ConAgra to pay $11.2 million in connection with Salmonella outbreak.

• In 2006-2007, Peter Pan peanut butter produced by ConAgra Foods, Inc. was recalled in connection with a nationwide Salmonella Tennessee outbreak.  The outbreak resulted in hundreds of infections and hospitalizations across 44 states.  The contamination ultimately was traced to plant and equipment conditions in a Georgia facility.  In 2011, the federal government launched a criminal investigation into the matter.
• To resolve the investigation, ConAgra has agreed to plead guilty to a single misdemeanor violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).  Under the plea agreement, the company would pay a fine and forfeiture in the amount of $11.2 million.  The plea agreement must be approved by the U.S. District Court in Albany, Georgia.
•  The ConAgra situation serves as a reminder to industry that the FD&C Act is a criminal statute with potentially severe financial and other penalties for violations.  Although many FDA enforcement actions ultimately are resolved before turning into criminal proceedings, plea agreements of this nature show that FDA (working through federal prosecutors) can impose significant consequences for companies when problems in a facility are linked to outbreaks of foodborne illness.

First lawsuit filed in wake of Blue Bell listeriosis outbreak.

• In recent months, Texas-based Blue Bell Creameries has recalled all of its products after the company’s ice cream was linked to listeriosis outbreaks in multiple states, resulting in hospitalizations and deaths.  FDA published an update alerting consumers to the issue and released a series of inspectional observations from Blue Bell production facilities, indicating the company’s awareness of positive tests for Listeria monocytogenes in one plant as far back as 2013.  We speculated that class action lawsuits were likely to follow.
• As anticipated, the first lawsuit has now been filed.  The affected consumer states that he contracted a severe listeriosis infection after consuming Blue Bell products in 2013 and alleges that Blue Bell acted with gross negligence for failure to use adequate sanitation in its plant to prevent product contamination.  The complaint includes specific references to the inspectional observations that FDA recently made public in connection with Blue Bell’s product recall.
• The lawsuit filed in this case is unlikely to be the last that Blue Bell faces in connection with the listeriosis outbreak.  Again, it serves as a reminder to industry that FDA regulatory violations can trigger significant product liability and litigation implications where human health consequences result.