Defective: Federal agency meant to protect consumers given little power to ban defective products
The deaths of dozens of babies in inclined sleepers exposed the sway manufacturers have over the U.S. Consumer Product Safety Commission.
ALPHARETTA, Ga. (InvestigateTV) - When Jan Hinson set her 7-week-old grandson in an inclined sleeper in 2014, she didn’t know that babies had stopped breathing while in the product.
But Fisher-Price, the maker of the Rock ‘n Play sleeper, knew.
And the federal agency created to protect consumers knew.
Yet both stayed quiet for years as hundreds of other babies were injured and dozens died.
The decade-long story of the Fisher-Price’s Rock ‘n Play – a product that defied the American Academy of Pediatrics guidelines for safe infant sleeping – exposed the powerlessness of the U.S. Consumer Product Safety Commission, according to an InvestigateTV analysis of federal court, government and Congressional documents and data.
Congress created the federal agency in 1972 to watchdog more than 15,000 consumer product categories – from appliances to xylophones. But CPSC officials often can’t alert the public to dangerous products when they learn of them because they are muzzled by the agency’s own governing law.
A provision in the Consumer Product Safety Act, known as section 6(b), gives manufacturers the power to make the decisions as to when and how the public is alerted to a defective product.
The CPSC cannot recall a dangerous product without the manufacturer’s consent. And it rarely issues warnings when a manufacturer won’t agree to a recall.
“We could now be in our homes with our families using products that not only the company, but our government know, are dangerous, and we have no idea,” said Nancy Cowles, executive director of Kids in Danger, a Chicago-based consumer advocacy group founded in 1998 by parents grieving over the death of their toddler in a defective crib.
The CPSC did not agree to repeated requests for an interview. But its former acting chairman Robert S. Adler, who stepped down last year, has long championed for the elimination of section 6(b).
“Section 6(b)’s cumbersome procedures and unnecessary delays put consumers’ lives and limbs at risk by requiring the CPSC to restrict the flow of critical safety information to the public,” he said in 2014.
Fisher-Price did not respond to requests for comment.
CPSC operates differently than other federal agencies with recall authority such as the Food and Drug Administration and the National Highway Transportation Safety Administration, which have sole authority to pull tainted food, hazardous drugs and defective cars from the market.
The CPSC doesn’t have the budget or manpower to investigate the vast majority of reports it receives about consumers who were injured or killed by a defective product. Rather those investigations are oftentimes conducted by the manufacturers themselves.
The CPSC has the authority to punish companies that fail to report dangerous products. Fisher-Price has faced such sanctions in the past.
But the agency rarely uses that power, last issuing a fine in 2018.
CPSC posts a database of incidents reported to the agency by consumers, doctors, coroners, and others. But that database does not contain any incidents reported directly to the manufacturers.
Fisher-Price, for example, was first alerted that a baby died in a Rock ‘n Play in 2012, according to the company’s own internal reports made public in federal court records. But CPSC public data shows that it received the first fatality report in 2018.
Even as CPSC had tallied hundreds of injuries and deaths related to inclined sleepers, including the Rock ‘n Play, only 10 deaths and 33 injuries show up in the public data, according to an InvestigateTV analysis of the agency’s public database of incidents.
In 2019, after an inadvertent public disclosure by CPSC showed at least 30 fatalities linked with the Rock ‘n Play, the agency and Fisher-Price issued a recall.
“It’s the fox watching the henhouse,” Hinson said. “If changes aren’t made, it’s gonna happen again.”
Federal law largely gives manufacturers the power to write their rules
In 2014, Hinson kept watch over her grandson, Asher Goodrich, while his mother decorated her first-grade classroom for the upcoming the school year.
They brought with them a Rock ‘n Play that a neighbor in Alpharetta, Georgia had lent to them. It was the first and last time Asher would use that inclined sleeper.
Within minutes of being placed in the product, Hinson, a former respiratory therapist, said that she noticed that Asher’s head had flopped to the side. He had turned blue and was lifeless.
“I panicked and forgot all my respiratory therapy skills, totally,” Hinson said. “I began screaming in his face, blowing in his face, yelling, ‘Baby baby,’ shaking him, everything I could possibly do, which was not any of it proper.”
Asher began breathing again after Hinson smacked his diapered bottom.
As his parents rushed him to the hospital, Hinson took a closer look at the Rock ‘n Play and started to wonder, how could this be safe for infants?
“Something’s not right,” she said. “No baby should be positioned like I just found him.”
The Rock ‘n Play came to market in the U.S. in 2009 as an affordable sleeping product that could especially help fussy or colicky babies. It cost as little as $50.
But consumer regulators in both Canada and Australia determined that the Rock ‘n Play was not safe for sleeping because of its incline and banned sale of it as a sleep product in their countries in 2010 and 2011, respectively.
Also in 2011, the United Kingdom’s Royal College of Midwives raised concerns about the Rock ‘n Play, writing to Fisher-Price, “This would not be suitable for a newborn infant as babies cannot be placed in a semi-prone position . . . this product must only be used for no more than two hours a day and for the purpose of play/interaction with parents/siblings.”
The report effectively killed any possibility that Fisher-Price could sell the Rock ‘n Play in the UK.
But back in the U.S., the Rock ‘n Play came to market under the voluntary standard written for bassinets and cradles.
Since 2008, the CPSC had been working on creating mandatory standards for infant and juvenile durable products such as cribs, highchairs, and strollers. The changes were prompted by a new law that year in the wake of numerous child deaths in baby products.
Mandatory standards are effectively laws that sets strict rules for the design and safety of children’s products. But it has taken the CPSC years to write those standards because there are dozens of child product categories.
When Rock ‘n Play was first developed, the CPSC had yet to address the bassinet standard, which did not specify that a sleeping surface must be flat. Fisher-Price used that loophole to bring the Rock ‘n Play to market.
But in 2013, the CPSC passed a mandatory standard for bassinets and cradles that required them to have flat sleeping surfaces as part of its ongoing efforts to meet the mandates of the 2008 law.
The new standard effectively eliminated Rock ‘n Play’s classification as a bassinet.
So, Fisher-Price and others in the industry created a new product category – the inclined sleeper. This new voluntary standard, largely written by designers and manufacturers of inclined sleepers, allowed for a sleeping product with a 30-degree angle.
It’s a typical process for all new product categories – the manufacturers themselves write the standards that specify the products materials, dimensions, and other design features.
“It’s all backward,” Hinson said. “You can’t put back in the lap of a profit center the ability to police themselves.”
The Rock ‘n Play also relied on one doctor, who was not a pediatrician and later lost his license to practice medicine, to endorse the safety of the inclined sleeper, Congressional records show.
CPSC does not perform its own safety analysis of new products, leaving Rock ‘n Play and other infant products to potentially go to market without any government-mandated medical input.
“Every night thousands if not millions of moms and dads are putting their babies in this product that they had no idea could be so dangerous,” said Cowles, the consumer advocate.
The Rock ‘n Play quickly became one of Fisher-Price’s best-selling products.
But trouble was brewing, court records show.
In October 2012, a mother reported to Fisher-Price that her son had stopped breathing while in the Rock ‘n Play, writing that its 30-degree incline allowed his head to droop to his chest, preventing him from breathing.
Two months later, another mother reported that her son had died in a Rock ‘n Play in 2011. A coroner had ruled the death sudden infant death syndrome.
Lack of CPSC funding leaves consumers at risk
In 2016, Asher’s parents, David and Courtney, sued Fisher-Price as they faced mounting medical bills from their son’s ongoing treatments.
Though she is a lawyer, Hinson wasn’t able to represent her grandson because she was the key witness in the case. But she used to her legal research skills to ferret out documents from Fisher-Price that showed that they were repeatedly warned that the product was dangerous.
The documents are publicly available in the federal court case.
In 2013, a pediatrician wrote to Fisher-Price, “I believe your Rock ‘n Play Sleeper is dangerous, especially because the name implies that this is an appropriate place for babies to sleep. It is not. The product doesn’t meet the guidelines for safe sleep.”
Fisher-Price dismissed his concerns. “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.”
By then, parents had been reporting to the CPSC that their babies’ heads had been deformed by the Rock ‘n Play, requiring months of physical rehabilitation to correct them.
When the CPSC is alerted to an injury or death, they often instruct the manufacturers to investigate the incidents and report back.
“They put it back on the corporation,” Hinson said. “And then invariably, the corporation is going to come back and say user error.”
Because of a lack of funding and staff, the CPSC only conducts its own investigations in about 3% of the incidents, former agency chairman Adler told Congress last March.
“We have been severely underfunded since our inception almost 50 years ago,” he wrote.
In FY 2020, for example, CPSC had a $135 million budget, which is dwarfed compared to the two other agencies with recall authority.
NHTSA operates with about $1 billion; the FDA, $6 billion.
“CPSC must still serve and protect the same 330 million Americans as our sister agencies,” Adler said. “I ask that the protection of its citizens from unsafe products be prioritized and funded as such.”
That lack of funding, which has led to CPSC’s inability to investigate all cases of potentially harmful products, gives even more power to the manufacturers, consumer advocates said.
Hinson was surprised when investigators contacted her about Asher’s case. They were from Fisher-Price, she said.
“The CPSC referred reports back to the manufacturer rather than the CPSC looking in and investigating,” Hinson said. “It’s like they’re the manufacturers’ protection commission.”
Federal law forces CPSC silence if manufacturers demand it
Hinson was so worried about the dangers posed by the Rock ‘n Play that she visited the infant products aisles in big box stores and attached a hand-made sticker that read, “Death trap.”
She perused the secondary marketplace and offered to buy Rock ‘n Plays from sellers.
“I bought 50 or 60 of them,” she said.
She felt she had to do something as federal safety regulators remained silent.
By 2017, the CPSC knew of more than 650 incidents involving inclined sleep products, including the Rock ‘n Play. Yet it could not issue a public warning about the dangers because it was gagged by section 6(b).
Lawmakers have long known that section 6(b) hampers the agency’s ability to protect consumers. In 2008, an attempt to repeal that provision failed in Congress.
Last year, partially in response to the Rock ‘n Play situation, three Democratic senators introduced a bill again to eliminate section 6(b).
“Current regulatory constraints allow companies to call the shots on how and when to notify the public about their hazardous products, keeping important safety information from the public,” Sen. Richard Blumenthal of Connecticut said at the time. “This bill will eliminate these constraints, restoring transparency to product safety for the sake of consumers.”
The proposal is idle.
A repeal of section 6(b) could have saved lives in the Rock ‘n Play case, Hinson said.
Had parents known, she said, some maybe wouldn’t have purchased the product.
Asher’s lawsuit was dismissed in 2018 after a judge ruled that there was a “lack of admissible expert testimony showing that the design of the product was defective.”
Frustrated by the inaction at the CPSC, Hinson directed a reporter from Consumer Reports in 2019 to the trove of internal Fisher-Price documents that she had unearthed for Asher’s case.
Those records along with an inadvertent release by CPSC of Rock ‘n Play incidents to the magazine brought the troubles into public view for the first time.
“The only reason Rock ‘n Play is off the market was because shit was hitting the fan,” Hinson said. “I’d say that I was the driving force behind the recall.”
Within days of the magazine’s publication, the CPSC and Fisher-Price announced a voluntary recall of the Rock ‘n Play on April 12, 2019, citing the deaths of about 30 babies.
By then, Fisher-Price had sold more than 4.7 million of its inclined sleepers.
A CPSC-commissioned medical study of inclined sleepers that was released six months after the Rock ‘n Play recall concluded, “none of the inclined sleep products that were tested and evaluated as a part of this study are safe for infant sleep.”
The study affirmed the dangers of inclined sleepers to babies: their muscles aren’t developed enough to self-correct if they roll – or get into another position where their air flow is cut off, leading to suffocation.
Last year, Fisher-Price said it was aware of nearly 100 fatalities, the first public acknowledgement that the death toll was much higher than previously reported.
At a congressional hearing last June, Ynon Kreiz, the CEO of Fisher-Price’s parent company, Mattel, said the incidents were related to user error.
“By the time we decided to recall the product, it became apparent that there is a pattern of use, where based on the data that we collected, that the product was not used in accordance with the instructions and warnings,” Kreiz told the committee members.
Last year, the CPSC banned the sale of all inclined sleeping products.
The consumer regulator rarely punishes companies who made defective products
Mattel is facing a litany of civil lawsuits filed by consumers related to the Rock ‘n Play injuries and deaths, according its filings with the Securities and Exchange Commission.
But to date, it hasn’t faced any consequences from the CPSC.
Companies are required by law to notify the CPSC that its product has a defect that could harm consumers.
Fisher-Price sent that notification in 2018, the company’s senior vice president Chuck Scothon told a congressional committee last June.
One of CPSC’s strongest tools to force compliance is its civil enforcement penalties – but it is rarely used, consumer advocates said.
Since 2000, when more than 6,500 defective products have been recalled, the agency only pursued 199 civil enforcement cases, according to an InvestigateTV analysis.
Nearly two-thirds of those cases involved failure to report defective products or injuries to the CPSC in a timely manner.
Since 2000, Fisher-Price has been fined twice for reporting failures. In 2001, it was fined $1.1 million for not reporting defective Power Wheels. In 2007, it paid a $975,000 for not reporting that one of its toys posed a serious choking hazard.
“If you don’t use those tools, and companies kind of assume you aren’t going to use them, then they’re not going to be an effective deterrent,” Cowles said. “You have to use them so that they understand they could face a severe civil penalty if they keep secrets about the safety of their products.”
The CPSC last publicly announced a civil enforcement action in 2018. It issued $1 million fine to company that failed to report that its trash cans caused laceration injuries to 13 people.
Associate producer Conner Hendricks contributed to this report.
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