SHB in the Windy City

I am pleased to report that the attorneys and staff from Chicago complex  litigation boutique Grippo & Elden LLC will join your humble blogger's firm, effective March 1, 2015.

Chicago is the fourth new city for Shook over the past three years: previous additions include my location in Philadelphia (2012), Seattle (2013), and Denver (2014). Shook now has 13 office locations, two in Europe and 11 in the U.S.

Founded in Chicago in 1988, Grippo & Elden boasts significant business and commercial litigation experience, including with class actions, which our readership is particularly interested in. The firm has been widely recognized for excellence by Chambers USA and Best Law Firms/Best Lawyers®. Firm attorneys have earned membership in several prestigious, invitation-only organizations, including the American College of Trial Lawyers and Litigation Counsel of America.

The group will be located in Grippo & Elden’s current space, at 111 S. Wacker Drive. Welcome aboard!
 

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Plaintiff Cannot Broaden Class After Certification Hearing

A not uncommon tactic in class actions is for plaintiffs to propose one class definition to obtain certification (one minimizing individual issues) and then to morph the definition after certification to try to make the case easier for plaintiffs to prevails at trial.  Another evolution is to broaden the class to increase its size, and thus maximize possible damages. The Alabama Supreme Court recently rejected a class action in which the trial court had accepted a new class definition after the certification hearing. See Baldwin Mut. Ins. Co. v. McCain, No. 1131058 (Ala., 2/20/15).

On September 29, 2010, McCain filed a class complaint against her insurance company.  The genesis of the claims was that Baldwin Mutual allegedly had wrongfully been reducing the amount paid on claims made on actual-cash-value polices inasmuch as its practice was to deduct some amount for depreciation not only of the damaged materials and the labor costs of initially installing those damaged materials (based on their condition prior to the covered damage and their expected life span), but also of the labor costs associated with the removal of the damaged materials. It is improper and impossible to depreciate those labor costs, McCain argued, because they had not previously been incurred at some defined time in the past; rather, they are being incurred at the time of the current repair.

Plaintiff originally sought certification of a class of all Baldwin Mutual policyholders with insured properties in Alabama who suffered a loss in the past six years for which Baldwin Mutual had reduced the actual cash value of the same by reduction for the loss of value of un-depreciable loss elements.  But after the certification hearing, plaintiff filed a brief in further support of class certification in which she proposed a new class definition: the new definition would also include insurance customers with replacement-cost policies in addition to those with actual-cash-value policies.

After the hearing, and after the supplemental briefing, over objections from Baldwin Mutual, the lower court certified the class and adopted McCain's later, broader class definition.  Baldwin Mutual had also argued that it was improper for McCain to seek to expand the proposed class after the
class-certification hearing.

Defendant appealed, and the supreme court reversed.  The class definition proposed by McCain in her brief submitted after the class-certification hearing was materially different from the class definition offered by McCain in her original complaint – the class definition proposed following the class certification hearing, which was accepted by the trial court, also included those Baldwin Mutual customers who held replacement-cost policies. The trial court exceeded its discretion in certifying the class in accordance with a definition proposed by McCain without giving Baldwin Mutual a full and fair opportunity to oppose the certification of the proposed class at a hearing conducted for that purpose pursuant to the Alabama rules.

The class-certification order must therefore be reversed, said the state Supreme Court.
 

 

Tea Class Action Dumped Overboard

A federal court rejected a putative class action against tea maker Twinings North America, Inc. over antioxidant labeling.  See Craig v. Twinings N. Am., Inc., No. 5:14-CV-05214 (W.D. Ark., 2/5/15).

Craig allegedly purchased Twinings Irish Breakfast Tea and other varieties, and then alleged that defendant had misbranded its products.  Craig contended that Twinings mislabeled its tea as a “natural source of antioxidants” in order to charge a premium for the products. Plaintiff alleged that the “teas do not meet the minimum nutrient level threshold to make such a claim which is 10% or more of the Reference Daily Intake (‘RDI’) or the Daily Reference Value (‘DRV’) of a nutrient with a recognized RDI per reference amount customarily consumed.”  According to Craig, tea that has been labeled this way cannot be legally sold or possessed, and misbranded food has no economic value. She further contended that had she known that the misbranded teas were illegal to sell or possess, she would not have purchased the teas. Craig brought  five claims, based upon violations of the Arkansas Food, Drug, and Cosmetic Act (“AFDCA”), Ark. Code Ann. § 20-56-201, et seq.: (1)
violations of the Arkansas Deceptive Trade Practices Act (“ADTPA”), Ark. Code Ann. § 4-88-101, et seq.; (2) unjust enrichment; (3) breach of implied warranty of merchantability;  (4) breach of express warranty; and (5) negligence.

Twining moved to dismiss, arguing Craig's Complaint was preempted by the FDCA as amended by
the Nutrition Labeling and Education Act (“NLEA”). The Supreme Court has long recognized that state laws that conflict with federal law are “without effect.” Maryland v. Louisiana, 451 U.S. 725, 746 (1981).  That is, Congress has the power to preempt state laws. Fid. Fed. Sav. & Loan Ass'n v. de la Cuesta, 458 U.S. 141, 152–53 (1982). Federal preemption occurs when: (1) Congress enacts a statute that explicitly preempts state law; (2) state law actually conflicts with federal law; or (3) federal law occupies a legislative field to such an extent that it is reasonable to conclude that Congress left no room for state regulation in that field.” See generally In re Aurora Dairy Corp. Organic Milk Mktg. & Sales Practices Litig., 621 F. 3d 781, 791-94 (8th Cir. 2010). In the instant case, only express preemption was at issue.

The FDCA grants the FDA the responsibility to protect public health by ensuring that “foods are safe, wholesome, sanitary, and properly labeled.” 21 U.S.C. § 393(b)(2). There is no private right of action under the FDCA. 21 U.S.C. § 337(a). In 1990 Congress passed the NLEA, amending the FDCA, to specifically address labeling requirements for certain food and beverage products. Pub. L. No. 101–535, 104 Stat. 2353 (1990). The NLEA provides for national uniform nutrition labeling and expressly preempts state law that is inconsistent with its requirements. 21 U.S.C. § 343–1(a).


Twinings argued that Craig was making an end-run around the private action bar by indirectly bringing a claim to obtain redress for an alleged violation of the FDA labeling regulations. While the NLEA expressly preempts state labeling laws that cover certain described foods, 21 U.S.C. § 343–1, it does not preempt requirements imposed by state law that effectively parallel the NLEA. See, e.g., N. Y. State Rest. Ass'n, 556 F.3d 114, 123 (2nd Cir. 2009); In re Simply Orange Juice Mktg. & Sales Practices Litig., 2013 WL 781785, at *3 (W.D. Mo. Mar. 1, 2013); Chavez v. Blue Sky Natural Beverage Co., 268 F.R.D. 365, 370 (N.D. Cal. 2010). The purpose of the NLEA is not to preclude all state regulation of nutritional labeling, but to prevent states from adopting inconsistent requirements with respect to the labeling of nutrients. Astiana v. Ben & Jerry's Homemade, Inc., 2011 WL 2111796, at *9 (N.D. Cal. May 26, 2011); Pub. L. No. 101–535, 104 Stat. 2353, 2364 (1990). Thus, the preemption issue here was whether the label violations on which Craig based her claim impose a requirement pursuant to state law that differs from the FDCA. 

Craig’s claims were ostensibly based on the AFDCA, which impliedly adopts the federal provisions as its own. See e.g. Ark. Code Ann. 20-56-209(7) (declaring food to be “misbranded” if it falls
short of standards prescribed by the FDCA). Craig contended that any labeling violation of
the AFDCA is also a violation of the ADTPA and drives her remaining state law claims.

A claim that expressly or implicitly characterizes the level of a nutrient of the type required to be in nutrition labeling may not be made on the label or in labeling of foods unless the claim is made in accordance with federal regulation. 21 C.F.R. § 101.13(b).  The labels attached to the Complaint attest that the tea is a “natural source of antioxidants,” but did not characterize the level of the antioxidants, and thus were not nutrient-content claims as defined in the regs.  “Natural” does not modify the word “source” to indicate the level of the ingredient.. The generic phrase “natural source of antioxidants” did not appear to the court to be either an express or implied nutrient-content claim. Express claims are those that make a direct statement about the level (or range) of a nutrient in the food, and implied nutrient-content claims are those that describe a food or an ingredient in a manner that suggests that a nutrient is absent or present in a certain amount (e.g., “high in oat bran”).  Here, the challenged statement did not fall under either category, as it did not make an
explicit claim or statement regarding antioxidants.

Further, tea and coffee are exempt from certain labeling requirements if they contain insignificant amounts of all of the nutrients and food components required to be included in the declaration of nutrition information.  Antioxidants are not listed in the nutrients required to be on the label.

The court concluded that Craig’s suit could not continue, as the very crux of her argument was that the term “natural source of antioxidants” is a misbranding of Twinings’ teas, and is therefore illegal.
Even if Twinings’ labels contain nutrient-content claims, the product labels do not violate the FDA’s labeling requirements because they do not characterize the level of antioxidants.  Because Craig’s allegations did not violate the FDCA, any related state law claims arising from the same facts were preempted. If allowed to proceed, the state law claims would impose liability inconsistent with the FDCA.

Turning to Craig’s false representation claim, the Court observed that while Craig alleged that “natural source of antioxidants” is a false representation affirmatively made to her by Twinings, and she relied on this representation in making the decision to purchase the teas, Craig has not suffered actual damages as contemplated by the statute.  Craig’s alleged damages were based solely upon Twinings’ alleged violation of the FDA’s general nutrient content labeling regulations. In the instant case, Craig paid for tea and received tea. The Court could not find, therefore, that this product was “not at all what defendant represented.”

 

MDL Court Rejects Plaintiffs' New Causation Experts

The MDL judge in the Denture Cream Products coordinated litigation has rejected all of plaintiffs' general causation experts. See In re Denture Cream Prods. Liab. Litig., No. 09-2051-MD-Altonaga (S.D. Fla. Jan.. 28, 2015).

Over three and a half years ago, in Chapman. v. Procter & Gamble Distributing LLC, Case No. 9:09-
CV-80625, the MDL court had granted Procter & Gamble’s motion to exclude the opinions of Plaintiffs’ general causation experts. See In re Denture Cream Prods. Liab. Litig., 795 F. Supp. 2d 1345 (S.D. Fla. 2011) . Since Chapman, Plaintiffs claimed to have obtained new evidence in support of their argument that products like Fixodent can cause copper deficiency myeloneuropathy (“CDM”), including clinical, epidemiological, background risk of disease, and dose-response relationship. Defendants filed an omnibus Daubert Motion challenging the reliability and significance of Plaintiffs’ alleged new general causation evidence and opinions — in particular a Fixodent Blockade Study and "Dr. Lautenbach’s cohort study."  The motion argued the previously identified analytical gaps in Plaintiffs’ chain of general causation still remained. In particular, Defendants contended that Plaintiffs still could not establish any of the following, that: (1) someone can ingest enough zinc from Fixodent to place the body in a negative copper balance; (2) a prolonged negative copper balance from denture cream use can lead to a copper deficiency; (3) a dose-response relationship exists between Fixodent and copper deficiency, much less myeloneuropathy; (4) Fixodent users face a greater risk of developing myeloneuropathy than the general population; or (5) a physiological mechanism explains how a copper deficiency can lead to a myeloneuropathy.

The alleged decades’ worth of underlying scientific literature” Plaintiffs relied on to prove general causation — most of which was presented in Chapman — pertained to excess zinc and copper deficiency, or copper deficiency and neurological disorders; it is not specific to the zinc compound in Fixodent. Particularly in light of the millions of consumers who have regularly used Fixodent for
decades without complaint, see Chapman, 766 F.3d at 1304 , the Court concluded first that Plaintiffs had not demonstrated the medical community generally recognizes the zinc compound in Fixodent as a known toxin, and thus the Court undertook an extensive Daubert analysis on the general question of whether Fixodent can cause CDM, in light of the allegedly new evidence. The Court examined Plaintiffs’ new evidence in support of proving general causation, including epidemiological studies, dose-response analysis, and the background risk in particular.

The opinion is quite lengthy, and worth a close read for readers with Daubert issues in toxic tort cases.  A few highlights:  Plaintiffs sought to rely on a recently conducted study supposedly showing the short term effects of zinc in the body.  But the Court could not "turn a blind eye to the myriad, serious methodological flaws in the Fixodent Blockade Study," which did not go just to the weight of the evidence. While some of these flaws, on their own, might not have been serious enough to justify exclusion of the Fixodent Blockade Study; taken together, the Court found this Fixodent Blockade Study was not “good science,” and was not admissible.   Consequently, Plaintiffs still had no evidence of the zinc in Fixodent’s ability to inhibit copper absorption at the relevant site of action — the intestines.

Plaintiffs relied on the opinions of a Dr. Grainger, on dose-response and relying on in vitro studies. Defendants argued Dr. Grainger’s opinions were unreliable because Dr. Grainger did not offer any explanation of how zinc dissociation properties observed in in vitro release designs would transfer to a live human, and did not consider factors that might allow him to make such an extrapolation. The court agreed that Dr. Grainger’s opinions were unreliable. The in vitro dissociation studies were the foundation for all of Dr. Grainger’s conclusions. The portion of his report dedicated to these studies was completely devoid of any pertinent details or analysis. His comments regarding “various in vitro release designs”  lacked support citations, and lacked any discussion about the study designs or methodology, and any details about the individual study results. See Ballard v. Keen Transp., Inc., No. 4:10-cv-54, 2011 WL 474814, at *4 (S.D. Ga. Feb. 3, 2011) (expert’s failure to cite any specific chapter, page, or line on which he based his conclusions “makes it appear that he is not being as careful in his litigation consulting as he is in his ordinary professional work.”).  Dr. Grainger’s failure to explain the relevancy of the in vitro studies to humans or to account for factors needed to make a proper extrapolation was notable given his critique of studies the defendants had relied on.  Accordingly, the court concluded, "In short, Plaintiffs are not much better off than they were at the time of Chapman."

The MDL court also noted that epidemiology is “generally considered to be the best evidence of causation in toxic tort cases.” Kilpatrick, 613 F.3d at 1337 n.8.  Epidemiology is the field of public health and medicine that studies the incidence, distribution, and etiology of disease in human populations. . . . Epidemiologic evidence identifies agents that are associated with an increased risk of disease in groups of individuals, quantifies the amount of excess disease that is associated with an agent, and provides a profile of the type of individual who is likely to contract a disease after being exposed to an agent. Epidemiology focuses on the question of general causation (i.e., is the agent capable of causing disease?) Green, REFERENCE MANUAL ON SCIENTIFIC EVIDENCE 3d ed., at 551–52.  There are two classes of epidemiological evidence: analytical and descriptive. See In re Denture Cream Prods. Liab. Litig., 795 F. Supp. 2d at 1353–54.  Analytical evidence consists of randomized controlled trials, case control studies, and cohort studies, while descriptive evidence consists of case studies and case series. 

Plaintiffs claimed they now had analytical epidemiological evidence to support their theory of general causation — Dr. Lautenbach’s cohort study.  However, Dr. Lautenbach’s cohort study did not account for the lack of information pertaining to the subjects’ denture cream usage, and it was based on the assumption this information was appropriately taken into account by the underlying treating physicians.  Dr. Lautenbach also assumed the treating physicians took into account the amount of denture cream use, claiming it was obviously a volume high enough to trigger that as a designation for physicians.  The court concluded that the extent of Dr. Lautenbach’s reliance was a
complete delegation of his responsibilities as an epidemiologist to assess the subjects’ exposure. The study had severe limitations as a reliable foundation for building a cohort study to formally assess the association between zinc-containing denture cream and CDM. At its core, the basis for Dr. Lautenbach’s cohort study was merely a summary of a collection of case reports, with severely inadequate information about denture cream usage. The layers of unsupportable estimations and
approximations, added to this already shaky foundation, confirmed the Court’s finding that Dr.
Lautenbach’s cohort study was unreliable evidence of general causation.

While plaintiffs had presented "a superficially appealing hypothesis that prolonged use of very large amounts of Fixodent may cause copper deficiency," the law requires more than a general theme to support causation, said the court.  Without Dr. Lautenbach’s cohort study, Plaintiffs continued to have no analytical epidemiological evidence on which to base their inference of causation. In addition to the absence of any analytical epidemiological studies, the absence of data on the background risk of CDM also remained a substantial weakness in Plaintiffs’ experts’ causal reasoning. When analyzing an expert’s methodology in toxic tort cases, the court should pay careful attention to the expert’s testimony about the dose-response relationship. The dose-response  relationship is a relationship in which a change in amount, intensity, or duration of exposure to an agent is associated with a change — either an increase or decrease — in risk of disease. For most types of dose-response relationships following chronic (repeated) exposure, thresholds exist, such that there is some dose below which even repeated, long-term exposure would not cause an effect in any individual.  See generally CASARETT AND DOULL’S TOXICOLOGY: THE BASIC SCIENCE OF POISONS Chs. 1, 4 (McGraw Hill 6th ed.2001).  Often low dose exposures — even for many years — will have no consequence at all, since the body is often able to completely detoxify low doses before they do any damage.  Even Plaintiffs conceded that Fixodent “is safe when used in moderate amounts.” 

So, the Court again found Plaintiffs had not presented sufficient proof of general causation using the indispensable primary methodologies identified by the Eleventh Circuit.

 

State Supreme Court Reinstates Defense Jury Verdict in Silica Litigation

The Mississippi Supreme Court confirmed last week that the jury could have properly determined that plaintiff's evidence failed to prove in a silica case that he was exposed to harmful quantities of a particular supply company's sand product.  See Dependable Abrasives v. Pierce,  No. 2013-IA-01162-SCT (Miss., 1/29/15).  "Product id", as it is often called, is really part of cause-in-fact, and part of plaintiff's causation burden in a toxic tort case.

Plaintiff sued a number of defendants, alleging their sand products were responsible for his diagnosis of silicosis. According to Pierce's trial testimony, his job involved a work week of five to seven days, depending on weather, and workdays of eight to ten hours, operating a sandblasting machine.  It would shoot out sand at a high rate of speed through a nozzle, which was wielded by the machine's user, in order to clean surfaces for painting. Pierce testified that the sand proceeds from the nozzle at a rate of 500 miles per hour and that, when sand hits metal, it ricochets back in the direction of the machine's user. Plaintiff's expert testified that the warning on defendants' sand products were grossly inadequate, because it failed to inform the user of the product of the latent, danger of respirable silica.

At trial, the parties disagreed about whether the plaintiff was actually exposed to this defendant's sand. Pierce claimed he remembered the bag and could identify the logo.  He recalled there was a warning on the bag, but when asked the color of the sand he used from Dependable, he was certain it was white sand.  Dependable Abrasives had bought the sand, processed it, and at the relevant time mostly sold it in tanker trucks.  It was "in the beginning mostly probably around 90 percent bulk sand; 10 percent bag sand." Dependable offered evidence that while its competitors sold white sand, defendant sold brown sand "mined out of the red clay hills of Wiggins, Mississippi."

The jury returned a defense verdict, but the appellate court entered an order granting the plaintiff a new trial after that court found the verdict to be "against the overwhelming weight of the evidence presented at trial."

The Supreme Court noted that the fact of product exposure is a threshold question in products liability cases: "[I]t is incumbent upon the plaintiff in any products liability action to show that the defendant's product was the cause of the plaintiff's injuries." Banks ex rel. Banks v. Sherwin-Williams Co., 134 So. 3d 706, 710 (Miss. 2014). Even accepting as true Pierce's allegation that the warnings on the Diamond Blast sand were "grossly inadequate," as posited by his expert, there could be no recovery if Pierce failed to prove that the Defendant's sand "caused the damage for which recovery is sought."

Dependable contended that the evidence showed that there were only narrow time periods during which Pierce could possibly claim exposure, and that Pierce could not recall where or when he used or was exposed to Defendant's brand of sand. While Pierce was able to identify the Dependable Abrasives bag, he could not correctly identify the sand itself. He testified that the sand was white, but there was un-contradicted testimony that this company's sand was distinctly brown in color, due to its extraction from the red clay hills in or near Wiggins, Mississippi. There was testimony that defendant never sold sand, directly at least, to any of the companies for which Pierce had worked.

The Supreme Court decided that the circuit court had failed to analyze whether the jury's determination of causation truly was against the overwhelming weight of the evidence. Even though evidence was presented regarding the extent of Pierce's exposure to respirable silica, with respect to Dependable Abrasives, the evidence on product identification was mixed.  Pierce remembered the bag and the warning label, but could not accurately recall the color of the sand, the very product that he alleged had caused his injuries. If he was exposed at all, the time frame in which Pierce could have worked with Defendant's sand was minimal. Indeed, said the court, the evidence in this case was more favorable to the defense than to the plaintiff.  So, under the facts presented, this jury's  conclusion cannot be said to have been "against the overwhelming weight of the trial evidence.  The jury should have been permitted to pass upon the question of fact raised by this conflicting evidence, and it did so.  No new trial.