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.
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.
In 2016, the Financial Times North America Innovative Lawyers report recognized Kirsten for her successful legal strategy, which freed her pro bono client after 30 years of wrongful imprisonment.
- JD, magna cum laude, Harvard Law School, 1998; Article Editor, Harvard International Law Journal
- M Phil (Philosophy), Columbia University, 1995
- BA, magna cum laude , with Distinction in Philosophy, University of Pennsylvania, 1991; Phi Beta Kappa
- Supreme Court of the United States
- U.S. District Court for the District of Massachusetts
- U.S. Court of Appeals for the First Circuit
- U.S. Court of Appeals for the Third Circuit
CLERKSHIPS : U.S. District Court for the District of Massachusetts
MEMBERSHIP & AFFILIATIONS :
- American Bar Association, Co-Chair, NE Regional Subcommittee for the White Collar Crime Committee
- Boston Bar Association
- American Health Lawyers Association
PROFESSIONAL & CIVIC ACTIVITIES :
- Faculty, NITA Trial Advocacy Program, New England Regional Session (2007-2015)
- Faculty, NITA Deposition Program, New England Regional (2006-2015)
- Faculty, NITA Trial Advocacy Program, National Session (2011)
- 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.
- Defends major pharmaceutical and medical device companies in False Claims Act litigation involving alleged kickbacks, off-label marketing and manufacturing violations.
- 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.
- Defended academic medical center in threatened state court litigation regarding issues related to research ethics and publication.
- Defended hospital system in False Claims Act driven DOJ investigation involving Stark, anti-kickback and medical necessity issues.
- 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.
- Co-lead counsel for major biotech company in First Circuit appeal involving the legal standard for anti-kickback based FCA claims.
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