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 Assists Client in $5 Billion Acquisition of Medical Therapy Company

A team of Epstein Becker Green attorneys represented Apax Partners LLP ("Apax"), a private-equity firm, as health care regulatory counsel in an acquisition of Kinetic Concepts Inc. ("KCI"). The purchasers included Apax and two Canadian pension funds. The deal, valued at more than $5 billion, closed on November 4, 2011.

The Epstein Becker Green team was led by Mark E. Lutes of the Washington, DC, office, and included Daniel G. Gottlieb, Benjamin S. Martin, Lesley R. Yeung, J. Andrew Lemons, James A. Boiani, Shawn M. Gilman, Amy F. Lerman, Julie E. Loyd, and Adam C. Solander.

Epstein Becker Green Assists Medical Technology Client in $12 Billion Acquisition

Epstein Becker Green (EBG), serving as health regulatory counsel, successfully assisted its client Becton, Dickinson and Company (BD), a medical technology company, in conducting health regulatory due diligence and negotiating the terms of a purchase agreement to be used in connection with the client’s acquisition of CareFusion Corporation, an international medical products manufacturer. The purchase price was valued at $12.2 billion. This deal will substantially expand BD’s geographic reach and catalog of medical devices, enabling BD to become a world leader in medication management and patient safety solutions. BD announced the signing of the purchase agreement on October 5, 2014, and the transaction is expected to close during the first half of 2015.

EBG attorneys Bradley Merrill Thompson and Kim Tyrrell-Knott led a team that conducted the preliminary due diligence on various health regulatory issues, particularly U.S. Food and Drug Administration (FDA) and privacy and security matters. As CareFusion is operating under a consent decree from FDA, an examination of the FDA regulatory issues and assessment of CareFusion’s FDA quality system were key components of the due diligence and critical to the transaction going forward. The EBG team, working alongside transactional counsel, negotiated health regulatory terms and advised on health regulatory issues associated with the value drivers for the deal and post-closing integration plans.

In addition to Mr. Thompson and Ms. Tyrrell-Knott, the EBG team included James A. Boiani, Ali Lakhani, Benjamin M. Zegarelli, Adam C. Solander, Stuart M. Gerson, and Colleen Hittle of EBG Advisors.

Epstein Becker Green Closes $46.5 Million Sale of Genetics Laboratory Client

On August 7, 2015, Epstein Becker Green attorneys, acting as deal counsel to the principals of Reprogenetics, LLC, successfully closed the sale of Reprogenetics’ equity to CooperSurgical, Inc., for approximately $46.5 million. Reprogenetics, headquartered in Livingston, New Jersey, is the largest genetics laboratory specializing in preimplantation genetic screening (PGS) and preimplantation genetic diagnosis (PGD) used during the in-vitro fertilization (IVF) process. CooperSurgical is one of two business units of The Cooper Companies, Inc., a global medical device company publicly traded on the NYSE Euronext (NYSE:COO). This transaction will enable CooperSurgical to strengthen its IVF business.

The Epstein Becker Green team included Purvi B. Maniar, Stephanie G. Lerman, Arthur J. Fried, Steven A. Ruskin, and Benjamin M. Zegarelli. 

Epstein Becker Green Assists in Launch of Mental Health App

Epstein Becker Green assisted iExhale in the launch of an application to promote mental health and happiness. The app allows users to speak with a board-certified therapist instantly via in-app messaging or by phone. Additionally, users have access to a social network to create a greater support system. iExhale has developed partnerships with after-school programs and youth centers in order to deliver mental health services to teenagers who may have restricted access to such services. The app launched on June 6, 2016.

The Epstein Becker Green team provided strategic advice and counseling regarding regulatory issues affecting the provision of telehealth services, including state licensure, scope of practice, credentialing and privileging, online prescribing, and coverage and reimbursement. Additionally, the team built the terms of use and condition, privacy policy, and consent documents for the app. Epstein Becker Green’s telehealth and security attorneys were supplemented by the business consultancy services of Epstein Becker Green’s affiliate EBG Advisors, Inc.

EBG Advisors will continue to assist iExhale in the app’s security management.

The Epstein Becker Green team included Adam C. Solander, Robert J. Hudock, Kevin J. Ryan, Amy F. Lerman, and Daniel G. Gottlieb.