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 Ginger.io, 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, Ginger.io 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 Ginger.io platform to reach out when patients need support.

Ginger.io 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 Ginger.io as the company prepared to launch that virtual care network.  Ginger.io 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.

Achieving the Dismissal of an Athlete’s Lawsuit Against a Dietary Supplement Company Client

Epstein Becker Green recently achieved a significant victory for a dietary supplement company client, Hi-Tech Pharmaceuticals, Inc. (“Hi-Tech”), in a case brought in federal court in New York by a mixed-martial arts fighter. The plaintiff claimed that Hi-Tech and Gaspari Nutrition, Inc. (“Gaspari”), sold him dietary supplements containing illicit anabolic steroids and thereby caused him to be suspended from the Ultimate Fighting Championship (“UFC”). While under contract with the UFC, the plaintiff allegedly consumed two dietary supplements, one of them being Anavite, which is manufactured by Gaspari and Hi-Tech.

On behalf of Hi-Tech, Epstein Becker Green attorneys Jack Wenik and Robert M. Travisano submitted a motion for summary judgment. In June 2020, the judge granted our motion to dismiss the case, ruling that there was no genuine dispute of material fact and that the defendants were entitled to judgment as a matter of law. Central to the judge’s decision was her finding that reports from a sports testing laboratory purporting to detect 1-androstenedione in two Anavite bottles submitted by the U.S. Anti-Doping Agency were inadmissible hearsay. The judge pointed out that the plaintiff’s initial disclosures didn’t include anyone from the sports testing laboratory to introduce the lab results and lay their foundation and that the plaintiff’s disclosures were never amended or supplemented to correct that omission. Consequently, without anyone to testify as to the lab results, the plaintiff had no evidence that Anavite was adulterated with illegal steroids.