Photo of Michelle Yeary

We know the real quote attributable to Bill Gates is “content is king,”  But as communications continue to become shorter and more compressed, context can get lost in the shuffle; and context as much as content, drives our knowledge and interactions.  So, when the court in Henry v. Nissin Foods (U.S.A.) Co., opined that “context is crucial” in determining whether the reasonable consumer would have been misled, it caught our eye. 2023 U.S. Dist. LEXIS 45491, *15 (E.D.N.Y. Mar. 17, 2023).  While this particular case is about whether a food label was misleading, the issue has transportability to labeling and warnings for drugs and devices.  All too often our clients face allegations based on cherry-picked information – an isolated study or the always dreaded bad document.  Or, plaintiff’s counsel wants to focus on a portion of the labeling to the exclusion of the treating physician’s knowledge.  So, it’s our job to make sure the context is not lost. 

In this particular food case, plaintiff claimed the defendant’s label that stated “No Added MSG” misled consumers into believing that the product contained no MSG or glutamates.  But plaintiff failed to place that statement in the proper context.  On the front of the package, next to that statement was a disclaimer: “contains small amounts of naturally occurring glutamates.”  Id. at *16.  A disclaimer can defeat a claim of deception if it dispels the misleading impression given by the labeling statement at issue.  Id.  Here, the court concluded that the disclaimer “puts consumers on notice” of the possibility that the product has glutamates and therefore it “clarifies any misconception caused by the label.”  Id. at *20.  This was enough to defeat plaintiff’s various state consumer protection violation claims and breach of warranty claims. 

There is another way context was important in this case.  And that’s the difference between the context of FDA statements and state consumer protection laws defining “misleading.”  Because the context is different the court would not allow plaintiff to import FDA guidance and statements about MSG into her state-law cause of action.  In making her arguments, plaintiff relied heavily on two FDA documents (a proposed rulemaking and a backgrounder) containing statements about whether “No Added MSG” is misleading if placed on a product that contains ingredients that contain glutamates.  But, “misleading under the FDCA is not necessarily the same a “materially misleading” under state consumer protection statutes.”  Id. at *12.  For example, the FDCA definition of misleading does not include the “reasonable consumer” standard.  The FDA’s experience while germane to whether there has been a violation of the FDCA, does not extend to whether something is materially misleading under state law.  Therefore, the FDA’s statements about MSG are irrelevant to the legal issue before the court and would not be considered.   

While it does not exactly fit into our “context is king” theme – there was also a useful pleading-related holding.  “Mere allegations in a complaint that a statement would mislead a reasonable consumer do not satisfy a plaintiff’s burden at the pleadings stage.”  Id at *9.  So, maybe the tie in is plaintiff better have context rather than unsupported conclusions to withstand a TwIqbal challenge.