Daniel Meron is Global Co-chair of the Latham & Watkins' Healthcare & Life Sciences Practice Group, as well as Co-chair of the firm’s Healthcare Services & Providers Industry Group. He is in the Litigation Department of the firm's Washington, D.C. office and is also a member of the Supreme Court and Appellate Practice Group.
Mr. Meron has deep regulatory, investigatory and litigation expertise across a broad range of healthcare and life sciences matters, from product approval, exclusivity determinations and promotional regulation by the US Food and Drug Administration (FDA) to coverage and reimbursement regulation by the Centers for Medicare & Medicaid Services (CMS), including fraud and abuse and white collar enforcement investigations and litigation. Mr. Meron focuses his practice on providing sophisticated counseling and advocacy (regulatory, investigative and litigation) to members of the pharmaceutical, biotech and medical device industries. He also represents providers.
Mr. Meron is frequently recognized as one of the leading healthcare lawyers in the country. In the 2012 edition of Chambers USA, he is particularly commended for his litigation and regulatory expertise. Sources applaud him for his “quality, reliable advice in time-sensitive situations." Legal Media Group – a part of Euromoney Institutional Investor PLC – has recognized the breadth of Latham’s Life Sciences Practice in its 2013 industry guide and identified Mr. Meron as one of the “stars” in the area of government investigations and fraud & abuse. Nightingale’s Healthcare News named him as one of the top 10 outstanding healthcare fraud and compliance lawyers.
Mr. Meron joined Latham from the United States Department of Health and Human Services (HHS), where he served as General Counsel from 2006 to 2007. At HHS, he supervised the work of approximately 500 lawyers and was heavily involved in advising the HHS's leadership on sensitive and high priority matters involving all of the key statutes and regulations that HHS enforces, including the Food, Drug and Cosmetic Act and the Medicare and Medicaid statutes, as well as the federal Anti-Kickback Statute. As General Counsel, Mr. Meron worked closely with the Office of Inspector General in coordinating positions on enforcement matters relating to FDA and CMS statutes and regulations. During his time at HHS, Mr. Meron also served as a senior policy advisor to Secretary Mike Leavitt on the Secretary's healthcare transparency initiative.
Prior to his service at HHS, Mr. Meron was the Principal Deputy Assistant Attorney General for the Civil Division of the US Department of Justice, where he supervised approximately 735 lawyers litigating thousands of cases. His duties as Principal Deputy included oversight of the Division's healthcare civil fraud (False Claims Act) and off-label promotion prosecutions, as well as defense of FDA and CMS regulations, policies and reimbursement decisions.
Prior to joining the Department of Justice, Mr. Meron was an appellate and regulatory litigation partner in the Washington, D.C. office of another international law firm.
Mr. Meron has argued approximately 15 cases in the US federal courts of appeals, including two appeals en banc, has argued numerous dispositive motions in the federal district courts and has led or co-led a number of trials, including a US$40 million dollar arbitration that ended in complete victory for his client.
Mr. Meron served as a law clerk to Justice Anthony M. Kennedy of the US Supreme Court and to Judge Laurence H. Silberman of the US Court of Appeals for the D.C. Circuit.
His selected speaking engagements include:
- "Commercial Speech: What Can The Constitution Protect? A Moot Appellate Court," Analysis of Off-Label Promotion of Medical Devices and the Constitution, FDLI/FDA 51st Annual Conference, Washington, D.C. (March 27, 2008)
- "Information and Incentives Relating to the Cost and Quality of Healthcare and Pharmaceuticals: Legal Developments in the Debate Between Market and Regulatory Forces," Address to the Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics, Harvard Law School (March 10, 2008)
- "Legal Developments in the Judicial and Legislative Arenas Affecting Biotechnology Companies," BIO's General Counsels' Committee Dinner Address (November 2007)
- "Major Legal Developments Affecting the Pharmaceutical and Biotechnology Industries: From the Food and Drug Administration Amendments Act of 2007 to the Supreme Court's Preemption Docket and Beyond," Luncheon Address at the FDLI Board of Directors Annual Meeting (October 2007)
- "Overview of the FDA's Regulatory Compliance Agenda," The Third Annual FDA Regulatory and Compliance Symposium: Managing Risks - From Pipeline to Patient (August 22, 2007)
- "Plans, Providers and Transparency: Legal Issues Relating to the HHS Transparency Initiative," American Health Lawyers Annual Meeting, Chicago, IL (June 2007)
- "The Role of Competition Analysis in Regulatory Decisions," AEI-Brookings Joint Center Event (May 15, 2007)
- "The Increasing Interplay of 'Life Sciences' and 'Healthcare' Law," Keynote Address, American Health Lawyers Association Life Sciences Institute, San Francisco, CA (April 26, 2007)
- "Legal Developments Relevant to the FDA's Authority," Address to the 50th Annual FDLI/FDA Annual Conference, Bethesda, MD (April 12, 2007)
- "Better Care, Lower Costs: Value-Driven Health Care," Presentation to the D.C. Bar Section On Administrative Law (March 2007)
- "Balancing Government Regulation Against Access To Drugs," Address To Seton Hall University School Of Law (February 16, 2007)
- "Trends in Enforcement of Off-Label Promotion and Anti-Kickback Prohibitions as Bases for False Claims Act Prosecutions," AdvaMed MedTech Conference (September 21, 2008)
- "New Trends in Medical Device Fraud and Abuse/Off-Label Promotion Enforcement," MDMA Medical Technology Executive Forum (October 15, 2008)
- "How Important Is an Indication? Off Label Promotion and Compendia: The Interplay between Compendia Listings of Unapproved Indications and False Claims Act Liability," FDLI Conference on Better Understanding CMS and its Relationship to FDA, (November 19, 2008)