A couple of weeks ago we praised a primary jurisdiction case out of California. It was a food case, but we wondered whether primary jurisdiction could be a more active, robust line of defense in drug and device cases 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 a forum-shopping plaintiff.  Now we have the privilege of reporting on a Minnesota case that applied the primary jurisdiction doctrine to put the brakes on a product liability case.  Again, it is a food case, but this is the time of the year when we often end up with unexpected food gifts.  And the next time we get disappointed by such a gift or turn it down will be the first.  Yes, that even goes for fruitcake.

In Taradejna v. General Mills, Inc., 2012 U.S. Dist. LEXIS 174264 (D. Minn. Dec. 10, 2012), the plaintiff brought a class action alleging violations under the Minnesota Prevention of Consumer Fraud Act, the Minnesota Unlawful Trade Practices Act, and the Minnesota Uniform Deceptive Trade Practices Act, related to the alleged mislabeling of Yoplait Greek yogurt products.  The plaintiff contended that “Yoplait Greek yogurt is neither yogurt nor Greek.”  Taradejna, 2012 U.S. Dist. LEXIS 174264 at *3.  (We are reminded of that European History class we took, where one could be assured of at least a B on the final exam by beginning the essay with this:  “The Holy Roman Empire was neither Holy nor Roman nor an empire.”  To this day, we do not know what that means, but we still declaim it whenever we want to show off the benefits of a liberal arts education.  It’s like referring to Proust without ever having read a word he 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 to tell.  According to that story, the defendants were unprepared for the popularity of Greek yogurt.  So far so good.  We confess that we feel ambushed by Greek yogurt – ambushed by luscious goodness.  Be that as it may, the unexpected huge demand for Greek yogurt prompted the defendants to use Milk Protein Concentrate (MPC). A blend of dry dairy products, MPC is sold in a powdered form.  We do not know whether that is good or bad.  We do not know whether that MPC is somehow anti-Greek.  But we do know this much:  the labeling of Yoplait Greek yogurt discloses MPC as an ingredient.  It is not as if that MPC is being smuggled in via a dairy Trojan Horse. 

Nevertheless, the plaintiff argued that the inclusion of MPC makes the Yoplait Greek yogurt an impostor.  In 1981, the FDA promulgated standards of “identity” for yogurt.  21 C.F.R. § 131.200.   As part of yogurt identity (admit it – you never expected a legal blog to discuss “yogurt identity” did you?), the FDA proposed to limit “other optional ingredients” that could be included in yogurt.  47 Fed. Reg. 41519 (Sept. 21, 1982). The FDA drafted a provision limiting the use of “other optional ingredients” in yogurt to certain milk-derived ingredients (e.g., concentrated skim milk, nonfat dry milk, buttermilk, whey), sweeteners, flavorings, color additives, and stabilizers. 21 C.F.R. §131.200 (d)(1)-(5).  Surely you noticed that the FDA’s list of “other optional ingredients” does not include MPC. Bad news for our defendant yogurt-slingers, right?

Well, because we are in FDA-land, nothing is as clear as one would like.  In response to comments and objections, the language regarding “other optional ingredients” was stayed, and the limitation, while published, was not put into effect. We are in yogurt limbo.  But the key to the plaintiff’s claim in the Taradejna case is that because MPC is not an ingredient expressly listed or described within the applicable standards of identity for yogurt, use of this ingredient is not permitted in yogurt.  Okay, says the defendant, we see your FDA paralytic reticence, and we raise you a belated FDA answer to a public question at a 2004 milk seminar: “May whey protein concentrate (WPC) and/or milk protein concentrate (MPC) be used as ingredients in yogurt to increase the nonfat solids content? 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 were stayed in 1982.”

Still with us, or have you decided to put the lid on this yogurt stuff and get yourself a proper breakfast, like waffles?  (Mmmmm … waffles.)

Now let’s turn to the FDA’s issuance of a Proposed Rule in 2009 (mind you, this yogurt saga started in 1981).  The rule would allow for certain modifications to the standards of identity for yogurt, including “the use of reconstituted milk and whey protein concentrate as standard dairy ingredients.” 72 Fed. Reg. 2443 (Jan. 15, 2009). The FDA observed that while the published standards do not permit the use of certain ingredients such as preservatives or a reconstituted dairy ingredient as a basic ingredient, “because of the stayed provisions, FDA has not taken enforcement action against the use of these ingredients in yogurt.…” 74 Fed. Reg. at 2224.  The FDA explained that, as of 2009, it has not held a public hearing to resolve these issues “due to the competing priorities and limited resources.” Id. at 2444.  It was apparently a very busy 28 years.  (True that – think about all the stuff that happened between 1981 and 2009.  The Soviet Union collapsed.  Then there were all those disasters:  Chernobyl, the Challenger explosion, Tiananmen Square, O.J., Katrina, the Wyeth v. Levine decision, Ishtar).

In the 2009 Proposed Rule, the FDA advocated incorporation of “technological flexibility into standards so long as the basic nature and essential characteristics of the food are not adversely affected.” Therefore, the FDA proposed to permit the optional use of any safe and suitable milk-derived ingredient as an optional dairy ingredient in the manufacture of yogurt to increase the nonfat solids content of the food above the minimum required 8.25 percent, provided the ratio of protein to total nonfat solids of the food and the protein efficiency ratio of protein present in the food are not decreased as a result of the use of such ingredients.  That Proposed Rule 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 2009 Proposed Rule.”  2012 U.S. Dist. LEXIS 174264 at *10.   As we said, the FDA has been busy.

The plaintiff, an Illinois resident, filed the complaint in March 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 label developed and approved by Defendants” at a Chicago grocery store. (So, as in the Minnesota case discussed last week, we have another carpet-bagging plaintiff in pursuit of snowdrifts and hospitable jurisprudence.)  The plaintiff alleged that while MPC was listed as an ingredient on the label, the label was “inadequate to disclose the fact that what Plaintiff was going to purchase and ultimately eat, was not actually ‘yogurt’ as marked.”  Id. at *11.

The defendant interposed a number of defenses.  The one that worked was primary jurisdiction.  Primary jurisdiction “applies where a claim is originally cognizable in the courts, and comes into play whenever enforcement of the claim “requires the resolution of issues which, under a regulatory scheme, have been placed within the special competence of an administrative body.” Id. at * 14-15.  Agency expertise is the most common reason that courts apply the doctrine of primary jurisdiction. “In addition, courts apply the doctrine to promote uniformity and consistency within the particular field of regulation.”  Id. at 15.  When the primary jurisdiction doctrine applies, the “district court has discretion either to stay the case and retain jurisdiction or, if the parties would not be unfairly disadvantaged, to dismiss the case without prejudice.”  Id.

In the Taradejna case, the underlying issue was whether MPC is a proper, permitted ingredient in yogurt. The court reasoned that “resolution of this question falls squarely within the competence and expertise of the FDA.”  Id. at *16.   Issues of food labeling are sufficiently complex that they “are best left to FDA for consideration prior to judicial review.” Id.  And here, just as with last week’s case, the Minnesota judge delivers some prose that is precise and delicious:  “The current standard of identity for yogurt, the stayed 1982 limitations, the Agency’s subsequent public statements about the standard, and the 2009 Proposed Rule 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 of identity for yogurt – a matter requiring scientific and nutritional expertise. Moreover, “given that the FDA has issued its 2009 Proposed Rule on the standard of 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 the standard of identity is pending.”  Id. at *17. 
 

As we said a couple of weeks ago, FDA expertise and the need for 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 know that FDA-created confusion can also be a factor in favor of applying primary jurisdiction, we are rubbing our hands together and getting ready to fire up some motions. 

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One week ago, the post was entitled “Good News and Bad News.”  Some bad news is especially tough to endure.  Some bad news is beyond our capacity to understand.  Some bad news is beyond our capacity to discuss without fury or despair. 

For most schools in this area, Winter break starts in the middle or end of this week.  The commuter trains have been full of little kids, some on field trips and some accompanying their parents to the holiday displays in Philadelphia.  We have been laying down our newspaper, closing our eyes, and listening to the laughter of the children.  It is much needed music.