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.

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.

Is That a Pomegranate You Have There?

It’s Memorial Day weekend, and it’s time for barbeques.  While many of us will choose an alcoholic drink to enjoy during the festivities, there may be non-alcoholic drinks involved too.  Maybe a nice juice drink.  That usually means grape, apple or cranberry juice, or some combination of them.  Lately some people are even choosing pomegranate juice.  Yeah, we know, but some people are drinking it.  But when those people pick their pomegranate juice, do they always know what they’re getting? 

That’s what the plaintiff complained about in Pom Wonderful LLC, v. Coca-Cola Co., 2012 U.S. App. LEXIS 9921 (9^th Cir. May 17, 2012).  The plaintiff claimed that the defendant misled consumers with the naming and labeling of its juice product, “Pomegranate Blueberry” a/k/a “Pomegranate Blueberry Flavored Blend of 5 Juices,” because the drink actually contained only 0.3% pomegranate juice and 0.2% blueberry juice, with the vast majority of the juice being apple and grape.  Id. at *2-3. 

Now, this was a business dispute.  The plaintiff was a rival juice distributor.  But it has broader implications because it addresses what can happen when two federal statutes clash. 

The plaintiff brought its claim under the Lanham Act, which broadly prohibits false advertising and authorizes a lawsuit by anyone who believes that s/he will likely be damaged by the false advertising.  Id. at *7 (citing 15 U.S.C. § 1125(a).  The FDCA, as we know, broadly regulates food and beverage labeling.  But, while the Lanham Act authorizes private plaintiff lawsuits, the FDCA does not.  It is solely enforced by the FDA.  Id. 

The plaintiff’s Lanham Act allegations at issue in the appeal were that (i) the name “Pomegranate Blueberry” misrepresented the actual contents of the drink, and (ii) the phrase “Flavored Blend of 5 Juices” was misleadingly smaller and less conspicuous than the name “Pomegranate Blueberry.”  

But FDA regulations and the FDCA itself address naming beverages, the words and statements that must or may be included in labeling, and their prominence and conspicuousness.  Id. at *11-14 (citing 21 U.S.C. §§343(f), (i); 21 C.F.R §§102.33 (c), (d)).  That’s a conflict between plaintiff’s claims under the Lanham Act and the FDCA. 

So which applies?  The court noted that courts should “try to give as much effect to both statutes as possible.”  Id. at *8 (citing Schering--Plough Healthcare Prods., Inc. v. Schwarz Pharma, Inc., 586 F.3d 500, 508 (7th Cir. 2009)).  But when it comes to the FDCA, courts have focused on the fact that Congress entrusted the FDA with enforcement, not private plaintiffs.  Under that reasoning, courts have held that the FDCA limits all sorts of Lanham Act claims:

A plaintiff may not, for example, sue under the Lanham Act to enforce the FDCA or its regulations because allowing such a suit would undermine Congress’s decision to limit enforcement of the FDCA to the federal government.  Nor may a plaintiff maintain a Lanham Act claim that would require a court originally to interpret ambiguous FDA regulations, because rendering such an interpretation would usurp the FDA’s interpretive authority.  Where the FDA has not concluded that particular conduct violates the FDCA, we have even held that a Lanham Act claim may not be pursued if the claim would require litigating whether that conduct violates the FDCA.

Id. at *8-9 (citations omitted). 

Not surprisingly, then, the court held “that the FDCA and its regulations bar pursuit of both the name and labeling aspects of [plaintiff’s] Lanham Act claim.”  Id. at *11.  The Court reasoned, properly, that Congress and the FDA have already spoken to such naming and labeling and that the FDA, not litigants and the courts, should impose any further restrictions or, if it so finds, declare defendant’s label misleading:

Congress and the FDA have . . .  considered and spoken to what content a label must bear, and the relative sizes in which the label must bear it, so as not to deceive.  . . . [T]he FDA has not (so far as we can tell) required that all words in a juice blend’s name appear on the label in the same size or that words hew to some other standard that [plaintiff] might have us impose.  If the FDA thought such a regulation were necessary . . .  it could have said so.  If the FDA believes that more should be done to prevent deception, or that [defendant’s] label misleads consumers, it can act.

Id. at *13-14 (citations omitted).

The Court finished by explaining that it is not the place of litigation to displace the expertise of the FDA:

[W]e must respect the FDA’s apparent decision not to impose the requirements urged by [plaintiff].  And we must keep in mind that we lack the FDA’s expertise in guarding against deception in the context of juice beverage labeling. In the circumstances here, “the appropriate forum for [plaintiff’s] complaints is the [FDA].”

Id. at *16. 

That is a nice way to finish.  So enjoy your Memorial Day weekend and, if you want, your Pomegranate Blueberry juice.  But know that there might be a lot of apple and grape in that drink.  Maybe a beer or mojito  is simpler.

More Inspiration from the Courts on Commercial Speech

When most of us think of the First Amendment, commercial speech is probably not what springs to mind.  A business talking about its products doesn’t fit our classic perception of free speech.  It will never equal the “I Have a Dream” speech or stir inspiration in your soul.  But it’s important.  It really is.  The Supreme Court says so:

Advertising, though entirely commercial, may often carry information of import to significant issues of the day.  And commercial speech serves to inform the public of the availability, nature, and prices of products and services, and thus performs an indispensable role in the allocation of resources in a free enterprise system.  In short, such speech serves individual and societal interests in assuring informed and reliable decision-making.

Bates v. State Bar, 433 U.S. 350, 364 (1977). 

And, generally, the worth of the information that is put into the commercial marketplace should be determined by the speakers and the audience hearing it, not the government:

The commercial marketplace, like other spheres of our social and cultural life, provides a forum where ideas and information flourish. Some of the ideas and information are vital, some of slight worth. But the general rule is that the speaker and the audience, not the government, assess the value of the information presented.

Edenfield v. Fane, 507 U.S. 761, 767 (1993).  This means that the government should not quiet commercial speech simply for paternalistic reasons: “The First Amendment directs us to be especially skeptical of regulations that seek to keep people in the dark for what the government perceives to be their own good.” 44 Liquormart, Inc. v. Rhode Island, 517 U.S. 484, 503 (1996).

Given its importance, we have discussed the FDA and its regulation of commercial speech often, and we recently saw yet another interesting opinion in this area, Fleminger, Inc. v. U.S. Dep’t of Health & Human Servs., No. 3:10cv855 (VLB), 2012 U.S. Dist. LEXIS 22892 (D. Conn. Feb. 23, 2102).  The Fleminger case involved green tea.  Its maker petitioned the FDA for authorization to make a “health claim,” which is a claim that relates nutrients in the product with a positive health effect.  Here, the particular health claim was that the green tea may reduce the risk of breast and prostate cancers.  Id. at *25.  

Generally, the FDA will allow such a health claim if there is (i) “significant scientific agreement” supporting the claim or (ii) “credible evidence” (a lower level of evidence) supporting the claim, but then only if the claim is accompanied by an appropriate disclaimer on the lower level of the scientific evidence.  The FDA calls this second category “qualified” health claims and readily admits that it arose from court rulings against the FDA in First Amendment cases.  See, e.g., Guidance for Industry: Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements (http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/ucm053832.htm). 

Fleminger involved a “qualified health claim.”  It was “qualified” because the FDA found that the scientific evidence supporting it was “the lowest level” that could still allow such a claim.  Id. at *26-28.  Hardly a ringing endorsement from the FDA, but this is where the First Amendment steps in.  The FDA can’t stop a company from making such a claim since it has sufficient supporting evidence.  The FDA, instead, can require the company to include an appropriate disclaimer, but only one that doesn’t violate the company’s First Amendment rights. 

The controversy in Fleminger did not involve the company’s health claim – that “Green tea may reduce the risk of breast and prostate cancers.”  That is good.  The FDA has recognized that the First Amendment does not allow it to simply strike down a health claim that has some support.  The controversy in Flemering, instead, involved the disclaimer.  The company wanted:

“The FDA has concluded that there is credible evidence supporting this claim although the evidence is limited.” 

Id. at *34-35.  The FDA believed that this disclaimer overstated the scientific evidence.  It wanted:

“FDA does not agree that green tea may reduce the risk because there is very little scientific evidence for the claim.” 

Id. at *33-34.  The company balked and took the issue to court on First Amendment grounds. 

The Fleminger opinion detailed the history of decisional law on the FDA’s regulation of commercial speech and, if interested, you should read the entirety of the opinion.  We will limit our discussion, however, to the court’s consideration of whether the FDA’s rejection of the company’s disclaimer and imposition of its own disclaimer was a “reasonable fit” with the government’s interest in preventing confusion about health claims and advancing the public health.     

First, the court addressed the company’s proposed disclaimer – “FDA has concluded that there is credible evidence supporting this claim although the evidence is limited.”  The court struck this down as misleading and inaccurate, basing its decision on its deference to the FDA’s finding that there was “very little scientific evidence” to support the company’s health claim.  Id. at *50-62.  The court considered the FDA’s ranking of the evidence to be very different from the company’s claim that it was “credible . . . although . . . limited.”  What is interesting, though, is that the FDA’s own guidelines define a “qualified health claim” as one that is supported by “credible but limited evidence.”   Id. at *57.  That language is very familiar.  It’s almost the same language that the company used in its disclaimer.  So how can the company’s disclaimer be inaccurate if it essentially tracks the description of qualified health claims found in the FDA guidelines? 

Well, the court found a difference between consumers' everyday understanding of the word “credible” and its unique and technical meaning within the FDA guidelines.  The court determined that a member of the public reading a disclaimer was more likely to understand “credible” to mean “offering reasonable grounds for being believed,” which is how Webster's dictionary defines it, than to mean the lowest level of evidence, which is how it applied under the FDA guidelines in this case.  Id. at *53-54, 57-58.  This reasoning didn't help the company.  But it could help the defense in other products and device cases.  We've seen plaintiffs' counsel try to use technical terms from FDA regulations and guidelines, such as "adulterated" or "misbranded," to create a false or overly negative impression with a jury.  The reasoning of the Fleminger court, however, can possibly be used to block such efforts or get a curative instruction from the judge. 

Next, the court addressed the FDA’s proposed disclaimer and upheld the portion stating that “very little scientific evidence” supported the company’s health claim.  Id. at *67-70.  This was sheer deference to the FDA’s findings.  This ruling, however, is not surprising.  The history of this case reveals that the FDA contoured the language of its proposed disclaimers to the case law as it developed.  The FDA has been chastened over the years by previous losses in First Amendment litigation.  The FDA has finally reacted and adjusted.  “[T]he First Amendment requires that the FDA allow Fleminger’s claim,” but the FDA can require “the addition of short, succinct and accurate disclaimers as to the level of scientific support of the proposed health claim.”  Id. at *68-69.  Here, the FDA provided the court with the details of its analysis and findings on the level of scientific evidence and proposed a short, succinct clause to describe those findings.

But the court did not uphold the FDA’s entire disclaimer.  The court struck down the FDA’s proposed language that “FDA does not agree that green tea may reduce that risk.”  That is not a disclaimer.  It’s an explicit announcement of the FDA’s own opinion that was to be inserted into the Company’s speech immediately after the company’s health claim.  It would have had the impermissible  “effect of negating any relationship between green tea and the reduction of breast or prostate cancer and therefore effectively swallow[ed] the entire claim.”  Id. at *71.  In essence, it was a way around the prohibitions of the First Amendment, and the court properly did not allow it.

The story ended fairly well.  The company was allowed to exercise its First Amendment rights and state its health claim about green tea, and the FDA was not allowed to inject its own opinion into that claim.  It’s probably not inspirational or moving.  But it’s another step in what has become a very interesting area of the law.