Medical (incl. medical device & pharma) - Written by on Sunday, May 22, 2011 23:11 - 0 Comments

SFO fire a warning shot across the bows of the Medical Device Industry

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The medical device industry has been subject to a sector wide SEC and DOJ investigation for years.  The investigation is being undertaken by the DOJ’s specialist health care fraud group.

A raft of companies are known to have received requests or subpoena’s for information in recent months (gleaned from disclosures in their public filings) and Johnson & Johnson recently settled its own investigation with the DOJ, SEC and the UK SFO paying out US$70m in the US and just under £5m in the UK through its affiliate De Puy International.

The Johnson & Johnson Deferred Prosecution Agreement with the US Department of Justice is notable in the received discount by J&J because (among other mitigating factors):

“J&J has cooperated and agreed to continue to cooperate with theDepartment in the Department’s investigations of other companies and individuals in connection with business practices overseas in various markets”.

It was also notable from a UK perspective in singling out no fewer than 7 British nationals as relevant individuals in the corruption investigation which lead to the J&J settlement.

Against this backdrop we were interested to hear Richard Alderman’s comments at the 2011 International Medical Device Industry Compliance Conference:

“The last topic I would mention is how we work with authorities in other jurisdictions. Of particular interest here is our relationship with the DOJ. It is a very close relationship. We work with them on cases and we share information. We discuss risks and priorities. You will all know that the healthcare sector is a high priority for the DOJ. It is important that we, in the SFO, do all we can to help our DOJ colleagues. Please, therefore, do not under-estimate the level of contact that takes place between the SFO and the DOJ.” [our emphasis]

A sobering reminder.


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