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. 
 

And then of course
there is that concern for uniformity and expertise.  Either it’s all Greek
to America, or it isn’t.  Or something like that.  And here’s a
non-surprise:  “several recently-filed yogurt lawsuits throughout the
country involve the same or similar issues as found in the instant suit. The
increasing volume of this litigation creates the potential for inconsistent
judicial rulings.”   Id.  Accordingly, the court dismissed the
case without prejudice and directed the parties to initiate the proper
proceedings with the FDA. 

Call it a blow against an overly litigious culture. 

 

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 BadNews.”  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.