Complying with the FCPA - An Exploration of Ethical Issues Raised by Recent Cases: Lessons Learned from Recent Enforcement Actions

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1 Complying with the FCPA - An Exploration of Ethical Issues Raised by Recent Cases: Lessons Learned from Recent Enforcement Actions Philip S. Brewster Brewster Law Firm LLC July 29, 2014

2 Schering Charitable Donations Schering-Plough Poland paid approximately $76,000 to a charitable foundation. SEC alleged donation designed to induce its director to influence purchase of Schering products. SEC alleged Schering's internal accounting controls were inadequate to prevent and detect the improper payments. Schering paid $500,000 civil penalty and entered into consent decree. Schering was required to retain independent consultant to review policies and procedures regarding FCPA compliance. Funds given solely to charitable organizations should be carefully examined for risk of indirect kickbacks. 2

3 Syncor Marketing Practices Alleged improper conduct involved marketing and educational activities with physicians. Payments for sponsorships of doctors' attendance at educational seminars, including registration fees, travel, lodging, and meals. However, gifts of computer equipment, software, office furniture and medical supplies were also made. Additionally, payments included sponsorships of social functions and fundraisers and monies to cover the cost of temporary employees. Foreign marketing activities with HCPs that could be characterized as violations of the US Federal Anti-Kickback Statute are high risk. 3

4 Nature s Sunshine Control Person CEO and CFO, in their capacities as control persons, alleged to have violated books and records and internal control rules in connection with Brazilian cash payments. Cash payments were made by Nature Sunshine s Brazilian subsidiary to import unregistered products. Subsequent falsification of Nature Sunshine s books and records to conceal such cash payments occurred. Nature Sunshine paid civil penalty of $600,000 and CEO and CFO individually paid $25,000. Focus on corporate leaders personal responsibility and the proper discharge of their duties as corporate officers. 4

5 Eli Lilly Settlement Investigation of Lilly began in 2003 and was one of the longest running FCPA investigations. In 2012, Lilly resolved FCPA charges relating to government bribes in Russia, Brazil, China, and Poland. SEC alleged Lilly failed to monitor third-party partners. These partners allegedly provided no real services and funneled money to government officials in return for business with Lilly. After Lilly became aware of possible FCPA violations, Lilly did not immediately terminate these partnerships in many cases. Significant penalties, consent decree and monitor. Failure to monitor business partners and immediately stop FCPA violations is punished severely. 5

6 Johnson & Johnson Benefits of Cooperation J&J entered into 3 year deferred prosecution agreement re: FCPA violations with criminal fine of $21 million. Criminal fine represented a 25% discount from the applicable sentencing guideline minimum. Fine was reduced because of J&J s cooperation and J&J had conducted an extensive internal investigation and voluntarily disclosed the conduct in question. No monitor was required. J&J is required to report its remediation and enhanced compliance efforts bi-annually to DOJ. DOJ credited J&J for self-reporting and cooperation. Reporting FCPA violations and cooperating with investigative agencies may result in lesser penalties. 6

7 Phillips Self-Reporting From 1999 to 2007, Phillips subsidiary in Poland allegedly made payments to healthcare officials to influence public procurement. Alleged kickbacks amounted to 3% to 8% of contract amounts. Payments were falsely characterized and accounted for. In 2009, 16 people were arrested for healthcare-related bribery, including Phillips employees. Phillips conducted internal investigation and self-reported findings to SEC and DOJ in $4.5 million fine. SEC noted lenient administrative action was justified by cooperation. Reporting FCPA violations and cooperating with investigative agencies may result in lesser penalties. 7

8 Pfizer/Wyeth Pre/Post Acquisition Issues Pfizer acquired Wyeth in Pfizer completed pre-acquisition FCPA due diligence review of Wyeth and post-closing Pfizer integrated Wyeth into Pfizer's global compliance program. Pfizer discovered Wyeth may have committed FCPA violations in China, Indonesia and Pakistan starting approximately in When identified, Pfizer voluntarily disclosed possible violations to SEC and DOJ. SEC agreed to Wyeth compliance reporting for 2 year period. In fashioning a lesser penalty, SEC noted Pfizer integrated Wyeth s operations into its global compliance program and cooperated. Robust compliance efforts, self-reporting and cooperation may result in lesser penalties. 8

9 Zimmer - Declination In 2007, SEC informed Zimmer of investigation regarding potential FCPA violations. DOJ requested information provided to SEC also be provided to DOJ voluntarily. In 2011, Zimmer received subpoena related to Asia Pacific activities. Zimmer produced documents and reported FCPA compliance concerns arising from Zimmer s internal review. DOJ and SEC issued letters of declination closing the investigations in December 2012 and February Highlights possible benefit of active internal engagement and cooperation. See also: Medtronic (2013), Baxter (2014), Merck (2014) 9

10 Emerging Issues Local Investigations Creating FCPA Liability FCPA Legal Malpractice Moving Beyond Prosecutorial Common Law Trying FCPA Cases and DOJ Missteps Notable On-Going Investigations 10

11 Local Investigations Creating FCPA Liability China alleges GSK engaged in massive scheme to bribe officials, drug associations, medical foundations, hospitals and doctors. Former GSK China head charged and faces possible life sentence. Hong Kong's Independent Commission Against Corruption arrested former head of JPMorgan China in connection with hiring children of government officials to secure business. US DOJ/SEC is investigating similar JPMorgan China allegations. Increased global fraud enforcement, such as in China, will likely increase FCPA investigations. 11

12 Watts Water FCPA Legal Malpractice Watts Water Technologies, Inc. is suing Sidley Austin for allegedly failing to properly draw attention to corruption issues as part of Sidley transactional due diligence. Sidley conducted transactional due diligence on a Chinese-based acquisition for Watts in Lawsuit alleges Sidley failed to inform Watts about potential corruption issues. Watts alleges Sidley unearthed suspicious document(s) with FCPA implications, but did not bring sufficient attention to such documents. Watts paid total penalties of approximately $3.8 million to settle subsequent SEC enforcement action. 12

13 O Shea, Africa Sting, Lindsay Trying FCPA Cases Judge Hughes ordered acquittal of John O'Shea, a former ABB manager, on all FCPA counts. Judge Hughes found government's primary witness 'knew almost nothing and criticized government for not producing witnesses/documents. Africa Sting Case, the mass FCPA indictment of individuals, resulted in no convictions. Prosecutorial misconduct involved. Text messages between FBI agent and government s chief witness in Africa Sting Case were embarrassingly unprofessional. After DOJ dropped the Africa Sting Case, Judge Leon noted it was the end of a long and sad chapter in the annals of white collar prosecutions. See also Smith & Wesson Declination (6/2014) Lindsay verdicts overturned because of prosecutorial misconduct. 13

14 Notable Healthcare FCPA Investigations AstraZeneca Bio-Rad Laboratories Bristol-Myers Squibb Cubist Pharmaceuticals Eli Lilly Fresenius Medical Care GlaxoSmithKline Grifols Mead Johnson Nutrition Novartis Orthofix International Sanofi Sciclone Pharmaceuticals Teva Pharmaceutical Industries Limited Source: FCPA Blog (As of 6/2014) 14