Guilty Plea
This recent post checked in on the Foreign Corrupt Practices Act enforcement action against Abraham Cigarroa Cervantes (pictured – a Mexican citizen described as a former finance director of the Latin America division of Stericycle).
In terms of background, in mid-2022, Stericycle (an Illinois based medical waste disposal company) resolved a net $59 million parallel DOJ and SEC Foreign Corrupt Practices Act enforcement action (see here and here for prior posts).
In the words of the DOJ: “From in or about and between at least 2011 and 2016, Stericycle, through certain of its employees and agents, knowingly and willfully conspired and agreed with others to corruptly offer and pay approximately $10.5 million in bribes to, and for the benefit of, foreign officials in Brazil, Mexico, and Argentina in order to obtain and retain business and other advantages for and on behalf of Stericycle. Stericycle earned approximately $21.5 million in profits from the corrupt scheme and through its corruptly obtained and retained government contracts.”
Balt Resolves $1.2 Million FCPA Enforcement Action
Earlier this month, the DOJ filed criminal charges against David Ferrera and Marc Tilman in connection with an alleged bribery scheme involving an alleged “foreign official” at Centre Hospitalier Universitaire de Reims, an alleged French state-owned and state-controlled public university hospital. (See here for the prior post).
Today, the DOJ returned to the same core allegations in announcing a $1.2 million Foreign Corrupt Practices Act enforcement action against Balt SAS (a medical device company headquartered in France). As stated in the DOJ release, Ferrera was an executive at Balt’s U.S. subsidiary and Tillman was hired by Balt’s U.S. subsidiary as a consultant.
Balt joins approximately 35 other companies not to contest the dubious FCPA enforcement theory that employees of certain foreign health care systems are “foreign officials” under the FCPA and thus occupy a status akin to a President or Prime Minister.
Time will tell if Ferrera and/or Tillman contest this enforcement theory as the previous post noted that the matter is believed to be the first DOJ individual FCPA enforcement action based on this theory.
Clinical Trials
Foreign Corrupt Practices Act risk is generally a function of a company – whether directly through employees or indirectly through third parties – having a point of contract with a “foreign official” in the global marketplace.
Points of contact are often industry/sector specific.
For healthcare companies (broadly speaking) points of contact may occur in the context of a clinical trial. Putting aside for the moment the DOJ/SEC’s dubious enforcement theory that employees of many foreign healthcare systems are “foreign officials” under the FCPA, several FCPA enforcement actions have involved, in whole or in part, clinical trials.
Healthcare Professionals As “Foreign Officials”
It is one of the more dubious FCPA enforcement theories there is.
It has never been subjected to judicial scrutiny.
It is a relatively new enforcement theory when one considers that the Foreign Corrupt Practices Act was enacted in 1977.
It is an enforcement theory that has been used 35 times since introduced to the FCPA context in 2002 and thus is one of the more obvious reasons for the general increase in FCPA enforcement in the modern era.
It is the enforcement theory that employees (such as physicians, nurses, mid-wives, lab personnel, etc.) of certain foreign health care systems are “foreign officials” under the FCPA and thus occupy a status akin to a President or Prime Minister.
The Largest FCPA Enforcement Actions Involving Healthcare Related Companies
In large part due to the expansive FCPA enforcement theory that physicians, lab personnel and others associated with most foreign healthcare systems are “foreign officials” under the FCPA (first brought to the FCPA context in 2002 – see here for the prior post), healthcare related companies have resolved numerous FCPA enforcement actions.
This post highlights the twenty largest FCPA enforcement actions (as measured by settlement amount) involving healthcare related companies (broadly speaking pharmaceutical, medical device, life sciences, and diagnostic companies as well as those selling health related products).