Toni-AnnCitera (Toni)

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Toni Citera is a solution-driven, client-focused lawyer and global leader with significant legal and compliance experience in the pharmaceutical, biotech, and health care industries. For more than 24 years, she has represented and counseled pharmaceutical companies in high-stakes civil and criminal investigations and litigations, including securing a favorable jury trial verdict in connection with alleged off-label promotion and challenging the Inflation Reduction Act and government enforcement related to the 340B drug pricing program.

Prior to rejoining Jones Day in 2020, Toni served as Senior Vice President, Chief Compliance and Risk Officer for Celgene Corporation, a global pharmaceutical company, where she sat on the Executive Committee of the company and reported directly to the CEO and the board's Audit Committee. Toni was responsible for, among other things, health care and good practice (GxP) compliance for U.S. and international markets, internal investigations, enterprise risk management, training and communication, monitoring, and privacy. She also advised the company on new product launches, including for novel therapies such as CAR-T cancer treatment, and on pertinent legal issues, including a congressional pricing investigation. Toni assisted with Bristol Myers Squibb's acquisition and integration of Celgene in 2019.

Toni has litigated and counseled clients in matters involving the False Claims Act (FCA); Anti-Kickback Statute (AKS); Food, Drug, and Cosmetic Act (FD&C); Racketeer Influenced and Corrupt Organizations Act (RICO); Foreign Corrupt Practices Act (FCPA); and fraud allegations related to issues such as pricing, off-label promotion, kickbacks, bribes, Medicaid rebates, and pharmacy benefit manager (PBM) relationships. Her representations include obtaining favorable settlements and no corporate integrity agreements in investigations and litigation for companies, including Celgene and Abbott Laboratories.

经验

  • 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.
  • BMS challenges Inflation Reduction ActJones Day filed a complaint on behalf of a pharmaceutical manufacturer, Bristol Myers Squibb Company ("BMS"), challenging the constitutionality of the Inflation Reduction Act ("IRA").
  • Sanofi successfully challenges HHS enforcement of Section 340B drug pricing statuteJones Day successfully represented Sanofi in litigation challenging the U.S. Department of Health and Human Services' (HHS) enforcement action under Section 340B of the Public Health Service Act.
  • Drug manufacturer obtains dismissal of Section 340B administrative dispute resolution claimJones Day successfully represented a drug manufacturer in obtaining dismissal of an administrative dispute resolution (“ADR”) claim alleging that the manufacturer had overcharged certain "covered entities" eligible for discounted drug pricing under Section 340B of the Public Health Service Act.
  • Drug manufacturer intervenes in litigation to defend Section 340B drug pricingJones Day represents a drug manufacturer in litigation challenging its discounted drug pricing practices under Section 340B of the Public Health Service Act.
  • Former pharmaceutical CEO testifies before CongressJones Day represented a former pharmaceutical CEO in his testimony before the Committee on Oversight and Reform, in the U.S. House of Representatives, relating to drug pricing.
  • Pharmaceutical company seeks advice on regulatory reporting obligationsJones Day counsels a major pharmaceutical company in connection with regulatory reporting obligations in more than 40 countries regarding diverted, counterfeited, tampered with, or lost or stolen pharmaceutical product.
  • Sanofi defeats class certification in putative nationwide consumer class actionThe United States District Court for the District of New Jersey recently denied a motion for class certification brought by plaintiffs seeking to represent all consumers nationwide who purchased insulin products sold by Jones Day’s client Sanofi-Aventis U.S. LLC.
  • Celgene resolves False Claims Act case related to alleged off-label promotion of Thalomid® and Revlimid®Jones Day represented Celgene Corporation in a False Claims Act lawsuit related to allegations that Celgene promoted the cancer treatment drugs Thalomid® and Revlimid® for off-label uses prior to their FDA approval for such uses, and paid kickbacks to physicians in order to get them to promote and prescribe those drugs.
  • Celgene prevails over Indian supplier in TRO/preliminary injunction hearing to prevent termination of supply agreementCelgene Corporation affiliate Abraxis Bioscience, Inc., represented by Jones Day, does not have to continue to supply pharmaceuticals to Indian distributor Biocon Limited in the face of evidence of continued product diversion, a district court judge ordered.
  • LabCorp obtains dismissal of qui tam action alleging violations of Anti-Kickback Statute and Medicare billing regulationOn behalf of Laboratory Corporation of America (LabCorp), a nationwide provider of health care diagnostic testing services, Jones Day successfully moved to dismiss a qui tam complaint filed in the U.S. District Court for the Southern District of New York under the federal False Claims Act (FCA) and the FCA analogs in 14 states and the District of Columbia.
  • CVS Caremark prevails in Second Circuit appeal of summary judgment dismissing hundreds of Robinson-Patman Act claimsThe Second Circuit affirmed summary judgment dismissing all claims by pharmacies against Jones Day client CVS Caremark Corporation and one other defendant, following the settlement by the other five defendants remaining in the case.
  • Celgene wins in district court case, invalidating patent asserted against its Thalomid® and Revlimid® brand cancer drugsJones Day successfully defended Celgene Corporation in a patent infringement case brought in the United States District Court for the District of Delaware by Andrulis Pharmaceuticals Corporation, which alleged that Celgene's THALOMID® and REVLIMID® brand cancer drugs infringed U.S. Patent No. 6,140,346 ("'346 patent").
  • Pharmaceutical and device manufacturers conduct compliance risk assessmentJones Day conducted a compliance risk assessment of two manufacturers' existing compliance programs.
  • Lehman Holdings defends actions brought by Barclays for alleged failure to pay placement feesJones Day represented Lehman Brothers Holdings Inc. and certain Real Estate Funds, which were all at one time owned by Lehman (collectively, "Lehman") in two actions brought by Barclays alleging that Lehman failed to pay more than $30 million dollars in placement fees to the "Private Investment Management" group, a former division of Lehman that was purchased by Barclays.
  • New York Appleseed releases groundbreaking study on reforms in consumer credit casesNew York Appleseed, a local nonprofit, and pro bono partner Jones Day, have examined trends in consumer debt litigation, which culminated with the release of a groundbreaking report, "Due Process and Consumer Debt: Eliminating Barriers to Justice in Consumer Credit Cases."
  • Abbott and TAP Pharmaceutical defend against Average Wholesale Price (AWP) litigationJones Day clients Abbott Laboratories and TAP Pharmaceutical Products, along with virtually the entire pharmaceutical industry, have been the subject of civil litigation alleging that drug manufacturers falsely reported the "average wholesale price," or "AWP," for various drugs in order to inflate the reimbursement paid by government and private payors for those drugs.
  • Abbott successfully resolves California Attorney General lawsuit alleging Medicaid fraudJones Day represented Abbott Laboratories in an action brought by the State of California and relator Ven-A-Care of the Florida Keys, alleging that Abbott fraudulently submitted false, inflated prices on many different pharmaceutical products and caused California to make inflated Medicaid payments.
  • Abbott and other pharmaceutical manufacturers successfully defend against Texas state court action alleging Medicare fraudJones Day represented Abbott Laboratories in an action brought by the State of Texas and relator Ven-A-Care of the Florida Keys, alleging that Abbott fraudulently submitted false, inflated prices on many different pharmaceutical products and caused Texas to make inflated Medicaid payments.
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    October 2024 Commentary

    DOJ Updates Corporate Compliance Program Guidance With a Focus on AI and Emerging Technologies

    2024年10月 法律评论

    美国司法部更新公司合规计划指南，重点关注人工智能和新兴技术

    May 2024 Commentary

    Canadian Drug Importation May Undermine Intellectual Property Protection

    May 2024 Commentary

    California Supreme Court Will Review Novel Negligence Theory for Pharmaceutical Manufacturers

    October 2023 White Paper

    Considerations for Addressing DOJ's Corporate Compliance Guidance on Mobile Devices and Messaging Platforms

    October 2023 Podcast

    JONES DAY TALKS® - The Evolution of Corporate Compliance Programs: Key Issues for Multinational Companies

    January 2023 Commentary

    DOJ Criminal Division Announces Revisions to its Corporate Enforcement Policy

    November 2022 White Paper

    Conducting an Effective Internal Investigation: An Overview

    March 2022 Newsletters

    Vital Signs: Digital Health Law Update | Winter 2022

    February 2022 Alert

    FDA Proposes National Standards for Wholesale Drug Distributors and Third-Party Logistics Providers
    查看全部观点

    其他出版物

    • June 2020
      DOJ Updates Its "Evaluation of Corporate Compliance Programs" Guidance

    • October 12, 2023
      PhRMA Annual Meeting — Litigation Working Group Fireside Chat
    • March 28, 2012
      Increased Scrutiny on Pharmaceutical and Medical Device R&D Activities: The Impact on Clinical Research Sites
    • March 28, 2012
      Healthcare 2012: Issues & Answers For A Complex Industry
    • June 29, 2011
      Roundtable on Designing and Implementing Compliance Systems in a Whistleblower and Bounty Hunter World, NYU Center for Labor and Employment Law

    Speaking Engagement Prior to Rejoining Jones Day

    May 6, 2019
    Law & Economics Symposium, The future of False Claims Act (FCA) and Anti-Kickback Statute (AKS) cases, MIT Sloan School of Management
    Cambridge, Massachusetts

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