Who Does the CPSC Protect?

This spring saw the reign of a popular infant sleeping device unravel. The Fisher Price Rock ‘N Play Sleeper was a type of infant hammock, consisting of a fabric and padding-covered plastic shell, suspended on a foldable metal frame. The Rock ‘N Play was the brainchild of Fisher Price industrial designer Linda Chapman, whose first-born had suffered colic years earlier. At the time, she testified, there was no good way to elevate an infant’s head, neck and torso, to relieve its gastric discomfort.

Fisher Price’s product development team started work on this idea in 2008 and began to sell it in October 2009, marketed as a safe way to put your baby to sleep, unattended, for prolonged periods, even though the company had no research to back that claim. Nearly a decade later, Fisher Price, which had sold 4.7 million units, recalled the product – but not because of efforts by the federal agency charged with protecting consumers from dangerous products – but by a reporter at Consumer Reports.

On April 8, the magazine published a story that tied the Rock ‘N Play to 32 infant deaths. Consumer Reports Special Projects editor Rachel Rabkin Peachman had investigated the safety record of the sleeper over three months, obtaining, through a commission error, unredacted incident reports.

(Last month, the CPSC notified numerous companies that their information had been disclosed in violation of Section 6B of the Consumer Product Safety Act, which gives manufacturers a lot of control over what negative information the CPSC can disclose about them. Since 2017, CPSC apparently released information to 29 recipients, affecting more than 11,000 firms. The CPSC requested that the recipients destroy or return the documents and refrain from publishing the information. Consumer Reports refused.)

Peachman found that there were more than three times as many deaths as the CPSC and Fisher Price disclosed in a vague April 5th warning to consumers. And with 32 fatalities associated with the Rock ‘N Play in the news, the dam broke. A coalition of consumer safety advocates and the American Academy of Pediatrics, which had repeatedly expressed concerns about the safety of inclined sleep products clamored for a recall. One week later, Fisher Price announced a limited recall. On April 11th, Consumer Reports called for the recall of Kids II’s inclined sleep product, Rocking Sleepers, after it found four infant deaths associated with that product. On April 26th, Kids II recalled 694,000 units.

“I cannot think of a single product that we worked on – not a class of products, but where an individual product led to that many deaths from the one company,” says Nancy Cowles, executive director of Kids in Danger, a member of the coalition. “Thirty-two deaths seem like an intolerable number. Clearly, action should have happened well before it got to that point. Who knew what about those deaths other than Fisher Price?”

The number of infant fatalities attributed to the Rock ‘N Play is likely to increase as some previously unaccounted deaths are reexamined for connections to the product.

What the public record does show, is an agency at odds with itself, safety advocates, pediatricians and regulators in other countries. Despite a long record of accord between the CPSC and the American Academy of Pediatrics, which has been for 27 years, issuing safe infant sleep recommendations for supine placement on a firm mattress in a crib devoid of soft sleeping materials, the agency began to shift its stance in the wake of demands from juvenile products manufacturers. It did so, even as the safety records for such products grew worse.

Only five months after the Rock ‘N Play hit the store shelves, the U.S. Consumer Product Safety Commission, under the mandates of the Consumer Product Safety Improvement Act, began to propose rulemaking for bassinets and cradles. The regulation, as first published in April 2010, would have eliminated bassinets and cradles with a rest angle of greater than 5º, based on a 1995 Australian study that videotaped the behavior of 11healthy infants sleeping in all commercial sleep products at the time. The study was conducted to assist the Adelaide State Coroner with an inquest into the death of two infants, and the Department of Public and Consumer Affairs to develop Australian Standards for rocking cradles. The study concluded that infants should never be left unattended in freely rocking cradles, and that Australian Standards should recommend that cradles cannot tilt to greater than 5 degrees. As part of the rulemaking, the CPSC outlined the need to establish a safe rest angle: “When a bassinet or cradle is not in a swinging or rocking mode, it needs to be level to facilitate a safe sleeping environment for infants. There was one death and several close calls associated with non-level bassinets/cradles.”

Fisher Price and Kids II, which manufactured inclined sleep products, and its trade representative, the Juvenile Products Manufacturing Association immediately protested. According to deposition testimony from Kitty Pilarz, Mattel’s senior director of  product safety, Fisher Price submitted comments composed by its outside counsel, Jones Day, asserting that the Rock ‘N Play filled an important, CPSC-recognized “niche market” for “products intended to calm colicky babies.” The JPMA had certified it as compliant with the ASTM standard (even though the standard did not address the Rock ‘N Play’s unique design), allowing Fisher Price to advertise it as "the only infant seat that meets industry safety standards for bassinets." There had been no injury incidents, so if the CPSC persisted in prohibiting the Rock ‘N Play, it might make matters worse, as “parents deprived of any appropriate product for calming their tired, colicky infants will look elsewhere and substitute products dangerous for that purpose.”

In the next nine years, the events involving the Rock ‘N Play would run on two tracks. On one, the CPSC and industry would come together to codify the safety of inclined sleep products via voluntary and mandatory standards. On the other, the AAP, the child safety advocacy community, and regulators in other countries would publicly reject inclined sleepers as safe for newborns, while the infant death toll involving the Rock ‘N Play and other inclined sleep products would rise.

Infant Deaths in Inclined Sleepers

In July 2010, Baby Matters, of Berwyn, Pa. recalled 30,000 Nap Nanny portable baby recliners, after  a 4-month-old girl from Royal Oak, Mich. died in one. The Nap Nanny was a wedge-style inclined sleep product with a harness, invented by a Philadelphia sportscaster Leslie Kemm Gudel, who had no product design experience or expertise in infant sleep. At the time, the CPSC and the firm had received 22 reports of infants, primarily younger than 5-months-old, hanging or falling out over the side of the product. Other Nap Nanny models continued to be sold, until three years later when the CPSC forced Baby Matters to recall all 165,000 units. The commission had received at least 92 incident reports, including five of infant deaths. Baby Matters closed up shop in November 2012. As of 2014, a total of six infants died in the product.

In September 2010, the CPSC posted a blog warning parents against using any type of sleep positioner: “CPSC and the U.S. Food and Drug Administration (FDA) are warning parents and caregivers to stop using sleep positioners. Over the past 13 years CPSC and FDA have received 12 reports of infants between the ages of 1 month and 4 months who have died when they suffocated in these positioners or when they became trapped between a sleep positioner and the side of a crib or bassinet. Both types of sleep positioners claim to help reduce the risk of Sudden Infant Death Syndrome (SIDS) by keeping babies on their backs, help with food digestion and reflux, ease colic, and prevent flat head syndrome.” The FDA and CPSC staffs have stated that there is currently no scientific evidence supporting these medical claims. The American Academy of Pediatrics (AAP) already tells parents to avoid “commercial devices marketed to reduce the risk of SIDS.”

In 2011, according to reporting by Consumer Reports, the first known death incidents in a Rock ‘N Play surfaced.

In 2012, The CPSC and the FDA  issued warnings to parents against using inclined sleep products, after the Centers for Disease Control published a weekly morbidity report on infant deaths that included inclined sleep products. “We urge parents and caregivers to take our warning seriously and stop using these sleep positioners,” Inez Tenenbaum, CPSC chairwoman said in a statement. “The sleep positioner devices come primarily in two forms. One is a flat mat with soft bolsters on each side. The other, known as a wedge-style positioner, looks very similar but has an incline, keeping a child in a very slight upright position.”

A June 2013 internal email from Fisher Price to the CPSC, which was produced in litigation, mentioned that the company was investigating a possible death in a Rock ‘N Play. In October of that year, the death of two-month-old Dayana Torres in Hildalgo County, Texas, was also linked to a Rock ‘N Play sleeper.

In November 2015, the CPSC published a report of injuries and deaths associated with nursery products, finding that in a three-year period covering 2010-2012, there were 17 deaths were associated with infant sleep products. They included seven deaths in an inclined sleeper, most in a foam-style sleeper which was being used inside a crib.

In May 2018, the CPSC issued a vague warning to parents urging them to always use restraints with inclined sleep products and to stop using them as soon as the baby can roll over. The alert acknowledged that the CPSC was aware of infant deaths associated with inclined sleep products: “Babies have died after rolling over in these sleep products.” No particular product, manufacturer, or death tally was named. Safety advocates today surmise that the alert was prompted by deaths in a Rock ‘N Play, but that Fisher Price hid behind Section 6 (b). Without the crucial identifying information, the warning was useless, because most parents would have no idea what an “inclined sleep product” was.

Nearly a year later, on April 5, the CPSC issued another warning – this time with Fisher Price acknowledging 10 deaths in a Rock ‘N Play sleeper since 2015. On April 8, Consumer Reports published its story revealing 32 deaths linked to the product. On April 11th, the magazine published n update linking four infant deaths to inclined sleep products manufactured by Kids II. 

Opposition to Rock ‘N Play

While the injuries, deaths, and close calls remained largely hidden, Fisher Price went looking for new markets for the Rock ‘N Play. It did not get the same concessions from regulatory agencies in other countries. In 2011, officials in Canada and Australia rejected the Rock ‘N Play as a sleep product. The company withdrew it from the Australian marketplace rather than change its marketing. In Canada, it was sold as a “soothing seat.” In the UK, where it is sold as a sleeper, the influential Royal College of Midwives refused to endorse the Rock ‘N Play for anything other than a playtime accessory of short duration: “It was agreed that: this would not be suitable for a new born infant as babies cannot be placed in a semi-prone position; This should not to be used for infants under six weeks; The lying surface is not suitable as an infant cot - and must not be used as infant cot to sleep next to mother's bed because babies must always sleep flat on their backs;  Unreservedly - this product must only be used for no more than two hours in a day and for the purpose of play/interaction with parents/siblings etc,” they wrote.

Pediatricians in the U.S. also raised the alarm. In 2012, Dr. Natasha Burgert, a Kansas City, Mo. Pediatrician published open letter to Fisher Price calling it “irresponsible to promote the Rock n’ Play™ Sleeper as an safe, overnight sleeping option for infants. By continuing to do so, you are putting babies at risk.  The Rock n’ Play™ Sleeper should not be used for extended, unobserved infant sleep for the following reasons. First, design features of this product are known to increase the risk of sudden infant death syndrome (SIDS). Second, I have personally seen infants with brachycephaly/plagiocephaly [flat head] and torticollis [twisted neck] as a direct result of using this product. Finally, infants are often left with poor sleep habits that continue long beyond the product’s use.”

Another blogging pediatrician, Dr. Roy Benaroch, published a similar opinion, and reached out to Fisher Price directly to express his concerns in great detail. He received a form reply: “Thank you for your inquiry and comments. We did receive your email on February 7. 2013.  We have provided these comments to the appropriate people within Fisher-Price. The Rock ‘n Play Sleeper complies with all applicable standards. We encourage consumers who have questions or concerns about providing a safe sleeping environment for their babies to discuss these issues with their doctors or pediatricians.”

The AAP, which had been issuing sleep recommendations to reduce the incident rate of SIDS since 1992, continued periodically to sharpen its advice to caregivers. In 2011, it issued specific safe sleep guidelines, which inclined sleep products could not meet, such as: “Infants should be placed for sleep in a supine position (wholly on the back) for every sleep by every caregiver until 1 year of life; Use a firm sleep surface—A firm crib mattress, covered by a fitted sheet; Sitting devices, such as car safety seats, strollers, swings, infant carriers, and infant slings, are not recommended for routine sleep in the hospital or at home; If an infant falls asleep in a sitting device, he or she should be removed from the product and moved to a crib or other appropriate flat surface as soon as is practical.”

The AAP also directly addressed the claims made by manufacturers in 2010, that their products were a godsend for babies with intestinal problems:

“The supine sleep position does not increase the risk of choking and aspiration in infants, even those with gastroesophageal reflux, because they have protective airway mechanisms. Infants with gastroesophageal reflux should be placed for sleep in the supine position for every sleep, with the rare exception of infants for whom the risk of death from complications of gastroesophageal reflux is greater than the risk of SIDS (ie, those with upper airway disorders, for whom airway protective mechanisms are impaired)”

Giving Inclined Sleep Products a Safety Stamp

Nonetheless, the CPSC and inclined sleeper manufacturers proceeded to develop safety standards. An ASTM sub-committee was formed, headed by Michael Steinwachs, a retired Fisher Price Product Integrity Engineer who worked on the development of the Rock ‘N Play.

In October 2012, the CPSC made official its regulatory approach to exclude inclined sleep products from the bassinet and cradles rulemaking that was underway. In a Supplemental Notice of Proposed Rulemaking the Commission wrote: [The] Commission believes that a separate standard targeted specifically to these products will more effectively address any hazards associated with them. Due to the significant progress in the development of a separate voluntary standard to address hammocks and inclined sleeping products, the Commission is not including them within the scope of this proposed rule.”

The ASTM released the first voluntary standard for inclined sleep products in May 2015 and a revision in 2017. And in April 2017, the CPSC published a Notice of Proposed Rulemaking specifically for inclined sleep products, in which it noted 14 fatalities between 2005 and 2016, with eight in rocker-like inclined sleep products. The CPSC pronounced itself satisfied that the current voluntary ASTM standard would address “the primary hazard patterns identified in the incident data.” All that was needed was “more stringent requirements” relating to the standard’s definition of accessory—which meant removing the term ‘‘rigid frame’’ from the definition, because, the CPSC said, not all inclined sleep products have a rigid frame. In fact, the CPSC was aware of a new inclined sleep product had entered the market without such a frame.

The child safety community was visibly dismayed. A coalition of groups, including Kids In Danger, Consumer Federation of America, Consumers Union, Consumer Reports, Public Citizen, and U.S. PIRG, submitted comments pointing out that there had been no studies showing that babies sleep better on an incline, nor any studies on the impact of continuous restraining sleeping infants on their development or safety. They urged the CPSC to promulgate a standard that ensure the same safe sleep as a full-sized crib.

The AAP  expressed “concerns about all inclined sleep products and the hazards they may pose to infants, and we are concerned that a safety standard could give parents and caregivers the mistaken impression that these products have been proven safe…The AAP continues to recommend that infants with gastroesophageal reflux should be placed for sleep in the supine position for every sleep, with the rare exception of infants for whom the risk of death from complications of gastroesophageal reflux is greater than the risk of SIDS (i.e., those with upper airway disorders, for whom airway protective mechanisms are impaired), including infants with anatomic abnormalities such as type 3 or 4 laryngeal clefts who have not undergone antireflux surgery. Elevating the head of the infant’s crib while the infant is supine is not recommended. It is ineffective in reducing gastroesophageal reflux; in addition, it might result in the infant sliding to the foot of the crib into a position that might compromise respiration.”

Controversy and Contradictions

Back in 2008, when Fisher Price was developing the Rock ‘N Play, there was no research to support the safety of inclined sleepers, because the products didn’t really exist. As documents produced in litigation show, Fisher Price couldn’t rely on data, so it called in a San Antonio family physician, named Gary Deegear, who aslo worked as an injury forensics consultant, to provide guidance.

“I'm not sure that we did specific research at this time about incline angles other than talk to Dr. Deegear,” Pilarz said in a deposition.

The decision to incline the rocker at 30 ° was an educated guess, somewhere between the 45° angle of infant car seat and a flat surface. In February 2009 email, Pilarz described the justification for this design decision:

“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. He will do a quick search. I explained that we are also researching this issue. I also have a call in to a local group of pedestrians to see if they are willing to offer an opinion.”

In that email exchange, Dr Deegear also sent Fisher Price the AAP’s safe sleep guidelines, which say nothing of the sort.

Similarly, the CPSC had no research to support a rulemaking decision to codify the safety of inclined sleep products in a way that would prevent infant deaths in these contrpations with any real confidence. What they did have on the one hand, was a major juvenile products manufacturer servicing a thriving market of parents desperate for sleep and on the other, the longstanding safe sleep recommendations of the AAP, which the commission has repeatedly endorsed.

“This idea they are giving the consumer something that will help them is not at all true,” Cowles says. “Fisher Price produced 5 million of these sleepers. There has been no reduction in sleep-related deaths. You would think that you would have seen some reduction, if these things were so effective. They convinced parents it would help their babies sleep, because we are all looking for a way to help babies sleep. And parents assume that if it’s for sale, someone made sure it was safe. That’s clearly not true with this product.”

Even former CPSC Chairman Inez Tenenbaum, on whose watch the CPSC took their peculiar stance, testified as an expert witness for Fisher Price in a personal injury lawsuit. Tenenbaum, now a lawyer in private practice with the Wyche Law Firm firm in South Carolina, testified in February 2018 that “the AAP has not come out against the incline[d] sleepers… The AAP has never said not to use an incline[d] sleeper.” You’d think the for the $1,000 an hour she charged Fisher Price for her expert opinion she might have read the AAP’s April 2017 comments to the docket in which they criticized the commission for giving parents the impression that theses products were safe when there was no evidence to support it.

But for the CPSC’s error and Consumer Reports persistent reporting, the public would never have known just how flimsy the foundation for these consequential decisions is.

Fisher Price’s walk-the-plank recall only reimburses parents who purchased a Rock ‘N Play in the last six months, pretty much ensuring that many units will remain uncaptured and many infants will be exposed to the risk of injury and death. That troubles Rachel Weintraub, the Consumer Federation of America’s executive director.

“This recall, while better than no recall has numerous problems. I am concerned, because from what we know about recall effectiveness, that this recall is not a recipe for success – much more needs to be done,” she said.

The Rock ‘N Play and other inclined sleepers have gotten so toxic, that earlier this month, the CPSC told Consumer Reports that it planned to “reevaluate” the entire product category. Steinwachs stepped down from the ASTM inclined sleep products standards sub-committee. Last week, its member rejected a call from safety advocates and the AAP to withdraw the product category, but intended to look into it further when it re-convenes in October.  

“We plan to keep pushing,” Weintraub says.

 

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