Fisher-Price thought it had a hit on its hands.
It was 2009, and a small team of engineers at the toy company outside Buffalo, New York, seemed to have solved one of the most vexing problems for new parents: getting babies to sleep. Their invention was an inclined sleeper. They named it the Rock 'n Play. It held babies on their backs in a padded frame at a 30-degree angle, like a recliner. There was nothing else like it. Cribs and bassinets laid flat. The difference was spelled out right on the box: "Baby can sleep at a comfortable incline all night long!"
"There was no product on the market that safely did that," was how the Fisher-Price employee who dreamed it up put it, according to a later court deposition.
Over the next decade, Fisher-Price would sell 4.7 million Rock 'n Play Sleepers at $US50 ($73) to $US80 each.
But Fisher-Price developed its revolutionary product based on faulty beliefs about infant sleep, with no clinical research into whether it was safe, and, rather than seeking the advice of Paediatricians, consulted just a single doctor - a family physician from Texas whose expertise had already been doubted by judges and who would eventually lose his medical licence, according to a review by The Washington Post of thousands of pages of court depositions, emails and medical studies, along with interviews of doctors and regulators.
In fact, the first time Fisher-Price hired a paediatrician to evaluate the Rock 'n Play was eight years later, as part of the company's defence in a product liability lawsuit, according to records.
"That's shocking. It would never cross anyone's mind that it wasn't tested for safety," said Nancy Cowles of the consumer advocacy group Kids in Danger. Cowles also sits on a committee that sets voluntary safety standards for infant sleep products, including the Rock 'n Play.
Last month, the Rock 'n Play was recalled by Fisher-Price globally (including in Austalia) after a series of infant deaths. The US Consumer Product Safety Commission (CPSC), which helped coordinate the recall, said more than 30 babies died in the product after they turned over while unrestrained or "under other circumstances". But regulators did not definitively blame the product for the deaths. The recall followed a report by Consumer Reports magazine days earlier that was the first to document concerns about the product's development and pushed for the recall after it obtained agency records about the deaths. Two weeks later, another 700,000 inclined sleepers made by another firm, Kids II, were recalled in relation to five more deaths.
And the death toll could still rise. Recalls are notoriously ineffective at removing products from the market and fatality reports have come into the CPSC since the April 12 recall, according to a senior agency official.
The roots of the recent recall and subsequent outcry over why it took regulators so long to act can be traced back to critical decisions Fisher-Price made a decade ago that first allowed the inclined sleeper into people's homes, illustrating how the nation's product safety system relies heavily on manufacturers - rather than regulators - to protect against dangers in new products.
"People assume we bless a product before it comes to market," longtime CPSC commissioner Robert Adler said. "That isn't the case."
Yet consumers trust that infant products, in particular, face scrutiny before hitting store shelves.
"It never crossed our mind it could be dangerous," said Sara Thompson, a mother from Reading, Pennsylvania, whose 15-week-old son Alex died in a Rock 'n Play in 2011.
#Recall: 4.7 Million @FisherPrice Rock ‘N Play Sleepers Due to Reports of Infant Deaths. Stop using the product and contact Fisher-Price for a refund or voucher. CONTACT: 866-812-6518 or https://t.co/qcX9yJ7hHz. Full recall notice: https://t.co/opDScutIgK pic.twitter.com/DCIqrTjpun— US Consumer Product Safety Commission (@USCPSC) April 12, 2019
Fisher-Price's owner, Mattel, declined to respond to a detailed list of questions about the Rock 'n Play and its creation. The company said in a statement: "Safety is priority number 1 for Fisher-Price" and the company "has a long, proud tradition of prioritising safety as our mission. We at Fisher-Price want parents around the world to know that we have every intention of continuing that tradition." Kids II said its "first priority is the safety of babies and parents who use our products".
Fisher-Price also pointed out that the Rock 'n Play met all applicable US regulations and safety standards.
But those safety standards didn't prevent Fisher-Price from selling a product that - despite a lack of evaluation by medical experts - dealt with one of the riskiest situations in an infant's life. Unexpected sleep deaths are the leading cause of accidental fatalities for children younger than one in the United States, killing 3,600 infants annually. While the causes of these deaths often remain medical mysteries, experts say they do know how to make sleep safer.
Yet the Rock 'n Play's design appeared to conflict with longtime American Academy of Pediatrics guidelines on what constitutes safe infant sleep. These guidelines have recommended since the mid-1990s that babies sleep faceup in an empty crib or bassinet to avoid accidental suffocation. The Back to Sleep campaign - supported by US medical authorities - also says babies should not sleep for long periods in inclined devices such as car seats or infant swings for the same reasons. Studies credit this advice with slashing US infant sleep deaths in half over the past two decades.
"There was no reason for this thing to be out there," said Benjamin Hoffman, a paediatrician in Portland, Oregon, who chairs the American Academy of Pediatrics' Committee on Injury, Violence and Poison Prevention. "It never should've been."
So how did it get there?
The origins of Rock 'n Play
The first sketch of an inclined sleeper came from a Fisher-Price industrial designer named Linda Chapman.
Her story of dreaming up the product was used by Fisher-Price for years to market the Rock 'n Play. And Chapman retold that story in greater detail during a deposition last year in a lawsuit against Fisher-Price. The lawsuit had been filed by a Georgia couple whose seven-week-old son survived after being found blue and lifeless in the product in 2014. The boy's grandmother, attorney Jan Hinson, ended up being the driving force behind the legal case against Fisher-Price - which was dismissed late last year by a judge who found a lack of evidence to support a product liability claim.
But the case - plus a Texas court case involving a baby's death in a Rock 'n Play in 2013 - led to transcripts of Fisher-Price workers laying out, in their own words, how the company created the inclined sleeper.
Chapman said the product's original design was based on what she remembered from her interactions with her son's doctor years earlier, when her newborn was suffering from reflux, a common issue that can cause spitting up and bouts of crying, according to a deposition transcript.
"I was recalling what my paediatrician recommended when my son was little," she said.
"And what did he recommend?" she was asked.
"To elevate his head when sleeping. He said you could put a pillow underneath the mattress, or he didn't really have a good way to do it."
Many parents - and a few doctors - still contend an incline helps babies who have reflux, which often causes them to spit up. But medical studies have shown little support for this. In 2009, the same year the Rock 'n Play debuted, two leading groups of pediatric gastroenterologists, building on accumulating evidence, released international consensus guidelines on managing stomach problems in babies, finding that elevating an infant's head actually worsens gastric reflux. The American Academy of Pediatrics adopted the findings.
Still, elevating a baby's head was one of the core beliefs behind the Rock 'n Play's development. The company used that claim in a 2010 letter to the CPSC as the agency first looked at regulating inclined sleepers.
In its letter, Fisher-Price wrote, "Doctors often advise letting such colicky infants sleep in an inclined supine position, of as much as 30 degrees". Fisher-Price, which declined to comment on the letter, appeared to be using "colicky" - a term used by Paediatricians to describe a baby who cries excessively - to mean a baby who cries because of reflux.
The company supported its claim by citing "a newsletter made available by the American Academy of Pediatrics" and quoting its suggestion for infants who regurgitate of "elevating the head of the crib and diaper changing table to 30 degrees so they never lay flat".
That argument aligned perfectly with the 30-degree Rock 'n Play.
But that newsletter, written by the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition, was based on the society's old treatment guidelines from 2001 - when inclining infants was still recommended. By 2010 - when Fisher-Price wrote its letter - that advice had been changed to say inclining babies was harmful.
"What changed? The data," said Benjamin Gold, a pediatric gastroenterologist and president-elect of the medical society that helped craft the guidelines. Inclined positioning "was no longer recommended for infants".
But Chapman, who did not respond to a request for comment, said in her deposition she never checked her recollection of her doctor's suggestion against up-to-date medical advice on infant sleep safety.
"That's not my job," Chapman said.
That was the job of the safety committee, she said, which was led by Kitty Pilarz, a Fisher-Price engineer working as a product safety manager. Today, she's vice president of product safety and regulatory compliance for Fisher-Price. She did not respond to a request for comment.
In her deposition, Pilarz said Fisher-Price didn't have medical professionals on staff.
"Once I saw the concept and we started working on the concept," Pilarz said, according to a transcript, "I did talk with our medical consultant about the concept."
"Dr. Deegear?" she was asked.
'Not even aware of the theory'
Gary Deegear of San Antonio, Texas, had been consulting on Fisher-Price products for years, according to depositions. Fisher-Price declined to talk about his work for the company.
Deegear specialised in family medicine and treated patients for a few years after graduating from the medical school at the University of Texas at San Antonio in 1988, according to court records and his online résumé. He then moved on to consulting, often in product liability lawsuits, where he was an expert witness focused on power tool injuries, according to records in other cases.
He also testified as a defence expert in a 2004 federal lawsuit resulting from a police shooting in La Porte, Texas. The judge excluded Deegear's theory of what happened because it did not appear to be accepted by scientists: "In fact, the scientific community is not even aware of the theory," according to court records.
This was not the only time Deegear had his theories doubted. In 1998, another judge excluded Deegear's expert testimony in the case of a man who lost four fingers in a radial arm saw accident, court records show. The judge ruled that Deegear's work was untested and subjective.
Deegear's medical license expired in 2015, according to Texas records. Last year, the Texas Medical Board filed a cease-and-desist order against him for allegedly practicing medicine without a license at a medical spa and for conducting unsafe practices.
Deegear could not be located for comment for this story, despite multiple attempts to find him through family members and former employers. Attorneys looking to take his testimony about his role in the Rock 'n Play's development also have not been able to find him.
But emails between Deegear and Fisher-Price workers detail his work on the Rock 'n Play.
In a February 2009 email, Pilarz recounted a phone call she had with Deegear about his reaction to a baby sleeping all night at an angle, according to emails contained in court records.
"Dr Deegear stated Paediatricians 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," she wrote.
She also said in her email that she had called a local group of Paediatricians to get their opinion.
But Pilarz later said in her 2018 deposition that she could not recall researching the issue. She said she never talked to local doctors or the American Academy of Pediatrics.
"He's the only one I recall talking to," she said.
Deegear did send two pieces of research to Pilarz, according to court records.
One was a link to a 1997 study abstract showing that preterm infants had fewer breathing problems during nursing when their heads were slightly elevated.
The second was a two-page brochure titled "A Parent's Guide to Safe Sleep" from the American Academy of Pediatrics.
"Always place babies to sleep on their backs during naps and at nighttime," it read, with an illustration of a baby sleeping in a flat, non-inclined crib.
A non-existent prototype
The sleep guidelines sent to Fisher-Price by Deegear captured the basics of the Back to Sleep campaign: The best sleep position for infants is on their backs, rather than on their stomachs, in an empty crib to avoid suffocation.
The American Academy of Pediatrics recommends "flat and firm" sleep surfaces, said Rachel Moon, a paediatrician at Children's National Hospital, who studies factors in infant sleep deaths and is considered the academy's topic expert.
"Inclined can cause a problem," Moon said, "because young infants have poor head control and can easily get into positions in which their airway is compromised."
Parents sometimes let babies sleep in inclined devices - car seats, for example. But those are required to carry warnings against using them for prolonged sleep because of potential dangers. Sitting in an infant car seat - which usually holds a baby at a 40- to 50-degree incline - has been shown in studies to potentially inhibit a baby's ability to breathe. The risk of what's called positional asphyxia is so well-known that many hospitals require preterm infants to pass a "car seat test", sitting in a car seat for a period while their breathing is assessed, before being allowed to go home.
Most car seats have a steeper incline than the Rock 'n Play's 30-degree angle.
Pilarz, in her deposition, argued the Rock 'n Play still allowed babies to sleep in the recommended "supine" position, despite being at an incline.
But Pilarz also said she didn't research how different inclines affected a baby's ability to breathe.
"I'm not aware that we did specific research at this time about incline angles," she said, according to a transcript, "other than talking with Dr Deegear."
In June 2009, four months before the Rock 'n Play hit store shelves, Deegear suggested Fisher-Price bring a prototype to a physician's conference to show other doctors, according to an email in court records.
That never occurred, according to Pilarz in her deposition.
Paediatricians only learned about the Rock 'n Play after it was on the market - and by chance.
Hoffman, the paediatrician in Portland, first saw it when a friend brought it over to his house. He said he was so worried by the inclined surface he refused to let his friend use it for his baby.
Natasha Burgert, a paediatrician in Kansas City, Missouri, heard so many parents raving about the Rock 'n Play that she decided she needed to go to a store to see one herself. She was surprised to see a device that, in her view, went against "safe sleep" guidelines. In August 2012, she published an open letter to Fisher-Price on her doctor's blog urging the company to stop marketing it as a sleeper. She said she also printed out her letter to give to parents during office visits.
"This is not something I'd recommend using," Burgert said. "But parents see that it's from Fisher-Price and think, 'They wouldn't be able to sell anything that isn't safe.' "
In 2013, Roy Benaroch, a paediatrician outside Atlanta, called and wrote an email to Fisher-Price's manager of risk management, warning that he thought the product was unsafe and providing links to various studies, according to documents shown to The Washington Post. Benaroch said he never heard back.
In 2017, because of the Georgia product liability case, Fisher-Price hired two experts to assess the Rock 'n Play. William Fox is a neonatologist who directs the Children's Hospital of Philadelphia's Infant Breathing Disorder Centre. Thomas Shaffer, an expert in pediatric breathing problems, heads the Centre for Pediatric Research at the Nemours/Alfred I. duPont Hospital for Children. The doctors did not reply to requests for comment.
Working for Fisher-Price, the two doctors placed six infants in Rock 'n Plays for 45 minutes while the doctors measured blood oxygen concentrations for signs of breathing difficulties, according to court records. The test did not replicate overnight sleeping, the purpose for which the product was marketed. But, the doctors wrote in a report filed with the court, "there was no suggestion from our observation of the infants that such positioning could induce respiratory risk".
The doctors also noted that newborns in the Philadelphia hospital's neonatal intensive care unit "are regularly placed on their backs on inclines up to 30 degrees".
But many neonatal intensive care units have moved away from that practice, said Sunah Hwang, a neonatologist at the University of Colorado.
For example, all the units in Massachusetts began in 2015 to push "safe sleep practices" that include a flat crib or bassinet with no incline.
"It really should be standard of care," said Hwang, who conducted a study of the practice.
That's true even at the Children's Hospital of Philadelphia, said David Munson, a neonatologist who is the medical director for the hospital's neonatal intensive care unit.
Inclines are used only with the most critically ill infants, such as a baby needing a mechanical ventilator or with facial deformities, Munson said. Babies sleep flat on their backs in the unit as soon as possible.
It's the safest way for babies to sleep, he said.
The long wait for new standards
Since 2008, when US Congress overhauled the nation's product safety laws, the Consumer Product Safety Commission has been required to write federal safety rules for durable infant products - things like cribs and highchairs.
These rules must be at least as stringent as the voluntary safety standards set by ASTM International - formally known as the American Society for Testing and Materials - which is an organisation made up of manufacturers, consumer advocates and government officials.
But each new standard and rule can take years to pass, and products can still be sold in the interim.
So far, the commission has passed mandatory safety rules for 23 of 25 infant product categories. The only two left: baby gates and inclined sleepers.
Fisher-Price designed the Rock 'n Play in 2009 to fit under the ASTM standard for bassinets, according to court records. That standard was silent on angle. No one had made an inclined bassinet before.
"Our product was tested to [the standard] and met all the requirements," said Mike Steinwachs during a deposition about his role as a Fisher-Price quality engineer who worked on the Rock 'n Play and served on the ASTM committee that wrote the bassinet standard. Steinwachs, who retired from Fisher-Price last year, did not respond to a request for comment.
But Fisher-Price faced a problem shortly after the Rock 'n Play's launch. Federal regulators were drafting their safety rule for bassinets and wanted to limit inclines. The agency was worried about infant hammocks, another product covered by the bassinet standard, after some hammock models were recalled for suffocation hazards.
But limiting the angle could have banned the Rock 'n Play.
So Fisher-Price wrote its 2010 letter to regulators asking them to create a separate standard for inclined sleepers, arguing that a ban could have unintended consequences.
"The restriction could even increase children's risk of injury, as parents reach for substitutes," the letter said.
The agency agreed to allow a separate standard.
But the agency's leader at the time, chairwoman Inez Tenenbaum, didn't appear to think of inclined sleepers as a place where babies would sleep for long periods, according to deposition transcripts - despite Fisher-Price's marketing of the Rock 'n Play.
Tenenbaum said she agreed with Paediatricians that babies should sleep in cribs with firm mattresses. But, she said, it was "not inconsistent" for a child to fall asleep in an inclined sleeper - like babies do in car seats - and then need "to be removed from the product and placed supine in a crib."
Tenenbaum declined to comment.
Her view of how inclined sleepers should be used is similar to how the product is marketed in Canada, where the Rock 'n Play is not sold as a sleeping device. In Canada, it's a "soothing seat". And the Canadian version carries a warning: "This product is not intended to replace a crib or bassinet for prolonged periods of sleep," according to court records.
No deaths or injuries involving the Rock 'n Play "soothing seat" have been reported since it was introduced in 2011, according to Health Canada. And the "soothing seat" was not included in the recent recall by the CPSC. But a small number of Rock 'n Plays sold and labelled as sleepers in Canada were recalled, adding to the confusion.
In the United States, it took the ASTM five years to pass a voluntary standard for inclined sleepers, defined as having angles of 10 to 30 degrees. Consumer advocates and the American Academy of Pediatrics objected to the standard. But they were outnumbered by industry representatives, including Steinwachs of Fisher-Price, who made up more than half of the committee's membership.
"We shout into the wind a lot," said Cowles of Kids in Danger, who sits on the committee.
Cowles was back at it in 2017, as regulators started working on a federal rule based on the ASTM standard. The American Academy of Pediatrics joined in, writing to the agency that "we are concerned that a safety standard could give parents and caregivers the mistaken impression that these products have been proven safe".
The commission's work on the safety rule was continuing this year, just as problems with the Rock 'n Play exploded into view. That work has been put on hold, the agency said.
The agency's long-term failure to address inclined sleepers has been criticised by safety consultants, including Sean Kane and Ellen Liberman at Safety Research & Strategies, who recently wrote a blog post, titled "Who Does the CPSC Protect?"questioning how regulators handled the product.
But the complicated nature of infant sleep deaths creates unique challenges for regulators. Agency staff members had been worried about the Rock 'n Play for more than a year before the April 12 recall, according to two people who requested anonymity to discuss internal agency discussions. Last May, the CPSC issued a "consumer alert" about the hazard of not strapping an infant into inclined sleepers, although the Rock 'n Play was not named. The agency also took the unusual step of hiring an outside expert to study the issue.
But several of the fatalities in the Rock 'n Play had confounding factors, such as added blankets or - in at least one case - a baby improperly placed face down in the product, according to data described to The Washington Post by one person and confirmed by another person.
"It was hard to isolate the issue," said one senior agency official.
The mystery was deepened by the lack of safety testing before the Rock 'n Play hit the market in 2009, leaving investigators to evaluate potential hazards only in hindsight.
Eliot Kaye, an agency commissioner, said he believes all inclined sleepers should be banned and that the agency made a mistake in allowing the ASTM to write a separate inclined sleeper standard in 2015.
"I'm sympathetic to what parents want," Kaye said, "but it's not worth the risk."
'I couldn't believe it'
The industry is not convinced that the recall has made infant sleep any safer.
Several companies still sell their versions of inclined sleepers. One of them, Summer Infant, said it has not received any reports of deaths or injuries, and the product meets ASTM standards.
The future of inclined sleepers came up at a ASTM meeting earlier this month. Dozens of representatives from companies, regulators and consumer advocacy groups gathered outside Philadelphia. The recall of the Fisher-Price and Kids II products hung over the discussion. Cowles argued against the standard. So did Consumer Reports and the American Academy of Pediatrics.
"We don't see any way to create a safe standard for the product," said Zach Laris, the pediatric group's director of federal advocacy.
But Rick Locker, an attorney for the Juvenile Products Manufacturers Association, which represents many of the biggest companies making products for children, urged the committee to slow down and wait until more data is gathered.
That argument seemed to win over many in the room.
"I factor in what the AAP says, but I am also very data driven," said Carol Pollack-Nelson, a former regulator who works as a safety consultant, but not on inclined sleeping products.
"I'm not sure the world is a safer place without them," Bob Coughlin, a former executive at Kids II, said of inclined sleepers. He added that he worried about parents improvising riskier solutions.
The committee decided to talk about the topic again in October.
The recalls, too, are not expected to stop people from using the Rock 'n Play.
Some parents greeted last month's recall by vowing to keep the product.
"I couldn't believe it," said Sara Thompson, whose son died in the product in 2011.
Alexis Dubief, a sleep consultant and author, said she's sympathetic to exhausted parents who are suddenly faced without any option except a crib.
Cribs are the safest place for infants, Dubief said. Yet she struggles with how that advice plays out in the real world. The Rock 'n Play was so popular because it worked.
"Parents," Dubief said, "don't have a good Plan B."
Mattel, Fisher-Price's parent company, estimated the recall would cost it $US27 million, plus at least $US30 million more in lost sales for the rest of the year. But Mattel's chief financial officer Joseph Euteneuer downplayed the impact during an earning calls late last month, saying damage from the Rock 'n Play - considering Mattel is a $US1 billion business - "is roughly a couple low percentage points".
Cowles, too, doubted the recall's impact - on preventing deaths. Many parents continue to believe the Rock 'n Play is safe.
"There's going to be a black market for these products," she said, "for years."
The Washington Post