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Teva Pharmaceutical Industries Ltd. (Teva), an Israeli company, stated in its Form 6-K filed with the SEC on November 15, 2016, that it has set aside approximately $520 million for a potential settlement of FCPA matters being investigated by the SEC and DOJ. Teva explained that the reserve relates to conduct that occurred between 2007 and 2013 in Russia, Mexico, and the Ukraine, and that it was discovered in the course of the investigation that began in early 2012 with the issuance of an SEC subpoena to Teva, as well as a concurrent internal investigation of its worldwide business practices.
Should Teva enter into a settlement, it will top the growing list of pharmaceutical companies that have been subject to multimillion dollar penalties for conduct in violation of the FCPA, including the following:
- AstraZeneca ($5.5 million settlement in 2016 of allegations relating to bribery of Chinese and Russian doctors)
- GlaxoSmithKline ($20 million settlement in 2016 of allegations relating to bribery of Chinese health care professionals)
- Novartis ($25 million settlement in 2016 of allegations relating to bribery of Chinese doctors
- Bristol-Myers Squibb & Co. ($14 million settlement in 2015 of allegations relating to bribery of healthcare professionals at state-owned hospitals in China)
- Eli Lily & Co. ($29 million settlement in 2012 of allegations relating to bribery of government employed physicians in Russia, Brazil, China and Poland)
- Johnson & Johnson ($70 million settlement in 2011 of allegations relating to conspiracy and bribery of doctors employed by state-controlled health care systems in Greece)
Anti-corruption enforcement initiative involving medical device manufacturers continues, as Smith & Nephew resolves US FCPA enforcement actions for $22 million.
On February 6, 2012, the U.S. Department of Justice and Securities and Exchange Commission announced resolved FCPA enforcement actions against medical device manufacturer, Smith & Nephew Inc., and its UK-based parent company, Smith & Nephew plc. The combined monetary sanction totals $22.226 million, and the UK parent must retain an independent compliance monitor for a period of 18 months. The conduct in question, as alleged in the SEC Complaint, involved the use of three UK shell companies created by a distributor in Greece for use as conduits to make payments to physicians in Greece working "at publicly-owned hospitals [and who were] government employees, providing healthcare services in their official capacities." The commercial relationship between Smith & Nephew and the distributor ended in 2008. Notable points: Compliance Monitor: The settlement requires Smith & Nephew to retain an "independent compliance monitor" for a period of 18 months, in contrast to the many recent FCPA cases that have been resolved with the retention of a "compliance consultant." Although the DOJ Press Release noted the company's "cooperation with the department's investigation, thorough self-investigation of the underlying conduct, and the remedial efforts and compliance improvements undertaken by the company," the resolution still involves a monitor. Distributor: The vast majority of FCPA matters involve a third party in some manner and in this case, the third party was a distributor. Although a few prior FCPA cases have involved distributors (see e.g., InVision in 2005), most involve a different type of commercial relationship, such as agents or consultants. Many companies classify distributors as a type of customer rather than as an intermediary, and in doing so apply compliance controls that may not be as robust as for agents or consultants. As this case confirms, distributor relationships may present acute corruption risks, and should be assessed and controlled for such risks. International Cooperation / Greece: In April 2011, medical device manufacturer DePuy International, a subsidiary of Johnson & Johnson, pleaded guilty to violating the FCPA for conduct related to sales to state-employed physicians in Greece. In both the DePuy and Smith & Nephew cases, the DOJ "acknowledge[d] and expresse[d] its appreciation for the assistance provided by the authorities of the 8th Ordinary Interrogation Department of the Athens Court of First Instance and the Athens Economic Crime Squad in Greece." This ongoing cooperation is consistent with the long term trend of international collaboration on anti-corruption matters. Industry-Wide Enforcement: As described in the SEC press release, "[t]he charges stem from the SEC's and DOJ's ongoing proactive global investigation of bribery of publicly-employed physicians by medical device companies." Prior enforcement actions have been lodged against device manufacturers AGA Medical Corp. (regarding conduct in China), Immucor Inc. (Italy) and Micrus Corp. (France, Turkey, Spain and Germany), and this action seems certain not to be the last. Smith & Nephew issued its own press release regarding the enforcement actions.
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