As a general rule, criminal liability requires criminal intent. The legal term of art, “Mens Rea,” (Latin for “guilty mind”), stands for the concept that deliberate wrongdoing is a condition precedent to criminality. It is based on the principle that society should not punish people for unintended violations of law. There are, however, exceptions to this rule—so-called strict-liability offenses.
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With strict-liability, the perpetrator’s intent and awareness of wrongdoing are irrelevant. Speeding, for example is a strict-liability offense. It does not matter whether the driver intended to speed or was aware they were speeding. Absent extraordinary circumstances, the driver is guilty of speeding purely by virtue of having exceeded the speed limit. Like speeding, violating the Food Drug and Cosmetic Act (FD&C Act) is a strict-liability offense.
The Responsible Corporate Officer Doctrine (RCOD), colloquially known as the “Park Doctrine,” is a controversial prosecutorial tool that allows for the criminal prosecution of companies and officers, regardless of whether they had unlawful intent or awareness of the violation. In U.S. v. Dotterweich, the Supreme Court explained that FD&C Act prosecutions dispense “with the conventional requirement for criminal conduct—awareness of some wrongdoing. In the interest of the larger good it puts the burden of acting at hazard upon a person otherwise innocent but standing in responsible relation to a public danger.”
In the decades since Dotterweich, federal prosecutors have routinely used the RCOD to successfully prosecute corporations and officers for FD&C Act violations. To obtain a conviction for an FD&C Act violation, prosecutors must prove each of the following beyond a reasonable doubt:
- The corporate officer was in a position of responsibility relevant to the violation;
- The corporate officer was able or authorized to prevent or correct the violation; and
- The corporate officer failed to prevent the violation.
RCOD jurisprudence, or case law, is both interesting and instructive. The written opinions of judges and justices are more than a mere conveyance of a rule’s meaning. They tell a story, putting the rule in meaningful context. Often, the story is far more instructive than the analysis of the rule. The story teaches us how to avoid unwittingly coming into conflict with the rule.
For example, we all understand that delivering adulterated food into interstate commerce is a violation of federal law. But until we understand what befell John Park, who, absent any intentional wrongdoing, was tried, convicted, and now has a criminal legal doctrine named after him, we cannot begin to understand how the law works.
United States v. Dotterweich, 320 U.S. 277 (1943)
The Dotterweich case, decided by the U.S. Supreme Court in 1943, established that corporate officers could be prosecuted for violating the FD&C Act, regardless of any knowledge or awareness of the violation.
Joseph Dotterweich was the president of Buffalo Pharmacal Company, Inc. Buffalo’s business involved purchasing bulk drugs, repackaging them, and selling them under its own label. Unbeknownst to Dotterweich, the company received a batch of adulterated drugs, which it subsequently repackaged and shipped into commerce. Dotterweich had no idea the products—which were guaranteed by the manufacturer—were adulterated. Nonetheless, Dotterweich and Buffalo were criminally charged for violating the FD&C Act.
Determined to prove his innocence, and apparently that of his company, Dotterweich took the case all the way to trial. Despite the supplier guarantee and Dotterweich’s lack of knowledge regarding the adulteration, the jury found him guilty.
Dotterweich appealed his conviction, and the case eventually reached the U.S. Supreme Court. Unfortunately for Dotterweich, the Court upheld his conviction, reasoning that “the only way in which a corporation can act is through the individuals who act on its behalf.”
Perplexingly, the jury found the company not guilty. To find Dotterweich guilty and Buffalo not guilty is illogical, and Dotterweich’s attorneys argued the verdict should be invalidated. The Supreme Court disagreed, holding “Whether the jury’s verdict was the result of carelessness or compromise or a belief that the responsible individual should suffer the penalty…is immaterial. Juries may indulge in precisely such motives or vagaries.” There is an important lesson here: Letting a jury decide your case is very risky. Juries are manifestly unpredictable, and even when a verdict is seemingly unjust, courts will rarely overturn it.
United States v. Park, 421 U.S. 658 (1975)
Three decades later in the early 1970s, Acme Markets, Inc. operated a large national retail food chain with 874 stores, 16 warehouses, and approximately 36,000 employees. As Acme’s CEO, John Park had broad operational oversight responsibility, but little involvement in the day-to-day operational duties. As CEOs often do, Park delegated operational responsibilities, including sanitation, to qualified division heads who, in turn, had their own staffs and departments under them.
Beginning in November 1971, FDA inspectors carried out a 12-day inspection at an Acme warehouse in Baltimore. During the inspection, inspectors discovered evidence of rodent activity in the warehouse. During a follow-up inspection three months later, the inspectors noted improvement, but nonetheless found evidence of continuing rodent activity.
Park first became aware of the violation a month after the fact, at which point he immediately contacted Acme’s vice president for legal affairs, who assured Park the head of the respective division “was investigating the situation immediately and would be taking corrective action and would be preparing a summary of the corrective action to reply to the letter.”
Soon thereafter, Park and Acme were charged with multiple misdemeanor violations of the FD&C Act. Acme, in its capacity as a corporate entity, pleaded guilty. Park, who had no personal involvement or knowledge, pleaded not guilty.
During his trial testimony, Park acknowledged that, as Acme’s CEO, he was ultimately responsible for “any result which occurs in our company.” That testimony was enough to ensure his conviction.
Park, widely regarded as the seminal case on the RCOD (hence the “Park Doctrine”), reaffirmed the holding of Dotterweich from 30 years earlier. Park stands for the proposition that FD&C Act violations are chargeable against anyone and everyone with a share of the responsibility for preventing such violations. In other words, criminal liability for a violation of the FD&C Act attaches “not only to those corporate agents who themselves committed the criminal act, but also to those who by virtue of their managerial positions or other similar relation to the actor could be deemed responsible for its commission.”
For the last 40 years, Park has withstood all challengers, and remains the law of the land. Upon conviction, defendants face the potential for significant fines and even jail time. Fortunately, there are some safeguards in place to prevent overzealous prosecutors from overstepping. For instance, before the U.S. Department of Justice (DOJ) can begin pursuing an investigation into criminal violations of the FD&C Act under the RCOD, the U.S. Attorney’s office must first notify and consult with the Consumer Protection Branch of the Civil Division. This additional layer of scrutiny is intended to foster uniformity in prosecutorial decision-making and is perhaps why criminal prosecutions have been the exception rather than the rule.
Nevertheless, even the possibility of prosecution is cause for alarm for food industry executives. Every executive should at least be cognizant of the potential for criminal liability. This is especially true given the increasingly aggressive approach taken by FDA and DOJ in recent years.
United States v. DeCoster, 828 F.3d 626 (8th Cir. 2016)
Austin “Jack” DeCoster owned Quality Egg, an Iowa company that operated a processing facility, six farms, and 97 barns housing chickens and hens. His son, Peter DeCoster, was Quality Egg’s COO. The DeCosters also owned and operated several egg production companies in Maine.
The DeCosters employed an environmental testing program for Salmonella. In 2006, the number of environmental positives began to gradually increase year over year. In 2009, seeking to reverse the increase in Salmonella positives, the DeCosters retained Dr. Charles Hofacre, a poultry disease specialist, and Dr. Maxcy Nolan, a rodent control expert. The DeCosters purportedly adopted all the consultants’ recommendations. They also provided a second round of Salmonella vaccinations to their chickens.
In August 2010, the company was responsible for an outbreak of Salmonella enteritidis. During the subsequent investigation, FDA identified a litany of sanitation problems at the chicken farms, eventually compelling the company to euthanize its animals, clean and repair its facilities, and disinfect its barns.
Following a criminal investigation, Quality Egg and the DeCosters were charged criminally. Quality Egg was charged with and pleaded guilty to: 1) felony bribery of a USDA inspector, 2) felony violation of the FD&C Act, and 3) misdemeanor violation of the FD&C Act. The DeCosters were not implicated in the felonies but were charged with misdemeanor violations of the FD&C Act under the RCOD. After pleading guilty, Jack and his son were each fined $100,000 and sentenced to three months in prison.
The DeCosters appealed, arguing that, because they did not know the eggs were adulterated, imprisonment was unconstitutional. The Eighth Circuit disagreed, succinctly and eloquently summarizing the law as follows:
The FD&C Act punishes neglect where the law requires care, or inaction where it imposes a duty because according to Congress, the public interest in the purity of its food is so great as to warrant the imposition of the highest standard of care on distributors.
The Supreme Court denied the DeCosters’ petition for review, thus closing any possibility of the RCOD being declared unconstitutional.
Where Do We Go from Here?
Over the last 20 years, food science, microbiology, forensic epidemiology, and information technology have vastly improved our understanding of food safety. As foodborne illness surveillance and traceability continue to improve, the food industry will likely face ever-increasing regulatory scrutiny. With it, there may come a corresponding increase in the number of RCOD prosecutions.
Unfortunately, no amount of effort or diligence can guarantee perfection every time; some things are simply beyond control. When it comes to the RCOD, the best defense is a good offense, as the adage goes. While knowledge and intent may be immaterial in terms of the law, they are very material to the investigators responsible for making charging decisions. In turn, the companies and executives who exercise the highest standard of care are not only less likely to violate the FD&C Act, they are also less likely to be targeted for prosecution.
Stevens, a food industry attorney, is a founding member of Food Industry Counsel, LLC. Reach him at email@example.com. Chappelle is also a food industry lawyer and consultant at the same organization. Reach him at firstname.lastname@example.org.