Hasemann v. Gerber Prods. Co.
| Decision Date | 28 September 2016 |
| Docket Number | 15-CV-2995 (MKB) |
| Parties | JENNIFER HASEMANN and DEBBIE HOTH, individually and on behalf of all others similarly situated, Plaintiffs, v. GERBER PRODUCTS CO., d/b/a Nestlé Nutrition, Nestlé Infant Nutrition or Nestlé Nutrition North America, Defendant. |
| Court | U.S. District Court — Eastern District of New York |
Plaintiffs Jennifer Hasemann and Debbie Hoth commenced the above-captioned putative class action on behalf of themselves and all others similarly situated against Defendant Gerber Products Co., doing business as Nestlé Nutrition, Nestlé Infant Nutrition or Nestlé Nutrition North America. (Compl., Docket Entry No. 1.) Plaintiffs allege claims for (1) deceptive, misleading and unfair practices in violation of the Florida Deceptive and Unfair Trade Practices Act, Fla. Stat. § 501.201 et seq. (the "FDUTPA"); (2) misleading advertising in violation of Florida Statutes § 817.41; (3) untrue, deceptive and misleading practices in violation of the Wisconsin Deceptive Trade Practices Act, Wis. Stat. § 100.01 et seq. (the "WDTPA"); and (4) false representations in violation of Wisconsin Statutes §§ 895.446 and 943.20. (Id. at ¶¶ 82-127.) Plaintiffs seek actual, statutory and punitive damages, restitution and disgorgement, and injunctive relief. (Id. at 29.) Defendant moves to dismiss or stay the action pursuant to the primary jurisdiction doctrine, dismiss Plaintiffs' claims for injunctive relief pursuant to Rule 12(b)(1) of the Federal Rules of Civil Procedure and dismiss the Complaint pursuant to Rule 12(b)(6) of the Federal Rules of Civil Procedure for failure to state a claim. (Def. Mot. to Dismiss ("Def. Mot."), Docket Entry No. 23; Def. Mem. of Law in Supp. of Def. Mot. ("Def. Mem."), Docket Entry No. 23-1; Def. Reply Mem. of Law in Further Supp. of Def. Mot. ("Def. Reply"), Docket Entry No. 25.)
For the reasons set forth below, the Court declines to dismiss or stay this matter pursuant to the primary jurisdiction doctrine and finds that Plaintiffs do not have standing to seek injunctive relief. The Court grants Defendant's motion to dismiss Plaintiffs' claim under Wisconsin Statutes § 100.18 and denies Defendant's motion to dismiss Plaintiffs' claims under the FDUTPA, Florida Statutes § 817.41, Wisconsin Statutes § 100.20 and Wisconsin Statutes §§ 895.446 and 943.20.
The facts alleged in the Complaint are assumed to be true for purposes of this motion. Plaintiffs' claims arise from Defendant's advertising and marketing of its "Good Start" line of infant formula (the "Infant Formula"). Plaintiffs allege that Defendant's advertising and marketing misrepresent that the Infant Formula reduces the risk that infants will develop allergies, and also misrepresent that the Infant Formula is the first and only infant formula that the Food and Drug Administration (the "FDA") endorses to reduce the risk of infants developing allergies. (Compl. ¶¶ 2-3.)
Since at least 2011, Defendant has manufactured, distributed and sold the Infant Formula, and has advertised the Infant Formula through television, print media, product labeling and on the Internet. (Id. ¶ 19.) The Infant Formula contains partially hydrolyzed whey protein, which is the ingredient that is purportedly responsible for the Infant Formula's ability to reduce the risk of developing allergies. (Id. ¶ 20, 27.)
In June of 2005, Defendant petitioned the FDA for approval of a qualified health claim1 to use in its marketing of the Infant Formula. (Id. ¶ 27.) Defendant sought approval to state that "emerging clinical research in healthy infants with family history of allergy shows that feeding a 100% Whey-Protein Partially Hydrolyzed formula may reduce the risk of common food allergy symptoms, particularly allergic skin rash." (Id.) The FDA denied Defendant's petition on May 11, 2006, concluding that there was "no credible evidence to support the qualified health claim relating consumption of 100 percent partially hydrolyzed whey protein in infant formula to a reduced risk of food allergy." (Id. ¶ 28.)
In May of 2009, Defendant again petitioned the FDA to approve a qualified health claim, stating:
emerging clinical research shows that, in healthy infants with family history of allergy, feeding a 100% Whey-Protein Partially Hydrolyzed infant formula instead of a formula containing intact cow's milk proteins may reduce the risk of developing the most common allergic disease of infancy — atopic dermatitis — throughout the 1st year of life and up to 3 years of age.
(Id. ¶ 29.) The FDA determined that this claim mischaracterized the scientific evidence and was therefore misleading. (Id. ¶ 30.) The FDA instead proposed four alternative qualified health claims, over which it would consider exercising its enforcement discretion not to challenge the qualified health claim.2 (Id. ¶ 32.) The FDA required that, if Defendant opted to use any of the four qualified health claims, Defendant also add a qualifying statement to its labeling. (Id. ¶ 33.) The qualifying statement specified that:
Partially hydrolyzed formulas should not be fed to infants who are allergic to milk or to infants with existing milk allergy symptoms. If you suspect your baby is already allergic to milk, or if your baby is on a special formula for the treatment of allergy, your baby's care and feeding choices should be under a doctor's supervision.
(Id. (the "qualifying statement") (emphasis omitted).)
Plaintiffs allege that, "since at least 2011," Defendant has marketed and advertised the Infant Formula using false and misleading representations. (Id. ¶ 42.) Plaintiffs allege six examples of the allegedly false and misleading representations: a statement on the seal of the Infant Formula that it is the "1st & only routine formula to reduce the risk of developing allergies," ; a statement on the label of the Infant Formula that it is "the first and only formula brand made from 100% whey protein hydrolyzed, and that meets the criteria for a FDA Qualified Health Claim for atopic dermatitis," (Compl. ¶ 44, 47; Ex. B, annexed to Compl.); a television commercial stating in relevant part: (Compl. ¶ 48 (alterations in original); Ex. C, annexed to Compl.); a print advertisement stating:
(Compl. ¶ 49; Ex. D, annexed to Compl.); and two additional print advertisements stating that it is the "the first and only infant formula that meets the criteria for a FDA Qualified Health Claim." (Compl. ¶¶ 50-51; Ex. E, annexed to Compl.; Ex. F, annexed to Compl.)
According to Plaintiffs, these representations can be categorized as making two deceptive representations: (1) that the Infant Formula reduces the risk that infants will develop allergies, and (2) that the Infant Formula meets the criteria for an FDA qualified health claim for atopic dermatitis. As to the representation that the Infant Formula "reduce[s] the risk of [infants] developing allergies," Plaintiffs allege that it is false because the FDA rejected this claim in May 2006, and the scientific evidence demonstrates that this claim is false. (Compl. ¶¶ 43, 48-49, 53.) In support of this argument, Plaintiffs allege that several scientific studies have concluded that partially hydrolyzed whey protein does not lower the risk that infants will develop allergies. (Id. ¶ 34.) Plaintiffs cite to a June of 2011 study by Adrian Lowe, Ph.D., University of Melbourne and Melbourne Royal Children's Hospital, which concluded that "[t]here was no evidence that introducing pHWF [(partially hydrolyzed whey formula)] at the cessation of breast-feeding reduced the risk of allergic manifestations, including eczema, asthma, and allergic rhinitis, in [a] study of high-risk infants." (Id. ¶ 35 (alterations in original) (quoting Adrian J. Lowe, Effect of a Partially Hydrolyzed Whey Infant Formula at Weaning on Risk of Allergic Disease in High-Risk Children: A Randomized Controlled Trial, 128 J. Allergy & Clinical Immunology 2, 360-65.e4 (2011)).)
As to the representation that the Infant Formula meets the criteria for an FDA qualified health claim for atopic dermatitis, Plaintiffs allege that this representation is deceptive because it not one of the four qualified health claims that the FDA approved and, in addition, because Defendant did not include the qualifying statement as required by the FDA. (Id. ¶¶ 44, 50-51, 53.)
On October 31, 2014, the FDA sent a warning letter to Defendant's President and CEO "outlining various false and misleading representations made in the promotion of [the Infant Formula]" (the "FDA Warning Letter"). (Id. ¶ 56.) After reviewing the labeling on the Infant Formula that was sold as a 23.2 ounce milk-based powder, the FDA concluded that the labeling on the Infant Formula bore "health claims that were not authorized by FDA" and that "the labeling [was] misleading."3 (FDA Warning Letter 1, annexed to Decl. of Geoffrey Castello, Docket Entry No. 23-2, as Ex. 4.) The FDA also noted that it had "previously considered and denied" the statement on the label of the Infant Formula that it was the "1st & only routine formula to reduce risk of developing allergies." (Id. at 2 (capitalization omitted).) The FDA acknowledged that...
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