FDA Erroneous Warning Costs Tomato Growers $15 Millions – Court Rules: FDA is Not Liable
On December 2, the 4th U.S. Circuit Court of Appeals ruled that the FDA could not be held financially liable for issuing the false warning. It is clear now that the FDA warning did not help customers who stopped buying perfectly healthy tomatoes, and continued to buy the contaminated hot peppers. This decision was devastating to the tomato growers. The demand for tomatoes plummeted by 40% due to the warnings, and prices fell by 50%. The tomato industry lost millions of dollars.
As part of the ruling judge Wilkinson described the detailed history of the case: “On May 22, 2008, the New Mexico Department of Health notified the Centers for Disease Control and Prevention that a number of local residents had been infected with Salmonella Saintpaul. Similar reports soon arrived at CDC from Texas.“ After interviewing patients, the CDC discovered a “strong statistical association” between the infections and eating raw tomatoes. This observation was supported by a “historical association” between salmonella and tomatoes. The CDC subsequently notified the FDA that tomatoes were the “leading hypothesis” for the source of the outbreak. On June 7 2008, FDA issued an updated contamination warning titled, “FDA Warns Consumers Nationwide Not to Eat Certain Types of Raw Red Tomatoes.” At the time, Salmonella Saintpaul was linked to 1,220 infections across forty-two states and the District of Columbia, as Seaside Farm and other growers were harvesting a large crop of tomatoes. Over the next month the CDC accumulated enough data to link Salmonella Saintpaul to jalapeño and serrano peppers imported from Mexico. Consequently the FDA withdrew the contamination warning and announced that fresh tomatoes were no longer associated with the outbreak. Seaside harvested a crop of tomatoes in South Carolina while the Salmonella Saintpaul contamination warning was in effect. By the time the agency admitted its error on July 17, the case had been amplified into the largest foodborne outbreak in the United States in more than a decade. The FDA incorrect warning costed producer millions and turned good tomatoes into waste. On May 18 2011, Seaside brought suit against the United States under the FTCA (Federal Tort Claims Act) alleging that the FDA negligently issued the contamination warning and impaired the value of Seaside’s crop by $15,036,293.95. The FDA was accused that they had no confirmation of a link between the outbreak of Salmonella and their tomatoes, and that the analysis done was flawed. On December 15 2015, the district court dismissed the case for lack of subject matter jurisdiction. The district court reasoned that the FDA had broad discretion to warn the public about a contaminated food supply, and that Seaside failed to allege any statute, regulation, or policy that required the FDA to proceed in a particular manner. The district court also acknowledged that contamination warnings were due to competing policy considerations of protecting the public from serious health risks and minimizing any adverse economic impact on associated industries.
The 4th Circuit agreed with the trial court that the FDA was acting within its authority to issue emergency food safety warnings based on preliminary information in order to protect public health. Turning down the $15 million claim from Seaside Farm, South Carolina “We refuse to place FDA between a rock and a hard place,” wrote Judge Wilkinson for the panel, sitting in Richmond. “One the one hand, if FDA issued a contamination warning that was even arguably over broad, premature, or of anything less than perfect accuracy, injured companies would plague the agency with lawsuits,” the judge said. “On the other hand, delay in issuing a contamination warning would lead to massive tort liability with respect to consumers who suffer serious or even fatal consequences that a timely warning might have averted,” Wilkinson said.
Questions to be asked
When government agencies like the FDA send an erroneous warning, as clearly happen in this case, and the action caused losses of millions of dollars to the growers, should there be a remedy against the agency? Should anyone be accountable for such losses? Should there be a compensation mechanism? If there is a remedy against the agency, will it prevent the agency from issuing warnings before all facts are known, and endanger the public?