By Suzy Khimm and Elizabeth Chuck - NBC News
This article is the first part of "Cause of Death: Delays," a series on how dangers in consumer products have claimed human lives.
BETHESDA, Md. — In September 2021, federal officials were so alarmed by the number of babies who had suffocated after lying on a popular baby bed that they issued an urgent notice to parents: Stop using it immediately.
The padded and padded Boppy newborn mattress, sold to exhausted parents who relied on it as a safe place to put their babies, was linked to the deaths of eight babies, the Consumer Product Safety Commission (CPSC) warned. The federal agency announced the recall of more than 3 million of the beds, which had been a mainstay of baby shower lists for years.
CPSC staff members wanted to go one step further. It wasn't just a manufacturer's infant bed that posed a potentially lethal threat; then, the agency planned to consider sweeping regulation of other padded baby beds, which some experts and officials believed were as unsafe as the Boppy lounger. The move could have forced manufacturers to redesign their loungers or stop selling them, according to interviews with current and former CPSC employees, industry representatives and consumer safety advocates.
But a day after Boppy's retirement was announced, CPSC's two Republican commissioners, who at the time held the majority, scrapped that more comprehensive action and approved an annual operating plan that eliminated a proposal to regulate baby mattresses, according to interviews and a detailed review of the documents.
Since then, babies have continued to die.
The Boppy company recalled more than 3 million sunbeds in 2021. Consumer Product Safety Commission
NBC News, sister network to Noticias Telemundo, found that at least five babies have died in incidents involving baby beds since late September 2021, according to CPSC records and reports made to the agency. Four days after the CPSC vote and less than a week after Boppy's retirement, a 3-month-old Texas boy died in his sleep on a company lounger; his father had fallen asleep and awoke to find his son lying on his stomach, according to a report local officials submitted to CPSC.
The following spring, according to another report, a 4-month-old boy suffocated to death on a Chinese-made bed that was advertised on Amazon as "perfect for sleeping along with your baby."
In addition to those five deaths, NBC News determined that at least 21 other babies died in infant beds from December 2015 to September 2021, more than double the deaths CPSC cited in public warnings about specific brands of loungers. This count is based on an examination of government data, court documents, CPSC-reviewed public reports, medical examiner reports, and records obtained through a Freedom of Information Act (FOIA) request.
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Many of the incident reports cited suffocation, suffocation or loss of oxygen as a cause of death, and seven lawsuits accused the loungers of causing the babies' deaths. In some of the reports to CPSC, bed beds were listed as one of multiple factors contributing to an unsafe sleep environment, while in others, no cause of death was mentioned. In one case, after an 11-day-old baby died of COVID-19 on a lounger, a local government agency identified "unsafe sleep" as a potential factor in death. All the babies were less than one year old; The child was 4 days old.
"It's outrageous and senseless," said Megan Parker, of Alton, Illinois, whose 2-month-old daughter, Layla, died on a Boppy lounger in 2019. "I don't understand why they wouldn't spread that information, knowing that there are more deaths that go unreported. It could save lives."
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The 26 deaths tallied by NBC News are almost certainly an undercount, according to product safety experts, since autopsies don't always mention specific consumer products.
"The death certificate is not clear, and if it doesn't include the product, then you don't know," said NJ Scheers, a statistician and former CPSC staffer who reviewed NBC News' methodology.
Before it was taken off the market, the Boppy Newborn Sunbed was loved by many parents who found that even the pickiest newborns tended to relax on the round, slightly recessed cushion. Other loungers are rectangular or oval in shape, with a raised perimeter surrounding a padded pad.
Layla Parker just after birth. Courtesy of the Parker family
While CPSC closely monitors baby sleep products, loungers have largely escaped regulation because they are described as a place for babies to lie down while awake. That means most loungers aren't subject to a new federal rule banning tilted surfaces and other potential hazards in baby sleep products.
However, newborns can fall asleep quickly at any time. Some companies explicitly advise customers to "transition" their babies to a crib or bassinet if they fall asleep on a lounger, but that doesn't always happen. And for years, photos of babies sleeping peacefully on loungers have proliferated on social media, muddying the message that the product should not be used for sleeping.
"You can't put that burden on parents," CPSC Chairman Alex Hoehn-Saric said in a recent interview. "If you have a product that you look like is good for sleep, you can't claim it's not a sleep product."
If you have a product that you look like is good for sleep, you can't claim it's not a sleep product."
Alex Hoehn-Saric CPSC CHAIRMAN
In some of the cases reviewed by NBC News, caregivers placed the loungers inside a crib. Other cases involved co-sleeping with the baby on a lounger on a bed next to the caregiver. The American Academy of Pediatrics' safe sleep guidelines recommend that babies sleep alone on their backs on a firm, flat mattress in a crib or bassinet without loose blankets, pillows, crib protectors, or other soft items.
Industry representatives argue that loungers are not dangerous if used as directed: on the floor as a place to put babies who are awake and closely watched to bed.
"Boppy products, including the newborn lounger, have never been marketed as baby sleep products," Amy St. Germain, a spokeswoman for The Boppy Company, said in a statement. "They are meant to help parents only during waking times and include warnings against unsupervised use."
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The Boppy lounger is distinct from the company's popular horseshoe-shaped nursing pillow, which has not been recalled. Nursing pillows have also been linked to reports of deaths, prompting CPSC to investigate and warn parents not to use them for sleep.
The decision to postpone new regulations for baby beds in 2021 was part of a series of amendments that CPSC's Office of Inspector General criticized for violating rules requiring notification to the commission of proposed changes.
In a statement to NBC News, CPSC Commissioner Richard Trumka Jr., a Democrat-designate who joined the commission in December 2021, called the delay a "grave mistake" by the previous commission that put the babies' lives at risk.
"It delayed a significant change that could have started to protect babies," Trumka said. "It set us back and delayed safety benefits for the public."
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Instead of following a strict rule, CPSC took a piecemeal approach to addressing the problem: the agency commissioned a study on baby pillows, a category that includes both loungers and breastfeeding pillows; worked with industry to develop voluntary safety standards for sunbeds; and took enforcement action against individual manufacturers.
"CPSC has long warned about the dangers of putting infants to sleep in products that are not intended for sleep, including soft pillow-like products," CPSC alleged in a statement to NBC News. "When we find evidence of dangers, especially that a product is associated with infant deaths, we can and have prioritized these risks and taken steps to warn and protect consumers of products featuring such risks."
CPSC Commissioner Peter Feldman, one of the Republicans who removed the baby pillow regulations from the 2022 operating plan, said the agency "simply hadn't yet laid the necessary groundwork" to move forward at that point, and that taking shortcuts could have made the new requirements more vulnerable to being struck down in court.
"The Commission cannot act rashly," Feldman said in a statement. "A rule that is suspended or overturned offers zero consumer protection."
The Commission cannot act rashly. A rule that is suspended or overturned offers zero consumer protection."
CCP COMMISSIONER PETER FELDMAN
Dana Baiocco, the other Republican commissioner at the time, declined to comment.
CPSC will begin considering a rule on baby loungers as soon as next month, according to two agency employees, after winning a Democratic majority last summer.
But any action is too late for families who have already lost their children.
"This thing was flawed as designed," said Joe Zarzaur, a Florida-based attorney representing a family whose baby died on a Boppy lounger in 2020, just before his 5-month-old birthday. "It should never have been available as a product at any time."
"More than adored"
On the night 2-month-old Layla died in December 2019, Parker, her husband and 1-year-old twins were out of town visiting relatives. The baby was staying at Parker's mother's home in Missouri.
Around 4 a.m., a panicked call from his mother woke Parker up. Layla wasn't breathing, Parker's mother shouted into the phone.
Nataley Seich died in 2020 just before her 5th birthday. "She was loved by everyone who came in contact with her," according to her obituary. Courtesy of the Seich family.
The baby had fallen asleep on a Boppy lounger, where she had to endure "horrific suffering and death by suffocation," lawyers for Parker and her husband allege in an ongoing wrongful death lawsuit against The Boppy Company and Parker's mother. The lawsuit accuses Parker's mother of negligence and argues that Boppy should have acknowledged that the lounger's "irrationally dangerous design" could cause babies to suffocate.
Boppy and an attorney for Parker's mother denied the allegations in court documents and declined to comment further.
In responses sent to CPSC about other deaths reported to the federal government, the company wrote, "At Boppy, our collective hearts ache for any parent who has lost a child," adding that its products "are safe when used correctly."
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Layla had just started smiling and was adored by her older sisters, who had proudly embraced her when she was born. The girls, who are now 4 years old, don't know how their little sister died.
“Pienso en cómo estaría interactuando ahora con sus hermanos”, contó Parker. “Es un poco desgarrador saber que tendré que decírselo algún día”.
Otros informes de muerte relacionados con tumbonas revisados por NBC News incluyeron a una bebé de 4 días en Nueva Jersey, nacida con una cabellera negra, cuyo obituario la describió como “más que amada y querida más que nada”. En otro caso, el obituario de una niña de casi 5 meses que murió en Florida unas semanas después de las vacaciones de invierno de 2019 la muestra con un gorro de Papá Noel que dice “La primera Navidad del bebé”.
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En algunos de los casos descubiertos por NBC News, las familias habían recibido las tumbonas como obsequio de sus listas de regalos para su baby shower. Otros habían comprado las tumbonas de los principales minoristas, incluido Amazon, que se negó a comentar, y Walmart, que no respondió. Muchos de los bebés murieron en casa, mientras que al menos dos murieron en una guardería.
En la mayoría de los casos, los bebés fueron encontrados por sus padres. Algunos realizaron desesperadamente compresiones torácicas mientras esperaban que llegara una ambulancia, según muestran los informes de incidentes.
La amenaza de las tumbonas puede surgir rápidamente, según el investigador principal de un estudio encargado por la CPSC y publicado por la agencia en octubre de 2022. El estudio encontró que los bebés morían en las tumbonas y otros productos de almohadas de dos formas principales: se sofocaban cuando se rodaban o volvieron la cara contra la superficie afelpada, o murieron de asfixia posicional, cuando se encorvaron hacia adelante o se arquearon hacia atrás, poniendo sus cuerpos en un ángulo que inhibía su respiración. Los bebés a veces también rodaban de las tumbonas y luego se sofocaban.
“Es una especie de trampa mortal aterradora para un bebé que no sabe cómo moverse muy bien, o un bebé que está dormido y no se mueve muy bien mientras duerme”, explicó Andrea De La Torre, propietaria y fundadora de la empresa consultora Baby Sleep Answers. “Tenemos que ser muy, muy estrictos al decir: ‘No, dormir no está bien, incluso si estás justo al lado de ellos’”.
Para confundir aún más el problema, algunos productos que actualmente se comercializan como tumbonas para recién nacidos se vendían anteriormente como colecho en la cama, como DockATot Deluxe+. La CPSC emitió a la compañía un aviso de violación el año pasado después de que entraron en vigencia nuevas reglas sobre productos para dormir para bebés.
Madelynn Rouh tenía 4 días cuando murió en 2019. "Era más que amada y querida más que nada", según su obituario.Cortesía de la familia Rouh.
DockATot negó haber actuado mal y dijo que sus tumbonas no son inseguras si se usan mientras los bebés están despiertos. “La agencia ha seguido destacando nuestros muelles Deluxe+ a pesar de no tomar ninguna medida sobre varios productos similares actualmente en el mercado”, aseguró la compañía en un comunicado. DockATot acordó eliminar gradualmente su tumbona modelo Deluxe+ después de la acción de la CPSC, pero el producto todavía está disponible para su compra y también está a la venta una versión más grande de la tumbona.
El hijo de 10 semanas de Brandon Movitz, Pierce, murió mientras dormía en un DockATot Deluxe+ en julio de 2020 en casa de la familia en Bloomfield Hills, Michigan.
Pierce era el “bebé más tranquilo, pacífico y amoroso”, que fue adorado por su hermano mayor, Jude, que ahora tiene 5 años, dijo Movitz. Jude habla a menudo de lo mucho que desearía poder ir al cielo para poder visitar a su hermano pequeño.
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Desde entonces, Movitz ha iniciado una fundación para ayudar a las familias que han perdido bebés a cubrir el costo de sus funerales y se ha conectado con otros padres cuyos bebés murieron en las tumbonas.
Dijo que es “ridículo” que todavía se vendan tumbonas.
“Si los bebés se están muriendo, ¿por qué permitimos esto?”. él dijo.
Los fabricantes de tumbonas sostienen que la forma más efectiva de prevenir este tipo de tragedias es educar a los padres y cuidadores sobre prácticas seguras para dormir.
Si no hubiera tumbonas para bebés disponibles, los cuidadores podrían terminar recurriendo a lugares mucho más peligrosos para acostar a sus bebés, como almohadas para adultos, alegó Carol Pollack-Nelson, consultora de seguridad de productos que ha trabajado en nombre de la industria y los consumidores.
Kate y Brandon Movitz con su recién nacido, Pierce, en 2020. Pierce tenía 10 semanas cuando murió mientras dormía en un DockATot Deluxe+.Andrea Peardon Photography
Deshacerse de productos como las tumbonas “no soluciona el problema”, dijo Pollack-Nelson. “No cambia cómo se pone a dormir al bebé, solo dónde se pone a dormir al bebé”.
A pesar de los hallazgos del estudio que encargó la CPSC, la agencia aún tiene que emitir advertencias amplias sobre el uso de tumbonas para bebés, y está muy limitada por una ley federal que exige que consulte con los fabricantes antes de divulgar públicamente los peligros o las muertes relacionadas con productos específicos.
Cuando Trumka, el comisionado de CPSC, anunció la acción de la agencia contra DockATot en noviembre, no proveyó ningún detalle específico sobre las muertes. En su lugar, pidió al público que buscará el nombre de la empresa en la base de datos SaferProducts.gov de la CPSC.
Al menos seis bebés han muerto en incidentes relacionados con las tumbonas DockATot de 2020 a 2023, de acuerdo con esos reportes, y algunos casos fácilmente no saltan a la vista porque el nombre de la compañía está mal deletreado.
"Demasiados niños han muerto"
Hace más de 30 años, la CPSC tomó la decisión de prohibir las almohadas para bebés rellenas con bolitas o cuentas –un diseño en forma de frijol– después de reportes de que 36 infantes habían muerto.
Ahora, como entonces, los niños fueron encontrados bocabajo sobre los rellenos, sofocados en el material suave que se adaptaba a la forma de sus cuerpos.
Décadas después, en medio de crecientes informes de muertes de niños, algunos en CPSC se convencieron de que las tumbonas modernas plantean un peligro similar, y quisieron que se considerara expandir la prohibición de los rellenos de 1992, de acuerdo con entrevistas con actuales y antiguos empleados de la agencia.
Por lo tanto, miembros del personal incluyeron una propuesta de extender la prohibición sobre las almohadas para bebés en el plan operativo presentado a los comisionados de la agencia para su aprobación, a mediados de septiembre de 2021, justo cuando la CPSC se estaba preparando para anunciar el retiro de la tumbona Boppy Newborn.
La tumbona DockATot Deluxe+.DockATot
Pero en el momento en que plan iba a ir a votación, los republicanos del Senado estaban bloqueando a tres nominados del presidente Joe Biden para la comisión de cinco miembros, que tenía dos asientos vacantes. Eso le dio a los dos comisionados republicanos de la CPSC una oportunidad para hacer cambios en el plan operativo, que el único comisionado demócrata, Robert Adler, denunció como un "gobierno por emboscada".
"This is not something CPSC staff has asked for nor has anyone shown a reason to put a stop to these packages," Adler said in a statement after the Sept. 24, 2021, vote. "This extension related to consumer safety is grossly inappropriate."
In the months that followed, the agency received reports of deaths in loungers produced by manufacturers around the world, including a high-end, $300 product from Europe and a cheap variant from China, according to an NBC News review.
In the absence of broad regulations, the agency instead attempted to focus on individual companies.
In January 2022, the agency sought to recall the Leachco Podster, which CPSC linked to the deaths of two infants. Unlike Boppy, however, the manufacturers refused to cooperate with the recall and insisted their product was safe.
The agency is now suing Leachco for refusing to remove its loungers and issued a rare one-sided warning to consumers to stop using them, despite the company's objections.
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"Alerting consumers was our top priority," CPSC said in a statement to NBC News.
The company sued the agency back, accusing it of overreaching.
Leachco blames the misuse of its products for the two deaths CPSC publicly linked to its loungers: One baby was left unsupervised in the Podster inside a crib, and another was in the Podster between two parents in a bed, the company's complaint said. In January, the agency alerted the company to a third death, which it had linked to its products, this time of a baby who had been "put to nap and left unattended for a while" in 2021, said Oliver Dunford, senior staff attorney at the Pacific Legal Foundation, a conservative group representing the company.
"The agency says the Podster® is defective because it is 'reasonably foreseeable' that parents and caregivers will ignore express warnings and fail to use common sense," the Pacific Legal Foundation alleged in a statement. "That claim is absurd: consumers can ignore the warnings of any product."
Pacific Legal Foundation and Leachco declined to comment.
It wasn't until June 2022 — nearly a year after Biden submitted his nominations — that CPSC's third and final commissioner, who faced opposition from Republican senators, was confirmed. That gave Democrats a majority for the first time during the Biden administration.
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The committee's new Democratic leadership has described the loungers as lethal and a latent danger that the agency must deal with through regulations, and added the task in CPSC's 2023 operating plan.
"There's a long history here, a lot of kids have died," said CPSC Chairman Hoehn-Saric.
The agency can't produce regulation overnight: Under federal law, staff must begin the painful process of gathering and analyzing relevant data, investigating incident reports, and justifying the need for regulation, which commissioners will then bring to a vote.
Feldman, the Republican commissioner, said the 2021 decision to slow down regulations in the end is going to help produce a more compelling data-driven proposal.
Others believe the work should have started earlier.
"It's quite possible that other deaths would have been prevented if the commission had had more freedom to take decisive action," said Adler, the former Democratic commissioner.
Manufacturers say the time has been well spent and point to voluntary safety standards now under development, which could include design guides and warning signs.
"It's a proven process. It's collaborative and unites all voices so everyone is involved," said Rachael Shagott, an industry consultant who is leading the effort through ASTM International, an independent standards organization.
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Work on those standards began in early 2022 and is expected to be finished by the end of the year, Shagott said. The process is open to the public and includes consumer advocates, parents of children who died on the loungers and CPSC officials. But consumer advocates point out that industry representatives outnumber the rest and that the standards won't be mandatory.
"To expect that process to take its course is to ignore what we already know," said Nancy Cowles, executive director of Kids In Danger, a consumer advocacy group.
"This can happen to any family"
While the federal process moves inch by inch, loungers are still on sale in stores across the country, and recalled models are easy to find secondhand. Ads for used Boppy loungers abound on Facebook Marketplace, even as the platform's rules prohibit the sale of recalled items.
Boppy said she's "frustrated" that its recalled products are so easy to find and that Facebook has failed to respond to a request to remove the ads. In a statement, Facebook's parent company Meta said it has taken the matter seriously: "When we find ads that violate our rules, we remove them."
Layla Parker died in 2019. Courtesy Parke Family
Some state lawmakers claim baby loungers are so dangerous that they should be banned immediately. In New York, an initiative was introduced that would ban its sale statewide. The bipartisan bill — the first of its kind — would fine retailers and second-hand sellers who put them up for sale by up to $500.
"If we can't make them safer, we have to get rid of them," said Dr. Warren Seigel, district president of the New York chapter of the American Academy of Pediatrics, which advised lawmakers on the bill.
Democratic Assemblywoman Amy Paulin drafted the proposal after two mothers on her team learned of the recall of Boppy loungers. He hopes it will help pave the way for a national ban.
"I think the federal government moves much slower than the states, and that's why we introduced the bill," Paulin said. "New York passing something will prompt the federal government to do the same."
The window to act this year is closing: Paulin's bill passed the Assembly in March, but is awaiting action by the state Senate, whose last session is June 8.
Parker, Layla's mother, hopes her daughter's story will help save other babies.
"I want people to know his name," he said. "I want people to know that this can happen to any family."
And he believes federal regulators need to be more transparent about the danger. "I just want this information to be released," he said. "It seems to me that it has been silenced a bit."