PHARMACEUTICAL AND DEVICE
DA TE
ENTITY
FCA ALLEGATIONS
AMOUNT
Pharmaceutical manufacturer agreed to pay $12.6 million to resolve FCA allegations that it channeled money through a foundation to pay co-pays for its myelofibrosis drug to induce Medicare and TRICARE beneficiaries to purchase it, in violation of the AKS. The government also alleged that as the sole donor to the fund, Incyte used its influence to pressure the foundation to pay the co-pays of government beneficiaries taking its drug that did not have myelofibrosis, and thus were not eligible for assistance from the fund. 39 French medical device manufacturer and its U.S. affiliate agreed to pay $1 million to resolve FCA allegations that they violated the AKS by providing entertainment and travel expenses to U.S. doctors in connection with a scoliosis conference in France to induce the physicians to purchase or order its spinal devices. The companies agreed to pay an additional $1 million to resolve allegations that the manufacturer violated CMS’s Open Payments Program by not reporting the entertainment expenses to CMS. 40 St. Jude Medical, Inc. agreed to pay $27 million to resolve FCA allegations that it caused the submission of false claims by knowingly selling defective heart devices to healthcare facilities that, in turn, implanted the devices into patients insured by federal healthcare programs. 41 Medical device distributor agreed to pay more than $22 million under a deferred prosecution agreement (DPA) to resolve a criminal healthcare fraud charge related to misbranding surgical gowns. As part of the DPA, Avanos admitted that between 2014 and 2015, it falsely marketed its MicroCool gowns as meeting the standards for the highest protection level for surgical gowns and thus eligible for use in surgeries and other high-risk procedures involving patients suspected of having infectious diseases. 42
Incyte Corporation
5/4/2021
$12.6 million
Medicrea International; Medicrea USA Inc.
$2 million
5/19/2021
St. Jude Medical, Inc.
7/8/2021
$27 million
Avanos Medical, Inc.
7/8/2021
$22.228 million
Two medical device manufacturers agreed to pay $38.75 million to resolve FCA allegations that they knowingly billed Medicare for defective point-of-care blood coagulation testing devices. 43
Alere Inc.; Alere San Diego Inc.
$38.75 million
7/8/2021
39 https://www.justice.gov/usao-edpa/pr/pharmaceutical-manufacturer-agrees-pay-126-million-resolve-allegations-it-provided. 40 https://www.justice.gov/usao-edpa/pr/french-medical-device-manufacturer-pay-2-million-resolve-alleged-kickbacks-physicians. 41 https://www.justice.gov/usao-md/pr/st-jude-medical-agrees-pay-27-million-allegedly-selling-defective-heart-devices. 42 https://www.justice.gov/opa/pr/avanos-medical-inc-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding-its. 43 https://www.justice.gov/usao-nj/pr/medical-device-companies-pay-3875-million-settle-false-claims-act-allegations.
NOTABLE SETTLEMENTS BASS, BERRY & SIMS | 52
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