Who doesn’t love a good cup of tea? This blogger takes hers iced, unsweetened with lemon in the summer and chai with a splash of milk in the winter. Who else is on the list of tea enthusiasts? The media has reported on President Obama’s preference for morning tea over coffee. C.S. Lewis said: “You can never get a cup of tea large enough or a book long enough to suit me.” We are going to assume Eleanor Roosevelt was a tea drinker based on this quote: “A woman is like a tea bag – you can’t tell how strong she is until you put her in hot water.” Singers have been toting the benefits of tea on vocal chords for years (green tea is supposedly the favorite for many vocalists). Arthur Dent in the Hitchhiker's Guide to the Galaxy is forever in quest of the perfect cup of tea. What about Captain Jean Luc Picard (“Computer, tea, Earl Gray, hot”) or Dr. Sheldon Cooper of The Big Bang Theory (“There isn't enough chamomile tea in the world to quell the rage in my heart.”). Who doesn’t want a spot o f tea while watching Downton Abbey? And, as if to solidify the current popular trend for tea, Donald Trump even started his own line of teas (“You won't find a more lavish tea drinking experience in the world than with my exclusive collection of premium blends.”).
Sure, the increased popularity of tea may have something to do with its increased presence in pop culture, but that also might be the effect not the cause. The cause may be more directly linked to tea’s reported health benefits. And, as we know, with reported health benefits comes litigation. Particularly litigation in California. So, it shouldn’t surprise you to learn that there is litigation pending in the Northern District of California over the nutrient content and health claims of certain teas – Clancy v. The Bromley Tea Company, 2013 U.S. Dist. LEXIS 112722 (N.D. Cal. Aug. 9, 2013). It should be equally non-shocking to learn that the Clancy plaintiffs have filed a putative class action alleging, among other things, violations of California's Sherman Law (which incorporates the requirements of the FDCA) and California's Unfair Competition Law (“UCL”). Frankly, on the issue of primary importance to us – preemption -- there isn’t a whole lot to distinguish this case from some other recent California food labelling cases about which we’ve posted.
Clancy, like Kane v. Chobani, Inc., 2013 U.S. Dist. LEXIS 98752 (N.D. Cal. July 12, 2013) (post) and Brazil v. Dole Food Co., 2013 WL 1209955 (N.D. Cal. Mar. 25, 2013) (post) before it, found that plaintiff’s UCL claims based on violations of the Sherman Law were state-law parallel violation claims and therefore, not preempted. In other words, plaintiffs were not seeking to enforce the FDCA, which prohibits private causes of action, but rather California’s Sherman Law. Because the Sherman Law is identical to the FDCA, state law claims to enforce it are not different from or in addition to federal regulations. Clancy, 2013 U.S. Dist. LEXIS 112722 at *24-32.
So, if Clancy is chapter 3 of California’s book on preemption and the Sherman Law, what does it add? A rather favorable discussion of the Ninth Circuit’s recent decision in Perez v. Nidek Corp., 711 F.3d 1109 (9th Cir. 2013). You can check out our post on Perez here, but in short plaintiffs made claims for “fraud by omission” alleging they should have been informed their surgeons were using prescription medical devices for off-label uses. The Ninth Circuit ruled such claims were expressly preempted as the type of additional warning requirement prohibited by the Medical Device Amendment’s “different from or in addition to” language. And, they are impliedly preempted because whether a use is “off-label” depends on the scope of the FDA’s labeling approval. A questioning of which would amount to an unlawful private attempt to enforce the FDCA.
In its preemption discussion, the Clancy court explained that to avoid preemption plaintiffs must fall into the “narrow gap” of “suing for conduct that violatesthe FDCA, but not because the conduct violates the FDCA. Id. at *27 (emphasis in original, citing Perez). Applying that definition to food-labeling claims and distinguishing the medical device-labeling claims of Perez, the court had this say:
Plaintiff is suing for violations of the Sherman Law, not attempting to impose requirements greater than those imposed by the FDCA. The Sherman Law is limited to the requirements of the FDCA. However, it exists independently of that law, and violating its requirements would be a valid state cause of action even if the FDA ceased to exist. The sole basis of Perez's claim was the FDA status of the device, and so his claim depended entirely on the existence of the FDA. But here, Clancy's claim does not depend on the FDA, except in the sense that the Sherman Law mirrors the requirements of the FDCA.
Id. at *29-30.
For seventeen years, we’ve been trying to decipher what constitutes a parallel claim under Medtronic v. Lohr, 518 U.S. 470 (1996) -- the opinion isn’t particularly helpful. The claim remains rather muddled, but we’ve always argued that it takes more than just an allegation that defendant violated federal law. While that may satisfy the requirement that the claim be “parallel” it doesn’t meet the requirement that plaintiff advance a “state-law” claim. So, while Clancy might be distinguishing food-labeling claims under the Sherman Act, we can fully support its interpretation of Perez and what it means for medical device cases. Without a traditional, recognized state law claim, plaintiffs are left with nothing more than a claim dependent entirely on the existence of the FDA -- an exclusively federal claim that is completely preempted.
So, while Clancy falls in line with the rest of the recent Sherman Law cases, the boost to Perezis enough to lift our spirits. Well, that and a nice cup of tea.