Mikayla M.Paolini

Associate

New York + 1.212.326.3422

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Mikayla Paolini's practice focuses on litigation and investigations in the health care and life sciences sectors. She has experience representing pharmaceutical companies in state and federal court cases, including a federal securities class action lawsuit. Recently, Mikayla helped secure a total defense verdict in Kentucky state court, defeating a multibillion dollar fraud claim. She also has experience in investigations before the FTC (Federal Trade Commission), DOJ (Department of Justice), OIG (Office of Inspector General), and state medical boards.

On the regulatory side, her practice involves counseling clients on digital health concerns, such as prescribing constraints, provider licensure, and remote supervision. Mikayla also counsels clients in the life sciences sector regarding compliance with the Federal Food, Drug, and Cosmetic Act.

Mikayla maintains an active pro bono practice. She participates in Jones Day's VetLex initiative, representing veterans appealing disability benefit decisions, and the Her Justice initiative, representing local women in U visa and Violence Against Women Act petitions.

Experience

  • Daiichi Sankyo affiliate defends against declaratory judgment action in collaboration disputeOn behalf of Daiichi Sankyo Europe GmbH ("DSE"), Jones Day successfully defended and resolved a pharmaceutical collaboration dispute filed in federal court in the Southern District of New York.
  • Celgene wins complete defense verdict in case filed by health insurer, Humana Inc., relating to off-label use of cancer medicationsOn March 2, 2023, Jones Day prevailed in a five-week jury trial on behalf of Celgene Corporation in a lawsuit brought by health insurance company Humana, Inc.
  • Hospital obtains favorable advisory opinion from HHS-OIG regarding use of nurse practitionersJones Day successfully advised a hospital in obtaining a favorable advisory opinion (Advisory Opinion 22-20) from the Department of Health and Human Services, Office of Inspector General, in connection with its utilization of its employed nurse practitioners to perform services that traditionally have been performed by attending physicians.
  • Global Medical Response acquires GrandView AviationJones Day advised Global Medical Response in the acquisition of GrandView Aviation, a leading North American organ procurement transport aviation company with 130 employees and a fleet of Phenom 300 aircraft.
  • Digital health companies, specialty hospitals, and health systems maintain compliance with multistate requirements through 50-state surveyJones Day is representing digital health companies, specialty hospitals, and health systems in maintaining compliance with multistate requirements through a regularly updated, extensive 50-state survey on state laws and regulations applicable to telehealth activities of physicians and other health care professionals including licensing, establishing patient relationships, provider-to-provider consulting, supervision and delegation among providers, and prescribing and treatment standards.
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    March 2022 Newsletters

    Vital Signs: Digital Health Law Update | Winter 2022

    April 2021 Newsletters

    Vital Signs: Digital Health Law Update | Spring 2021

    February 2021 Commentary

    DOJ Announces $2.2 Billion in 2020 FCA Recoveries and Identifies 2021 Priorities

    February 2021 Commentary

    Recent Changes to the Anti-Kickback Statute’s Personal Services Safe Harbor

    January 2021 Newsletters

    Vital Signs: Digital Health Law Update | Winter 2021

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