Seven Ways To Protect Your Company

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Presentation transcript:

Seven Ways To Protect Your Company Robert S. Litt Arnold & Porter LLC

Seven Ways to Protect Your Company Legal as Input Or Why is a Lawyer Like an Insurance Policy?

Seven Ways to Protect Your Company One: Have a Real Compliance Program Show Your Commitment to Law, Don’t Tell It

Seven Ways to Protect Your Company DOJ: “A truly effective compliance program . . . may result in a decision to charge only the corporation’s employees and agents.”

Seven Ways to Protect Your Company OIG: “A good faith effort by the company to comply . . . demonstrated by an effective compliance program, significantly reduces the risk of unlawful conduct and any penalties that result from such behavior.”

Seven Ways to Protect Your Company Training, Supervision and Discipline

Seven Ways to Protect Your Company Two: Separate Science and Sales Safety Counts!

Seven Ways to Protect Your Company Three: Sometimes the Envelope Breaks if You Push Too Hard

Seven Ways to Protect Your Company Four: Investigate and Remediate

Seven Ways to Protect Your Company Five: To Cooperate or Not To Cooperate?

Seven Ways to Protect Your Company Six: Don’t Say Too Much Too Soon

Seven Ways to Protect Your Company Seven: The Cost of Saving Your Company: Throwing Culpable Individuals Overboard Deferred Prosecution/Corporate Integrity Agreement Monitor

Seven Ways to Protect Your Company Resources: DOJ McNulty Memorandum: http://www.usdoj.gov/dag/speeches/2006/mcnulty_memo.pdf DOJ Memo on Monitors: http://www.usdoj.gov/dag/morford-useofmonitorsmemo-03072008.pdf HHS OIG Guidance on Compliance (Pharma): http://oig.hhs.gov/authorities/docs/03/050503FRCPGPharmac.pdf Recent Medical Device Criminal Settlements: can be found at http://www.usdoj.gov/usao/nj/press/2007releases.html, 9/27/07 releases