Thanks very much to the FCPA Professor for finding and posting the criminal complaint and DPA in the Smith & Nephew case. I found one thing extremely interesting.
5. The Office acknowledges that, to date, the Company has taken actions to develop a robust compliance program to protect against violations of federal health care laws. These actions include: the appointment of key personnel with enforcement responsibilities; the development of policies and procedures governing R&D project/program approval and selection and engagement of potential service providers; the requirement of consistent, accurate reporting of services performed on behalf of the Company; and ongoing monitoring and management of payment processes. The Company continues to commit to these compliance measures, as it strives to foster innovation in medical technology and promote exemplary, cost-effective patient care. The Office agrees with these goals and seeks to ensure that the Company and the Orthopedic industry at large comply with applicable law in the course of achieving these goals.
Sounds good, right?
Except this paragraph doesn’t come from the DPA that was signed this week. It comes from the DPA that was signed in 2007.
Now comes the paragraph from this week’s:
3. Relevant Considerations: The Department enters into this Agreement based on the individual facts and circumstances presented by this case and Smith & Nephew. Among the facts considered were the following:
d. Smith & Nephew undertook remedial measures, including the implementation of an enhanced compliance program and agreed to undertake further remedial measures as contemplated by this Agreement.
I cannot believe that the DOJ didn’t know about the previous case. But just from reading these two paragraphs, it seems that the compliance remediation efforts got counted twice. Double credit for the same dollars spent on remediation, it seems like.
What a bargain!