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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 [1] 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).

As indicated by the below list, the top two enforcement actions involve foreign companies and four of the top ten enforcement actions involve foreign companies.

Company Amount               Year

 

1.      Teva Pharmaceutical $519 million

(DOJ – $283 million)

(SEC – $236 million)

2016
2.      Fresenius Medical Care $231.7 million

(DOJ – $84.7 million)

(SEC – $147 million)

2019
3.      Avon $135 million

(DOJ – $67.6 million)

(SEC – $67.4 million)

2014

 

4.      Johnson & Johnson $70 million

(DOJ – $21 million)

(SEC – $49 million)

2011
5.      Pfizer / Wyeth $60 million

(DOJ – $15 million)

(SEC – $45 million)

2012
6.      Bio-Rad Laboratories $55 million

(DOJ – $14.5 million)

(SEC – $40.5 million)

2014
7.      Zimmer Biomet $30.4 million

(DOJ – $17.4 million)

(SEC – $13 million)

2017

 

8.      Eli Lilly $29.4 million

(SEC – $29.4 million)

2012
9.      Sanofi $25.2 million

(SEC – $25.2 million)

2018
10.  Novartis

 

$25 million

(SEC – $25 million)

2016
11.  Biomet $22.8 million

(DOJ – $17.3 million)

(SEC – $5.5 million)

2012
12.  Olympus Latin America $22.8 million

(DOJ – $22.8 million)

2016
13.  Smith & Nephew $22.2 million

(DOJ – $16.8 million)

(SEC – $5.4 million)

2012
14.  GlaxoSmithKline $20 million

(SEC – $20 million)

2016

 

15.  Analogic  / BK Medical

 

$14.9 million

(DOJ – $3.4 million)

(SEC – $11.5 million)

2016
16.  Bristol-Myers $14.7 million

(SEC – $14.7 million)

2015

 

 

17.  Stryker $13.2 million

(SEC – $13.2 million)

2013
18.  SciClone Pharmaceuticals $12.8 million

(SEC – $12.8 million)

2016
19.  Mead Johnson $12 million

(SEC – $13.2 million)

2015

 

20.  Cardinal Health $8.8 million

(SEC – $13.2 million)

2020

[2]