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.