This case dates back to the southwest tomato-turned-jalapeno FDA salmonella warning issued in 2008.  The FDA had originally issued this warning against consuming raw tomatoes in the southwest, then took the warning national.  Then a month and a half afterwards, the FDA lifted the warning finding the tomatoes were not associate with the outbreak.  It was peppers.

(if you really want to geek out on FDA pathogen tracking kung-fu check out the salmonella traceback and distribution flowchart created about the incident – they always get their man).

Not surprisingly, demand for tomatoes plunged and so did their market price in the period during and after the warning.  Farmers sued the FDA for damages caused when they lost the value of their tomato crops based the later-determined unwarranted warning.  Some farmers claimed that as much as 32% of their tomato crops for that year were just left in the field; that prices went from $18 a box to less that $4.

One particular lawsuit alleged outside the regular U.S. Court of Claims actions brought by most farmers wanted money from the FDA under the Federal Tort Claims Act (28 USC 2671)- an act that provides a limited waiver of the federal government’s sovereign immunity and allows injured parties to sue the United States for damages resulting from “the negligent or wrongful act or omission of any employee of the Government while acting within the scope of his office or employment.”  The lawsuit claimed that the FDA negligently issued the 2008 tomato contamination warning and devalued the farmers crop by $15 million and asked for that money back in damages.

After some discovery the district court held that the FDA was exercising its discretionary function in connection with the 2008 warning and dismissed the lawsuit based on the exemption to liability afforded an agency under section 2680(a) of the FTCA that applies when the claims made are based on the agency’s exercising or performing a discretionary function.  This exemption  strips the district court of jurisdiction if such a discretionary act is at issue:

The provisions of this chapter and section 1346(b) of this title shall not apply to—

(a) Any claim based upon an act or omission of an employee of the Government, exercising due care, in the execution of a statute or regulation, whether or not such statute or regulation be valid, or based upon the exercise or performance or the failure to exercise or perform a discretionary function or duty on the part of a federal agency or an employee of the Government, whether or not the discretion involved be abused.

The farmer appealed the dismissal.

The 4th Circuit affirmed that dismissal in this opinion (Seaside Farm, Inc. v. U.S.) leaving no doubt as to the applicability and current vitality of the “discretionary” exception to the Federal Tort Claims Act – “government conduct is protected by the discretionary function exception if it involves an element of judgment or choice, and implicates considerations of public policy.”  The Court held that the Federal Food , Drug and Cosmetic Act empowered the FDA to disseminate information involving food in situations that, in the opinion of the commissioner, posed an imminent danger to health or gross deception of the consumer and that the “in the opinion of the commissioner” part is the essence of discretion afforded a federal agency.

The Court also left no doubt about the public policy considerations inherent in contamination warning, i.e., the monetary interests of agribusiness vs. the health interests of the public.  These interests come up frequently in regulatory disputes, but rarely do you see such stark language used by a court in an absolute denouncement of the economic interests in favor of public health:

“We refuse to place FDA between a rock and a hard place. On the one hand, if FDA issued a contamination warning that was even arguably overbroad, premature, or of anything less than perfect accuracy, injured companies would plague the agency with lawsuits. 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. All this would loom if contamination warnings were not protected by the discretionary function exception. …

“While we acknowledge and regret any financial loss Seaside may have incurred as a result of the Salmonella Saintpaul contamination warning, allowing Seaside’s claim to proceed would allow the law of tort to distort one of the most critical of governmental functions, that of safeguarding the public health and welfare.“We refuse to place the FDA between a rock and a hard place.”  

It’s important to remember here that no tomato in the U.S. ever tested positive for salmonella during this outbreak.  In fact, there were no tests performed on tomatoes before the warning was issued.  The initial warning about tomatoes went out on June 3, 2008, and according to the press briefings, the notions of peppers didn’t arise until sometime after July 1, 2008 and before the July 9 press briefing identifying them:

“We have had an evolving information set around the investigations that have been going on and last week we added to the list of potential candidates in addition to tomatoes which continue to be a prime suspect, we added to that list the jalapeno peppers and cilantro and now based on the most recent information that we’re assembling and I should stress we’re continuing to gather information, we thought it was important to provide new interim guidance for people at greatest risk for Salmonellosis.”

Perhaps a greater public interest is served by imposing liability to force federal agencies to properly ferret out the real, or at least potential cause of a public health crisis through actual testing or to have some verified scientific results before issuing a false warning which has no benefit and might even cause people to act detrimentally by selecting behaviors that place them at greater risk of contacting the real threat before it is identified.  Tomato free salsa, anyone?

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