This information should be passed on to anyone you know who has a baby or is going to have one.

The FDA is warning parents and other caregivers not to use infant sleep positioners because the baby may die from suffocation. The agency asked manufacturers to stop making these products about 8 years ago, but they are still being made and sold. Because the FDA can’t force a recall without a very lengthy legal process, babies continue to be at risk.

These products were and are being marketed as “safe sleep” solutions. But a FDA Consumer Update states that these products “can cause suffocation (a struggle to breathe) that can lead to death” (FDA).

Baby Suffocation a Risk with Sleep Positioner

The federal government (FDA and Consumer Product Safety Commission) has received reports of infants who died from suffocation in connection with the use of a sleep positioner. ” In most of these cases, the babies suffocated after rolling from their sides to their stomachs” (FDA).

The federal government also has received reports about babies placed in these products as suggested by the manufacturer, but were then found in dangerous positions within or next to them.

What is a Sleep Positioner?

These products are marketed as a way to keep a baby in a specific position while sleeping. Two common types are those with “bolsters” (like pillows) attached to the sides of a mat and those The two most common types of sleep positioners feature raised supports or pillows (called “bolsters”) that are attached to each side of a mat, or a wedge to raise a baby’s head.

The FDA Says “Beware of Medical Claims About Sleep Positioners”

A baby product is regulated by the FDA if the maker of the product makes medical claims regarding it. For example, with these products, “some manufacturers have advertised that their sleep positioners prevent SIDS; gastroesophageal reflux disease (GERD), in which stomach acids back up into the esophagus; or flat head syndrome (plagiocephaly), a deformation caused by pressure on one part of the skull” (FDA).

The FDA is warning consumers to beware of these claims and has provided the following information:

  • “The FDA has never cleared an infant sleep positioner that claims to prevent or reduce the risk of SIDS. [Please note that this means advertising this unfounded claim violates federal regulations.] And, there is no scientifically sound evidence to support medical claims about sleep positioners.”
  • “The FDA had previously approved some of these products for GERD or flat head syndrome. But because the agency learned in 2010 that these products have a risk of suffocation, the FDA then required manufacturers of FDA-cleared sleep positioners to submit data showing that the products’ benefits outweigh the risks.”

Although the FDA can continue to take action against manufacturers who make unproven medical claims about their products, it appears not enough has been done to protect infants from the risks posed by these products.

A Similar Case That Resulted in a Recall

This is similar to another baby product that was associated with the death of the child of one of our clients. A mother was using a baby product that was readily available for purchase online and in stores. She was also using the product as suggested by the manufacturer. As she was removing her baby from this product, she realized the little one was no longer breathing. Attempts were made to save the baby’s life, but the little one died.

The mother called our law firm and hired us to help. Attorney Fred Pritzker and his team found evidence that 6 other deaths had been reported to the federal government over several years. Fred contacted the Consumer Product Safety Commission (the appropriate agency for this product because it was not marketed with medical claims) and urged them to force a recall of the product. A few weeks later, the company issued a recall. We pursued a lawsuit and won a large wrongful death settlement for the family. This was the only way to hold the company accountable.

We urge the FDA and the CPSC to take action now with the sleep positioner products in question. Parents need to know when they use a product marketed for infants that it is absolutely safe. Profit should never come before the safety of our children.

Fred Pritzker
Attorney Fred Pritzker can be contacted at 1-888-377-8900 (toll free).

As a note of explanation, the CPSC is the agency that is responsible for regulating sleep positioners that not advertised as solving or alleviating medical problems.