Head Shaping Pillow Lawsuit in 2025 (Latest Updates)

What are Head Shaping Pillows?

Infant head-shaping pillows are typically small pillows with an indent or hole in the center intended to cradle the back of a baby’s head while the infant lays face up on his or her back. Others are rectangular with no hole or indent. Head-shaping pillows may be marketed with claims that they can prevent or improve an infant’s head shape or symmetry.

Infant Head Shaping Pillows Can Cause Suffocation: FDA Warning

According to the FDA Safety Communication on Nov. 3, 2022, warning parents, caregivers, and healthcare providers that the safety and effectiveness of infant’s head shaping pillows has not been established for the prevention or treatment of flat head syndrome (positional plagiocephaly), deformational plagiocephaly, or craniosynostosis. [1]

The FDA is not aware of any demonstrated benefit with the use of infant head shaping pillows for any medical purpose. The use of head shaping pillows can create an unsafe sleep environment for infants and may contribute to the risk of suffocation and death. Infant head shaping pillows are not FDA-approved. – FDA said.

What is Plagiocephaly?

Plagiocephaly refers to a flat spot on a baby’s head. The condition develops when a baby spends too much time lying on their back. The flat spot is typically most noticeable when looking at the baby’s head from above. The cheekbone and ear on the flat side may look pushed forward.

Is Plagiocephaly a Disability?

Most cases of positional plagiocephaly do not cause issues with the baby’s brain growth or function. However, if plagiocephaly is left untreated, children are at risk of developmental, neurological, or psychological difficulties.

Can Babies Grow Out of Plagiocephaly?

The heads of infants with positional plagiocephaly may not return to a completely perfect shape, but by the time they’re 1 or 2 years old, any flattening will be barely noticeable. More severe cases will also get better over time, although some flattening may remain.

FDA Recommendation on Head-Shaping Pillows

If you own an infant head-shaping pillow or similar device, you should keep it out of the reach of children and throw it away immediately. Do not donate it or give it to anyone else.

Recommendations for Pediatricians

Pediatricians should continue to remind parents not to use infant head-shaping pillows and to discard them. Healthcare providers can educate their communities about the importance of a safe sleep environment for babies and associated management options for positional plagiocephaly.

According to the National Institutes of Health (NIH) and the American Academy of PediatricsExternal Link Disclaimer (AAP) research from 2021 infants should sleep on their backs in a bare crib on a flat (not inclined) surface without pillows, toys, soft objects, or loose bedding. The AAP guidelines regarding a safe sleep environment are intended to help reduce the risk of SUID as described in the NIH Safe to Sleep Campaign. [2]

Are There Safe Alternatives to Head-Shaping Pillows?

The FDA has cleared caps, helmets, or headbands for use as cranial orthosis devices intended to improve cranial symmetry or shape in babies ages 3-18 months who suffer from moderate to severe non-synostotic positional plagiocephaly.

FAQs

What safety recommendations exist regarding infant sleep products?

Safety recommendations for infant sleep products include placing infants on their backs to sleep, using a firm mattress, avoiding soft bedding and pillows, and keeping the sleep environment free of hazards. Head shaping pillows are generally not recommended due to safety risks.

Can I join a class action lawsuit if my child was affected by a head shaping pillow?

Yes, parents or guardians of children affected by head shaping pillows may join a class action lawsuit if one is available. Class action lawsuits allow multiple plaintiffs to combine their cases, providing a stronger collective legal action against the manufacturer.

How long do I have to file a head shaping pillow lawsuit?

The time limit to file a head shaping pillow lawsuit, known as the statute of limitations, varies by state. It’s crucial to consult with a lawyer promptly to ensure your claim is filed within the legal timeframe to preserve your rights.

What evidence is needed to support a head shaping pillow lawsuit?

Evidence needed to support a head shaping pillow lawsuit includes medical records documenting the injury or death, incident reports, expert testimony linking the product to the injury, and any documentation of previous complaints or recalls of the product.

Other Infant Sleeper or Pillow Lawsuits:

• Boppy Infant Recall Litigation
• Infant Sleep Positioner Suit
• Pillowfort Weighted Blanket Lawsuit
• Style Life Eleven Baby Lounger Lawsuit

See all related product liability lawsuits our attorneys covered so far.

Get a Free Head Shaping Pillow Lawsuit Evaluation With Our Attorneys

The Products Liability Litigation Group at Schmidt & Clark, LLP law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in head-shaping pillow Lawsuits. We handle individual litigation nationwide and accept new cases in all 50 states.

Again, if your child or other loved one was asphyxiated, suffocated, or died after using a head-shaping pillow, you should contact our law firm immediately. You may be entitled to compensation by filing a Head Shaping Pillow Lawsuit and our product liability lawyers can help.

References:

1. https://www.fda.gov/medical-devices/safety-communications/do-not-use-infant-head-shaping-pillows-prevent-or-treat-any-medical-condition-fda-safety
2. https://www.fda.gov/medical-devices/baby-products-sids-prevention-claims/recommendations-parentscaregivers-about-use-baby-products