Fisher-Price and the era of inclined sleepers

In 2019, the American toy company Fisher-Price voluntarily recalled nearly 5 million Rock ‘n Play Sleepers, an extremely popular product that essentially ushered in an era of inclined infant sleep when they first hit the market in 2008. The recall came only after the Rock ‘n Play was implicated in the death of at least 32 infants over the preceding 10 years. But this was just the tip of a giant floating mass of corporate greed and inept governmental regulations.

As long as I have been a pediatrician, which is just shy of 20 years, I have recommended that babies sleep flat on their backs rather than in inclined sleepers like the Rock ‘n Play. This has, in fact, been a part of the official American Academy of Pediatrics policy on safe sleep going back to the mid ’90s. This policy also strongly recommends avoiding plush bedding and any restraints used to force a baby into a certain position. The Rock ‘n Play and copycat products that emerged soon after it hit store shelves ignored all of these recommendations, yet they quickly became very popular with parents and made millions in profits for manufacturers.

Inclined sleep didn’t begin with the Rock ‘n Play, rather it was simply the first product specifically designed and marketed for that purpose. Prior to 2008, some babies were propped up in other ways, such as by placing a pillow under their mattress or letting them sleep in a “bouncer” or car seat despite warnings from the manufacturers. There was a time when some pediatricians and pediatric gastroenterologists even recommended inclined sleep, usually at an angle of 30 degrees or less, for fussy infants with reflux disease or nasal congestion. Sadly, some still do, despite the fact that no evidence supports this practice and inclined positioning can actually worsen reflux. But because these products were marketed as a way to improve infant sleep and quickly benefited from parental placebo-infused word of mouth, the Rock ‘n Play and its ilk saturated the market.

As I mentioned above, since 1994 the official recommendation from the AAP has been a flat sleeping surface. Although not always entirely clear, the most common mechanism for injury and death in these cases is suffocation. A baby that is propped up can more easily roll onto their side or stomach with their face potentially pressed against soft bedding or other plush material (stuffed animal, blanket, pillow, etc.) in their sleep environment. Children can also become trapped in an unsafe position by restraints meant to keep them from falling out of the chair. And very young infants, or infants with medical conditions that cause muscle weakness, might have difficulty maintaining an adequate airway because of poor neck strength, which can result in lengthy periods of decreased oxygen levels and even death.

I remember being angry when I heard of the deaths and somewhat relieved by the recall. I was frustrated at the reality that these products were allowed to be sold to parents and I worried that Fisher-Price and other companies had been prioritizing profit over safety. I had no idea just how bad their behavior was, and how lacking safety regulations were, until a new warning from the U.S. Consumer Product Safety Commission (CPSC), again involving infant deaths in a Fisher-Price product, inspired a deeper look into this issue.

The Rock ‘n Play recall of 2019

When Fisher-Price issued a voluntary recall of the Rock ‘n Play, it wasn’t because they had just discovered that babies were dying in their product. It took a damning report from Consumer Reports to reveal the serious safety concerns to the public. According to a 2021 Committee on Oversight and Reform investigation, both Fisher-Price and the CPSC were aware of the danger, but neither were interested in a recall until Consumer Reports forced their hand by disclosing information on infant injuries and deaths that the CPSC had accidentally sent to them. More on all this a bit later.

The AAP, which had been warning against these products for years, issued a statement demanding a recall after the Consumer Reports bombshell, and stressed the need for improved regulation of infant products that don’t follow safe sleep recommendations. At the time, the chair of the AAP’s Council on Injury, Violence, and Poison Prevention Executive Committee raised a serious and prescient concern:

While this recall is specific to the Rock ‘n Play, there are other inclined and padded sleeping products on the market that can put infants’ safety at risk.

These concerns weren’t new, however. Consumer Reports CEO Marta Tellado shined a light on the problem of weak regulation at the federal level and, it seems with hindsight, perhaps threw some shade at Fisher-Price, which was less than forthcoming about the many reports of injuries and deaths that they had received over the years:

The Fisher-Price recall of the Rock ‘n Play is long overdue. It took dogged investigation and the voices of doctors, victims’ families, and advocates across the country to make this recall a reality. Congress needs to take a hard look at the CPSC and make sure it is a watchdog that consumers can rely on.

As I mentioned above and will discuss in more detail soon, Congress would eventually take that hard look, though the wheels turned slow which allowed many more kids to die. Fisher-Price offered a full refund to consumers who had purchased a Rock ‘n Play less than 6 months prior to the recall, and a voucher to some of those who had owned one for a bit longer. Safety experts at the time were less than impressed, however, and called for full refunds for all owners so that parents would be more likely to return the sleepers. That didn’t happen and millions of used inclined sleepers remained in homes, daycare centers, and available for purchase on secondary markets online.

One of the biggest concerns that this episode raised was obviously the lack of adequate safety regulations. Many, and perhaps even most parents do not realize that a product sold for use by infants is not necessarily safe just because it can be legally purchased in a store or online. Sadly, despite the 2019 recall of the Rock ‘n Play and widespread media coverage, infants continued to die in inclined sleepers and other similar products because the core problem wasn’t solved.

Corporate greed and weak regulations

In December of 2019, Consumer Reports published an investigative piece that looked behind the scenes of the development of the Rock n’ Play and its continued availability despite knowledge of the risk posed to babies. As articles about dangerous products often do, it started with an emotional anecdote about an injured child and a lawsuit:

Courtney and David Goodrich of Atlanta had brought the case after their 7-week-old son Asher had nearly died in the sleeper in July 2014. He was napping when Jan Hinson, Asher’s grandmother, noticed his head oddly flopped forward and to the side. When Hinson got closer, she saw that Asher wasn’t breathing and that his face was blue.

Thankfully Asher did not die, but his family wasn’t satisfied with Fisher-Price’s response to their concerns over the safety of the Rock ‘n Play. In a nutshell, the company disagreed and had no plans to look any further into the issue. The lawsuit that resulted from this event revealed that Fisher-Price already knew that the product was unsafe and was implicated in at least 14 deaths at that point. A 7-week-old infant in Tennessee even died in a Rock ‘n Play on the same day in early 2018 that the product’s inventor was being deposed.

In April of 2019, the recall involving Fisher-Price discussed above happened. Soon after, two additional companies (Kids II and Dorel) recalled incline sleepers that had been implicated in additional deaths. In total, these products were to blame for at least 70 infant deaths and more than 1,000 events similar to what happened to Asher in the above anecdote, many of which resulted in serious injuries. In reality, there were certainly many more than this that weren’t captured by the investigation.

By the end of 2019, most major retailers were pulling all inclined sleepers from sale regardless of whether or not they had been recalled. More good news came that December when lawmakers in Washington finally began to move on legislation that would ban the sale of these products entirely. The process, which also included a lengthy congressional investigation, ultimately took more than two years from when the Rock ‘n Play was recalled to when the Safe Sleep for Babies Act of 2021 was signed into law by President Biden in May of this year:

This bill makes it unlawful to manufacture, sell, or distribute crib bumpers or inclined sleepers for infants. Specifically, inclined sleepers for infants are those designed for an infant up to one year old and have an inclined sleep surface of greater than 10 degrees. Crib bumpers generally are padded materials inserted around the inside of a crib and intended to prevent the crib occupant from becoming trapped in any part of the crib’s openings; they do not include unpadded, mesh crib liners.

The Safe Sleep for Babies Act may have finally gone into effect last month, but it allows 180 days for manufacturers to comply. So parents may still see these dangerous products for sale on store shelves or online until late November. This obviously has taken way too long and, again, the people who put these products into the marketplace should have known better from the beginning.

The December 2019 Consumer Report exposé uncovered numerous problems with the way Fisher-Price went about designing and marketing the Rock ‘n Play. Though hard to believe, at no point in the process was safety really even considered:

But members of that safety team didn’t research the medical premise of the Rock ‘n Play Sleeper, either. “That was not part of my charge at that time,” said Michael Steinwachs, the project’s product integrity engineer on the hazard analysis team, who was deposed in the Goodrich lawsuit a day after Chapman. That was the responsibility of Kitty Pilarz, he said, who was then a director of product safety for Fisher-Price’s parent company, Mattel.

Pilarz, however, did nothing of the sort despite her job title. She never spoke to a single pediatrician or consulted any infant sleep expert. And it turns out that they chose an angle of 30 degrees for the amount of incline provided by the product almost randomly, assuming that anything less than 45 degrees, which is typical for car seats, would be fine. No independent safety testing was performed and the one physician involved had no pediatric expertise and was eventually forbidden from seeing patients by the Texas medical board after he practiced medicine high or drunk with an expired license.

When the Rock ‘n Play first hit store shelves, it was marketed as a bassinet, a designation regulated by the non-governmental ASTM International that required some minimal safety standards to be met. The angle of incline was not one of these standards, but 6 months after first going on sale in 2008 the CPSC proposed a limit of 10 degrees. This would have caused serious problems for Fisher-Price if enacted, so they requested that the Rock ‘n Play be given a brand new distinction as an “inclined infant sleep product” and allowed to have an incline up to 30 degrees and to provide restraints to hold a baby in place. It worked:

The CPSC agreed, paving the way for Fisher-Price to propose a new product category to ASTM called infant inclined sleep products. The chairman of the ASTM subcommittee charged with creating the standard was none other than Michael Steinwachs, the Fisher-Price product engineer who helped develop the Rock ‘n Play Sleeper.

This “safety standard” was based on no safety testing and potentially fooled many parents into believing that these inclined sleepers were safe. Fisher-Price met with resistance in other countries, in particular Australia, England, and Canada, who either banned sales of the Rock ‘n Play or forced Fisher-Price to stop promoting them as safe for sleep or unsupervised use. Despite this, and an increasing number of deaths, these products remained available and parents remained unaware.

Fisher-Price knew, however. And so did the CPSC. The CPSC, though, was limited by law from disclosing injuries and deaths without permission from the involved manufacturer. It also does not have the power to recall products without taking the company to court, unless they can convince them to voluntarily comply. In that case, the manufacturer has the right to control the language used in any press releases.

There is actually even more to this story, such as how Fisher-Price blamed parents for the death of their babies and how the CPSC tried to prevent Consumer Reports from going public with the data on infant deaths caused by Rock ‘n Play use. The article also goes into detail on the absurdly long and arduous journey that eventually led to the CPSC warning parents to avoid all inclined sleepers and the beginning of the lengthy process required to ban them outright. I encourage you to read the entire article. Here is the link again.

Two years later…

After the recall of 2019 and the subsequent fall out that resulted in increased awareness of the dangers of inclined sleepers by the public and the federal government, infants continued to die. Sometimes these deaths involved continued use of recalled products. Many deaths involved inclined products not promoted for sleep but used for that purpose anyway. There have been additional recalls of these products, such as the Fisher-Price 4-in-1 Rock ‘n Glide Soother in 2021. It was linked to 4 deaths of sleeping infants. The answer obviously wasn’t to just to slap a warning label on a package because the problem is the incline.

As I referenced earlier, in June of 2021 a report summarizing the findings of a 2-year-long investigation by the House Committee on Oversight and Reform on infant inclined sleep products was published. Along with copious detail supporting them, the report included the following findings in the executive summary:

  1. Fisher-Price failed to ensure the Rock ‘n Play was safe, ignored warnings that it was dangerous, and marketed it for overnight use despite risks
  2. CPSC does not have adequate regulatory or enforcement powers to protect the public

In the report’s conclusion, a very important point was made:

Manufacturers are private companies driven by profit, and they have an obvious financial incentive to keep their products on the market. They should not be empowered to determine whether these product are safe for the public.

Infants remain at risk but there may be a light at the end of the tunnel

What inspired me to look into the history of inclined sleepers, and the Fisher-Price recall of 2019, was a June 14th CPSC warning about two more Fisher-Price product being linked to at least 13 infant deaths. This time the products are the Infant-to-Toddler and Newborn-to-Toddler Rockers and the deaths were attributed to their use for sleep, which if you’ve learned anything from this post it should be that this is a dangerous practice when an incline is involved. And now you know why this was just a warning rather than a recall.

It’s the same nonsense all over again. Fisher-Price isn’t going to voluntarily agree to a recall and the CPSC isn’t going to invest time and money into forcing one. As of yesterday, however, new CPSC regulations are now in effect requiring all infant products marketed for use during sleep to follow a universal federal guideline that includes an incline of 10 degrees or less, but that won’t magically make all the unsafe older versions disappear and that won’t make products like rockers, swings, and bouncers any safer when a baby falls asleep in one.

One potential legislation that might make a big difference is Richard Blumenthal’s Sunshine in Product Safety Act. If passed, it would give the CPSC more freedom to disclose safety concerns to the public. Fingers crossed.

Author

  • Clay Jones, M.D. is a pediatrician and a regular contributor to the Science-Based Medicine blog. He primarily cares for healthy newborns and hospitalized children, and devotes his full time to educating pediatric residents and medical students. Dr. Jones first became aware of and interested in the incursion of pseudoscience into his chosen profession while completing his pediatric residency at Vanderbilt Children’s Hospital a decade ago. He has since focused his efforts on teaching the application of critical thinking and scientific skepticism to the practice of pediatric medicine. Dr. Jones has no conflicts of interest to disclose and no ties to the pharmaceutical industry. He can be found on Twitter as @SBMPediatrics and is the co-host of The Prism Podcast with fellow SBM contributor Grant Ritchey. The comments expressed by Dr. Jones are his own and do not represent the views or opinions of Newton-Wellesley Hospital or its administration.

Posted by Clay Jones

Clay Jones, M.D. is a pediatrician and a regular contributor to the Science-Based Medicine blog. He primarily cares for healthy newborns and hospitalized children, and devotes his full time to educating pediatric residents and medical students. Dr. Jones first became aware of and interested in the incursion of pseudoscience into his chosen profession while completing his pediatric residency at Vanderbilt Children’s Hospital a decade ago. He has since focused his efforts on teaching the application of critical thinking and scientific skepticism to the practice of pediatric medicine. Dr. Jones has no conflicts of interest to disclose and no ties to the pharmaceutical industry. He can be found on Twitter as @SBMPediatrics and is the co-host of The Prism Podcast with fellow SBM contributor Grant Ritchey. The comments expressed by Dr. Jones are his own and do not represent the views or opinions of Newton-Wellesley Hospital or its administration.