There are plenty of f-words in this post, but fear not, for they are all fully capable of traveling in polite company. Most are even family-friendly. The most tasty f-word here is the “F” in FDA: food. While we focus on drug and device cases in this blog, we frequently find that food cases furnish fine fodder for some of the legal issues we fiddle with, such as in this 2008 post on food as a four letter word. Food cases can also suggest flanking maneuvers to prop up our favorite f-word defense, federal preemption. For example, feast your eyes on the recent case of Organic Consumers Ass’n v. Hain Celestial Grp., Inc., 2018 U.S. Dist. LEXIS 1053 (D.D.C. Jan. 3, 2018). The plaintiff alleged that the defendant’s infant formulas were falsely labeled as “organic” because they contained products that flunked the federal Organic Food Production Act of 1990 (“OFPA”). The defendant filed a motion to dismiss the complaint on the ground that private enforcement of organic labelling is preempted by the OFPA.
The court fastidiously began with the standing issue, and held that the Organic Consumers Association had standing to sue. Then the court forfeited some more goodwill with us by presuming that “Congress does not cavalierly preempt state causes of action.” Such reference to a presumption against preemption is foolish and makes us feel forlorn. (As we have blogged before, the presumption against preemption has fallen by the wayside when it comes to express preemption.) At this early point in the decision, we are fidgeting and fuming. But then the court mentioned another, much more formidable principle: that “the purpose of Congress is the ultimate touchstone.” That further point should foreclose the need to indulge in any feckless presumption against preemption, because, in enacting the OFPA, Congress made forcefully clear its purpose to establish national standards for marketing organic products, to assure consumers of consistency, and to facilitate interstate commerce of organic products. These purposes were folded into a USDA final rule that created the National Organic Program, with regulations requiring that a product can be sold as “organic” only if it contains at least 95% organically produced products, with the remaining five percent consisting of synthetic ingredients included on a “National” list. The OFPA also provides for a “certifying agent” to certify a manufacturer’s fidelity to an approved organic plan.
The products in question in the Organic Consumers case were certified, but the plaintiff argued that such certification is not synonymous with OFPA compliance. The plaintiff argued that its lawsuit would not foil the federal scheme but, in fact, was faithful to it. That position seems to be, in a literal sense, fantastic. The plaintiff’s position certainly failed to convince the judge.
This is not the first case to face the issue of preemption under the OFPA. Far from it. In the only appellate case on point, In re Aurora Dairy Corp. Organic Milk Mktg. & Sales Practices Litig., 621 F.3d 781 (8th Cir. 2010), the Eight Circuit held that any attempt to hold the defendant liable under state law for products mislabeled as organic would directly conflict with the OFPA and the role of the certifying agent. The Eighth Circuit rejected the defendant’s express and field preemption arguments, but concluded that the plaintiff’s lawsuit present an obstacle to the federal scheme. Permitting private suits to challenge the federal certification of a product as “organic” would result in different interpretations and different enforcement, inevitably plunging manufacturers and consumers into a fog of confusion. Based on the fundamental need for uniformity, the plaintiff’s claims were fatally preempted.
We are unabashedly fond of the Aurora case, and we are hardly alone. F. Supp. 3d is filled with cases that followed Aurora’s reasoning. (We will not make the mistake of praising the Aurora court for its “fulsome” reasoning. “Fulsome” is not a dressed-up stand-in for other, perfectly adequate words such as “complete,” “thorough,” or, perish the thought, the simple, direct “full.” Most uses in our presence of the word “fulsome” are wrong. We become flush and fight hard to contain our fury. You see, we adhere to the primary dictionary definition of “fulsome” as “excessively flattering.” Yes, we have become fossilized. We follow Fowler’s Modern English Usage – the oldest, crankiest edition. Get off our lawn.)
But, of course, there is one pesky fluke out there: Segedie v. Hain Celestial Grp., Inc., 2015 U.S. Dist. LEXIS 60739 (S.D.N.Y. May 7, 2015). Not to put too fine a point on it, but the Segedie is not a favorable decision to those of us who are fans of preemption. The reasoning in Segedie is sheer folly, but one cannot be sure that some other courts won’t flock to its flawed logic just because of SDNY’s fame. The Segedie court found fault with Aurora‘s preemption analysis, and concluded that private enforcement of what is and is not “organic” would boost consumer confidence, and that the risk of divergent interpretations did not present a “sharp” obstacle to uniformity. That logic is hard to fathom. We were not aware that the degree of “sharp”-ness – whatever that is – is a factor in preemption analysis. Segedie is a flop.
The Organic Producers court sided with Aurora and declined to adopt the faux reasoning of Segedie. Permitting a plaintiff to sue on the basis that a product labeled and federally certified as organic is not, in fact, organic runs afoul of all three purposes of the OFPA:
1. Local fact-finders can be fickle and there is no reason to expect uniformity from their outcomes. Forget about ever having a national standard. What is “organic” in Florida might not be on F Street in D.C. 2. Consumers would be flummoxed by the different rules governing what is and is not organic. 3. Rather than foster interstate commerce, the differing outcomes would provide the worst possible feedback to food manufacturers – they would not be able to sell their products in certain parts of the country where some jurors decided that the “organic” should be forbidden for such products.
Naturally, the plaintiff fought against the flow of this reasoning. The plaintiff made a foray into the usual anti-preemption fallback position that states can impose more restrictive standards. But the plaintiff forgot that the federal system included an enforcement system that never mentioned private enforcement but, rather, forged a system of inspections, compliance reviews, suspensions or revocation of certifications, and other civil and criminal penalties. Permitting private enforcement would be unnecessary and would flirt with disaster.
We are not merely fond of the Organic Producers because it is a fair statement of food preemption. Nope. We think that Organic Producers represents a return to first principles of preemption law, which are just as applicable to personal injury drug and device litigation as to food labeling. Flipping issues of drug or device product defect and adequate warning to various jurors scattered around the country, including jurors flailing about in that fever-dream litigation festival known as an MDL, wrecks uniformity, fans the flames of confusion, and is a fist to the gut of interstate commerce. Rather than flatter jurors, we ought to acknowledge that their foibles and the varying, frenzied, irrational outcomes they permit plaintiff lawyers to foist on the public are a rotten way to fix health and safety problems.
The pro-preemption holding in Organic Producers flat-out makes sense. It should flourish. It should be the way forward.