There are some statistics you force yourself to forget as soon as you hear them because the alternative is unbearable. This is one: Between 1,000 and 3,500 babies die in their sleep every year in the United States.
Sometimes caretakers are blamed for these deaths. A mother who falls asleep breastfeeding is charged with reckless homicide. A couple is charged with neglect for putting their three-month-old to sleep on the couch.
And sometimes the government draws the causal line back further, looking not just at caretakers’ decisions but the products they used: crib bumpers, rockers, swings, baby loungers. Baby gifts that were ubiquitous for years—on every new mother’s registry—are suddenly recalled by the Consumer Product Safety Commission (CPSC).
The Commission, created in 1972, has jurisdiction over more than $1.6 trillion in consumer products. It can ban any product it unilaterally deems to cause an “unreasonable risk of injury.” It can also decide to inspect factories, warehouses, or anywhere products are made or stored. And it can hold administrative proceedings to force a company to recall a product and offer refunds to all past customers.
Are the Commission’s recalls always justified? No: Sometimes they’re irrational, unsupported by any evidence of a product defect. We know this because of what the Commission did to Leachco.
A Family-Run Company
Last year, over the course of four days in the oppressive heat of August, Jamie Leach and her Pacific Legal Foundation attorneys defended Leachco in an administrative trial prosecuted by the Consumer Product Safety Commission and held at the Commission’s grayscaled offices in Bethesda, Maryland.
“There was no cooperation. There was no communication. It was just: We want you gone, and you will be gone.”
Jamie Leach
Jamie is an Oklahoma inventor, registered nurse, and grandmother who founded her company Leachco three decades ago with her husband, Clyde. They make products for children and their parents, including safety wraps and nursing pillows. Their big break came in 1991, when Jamie made a chance call to a Walmart rep who was excited about Leachco’s samples. (“She said, ‘Can you do 20,000 pieces and have it ready in six weeks?’” Jamie remembers.)
Today the company has around 40 full-time employees, more than 40 patents, and annual revenues of about $7 million. Leachco’s tagline: We didn’t invent motherhood, just the products that make it better.
One of their products is the Podster, a lounger for babies. Loungers are common and beloved by parents: They’re semi-soft, portable cushions that prop up a baby. On its website, Leachco clearly notes the Podster is not a bed. Rather, the company says, it’s
specifically designed to help with daytime care of awake infants for the countless times each day when parents and caregivers need to free up their hands for the activities of daily life. The Podster provides a safe, secure spot to place an infant on its back as the parent or caregiver supervises hands-free, able to prepare a meal, pay bills, check email, give a hand to siblings, and many other daily tasks.
The Podster is a popular product with parents: Since launching it in 2009, Leachco has sold around 180,000 Podsters. But of those 180,000, the Commission claims that three were “associated with” accidents where infants died while sleeping unsupervised.
Two of the infants who died in Podsters were left to sleep in them unsupervised at daycares—one for 45 minutes and the other for 90. Another, a three-week old girl, died when her parents co-slept in bed with her and a Podster, pillows, and bedding, violating pediatricians’ advice on safe sleep for newborns. (During the night, the baby fell off the Podster onto the bed. One of her parents rolled onto her.)
‘We Want You Gone’
The Consumer Product Safety Commission blamed Leachco.
First the agency issued a press release calling the Podster a “hazard” and warning the public not to use it. A month later, the Commission filed an administrative complaint against the company, demanding Leachco mail or email past Podster customers—all 180,000—notifying them of “the defect” and offering a full refund.
For Jamie, it was devastating: A federal agency was publicly accusing her company of being responsible for babies’ deaths. She felt helpless.
“We didn’t have an avenue to express ourselves,” she says. Leachco was, as Jamie puts it, “obliterated with one unilateral statement.” Retailers—including Amazon and Bed Bath & Beyond—dropped Leachco products. The Commission’s accusation, as arbitrary and opaque as it seemed, was crushing the company.
“It was incomprehensible to us,” Jamie says. “And there was no solution. There was no cooperation. There was no communication. It was just: We want you gone, and you will be gone.”
The Commission’s In-House Trial
Pacific Legal Foundation reached out to Jamie and Clyde after hearing about what the Commission had done. We volunteered to represent Leachco in the administrative proceeding against the CPSC. PLF would also help Leachco file a lawsuit in federal court to challenge the constitutionality of the Commission’s process—because, as Jamie put it, “it’s the process you’re subjected to that’s destroying you.”
Usually, the Commission’s recall demands don’t get to a hearing. Most end in settlements when a company backs down. But Jamie and Clyde knew the Commission’s allegations were wrong. And they believed that acceding to the Commission’s demands and “voluntarily” recalling the Podster would be tantamount to admitting the lounger was defective. It could destroy their company, but more than that: How do you publicly accept guilt for a baby’s death when it wasn’t your fault?
And so the adjudication came to a head last August at a four-day hearing. The modestly titled “hearing” was effectively a full-blown trial, with opening statements, cross-examinations, evidentiary disputes, etc. Except that it wasn’t held in a courtroom before an independent judge and jury, but rather, in a conference room at the Commission’s own offices, where an administrative law judge sat with his law clerk at the Commissioners’ dais. Jamie and her PLF team had to sign into the Commission’s offices every day for four days to attend the hearing.
“I had no frame of reference and no context for what I was experiencing,” Jamie says. “Never seen it on TV; never read about it. I had no idea what I was walking into.”
Jamie wasn’t the only one who found the hearing a novel experience: The Commission’s own employees came to watch, filtering in from elsewhere in the building. It was a rare thing, seeing a company fight back against the Commission.
Up until this point, in most ways, Leachco had been unlucky—on the wrong end of awful statistics, caretakers’ mistakes, and a rigged regulatory system. But while Commission lawyers prosecuted the case against Leachco, the administrative law judge was not a Commission employee. He was an ALJ from the Federal Mine Safety and Health Review Commission, assigned by the CPSC to preside over the Leachco case.
And in a 66-page decision released in July, nearly a year after the hearing, the administrative law judge sided with Leachco and dismissed the complaint.
“The Podster is not and never has been advertised by Leachco as a sleep product,” ALJ Michael Young wrote in his decision.
He emphasized that Leachco specifically warned parents against allowing babies to sleep in the lounger. There was, he said, “not a single piece of evidence” that Leachco “lured caregivers en masse into placing the children in their care in a dangerous setting.” In fact, looking at how many Podsters were sold, Young guessed that Podsters were used “tens of millions” of times in America, with three misuses ending in tragedy.
“It is tempting, of course, to be swayed by the tragedy authored by the death of even a single child,” Young wrote. But if the CPSC’s allegations about the Podster were correct, “one would expect a profound and disturbing number of infant deaths from use of the product,” he said. Instead, “the risk of injury from use of the Podsters appears to be vanishingly small.”
Ultimately, the ALJ concluded that the Commission failed to prove that the Podsters “have a substantial design or other defect and, even if a defect might be found to exist in some technical sense, the Commission … also failed to demonstrate that such defect creates or has created a substantial risk of injury to the public.”
Jamie and PLF had successfully defended Leachco against the Commission’s arbitrary accusation. The victory drew notice: It was only the third such decision on a recall case in thirty years, one private law firm noted.
The Commission Appeals—to Itself
When it first targeted Leachco, the Consumer Product Safety Commission sent out a press release warning the public not to use the Podster. The agency sent another press release a month later when it filed its complaint.
In the warped world of agency adjudication, “you are victimized by a system,” Jamie says.
But there were no government press releases about Leachco’s vindication. Instead, the Commission quietly decided to appeal the administrative law judge’s decision. The appeal will be in the hands of the Commission’s own commissioners—those who authorized the lawsuit in the first place and who will now have the opportunity to overrule Leachco’s victory.
In the warped world of agency adjudication, “you are victimized by a system,” Jamie says. Taxpayer-funded regulators have targeted her company and aren’t giving up. “We’re financing our own destruction,” she says. Even an administrative law judge’s strongly worded decision dismantling the Commission’s case isn’t bringing common sense to the process.
PLF will continue to represent Leachco in the appeal. Meanwhile, in August, we asked the Supreme Court to hear the Leaches’ federal lawsuit challenging the constitutionality of the Commission’s adjudication process. The five commissioners who will now decide Leachco’s fate are not accountable to anyone: They can’t be fired except for cause—a violation of the Constitution, PLF’s cert petition argues.
Lower courts have ruled that violating the separation of powers “cannot cause irreparable harm,” unlike violating individual rights. But the Leachco story clearly shows harm: A family company was publicly accused of causing the deaths of three babies, and they felt powerless to defend themselves. Even after PLF helped them achieve the unimaginable—a victory at the Commission’s in-house hearing, something almost no other company has managed—Leachco is back at square one with its appeal in the hands of the Commission’s own commissioners.
Unless the Supreme Court intervenes, “parties targeted for administrative enforcement will continue to be forced to defend themselves—sometimes for years—in the very agency tribunals they challenge as unconstitutional,” our petition concludes. “Leachco’s plight exemplifies the problem.”
The Supreme Court will consider taking the case when it reconvenes for the October 2024 term.
