Case Studies

Epstein Becker Green Negotiates Very Favorable Settlement of False Claims Act Case

On February 2, 2010, Epstein Becker Green attorneys successfully executed a very favorable settlement for their client, AtriCure Inc., in a False Claims Act (FCA) case that began with a qui tam relator's charges filed in 2007. AtriCure is a developer and manufacturer of cardiac surgical ablation devices.

This case presented sophisticated claims relating to alleged improper off-label promotion. This is an issue that has become a high priority for Department of Justice enforcement of which both drug and device manufacturers and distributors should be aware.

The settlement, based on an ability-to-pay methodology accepted by the government, requires AtriCure to pay total of $3.8 million, plus interest, periodically over five years; resolves issues of potential FCA and common law violations relating to the marketing practices of AtriCure's surgical ablation devices; and includes AtriCure's declaration that the company and its employees haven't engaged in any wrongdoing or illegal activity. The settlement agreement has been approved and resolves a related qui tam matter, which Epstein Becker Green attorneys have been handling, regarding AtriCure's marketing of the devices. (Epstein Becker Green also represents AtriCure in a related and ongoing private securities class action.) Additionally, AtriCure signed a corporate integrity agreement with the Office of Inspector General of the U.S. Department of Health and Human Services.

The Epstein Becker Green team that represented AtriCure was led by Stuart M. Gerson, a leading litigator and national authority on the FCA.

Epstein Becker Green Successfully Advises on Regulatory Issues for Mental Health Platform

Epstein Becker Green has successfully advised, Inc., a big data/behavioral analytics health care company based in San Francisco, on a number of regulatory issues concerning, among other things, telehealth, corporate practice of medicine, reimbursement, the Food and Drug Administration (FDA), compliance, and fraud and abuse.

Named a “2015 Technology Pioneer” by the World Economic Forum, is an industry leader whose mobile app analyzes passive data and analytics to identify patterns in users’ behavior and mental state that may impact their health and well-being. Providers can use the platform to reach out when patients need support. also provides a virtual care network of mental health providers to enable users to receive virtual care therapy through the mobile app. Our team counseled as the company prepared to launch that virtual care network. has collaborations and partnerships with a number of leading hospitals, academic medical centers, and insurers.

The Epstein Becker Green team included Kevin J. Ryan, Jason E. Christ, John W. Eriksen, Helaine I. Fingold, Paul A. Gomez, Daniel G. Gottlieb, Zachary C. Jackson, Amy F. Lerman, Jennifer L. Nutter, Kim Tyrrell-Knott, and Patricia M. Wagner.