Jeffrey M. Senger, Esq., FCIArb, joined JAMS after a distinguished career as the acting general counsel of the U.S. Food and Drug Administration (FDA), a life sciences partner at the international law firm of Sidley Austin, and a foundational leader of the U.S. Department of Justice’s Alternative Dispute Resolution program. He serves as a mediator, arbitrator, special master/referee and neutral evaluator.

Mr. Senger is an experienced neutral who has been recognized as a Fellow of the Chartered Institute of Arbitrators, a Distinguished Neutral in arbitration and mediation with the CPR International Institute for Dispute Resolution, an arbitration panelist with the American Arbitration Association and District of Columbia Bar Association, and a mediator for the District of Columbia Superior Court and United States District Court.

At the FDA, he directed the agency’s legal activities, including managing civil and criminal litigation, approving regulations and warning letters, and overseeing a team of 100 lawyers.

As a Sidley partner, Mr. Senger handled significant matters for life sciences, pharmaceutical, medical device, and technology companies worldwide.

At the Justice Department, Mr. Senger served as the leader of the Office of Dispute Resolution (coordinating mediations and arbitrations for all federal agencies), senior counsel in the Office of the Associate Attorney General (assisting with the strategic management of more than 6,500 employees and a collective budget over $3 billion), training director at the National Advocacy Center, and special assistant United States attorney (prosecuting federal felony cases).

Mr. Senger began his career as a law clerk for a United States district judge and is an honors graduate of Harvard College and Harvard Law School.

Mr. Senger has mediated, arbitrated and litigated hundreds of cases involving a wide variety of complex commercial disputes, with significant experience in life sciences, health care and governmental/public agency matters.

Mr. Senger believes mediation can guide the parties in resolving their dispute more effectively and efficiently than unassisted negotiation or litigation. He sees all phases of the process as critical: careful preparation, a thoughtfully run mediation session and diligent follow-up. Through effective communication, patience and perseverance, he works to achieve a fair, appropriate and durable resolution.

Regarding arbitration, Mr. Senger’s philosophy is to deliver a just and fair result through a process that is more efficient and economical than litigation. He believes that the parties deserve a well-managed proceeding, due process, speed and economy. In his role as an arbitrator, he treats each matter with diligence, care and promptness, and understands that the result must be impartial, fair minded and well reasoned under the facts and law.

ADR Experience and Qualifications

• An authority on dispute resolution, Mr. Senger has written an award-winning book, numerous law review articles, and several book chapters on mediation, negotiation and life sciences law. He has spoken on behalf of the United States government on five continents.
• Mr. Senger has led mediation, negotiation and arbitration programs at Harvard Law School, Columbia Law School, Georgetown University Law Center, the U.S. Department of Justice, the federal Interagency Alternative Dispute Resolution Working Group and the Chartered Institute of Arbitrators (international arbitration).

Representative Matters

• Life Sciences
• Mediated nationwide, multimillion-dollar class action involving FDA-regulated warning labeling regarding side effects from an ingredient used in pharmaceuticals, monetary relief, and attorney fees
• Handled mediation of multimillion-dollar claim that one of the world’s largest pharmaceutical development/clinical research organizations (CROs) had mismanaged a multisite clinical trial program for a development-stage drug company
• Handled mediation of multimillion-dollar claim that one of the world’s largest pharmaceutical companies failed to make commercially reasonable efforts under marketing and distribution contract
• Handled $100 million arbitration for fraud, breach of contract and violation of securities laws involving a failed collaboration to develop a cancer therapy
• Handled multimillion-dollar arbitration involving drug manufacturing, supply chain, transportation, storage and alleged failure to follow current Good Manufacturing Practices (cGMP)
• Handled mediation involving dispute between patient organizations and the FDA over allegedly unsafe medical devices implanted in millions of patients
• Handled mediation of a multimillion-dollar dispute over an allegedly defective medical device used with a drug, involving claims of breach of contract, breach of warranty, fraud and negligence
• Litigated multiple product liability cases involving products ranging from drug-delivery devices to birth control pills
• Served as expert witness in dispute involving generic, branded, grandfathered, Drug Efficacy Study Implementation (DESI) and unapproved drugs; handled many other cases involving Hatch-Waxman, 505(b)(1), 505(b)(2), 505(j), Orange Book and related generic drug issues
• Significant experience with medical technology, software, clinical decision support, artificial intelligence and machine learning issues
• Health Care
• Mediated multimillion-dollar dispute between a private hospital network and the Department of Justice/Department of Health and Human Services over Medicare payments for inpatient hospital services
• Litigated multibillion-dollar federal claim alleging improper reporting of base date average manufacturer prices (AMPs) under the Medicare Drug Rebate Program
• Litigated multimillion-dollar cases under the False Claims Act involving allegedly violative and recalled medical devices, alleged improper promotion of cancer drugs and alleged violations of cGMP
• Litigated FDA issues related to multibillion-dollar lawsuit to terminate a merger agreement between two drug companies that alleged Material Adverse Effects, failure to follow the “ordinary course of business,” and failure to comply with FDA data integrity and other requirements
• Governmental & Public Agency
• Represented U.S. government in multibillion-dollar mediation involving allegations of federal mismanagement of land and trust funds for hundreds of thousands of Native Americans for over a century
• Represented U.S. government in mediation of suit alleging multibillion-dollar civil RICO violations by major international corporations
• Business Commercial
• Sole or panel arbitrator in dozens of commercial cases involving breach of contract, Uniform Commercial Code (UCC), tort, fraud, Consumer Protection Act, Deceptive Trade Practices Act, Fair Credit Reporting Act (FCRA), Telephone Consumer Protection Act (TCPA), Truth in Lending Act (TILA), Magnuson-Moss Warranty Act (MMWA), Equal Credit Opportunity Act (ECOA), Fair Debt Collection Practices Act (FDCPA), reasonable and customary fees, and Electronic Funds Transfer Act (EFTA)
• Sole mediator in broad range of commercial cases involving breach of contract, insurance, negligence and employment law
• Agribusiness & Food Law
• Handled multiple disputes involving animal feed and animal drug manufacturing
• Served as expert witness in case alleging violation of provisions involving food generally recognized as safe (GRAS), health claims, food additives and the Nutrition Labeling and Education Act (NLEA)
• International & Cross Border
• Handled international (ICC) arbitration of multimillion-dollar claim of fraud and breach of contract in a gene therapy drug partnership
• Served as expert witness in international arbitration involving insurance coverage and product liability for allegedly defective artificial joint medical device

Honors, Memberships, and Professional Activities

Memberships and Affiliations

• Distinguished Neutrals Panelist for Mediation and Arbitration, CPR International Institute for Conflict Prevention & Resolution, 2018–2024
• Fellow, Chartered Institute of Arbitrators, 2020–2024
• Member, Reserve Panel of Arbitrators, Singapore International Arbitration Center 2023–2024
• Commercial Arbitrator, American Arbitration Association, 2021–2024
• Member, American Law Institute, 2004–2024
• Member, D.C. Circuit Judicial Conference, 2005–2024
• Chair, Editorial Board, Food and Drug Law Journal, 2014–2015
• Financial Industry Regulatory Authority (FINRA) Panel of Arbitrators, 2023–2024
• Federal Mediator, United States District Court, 1998–2006
• Civil and Family Mediator, District of Columbia Superior Court, 1997–2005
• Council Member, Dispute Resolution Section, American Bar Association, 2003–2006
• Executive Committee and Council Member, CPR Institute for Dispute Resolution, 2003–2006, 2015–2019
• Fellow, American Bar Foundation, 2001–2024
• Official Observer, Uniform Mediation Act Drafting Committee, National Conference of Commissioners on Uniform State Laws, 1999–2001

Selected Awards and Honors

• Chambers USA, Top FDA Lawyers, 2021–2023
• FDA Medical Devices Attorney of the Year, LMG Life Sciences, 2017 (ranked as a “Star” and “industry leader” for both pharmaceuticals and medical devices)
• Who’s Who Legal, Life Sciences
• Legal 500
• 2004 Best Book of the Year, CPR Institute (for Federal Dispute Resolution)

Selected International ADR Presentations

• Indian Law Institute in Calcutta, India; Legal Aid Services of West Bengal, India; Istanbul Bar Association in Turkey; Administration of Courts in Jerusalem, Israel; Yarmouk University in Irbid, Jordan; Court of Cassation in Amman, Jordan; Lagos Business School in Nigeria; Federal High Court of Nigeria; Nigerian Law School; Supreme Constitutional Court in Cairo, Egypt; Ministry of Justice in Cairo, Egypt; National Center for Judicial Studies in Abbassiya, Egypt; Cairo Regional Center for International Commercial Arbitration and Mediation in Egypt; Judicial School in Buenos Aires, Argentina; Ministry of Justice in Buenos Aires; Center of Judicial Training/Council of Magistrates of the City of Buenos Aires; the Senate of Argentina; Supreme Court of the Province of Santa Fe, Argentina; Law School of the National University of Rosario, Argentina; Law School of the University of Buenos Aires; Federal Board of Provincial Supreme Courts of Argentina; V International ADR Forum in Bologna, Italy

Selected Publications

• Book: “Federal Dispute Resolution: Using ADR with the United States Government” (Wiley, 2004) (endorsed by former Attorney General Janet Reno as a “splendid reference”; by former Secretary of State and White House Chief of Staff James A. Baker III as a “wise and practical book”; and by former United States Senate Majority Leader George Mitchell as a “valuable guide”
• Book Chapters: “Analyzing Risk,” in The Negotiator’s Fieldbook (Christopher Honeyman and Andrea Schneider, eds., American Bar Association, 2006); “Cracking the Hard-Boiled Student: Translating Research Findings Into Interactive Exercises” (with Christopher Honeyman), in The Conflict Resolution Practitioner (Shinji Morokuma, ed., 2001); “Decisionmaking Under Uncertainty” in The Negotiator’s Desk Reference (DRI Press, 2017); “Big Data and Human Medical Judgment: Regulating Next Generation Clinical Decision Support,” (with Patrick O’Leary) in Big Data, Health Law, and Bioethics (Cambridge University Press, 2018)
• Articles: Dispute Resolution and the Vanishing Trial, 24 Ohio State Journal on Dispute Resolution 225 (2009) (with Lisa Bingham, Tina Nabatchi, and Michael Jackman); Advocacy in Mediation with the Government, 61 Dispute Resolution Journal 50 (2006); Decision Analysis in Negotiation, 87 Marquette Law Review 723 (2004); Tales of the Bazaar: Interest-Based Negotiation Across Cultures, 18 Negotiation Journal 233 (2002); ADR and the Federal Government: Not Such Strange Bedfellows After All, 66 University of Missouri Law Review 709 (2001) (with Daniel Marcus); Turning the Ship of State, 2000 Journal of Dispute Resolution 79 (2000)

Background and Education

• Partner, Sidley Austin, 2010–2023
  • Member, Food, Drug and Medical Device Regulatory and Enforcement Practice Group
• Food and Drug Administration, 2006–2010
  • Acting Chief Counsel and Deputy Chief Counsel
• Office of the Associate Attorney General, U.S. Department of Justice
  • Senior Counsel, 2004–2006
• Office of the Assistant Attorney General, Civil Division, U.S. Department of Justice
  • Counsel, 2004
• Special Assistant United States Attorney for the District of Columbia, 2003
• U.S. Department of Justice
  • Senior Counsel, Office of Dispute Resolution, 1998–2003
  • Assistant Director, Executive Office for the United States Attorney, 1995–1997
  • Senior Trial Attorney, Attorney General’s Honor Program, 1989–1995
• Judicial Law Clerk to the Honorable Earl B. Gilliam, U.S. District Court, Southern District of California, 1989
• J.D., cum laude, Harvard Law School, 1988
• A.B., magna cum laude, Harvard University, 1984