Implications of the Jensen Arrests

This is different than where officials knew they were shipping contaminated product. As seen in the Jensen case, it is more of a point that they should have known and taken preventive actions.

Many were surprised by the recent arrest of the Jensen Farm’s owners for selling Listeria contaminated cantaloupes that caused 33 deaths. Introducing the Park Doctrine. All responsible company officials, whether their company is manufacturing food items OR distributing food items manufactured by someone else, should be aware of the implications.

From the FDA Law Blog – Feb 2, 2011 (reference below):

“… a corporate official can be convicted of a misdemeanor based solely on his position of responsibility and control to prevent the underlying violation of the FDCA. There is no requirement that the official acted personally in the wrongdoing, or that he even had knowledge of it. The Supreme Court determined that the FDCA “imposes not only a positive duty to seek out and remedy violations when they occur but also, and primarily, a duty to implement measures that will insure that violations will not occur.” Park, 421 U.S. at 672.”

This is not limited to the processors, but to those who utilize contract manufacturers. From the FDA Law Blog – May 28, 2013 (reference below):

“The letters cite Park and Dotterweich to support the legal theory that a distributor that uses contract manufacturers or labelers may be liable (or convictable) for Current Good Manufacturing Practice (“CGMP”) violations by its contractors.”

Read more from the FDA on the Park Doctrine.