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Danny Tobey

Danny Tobey M.D., J.D.

Partner
Chair, AI & Data Analytics
About

Danny Tobey is a medical doctor and software entrepreneur who represents life sciences, technology and healthcare clients in a variety of regulatory and litigation matters involving FDA, CDC, HHS, CMS, private payers, and tort and commercial litigants. Danny leads Insider's 2022 list of top lawyers helping companies adopt artificial intelligence (AI) and leads the firm's team helping companies navigate the legal landscape of emerging and disruptive technologies including AI and data science. The Library of Congress gave Danny a Burton Award recognizing "the best of the best writers in the legal profession" among the nation's top 1,000 largest law firms.

A graduate of Harvard College, Yale Law School, and UT Southwestern Medical School, Danny has handled successfully some of his clients' most challenging and important matters. He played a key legal role in the Covid vaccine effort, designed the winning scientific case in the first Hatch-Waxman suit in the Eastern District of Texas, and obtained a unanimous reversal in federal appellate court in an R&D tax case of first impression. He has successfully handled as lead counsel litigations arising from biotech M&A transactions and has resolved board and shareholder disputes for life-science companies. Danny has represented healthcare clients in matters ranging from credentialing and internal investigations to peer review and business tort claims.

Danny is a thought leader on legal issues in medicine and AI. He sits on Pfizer's Digital Health Scientific Advisory Board and on the Executive Committee of the UN's AI for Good legal track. Danny is a founding member of the Health AI Partnership with the Mayo Clinic, Duke, and others. In 2022, he moderated the closed-door Ministerial Roundtable in Morocco on Improving Health Outcomes in Africa through Innovative Solutions. Danny advised the American Medical Association on its AI and medical liability policy and was an invited speaker at the inaugural AI, Ethics, and Society conference sponsored by Google and IBM. He guides leading global pharmaceutical, robotics, and device companies on adopting and designing AI systems and has helped create and implement enterprise-wide AI governance policies. His clients include IDx, the first FDA-approved fully autonomous AI diagnostic, with whom he authored the peer-reviewed Lessons Learned About Autonomous AI: Finding a Safe, Efficacious, and Ethical Path Through the Development Process. Danny's writing on legal issues in medicine and biotechnology appears in National Law Journal, American Health Law Association Connections, Proceedings of the Association for the Advancement of Artificial Intelligence, Yale Journal of Law & Technology, and Health Law Litigation. Danny led a successful software company from inception to acquisition. His original medical research appears in Pediatric Blood & Cancer and Journal of Child and Adolescent Psychopharmacology.

Beyond healthcare, Danny has represented private equity, finance and other clients in some of their most pressing cases in state and federal court. He has argued successfully before the en banc Delaware Supreme Court and the Fifth Circuit Court of Appeals among others.

Danny is Chair of the Board of Directors of the AT&T Performing Arts Center, the largest performing arts district in the United States. He chairs the Legal Advisory Counsel of the Perot Museum of Nature and Science and has served on the boards of the Parkland Foundation, the SPCA of Texas, the Texas Israel Alliance, and the regional Anti-Defamation League. He has co-chaired the Judiciary Committee and the Membership & Admissions Committee of the Dallas Bar Association and served on the Governing Council of its Business Litigation Section. Danny previously served on the Executive Committee of the Yale Law School Association.

Bar admissionsTexas

EXPERIENCE

  • Advising numerous machine learning, robotics, and digital health companies on regulatory, liability, and risk mitigation issues
  • Obtained as lead counsel for Fortune 100 company a voluntary complete dismissal with prejudice of all claims against it in federal court on the eve of filing motion to dismiss
  • Successfully argued before Fifth Circuit Court of Appeals, winning affirmance of dismissal of all claims against client in a trade secrets case; opinion issued two weeks after oral argument
  • Successfully represented life-sciences company as lead counsel in eight-figure dispute over acquisition
  • Argued before en banc Delaware Supreme Court, winning affirmance of nearly US$1 million fee award for private equity client against bad-faith litigants; affirmed one day after oral argument by the Chief Justice writing for the full court
  • Argued before Fifth Circuit Court of Appeals, winning unanimous reversal and remand on complex tax issue of first impression involving research and development tax credits; authored winning brief on remand
  • Represented Medicare Administrative Contractor in defense against consolidated complaint before the US Department of Health and Human Services (HHS)
  • Represented client in litigation with the US Food and Drug Administration (FDA) involving clinical trial design
  • Helped obtain complete victory for pharmaceutical client in first Hatch-Waxman case in the Eastern District of Texas; used medical background to prepare scientific non-obviousness case; federal court validated all three patents and enjoined competitors from violating them; result affirmed by the Federal Circuit Court of Appeals
  • Successfully defended major bank against US$19 billion alternative credit manager; handled winning first-chair argument preserving client's counterclaims for US$37.5 million; led drafting of defense motions resulting in dismissal of US$7 million of plaintiff's US$11 million in claims
  • Obtained dismissal on forum-selection grounds for private equity fund in suit involving allegations of fraud and breach of contract
  • Represented multiple hospitals in peer review and credentialing matters
  • Representing molecular diagnostics laboratory in major reimbursement dispute with payor
  • Conducted investigation for hospital system involving allegations of self-referral and anti-kickback violations
  • Successfully resolved as mediator case involving allegations of self-referral and anti-kickback violations
  • Obtained affirmance of complete dismissal of health privacy invasion claims against prominent media outlet in state appellate court
  • Represented healthcare system in major case involving allegations of physician misconduct and reporting obligations; client found to have no liability on appeal
  • Represented Quality Improvement Organization against allegations of medical malpractice invoking federal immunity
  • Represented distressed lender advising on payor disputes of a portfolio hospital system and related proceedings
  • Successfully defended as lead trial counsel a historic religious denomination sued by a breakaway faction in a church property case in Texas state court; obtained a multimillion-dollar (net) settlement payment to defendant-client and dismissal of all plaintiffs' claims
  • Lead trial counsel for the SPCA of Texas defending against a complex probate matter; settled favorably at mediation
  • Second-chaired six-week jury trial in state court defending against US$22 million fraud claim; successfully argued opposition to summary judgment, preserving the client's suit for aiding and abetting breach of fiduciary duty; examined trial witnesses, argued directed verdict and delivered portion of the closing argument
  • Handled summary judgment proceedings for preeminent law-firm client, obtaining dismissal of all claims in a breach of contract suit
  • Obtained denial of petition for review by Texas Supreme Court for prominent New York law firm, leaving in place reversal and rendition of dismissal by Dallas Court of Appeals
  • Led briefing before Fifth Circuit Court of Appeals, winning affirmance in pertinent part of plaintiff investment firm's summary judgment win on claims of fraudulent transfer and piercing the corporate veil (monetary damages)
Education
  • M.D., The University of Texas Southwestern Medical School 2008
    Southwestern Foundation Scholarship for outstanding scholastic achievements; four-year Alumni Scholar

  • J.D., Yale Law School 2003
    Benjamin Scharps Prize for "the best paper by a third-year student"
    Margaret Gruter Prize for the best paper on biological sciences and the law

  • A.B., Harvard University 1999
    magna cum laude with Highest Honors in Social Studies
    1999 Philo Sherman Bennett Award for "the best essay discussing the principles of free government"
    John Harvard Scholarship for "academic achievement of the highest distinction"
    Phi Beta Kappa

Awards

  • The Legal 500 United States
    2020 - Recommended, Healthcare: Life Sciences
    The Legal 500 comments, "Danny Tobey and Lukas Pryzmusinski are physicians in addition to being lawyers which enhances their ability to serve life sciences clients."
    2020 - Recommended, Healthcare: Service Providers
  • Named a Fellow of the Texas Bar Foundation
  • Selected to the Texas Rising Stars list, Super Lawyers (Thomson Reuters), 2012–2016
  • Cardozo Society, "Outstanding Attorney Under 40," 2012–2015

Publications and Media

Seminars

  • Speaker, "Ethics & Technology: The Evolving Practice of Law and Your Ethical Responsibilities," 43rd Annual Ray Garrett Jr. Corporate & Securities Law Institute, October 5, 2023
  • Invited Speaker, "NACD Master Class® on AI's Impact on Strategy and the Board," moderated by Karim Lakhani, Harvard Business School; Chair, D3 Institute at Harvard; Director, Mozilla, August 21, 2023
  • Speaker, "Council of Public Funds Compliance Officers call on Emerging Standards in AI Governance," July 31, 2023
  • Invited Panelist, "AI and the AG," AG Alliance Annual Meeting, moderated by Attorney General Kris Kobach, Kansas, June 20, 2023
  • Presenter, "Private Attorneys General Act (PAGA) Claims, Appeals, and Efforts to Reform the Law," the National Retail Federation, June 7, 2023
  • Presenter, "Tech & Trade Forum in Seoul," the Korea Chamber of Commerce and Industry, May 9, 2023
  • Speaker, "The Intersection of Law and Artificial Intelligence," Eye on AI #121, April 28, 2023
  • Speaker, "Adaptive Law: What Will Regulation Become?" CodeX Futurelaw Conference 2023," The Stanford Center for Legal Informatics, April 13, 2023
  • Speaker, "Legal Framework of AI in the United States, Swissnex New York and Boston," Swiss Embassy in the U.S., March 10, 2023
  • Moderator, AI: Opportunities and Challenges, panel of FICO and others, Structured Finance Association’s SFVegas, February 26 - March 1, 2023
  • Moderator, "Leveraging the Private Sector to Reach Health Security Goals in Africa" on the sidelines of the 2022 U.S.-Africa Leaders Summit, January 09, 2023
  • Moderator, "Fireside Chat on Improving Health Security in Africa through Strategic Partnership," US-Africa Leaders’ Summit, December 13, 2022
  • Moderator, "Ministerial Roundtable on Improving Health Outcomes in Africa through Innovative Solutions," July 2022
  • Moderator, "Advancing Patient Outcomes Through Partnerships," Disease Foundation Forum, March 21, 2022
  • Invited Panelist, "Explainable AI," UTA, 6th Annual Business Analytics Symposium, March 3, 2022
  • Moderator, "Advances in Healthcare Technology – Cure or Cause?" International Institute for Conflict Prevention & Resolution, Annual Meeting 2022, March 3, 2022
  • Panelist, "Machine Learning & AI for Healthcare," HIMSS Conference, December 14-15, 2021
  • Panelist, "Healthy vs Hype: The State of AI in Healthcare," August 30th, 2020
  • Speaker, "Artificial Intelligence and Health Care: The Intersection of Science and Law," WCL, July 8, 2020
  • Panelist: "The People vs. OJ Simpson: Strategy Lessons from the Trial of the Century," February 2020
  • Panelist: "Effective Motion Presentation for the Busy Trial Court: Drafting and Oral Arguments," February 2020
  • Moderator, "Fireside Chat with Dr. Amy Abernethy," Principal Deputy Commissioner of the US Food and Drug Administration, Texas Israel Life Sciences and Healthcare Innovation Conference, October 25, 2019
  • Distinguished Speaker, "Texas Analytics Summit 2019," Sponsored by Dell, McCombs School of Business, University of Texas, "Streamline Your Legal and Privacy Approach to AI" October 17-18, 2019
  • Speaker, "Texas Analytics Summit," October 2019
  • Speaker, "Streamline Your Legal and Privacy Approach to AI," Xavier AI Summit, August 2019
  • Moderator, "Raising Funds for Your Medical Device Company," Biocom's DeviceFest & Digital Health Conference, Moderator, Correlation Ventures, GTCR, August 2019
  • Moderator, "AI is Everywhere: A Sector-by-Sector discussion regarding the Opportunities and Challenges with Artificial Intelligence," Healthcare: Novartis, IBM Watson Health, Athenahealth, IDx, Suffolk Law School, June 2019
  • Faculty, TMXc Accelerator, Texas Medical Center, "Digital Health Regulation," February 25, 2019, with Kristi Kung
  • "Fireside Chat," Duke Institute for Health Innovation, December 3, 2018
  • Presenter, "Mitigating Legal Risks in Digital Health Adoption," with Kristi Kung, November 13, 2018
  • Presenter, "Emerging Medical and Legal Issues in AI," October 7, 2018
  • Presenter, "Email Through the Eyes of Judges and Juries"

Media Mentions

Prior Experience

  • Legal intern to the Chief of Criminal Appeals, United States Attorney’s Office for the Southern District of New York, 2001

Memberships And Affiliations

  • AT&T Performing Arts Center – Chair of the Board (2021–present); Chair-Elect (2019–2021); Board of Directors, 2016–present (Executive Committee, 2018–present)
  • Parkland Foundation - Board of Directors, 2016–present (Executive Committee, 2017–present); Capital Campaign Steering Committee, 2013–2015
  • SPCA of Texas - Board of Directors, 2016–2019
  • Perot Museum of Nature and Science – Board of Directors, 2016–present (Chair, Legal Advisory Committee (2019–present), Executive Committee (2019–present)); Museum Board, 2013–2016; Legal Advisory Committee, 2013–present; Advisory Board, 2012–2013
  • Anti-Defamation League, Texoma region – Board of Directors, 2017–present
  • Dallas Bar Association - Judiciary Committee, 2012–present; Co-Chair, 2016; Admissions and Membership Committee, 2013–present; Co-Chair, 2018; Governing Council, Business Litigation Section 2018–present
  • Texas Israel Alliance (Board of Directors, 2019–present)
  • Harvard Club of Dallas - Harvard Schools Committee, Interviewer, 2003–present
  • Leadership Arts Institute - Business Council for the Arts, Leadership Class of 2011–2012

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