Synthes and the Responsible Corporate Officer Doctrine

November 23, 2011 – In The News
Med City News

William Maruca commented on the case involving Synthes medical device manufacturer and the use of the corporate officer doctrine by the US Food and Drug Administration.

In the 1975 case United States v Park, the court ruled that individuals who assume positions of authority in businesses that affect public health are held to a strict and rigorous standard of accountability under the Food and Drug and Cosmetics Act.

"It's a growing trend for enforcement agencies to threaten to exclude or imprison executives or officers instead of merely invoking fines or exclusion on the company involved."

"The theory is that crooked companies will simply consider fines and litigation another cost of doing business, so they have to make some examples out of individuals. I'm seeing it all over health care fraud cases, not just device/pharma."

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