Update: On April 11, Consumer Reports linked an additional four deaths to inclined sleepers, from the company Kids II, and called for their recall as well.
Update: On April 9, the American Academy of Pediatrics called on the Consumer Product Safety Commission to immediately recall the Fisher-Price Rock ‘n Play Sleeper, citing Consumer Reports’ investigation. This story was originally published on April 8.
A Consumer Reports investigation into the safety of the Fisher-Price Rock ’n Play Sleeper—a product designed and marketed for babies to sleep on an incline—found that it is tied to at least 32 infant deaths.
Amid CR’s investigation—and days after we asked for comment—the federal government and Fisher-Price on April 5 issued a warning about the product, which safety advocates believe does not go far enough. Medical experts tell CR that babies should be placed flat on their back alone and free of soft bedding—and not at an incline—to minimize the risk of accidental suffocation. Products such as the Fisher-Price Rock ’n Play Sleeper do not align with these recommendations.
The safety alert from the Consumer Product Safety Commission and Fisher-Price includes a warning from the CPSC for consumers to stop using the product when infants turn 3 months old or “as soon as an infant exhibits rollover capabilities.” The alert cites reports of “10 infant deaths in the Rock ’n Play that have occurred since 2015, after the infants rolled from their back to their stomach or side, while unrestrained.”
Despite these numbers, the product has not been recalled by Fisher-Price, part of the children’s products giant Mattel, which had about $4.5 billion in sales in 2018. The deaths have prompted only warnings from the company and the CPSC, which does not have a mandatory safety standard for infant inclined sleep products.
Fisher-Price told CR in an emailed statement, “The loss of a child is a devastating tragedy. We will continue to do all we can to ensure that parents and caregivers have the information necessary to create a safe sleep environment for infants.”
But CR’s ongoing investigation has turned up deaths of babies even younger than the 3-month threshold cited in the April 5 warning, and go beyond the risk of rollover.
Fisher-Price confirmed to CR that the company is aware of approximately 32 fatalities since the 2009 introduction of the Rock ’n Play Sleeper, including the 10 noted in the joint release with the CPSC. Fisher-Price told CR that the company does not believe that “any deaths have been caused by the product,” citing “the many situations where a medical/health condition was identified as the cause of death, and/or those in which the product was clearly used in a manner contrary to the safety warnings and instructions.”
While CR’s review of the data shows that certain cases did have contributing factors such as illness or additional bedding, the number of incidents associated with the Rock ’n Play Sleeper, combined with long-standing expert medical advice that babies should sleep on firm, flat surfaces, raises serious safety concerns about the product.
Further, the American Academy of Pediatrics says it does not recommend products for routine sleep that require restraining a baby, especially if that product also rocks. “To [fasten] a baby down to a surface and then rock the baby is not consistent with our recommendations,” said Lori Feldman-Winter, M.D., a member of the AAP task force on Sudden Infant Death Syndrome (SIDS) and a professor of pediatrics at Cooper Medical School of Rowan University in Camden, N.J.
“Based on the deaths and injuries associated with the Fisher-Price Rock ’n Play, the product clearly puts infants’ safety at risk and should be recalled immediately,” says William Wallace, senior policy analyst at CR. “All other inclined sleepers should be investigated by the Consumer Product Safety Commission. These products conflict with American Academy of Pediatrics’ safe sleep recommendations, and manufacturers should pull them off the market.”
The alert issued Friday by the CPSC and Fisher-Price follows a previous one from the CPSC nearly a year ago, warning consumers about infant deaths associated with inclined sleep products without naming the Fisher-Price Rock ’n Play Sleeper.
The CPSC told CR in an emailed statement, “At this time, we are focusing on deaths associated with the rollover hazard, though we acknowledge that we are aware of other deaths that have occurred in the Rock ’n Play.” The statement also said that the agency is “continuing to evaluate the product and investigate whether it contains a defect . . . and if the evidence indicates a need for a recall, we will take that step.”
But CR’s investigation—based in part on previously undisclosed CPSC data as well as reviews of lawsuits and interviews with numerous medical experts, product engineers, government and industry officials, and parents—raises questions about how the product was developed and marketed in the first place, and allowed to remain for sale despite incidents dating back many years. It also highlights a larger weakness in the regulatory systems meant to protect consumers, including children, from hazardous products.
The earliest death that CR uncovered occurred in 2011, with more in the years that followed. There is, for example, the mother in Hidalgo County, Texas, who placed her 2-month old daughter on her back for a night’s sleep on Oct. 19, 2013, according to a lawsuit filed by the family against Fisher-Price. At 4 a.m., when the mother checked, all was well, but by 7 a.m., the baby had stopped breathing. Her head was tilted to the side with her chin on her shoulder, compressing her airway. She was pronounced dead at the scene from positional asphyxia, or an inability to breathe caused by her position.
The most recent deaths CR found occurred in spring 2018—one involving a 1-month-old girl in Knoxville, Tenn., and the other a 9-day-old boy in Copperas Cove, Texas.
There have also been some close calls. In one, on July 25, 2014, a 7-week-old boy was placed in a Rock ’n Play Sleeper while his grandmother was in the room, according to a lawsuit filed against Fisher-Price that was ultimately dismissed.
The grandmother, Jan Hinson, of Greenville, S.C., says she looked at her grandson and saw he was “cocked over all the way, and he was blue and lifeless. It was absolutely awful.” She got the infant breathing again, and after a stay in the hospital, he was released.
Hinson, who is also a lawyer, is now representing a Virginia couple, Evan and Keenan Overton, whose son died while in a Rock ’n Play Sleeper.
A few days before Christmas in 2017, 5-month-old Ezra was asleep in the product while Keenan slept on a couch nearby. When Keenan woke in the middle of the night, he found Ezra on his stomach, unresponsive, and yelled for Evan to call 911. “He was blue, and his body was, it was hard, and he didn’t feel real,” Evan said. Ezra was pronounced dead at the hospital; “asphyxia” was listed as the immediate cause of death. (The Overtons say Ezra was buckled in the sleeper, though the death certificate states the baby was unrestrained.)
In the days and weeks following the death, as the Overtons tried to make sense of what happened, they looked online and read about the Fisher-Price Rock ’n Play. The new parents had trusted that the product was safe for sleeping because that is how it is marketed. On the Fisher-Price website, the product is touted for “naptime and nighttime,” and the product’s packaging says things such as “Inclined sleeper designed for all-night sleep.”
But the couple’s internet searches revealed a different story. There were posts from parents and pediatricians describing the product as dangerous, prone to interfering with an infant’s ability to breathe. The Overtons learned that though sudden infant deaths can occur with no clear cause—and there can be many factors involved—experts warned that this particular product, and infant inclined sleep products in general, pose an increased risk of infant death.
The Overtons had received their Rock ’n Play Sleeper as a hand-me-down from their neighbors, who had said that, when their child was an infant, the product had been a lifesaver. But, Keenan said, the Overtons became convinced that was “the opposite of what it was.”
On Jan. 6, 2018, Evan posted a review on Amazon warning parents about the product: “I lost my son in this horrible contraption December 22 . . . this should not be marketed as a sleeper!”
When asked by CR about the Overton incident, the company responded, “The loss of a child is an unimaginable tragedy.” Fisher-Price also confirmed that the Overtons’ case was one of the 10 cited by the company in the joint alert issued with the CPSC on April 5.
History of a Dangerous Product
Fisher-Price says on its website that the company started developing the Rock ’n Play Sleeper when one of its designers had a baby boy who had trouble sleeping because of acid reflux. The designer’s doctors suggested elevating the infant’s head, prompting her and the company to create a sleeper that would keep her son at a 30-degree incline during sleep.
Fisher-Price told CR that it “engaged a leading engineering and scientific consulting firm,” which concluded that the “Rock ’n Play Sleeper presents a lower risk of fatality than cribs and bassinets/cradles.”
Documents filed in an Atlanta lawsuit against Fisher-Price identified a medical consultant hired by the company to be Gary Deegear, M.D., a physician in San Antonio. According to these documents, he offered Fisher-Price assurance about the Rock ’n Play Sleeper’s safety. For example, Kitty Pilarz—vice president of product safety and regulatory compliance for Mattel—wrote in one email: “Dr. Deegear stated pediatricians recommend babies with reflux sleep at 30 degrees, this is just fine, or sleep in a car seat.”
But there are several reasons to be concerned about this advice.
For one, Deegear is not a pediatrician or a sleep specialist, according to the Texas Medical Board, but was a family practice doctor. CR attempted to contact Deegear but could not reach him for comment.
For another, the AAP and the National Institute of Child Health and Human Development have long counseled against letting infants sleep unsupervised in a reclined position.
Shortly after the recent joint alert from the CPSC and Fisher-Price, the AAP tweeted that “The Rock ’n Play should not be used for routine sleep; If you use the Rock ’n Play for soothing, always strap the baby in and never leave the baby unattended.”
“We don’t recommend that babies are placed to sleep with their heads elevated because that is a position that would be subject to accidental suffocation [and] strangulation in bed,” said Feldman-Winter of the AAP. Instead, the AAP says that for prolonged or nighttime sleep, babies should be put on their backs, unrestrained, alone, on a flat, firm surface, such as a mattress covered by a fitted sheet in a bare crib, bassinet, or play yard.
And, experts say, parents should never use a car seat, stroller, swing, sling, wedge, or any other similar product for unsupervised sleep.
That recommendation applies even to babies with acid reflux, Feldman-Winter said. She recognizes that some parents have heard that sleeping on an incline can ease that problem and understands the desperation parents can feel when a crying baby can’t sleep. But “there’s no evidence to suggest that being on an incline is helpful for reflux,” she said. “There is a misconception that that’s somehow an okay, safe sleep position, and it’s just not.”
The AAP also doesn’t recommend for routine use sleeping devices that require the use of restraints because a baby could roll or turn into an unsafe position and be incapable of moving, leading to suffocation or strangulation.
That’s one of the reasons experts caution against using infant car seats for unsupervised sleep. Those products are “acceptable for shorter periods of time because it’s the safest position for a crash,” said Paul Gaudreau, a mechanical engineer who currently works for UPPAbaby and has experience in the car-seat industry. But, he said, research (PDF) shows that a baby’s oxygen level can drop when sleeping at an incline in a car seat. And medical experts warn that the straps can lead to strangulation. “That’s why I’ve steered companies that I’ve worked for away from doing inclined sleepers.”
Finally, the basic advice—that babies should sleep on level, firm surfaces—dates back to 1994, well before Fisher-Price created its Rock ’n Play Sleeper. That’s when the AAP and other groups introduced the “Back to Sleep” campaign to reduce the risk of SIDS and other sleep-related causes of death. That campaign (now called “Safe to Sleep”) has helped cut the rate of SIDS by almost a half.
Roy Benaroch, M.D., an associate adjunct professor of pediatrics at Emory University in Atlanta, who has blogged about the safety risks of the Rock ’n Play Sleeper, told CR that parents are confused by the product at a time when they are especially vulnerable.
“It’s tough because you don’t sleep, the baby is not sleeping, parents are exhausted, and they’re looking for a solution,” he said. But “parents are assuming a lot of risk by using this rather than following the safety guidelines.” Bottom line: “If you let your baby sleep in this thing, there’s an increased risk of death,” Benaroch said.
Regulatory Side Steps
When Fisher-Price first introduced the Rock ’n Play Sleeper, it marketed the product along with its bassinets. But less than a year later, in 2010, the CPSC began revising the standards for infant sleep surfaces, including bassinets, and issued a proposed rule that would require those products to be firm and flat, with an angle of 5 degrees or less when the product was at rest, rather than rocking or swinging.
Instead of adjusting the incline of its product, Pilarz, at Mattel, asked the CPSC for a revision to that proposed rule to account for products like the Rock ’n Play Sleeper. Not making that change, she said, could actually “increase the risk of injury: Parents deprived of any appropriate product for calming their tired, colicky infants will look elsewhere—and substitute products dangerous for that purpose.”
Ultimately, in October 2013, the CPSC excluded products with an incline of greater than 10 degrees from its mandatory bassinet and cradle standards.
Armed with that exclusion, Fisher-Price and other industry reps went to ASTM International—an organization that sets voluntary safety standards for consumer products and includes representatives from the government, industry, and the public—to finish a voluntary standard for a new category: inclined infant sleep products.
Some ASTM members had objected to creating a new category and standard for those products. “By putting a standard in, you’re telling people that . . . it must be safe,” said Nancy Cowles, executive director of Kids in Danger, a nonprofit that focuses on reducing childhood injuries from consumer products. The voluntary ASTM standard, she worried, would create confusion for consumers and give new parents a false sense of security about a product that she felt was anything but secure.
Nevertheless, ASTM agreed to form a committee to develop a standard for the category. And they appointed Michael Steinwachs—one of the primary engineers at Fisher-Price involved in designing the Rock ’n Play Sleeper—chairperson of that committee. The voluntary standard for infant inclined sleep products was ultimately established in 2015.
Cowles, at KID, was disappointed but not surprised that the product category was established. “You can talk safety till you’re blue in the face, but if parents will buy them—and [the company] can always justify the incidents that happen as being the parents’ fault—then they’re going to keep selling them,” Cowles said.
Warnings From Around the World
Other health and regulatory agencies were not as easily sold on the infant inclined sleeper, according to documents in the Hidalgo County lawsuit.
Around January 2011, Australian regulators, for example, wrote to Mattel, explaining why they did not think the item should be marketed as a sleep product. They said that the Rock ’n Play Sleeper “is at odds with widely accepted and promoted best practices that these types of products should not be used as an infant bedding alternative.” They also explained that because of the product’s angle, “babies’ heads can easily fall forward in a way that obstructs their airways.” Fisher-Price confirmed it still does not sell the product in Australia.
In Canada, the product is available—but was reclassified from a “sleeper” to a “soother” and is now marketed and sold as the Rock ’n Play Soothing Seat. This was because in February 2011 a representative from Health Canada wrote to Mattel Canada stating that public health officials there had concerns about the Rock ’n Play Sleeper “in light of the Safe Sleep recommendations of Health Canada, the Public Health Agency of Canada, and the Canadian Pediatric Society.”
In the United Kingdom, the Rock ’n Play is for sale as a “sleeper,” despite misgivings from health organizations. In February 2011, the Royal College of Midwives in the U.K. told Fisher-Price that the product was suitable only for short periods of supervised play and that the group would not endorse the product as a sleeper. After receiving that news, a Fisher-Price employee wrote in an internal email, “Please see attached the findings from the Royal College of Midwives testing on the sleeper. I’m afraid the findings don’t have good implications for a UK launch.”
What Parents Should Do
Given the number of injuries and deaths, consumer safety advocates question why neither Mattel nor the CPSC has yet initiated a recall.
“In cases like these, where the product is on the market and there have been incidents associated with it, it’s very difficult to understand why the enforcement agency with jurisdiction over this product wouldn’t take action,” said Rachel Weintraub, legislative director and general counsel of the Consumer Federation of America. “When we know there are products that are posing risks and causing fatalities, that product in almost every case needs to be taken off the market.”
The alert issued by the CPSC and Fisher-Price is inadequate, said Cowles of KID. She reiterated that children should not sleep restrained, and that children should sleep on flat surfaces, not inclines.
“They should get rid of this product category,” Cowles said. “Anything intended for infant sleep should be flat. And then there should be specific recalls on the products that have been involved in deaths.”
CR safety experts agree and recommend that anyone who currently has a Rock ’n Play Sleeper should immediately stop using it for routine sleep. Instead, babies should be put to bed alone, on their backs, on a firm, flat mattress in a crib, bassinet, or play yard.