It is Groundhog Day. So we will write about a fact pattern we’ve written about before. Multiple times.
We cringe whenever we see a case involving over-the-counter (OTC) drugs and children. It brings back memories of lawsuits with sympathetic plaintiffs and difficult facts. We remember one case in which a three year old gobbled half a bottle of pain pills. The child survived, but it was a near thing for a couple of weeks. The parents sued, claiming that confusing packaging made them buy a bottle without a child-proof cap. We initially thought the claim silly – after all one could read the box and see that there wasn’t a child-proof cap. But later we interviewed the head of the state’s drug safety department. By the reception desk there was a glass cabinet containing OTC drug packages that the state had concluded were unduly confusing. Front and center on the second shelf was our product. Ugh.
But today’s case, Robinson v. Walgreen Co., 2022 WL 204360 (N.D. Ill. Jan. 24, 2022), does not involve any physical injuries. Rather, parents filed class actions alleging that the smaller dose and higher priced “infants” version of OTC acetaminophen-based pain relievers, when compared to the “children’s” version with the same formula, violated Illinois and Texas consumer fraud statutes. Essentially, the parents argued that they had been hoodwinked into paying more for infant medications that were the same as children medications. They claimed that “they and similar consumers are injured by defendant’s deceptions because they ‘are not getting what they pay for — a pediatric pain reliever that is specifically formulated or medically unique for infants. Instead, they pay a price premium for a product that is identical to another pediatric product manufactured and marketed by Defendant.”
And now let’s take a definitional interlude. “Infants” range from birth to two years, while “children” range from two to 12 years. OTC medications for infants and children typically sit next to each other on store shelves.
The plaintiffs were wrong on the law and on the facts. That is why the defendant managed to get the case dismissed on a 12(b)(6) motion. The plaintiffs were wrong on the law because their claims were preempted. As the court’s opinion explains in considerable detail, the distinction between “infant” and “children” OTC medications was created with the FDA’s agreement, through a “tentative” final monograph (TFM) published in 1988 to prevent overdosing of infants by restricting the dosage. A 2020 statutory change (the CARES Act) deemed these tentative monographs to be final FDA action, thus creating an avenue for express OTC preemption in non-personal injury cases such as this. The defendant argued that because the TFM does not require a disclosure that the infants’ and childrens’ products are identical formulations, the plaintiffs were seeking, through resort to state law, to impose a requirement “that is different from or in addition to, or that is otherwise not identical with, a requirement” in the TFM and would thus violate 21 U.S.C. Section 379r(a)(2). The Robinson court agreed with the defendant and held that the consumer fraud actions were preempted.
The Robinson opinion discusses a number of prior decisions, all but one (sadly, from our old home district of C.D. Cal.) of which are favorable, and a couple of which we have already blogged about here and here.
The plaintiffs were wrong on the facts because the “infant” and “children” medications were not precisely the same. True, the active ingredient and concentration per milliliter were the same. That was not always the case. Earlier, the infant formula was more concentrated. But in 2011, the FDA issued a Safety Communication noting that, due to dosing errors that occurred with the more concentrated infants’ formulation, some manufacturers decided to change their liquid acetaminophen products marketed to infants to the same concentration for childrens’ products.
By the way, the fact of equal concentrations was not hidden. It was right there on the labels. This case involved store brand medications, so the purchasers were presumably people who read labels and made sure that the product was the same as the national brands. (At this point we must confess that our word choice is sloppy. We learned from clients manufacturing store brands that they must be careful not to say the products were the same; packages say things such as “Compare to the [national brand].” But you and the consumer get the point. The active ingredient and concentration are the same. Why not save some money? When our heirs were toddlers – whether infants or children – we often brought home store brand meds to treat their sniffles. The Drug and Device Law Spouse was invariably displeased. Our argument about same-ingredient, etc. fell on deaf ears. How could we be so cheap when it came to the health of our kids? Slack-jawed, we had no response. The truth is that we’re cheap about everything. We’d sheepishly grab the car keys and head back to the store.).
The point is that there was nothing deceptive about the infants’ and childrens’ product packaging. And even though the meds were the same, the infants product came with a syringe for more accurate dosing. The children’s product came with a dosing cup. The 2011 Safety Communication contained a Q&A stating that the dosing devices must not be interchanged. You might quibble with whether the syringe justifies a higher price, but there was no deception.