As product liability lawyers, we keep a close watch on the Food and Drug Administration and the Consumer Product Safety Commission. On September 30, 2016, the FDA issued a warning advising parents to stop using homeopathic teething tables and gels. The warning specifically mentioned Hyland’s products and products sold at CVS Pharmacy stores. The FDA is vague about the reasons for the warning, although the FDA does say:
Consumers should seek medical care immediately if their child experiences seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after using homeopathic teething tablets or gels.
The FDA is still investigating the products, although it has said that ten deaths of children were reported. Hyland’s has pulled the teething tablets and gels from shelves, but has not issued a recall.
The FDA might be vague about its investigation, but I can be more specific: the teething products contain poison. Specifically, Hyland’s teething products contain atropa belladonna, better known as deadly nightshade.
Deadly nightshade is one of the most famous poisons in human history. Back in ancient times, the Romans used it as a poison, including for poison-tipped arrows. Supposedly the wives of Augustus and Claudius used it to murder their enemies. It’s extremely toxic, to the point that a berry or two is enough to kill a child, and a single leaf can kill an adult.
Hyland’s of course disputes there’s any risk in using their teething tablets and gels, and on their website they responded to the FDA with a statement that said “The amount of Belladonna used in Hyland’s Baby Teething Tablets is miniscule. There’s two trillionths of a milligram in a tablet.” (We’ll put aside for the moment the obvious questions about why belladonna is in the product at all, and why Hyland’s would expect it to have any useful effect on a teething infant in those amounts.)
That’s probably what the amount of belladonna that they intend to put in the tablets, but when it comes to manufacturing, there’s a big difference between how a company intends to make its product and how the products actually come out. In product liability law, we call this a “manufacturing defect.”
Manufacturing defects in consumer drugs are far more common than most people realize. Just this week, for example, the FDA withdrew two generic versions of the ADHD drug Concerta, because they didn’t release the active chemical in the same way as the brand-name drug. The FDA releases letters from its Office of Manufacturing Quality and, as you can see, they’re quite busy, issuing several a month.
Indeed, back in 2010, the FDA issued a warning about and recall of Hyland’s teething tablets, saying,
Hyland’s Teething Tablets are manufactured to contain a small amount of belladonna, a substance that can cause serious harm at larger doses. For such a product, it is important that the amount of belladonna be carefully controlled. FDA laboratory analysis, however, has found that Hyland’s Teething Tablets contain inconsistent amounts of belladonna. In addition, the FDA has received reports of serious adverse events in children taking this product that are consistent with belladonna toxicity. The FDA has also received reports of children who consumed more tablets than recommended, because the containers do not have child resistant caps.
It’s not too much of a leap to wonder if the same thing happened again. Maybe Hyland’s will eventually be vindicated, but we won’t know until samples are tested, and until the lawsuits proceed.
If your child used a Hyland’s teething tablet or gel and suffered an injury, you should discuss your case with a product liability lawyer. Importantly, do not dispose of the tablets you have, and instead keep them somewhere safe where children can’t get them. They may end up being evidence down the line.