The Largest FCPA Enforcement Actions Involving Healthcare Related Companies

March 1, 2024

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).

Company Amount               Year

 

1.      Teva Pharmaceutical $519 million

(DOJ – $283 million)

(SEC – $236 million)

2016
2.      Novartis $347 million

(DOJ – $234 million)

(SEC – $113 million)

2020
3.      Fresenius Medical Care $231.7 million

(DOJ – $84.7 million)

(SEC – $147 million)

2019
4.      Avon $135 million

(DOJ – $67.6 million)

(SEC – $67.4 million)

2014

 

5.      Johnson & Johnson $70 million

(DOJ – $21 million)

(SEC – $49 million)

2011
6.      Phillips $62.2 million

(SEC – $62.2 million)

 2023
7.      Pfizer / Wyeth $60 million

(DOJ – $15 million)

(SEC – $45 million)

2012
8.      Stericycle $59 million

(DOJ – $35 million)

(SEC – $24 million)

2022
9.      Bio-Rad Laboratories $55 million

(DOJ – $14.5 million)

(SEC – $40.5 million)

2014
10.      Zimmer Biomet $30.4 million

(DOJ – $17.4 million)

(SEC – $13 million)

2017

 

11.      Eli Lilly $29.4 million

(SEC – $29.4 million)

2012
12.      Sanofi $25.2 million

(SEC – $25.2 million)

2018
13.      Novartis

 

$25 million

(SEC – $25 million)

2016
14.      Biomet $22.8 million

(DOJ – $17.3 million)

(SEC – $5.5 million)

2012
15.      Olympus Latin America $22.8 million

(DOJ – $22.8 million)

2016
16.      Smith & Nephew $22.2 million

(DOJ – $16.8 million)

(SEC – $5.4 million)

2012
17.     Alexion Pharmaceuticals 21.5 million

(SEC – 21.5 million)

2020
18.      GlaxoSmithKline $20 million

(SEC – $20 million)

2016

 

19.      Analogic  / BK Medical

 

$14.9 million

(DOJ – $3.4 million)

(SEC – $11.5 million)

2016
20.      Bristol-Myers $14.7 million

(SEC – $14.7 million)

2015