Wednesday, September 19, 2012

FDA Regulatory Muscles: Ripped and Oiled

Here's a shocker: your average drug and device law lawyer seldom hoists more weight at any one time than 22 ounces of F.3d or three ounces of The Glenlivet. There is usually a long, nerdy history behind this state of indolence. For example, when we were in high school, we got a varsity letter for being a "Mathlete." Take that in for a moment. That's right, we were on the Math team. The true jocks snickered. But it was not entirely funny to them. They thought we pencil-necked geeks were devaluing their football and track letters. They were probably right. They were also - let's be honest about this - thoroughly repulsed by the more academic types.




Let's say two things about that (now that we have the big megaphone of the blog and now that those mesomorphs can no longer menace us at our locker):



(1) Who has the last laugh now? When she was in high school, we used to tell the Drug and Device Law Daughter that she should befriend the wonks because some day they might flower into a Bill Gates or Marc Zuckerberg. Did she listen? She did not. And what do you suppose will happen to the hockey player and Goth who captured her young heart? The closest they will come to Microsoft or Facebook will be inputting customer data at a bad retail job or posting a bong as their profile picture. Now she is in college and dating an engineering student. Maybe there's hope. Maybe some day money will flow toward us, not away from us. Maybe we won't have to eat cat food in our dotage. Maybe we should veer away from this digression.



(2) That repulsion went both ways. The wrestlers went around on match days incessantly spitting into a cup (kind of like a Texas plaintiff lawyer during a deposition). One guy in our class got into bodybuilding quite early. The movie Pumping Iron came out around this time. It was Arnold Schwarzenegger's break-through. Schwarzenegger was remarkable for more than his trolley-car sized biceps.  He was also inordinately clever at getting into his competitors' heads. He would give them "the wrong advices" (a preview of Schwarzenegger's charming battles with the English language) whilst crushing their egos. Our classmate emulated Schwarzenegger by carrying a can of protein powder around and occasionally disrobing in class to display his "guns" and "pythons". He is now a self-help maven on the Internet and claims he can uncover your past lives and make them "work for you". Perhaps he takes control over those past lives the same way he took control over things back in 1977: with threats and headlocks.



One might have thought that after four years of a fine liberal arts education and then three years of that hazing ritual known as law school, that we would cease to have very much to do with the bodybuilding cult. One would be wrong. We spent a year on a case defending a nutraceutical company accused of making a bad product and phony claims. These folks operate on a wholly different level from companies that manufacture prescription drugs or class III devices. The word "aggressive" does not begin to do them justice. One of our key company witnesses was a champion body-builder who had some sort of Ph.D. We can not remember what the Ph.D was for, but this guy clearly knew a few things. He had taken a hearty dislike of the plaintiff's lawyer. The night before he was to be deposed, he downed a concoction of herbs and other goodies that would render his breath toxic and his gastrointestinal system explosive. It worked. The deposition was extremely unpleasant for the plaintiff lawyer. (As it was for everyone there except, perhaps, the witness.) The deposition did not last very long.



As we said, nutraceuticals are different from pharmaceuticals. But they are both regulated by the FDA. And therein lies the tale of today's case, Cytosport, Inc. v. Vital Pharmaceuticals, Inc., 2012 U.S. Dist. LEXIS 126976 (E.D. Cal. Sept. 6, 2012). Cytosport makes Muscle Milk, a ready-to-drink protein shake in an octagonal bottle. Vital Pharmaceuticals makes Muscle Power, a ready-to-drink protein shake in an octagonal bottle. Cytosport sued Vital under the Lanham Act, claiming that the Muscle Power product infringed on its trademark and trade dress for Muscle Milk. Vital counterclaimed, arguing that the Muscle Milk trademark was invalid and deceptive because Muscle Milk contains not a drop of milk. Thus, this is a case concerning intellectual property. Linger on the richness of that. Much of the back-and-forth in the case involves competing surveys, with competing experts opining as to whether consumers were confused. You don't want our opinion on that, do you?



Anyway, you ask, what does any of this have to do with drug and device law? First, we don't like your tone of  impatience one little bit. This sort of 'roid rage does not become you. Frankly, you're scaring us.  Second, relax. The Cytosport case is fun. No heavy lifting required. Vital's counterclaim cited a warning letter sent from the FDA to Cytosport taking issue with the use of the word "Milk." According to Vital, the FDA warning letter should prompt the court to find the "Muscle Milk" trademark to be deceptive and, hence, invalid under 15 U.S.C. section 1125(a). If all this sounds vaguely reminiscent of Pom Wonderful, LLC v. Coca-Cola Co., 679 F.3d 1170 (9th Cir. 2012), it should. The Cytosport court leaned heavily on the Pom Wonderful case, which it characterized as follows: "When the FDA extensively regulates a certain area and does not act to enforce its regulations, the Lanham Act may not be used by a private party to 'usurp, preempt, or undermine FDA authority.'" Cytosport, 2012 U.S. Dist., LEXIS 126976 at *17, quoting Pom Wonderful, 679 F.3d at 1176. Which way does Pom Wonderful cut in this Muscle contest? The Cytosport court says that Pom is not wonderful news for the Vital counterclaim, because "the FDA regulates the use of the term 'milk' on food labels. The FDA is aware of Cytosport's labeling and has not acted." Id.



But wait a minute, what about the FDA warning latter? And here, we encounter the same point that we blogged about yesterday. A warning letter is not a final action. It does not mean anything until it culminates in some final action by the FDA. A warning letter is an invitation to dialogue and compliance. It is almost like that semi-surprising notion in first-year Contracts class about how an advertisement is not in itself an offer, but merely an invitation to the customer to make an offer. Here is how the Cytosport court dealt with the FDA warning letter: "The fact that the FDA sent a warning letter to Cytosport concerning its labeling does not require a different finding. FDA warning letters are informal and advisory, and do not amount to an FDA action." Id. Vital then offered a back-up position: "the Court should defer granting judgment until the FDA issues a final decision on Cytosport's use of 'Muscle Milk.'" Id. at *18. Nice try. The Cytosport refused to defer. The FDA's final decision might end up supporting Cytosport, supporting Vital, or falling somewhere in between. But "the Pom holding is clear that the claims are barred until the FDA issues its decision, not that they are stayed or deferred." Id.



That is the part of the case that matters to us. Once again, private causes of action cannot muscle in on the FDA's turf. That is good news for all of us high-minded defense hacks. We put the "clean" in the clean-and-jerk. (Guess who puts in the other part.) Further, an FDA warning is tentative, incomplete, and - ta da - meaningless. More good news. Where it counts, the Cytosport opinion is a strong one for us. Use it. Hold it up. Flex with it. Feel the burn.



There are other bits that do not matter as much to us or that we don't understand. For example, Vital also brought "two state law claims which reference the FDA regulations to show that Cytosport's use of the term 'Milk' is inconsistent with FDA regulations." Id. The court holds that these state law claims "are not barred by the ruling in Pom because the FDA specifically permits states to create labeling requirements that are identical to the FDA's and establish independent causes of action for those claims." Id. Sounds like more "parallel claim" Hell to our ears. Also, the court upholds Muscle Power's advertising assertion that it has "600% less sugar and 187% less fat than Muscle Milk." Id. at *37. We agree with Cytosport that there is something mathematically nonsensical about saying that something has "600%" less of something.



Once a mathlete, always a mathlete.

1 comment:

Anonymous said...

Read this post with the accent of Hanz und Franz from SNL and its even funnier.

Can't believe there is no reference to "We're going to pump you up!" in it.