Inclined Sleeper Deaths Rise to 50 as Industry Continues to Sell the Products

The CPSC has left the future of inclined sleepers to ASTM International, an organization that brings manufacturers, government officials, medical experts, consumers, and others together to establish voluntary industry standards for thousands of products and processes. (CR is a member and participates in working groups, including the subcommittee for infant inclined sleep products.)

But in May, the ASTM infant inclined sleep products subcommittee decided—against objections from CR and some other members—that rather than pulling the category from the market, it would simply investigate the product’s standard and potential hazards further and reconvene in October 2019.

In the interim, infant inclined sleepers remain on the market.

“It was unbelievable to be in that meeting and hear that the industry needs more data to eliminate the category,” says Don Huber, director of product safety at CR, who sits on more than a dozen ASTM panels. He notes that when Fisher-Price and others introduced inclined sleepers a decade ago, they did not have to provide evidence that the products were safe for sleep. “Why is there a greater burden to provide data to remove a hazard than to introduce one?” Huber says.

While industry and the CPSC delay, some members of Congress are introducing legislation to stop the sale of inclined sleepers. Rep. Tony Cárdenas, D-Calif., and Sen. Richard Blumenthal, D-Conn., introduced legislation that would prohibit the manufacture, import, and sale of infant inclined sleep products. The Senate version would prevent the CPSC from signing off on any infant sleep products that are not “consistent with safe sleep best practices.”

Rep. Cárdenas said June 13 at a House hearing that he introduced the bill because “companies decided making money was more important than the lives of innocent babies” and “because the regulatory agency charged with protecting Americans decided to be puppets for industry and stood by as more precious lives were lost.” He added that though there have been two recent major recalls of inclined sleepers, products from other companies are still available. “As a grandparent, it’s just appalling,” he said.

Many parents have long believed not only that inclined sleepers are safe but also that they help babies who seem to suffer from frequent spit-up, also known as reflux. But experts say that sleeping at an incline is not helpful for babies with reflux. And numerous studies have shown that sleeping on an incline—whether in a sleeper, car seat, or bouncer seat, and especially when restrained—poses several serious risks.

For one, sleeping at an incline can cause a baby’s head to fall forward, which can compress the neck and airway and lead to a drop in oxygen, lowered heart rate, and even suffocation (also known as asphyxia). And because babies don’t have strong neck muscle control, they may not be able to lift their head up and restore airflow to the lungs.

Further, research shows that restraints, such as those in inclined sleepers, increase the risk of strangulation and entrapment.

The AAP’s Hoffman also says the design of many inclined sleepers, which often includes rocking babies and nestling them in soft padding, “actually lull the baby into a deeper sleep than they are supposed to have,” making them less able to rouse themselves if their airflow is compromised.

He explains that babies are meant to wake up throughout the night, especially within the first four to six months. Though it can be exhausting for parents, night waking is normal for a baby’s developing brain and is even protective against sleep-related death.

Airway compression due to an inclined sleep position seems to be what happened to many of the babies who died in the Fisher-Price Rock ’n Play Sleeper, according to the medical investigations and legal documents CR has reviewed. And it seems to be what happened in all four of the deaths described in the latest lawsuit, filed June 12 by the firms Wolf Haldenstein and Blank Rome against Fisher-Price and its parent company, Mattel.

In one of those deaths, Amanda Butler of Crossroads, Ala., alleges that she nursed her 10-week-old daughter Arya on the morning of Jan. 2, 2019, and put her to sleep in a Rock ’n Play Sleeper next to her own bed. When Amanda woke around 9 a.m., Arya was on her back in the sleeper; her head was tilted forward and to the side, her skin was blue, and her body limp.

Amanda called 911 and performed CPR while her 5-year-old son—who’d heard Amanda’s screams—came into the room and looked on. “When Amanda pumped Arya’s tiny chest, blood came from Arya’s mouth,” the lawsuit alleges. “The taste of Arya’s blood remained in Amanda’s mouth for hours.”

Emergency medical technicians at the house and emergency room staff in the hospital tried, but failed, to resuscitate Arya, the lawsuit alleges.

While the risk of inclined sleepers became widely known only after CR reported on the large number of deaths linked to the Rock ’n Play Sleeper, Fisher-Price and the CPSC knew of the risks well before then, according to CPSC data and lawsuits filed against Fisher-Price.

What’s more, Fisher-Price failed to adequately test its product for safety before bringing it to market in 2009, according to Fisher-Price emails and depositions obtained through discovery in lawsuits against Fisher-Price. The company never conducted a thorough medical analysis or commissioned independent third-party testing to establish whether it was safe for infants to sleep at a 30-degree incline.

The documents show that as Fisher-Price developed its product, the only medical expert the company consulted was Gary Deegear, M.D., of San Antonio, who was a family practice physician, not a pediatrician or sleep specialist. In the years following his work on the Rock ’n Play Sleeper, Deegear failed to renew his medical license, according to the Texas Medical Board’s website. And when the board later learned that Deegear continued to treat patients without a license at several medical spas, sometimes while he was under the influence of drugs or alcohol, it issued a cease-and-desist order forbidding him from acting “in the guise of a physician.” CR attempted to contact Deegear at multiple phone numbers but could not reach him.

Fisher-Price emails show that Deegear’s evaluation of the Rock ’n Play Sleeper prototype was far from comprehensive and that his advice ran counter to established safe sleep recommendations. For example, in one email, Kitty Pilarz, who was then the director of product safety at Mattel, wrote: “Dr. Deegear stated pediatricians recommend babies with reflux sleep at 30 degrees, this is just fine, or sleep in a car seat overnight for months or even a year. The Back to Sleep campaign places children on their backs, and elevated positions of the head is fine. He is not aware of research on this.”

Based in part on that faulty advice, Fisher-Price determined that the Rock ’n Play Sleeper was safe.

In a deposition, Pilarz acknowledged that the company had little evidence documenting the product’s safety. At one point, the lawyer for a family whose child suffocated while in the Rock ’n Play Sleeper asked: “Prior to introduction into the market in 2009 with the Rock ’n Play Sleeper, . . . you’re not aware of having found any literature that says it was safe for a child to sleep on their back all night long at this elevated position, correct?” Pilarz responded: “Correct.”

And when asked whether Fisher-Price had conducted any independent research to determine whether sleeping all night at a 30-degree incline was safe for infants, Pilarz admitted that the company had not.

But that didn’t stop Fisher-Price from moving forward with its product. As CR previously reported, the Rock ’n Play Sleeper bobbed and weaved its way through a regulatory maze and onto store shelves in 2009, and in fact later helped to create the industry’s voluntary standard for this new product category.

Other companies soon followed, creating their own inclined sleepers—which were marketed aggressively for naptime and nighttime sleep. Ultimately, the misconception that inclined sleepers were safe seeped into the sleep-deprived consciousness of parents across the country.

There still is no research supporting the notion that putting babies to sleep on an incline is safe. Yet many sleep products designed for that purpose are still for sale. (CR has compiled a list of the inclined sleepers that have been recalled, and it will be updated as needed.)

CR attempted to identify as many of those products as we could, by canvasing the marketplace and asking manufacturers that are members of ASTM about their products. Several—including Baby Trend, Delta, Kolcraft, and Uppababy—said they do not make inclined sleepers and have no plans to do so. Others confirmed that they sell inclined sleepers, and said their products are safe and not linked to any reported deaths or injuries.

In some cases, deciding what advice to give consumers was difficult, in part because a few manufacturers are currently changing their descriptions for the intended uses of the products.

For example, soon after CR asked Graco about its DreamGlider Gliding Seat & Sleeper, the company removed “& Sleeper” from the product’s name on its website. Graco made the change after “a thorough internal review” to “help prevent consumer misinterpretation of how the product should be used,” according to a company spokesperson. “When the products are used as a napper, they are not intended for unsupervised or prolonged periods of sleep,” the spokesperson said. “If consumers are searching for an overnight sleep option, we recommend consumers consider a crib, bassinet, or play yard (without blankets, pillows, or stuffed animals).”

Note that there are many other products, such as bouncers, that put babies at an incline but that are not meant for sleep. They are fine for supervised play, but babies should always be transferred to an approved, flat surface for sleep. Similarly, car seats, which are inclined, are meant to protect children while traveling but are not intended for unsupervised sleep outside of a car.

While the list below is not exhaustive, here are the products CR has identified so far.