the federal Anti-Kickback Statute, to make false certifications that were material to the government's decision to pay for the implantation of the companies' cardiac devices.