The federal government could effectively shut down a small, family-owned Oklahoma business in Ada because in two isolated instances customers experienced tragedies after ignoring explicit product warnings.

The company, Leachco, is fighting back in court in a process that has dragged out for more than a year now.

In a blog post, the Pacific Legal Foundation, which is representing Leachco free of charge, said the case could have far-reaching impact if the Consumer Product Safety Commission (CPSC) is allowed to penalize Leachco for customers’ misuse of its products.

“The claim is absurd: Consumers can ignore the warnings on any product,” the Pacific Legal Foundation stated. “If CPSC’s logic were applied broadly, it would eliminate virtually every product from the market.”

Jamie and Clyde Leach formed Leachco in 1988. The company, which has 40 full-time employees and seven temporary employees, produces a range of products. Jamie Leach holds more than 40 patents and numerous trademarks.

Among the products sold by the company is an infant lounger called the Podster.

The Podster comes with a warning that explicitly states, “Do not allow baby to sleep in this product.”

The Podster’s product instructions state, “WARNING! TO PREVENT SERIOUS INJURY OR DEATH. Constant adult supervision is required at all times. Do not allow baby to lie face down or on side in the Podster. For use on the floor only. Never place in the crib, on the bed, table, playpen, counter, or any elevated surface. Never move the Podster while baby is on it. Do not use for sleeping. Intended to be used by healthy infants not to exceed 16 pounds, or until infant is able to roll over, push up on hands and knees, whichever is achieved first. Never leave child unattended.”

Since 2009, Leachco has sold more than 180,000 Podsters.

But on Feb. 9, 2022, the Consumer Product Safety Commission approved a complaint accusing Leachco of creating “substantial risks of injury” due to two isolated instances of child harm out of the 180,000 products sold. In both cases, the harm occurred after users ignored the warnings that come with the Podster.

The Consumer Product Safety Commission conceded that the Podster “is not and has never been advertised” as a sleep product, “contains warnings that the product should not be used for sleep and that adult supervision is always required,” and contains warnings “that the product should only be used on the floor, and not in another product, such as a crib, on a bed, table, playpen, counter, or any elevated surface.”

But the commission argued Leachco should be held liable for harm caused by misuse of the product despite those explicit warnings.

“Despite the warnings and instructions, it is foreseeable that caregivers will use the Podster without supervision,” the CPSC complaint stated. “It is also foreseeable that caregivers will use the Podster for infant sleep.”

The commission argued that caregivers “facing difficulties in getting their infant to sleep may choose to use the Podster for that purpose if the Podster appears to help with sleep or if the infant appears to be comfortable in the Podster, even if the caregiver is aware of the contrary product warnings.”

The commission also argued, “Caregivers with an infant who are traveling or who are dealing with significant financial hardship may be more likely to allow an infant to sleep in the Podster, as they may not have a crib or safe infant sleep product readily available.”

The Consumer Product Safety Commission is demanding that Leachco recall Podster products and provide refunds and reimbursements.

The commission cited only two instances of child harm involving a Podster.

On Dec. 16, 2015, a four-month-old infant suffocated after being placed face-up or on the child’s side in the Podster in a crib. The infant was later found face-down on the Podster and died of complications from asphyxia.

On Jan. 27, 2018, a 17-day-old infant suffocated after being placed face up in the Podster on an adult bed between two caregivers.

But in the company’s lawsuit challenging the Consumer Product Safety Commission’s action, Leachco officials noted both instances involve misuse of the Podster product and, in one case, egregious neglect.

“The two tragic deaths were not caused by any defect in the Podster,” Leachco’s complaint stated. “The two incidents—one more than five-and-a-half years ago, and the other more than three-and-a-half years ago—were caused because of multiple misuses of the Podster that were not reasonably foreseeable uses of the product and violated multiple express warnings, as well as safe sleep practices.”

In one of the two incidents, Leachco officials noted, a daycare “violated multiple state facility-operating regulations, as well as its own rules, safe-sleep practices, and multiple express warnings on the product when it left an infant with a recent respiratory problem to sleep unsupervised in the product, in a crib, for an extended period of time. The infant was not visible to employees, who failed to check on the infant as required. Additionally, the day care allowed other soft products to be in the crib. Each of these actions (i) contradicted Leachco’s express warnings and instructions, (ii) violated the day-care center’s operating rules, and (iii) violated state law and regulations. The daycare center’s state license was revoked because of this incident.”

In the second incident, Leachco officials noted the 17-day-old infant was placed in the Podster and then placed on an adult bed, between the infant’s parents, along with bedding and pillows, for co-sleeping—“contrary to Leachco’s express warnings and instructions.”

“These two isolated incidents followed multiple unsafe practices, uses of the product not intended and directly contrary to multiple express warnings, and they are the only injuries known to have occurred in the vicinity of the more than 180,000 Podsters sold to date,” the company’s complaint stated.

Leachco’s complaint also noted that Jamie Leach is a registered nurse, mother, and grandmother, and that the Leaches “have used the Podster with their own children and grandchildren.”

Because of the Consumer Product Safety Commission’s allegations, large retailers like Amazon, Buy Buy Baby, and Bed, Bath, and Beyond no longer carry the Podster and Leachco’s revenues have decreased.

Leachco’s lawsuit argues the Consumer Product Safety Commission is unconstitutionally structured because the president cannot remove commissioners except “for cause” and because the administrative adjudicator conducting the Commission’s proceeding has two levels of for-cause removal protections that violate the Separation of Powers. The lawsuit also argues that the commission’s proceedings violate constitutional separation of powers by granting judicial authority to an executive branch entity, and that the commission’s proceedings violate Leachco’s constitutional rights to due process and a jury trial.

“Jamie and Clyde see Leachco as their story of the American way: work hard, innovate, and never give up,” the company’s complaint stated. “They have always modeled these virtues for their children and hope their kids can carry on in the business one day. The Commission’s baseless allegations and arbitrary administrative proceeding threaten everything the Leaches have worked so hard for.”