PHARMACEUTICAL AND DEVICE
DA TE
ENTITY
FCA ALLEGATIONS
AMOUNT
Pharmaceutical manufacturer agreed to pay $49 million to resolve FCA allegations related to price fixing for certain generic drugs. The government alleged that Apotex and two other pharmaceutical manufacturers, Taro and Sandoz, paid and received compensation prohibited by the AKS in connection with agreements on price, supply and allocation of customers for certain generic drugs, resulting in higher drug prices for federal healthcare programs and beneficiaries. As part of the resolution, the company entered into a five-year CIA with HHS-OIG. Apotex entered into a deferred prosecution agreement with DOJ’s Antitrust division in 2020 for related criminal charges and paid a $24.1 million criminal penalty. 48 Medical device manufacturer agreed to pay $16 million to resolve FCA allegations that it paid kickbacks to a surgeon in the form of sham royalty payments for the surgeon’s contributions to its SutureBridge and SpeedBridge products when the payments were in fact intended to induce the surgeon’s use and recommendation of the products. As part of the resolution, the company entered a five-year CIA with HHS-OIG. 49 Pharmaceutical manufacturer of an injectable drug indicated for use to reverse opioid overdose agreed to pay $12.7 million to resolve FCA allegations that it paid kickbacks to increase prescriptions for its drug, Evzio, through a scheme whereby kaléo: (1) directed prescribing physicians to certain preferred pharmacies that falsified prior authorization paperwork to obtain the prescription drug; (2) waived co-pays for government beneficiaries; and (3) provided illegal remuneration to prescribing physicians and their office staff to induce and reward prescriptions. 50 Medical device manufacturer agreed to pay $1.2 million to settle FCA allegations that it paid kickbacks to the CEO and medical director of an ENT practice to induce the practice's physicians to use the medical device company’s products and to increase the number of sinus surgeries requiring the company’s products. The CEO/medical director entered into a separate settlement regarding these allegations. 51
Apotex Corp.
10/1/2021
$49 million
Arthrex Inc.
11/8/2021
$16 million
kaléo, Inc.
$12.7 million
11/9/2021
Entellus Medical
$1.2 million
12/8/2021
48 https://www.justice.gov/opa/pr/pharmaceutical-companies-pay-over-400-million-resolve-alleged-false-claims-act-liability. 49 https://www.justice.gov/opa/pr/medical-device-company-arthrex-pay-16-million-resolve-kickback-allegations. 50 https://www.justice.gov/opa/pr/kal-o-inc-agrees-pay-127-million-resolve-allegations-false-claims-anti-overdose-drug. 51 https://www.justice.gov/usao-ndga/pr/dr-jeffrey-m-gallups-and-entellus-medical-agree-pay-42-million-resolve-false-claims-act.
NOTABLE SETTLEMENTS BASS, BERRY & SIMS | 54
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