DENVERFederal prosecutors who have charged two brothers with misdemeanor crimes for their alleged roles in a deadly outbreak of foodborne illness wield a powerful weapon that dates back 38 years.

It is known as the "Park Doctrine", referencing a 1975 Supreme Court decision that examined the prosecution of a chief executive officer who was accused of violating the Federal, Food Drug & Cosmetic (FD&C) Act by failing to keep a Baltimore, Md., facility sanitary (free of rats).

In the prosecution against Colorado cantaloupe farmers Eric and Ryan Jensen whose business was linked to 33 deaths and 147 illnesses, the U.S. Attorney's Office need not prove that the men intended to violate the law, legal experts said. Instead, prosecutors must show the food was "adulterated", placed into interstate commerce, and the defendant "knew or should have known and was in a position to prevent the violation from happening," said Frederick Ball, vice-chair of the white-collar criminal defense division of Duane Morris LLP.

In such a case, prosecutors don't even have to prove the defendants were aware that they were violating the law, sources said. Establishing "negligence" is not even required, according to an FDA procedures manual on the Park Doctrine. 

"It's a strict liability offense," said Ronald Friedman, a former federal prosecutor in Seattle and current co-chair of the white collar criminal defense, regulatory compliance and special investigations practice group of Lane Powell PC.  

Consequently, a defendant has few defenses in such a case, he said.

"My strong suspicion is that those that produce and sell food are now paying attention," Bill Marler, a food-safety lawyer representing victims of the Jensen Farms outbreak in civil lawsuits, wrote last week in a blog, commenting on the seldom used Park Doctrine.

The Jensen Farms misdemeanor cases are distinguishable from the pending felony cases against Peanut Corp. of America executives for an outbreak of Salmonella in which prosecutors must establish intent, lawyers said.

In documents filed last month with the U.S. District Court, prosecutors characterized the Jensens as the "primary principals" of the farming operation in Granada, Colo. The family-owned business was first incorporated in 1979, according to records from the Colorado Secretary of State.

If convicted of all the misdemeanor counts, the Jensens could face up to six years in prison and $1.5 million in fines. A misdemeanor conviction also could lead to the brothers being barred from working in the industry.

Jensen Farms filed for bankruptcy in 2012 and didn't intend to plant any crops this year, James Markus, a bankruptcy lawyer representing the business, told Food Product Design in June.  

On Sept. 26, Denver-based attorneys for the brothers entered pleas of not guilty, and U.S. Magistrate Judge Michael Hegarty set a tentative trial date of Dec. 2. The brothers were both released from custody on a $100,000 unsecured bond, and Hegarty recently granted 33-year-old Ryan Jensen permission to travel between Colorado and Kansas as part of his current employment.

"The charges against Eric and Ryan Jensen do not imply that they knew, or even should have known, that the cantaloupes had been contaminated," according to a press release from Ryan's Denver-based attorney, Richard Banta. "The Jensens acknowledge that producers and processors of food must be strictly liable for the safety of our food supply. As they were from the first day of this tragedy, the Jensens remain shocked, saddened, and in prayerful remembrance of the victims and their families."

Prosecutors announced the charges about two years after victims began falling ill from cantaloupes that state and federal officials traced back to Jensen Farms. The fruit was found to be contaminated with Listeria moncytogenes, which causes the human illness listeriosis.

The outbreak caused 147 illnesses in 28 states and claimed the lives of 33 people, including former podiatrist Mike Hauser. The elderly and individuals with compromised immune systems were particularly vulnerable.

In an Oct. 19, 2011 report, FDA cited a number of potential causes for the spate of foodborne illnesses. According to prosecutors, Jensen Farms could have mitigated the risk of contamination had they washed the fruit with chlorine. A guidance document from FDA had recommended using such an anti-microbial solution.

The Jensens "had the power and authority to maintain the packing equipment at Jensen Farms in such a way that the cantaloupes produced, packed and shipped from Jensen Farms would be washed with sufficient anti-bacterial solutions so that the fruit was not adulterated in the process," prosecutors allege in court documents.

Lawyers for the brothers did not respond to requests for comment on whether they are in negotiations with prosecutors to enter into plea agreements.

Ball said this is the first case being prosecuted under the Park Doctrine that he can recall in some time.

"FDA has said they were planning on doing it more," he added. "I think they are doing it because Congress has put a lot of pressure on them to bring criminal charges [against] companies subject to the Food, Drug and Cosmetic Act."

An FDA manual specifies several factors officials should consider in deciding whether to recommend a criminal prosecution under the Park Doctrine. Some of those factors include the potential or actual harm to the public, whether the official could have prevented or corrected the violation of federal law, whether the infraction was widespread and whether it was obvious.

The manual makes clear that high-level officials with FDA and U.S. Department of Justice should vet recommendations for such a prosecution.

At least one attorney has argued the factors cited by FDA are not particularly helpful.  

"These criteria are the same as those considered in any decision of whether to proceed criminally, misdemeanor or felony," Anne Walsh of Hyman, Phelps & McNamara, P.C. wrote in a 2011 blog after the FDA released the criteria . "They are hardly unique to this incredibly stringent strict liability standard against responsible corporate officials."