Manhattan U.S. Attorney Files Lawsuit Against Spinal Implant Company, Its CEO, And Another Executive

https://www.justice.gov/usao-sdny/pr/manhattan-us-attorney-files-lawsuit-against-spinal-implant-company-its-ceo-and-another

Department of Justice
U.S. Attorney’s Office
Southern District of New York

FOR IMMEDIATE RELEASE
Tuesday, July 23, 2019

Manhattan U.S. Attorney Files Lawsuit Against Spinal Implant Company, Its CEO, And Another Executive For Illegally Paying Millions Of Dollars In Kickbacks To Surgeons In Exchange For Using Its Products

Suit Alleges Approximately Half of Company’s Spinal Product Sales Were for Procedures Performed by Surgeons Who Received Payments from Company

Geoffrey S. Berman, the United States Attorney for the Southern District of New York, William F. Sweeney Jr., Assistant Director-in-Charge of the New York Office of the Federal Bureau of Investigation (“FBI”), and Scott J. Lampert, Special Agent in Charge of the New York Regional Office of the U.S. Department of Health and Human Services, Office of the Inspector General (“HHS-OIG”), announced today that the United States has filed a civil healthcare fraud lawsuit against LIFE SPINE INC. (“LIFE SPINE”), MICHAEL BUTLER, the founder, president, and chief executive officer of LIFE SPINE, and RICHARD GREIBER, the vice president of business development of LIFE SPINE. The Government’s complaint seeks damages and civil penalties under the False Claims Act for paying kickbacks in the form of millions of dollars of consulting fees, royalties, and intellectual property acquisition fees to surgeons to induce them to use LIFE SPINE’s spinal implants, devices, and equipment. The lawsuit alleges that the surgeons who received these payments accounted for approximately half of LIFE SPINE’s total domestic sales of spinal products from 2012 through 2018. As set forth in the complaint, these payments violated the Anti-Kickback Statute and, as a result of this unlawful conduct, LIFE SPINE, BUTLER, and GREIBER caused hospitals and surgeons to submit false claims for payment to Medicare and Medicaid.
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LIFE SPINE is a Delaware corporation with its principal place of business in Huntley, Illinois. LIFE SPINE designs, develops, manufactures, and markets medical devices and equipment primarily used in spinal surgeries performed by orthopedic surgeons and neurosurgeons, including implants and instruments (“Life Spine Products”). BUTLER is the founder, president, and chief executive officer of LIFE SPINE and is its majority shareholder. BUTLER was closely involved in overseeing the operations of LIFE SPINE. From 2012 to 2015, GREIBER was involved in selecting and approving surgeons who served as paid “consultants” for LIFE SPINE.

LIFE SPINE paid surgeons to induce them to use Life Spine Products during their surgeries. LIFE SPINE aggressively recruited surgeons who had the potential to use a high volume of Life Spine Products to enter into agreements to serve as paid consultants and/or to transfer their patents/patent applications to LIFE SPINE in exchange for payments and promised support to bring the surgeons’ new products to market. LIFE SPINE tied these agreements and the associated payments – as well as the company’s continued commitment to devote resources to the surgeons’ product development projects – to the surgeons’ usage of Life Spine Products. LIFE SPINE and BUTLER expected surgeons to commit to using Life Spine Products at a certain level in exchange for the consulting fees, royalties, and intellectual property acquisition fees paid to them.

LIFE SPINE, with the knowledge, involvement, and participation of BUTLER and GREIBER, entered into agreements with dozens of surgeons. These agreements included medical education agreements under which the surgeons were paid to provide training and/or educational services; product development agreements under which the surgeons were paid to purportedly provide input on new products and then would receive royalties on future sales of the product; and intellectual property agreements under which the surgeons were paid large up-front acquisition fees for their patents/patent applications and then would receive royalties on sales of any products developed based on the patents. Life Spine paid surgeons millions of dollars in consulting fees, royalties, and intellectual property acquisitions pursuant to these agreements.

BUTLER informed LIFE SPINE staff that he expected surgeons who were paid for their consulting services to commit to using Life Spine Products. LIFE SPINE’s senior management, including BUTLER, closely tracked surgeons’ usage of Life Spine Products to ensure that the payments to surgeons were generating sufficient sales revenues for the company and that the surgeons were fulfilling their “commitment” to use Life Spine Products. LIFE SPINE went so far as to generate a report that compared surgeon consulting, royalty, and intellectual property payments to surgeon product usage levels, and then calculated an “ROI” (return on investment) for each surgeon based on those figures. If a surgeon’s usage was too low, LIFE SPINE managers, including BUTLER, pressured the surgeon to use more Life Spine Products during his or her surgeries.

The kickback scheme was successful. Surgeons who received payments from LIFE SPINE accounted for approximately half of LIFE SPINE’s total domestic sales of spinal products between 2012 and 2018. Most of these surgeons substantially increased their usage of Life Spine Products after entering into agreements with LIFE SPINE. These surgeons used Life Spine Products during procedures performed on Medicare and Medicaid patients, which resulted in the submission of kickback-tainted false claims to Medicare and Medicaid.

The Government intervened in a private whistleblower lawsuit before Judge Jed S. Rakoff that had previously been filed under seal pursuant to the False Claims Act.
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