Kirsten Mayer represents clients in criminal, civil and regulatory enforcement matters and in related complex civil litigation. Drawing on her extensive experience defending corporations and individuals in a wide range of investigations, Kirsten has helped clients win or favorably resolve matters involving both federal and state enforcement agencies. 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.
- Represents major pharmaceutical and medical device companies in wide-ranging criminal and civil investigations into potential off-label marketing, kickbacks and price reporting violations.
- Represents major medical device company in investigation of potential cGMP and QSR violations.
- 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 a major PBM in False Claims Act litigation, obtaining dismissal of complaint that was upheld on appeal.
- Negotiates CIAs in connection with global resolutions of significant investigations.
- Advises clients operating under a CIA on CIA implementation and self-disclosure obligations.
- Defends 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.
Massachusetts Super Lawyers - Rising Stars (2005 - 2007)
White Collar Defense
- “Minimising Corruption Risks in African Investment Opportunities,” Kirsten Mayer, Alex Rene, Amanda Raad, and Patrick Welsh, Financier Worldwide (July 2014)
- “You’re Not Done Yet – How Judicial Intervention is Reshaping the Corporate Settlement Landscape,” Kirsten Mayer, Maria Carboni, David Derusha, and Rebecca Ellis, 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)
- "FDA Offers Incomplete Guidance on Park Prosecutions," Kirsten Mayer and Aaron M. Katz, BNA Inc. Pharmaceutical Law and Industry Report (March 2011) andBNA 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, “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)
- “Court Affirms Judicial Authority to Limit Discovery in False Claims Suits,” Kirsten V. Mayer, Thomas Sutcliffe and Zachary Golden, 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)
- “Beyond Citigroup: A Look at Corporate Settlements,” Kirsten Mayer, Nicholas Linder and David Derusha, Law360 (July 21, 2014)
- "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)
- 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 Assocation 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)