Head Shaping Pillow Lawsuit | 2025 Latest Updates

Head-Shaping Pillow Lawsuit Overview

Head shaping pillow lawsuits involve claims against manufacturers of infant head-shaping pillows that have caused suffocation, asphyxiation, and death in babies.

The primary allegations focus on manufacturers marketing these products without FDA approval and failing to warn consumers about the serious safety risks.

The FDA issued a safety communication on November 3, 2022, warning that these products create unsafe sleep environments and may contribute to suffocation and death.

The FDA has explicitly stated that head shaping pillows are not FDA-approved and have no demonstrated medical benefit for preventing or treating flat head syndrome, positional plagiocephaly, or craniosynostosis.

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.

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.

Latest Head-Shaping Pillow Lawsuit Updates

• November 3, 2022 – The FDA issued a comprehensive safety communication warning parents, caregivers, and healthcare providers that infant head shaping pillows have not been proven safe or effective and may contribute to suffocation risk and death in infants [1].
• 2022 – The FDA recommended that consumers immediately dispose of head shaping pillows and keep them out of reach of children, emphasizing that these products should not be donated or given to others due to safety concerns [2].
• 2021 – The National Institutes of Health (NIH) and American Academy of Pediatrics (AAP) reinforced guidelines that infants should sleep on their backs in bare cribs without pillows, toys, soft objects, or loose bedding to reduce SUID (Sudden Unexpected Infant Death) risk [3].

FDA Reports and Statistics

According to the FDA Safety Communication from November 3, 2022:

• FDA Approval Status: Head shaping pillows are NOT FDA-approved for any medical purpose
• Demonstrated Benefits: The FDA is not aware of any demonstrated benefit with the use of infant head shaping pillows
• Safety Classification: These products create unsafe sleep environments that may contribute to suffocation and death
• Regulatory Action: FDA issued official warning against use for prevention or treatment of any medical condition
• Target Age Group: Products typically marketed for infants from birth to 18 months

The FDA’s safety communication specifically addresses concerns about products marketed for positional plagiocephaly, deformational plagiocephaly, and craniosynostosis treatment or prevention.

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.

Head Shaping Pillow Injuries & Side Effects

The FDA has identified serious safety risks associated with infant head shaping pillows that can result in life-threatening injuries and death.

Serious injuries and complications include:

• Suffocation: Blocking of airways leading to oxygen deprivation and death
• Asphyxiation: Restriction of breathing causing brain damage or death
• Sudden Unexpected Infant Death (SUID): Unexplained infant deaths during sleep
• Respiratory Distress: Compromised breathing leading to emergency medical intervention

Do You Qualify for a Head Shaping Pillow Lawsuit?

You may qualify for a head shaping pillow lawsuit if:

• Your child used a head shaping pillow at any time since these products have been marketed
• Your child experienced serious complications including suffocation, asphyxiation, respiratory distress, or death
• The incident required emergency medical treatment or resulted in hospitalization
• You can provide medical documentation linking your child’s injuries to the head shaping pillow
• The product was marketed for preventing or treating flat head syndrome, plagiocephaly, or craniosynostosis

Evidence Required for a Head Shaping Pillow Lawsuit

To pursue a successful lawsuit, you will need:

• Medical Documentation: Complete medical records documenting the injury, emergency treatment, hospitalization, and any ongoing medical care related to the head shaping pillow incident.
• Product Evidence: Documentation of the specific head shaping pillow used, including product packaging, purchase receipts, photographs of the product, and any marketing materials or instructions.
• Incident Reports: Any incident reports filed by emergency responders, hospitals, or medical facilities, as well as any reports to the Consumer Product Safety Commission (CPSC) or FDA.
• Expert Testimony: Medical expert testimony linking the product to the injury and establishing that the head shaping pillow created an unsafe sleep environment.

Damages You Can Recover

Compensation in a head shaping pillow lawsuit may include:

• Medical Expenses: Coverage for all medical costs including emergency treatment, hospitalization, ongoing care, and rehabilitation services.
• Lost Wages: Compensation for time missed from work due to caring for your injured child or attending medical appointments.
• Pain and Suffering: Damages for physical pain, emotional trauma, and the impact on your family’s quality of life.
• Punitive Damages: In cases involving gross negligence or willful misconduct by manufacturers who continued marketing dangerous products despite known risks.

Head Shaping Pillow Recall Information

• FDA Action Date: November 3, 2022
• Action Type: Safety Communication Warning (not formal recall)
• Affected Products: All infant head shaping pillows, including those with indents, holes, or rectangular designs
• FDA Recommendation: Immediately dispose of all head shaping pillows and keep out of reach of children
• Reason: Products create unsafe sleep environments and may contribute to suffocation and death
• Product Types Affected:
  • Small pillows with center indents or holes designed to cradle baby’s head
  • Rectangular pillows without holes or indents
  • Any pillow marketed for preventing or improving infant head shape or symmetry

Statute of Limitations for Head Shaping Pillow Lawsuits

The time limit to file a head shaping pillow lawsuit varies by state, typically ranging from 1-3 years from the date of injury or discovery of the connection between the product and the injury.

Some states have specific provisions for product liability cases involving infant products that may extend these deadlines.

Given the serious nature of these cases and the complexity of proving causation, it’s crucial to consult with an experienced attorney immediately to ensure your claim is filed within the applicable time limits.

Other Infant Sleeper or Pillow Lawsuits:

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

FAQs

1. 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.

2. 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. A class action lawsuit allows multiple plaintiffs to combine their cases, providing a stronger collective legal action against the manufacturer.

3. 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.

4. 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.

5. Are head shaping pillows FDA-approved?

No, the FDA has explicitly stated that infant head shaping pillows are not FDA-approved for any medical purpose and have no demonstrated benefit for preventing or treating any medical condition.

6. What are safe alternatives to head shaping pillows?

The FDA has cleared caps, helmets, or headbands as cranial orthosis devices for babies ages 3-18 months with moderate to severe positional plagiocephaly, but these require medical supervision and a prescription.

7. What should I do if I own a head shaping pillow?

The FDA recommends immediately disposing of head shaping pillows and keeping them out of reach of children. Do not donate or give the product to anyone else due to safety risks.

8. Can plagiocephaly be treated safely?

Yes, mild cases often improve naturally as babies grow, and severe cases can be treated with FDA-cleared cranial orthosis devices under medical supervision, but head shaping pillows are not safe or effective treatments.

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

Get a Free Head Shaping Pillow Lawsuit Evaluation With Our Lawyers

Time is limited to pursue legal action against manufacturers of dangerous head shaping pillows that have caused suffocation, asphyxiation, and death in infants.

Most states have strict statutes of limitations, typically allowing only 1-3 years from the date of injury or discovery to file a lawsuit.

Our legal team offers:

• Free, confidential consultations to evaluate your case
• No upfront costs or fees – you pay nothing unless we win
• Experienced representation in product liability litigation nationwide
• Comprehensive investigation with medical and product safety experts

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.

References

1. https://www.healthline.com/health-news/fda-says-head-shaping-pillows-for-infants-can-be-dangerous-what-parents-should-know
2. https://publications.aap.org/aapnews/news/22583/Infant-head-shaping-pillows-can-cause-suffocation?autologincheck=redirected
3. https://publications.aap.org/aapnews/news/22583/Infant-head-shaping-pillows-can-cause-suffocation?autologincheck=redirected