A new study exploring the link between cardiovascular disease and a gut bacteria metabolite known as trimethylamine-N-oxide (TMAO) has reported that “higher TMAO levels predict higher future risk of death from heart failure, independent of other clinically used blood tests or risk factors.” W.H. Wilson Tang, et al., “Prognostic Value of Elevated Levels of Intestinal Microbe-Generated Metabolite Trimethylamine-N Oxide in Patients With Heart Failure: Refining the Gut Hypothesis,” Journal of the American College of Cardiology, November 2014. Led by the Lerner Research Institute’s Department of Cellular and Molecular Medicine Chair Stanley Hazen, a Cleveland Clinic team followed 720 patients with stable heart failure over a five-year follow-up period, finding that “higher plasma TMAO levels were associated with a 3.4-fold increased mortality risk.” They also noted that patients with elevated levels of TMAO and B-type natriuretic peptide “had more than a 50 percent mortality rate over [five] years.” This latest study builds…
Category Archives Issue 544
The Center for Science in the Public Interest (CSPI) has submitted a request to the U.S. Food and Drug Administration (FDA) under the Freedom of Information Act for “the data collected by the Center for Veterinary Medicine under its Raw Milk Drug Residue Survey.” According to CSPI, FDA conducted the survey in 2012 “because excess and sometimes illegal drugs are more frequently found in animals from dairy farms at slaughter plants than animals coming from other sources.” CSPI’s review of drug testing reports in 2011 purportedly revealed that “animals coming from dairy farms accounted for 67 percent of reported drug residue violations at slaughter” and that, in some cases, “the reported residues were for drugs that are not approved for use in cattle.” While FDA informed consumer groups that it would make the raw data available when its report is released, it has yet to release the survey results. CSPI attorney…
Bob Evans servers who were paid under the “tip credit” provisions of the Fair Labor Standards Act (FLSA) claim in a collective action filed in a Florida federal court that they “were not compensated at least the proper minimum wage for all hours worked as a result of being required to pay for uniforms.” McDaniel v. Bob Evans Farms, LLC, No. 14-2767 (M.D. Fla., filed November 3, 2014). Named plaintiff Emily McDaniel alleges that she was paid an hourly rate of $4.77 plus tips, which increased to $4.91 plus tips, and that she and other servers “were required to pay Defendant for uniforms, including but not limited to, Bob Evans T-shirts and aprons.” She claims that this resulted in an FLSA violation because servers “have not been paid the minimum wage for each hour worked during their employment.” She seeks certification of a class of servers, declaratory relief and awards of…
A California resident has filed a putative nationwide class action in federal court against Olé Mexican Foods, Inc., alleging that its Xtreme Wellness® whole-wheat tortillas contain partially hydrogenated vegetable oil, “banned in many parts of the world due to its artificial trans fat content,” thus belying the health and wellness representations the company uses on product labels. Guttmann v. Olé Mexican Foods, Inc., No. 14-4845 (N.D. Cal., filed October 31, 2014). The plaintiff alleges that artificial trans fat causes cardiovascular disease; Type 2 diabetes; breast, prostate and colorectal cancer; Alzheimer’s disease and cognitive decline; and damage to vital organs. He claims that he purchased one package each month for two years at a higher price than comparable products relying on package labeling stating “Healthy Life Style,” “Better Choice for Your Health,” “Whole Wheat,” and “High Source of Fiber and Protein.” According to the complaint, because the product contains trans fat, small amounts…
The Center for Food Safety and two other public interest organizations have filed a lawsuit against the U.S. Food and Drug Administration (FDA) seeking to overturn its approval of 11 animal drugs containing ractopamine hydrochloride on the ground that the agency failed to undertake the analysis purportedly required under the National Environmental Policy Act (NEPA) before approving them. Ctr. for Food Safety v. Hamburg, No. 14-4932 (N.D. Cal., filed November 6, 2014). The Center previously petitioned FDA to reduce the allowable levels of ractopamine, administered in animal feeds to boost growth and leanness in meat production, and to study its potential effects on human health and animal welfare. Information about the petition appears in Issue 466 of this Update. The complaint sets forth the effects these drugs allegedly have on livestock, like pigs, and on the environment. The plaintiffs claim that the company that makes ractopamine has acknowledged the “risk…
Days after the U.S. Federal Trade Commission (FTC) filed a lawsuit to enjoin Gerber Products Co. from claiming that its Good Start® Gentle infant formula helps reduce allergies in children, a consumer filed a putative class action in Arizona federal court alleging the same facts. Werthe v. Gerber Prods. Co., No. 14-8216 (D. Ariz., filed November 3, 2014). Additional information about FTC’s lawsuit against Gerber appears in Issue 543 of this Update. Like the FTC complaint, the consumer action alleges that Gerber advertises the partially hydrolyzed whey protein (PHWP) in its Good Start® Gentle formula as reducing the risk of atopic dermatitis in infants. As a result, Gerbercharges “a significant premium” over other infant formulas, the plaintiff asserts. The complaint cites Gerber’s labeling, which allegedly promises thatits product is the “1st & Only Routine Formula to Reduce the Risk of Developing Allergies” and that it “Meets FDA [U.S. Food and Drug…
Reversing a lower-court decision, a California appeals court has ruled that state dram shop statutes—meant to protect some sellers of alcohol beverages from liability for injuries related to the beverages’ consumption—do not provide immunity for City Brewing Co. in a lawsuit alleging that the company was negligent in producing Four Loko. Fiorini v. City Brewing Co., No. F067046 (Cal. Ct. App., 5th Dist., order entered November 6, 2014). After drinking two 23.5-ounce cans of Four Loko, the plaintiff’s son was shot to death by police in October 2010. The plaintiff alleged that City Brewing, which brewed, bottled and labeled Four Loko, was liable for negligence for producing an alcohol beverage in a nonresealable can apparently containing alcohol “equivalent to five or six 12-ounce cans of beer” and “as much caffeine as two cups of coffee” because “combining alcohol, a depressant, with caffeine and other stimulants created a product that had unreasonably…
An Illinois federal court has declined to certify a class in a lawsuit alleging that Skinnygirl Margarita, a pre-mixed alcohol beverage sold by Skinnygirl Cocktails, and its founder, Bethenny Frankel of reality show "The Real Housewives of New York City" and talk show "Bethenny," was labeled as “all natural” despite containing the non-natural preservative sodium benzoate. Langendorf v. Skinnygirl Cocktails, LLC, No. 11-7060 (N.D. Ill., order entered October 30, 2014). The plaintiff sought to represent a class of all consumers who purchased Skinnygirl Margarita spirits in Illinois after March 1, 2009, but the court identified several shortcomings with the proposed class. First, the court found that the plaintiff failed to offer a valid method to identify the purchasers. “Plaintiff says class membership can be verified by the dates of purchase, the locations of retail establishments, the frequency of purchases, the quantity of purchases, and the cost of purchase, but does not…
A California federal court has granted a motion for reconsideration in a case alleging that Wallaby Yogurt Co. includes “evaporated cane juice” (ECJ) on its ingredient lists rather than what plaintiffs allege is the more common name, sugar. Morgan v. Wallaby Yogurt Co., No. 13-296 (N.D. Cal, order entered November 5, 2014). Wallaby had moved for reconsideration of prior orders allowing the case to proceed. The text-only docket indicates that the motion for reconsideration has been granted and the case stayed, with a written order to follow. The stay follows a series of similar actions in other cases after the U.S. Food and Drug Administration (FDA) announced in March 2014 that it would reconsider its 2009 draft guidance discouraging use of the term. In two similar putative class actions, courts have extended stays originally imposed in May 2014 because FDA has not yet issued further guidance. Figy v. Lifeway Foods, No.…
A federal court in California has decertified a damages class in litigation alleging that Dole Packaged Foods, LLC misleads consumers by labeling 10 of its fruit products as “All Natural Fruit” because they contain allegedly synthetic ingredients ascorbic acid and citric acid. Brazil v. Dole Packaged Foods, LLC, No. 12-1831 (N.D. Cal., order entered November 6, 2014). The court found flaws in the regression model that the plaintiff’s expert (Oral Capps) used to determine the price premium attributable to the company’s use of the “All Natural Fruit” label statements, finding that the model “does not sufficiently isolate the price impact” of the labeling statement. The court disagreed with Dole that the expert performed a “price” regression rather than a “sales” regression and thus “measured the wrong thing.” According to the court, while the initially proposed analysis differed from the one actually carried out, given that the expert had initially proposed…
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