asfora settlement agreement

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Asfora Settlement Agreement

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  • SETTLEMENT AGREEMENT

    I. PARTIES

    This Settlement Agreement (Agreement) is entered into among the United States of

    America, acting through the United States Department of Justice (the United States) and the

    State of South Dakota (collectively, the Governments); Sanford, d.b.a. Sanford Health;

    Sanford Medical Center, d.b.a. Sanford USD Medical Center; Sanford Clinic (including its

    division, Sanford Clinic Neurosurgery and Spine); Medical Designs, LLC;

    Wilson Asfora, M.D.; Bryan Wellman, M.D. (collectively, the Defendants); and David Dubay

    (Relator) (hereafter collectively referred to as "the Parties"), through their authorized

    representatives.

    II. RECITALS

    A. Sanford is an integrated, not-for-profit health system organized under the laws of

    North Dakota. Sanford USD Medical Center and Sanford Clinic are subsidiaries of Sanford

    organized under the laws of South Dakota. Drs. Wilson Asfora and Bryan Wellman are

    neurosurgeons employed by Sanford Clinic.

    B. Dr. Asfora is the founder and part owner of Medical Designs, LLC, a medical

    device manufacturer based in South Dakota. At all relevant times, Medical Designs

    manufactured and marketed the Asfora Bullet Cage, a medical device used in spinal inter-body

    fusion procedures.

    C. On January 25, 2011, Relator filed a qui tam action in the United States District

    Court for the District of South Dakota captioned United States ex rel. Dubay v. Sanford Health,

    et al., Case No. 11-4104 (D.S.D.), pursuant to the qui tam provisions of the False Claims Act,

    31 U.S.C. 3730(b) (the Civil Action). On April 1, 2013, the United States notified the Court

    that it declined to intervene in the Civil Action.

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    D. The Governments contend that Defendants submitted or caused to be submitted

    claims for payment to the Medicare Program (Medicare), Title XVIII of the Social Security Act,

    42 U.S.C. 1395-1395kkk-1; the Medicaid program, Title XIX of the Social Security Act,

    42 U.S.C. 1396-1396w-5 (Medicaid); and the Veterans Affairs Program,

    38 U.S.C. 1701-1743.

    E. The Governments contend that they have certain civil claims against Defendants,

    as specified in Paragraph III.4 below, arising from the following conduct, referred to below as

    the Covered Conduct:

    From May 2010 to April 2011, Medical Designs made payments identified as consulting fees to Dr. Bryan Wellman and two other Sanford Health employees intended to induce them to promote and/or use the Asfora Bullet Cage, in violation of the Federal Anti-Kickback Statute, 42 U.S.C. 1320a-7b(b).

    F. Relator claims entitlement under 31 U.S.C. 3730(d) to a share of the proceeds of

    this Settlement Agreement and to Relators reasonable expenses, attorneys fees, and costs.

    G. This Agreement is made in compromise of disputed claims. This Agreement is

    not an admission of facts or liability by Defendants, nor a concession by the Governments that

    their claims are not well-founded. Defendants expressly deny the allegations and deny that they

    engaged in any wrongful conduct in connection with the Covered Conduct.

    To avoid the delay, uncertainty, inconvenience, and expense of protracted litigation of the

    above claims, and in consideration of the mutual promises and obligations of this Settlement

    Agreement, the Parties agree and covenant as follows:

    III. TERMS AND CONDITIONS

    1. Defendants shall pay to the Governments Six Hundred and Twenty-Five

    Thousand Dollars ($625,000) (the Settlement Amount) no later than seven (7) calendar days

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    after the Effective Date of this Agreement by electronic funds transfer pursuant to written

    instructions to be provided by the United States Attorney for the District of South Dakota.

    2. Conditioned upon the Governments receiving the Settlement Amount from

    Defendants and as soon as feasible after receipt, the United States shall pay $156,250 to Relator.

    3. Subject to the exceptions in Paragraph III.5 (concerning excluded claims) below,

    and conditioned upon Defendants full payment of the Settlement Amount, the Governments

    release Defendants, together with their current and former members, officers, directors, trustees,

    employees, agents, parent corporations, direct and indirect subsidiaries, brother and sister

    corporations, divisions, and the successors and assigns of any of them from any civil or

    administrative monetary claim the Governments have for the Covered Conduct under the False

    Claims Act, 31 U.S.C. 3729-3733; the Civil Monetary Penalties Law, 42 U.S.C. 1320a-7a;

    the Program Fraud Civil Remedies Act, 31 U.S.C. 3801-3812; or the common law theories of

    payment by mistake, unjust enrichment, and fraud.

    4. Subject to the exceptions in Paragraph III.5 below, and conditioned upon

    Defendants full payment of the Settlement Amount, Relator, for himself and for his heirs,

    successors, attorneys, agents, and assigns, releases Defendants together with their current and

    former members, officers, directors, trustees, employees, agents, parent corporations, direct and

    indirect subsidiaries, brother and sister corporations, divisions, and their heirs, successors, and

    assigns from any civil monetary claim the Relator has on behalf of the United States for the

    Covered Conduct under the False Claims Act, 31 U.S.C. 3729-3733.

    5. Notwithstanding the releases given in paragraphs III.3 and III.4 of this

    Agreement, or any other term of this Agreement, the following claims of the Governments are

    specifically reserved and are not released:

    a. Any liability arising under Title 26, U.S. Code (Internal Revenue Code);

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    b. Any criminal liability;

    c. Any administrative liability, including mandatory or permissive exclusion

    from Federal health care programs;

    d. Any liability to the Governments (or their agencies) for any conduct other

    than the Covered Conduct;

    e. Any liability based upon obligations created by this Agreement;

    f. Any liability for express or implied warranty claims or other claims for

    defective or deficient products or services, including quality of goods and

    services;

    g. Any liability for failure to deliver goods or services due; or

    h. Any liability for personal injury or property damage or for other

    consequential damages arising from the Covered Conduct.

    6. Relator and his heirs, successors, attorneys, agents, and assigns shall not object to

    this Agreement but agree and confirm that this Agreement is fair, adequate, and reasonable under

    all the circumstances, pursuant to 31 U.S.C. 3730(c)(2)(B). Conditioned upon Relators receipt

    of the payment described in Paragraph III.2, Relator and his heirs, successors, attorneys, agents,

    and assigns fully and finally release, waive, and forever discharge the United States, its agencies,

    officers, agents, employees, and servants, from any claims arising from the filing of the Civil

    Action or under 31 U.S.C. 3730, and from any claims to a share of the proceeds of this

    Agreement and/or the Civil Action.

    7. Relator, for himself, and for his heirs, successors, attorneys, agents, and assigns,

    releases Defendants, and their members, officers, directors, trustees, agents, employees, heirs,

    successors, and assigns from any liability to Relator arising from the filing of the Civil Action, or

    under 31 U.S.C. 3730(d) for expenses or attorneys fees and costs.

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    8. Defendants waive and shall not assert any defenses they may have to any criminal

    prosecution or administrative action relating to the Covered Conduct that may be based in whole

    or in part on a contention that, under the Double Jeopardy Clause in the Fifth Amendment of the

    Constitution, or under the Excessive Fines Clause in the Eighth Amendment of the Constitution,

    this Agreement bars a remedy sought in such criminal prosecution or administrative action.

    Nothing in this paragraph or any other provision of this Agreement constitutes an agreement by

    the Governments concerning the characterization of the Settlement Amount for purposes of the

    Internal Revenue laws, Title 26 of the United States Code.

    9. Defendants fully and finally release the Governments, their agencies, officers,

    agents, employees, and servants, from any claims (including attorneys fees, costs, and expenses

    of every kind and however denominated) that Defendants have asserted, could have asserted, or

    may assert in the future against the Governments, their agencies, officers, agents, employees, and

    servants, related to the Covered Conduct and the Governments investigation and prosecution

    thereof.

    10. The Settlement Amount shall not be decreased as a result of the denial of claims

    for payment now being withheld from payment by any Medicare contractor (e.g., Medicare

    Administrative Contractor, fiscal intermediary, carrier) or any state payer, related to the Covered

    Conduct; and Defendants agree not to resubmit to any Medicare contractor or any state payer any

    previously denied claims related to the Covered Conduct, and agree not to appeal any such

    denials of claims.

    11. Defendants agree to the following:

    a. Unallowable Costs Defined: All costs (as defined in the Federal Acquisition

    Regulation, 48 C.F.R. 31.205-47; and in Titles XVIII and XIX of the Social Security Act, 42

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