Kirsten Mayer represents health care and life sciences 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 CIA 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 FCA litigation, obtaining dismissal of complaints on statute of limitations and Rule 9(b) grounds.
- Defended a major PBM in FCA litigation, obtaining dismissal of complaint that was upheld on appeal.
- Negotiates CIAs in connection with global resolutions of significant investigations.
- Advises health care and life sciences clients operating under a CIA on CIA implementation and self-disclosure obligations.
- Defends major pharmaceutical companies in FCA and consumer protection litigation related to price reporting.
- Defends major pharmaceutical and medical device companies in FCA litigation involving alleged kickbacks, off-label marketing and manufacturing violations.
Massachusetts Super Lawyers - Rising Stars (2005 - 2007)
- Quoted, "Justices Leave FCA Pleading Dispute To Circuits, For Now," Law360 (March 31, 2014)
- Quoted, "4th Circ. Leaves 'Excessive' FCA Fines Up In The Air," Law360 (January 9, 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, 2014 ed.: Leading Lawyers on Understanding the False Claims Act, Filing Bid Protests, and Working with Government Agencies, Inside the Minds series, Kirsten Mayer, Patrick Welsh, and Jennifer Walker (November 2013)
- Quoted, "High Court Sets Stage For Momentous FCA Ruling," Law360 (October 9, 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. MedQuest Is Important For Health Care FCA Cases," Law360 (May 17, 2013)
- Kirsten Mayer, Doug Hallward-Driemeier, Thomas Sutcliffe, and Kathryn Wilhelm, “US V. Takeda Will Be Useful In Off-Label Promotion Cases,” Law360 (January 25, 2013)
- Kirsten Mayer, Jacob Scott and Katy Wilhelm "FCA's First-To-File Rule — Mass. Weighs In," Law360 (July 16, 2012)
- Kirsten Mayer and Douglas Hallward-Driemeier, "Case Study: Davis v. District Of Columbia," Law360 (June 11, 2012)
- Kirsten Mayer, Amanda Raad, Elena Glas and Arefa Shakeel, "Facing FCPA Charges In Foreign Countries," Law360 (January 2012)
- “Whistleblowing Lessons,” The Dodd-Frank Watch Blog, Boardmember.com (June 16, 2011)
- “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)
- Kirsten Mayer and Aaron M. Katz, "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)
- "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)
- "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)
- "Firms Receiving U.S. Stimulus Funds May Also Receive False Claims Act Scrutiny," The Bureau of National Affairs Banking Report (March 2009)
- "The Medicaid/340B Program "Best Price" Enforcement Landscape, American Conference Institute," Big Four Pharmaceutical Pricing Boot Camp (May 2007)
- "Attorney-Client Privilege Waiver: Charging Corporations Under the McNulty Memorandum," Privacy & Data Security Law Journal (April 2007)
- 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)
- Minimizing FCA Liability Attaching to Any Price Reporting when Making Reasonable Assumptions, American Conference Institute’s Rx Drug Pricing Boot Camp (November 2013)
- 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 (June 2013)
- Anti-Kickback and Other Challenges: Regulatory and Enforcement Update, American Conference Institute’s Rx Drug Pricing Boot Camp (January 2013)
- Mitigating Risk in Best Price Litigation, American Conference Institute’s National Forum on Pharmaceutical Pricing Litigation (October 2012)
- The Age of the Whistleblower: Exploring the Role of Qui Tams in Pricing Actions, American Conference Institute’s 10th Annual In-House Forum on Government Regulation of Prescription Drug Pricing (June 2012)
- Avoiding Anti-Kickback Challenges Related to Pricing and Contracting, American Conference Institute’s Rx Drug Pricing Boot Camp (November 2011)
- Dealing with Fraud and Waste in Healthcare from a Legal Perspective, webcast hosted by The Knowledge Group (October 2011)
- False Claims Act Developments, American Bar Association’s 21st Annual National Institute on Health Care Fraud (May 2011)
- The Park Doctrine, Exclusion and the Focus on Individual Criminal Liability, Boston Bar Association Continuing Legal Education: Issues in the Life Sciences Industry 2011 (April 2011)
- Recent Developments in False Claims Act Litigation: Current Topics in False Claims Act Litigation, Suffolk University Law School Advanced Legal Studies Conference (March 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)
- Surveying Pricing Related Provisions of Settlements and CIAs to Enhance Compliance Efforts, American Conference Institute's 8th Annual Advanced Forum on Government Regulation of Prescription Drug Pricing (March 2010)
- Off-Label Uses of FDA-Approved Drugs, Northwestern Law Judicial Symposium on the Pharmaceutical Industry: Economics, Regulation, and Legal Issues (May 2009)
- Lessons Learned From Recent Settlements, Pharmaceutical Associates' 6th Annual Off-Label Usage Conference (March 2008)
- Enforcement Landscape in Pharmaceutical Government Contracting, American Conference Institute's Big Four Pharmaceutical Pricing Boot Camp (May 2007; May 2008)
- Current Issues in Health Care Fraud Enforcement: Off-Label Enforcement, American Bar Association's Regional White Collar Crime Committee Meeting, Boston (February 2007)