HARRISBURG – A federal judge has denied an attempt by chocolate and candy manufacturer Hershey to dismiss litigation from four plaintiffs who claimed they suffered permanent cardiac damage as a result of eating Hershey-brand black licorice.
Jane Lavoie-Fern of Tacoma, Wash., Sherry Konwaler of Soddy Dolly, Tenn., Harvey Horowitz of Lake Worth, Fla. and Marie Bruen of Boston, Mass. filed suit in the U.S. District Court for the Middle District of Pennsylvania on July 15 versus The Hershey Company, of Hershey.
“Defendant Hershey is now, and at all times mentioned in this complaint was, in the business of producing and selling various food and beverage items, including certain black licorice products such as its Twizzlers and Good and Plenty brands. Black licorice contains the compound glycyrrhizin (also known as glycyrrhizic acid), which is the sweetening compound derived from licorice root,” the suit stated.
“Glycyrrhizin can have very harmful effects on the body, such as causing potassium levels in the body to fall dramatically, and can create harmful imbalances in other minerals such as sodium. As a result, consumption of black licorice can cause people to experience abnormal heart rhythms, high blood pressure, edema (swelling), lethargy, and/or congestive heart failure.”
The suit alleged while “many black licorice products in the United States use one or more synthetic ingredients that mimic the flavor and smell of the black licorice root and that are safer,”, the defendant “has refused to use such substitutes, and instead continues to use the dangerous glycyrrhizin compound.”
Additionally, the suit said that while Hershey has faced litigation from other plaintiffs and/or their estates, who suffered permanent atrial fibrillation or death as a result of eating their black licorice product, it has not placed any warnings on that product.
According to the lawsuit, the four plaintiffs, all ranging in age from their 50’s to their 70’s, each suffered various cardiac maladies – allegedly as a result of eating the defendant’s black licorice product – including heart failure, edema, skyrocketing blood pressure and atrial fibrillation.
Hershey’s counsel filed a motion to dismiss on Dec. 3, citing the U.S. Constitution’s Supremacy Clause as invalidating state law which runs contrary to federal law, and thus, nullifying the relief sought by the plaintiffs.
“Plaintiffs’ claims – and the underlying relief sought (mandatory food labeling and/or alteration of GRAS ingredients) – directly conflicts with the FDA’s role under federal law to establish a uniform, national policy for food safety,” the dismissal motion read, in part.
“Plaintiffs do not allege that defendant’s labeling is anything other than truthful and in full compliance with FDA regulations. Instead, by way of their state tort law claims, plaintiffs impermissibly seek to impose additional and separate labeling requirements that go far beyond those the FDA specifically determined were appropriate and required.”
According to the defendant, the plaintiffs seek to have Hershey do more than list the “common or usual name” with respect to the ingredient glycyrrhizin – but instead, to claim that without some unspecified warning language regarding the health effects of ingesting large amounts of glycyrrhizin, Hershey’s products are defective.
“Inclusion of any such warning language would be at odds with express preemption provisions contained in the regulatory scheme implemented pursuant to the Nutrition Labeling and Education Act and the Food, Drug and Cosmetic Act. Plaintiffs’ claims are therefore expressly pre-empted,” the defendant said.
The plaintiffs responded to the company’s dismissal motion with an opposing brief on Dec. 24, rejecting Hershey’s arguments to have the case thrown out.
“Defendant’s argument is wrong for several reasons. First, there is no standard of identity here for the Twizzlers or Good and Plenty products at issue, so the NLEA does not apply. In the cases cited by defendant, the courts were dealing with items that had standards of identity and regulations as to how they could be labeled. Second, there are no federal warning regulations here, so again, the NLEA would not apply. Third, this case deals with a safety warning, which is expressly exempted from the NLEA. And fourth, plaintiffs are not seeking to mandate that defendant have to do anything on its labels,” the brief stated, in part.
“Whether or not defendant placed a warning (which contrary to defendant’s naked argument, would not have to vary by state) would be defendant’s choice. However, in the absence of defendant voluntarily placing a warning on its labels, defendant leaves itself open to suits for products liability and negligence. That is a conscious business choice to be made by defendant; it is not a requirement by the States to create any sort of requirement on defendant.”
According to the plaintiffs, the NLEA expressly exempts from its pre-emptive reach safety warnings for food or any of its components, and therefore, “any pre-emption resulting therefrom, does not apply to this case.”
“Plaintiffs do not seek to hold defendant liable under any sort of unlawful or unfair business practice statute, nor a declaration that the sale of any product containing glycyrrhizin is unlawful or an unfair business practice. Nor have there been any sort of regulations from the FDA or Congress related to the use of glycyrrhizin, such that defendant using an alternative ingredient would be an obstacle to the accomplishment of a regulatory or congressional objective. As such, defendant’s case law is simply inapplicable to this case, and its argument must be rejected,” the brief stated.
UPDATE
In a July 11 memorandum opinion, U.S. District Court for the Middle District of Pennsylvania Judge Sylvia H. Rambo denied Hershey’s dismissal motion.
“Hershey’s motion fails to overcome the presumption against presumption. Assuming for the sake of argument that plaintiffs’ claims fall within the scope of the NLEA’s express pre-emption provision, they are saved from pre-emption under the statute’s safety exception. Plaintiffs’ state law claims allege that Hershey failed to warn black licorice customers about the health risks of consuming glycyrrhizin or too much glycyrrhizin, which include abnormal heart rhythms, high blood pressure, swelling, lethargy and congestive heart failure,” Rambo said.
“The central question raised by each of plaintiffs’ claims is therefore, whether, under the circumstances, Pennsylvania law requires Hershey to provide a safety warning on the label of its black licorice products regarding the health risks associated with one of the product’s components. And to the extent such a requirement is established, it would fall squarely within the language of the NLEA’s safety exception as a ‘requirement respecting a statement in the labeling of food,’ which ‘provides for a warning concerning the safety of the food or component of the food.”
Rambo further refuted Hershey’s argument that glycyrrhizin is considered generally safe by the FDA, finding that the company “offers no principled basis for concluding that such a determination precludes application of the safety exception.”
“The plain language of the statute makes clear that the safety exception applies to ‘any’ state food labeling requirement, so long as the requirement calls for ‘a warning concerning the safety’ of the food or one of its components. Nothing in the text of the safety exception, or its surrounding provisions, can be reasonably interpreted as limiting the exception’s reach to warnings about food and food additives that have not received GRAS status,” Rambo said.
“And nothing in the statute provides any indication that Congress intended to save from preemption only those food label warning requirements that conform to the prior findings and statements of the FDA. Tension may very well exist between plaintiffs’ failure to warn claims and the FDA’s GRAS designation of glycyrrhizin, but as the Third Circuit has explained, the NLEA’s statutory scheme was deliberately designed to tolerate such tension.”
Rambo concluded by saying that Hershey’s motion “urges the court to interpret the statute in a way that is not plausible.”
“Even if it were, the safety exception creates a reasonable alternative interpretation prohibiting pre-emption, which the presumption against pre-emption requires this court to accept, absent Congress’s ‘clear and manifest’ intent to pre-empt. Finding the proffered evidence of Congress’s intent to be woefully insufficient, the court will deny Hershey’s motion,” Rambo stated.
For counts of negligence and strict liability, the plaintiffs are seeking general damages, special damages, and punitive damages in an amount to be proven at trial, plus pre-judgment and post-judgment interest, attorneys’ fees, the costs and disbursements of the within action, and such other, further and different relief, which this Court deems just and proper.
The plaintiffs are represented by Walter T. Grabowski of Holland Brady & Grabowski in Wilkes-Barre, plus Jonathan Ellery Neuman of the Law Offices of Jonathan E. Neuman, in Fresh Meadows, N.Y.
The defendant is represented by Emmanuel Brown, Rebecca L. Trela and James A. Frederick of Faegre Drinker Biddle & Reath, in Philadelphia and Washington, D.C.
U.S. District Court for the Middle District of Pennsylvania case 1:21-cv-01245
From the Pennsylvania Record: Reach Courts Reporter Nicholas Malfitano at nick.malfitano@therecordinc.com