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).
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 |
