Attorneys
Related Practices
The juvenile products category – i.e., products intended for infants and children under the age of 12 – is a subcategory of consumer products that has recently drawn the attention of both the U.S. Consumer Product Safety Commission and the plaintiffs bar.
So far this year alone, the CPSC has already:
- Finalized and passed its new federal safety standard for water beads, effective as of March 12;[1]
- Reached an $11.5 million civil penalty settlement with bicycle component manufacturer Shimano Inc. on March 16, for
failing to immediately report a product defect that could create a substantial product hazard;[2] and - Issued product safety warnings on March 19, regarding bear-shaped infant support cushions that posed a suffocation risk,[3] and on April 2, regarding swim floats designed for babies that led to one reported death.[4]
This follows the CPSC's oversight of 542 recalls in 2025 – an all-time agency record – with over a third of these recalls involving juvenile products.
These actions are part of the commission's recent and ongoing focus on the juvenile products category, which the CPSC has always viewed as serving the most vulnerable population of consumers.
It is now more important than ever for manufacturers and retailers of such products to be vigilant in their practices by ensuring compliance with applicable regulations and industry standards, and to vet their suppliers by requiring appropriate testing data.
In the event such compliance is not feasible, there should be a sufficient paper trail explaining why such compliance was not doable under the circumstances.
It is also important to note that a frequent byproduct of the CPSC's actions in the juvenile products category is an uptick in product liability litigation against manufacturers, distributors and retailers – especially in the high-risk category of infant products.
How Regulatory Action Catalyzes Litigation
Recalls and other regulatory actions against infant products can act as litigation catalysts, often serving as a road map for plaintiffs counsel. For example, plaintiffs routinely cite product safety warnings, recalls and regulatory enforcement actions as evidence of a product defect.
Even in the case of many juvenile products that lack specific CPSC safety standards – and that, in some cases, also lack an applicable voluntary industry safety standard, such as an American Society for Testing and Materials standard – plaintiffs use litigation to fill the gap by arguing the product was unreasonably dangerous because it was unregulated and lacked oversight.
In doing so, plaintiffs attempt to improperly shift their burden of proving a defect in the product by instead employing a circular theory that a product is unsafe until it is proven to be safe by industry standards or regulations.
Under this theory, a product is presumed to be unsafe when specific regulations do not exist, despite the fact that many consumer products are not subject to any standards at all.
The CPSC's regulation and enforcement of juvenile products is only going to increase. Congress plans to bolster the CPSC's powers through its proposed Consumer Advocacy and Protection Act, which aims to drastically increase penalties for violating consumer product safety laws.
This likely means there will be more litigation involving products in this category. The combination of the CPSC's emphasis on regulating juvenile products and the emotional appeal these cases present to a jury makes them ripe for so-called nuclear verdicts.
Litigation Risks
Brain injuries, developmental delays and deaths create high economic and noneconomic damages in the form of future medical expenses, loss of future earning capacity, and pain and suffering. Punitive damages also become likely when a child or infant is injured or dies while using a juvenile product.
These injuries generally mean sympathetic plaintiffs – parents and caregivers – who appeal to jurors' emotions. This makes it more likely that jurors will fall prey to plaintiffs counsel's so-called reptile theory strategy, which seeks to speak to and scare the primitive part of jurors' minds that responds to threats of danger.
Unlike other consumer products, juvenile products cases present a unique challenge to common defenses such as contributory or comparative negligence and misuse, because they risk the perception of blaming grieving parents and caregivers for the infant or child's injuries. This is a theme jurors are unlikely to accept – no matter how strong the defenses are.
For these reasons, these cases often become bet-the-company litigation, especially considering most juvenile product manufacturers are relatively small companies with a lot at stake in the face of a potentially high verdict.
Given these challenges, very few product liability cases involving infant or child injuries are litigated to verdict. Indeed, the cases where jurors have rendered verdicts for plaintiffs illustrate the risk associated with trying these cases.
In April, in Mendez v. Abbott Laboratories, a jury in the Circuit Court of Cook County, Illinois, awarded $53 million in compensatory damages and $17 million in punitive damages against Abbott. In this litigation, mothers alleged the company's formula for premature infants caused their babies to develop necrotizing enterocolitis, or NEC.[5]
Similarly, in Gill v. Abbott Laboratories, a jury in the 22nd Judicial Circuit Court of Missouri awarded $95 million in compensatory damages and $400 million in punitive damages against Abbott Laboratories in 2025.
The plaintiff alleged an infant developed NEC after consuming its cow's milk-based formula.[6] This verdict was recently upheld by the Missouri Court of Appeals for the Eastern District.
And in 2016, in Hinson v. Dorel Juvenile Group Inc., a jury in the U.S. District Court for the Eastern District of Texas awarded $34.4 million to the family of a 4-year-old boy paralyzed in a 2013 car accident because of an alleged defect in the car safety seat used by the plaintiffs.[7]
Cases outside the product liability context further underscore that juries are particularly sensitive to injured infants, and likely to award significant damages.
In 2016, for example, in Louis v. Gwinnett Medical Center, a jury in the Georgia State Court of Gwinnett County awarded a $30.5 million verdict to a mother and her child who was left severely brain-damaged by what the plaintiffs described as a failure to promptly address a problem with the blood flow through the unborn baby's umbilical cord.
This verdict came despite evidence of the mother "'repeatedly [ignoring] the welfare of her baby' during her pregnancy by failing to keep her gestational diabetes under control."[8]
More recently, in 2025, in Zancanella v. Steward Health Care, a jury in the Third District Court for Salt Lake County, Utah, awarded a massive $951 million for a birth injury involving alleged negligence during delivery.[9]
In that case, a mother was given excessively high doses of pitocin to induce labor while the on-call physician slept in a nearby room. While there were signs of fetal distress, over 24 hours passed before a cesarean section was performed.
As a result, the infant suffered hypoxic-ischemic brain injury. The court in that case said "[t]he person she was to be, the person she deserved to be, is trapped inside a braindamaged child. I cannot think of anything more profound, total or complete than that loss."
While such high verdicts are a significant risk for companies in the juvenile products industry, the reputational harm associated with these cases further drives up the value of such lawsuits.
Where injured or deceased infants or children are involved, an ordinarily defensible case becomes extraordinarily risky. To avoid a nuclear verdict and the resulting reputational harm, companies are more likely to settle these types of cases for larger-than-usual sums.
Takeaways
Exposure to millions of dollars in damages, uphill battles with emotional juries and plaintiffs' tactics, and a complicated regulatory landscape all seem to paint a bleak picture for juvenile products manufacturers, distributors and retailers. So what should companies do?
- If there is no regulation, manufacturers should try to comply with the closest, most applicable or analogous industry standard, even though such compliance is voluntary. In some circumstances, referring to international European Union or
International Organization for Standardization standards could be helpful. Always document your rationale. - If you are unable to comply with any such standard, create a paper trail or internal memorandum discussing why such compliance is not reasonable and why the product is still safe without such compliance. Where possible, work with counsel to ensure privilege around this work product.
- Adopt a "safety by design" framework: Perform hazard analyses and foreseeable misuse analyses and, most importantly, have a written record of these analyses.
- Perform postmarket surveillance by tracking complaints, incidents and near misses – and of course, disclose all reportable incidents to the CPSC, and to other regulatory bodies if the product is sold outside the U.S.
- When complaints are noted, use them to help inform whether additional design improvements should be made to either comply with a nonmandatory standard or to address customer concerns that were not previously foreseeable or anticipated during the design phase. This should also help to mitigate litigation risk, and subsequent remedial measures are generally excluded as evidence in litigation.
- Have counsel – and, where appropriate, industry experts – perform a risk/litigation assessment during the premarket phase, and certainly when postmarket data suggests the likelihood of litigation.
As for retailers, it is important to note that they are no longer passive sellers. Retailers are treated as part of the chain of distribution for the purposes of product liability litigation.
A retailer does not have to create the defect to be exposed to liability. Plaintiffs know this and will generally target deep-pocket retailers, especially when the manufacturers and/or distributors are insolvent, foreign or lack sufficient insurance. So what should retailers do?
- Sufficiently vet suppliers by requiring testing data and auditing their verifications.
- Timely remove recalled products from the shelves by implementing real-time stockkeeping unit tracking and protocols for immediate removal of products.
- Do not overrely on manufacturer certifications. Instead, consider a process that confirms the validity of the information contained in the certification.
- Have appropriate indemnity provisions and insurance requirements for your suppliers.
Heightened regulatory scrutiny has turned the juvenile products space into one of the most high-stakes legal areas in the consumer goods market.
Manufacturers, distributors and retailers must recognize that compliance alone is no longer sufficient. They should adopt proactive, well-documented and safety-centered procedures at every stage of a product's life cycle.
By anticipating regulatory developments, evaluating product risks and maintaining defensible internal processes, companies can better position themselves against enforcement actions and bet-the-company litigation.
The opinions expressed are those of the author(s) and do not necessarily reflect the views
of their employer, its clients, or Portfolio Media Inc., or any of its or their respective
affiliates. This article is for general information purposes and is not intended to be and
should not be taken as legal advice.
[1] https://www.cpsc.gov/Newsroom/News-Releases/2026/CPSC%E2%80%99s-New-
Federal-Water-Beads-Safety-Standard-Takes-Effect-to-Protect-Children-from-Deadly-
Hazard.
[2] https://www.cpsc.gov/Newsroom/News-Releases/2026/Shimano-Agrees-to-Pay-11-5-
Million-Civil-Penalty-for-Failure-to-Immediately-Report-Bicycle-Cranksets-that-Posed-a-
Crash-Hazard.
[3] https://www.cpsc.gov/Warnings/2026/CPSC-Warns-Consumers-to-Stop-Using-
LullaBear-Choco-Bear-Infant-Support-Cushions-Immediately-Due-to-Risk-of-Serious-Injuryor-
Death-from-Suffocation-Violates-Mandatory-Regulations.
[4] https://www.cpsc.gov/Warnings/2026/CPSC-Warns-Consumers-to-Stop-Using-Relaxing-
Baby-Swim-Floats-Immediately-Due-to-Risk-of-Serious-Injury-or-Death-from-Drowning-
One-Child-Death-Reported.
[5] https://www.butlereagle.com/20260412/jury-awards-total-of-70-million-in-damages-incase-
against-abbott-over-infant-formula/.
[6] https://www.firstalert4.com/2024/07/27/st-louis-jury-awards-495-million-metro-eastmother-
baby-formula-case/.
[7] https://www.lexisnexis.com/jvsubmission/b/document_of_week/archive/2016/06/23/jur
y-awards-34-million-in-texas-federal-product-liability-action-brought-against-manufacturerfor-
injuries-sustained-by-22-month-old-child-placed-in-forward-facing-car-seat-whosuffered-
spinal-cord-injury.aspx.
[8] https://feldmanshepherd.com/blog/feldman-shepherd-wins-30-5m-ga-brain-damagedbaby-
case/.
[9] https://www.childbirthinjuries.com/blog/nearly-1-billion-utah-birth-injury-verdict/.
This article first appeared in Law360 on June 11, 2026, and is republished here with permission from the publication.