Showing posts with label Food. Show all posts
Showing posts with label Food. Show all posts

Monday, June 18, 2012

Read! Read! Read!

“Read!  Read!  Read!”  That’s what our late-great civil procedure professor, Bob Carter, would always shout as he led the class through another close reading of the language in a key opinion.  He was a stickler for reading the whole thing.  (He was funny too, like when he told us the story of a panhandler who failed to convince a lawyer passing by that he too had once been a lawyer, at least until he shouted to the lawyer as he walked away, “Pennoyer v. Neeeeeffffffff!!!”)  But Professor Carter was right.  You’d better read the whole thing.  He didn’t shout “Parse!  Parse!  Parse!” or “Assume!  Assume!  Assume!”  That sure doesn’t work.

And that, along with preemption, is why the plaintiff lost in Hairston v. South Beach Beverage Co., 2012 U.S. Dist. LEXIS 74729 (C.D. Cal. May 18, 2012.)  The plaintiff claimed that the labeling of a drink that he purchased had misled him.  So he brought claims under three different California statutes and the federal Magnuson Moss Warranty Act, arguing that the defendant had misrepresented its drink by (1) calling it “all natural,” (2) using fruit names to describe its flavors when it didn’t contain fruit juice, and (3) stating that it contained certain vitamins, but the vitamins were synthetic. 

The court disposed of the last two claims under California law first.  They’re preempted by the Federal Food, Drug, and Cosmetic Act (“FDCA”).  Id. at *8-9.  As we’ve posted before,
the Nutrition Labeling and Education Act (“NLEA”), which amended the FDCA, contains an express preemption provision:

[N]o State or political subdivision of a State may directly or indirectly establish under any authority or continue in effect as to any food in interstate commerce . . . any requirement respecting any claim . . . made in the label or labeling of food that is not identical to the requirement . . .  of this title.

The court next dismissed the “all natural” claims under California law, adopting Professor Carter’s wisdom.  “Read! Read! Read!”  The label didn’t say “all natural” and stop there.  It also said “with vitamins.”  To the extent that plaintiff argued that this actually meant “with all natural vitamins,” the label also included an ingredients list.  And that list was explicit on what was in the drink, including the vitamins: 
[T]o the extent there is any ambiguity [to the “all natural” and “with vitamins” language], it is clarified by the detailed information contained in the ingredient list, which explains the exact contents of [the drink]  [R]easonable consumers expect that the ingredient list contains more detailed information about the product that confirms other representations on the packaging.
Id. at *14-14 (citations omitted).  Goodbye “all natural” claim under California state law.

We would have preferred it if the court had summarily dismissed the “all natural” claim on the basis of preemption.  The explicit preemption language of the NLEA is broad enough to encompass this claim, even if the FDA’s labeling regulations do not yet explicitly address the term “all natural.”  We’ve addressed this before.  But we’re also glad that this gave the court an opportunity to hold the plaintiff accountable for trying to parse the label to create a claim.  That’s not how lawsuits should work.

Finally, the court dismissed the federal claim under the Magnuson Moss Warranty Act.  Id. at *16-19.  We’ve already blogged on how the FDCA bars claims under other federal statutes (such as the Lanham Act) when it comes to food labeling.  This is true, too, for claims under the Magnuson Moss Warranty Act, which itself has a clause that says that its warranty protections give way to other federal legislation, such as the FDCA.  Id. at *17. 

Professor Carter was right then, and he’s right now.  If the plaintiff has just Read! Read! Read! he would have seen what the defendant was telling him all along, and this lawsuit wouldn’t have been necessary.  But then again it was fun to reminisce about Professor Carter.  Maybe a future decision will give us another opportunity to quote him.  He said lots of funny stuff. 

Monday, June 4, 2012

Mixing Caffeine and Alcohol

In old movies, everybody seemed to use coffee to sober-up a friend who’d had too much to drink.  (The only other option, if our movie-memory is correct, was a bucket of ice water.)  Do you remember “Dead Men Don’t Wear Plaid” – an old movie about older movies?  Steve Martin played a Sam-Spade-like detective who made “a cup of my java” for anyone who was drunk.  Apparently it would sober them up.  But he didn’t brew it quickly enough to get Burt Lancaster up and moving in this scene. 

Now, we all likely understood that coffee really didn’t help.  That’s only in the movies.  In reality, the most it might do is turn a drunk into a suddenly wide-awake drunk. 

In the last few years, caffeine and alcohol have been mixed in a single drink, the recently popular alcoholic energy drinks.  And they have sparked litigation.  In Cook v. MillerCoors, LLC, 2012 U.S. Dist. LEXIS 73205 (M.D. Fla. May 25, 2012), the plaintiff was injured in a motorcycle accident in which the motorcyclist was drunk from alcoholic energy drinks.  The plaintiff sued the drink manufacturer, asserting design defect and failure to warn claims (a negligent manufacturing claim had been dismissed previously).  Id. at *1-5.

There isn’t much that is new in the decision.  But it is helpful because it reinforces a longstanding principle about private rights of action under the Food, Drug and Cosmetic Act (FDCA) – they don’t exist. 

The court dismissed plaintiff’s design defect claim because, in short, consumers understand the dangers of alcohol and so it’s not unreasonably dangerous, and the motorcyclist’s decision to drink, not the manufacturer’s actions, was the proximate cause of the plaintiff’s injuries.  Id. at *6-11. 

Plaintiff’s failure to warn claim is where the FDCA comes in.  The court determined that the manufacturer had no duty to warn because everybody already knows that consumption of alcohol can be dangerous:

Generally, however, a manufacturer does not have a duty to warn consumers of dangers which are obvious or commonly known. . . . Because the dangers associated with alcohol consumption are very well known, courts have usually found that alcohol manufacturers and retailers do not have a duty to warn consumers about the risks posed by the excessive  use, or prolonged use of alcohol because those risks are common knowledge.

Id. at *12-13.  The court was not convinced that the addition of caffeine to the drink somehow obscured this understanding.  Id. at *14. 

So plaintiff looked to the FDCA and FDA regulations to save her claim.  She alleged that adding caffeine (and guarana, another additive) to an alcoholic drink violated FDA regulations.  Id. at *14-15. 

The defendant denied this was true but, more important, argued that, even if it were true, it wouldn’t matter.   Id. at *15.  As we discussed in our recent post about pomegranate juice, only the FDA can enforce its regulations, not private citizens and attorneys in courtrooms.  The Cook court agreed:

Where the substance of a plaintiff’s claims seeks to assert a private right of action under the FDCA, they must be dismissed.  If a defendant's conduct would not expose it to liability but for the FDCA then the plaintiff is effectively suing for a violation of the FDCA (no matter how the plaintiff labels the claim).  Thus, [plaintiff’s] allegations regarding the FDCA are of no moment.

Id. at *15.  The court dismissed plaintiff’s complaint with prejudice.  Id. at *19. 

The moral of this story?  Nothing new really.  We know what we’ve always known.  Caffeine plus alcohol doesn’t equal sober.  But it doesn’t equal a private right of action under the FDCA either.

Tuesday, April 24, 2012

A 100% Naturally Bad Preemption Decision

            Sometimes a decision bounces around a bit before it lands on our plates.  But when we finally spot it and read it, we realize it might be worth a quick chew.  It may be a tasty little tidbit like a particularly good Twiqbal decision outside the drug/device arena.  A savory morsel on a regulatory scheme and preemption involving an agency other than the FDA.  And, sometimes it can be a sour bite – the type that makes your lips pucker and want to spit it out.  That’s precisely what we’d like to do with almost all of a recent decision by the Central District of California – spit it out and throw it away.  Since we can’t do that – we decided we’d blog about it. 

            If our above metaphors weren’t obvious enough, we’re talking about a food case – Briseno v. ConAgra Foods, Inc., 2011 U.S. Dist. LEXIS 154750 (C.D. Cal. Nov. 23, 2011).  And, I guess we can start with the good news – the case was dismissed without prejudice under Rule 9(b) for failure to plead fraud with particularity.  Id. at *29-41.  While we applaud the court for getting it right on the deficiency of the pleadings – they left the door wide open for this suit to spring back to life.  That’s the sour part. 

            The case is about oil – not the black gold kind – the kind we pour on salads and use to fry chicken.  Wesson Oil to be exact.  Do you remember the Florence Henderson TV commercials from the 1970s – “Your chicken has a certain Wessonality” and 1980s – “with every bite you know you’re frying right.”    Who wouldn’t buy cooking oil from Mrs. Brady (wait a minute, didn’t Alice do all the cooking?).  In fact, some form of Wesson cooking oil has been on the market since the 1860s.  So, who can possibly have a problem with it?  Answer:  a group of plaintiffs who filed a nationwide putative class action alleging that Wesson’s labeling of the product as “100% Natural” is false and misleading because the manufacturer “uses plants grown from genetically modified organism seeds.”  Briseno, at *4.  We direct your attention back to the 1980s Mrs. Brady ad – Wesson’s label has said 100% Natural since at least then – 25 years ago.  So what’s the problem?  And, if this is a food labeling issue – why isn’t it preempted?  Like we said, we’re making the lemon face.

            Plaintiffs alleged causes of action for violations of California’s false advertising law (“FAL”), unfair competition law (“UCL”), Consumer Legal Remedies Act (“CLRA”), and breach of express warranty.  In addition to restitution, plaintiffs sought 1) “a permanent injunction enjoining ConAgra from continuing to harm [plaintiffs]” and 2) “an order requiring ConAgra to adopt and enforce a policy that requires appropriate disclosure of genetically modified ingredients and/or removal of misleading natural claims.”  Id. at 5-6.  We mention these two requests because somehow the court found #2 was preempted but #1 was not.  If the alleged harm is that the FDA-approved label says “100% Natural” and doesn’t identify genetically modified ingredients, then isn’t an injunction to stop that harm a court-ordered revision of the label?  In other words, a state law requirement that ConAgra label its product differently than what is required by the FDA?  We fail to see how the requested injunctive relief is different from an order requiring removal of “natural” claims.  They both have the same effect – a change of the label contrary to the requirements of the FDA.  So shouldn’t both be preempted?

            To try to understand the court’s reasoning, let’s start where it did – the Nutrition Labeling and Education Act (“NLEA”) which contains an express preemption provision:

[N]o State or political subdivision of a State may directly or indirectly establish under any authority or continue in effect as to any food in interstate commerce . . . any requirement respecting any claim . . . made in the label or labeling of food that is not identical to the requirement . . .  of this title.

21 U.S.C. § 343-1(a)(5).  We think this is the equivalent of “Check, please.”  This meal is over – case preempted.  But even if there remain a few notches on the belt that can be loosened to allow for another course, we don’t think the analysis leads to the conclusion the court reached here.
 
            The Briseno court cites other cases where plaintiffs claimed to have been misled by a manufacturer’s use of the term “all natural” (usually dealing with the inclusion of high fructose corn syrup) and those claims were held to be not preempted.  We’d probably disagree with the reasoning of those decisions as well.  What we found more interesting was the court’s attempt to distinguish this case from others where plaintiffs were asking the court to require a manufacturer to change a label that was permissible by the FDA.  For example, they dismiss the holding in Dvora v. General Mills, Inc., 2011 U.S. Dist. LEXIS 55513 (C.D. Cal. May 16, 2011) as inapplicable.  There plaintiffs alleged that the manufacturer’s advertising of “Total Blueberry Pomegranate” cereal was false and misleading.  In finding the claims preempted, that court said:

Defendant persuasively argues that Plaintiff's lawsuit seeks to impose requirements that are not identical to th[e] regulatory scheme. First, Plaintiff apparently seeks to forbid General Mills from labeling its product “Total Blueberry Pomegranate,” even though such descriptions of “characterizing flavor” are expressly authorized by federal law. Second, Plaintiff appears to demand that General Mills affirmatively state on the package that the cereal “does not actually contain blueberries or pomegranates,” even though FDA regulations would not require this. Third, Plaintiff objects to the depiction of brown colored “clusters” that (according to Plaintiff) allegedly “resemble blueberries and/or pomegranate seeds,” even though FDA regulations would have permitted General Mills to depict even fresh blueberries and pomegranates on its box.

Dvora, at *4.  That’s different from the Wesson Oil case how?  The FDA regulations don’t prohibit pictures of blueberries on the cereal box just like they don’t prohibit defendant from putting “100% Natural” on its bottle.  If the lawsuit “seeks to impose requirements that are not identical to the regulatory scheme” – the claims are preempted.  The regulatory scheme here seems to have allowed a claim of “100% Natural” for at least 25 years. A court order that requires that claim be removed is most certainly “not identical.”  Indeed, the Briseno court itself found:

Congress and the FDA have thoroughly regulated the manner in which ingredients must be listed on packages, including specifying how oil products must be labeled. See, e.g., 21 U.S.C. § 343(i)(2); 21 CFR § 101.4(b)(14).  Entering an order of the type Briseno seeks would impose a requirement that is not identical to federal law, and his prayer for such relief is thus preempted.

Briseno, at *26-27 (emphasis added).  Again, we are left perplexed by the court’s ability to use this analysis to reach different conclusions on two claims that seek the same relief – a change in the label.   

The court seemed to be singularly focused on the fact that despite the “considerable interest to consumers and industry,” FDA has not sought to define terms like “natural” in the food context (FDA invokes the “limited resources” defense).  Id. at *16.  But that doesn’t change the fact that Congress has empowered FDA – not the judiciary – with controlling the labeling content of food.  So, we also support ConAgra’s second argument, that if not preempted, the case should be dismissed or stayed under the doctrine of primary jurisdiction.

[P]rimary jurisdiction is properly invoked when a claim is cognizable in federal court but requires resolution of an issue of first impression, or of a particularly complicated issue that Congress has committed to a regulatory agency.

Id. at *28 (citation omitted).  Essentially, the doctrine provides that courts may decide that for the sake of “better informed and uniform legal rulings,” initial decision-making responsibility should be performed by an agency with “specialized knowledge, expertise, and central position within a regulatory regime.”  Id. at *27.  If the agency entrusted to decide these issues has yet to resolve the question, why should the courts? 

            This is something we like to call “judicial triumphalism” – the use of tort litigation for social purposes to induce courts to step in and make decisions on issues that are more competently addressed by other branches of government – here the FDA.  If people want to attack the use of genetically modified food, they should be going to Congress and the FDA and courts should be stepping aside, rather than be used as a platform for the advancement of social causes.  If you haven’t already guessed, the court was not persuaded by the primary jurisdiction argument either. One of the court’s reasons was because FDA has not shown an indication that will “provide guidance on the use of the term ‘natural’ in the immediate future.”  Id. at *29.  Well, maybe if the champions of this cause were properly blocked from using the courthouse to fight their battle, they would re-direct their efforts where they belong – at the FDA.

            FYI – plaintiffs did file an amended class action complaint and defendant has filed another motion to dismiss set to be heard next month – so stay tuned, we haven’t reached the final course. Although we aren’t optimistic that what’s coming will be any easier to swallow.

Wednesday, November 23, 2011

Turkey, Mashed Potatoes and a Dollop of Preemption

Tomorrow is Thanksgiving – the biggest American “eating” day of the year.  So we thought we’d share a few fun facts.  Did you know the average person on Thanksgiving eats around 4,500 calories?  (By the way, that's more than double the daily amount a person should eat).  For instance, on average one cup of mashed potatoes is 238 calories.  One cup of stuffing is 363 calories. One cup of eggnog is 342 calories and a slice of pumpkin pie will set you back 323 calories. We haven’t even gotten to the sweet potatoes covered in marshmallows, the cranberry sauce or the gravy.  Yikes! 

On a day like Thanksgiving -- when let’s face it, we are going to eat it anyway -- maybe it is better not to know things like you’ll have to walk 30 miles or swim for 5 hours to work off your Thanksgiving feast.  But, for most of the other days of the year, we generally like knowing what is in the food we are eating (if you really want to know, check out this article about how the average Thanksgiving dinner is chock-full-of chemicals – just not enough to kill us).  So, while as drug and device lawyers we focus on the "D" in FDA, as consumers we appreciate the "F".  And, when there is a favorable preemption decision in the food arena, it piques our interest as drug lawyers and as eaters. 

That is exactly what we get in the case of Jones v. Dinequity, Inc., 2011 Cal. App. Unpub. LEXIS 8724 (Cal. App. Nov. 14, 2011).  Defendant is the parent company of the popular restaurant chain, Applebee’s.  Applebee’s menu includes a selection of “Weight Watchers” items for which it lists the grams of fat, grams of fiber and calories.  Id. at *2.  Plaintiff filed a putative class action on behalf of California residents who ordered Weight Watchers menu items at Applebee’s claiming discrepancies between the actual and the posted nutritional information and seeking relief under California’s consumer rights statutes.  Id.  Plaintiff based her allegations on independent laboratory testing of certain menu items.  Id.  The court found plaintiff’s state law claims were preempted by the Food, Drug, and Cosmetic Act (FDCA) and its 1990 amendment, the Nutrition Labeling and Education Act (NLEA) because plaintiff was attempting to impose on Applebee’s a broader obligation than that required by the federal government.  We like the sound of that.

We all know that when you flip over a package of food in the supermarket, you are going to see a Nutrition Facts Panel.  That panel on packaged foods is required by the NLEA and its content is heavily regulated by the FDA – much like drug labeling.  But, prior to some 2010 amendments, restaurants like Applebee’s were exempted from those mandatory labeling requirements.  So, restaurants could “voluntarily” decide to include on their menus nutrient content or health benefits claims regarding their food.   And, that’s where food and drugs part company – there is no such thing as “voluntary” labeling of a drug.  A pharmaceutical manufacturer can’t opt to include additional information in its label, but a restaurant (and any other food manufacturer) can.

But, just because it’s voluntary, doesn’t mean it isn’t regulated – and we’re back on familiar ground.  The NLEA says is that if a restaurant chooses to make “nutrient content claims” – statements such as “low sodium” or “contains 100 calories” -- they must meet the requirements of §343(r) which governs claims on food labels regarding levels of nutrients or the relationship of such nutrients "to a disease or health-related condition."  The NLEA also contains an express preemption provision preventing states from imposing "any requirement on nutrient content claims in the label or labeling or food that is not identical to the requirement of section 343(r).”  Id. at *9.  What does §343(r) require?  That

restaurants making nutrient content claims are subject to the reasonable basis standard.  [I]n lieu of analytical testing, restaurants may show they have a reasonable basis for making the claim.

Id. at *8-9 (citation and quotation marks omitted).  But the plaintiff’s claims were based on analytical testing – and that’s where preemption comes in.

            While plaintiff attempted many arguments to avoid preemption, the one most interesting to us non-food lawyers was her claim that consumer protection laws “are not preempted by the NLEA because they do not impose labeling requirements, and thus fall outside the federal statutory scope.”  Id. at *15.  To make her argument, plaintiff misplaced her reliance on a pesticide labeling case that actually supported the defense position (Bates v. Dow Agrosciences LLC, 544 U.S. 431 (2005)), but she could just have easily cited any number of drug or device cases that likewise would have gone against her.  Whatever the context, it afforded the court an opportunity to make a nice preemption statement:

Here, plaintiff is suing under regulatory state laws proscribing deceptive practices. The gravamen of her claim is that the menu labels are not precisely accurate as shown by lab testing, and are thus deceptive.  This imposes a broader obligation on defendant's food labeling than the federal "reasonable basis" standard, by seeking to enforce a more exacting standard of compliance. Thus, her state law claims are preempted . . . to the extent they exceed the federal standard.

Jones, at *15-16. 
            The court also quickly dismissed plaintiff’s argument about the “strong presumption against preemption” finding that the “presumption is inapplicable when Congress has shown its clear and manifest purpose to preempt.”  Id. at *17.

            Because plaintiff’s complaint also contained a “brief, general allegation that defendant lack a reasonable basis for the menu postings,” id. at *4, the court entertained what appears to be a purported parallel claim to enforce the federal food labeling regulations. Id. at *18.  After considering the evidence, the court concluded that Applebee’s procedures for determining nutrient levels were reasonable and plaintiff “presented no competent evidence to the contrary.”  Id. at *22.  So, it was a win-win for the defense. 

            As for Thanksgiving, we say forget the calories, the fat, the sugar, the sodium, the chemicals and go for it.  Loosen the belt a few notches and enjoy.  Then you can start that 30 mile walk at midnight (or sooner) at your local mall!

Friday, March 25, 2011

Florida Food Class Certification Vacated, But....

Today the Eleventh Circuit vacated the certification of a Florida consumer protection (FDUTPA) class action in Fitzpatrick v. General Mills, Inc., ___ F.3d ___, No. 10-11064, slip op. (11th Cir. March 25, 2011).  The complaint alleged false statements about the health benefits of Yoplait yogurt.  The trial court has certified a class consisting of class as “all persons who purchased YoPlus in the State of Florida to obtain its claimed digestive health benefit.”

Generally we cheer when class certification are reversed.  But not this time.  Check out what the court actually said:
The district court’s analysis in its Order on Motion for Class Certification is sound and in accord with federal and state law. . . .  And, if the definition of the class had been in accord with the legal analysis, we would have readily affirmed. . . .  In its analysis, the district court repeatedly stated that a plaintiff need not prove reliance on the allegedly false statement to recover damages under FDUTPA . . . [a]nd, this is correct.


The court reversed because the class definition was too narrow - that it "takes into account individual reliance."  Id. at 9.  The proper definition, according to the court, should simply have been "all purchasers . . . in the state of Florida."  Id. at 8 n.1.

We don't know when we've last seen a class certification reversed on this basis - if ever.
Slip op. at 8-9.  Not what we like to see.

Tuesday, March 22, 2011

Like Butter

We had Pitt and Louisville in our Final Four. Plus our favorite hoops coach, Bruce Pearl, was just axed. No man ever looked finer in an orange sport coat. All of Rocky-top, and fans of wacky YouTube videos, will miss him desperately. Put plainly, we are broken-hearted and broken-bracketed. And paralyzed. Therefore, no Monday post.

At moments like this, we think of our favorite character from Entourage, Bob Ryan. He is a has-been -- or maybe, never-was -- agent whose stilted pitch is always the same: "If I had x, do you think that's something you'd be interested in?" You know, like "If I had a script and songbook for a musical version of Franz Kafka's Metamorphosis -- Roach! - is that something you might be interested in?" Martin Landau plays Bob Ryan like the Willy Loman to Jeremy Piven's profane Super-Agent Ari. Bob Ryan is way more likeable than Bela Lugosi in the film Ed Wood, or the guy on the old Mission Impossible television show, or the creepy villain in North by Northwest -- all brilliant creations of Landau's. We can imagine Bob Ryan catching us in a down-mood today and saying, "If I had a case where a product could have a statement that was factually wrong on its label, and even falsely said it was 'healthy,' but the court said the plaintiff was out of luck because the FDA had approved such language, would that be something you might be interested in?" Golly, yeah. Where do we go for such enlightened jurisprudence?

Turns out it's not a place. It's another area of litigation: food, glorious food. In Yumul v. Smart Balance, Inc., CV 10-00927 (C.D. Cal. March 14, 2011), the plaintiff filed a putative class action alleging violations of California consumer fraud laws because the margarine product in question had a few iffy statements on its label. For example, the label said "cholesterol free" while also disclosing that it contained partially hydrogenated soybean oil and that each serving contained 1.5g of trans fat. The label also contained the word "healthy." The plaintiff said the label lied because the margarine raised LDL ("L" for lousy) cholesterol, and there is nothing "healthy" about trans fat.

Almost right away the court feeds us some goodies. First, the court acknowledges that a court sometimes has to look at the merits of the underlying claims to ensure that Rule 23 class certification requirements are met. Nice. Then the court rejects the plaintiff's argument that the defendant waived the preemption defense by not including it in prior motions to dismiss. Rule 12(h) governs waiver of defenses -- lack of personal jurisdiction, improper venue, and insufficient process. But preemption is a 12(b)(6) defense saying that there is a failure to state a claim upon which relief can be granted. Such a defense can be raised in an answer, motion for judgment on the pleadings, or at trial. No waiver. Nice.

Now let's get to the nicest part. Here's a newsflash: food is different from drugs. They are both covered by the FDCA and the FDA. But the Nutrition Labeling and Education Act of 1990 specifically addressed labeling of foods. Among other things, the NLEA added an express preemption provision to the FDCA preventing states from imposing "any requirement respecting any claim of the type described in section 343(r)(l) of this title, made in the label or labeling of food that is not identical to the requirement of section 343(r) of this title." Section 343(r)(l) of the NLEA governs claims on food labels regarding levels of nutrients or the relationship of such nutrients "to a disease or health-related condition."

It turns out that the FDA regulations permitted the margarine to say "Cholesterol free" and "healthy." You can read the opinion all you want, but the logic of why FDA regulations permit those words to appear on the label is utterly opaque. But, in a way, that's the beauty of the opinion. With preemption, once the regulator approves the conduct or statement in question, it's over. (Just like it's over for Texas because of that crummy five-second call. Oops - there we go again.) Why can't drug cases be more like food cases? Well ... there are some similarities.

Now the plaintiff in the Yumul case didn't quite think it was over. She took one last-second half-court shot. She argued that her claims were not preempted because she was seeking "only to enforce federal food labeling regulations." (Emphasis in original.) Sound familiar? This is the food version of a parallel claim. The plaintiff identified purported per se violations of the FDCA, which, she argued, then permitted her to bring actions under California consumer fraud law.

And at this point it's not clear whether plaintiff missed or managed to send the game into overtime. The court held that this theory was brand new, it wasn't in the complaint, and that the defendant hadn't been placed on proper notice. Therefore, the complaint, "as currently pled, is preempted by federal law." But the dismissal is without prejudice. The plaintiff gets ten days to replead and to seek class certification yet again.

Just like with Bob Ryan, the promise of the pitch is glitzier than the reality.

Wednesday, March 2, 2011

Ninth Circuit Tells Organic Farmers To Beet It

Apologies for the groan-worthy pun in the title, but what did you expect in a case involving sugar beets? Sugar beets, in case you don’t know (we didn’t), are responsible for 44% of the domestic refined sugar supply. In the past few years, Monsanto and others have developed genetically engineered sugar beets that can tolerate herbicides – these are known as Roundup Ready sugar beets. The sugar produced from these genetically engineered beets is identical to conventional sugar beet sugar, and both the US and EU have approved the sugar as safe.

Notwithstanding this, for the last several years, there has been a back-and-forth brawl between organic farmers and the Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS). DOA delegated to APHIS the responsibility for regulating genetically engineered “plant pests.” Roundup Ready beets originally fell within this category because the modified gene sequence included donor DNA from an organism that is a plant pest. But for the past few years, APHIS has been trying to completely or partially deregulate genetically engineered sugar beets, and has been sued repeatedly by organic farmers as a result. In 2005, APHIS attempted to completely deregulate Roundup Ready sugar beets, but a district court blocked that attempt in the aptly-named Sugar Beets I. Undeterred, APHIS went back to the drawing board and has again taken action to partially deregulate Roundup Ready sugar beets. In the meantime, in August 2010 APHIS issued permits authorizing the planting of Roundup Ready sugar beet stecklings (stecklings are baby beet plants that have neither roots nor seeds). These permits specifically called for the destruction of the stecklings before they could flower or cross-pollinate, unless APHIS issued new permits or took other regulatory action that would allow the stecklings to survive and mature. Again, the organic farmers sued, and again the district court sided with the farmers, issuing a preliminary injunction and ordering the destruction of the stecklings in a case called – you guessed it – Sugar Beets II.

This time, however, the Ninth Circuit overturned the injunction, holding that the plaintiffs had not established that irreparable harm was “likely,” as opposed to merely possible. Center for Food Safety v. Vilsack, __ F.3d __, 2011 WL 676187, at *5 (9th Cir. Feb. 25, 2011). The court found the record barren of any evidence that planting the stecklings would lead to contamination or cross-pollination, and thus the farmers’ concerns were overblown. Id. Although the farmers raised Cain (cane?) about the possibility that the stecklings would in the future blossom and cross-pollinate with organic sugar beets, the court found that these fears were nothing more than speculative forecasts about future regulatory decisions, and weren’t ripe for challenge until the potential regulations actually sprouted to life and took root. Id. at *6. (OK, maybe we went a bit nuts with the agri-puns). In other words, wait until APHIS actually deregulates sugar beets before suing.

We found this case interesting, not just for the opportunity to make some pretty lame puns, but also because of how the Ninth Circuit handled a premature challenge to future potential regulation (“[A]n invocation to chaos theory is not sufficient to justify a preliminary injunction.”). But we have to confess, we also thought the opinion was worth mentioning because it quoted both Jurassic Park and Richard II. That has to be a first, and surely both Michael Crichton and William Shakespeare would be proud.