A couple of weeks ago we praised a primary jurisdiction caseout of California. It was a food case, but we wondered whether primaryjurisdiction could be a more active, robust line of defense in drug and devicecases now that Wyeth v. Levine has curtailed the preemption defense. Just last week we showered praise upon a Minnesota judge for showing the door to aforum-shopping plaintiff. Now we have the privilege of reporting on aMinnesota case that applied the primary jurisdiction doctrine to put the brakeson a product liability case. Again, it is a food case, but this is thetime of the year when we often end up with unexpected food gifts. And thenext time we get disappointed by such a gift or turn it down will be thefirst. Yes, that even goes for fruitcake.
In Taradejna v. General Mills, Inc., 2012 U.S. Dist. LEXIS174264 (D. Minn. Dec. 10, 2012), the plaintiff brought a class action allegingviolations under the Minnesota Prevention of Consumer Fraud Act, the MinnesotaUnlawful Trade Practices Act, and the Minnesota Uniform Deceptive TradePractices Act, related to the alleged mislabeling of Yoplait Greek yogurtproducts. The plaintiff contended that “Yoplait Greek yogurt is neitheryogurt nor Greek.” Taradejna, 2012 U.S. Dist. LEXIS 174264 at *3. (We are reminded of that European History class we took, where one could beassured of at least a B on the final exam by beginning the essay withthis: "The Holy Roman Empire was neither Holy nor Roman nor anempire." To this day, we do not know what that means, but we stilldeclaim it whenever we want to show off the benefits of a liberal artseducation. It’s like referring to Proust without ever having read a wordhe wrote. We also remember the Linda Richman character from the old Saturday Night Live "Coffee Talk" skits, who would pose similar topics for her audience. For example, "Rhode Island is neither a road nor an island. Discuss.")
How can yogurt lie? The plaintiff has a story totell. According to that story, the defendants were unprepared for thepopularity of Greek yogurt. So far so good. We confess that we feelambushed by Greek yogurt – ambushed by luscious goodness. Be that as it may, theunexpected huge demand for Greek yogurt prompted the defendants to use Milk ProteinConcentrate (MPC). A blend of dry dairy products, MPC is sold in a powderedform. We do not know whether that is good or bad. We do not knowwhether that MPC is somehow anti-Greek. But we do know this much: the labeling of Yoplait Greek yogurt discloses MPC as an ingredient. Itis not as if that MPC is being smuggled in via a dairy Trojan Horse.
Nevertheless, the plaintiff argued that the inclusion of MPC makes theYoplait Greek yogurt an impostor. In 1981, the FDA promulgated standardsof "identity" for yogurt. 21 C.F.R. § 131.200. Aspart of yogurt identity (admit it – you never expected a legal blog to discuss“yogurt identity” did you?), the FDA proposed to limit “other optionalingredients” that could be included in yogurt. 47 Fed. Reg. 41519 (Sept.21, 1982). The FDA drafted a provision limiting the use of “other optionalingredients” in yogurt to certain milk-derived ingredients (e.g., concentratedskim milk, nonfat dry milk, buttermilk, whey), sweeteners, flavorings, coloradditives, and stabilizers. 21 C.F.R. §131.200 (d)(1)-(5). Surely younoticed that the FDA’s list of “other optional ingredients” does not includeMPC. Bad news for our defendant yogurt-slingers, right?
Well, because we are in FDA-land, nothing is as clear as onewould like. In response to comments and objections, the languageregarding “other optional ingredients" was stayed,and the limitation, while published, was not put into effect. We are in yogurtlimbo. But the key to the plaintiff’s claim in the Taradejna case is thatbecause MPC is not an ingredient expressly listed or described within theapplicable standards of identity for yogurt, use of this ingredient is notpermitted in yogurt. Okay, says the defendant, we see your FDA paralyticreticence, and we raise you a belated FDA answer to a public question at a 2004milk seminar: "May whey protein concentrate (WPC) and/or milk proteinconcentrate (MPC) be used as ingredients in yogurt to increase the nonfat solidscontent? Yes, 21 C.F.R. 131.200(d), which would have precluded WPC or MPC use,was one of several provisions of the standard of identity for yogurt that werestayed in 1982."
Still with us, or have you decided to put the lid on thisyogurt stuff and get yourself a proper breakfast, like waffles? (Mmmmm …waffles.)
Now let’s turn to the FDA’s issuance of a Proposed Rule in2009 (mind you, this yogurt saga started in 1981). The rule would allowfor certain modifications to the standards of identity for yogurt, including“the use of reconstituted milk and whey protein concentrate as standard dairyingredients.” 72 Fed. Reg. 2443 (Jan. 15, 2009). The FDA observed that whilethe published standards do not permit the use of certain ingredients such aspreservatives or a reconstituted dairy ingredient as a basic ingredient,“because of the stayed provisions, FDA has not taken enforcement action againstthe use of these ingredients in yogurt.…” 74 Fed. Reg. at 2224. The FDAexplained that, as of 2009, it has not held a public hearing to resolve theseissues “due to the competing priorities and limited resources.” Id. at2444. It was apparently a very busy 28 years. (True that – thinkabout all the stuff that happened between 1981 and 2009. The Soviet Unioncollapsed. Then there were all those disasters: Chernobyl, theChallenger explosion, Tiananmen Square, O.J., Katrina, the Wyeth v. Levine decision, Ishtar).
In the 2009 Proposed Rule, the FDA advocated incorporationof “technological flexibility into standards so long as the basic nature andessential characteristics of the food are not adversely affected.” Therefore, the FDA proposed to permit the optional use of any safe and suitablemilk-derived ingredient as an optional dairy ingredient in the manufacture ofyogurt to increase the nonfat solids content of the food above the minimumrequired 8.25 percent, provided the ratio of protein to total nonfat solids ofthe food and the protein efficiency ratio of protein present in the food arenot decreased as a result of the use of such ingredients. That ProposedRule remains a Proposed Rule. The Taradejna court points out, perhaps ruefully,that “[i]t appears that no public hearing has yet been held on the 2009Proposed Rule.” 2012 U.S. Dist. LEXIS 174264 at *10. As wesaid, the FDA has been busy.
The plaintiff, an Illinois resident, filed the complaint inMarch 2012, in Minnesota state court. The defendants removed the case to federal court. The plaintiff alleged that in March 2012,he “purchased a serving of Yoplait Greek yogurt, which brandished the labeldeveloped and approved by Defendants” at a Chicago grocery store. (So, as inthe Minnesota case discussed last week, we have another carpet-baggingplaintiff in pursuit of snowdrifts and hospitable jurisprudence.) Theplaintiff alleged that while MPC was listed as an ingredient on the label, thelabel was “inadequate to disclose the fact that what Plaintiff was going topurchase and ultimately eat, was not actually ‘yogurt’ as marked.” Id. at*11.
The defendant interposed a number of defenses. The onethat worked was primary jurisdiction. Primary jurisdiction “applies wherea claim is originally cognizable in the courts, and comes into play wheneverenforcement of the claim “requires the resolution of issues which, under aregulatory scheme, have been placed within the special competence of anadministrative body.” Id. at * 14-15. Agency expertise is the most commonreason that courts apply the doctrine of primary jurisdiction. “In addition,courts apply the doctrine to promote uniformity and consistency within theparticular field of regulation.” Id. at 15. When the primaryjurisdiction doctrine applies, the “district court has discretion either tostay the case and retain jurisdiction or, if the parties would not be unfairlydisadvantaged, to dismiss the case without prejudice.” Id.
In the Taradejna case, the underlying issue was whether MPCis a proper, permitted ingredient in yogurt. The court reasoned that“resolution of this question falls squarely within the competence and expertiseof the FDA.” Id. at *16. Issues of food labeling aresufficiently complex that they “are best left to FDA for consideration prior tojudicial review.” Id. And here, just as with last week’s case, theMinnesota judge delivers some prose that is precise and delicious: “Thecurrent standard of identity for yogurt, the stayed 1982 limitations, theAgency’s subsequent public statements about the standard, and the 2009 ProposedRule do not constitute a model of clarity.” Id. at *16-17. The FDA is in the best position to resolve any ambiguity about the standard ofidentity for yogurt – a matter requiring scientific and nutritional expertise.Moreover, “given that the FDA has issued its 2009 Proposed Rule on the standardof identity for yogurt, it would be imprudent for the Court, at this juncture,to substitute its judgment for that of the Agency’s while revision of thestandard of identity is pending.” Id. at *17.
And then of coursethere is that concern for uniformity and expertise. Either it’s all Greekto America, or it isn’t. Or something like that. And here’s anon-surprise: “several recently-filed yogurt lawsuits throughout thecountry involve the same or similar issues as found in the instant suit. Theincreasing volume of this litigation creates the potential for inconsistentjudicial rulings.” Id. Accordingly, the court dismissed thecase without prejudice and directed the parties to initiate the properproceedings with the FDA.
Call it a blow against an overly litigious culture.
As we said a couple of weeks ago, FDA expertise and the needfor uniformity also exist in the drug and device arena. If primary jurisdiction applies in Taradejna, imagine how much stronger the primary jurisdiction argument would be where the FDA has actually done more on a subject than one proposed rule in 30 years. Moreover, now that we knowthat FDA-created confusion can also be a factor in favor of applying primaryjurisdiction, we are rubbing our hands together and getting ready to fire upsome motions.
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One week ago, the post was entitled “Good News and BadNews.” Some bad news is especially tough to endure. Some bad newsis beyond our capacity to understand. Some bad news is beyond our capacityto discuss without fury or despair.
For most schools in this area, Winter break starts in themiddle or end of this week. The commuter trains have been full of littlekids, some on field trips and some accompanying their parents to the holiday displaysin Philadelphia. We have been laying down our newspaper, closing our eyes, andlistening to the laughter of the children. It is much needed music.
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