On March 26, 2012, Biomet entered into a DPA with the DOJ and an agreement with the SEC as part of an investigation by the DOJ and the SEC into possible FCPA violations in the marketing and sale of medical devices in certain countries. In accordance with the data protection authority, the DOJ has agreed to postpone Biomet`s follow-up on these issues, provided that Biomet meets its obligations under the data protection authority over the life of the data protection authority. The data protection authority had a three-year mandate and provided that it could be extended by an additional year at the sole discretion of the DOJ. In the context of a series of active investigations, some of which are employed by the government in their second face, the expansion of Biomet-DPA, the first of its kind in the recent history of FCPA resolutions, shows once again that the life sciences sector remains clearly in the crosshairs of the FCPA`s application. While information on Biomet`s “new” concerns and the resulting extension of the DPA is limited, the enlargement underlines the seriousness with which regulators are tackling not only investigations, but also the supervision of corporate offenders, and stresses that DPA closures are not automatic. For companies within the framework of data control authorities, the best strategy to avoid increased external surveillance is above all the same strategy of avoiding government prosecution: establishing and maintaining hard-earned credibility with supervisory authorities by: WARSAW, Ind., Sept 27, 2007 /PRNewswire-FirstCall via COMTEX News Network/ — Zimmer Holdings, Inc. (NYSE: ZHM; SWX: ZMH) announced today that it has concluded an ongoing federal investigation with the U.S. Attorney`s Office in New Jersey into its financial relationship with the Orthopaedic Surgeon Board. Under the terms of the transaction, Zimmer has reached an agreement on late lawsuits, will pay a us$169.5 million civil transaction and will be subject to the supervision of a federal monitor appointed by the U.S. Department of Justice for 18 months. Zimmer did not admit wrongdoing, pleaded guilty to paying a criminal complaint or paying fines.
In addition, the government has agreed not to lay criminal charges against the company if it complies with the agreement on late prosecutions. As part of federal regulations, the company also enters into a five-year enterprise integrity agreement with the Office of the Inspector General of the Department of Health and Human Services. Zimmer believes that the other four orthopaedic companies active in this case have also entered into resolution agreements. The company expects an effort of $169.5 million in the third quarter. David Dvorak, President and CEO of Zimmer, said: “We believe this resolution is in the best interests of our shareholders and we are pleased that the colony is preserving our ability to work with physicians to improve the quality of life for patients. It is important that resolution agreements clearly define how we and our major competitors interact with physician staff, creating a standard of cross-sectoral behaviour. We believe Zimmer is well positioned to meet management requirements through our business compliance program, which we developed in 2004 and implemented in 2005. U.S.
Attorney General Christopher J. Christie acknowledged that Zimmer`s current program already meets many of the compliance requirements contained in agreements with orthopaedic companies. The solution for the first four companies mentioned above was an agreement on deferred criminal prosecutions (“DPA”), a civil agreement and an agreement on corporate integrity (“CIA”).