Class Action Claims TopCare Infants’ Pain Reliever ‘Exactly the Same’ as Cheaper Children’s Product [UPDATE]
by Erin Shaak
Last Updated on July 21, 2021
Harris v. Topco Associates, LLC
Filed: July 24, 2020 ◆§ 1:20-cv-04355
A lawsuit claims Topco Associates sells infants’ and children’s pain reliever products for different prices despite the fact that the medications are essentially the same.
Case Updates
July 21, 2021 – Case Dismissed
The proposed class action detailed on this page was dismissed without prejudice on May 11, 2021.
In an 11-page order, U.S. District Judge Sara L. Ellis tossed the lawsuit on the grounds that the plaintiff’s claims were preempted by the Food, Drug, and Cosmetic Act (FDCA).
“The FDCA does not provide a private right of action; therefore, [the plaintiff] may only seek relief pursuant to related state-law causes of action…States can impose requirements that are identical to those imposed by the FDCA, but not different from or more burdensome than those requirements…Thus, to avoid preemption, a state law claim related to misleading labeling must allege a violation of the FDCA.”
Although the plaintiff argued that her claims were consistent with, and not different from, the FDCA, the consumer “misses the points of preemption, however, as her claims are based on the labeling of the products themselves, not a legal theory,” the judge wrote.
The dismissal order states that the plaintiff’s claims in her amended complaint would “require Topco to label its products in a particular way, as she seeks to impose ‘clear disclosures that there is no pharmacological distinction between ‘infant’s product’ and ‘children’s product.’” Essentially, the judge relayed, the plaintiff asked for relief that went beyond what the FDA requires.
“Because the [FDA’s 1988 Tentative Final Monograph] does not require any specific disclaimers concerning infant products nor the interchangeability of the two products at issue, [the plaintiff’s] claims are preempted because she seeks to impose additional obligations on Topco not imposed by the TFM,” the order says.
A proposed class action claims Topco Associates, LLC sells over-the-counter infants’ and children’s pain reliever products for different prices despite the fact that the medications are essentially the same.
According to the 21-page lawsuit, the defendant sells TopCare brand Infants’ Pain & Fever Acetaminophen and Children’s Pain & Fever Acetaminophen at its member-owner retail stores, including Hy-Vee, Wegmans, and Giant Eagle.
Noting that acetaminophen can be dangerous and even fatal if ingested in large doses, the suit alleges Topco has attempted to prey on parents’ and caregivers’ overdose fears by misleading buyers into believing infants cannot safely take the children’s pain reliver even though both contain “the same exact amount of acetaminophen in the same dosage amounts.”
Moreover, the defendant charges a “substantially higher price” for its infants’ pain reliever than for the product labeled as appropriate for children despite the fact that both are “exactly the same,” the case says.
“No reasonable consumer would pay two to three times as much for Infants’ Products, as compared to Children’s Products, unless he or she was deceived into thinking that infants cannot safely take Children’s Products,” the complaint reads.
Prior to 2011, liquid acetaminophen for infants was available only in concentrations of 80 mg/0.8 mL or 80 mg/mL while a product marketed toward “children” was only available in concentrations of 160 mg/5 mL, the lawsuit explains. Per the complaint, the difference in concentrations caused several accidental overdoses, which led the FDA to decide that acetaminophen for infants would only be made available in 160 mg/5 mL concentrations thereafter.
Since December 2011, the only difference between acetaminophen marketed for infants and children has been the price and dosage instrument—a syringe for infants’ products and a plastic cup for children’s products, the case says. Thus, the two medications are interchangeable, and can be administered to both children and infants while adjusting the dosage amount based on the weight and age of the child, the suit argues.
Given that the TopCare infants’ and children’s pain reliever products are essentially the same, the defendant’s implication that parents and caregivers cannot purchase the “significantly cheaper” children’s product for an infant is “unfair, unlawful, deceptive, and fraudulent,” the lawsuit contests.
“Defendant misleads consumers by using deceptive marketing techniques which obscure critical facts—that infants can safely take Children’s Products and that the Products are exactly the same—from consumers,” the complaint scathes.
The plaintiff, who purchased TopCare Infants’ Pain & Fever Acetaminophen for her one-year-old son, says she would not have bought the medication—or paid a premium price for it—had she known the infants’ products “were nothing more” than their children’s counterpart.
The lawsuit, echoing similar suits filed against Walmart and RiteAid, looks to represent anyone who purchased TopCare infants’ acetaminophen at the defendant’s stores in the U.S. for personal use, with a proposed subclass of those who did so in Pennsylvania.
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