Kirsten Mayer advises industry-leading health care and life science companies in criminal, civil and regulatory enforcement matters and in related complex civil litigation, including civil False Claims Act litigation. Drawing on her extensive experience defending corporations and individuals in a wide range of matters, Kirsten has helped clients win or favorably resolve cases involving both federal and state enforcement agencies, and private plaintiffs. Recently, Kirsten has been providing guidance to health care clients in connection with the COVID-19 outbreak and the CARES Act, including advising hospitals and academic medical centers on how to evaluate and develop policies and procedures in the context of evolving state and federal public health guidance.
In addition to defending clients in litigation, Kirsten advises clients with respect to fraud and abuse and compliance in several contexts, including Corporate Integrity Agreement implementation, internal investigations, and strategic transactions in the health care industry.
Kirsten is a frequent speaker on litigation and enforcement in the health care and life sciences industries, and on the False Claims Act. She has been a faculty member for National Institute of Trial Advocacy programs since 2005.
- Represents major pharmaceutical and medical device companies in wide ranging criminal and civil investigations into potential off-label marketing, kickbacks and price reporting violations.
- Represented major medical device company in investigation of potential cGMP and QSR violations; co-lead counsel in negotiating favorable global resolution of matter.
- Defended a major PBM in False Claims Act litigation, obtaining dismissal of complaint.
- Defended major pharmaceutical companies in False Claims Act and consumer protection litigation related to price reporting.
- Defends major pharmaceutical and medical device companies in False Claims Act litigation involving alleged kickbacks, off-label marketing and manufacturing violations.
- Represented major medical device supplier in internal investigation relating to Medicare billing requirements and adequacy of compliance controls.
- Represented major international pharmaceutical company in a DOJ investigation and False Claims Act litigation, successfully obtaining a decision by DOJ not to intervene and the subsequent dismissal of the relator’s complaint.
- Represented major pharmaceutical company in DOJ investigation and represents client in subsequent False Claims Act litigation involving antikickback and off-label marketing theories. Successfully achieved decision by DOJ not to intervene. Won summary judgment on all claims.
- Defends for profit hospital systems in False Claim Act litigation involving novel theories of implied certification and antikickback claims.
- Defended for profit and not-for profit hospitals in False Claims Act litigation, obtaining dismissal of complaints on statute of limitations and Rule 9(b) grounds.
- Defended academic medical center in threatened state court litigation regarding issues related to research ethics and publication.
- Defended federal contractor in civil False Claims Act litigation challenging cost accounting under federal contracts and other issues, including retaliation claim by whistleblower.
- Defends medical device manufacturer in civil False Claims Act litigation alleging procurement fraud and violation of minority business set aside regulation.
- Defended hospital system in False Claims Act driven DOJ investigation involving Stark, anti-kickback and medical necessity issues.
- Defended academic medical center in NIH investigation relating to cost and effort reporting under Federal grants, obtains a decision by NIO to take no action.
- Advised university in dispute with private company involving issues related to human subjects research protections, research integrity, defamation, and the First Amendment.
- Negotiates CIAs in connection with global resolutions of significant investigations.
- Advises clients operating under a CIA on CIA implementation and self-disclosure obligations.
Supreme Court & Appellate
- King vs Burwell (U.S. Supreme Court) - lead counsel for Lambda Legal in amicus brief supporting the United States on the issue of whether the ACA grants Federal tax subsidies to individuals purchasing insurance through federally facilitated exchanges.
- Commonwealth vs Brewer (Mass. SJC) - lead counsel for Massachusetts Association of Criminal Defense Lawyers in amicus brief addressing the authority of the courts in the Commonwealth to grant defense witness immunity at trial over the objection of the prosecution.
- Commonwealth vs Walters (Mass. SJC) - lead counsel for American Civil Liberties Union of Massachusetts in amicus brief addressing scope of First Amendment in criminal prosecution for threat made on Facebook.
- Commonwealth vs Celester (Mass. SJC) - lead counsel for Massachusetts Association of Criminal Defense Lawyers in amicus brief, obtaining precedential SJC decision on criminal defendants’ right to counsel in pre-arraignment custodial interrogations.
- U. S. ex rel Booker v Pfizer (1st Circuit) – lead counsel; won affirmance of grant of summary judgment on relator’s off-label and anti-kickback based FCA claims and on relator’s retaliation claim.
- Co-lead counsel for major biotech company in First Circuit appeal involving the legal standard for anti-kickback based FCA claims.
- Co-lead counsel for leading PBM in Third Circuit appeal involving the legal standard for implied certification based FCA claims.
Post-Conviction Criminal Defense
- Lead counsel for defendant in winning motion for new trial based on recently developed evidence that testimony in 1992 trial exceeds the limits of science.
Drug Pricing and Price Reporting
- Co-author, “The Trump Administration's Latest Drug Pricing Initiatives,” Law360 (January 14, 2019)
- Co-author, “A Look Inside Trump's 4-Point Plan For Curbing Drug Prices,” Law360 (May 17, 2018)
- Author, “10th Circ. Correctly Affirmed Tough FCA Materiality Standard,” Law360 (March 17, 2020)
- Quoted, “FCA's Epic Run In 2010s Will Be Hard To Match In 2020s,” Law360 (January 24, 2020)
- Co-author, “When DOJ Seeks Dismissals Of Life Sciences FCA Cases,” Law360 (December 12, 2019)
- Co-author, “The 7th Circ. Stance In Uhlig V. Fluor,” Law360 (December 15, 2016)
- Co-author, “There May Be a New Standard for FCA Liability Soon,” Law360 (April 19, 2016)
- Co-author, “Big False Claims Act year in 9th Circuit,” The San Francisco Daily Journal (August 10, 2015)
- Co-author, “9th Circuit had another big False Claims Act year,” The San Francisco Daily Journal (January 15, 2015)
- Co-author, “Justices Address Boundaries of 2 FCA Defenses in KBR Case,” Law360 (January 13, 2015)
- Co-author, “False Claims Act Enforcement of Customs Duties – Emerging Trends,” Bloomberg BNA International Trade Reporter, (October, 2014)
- “The False Claims Act: Practical Tips for Responding to a FCA-Driven Investigation and the Impact of Recent Developments in the Law,” Litigation Strategies for Government Contracts: Leading Lawyers on Understanding the False Claims Act, Filing Bid Protests, and Working with Government Agencies, Inside the Minds series, Kirsten Mayer (November 2013)
- Kirsten V. Mayer, Thomas Sutcliffe and Zachary Golden, “Court Affirms Judicial Authority to Limit Discovery in False Claims Suits,” Counsel’s Advisory (August 23, 2013)
- “US v. Takeda Will Be Useful In Off-Label Promotion Cases,” Kirsten Mayer, Doug Hallward-Driemeier, Thomas Sutcliffe, and Kathryn Wilhelm, Law360 (January 25, 2013)
- "FCA's First-To-File Rule — Mass. Weighs In," Kirsten Mayer, Jacob Scott and Katy Wilhelm, Law360 (July 16, 2012)
- "Case Study: Davis v. District Of Columbia," Kirsten Mayer and Douglas Hallward-Driemeier, Law360 (June 11, 2012)
- “Actual Loss After SAIC: A Return to Basics,” American Bar Association’s 21st Annual National Institute on Health Care Fraud, Kirsten V. Mayer, Lara A. Oravec, and Kevin P. Daly (May 2011)
- "State False Claims Laws and Compliance with the DRA: What is Required After FERA and PPACA?" American Bar Association's Eighth Annual National Institute on the Civil False Claims Act and Qui Tam Enforcement, Kirsten V. Mayer, John J. Reynolds III, Joshua Cippel (May 2010)
- Co-author, “U.S. Anti-corruption Enforcement Priorities: Three Key Risk Areas for 2015,” Corporate Disputes (April 2015)
- Co-author, “Minimizing Corruption Risks in African Investment Opportunities,” Financier Worldwide (July 2014)
White Collar Defense
- “Beyond Citigroup: A Look at Corporate Settlements,” Kirsten Mayer, Nicholas Linder and David Derusha, Law360 (July 21, 2014)
- Co-author, “You’re Not Done Yet – How Judicial Intervention is Reshaping the Corporate Settlement Landscape,” American Bar Association’s 28th Annual National Institute on White Collar Crime (March 2014)
- “Whistleblowing Lessons,” The Dodd-Frank Watch Blog, Boardmember.com (June 16, 2011)
- Co-author, “FDA Offers Incomplete Guidance on Park Prosecutions,” BNA Inc. Pharmaceutical Law and Industry Report (March 2011) and BNA Inc. Medical Devices Law & Industry Report (March 2011)
- “Attorney-Client Privilege Waiver: Charging Corporations Under the McNulty Memorandum,” Privacy & Data Security Law Journal (April 2007) False Claims Act
- Co-author, “What OIG Self-Disclosure Guidance Means For HHS Grantees,” Law360 (August 8, 2019)
- “Facing FCPA Charges In Foreign Countries," Kirsten Mayer, Amanda Raad, Elena Glas and Arefa Shakeel, Law360 (January 2012)
- “What Every Private Equity Professional Should Know About the Expanded Scope of Global Anticorruption Enforcement,” Journal of Private Equity, Vol. 13, No.4, Joan McPhee, Kirsten Mayer, Amanda Raad (Fall 2010)
Quoted in the news
- Quoted, “How Supreme Court Conservatives Have Shaped The FCA,” Law360 (May 17, 2019)
- Quoted, “Attys React To High Court FCA Statute Of Limitations Ruling,” Law360 (May 13, 2019)
- Quoted, “Justice’s False Claims Guide Meant to Spur Cooperation,” Bloomberg Law (May 9, 2019)
- Quoted, “Pointed Questions Suggest Longer FCA Time Limit Is Likely,” Law360 (March 20, 2019)
- Quoted, “Expect legislative baby steps, not big leaps on drug prices,” Medical Marketing & Media (March 4, 2019)
- Quoted, “Charges are dropped against Springfield man who spent decades in prison on rape conviction,” The Boston Globe (October 19, 2017)
- Quoted, “Mass. Voter Registration Cutoff Unconstitutional, Judge Says,” Law360 (July 24, 2017)
- Quoted, “Whistle-blowing Kasowitz Firm Seeks Billions From Chemical Giants (Corrected),” Bloomberg BNA’s Toxics Law Reporter (June 29, 2017)
- Quoted, “Grant of judicial immunity to witnesses may be a first,” Massachusetts Lawyers Weekly (January 6, 2017)
- Quoted, “U.S. Supreme Court endorses theory that could expand False Claims Act liability,” Modern Healthcare (June 16, 2016)
- Quoted, “Federal Fraud Penalties Might Soon Double for Providers,” Modern Healthcare (May 10, 2016)
- Quoted, “Whistle-blower in $320 million SCAN case not entitled to cash,” Modern Healthcare (August 31, 2015)
- Quoted, “Justices Hand Partial Victory to Contractors For U.S. Government; U.S. Supreme Court,” The New York Law Journal (May 28, 2015)
- Quoted, “Justices Give Companies Partial Win in Whistleblower Suits,” The National Law Journal (May 27, 2015)
- Quoted, “5 FCA Takeaways from High Court’s KBR Ruling,” Law360 (May 26, 2015)
- Quoted, “Supreme Court hears case with potential to spur more fraud suits,” Modern Healthcare (January 13, 2015)
- Quoted, “High Court KBR Fight Could Lead to Endless FCA Litigation,” Law360 (January 12, 2015)
- Quoted, “Were Patients Really Sicker?,” Modern Healthcare (November 22, 2014 (online); November 24, 2014 (print))
- Quoted, “Supreme Court Obamacare Case: Ruling Against Subsidies Could Be Matter Of 'Life Or Death',” International Business Times (March 6, 2015)
- Quoted, “Attys Predict Supreme Court Will Uphold ACA's Tax Credits,” Law360 (March 2015)
- Speaker, “What’s Happening (And Likely to Happen) With Prescription Drug Pricing?,” (December 11, 2019)
- Presenter, “Self-Disclosure for Grant Recipients: New OIG Guidance” Strafford Teleconference (November 7, 2019)
- Speaker, ACI – Advanced Forum on False Claims and Qui Tam Enforcement (January 2019)
- Speaker, BBA Life Sciences Conference on Government Enforcement (September 2018)
- Speaker, DRI Life, Health, Disability and ERISA Seminar on “A Practical Guide for Health Insurers in Defending False Claims Act Cases after Escobar” Panel (April 2018)
- Speaker, ABA White Collar Crime Conference on Significant Legal Developments in the Regions held in San Diego (February 2018)
- “Economic Crime,” American Bar Association Event (September 2015)
- Health Care Fraud 2015: New Approaches and New Developments, Boston Bar Association (May 2015)
- cGMPs: Drugs and Biologics (current Good Manufacturing Practices), ACI FDA Boot Camp (2014-2015)
- Criminal Law 2014, Corporate LiveWire Virtual Roundtable (July 2014)
- Recent Developments on Liability, ABA’s 10th National Institute on the Civil False Claims Act and Qui Tam Enforcement (June 2014)
- Emerging Issues – Liability Under the Park Doctrine – Duties and Pitfalls, Food and Drug Law Institute’s Annual Conference (April 2014)
- Compliance Programs and Corporate Monitors—If the Compliance Program fails, a Corporate Monitor May be Necessary, Boston Bar Association Brown Bag Lunch Program (March 2014)
- Shedding Light on Individual Liability, American Conference Institute’s 14th Annual Pharmaceutical Compliance and Enforcement Congress (March 2014)
- Significant Legal Developments in the Regions – Northeast Panel, 28th National American Bar Association National Institute on White Collar Crime (March 2014)
- Minimizing FCA Liability Attaching to Price Reporting, American Conference Institute’s Rx Drug Pricing Boot Camp (2013-2014)
- Emerging Trends in Health Care Fraud Litigation, Suffolk University Law School Advanced Legal Studies Conference (November 2013)
- Avoiding Anti-Kickback Challenges Related to Pricing and Contracting, American Conference Institute’s Rx Drug Pricing Boot Camp (2011-2013)
- False Claims Act Developments, American Bar Association’s 21st Annual National Institute on Health Care Fraud (May 2011)
- Current Controversies in Food and Drug Law: Recent Developments in the Enforcement of Off-label Promotion, Harvard Law School (January 2011)
- State Qui Tam Enforcement, American Bar Association's Eighth Annual National Institute on the Civil False Claims Act and Qui Tam Enforcement (May 2010)
- Strict Liability Crimes for Managers: Targeting of Responsible Corporate Officers and Strategies to Minimize Exposure, Washington Legal Foundation Web Seminar Series (April 2010)
- Off-Label Uses of FDA-Approved Drugs, Northwestern Law Judicial Symposium on the Pharmaceutical Industry: Economics, Regulation, and Legal Issues (May 2009)
- JD, magna cum laude, Harvard Law School, 1998; Article Editor, Harvard International Law Journal
- M Phil (Philosophy), Columbia University, 1995
- MA (Philosophy), Columbia University, 1994
- BA, magna cum laude , with Distinction in Philosophy, University of Pennsylvania, 1991; Phi Beta Kappa