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Last month, in Quesada v. Herb Thyme Farms, Inc., 361 P.3d 868 (Cal. 2015), the California Supreme Court did to “organic” foods what it had done to most other foods in Farm Raised Salmon Cases, 175 P.3d 1170 (Cal. 2008) – which is to expose them to still more garbage class actions over labeling that complies with federal government standards.  As we discussed here, in the Salmon cases the court had to work reasonably hard to come up with an (uncodified) food-related exception to the general ban on private enforcement of the Food, Drug & Cosmetic Act (“FDCA”).

The court had an easier job of it in Quesada because the federal statute that conferred on the Department of Agriculture the power to certify food as “organic” didn’t have a private enforcement provision similar to the FDCA’s 21 U.S.C. §337(a).  Rather, “With respect to enforcement, . . . [t]he act contemplates a cooperative state-federal enforcement regime.”  361 P.3d at 871 (citations omitted).  See also Id. at 875 (with respect to act’s section on “sanctions for misuse of the organic label,” “nothing in [it] suggests these federal remedies are intended to displace whatever state law remedies might exist”).

So why are we telling you this?  We’re not the food blog, after all.  Unlike the Salmon decision, this latest addition to food class action mania in California doesn’t even involve the FDCA.Continue Reading California Supreme Court – Presumption Against Preemption Still Around

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While some of us are naturally jacked up—have you seen Bexis in short sleeves?—others turn to supplements to build up their beach bodies.  We are not talking about the injectables favored by 1970s East German Olympians or 1980s NFL draft flops.  And certainly not the supplements advertised on late night television as more targeted enhancers. …

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Here at the DDL Blog, we write from time to time on food litigation.  You might think it’s out of left field, and sometimes we even justify our food posts by pointing out that the “F” in FDCA stands for “Food.”  But we need not be so clever.  The real reasons why we write on food cases can be summed up in two phrases:  federal preemption and class actions.  You might throw in preemption’s weaker sibling, primary jurisdiction, but that rarely applies in drug and device cases, so we won’t.  (Although we do sometimes write on primary jurisdiction, such as here)  You might also say that class actions have gone the way of the horse and buggy in the drug and device space, and you would be doing so with substantial justification. But we write on class actions anyway, both because they are interesting and because even the black swan event of class certification would have devastating consequences for our clients.

A recent food case called Mee v. IA Nutrition, Inc., No. C-14-5006, 2015 U.S. Dist. LEXIS 63038 (N.D. Cal. May 13, 2015), combines our two marquee issues—it is a class action and the plaintiffs pleaded claims that ran squarely into preemption by alleging that the defendants should have followed testing standards different from what appear in FDA regulations. This is a lesson that could translate to drugs and devices, and here is how it sets up:  The plaintiffs sued a seller of dietary supplements claiming that the defendant labeled and sold five products in a misleading and deceptive manner under California and Florida law.  Id. at **2-6.  According to the plaintiffs, the product labels misrepresented the amount of protein and amino acids in the various products, and the labels also allegedly omitted certain amino acids that were in the products and listed others than allegedly were not.  Id. 

How did the plaintiffs know these facts?  They allegedly discovered them through “scientific testing.”  Note that the quotation marks are not ours.  They were provided by the district court, which used quotations marks every time it mentioned the plaintiffs’ “scientific testing.”  According to the style manual that we used in law school, quotation marks can denote a direct quote.  Or they can denote that the phrase is being used as a euphemism, sometimes to communicate sarcasm.  We do not attribute sarcasm to this learned court, but we suspected things would not go well for the plaintiffs when we saw that the court felt compelled to demarcate their “scientific testing” as something other than “scientific” throughout its order.Continue Reading Weird “Science” = Preemption

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Anybody who watched the Mayweather-Pacquiao fight knows that a long fight does not necessarily make for an exciting fight. Thirty-six minutes of “action” can actually contain very little action. The exceedingly long decision of the court in Grocery Manufacturers Assoc. v. Sorrell, No. 5:14-cv-117, 2015 U.S. Dist. LEXIS 56147 (D. Vt. Apr. 27, 2015), has little to keep our DDL-centric attention—its discussion of preemption based on various federal statutes, including the FDCA.  As the court forcefully rejected most preemption arguments raised by trade groups whose members were likely to be affected by Vermont’s labeling rules for foods derived in whole or in part from genetic engineering, we are reminded of another dynamic from the “Fight of the Century.”  Watching live, with the volume up, a viewer might have been swayed by the cheering of the decidedly pro-Pacquiao crowd into thinking Pacquiao was doing damage during many of the too-infrequent exchanges of punches.  However, almost invariably, the slow-motion replay between rounds showed Pacquiao’s blows had been deflected and followed by a Mayweather punch to the face, the latter almost too quick to see in real time.  Similarly—or at least as similarly as pugilistic analogy allows—the court’s analysis of preemption relied on borrowing concepts from one type of preemption and applying them to another without saying what it was doing.

As our resident state historian cum travel brochure maker (and boxing aficionado) has noted here and here, Vermont has been known to do its own thing. That has included enacting peculiar statutes that unconstitutionally impinge on national commerce.  Based upon its judgment that the various federal statutes and regulations—and the pendency of federal legislation—did not do enough to inform consumers of the existence of ingredients created through some degree of genetic engineering in products they might purchase, the Vermont legislature enacted Act 120.  It contained two provisions challenged in the GMA case, one requiring packaging or site-of-sale displays disclosing the presence of ingredients derived from genetic engineering in products for sale and one prohibiting labeling or advertising describing the product as “natural” in one way or another.  (We will skip the discussion of how much genetic engineering counts, given that humans have been eating “genetically engineered” food ever since our ancestors started selectively mating captured aurochs or zebu and have known that this was a manipulation of genetics at least since Gregor Mendel started playing with peas in his abbey.)  The legislature could not say that foods with one or more genetically engineered ingredients were less safe than those without, but cared that polls showed Vermonters wanted to know about the presence of such ingredients so they can make “informed decisions” and not be “confus[ed] and dece[ived]” by claims of “natural” products.  Before Act 120 even took effect, a multi-faceted constitutional challenge was brought.  The decision we are discussing results from the Vermont AG’s motion to dismiss and the plaintiff’s motion for preliminary injunction.  If you want to read about the Commerce Clause or First Amendment issues with Act 120, knock yourself out, but we will not discuss them here.Continue Reading Going The Distance To Limit Preemption

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Those of us who have been paying at least marginal attention to developments in popular culture and product liability law—not necessarily the fanatical level of attention to these subjects paid by certain of our co-contributors—will recall that the “Cola Wars” and medical monitoring (for otherwise uninjured plaintiffs) were a big deal back in the 1980s and 1990s.  For the former, people used to pay attention to new slogans, new formulations, celebrity endorsements, and ad campaigns.  Whether one self-identified as a “Coke” or “Pepsi” person somehow mattered.  (Maybe people still do care about these things, but they do not seem to have the place in our national consciousness that they once did.)  Similarly—OK, not similarly at all, but we get latitude in an introduction like with leading questions to an expert about her qualifications at the start of direct examination—medical monitoring used to be a big deal and it was unclear where the weight of authority would eventually come down on whether manufacturers or other tort defendants might be regularly saddled with the cost of paying to monitor for diseases that had not been (and might never be) diagnosed.  In 1984—a few months after Michael Jackson’s hair caught on fire filming a Pepsi ad—Judge Starr, with Judge Bork concurring, wrote the landmark decision in Friends for All Children, Inc. v. Lockheed Aircraft Corp., 746 F.2d 816 (D.C. Circ. 1984), which is often credited with creating medical monitoring as a cause of action or type of relief, although the term “monitor[ing]” is not to be found in it.  For years after Friends, there seemed to be trend toward acceptance of medical monitoring around the country for classes of plaintiffs who would not have been able to recover damages under traditional tort principles because they did not have compensable, present injuries.  Somewhere in the early 2000s, the tide clearly shifted—for selfish reasons,  we point to Wood v. Wyeth-Ayerst Labs., 82 S.W.3d 849 (Ky. 2002), as the arguable tipping point—and the recognition of medical monitoring for uninjured people became a clear minority position.

Yet, even well into the second decade of this millennium, we still have fights over colas and medical monitoring. Today’s case is about both.  Riva v. Pepsico, Inc., No. C-14-2020 EMC, 2015 U.S. Dist. LEXIS 26494 (N.D. Cal. Mar. 4, 2015), also weaves in some of our favorites subjects, like the toxicological concept of dose, an aggressive look at pleadings, and rejecting serial amendments.  The case stems from California’s notorious Proposition 65, which has spawned litigation over the years, but requires disclosure of purported carcinogens in consumer products rather than anything approaching medical monitoring for those who consume those products.  Apparently, levels of a chemical called 4-methylimidazole (“4-Mel” in the opinion) in Diet Pepsi and Pepsi One sold in California passed the Prop 65 thresholds for disclosure in 2013.  Id. at *5.  In 2014, nine separate putative class actions were brought and, after some procedural wranglings, the court allowed an amended complaint to be filed by some plaintiffs to try to state a claim for medical monitoring on behalf of all California purchasers (not consumers) of these products over the course of about four years.  Id. at **1-2 & 6.  The defendant challenged the amended complaint on the grounds that it did not properly plead standing, the elements of medical monitoring in California, or the requirements for class certification.Continue Reading Medical Monitoring For Soft Drink Purchasers: Not The Choice For This Generation

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We like Velveeta, frozen yogurt, and Pringles—just never all at the same time.  Anyone who has ever encountered or consumed these products knows that the creamy orange substance known as Velveeta is not cheese, but is a “pasteurized prepared cheese product.”  We all know that frozen yogurt is not ice cream.  Pringles are not potato chips.  They are “potato crisps,” not to be confused with the potato “crisps” that our readers in the U.K. purchase at the shop.  (“Crisps” in the U.K. would qualify as “chips” in the U.S., but the Brits already use the word “chips” to refer to French fries, which may or may not have anything to do with British-French relations, but we digress.)

Why do these foods suffer from identity crises?

Because the FDA says so. The rules are known as food “standards of identity,” and in them the FDA sets forth the criteria that foods must meet to bear certain monikers.  Velveeta, Pringles, and frozen yogurt do not meet the identity standards to be called the foods that they aspire to be, so their sellers cannot use those names on their labels.  William Shakespeare wrote that a rose by any other name would smell as sweet.  The FDA would not agree.  You can call a chip a Pringle, but in the regulators’ minds, those are two different things, even if they smell somewhat the same.

The tie-in to the Drug and Device Law Blog is federal preemption, because the FDA’s identity standards are federal laws that have strong preemptive impact over state laws imposing different requirements.  In Nemphos v. Nestle Waters N. Am., Inc., No. 13-2146, 2015 U.S. App. Lexis 275 (4th Cir. Jan. 8, 2015), the product at issue was bottled water.  The plaintiff alleged that the bottled water, infant formula, and baby food that her baby consumed contained fluoride, resulting in a condition known as dental fluorosis.  Id. at **1-2.  According to the plaintiff, the food sellers failed to warn about the risks of dental fluorosis and engaged in misleading marketing in connection with their fluoride-containing product.  Id. at **4-5.Continue Reading Preemption: How Do You Define Water?

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Today the United States Supreme Court ruled in POM Wonderful v. Coca-Cola Co., No. 12-761, slip op. (U.S. June 12, 2014), that at least in food cases – where “the FDA does not preapprove [product] labels,” id. at 5 – the FDA’s food regulations do not preclude competitor lawsuits under another federal statute, the Lanham Act.  The opinion (by Justice Kennedy) was unanimous.

We’re mostly interested in prescription medical products, and in preemption of state product liability litigation, so what does POM mean for our clients?  Not a whole lot, at least directly.  The Court made sure, right off the bat, to explain what POM was not.  Here’s the second paragraph of the legal analysis portion (Part II) of POM:

First, this is not a pre-emption case.  In pre-emption cases, the question is whether state law is pre-empted by a federal statute, or in some instances, a federal agency action.  This case, however, concerns the alleged preclusion of a cause of action under one federal statute by the provisions of another federal statute.  So the state-federal balance does not frame the inquiry.  Because this is a preclusion case, any “presumption against pre-emption,” has no force.

POM, slip op. at 7 (citations omitted).  So anybody worried that the Court would damage the preemption arguments of either side can rest easy.  Nor is the status of the presumption against preemption changed.

Half our readership now clicks away.Continue Reading Breaking News: No FDCA Preclusion of Lanham Act Food Cases

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Have you ever heard the phrase “A Snickers Bar a day keeps the doctor away”?  Neither have we.  That is because chocolate is a dessert, a luxury, and not a food with significant health benefits.  Sure, chocolate can provide much needed energy, and a taste of chocolate from time to time won’t do a typically…

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More and more we find ourselves at parties on Oscar night.  Lately they’ve become red carpet parties.  Jeez.  We have no idea how that happened, but that’s where things are.  There’s an upside though: the alcohol.  Oh, and the snide comments.  The alcohol and the snide comments make for fun.  A couple of years ago, we stood watching yet another actor wrapped in suspect confidence and dazzling designer fabric standing in front of a microphone on the red carpet talking about [insert far away country] and how uninformed we are about its dire circumstances and how this actor was now going to inform us.  Yummy.  A guy holding a beer next to this particular DDL blogger summed things up:  “Actors.  What would we do without them?”

That’s pretty funny.  But watch out.  Lawyers may be worse. At those same parties others seem to think that you as a lawyer mysteriously have the answers to all sorts of difficult questions because your daily work-life is filled with complicated, intellectual problems that you approach in complicated, intellectual ways.  But then you leave the party, go to work the next day and deal with crazy stupid stuff.

A Ninth Circuit panel seems to have faced this same feeling 11 days ago when it wrote this opening paragraph:

Some days we are called upon to consider such profound issues as eleventh-hour death penalty appeals, catastrophic threats to the environment, intense and existential questions of civil and human rights, and the most complicated, controversial problems in civil, criminal and administrative law.  Today we consider the coating on sunflower seeds.

Lilly v. ConAgra Foods, Inc., 2014 U.S. App. LEXIS 3159, at *2 (9th Cir. Feb. 20, 2014).Continue Reading More Food Litigation in California: Attack of the Sunflower Seeds

Drug & Device Resources

Bexis’ Book

FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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