Man unsure of the safety of his medicine

Breaking news and expert analysis on legal and compliance issues

[Back To Home][Back To Archives]

From Products Liability Law Daily, January 9, 2015

Warning defect claims against Nestle, Gerber and Dannon preempted in fluoride tooth damage case

By Bryant Storm, J.D.

The U.S. Court of Appeals for the Fourth Circuit held that federal law preempted the state law claims of a mother who brought tort and fraud challenges against the manufacturers of bottled water, infant formula, and baby food because of aesthetic damage it caused to her daughter’s teeth. The court affirmed the holding of a federal district court, concluding that the state law claims sought to impose requirements that were not identical to the uniform federal labeling requirements (Nemphos v. Nestle Waters North America, Inc., January 8, 2015, Wilkinson, J.).

Background. Michelle Nemphos filed suit under Maryland state law against Nestle Waters North America, Inc., Nestle USA, Inc., The Dannon Company Inc., and Gerber Products Company related to the dental fluorosis that Nemphos’ minor daughter allegedly developed as a result of ingesting the manufacturers’ water, infant formula, and baby food products. After consuming the manufacturers’ products throughout her childhood, Nemphos’ daughter developed dental fluorosis, an aesthetic condition characterized by specks of discoloration, mottled enamel, and pitting of the teeth, allegedly from Nemphos’ reliance on the fact that fluoridated products was beneficial for her daughter’s teeth. Dental fluorosis occurs when young children ingest excessive quantities of fluoride over extended periods of time. Nemphos’ suit alleged claims for strict liability, negligence, breach of implied warranties, fraud, negligent infliction of emotional distress, and violation of the Maryland Consumer Protection Act.

District court. At the district court level, all of the claims were dismissed on the grounds that they were preempted by federal law because the Food, Drug, and Cosmetic Act (FDC Act) (21 U.S.C. § 301 et seq.) expressly preempts state attempts to create food labeling requirements that are different or additional to Food and Drug Administration (FDA) requirements (see the Products Liability Law Daily August 23, 2013, analysis). On appeal, Nemphos asserted that her claims related to Dannon and Nestle’s bottled water products were not preempted because those products failed to adequately warn consumers as to the risks of dental fluorosis.

Standard of identity. The court held that under uniform food labeling standards set by the Nutrition Labeling and Education Act of 1990 (NLEA) (P.L. 101-535), the FDC Act, and the related express preemption provisions, the FDA has the sole authority to set the “standard of identity” and labeling requirements for food products. Accordingly, the court reasoned, states are prevented from creating standard or labeling requirements that are not “identical to the federal requirement.” The court noted that under the FDA’s standard of identity for bottled water (21 C.F.R. Sec. 165.110), manufacturers may add fluoride up to certain levels, and because the bottled water manufacturers complied with those fluoride level requirements, the manufacturers were deemed to have complied with FDA regulations and were, therefore, not otherwise required to warn Nemphos regarding the fluoride content of their products. Similarly, because the FDA standard of identity for bottled water require no specific warning regarding dental fluorosis, the court reasoned that any claims requiring that the manufacturers have such a warning were preempted because they created non-identical food labeling standards.

Misleading marketing. Nemphos also asserted that Dannon and Nestle misleadingly marketed their fluoridated bottled water products by asserting that they were especially beneficial to children. The court concluded that the misleading marketing claim was a failure-to-warn claim in disguise and therefore conflicted with the standard of identity preemption requirements that invalidated Nemphos’ other claims.

Formula and food. The court similarly rejected Nemphos’ failure-to-warn claims regarding the risk of dental fluorosis posed by Nestle and Gerber’s infant formula and baby food. The court held that Nemphos failed to state a failure-to-warn claim because she did not point to any violation of federal regulation or allege that the manufacturers added fluoride to their products. The court held that it would be unreasonable to impose an obligation for food manufacturers to warn consumers about dental fluorosis when the manufacturers themselves were prohibited from adding additional fluoride to their food products. The court dismissed the vague and conclusory allegations regarding infant formula and baby food. Because Nemphos’ third amended complaint failed to state a claim and because she failed to follow local court rules when requesting leave to amend, the Fourth Circuit held that the district court appropriately dismissed the case with prejudice and denied Nemphos “a fourth bite at the apple.”

The case number is No. 13-2146.

Attorneys: Leslie Agnes Brueckner (Public Justice, PC) for Michelle Nemphos. Lauren S. Colton (Hogan Lovells U.S. LLP) for Nestle Waters North America, Inc., Nestle U.S.A., Inc., and Gerber Products Co. Peter Buscemi (Morgan Lewis & Bockius, LLP) for The Dannon Company, Inc.

Companies: Nestle Waters North America, Inc.; Nestle U.S.A., Inc.; Gerber Products Co.; The Dannon Company, Inc.

MainStory: TopStory WarningsNews PreemptionNews FoodBeveragesNews MarylandNews NorthCarolinaNews SouthCarolinaNews VirginiaNews WestVirginiaNews

Products Liability Law Daily

Introducing Wolters Kluwer Products Liability Law Daily — a daily reporting service created by attorneys, for attorneys — providing same-day coverage of breaking news, court decisions, legislation, and regulatory activity.

A complete daily report of the news that affects your world

  • View full summaries of federal and state court decisions.
  • Access full text of legislative and regulatory developments.
  • Customize your daily email by topic and/or jurisdiction.
  • Search archives for stories of interest.

Not just news — the right news

  • Get expert analysis written by subject matter specialists—created by attorneys for attorneys.
  • Track law firms and organizations in the headlines with our new “Who’s in the News” feature.
  • Promote your firm with our new reprint policy.

24/7 access for a 24/7 world

  • Forward information with special copyright permissions, encouraging collaboration between counsel and colleagues.
  • Save time with mobile apps for your BlackBerry, iPhone, iPad, Android, or Kindle.
  • Access all links from any mobile device without being prompted for user name and password.