Recently, Fisher-Price recalled their “Rock ‘n Play” device, which, despite the name, was a kind of baby hammock in which infants would lie down at a 30-degree angle and take a nap. Parents on both sides of the safety debate were outraged; some parents saw the device as a godsend for getting restless babies to sleep, while others were upset because the recall didn’t happen until the device had been around for 10 years, and 30 infants had died.
The recall happened after an expose in the Washington Post revealed that Fisher Price released the Rock ‘n Play without conducting even the most basic testing any parent would expect before bringing a baby sleeper to market. According to the report, they instead relied on an okay from a single Texas doctor who later lost his license. Despite the lack of rigorous testing, starting with its debut on the market in 2010, Fisher Price manufactured and sold nearly 5 million of these devices at between $50 and $80 each. Unfortunately for the company, according to documents uncovered by the Post, the product was developed without input from anyone but a single family physician, Dr. Gary Deegear of San Antonio, whose expertise was already being questioned by judges in several courts and who would subsequently lose his medical license. There was no clinical research into product safety, and Fisher Price didn’t even consult a pediatrician for an evaluation until the Rock ‘n Play had been on the market for eight years, as part of their defense in a product liability lawsuit.
A Recall, But No Blame
In the wake of the recall, which was requested by the Consumer Product Safety Commission (CPSC) after Consumer Reports reported concerns over the development of the product and after they discovered that 30 infants had died in the product after they turned over while unrestrained or under “other circumstances.” However, even then, the CPSC would not explicitly blame the Rock ‘n Play for all of the deaths.
Regulators from the CPSC expressed disbelief that such a product could have made it to market without proper testing, but many other safety experts are less skeptical, noting how the product safety system largely relies on the manufacturers, rather than regulators and safety experts, to make their products safe. A longtime CPSC Commissioner noted that many consumers believe every product on the market has the approval of one or another federal safety agency, when that is simply not the case.
Fisher Price’s owner, Mattel, issued a statement with the recall, saying that the Rock ‘n Play met all applicable U.S. regulations and safety standards. However, those standards failed to prevent the company from putting out a product related to one of the riskiest aspects of a baby’s life, which is sleep. Unexpected sleep deaths are the leading cause of accidental deaths for babies in the United States, killing more than 3,600 infants every year. While many of these deaths are considered mysterious, many medical experts believe they know how to make sleep safer for babies.
The Product In Conflict With Accepted Practice
And yet, the design of the Rock ‘n Play seemed in conflict with the guidelines offered by the American Academy of Pediatrics for safe infant sleep, which have been around since the mid-1990s and recommend that babies should sleep face-up in an empty crib or bassinet, to avoid suffocation. They also recommend that infants not sleep in inclined devices for long periods of time. According to numerous studies, this advice has resulted in cutting the number of infant deaths in half over the last 20 years or so.
The discovery that Fisher Price had not tested the Rock ‘n Play started to unravel in the last few years. During a deposition in a product liability case against Fisher Price, which was filed by a Georgia couple who found their 7-week-old son blue and lifeless in the device back in 2014 (he survived), the Fisher Price industrial designer who came up with the initial design for the sleeper. That case was later dismissed by a judge who found a lack of evidence for a product liability claim, but the transcripts from that case and a second case filed in Texas court, tell the story of how the company came up with the product, which was based on something her child’s doctor suggested years earlier, when her newborn son was suffering from reflux and was spitting up. That doctor had recommended elevating his head when sleeping. While many parents and some doctors still believe an incline helps relieve gastric reflux, numerous studies have shown that elevating the head and laying a baby in an incline can actually worsen the problem.
Fisher Price actually used the claim about inclines helping with reflux when thye wrote a letter to the CPSC in 2010, just as the agency was considering regulating inclined sleepers. They wrote, “Doctors often advise letting such colicky infants sleep in an inclined supine position, of as much as 30 degrees.” Fisher-Price had decided to use the term “colicky,” which is a term used by pediatricians to describe a baby who cries constantly, to refer to a baby who cries because of reflux.
Parents occasionally allow babies sleep in inclined devices, such as car seats, but car seats are required to carry warnings against using them for prolonged sleep because of potential dangers, such as the risk of what’s called positional asphyxia, which inhibits an infant’s ability to breathe.
Whether or not Fisher Price’s product is dangerous because the company failed to conduct proper testing is a matter of perspective. As noted, thousands of infants die in their sleep every year, and “only” 30 babies died in the Rock ‘n Play over the course of ten years. Still, manufacturers of baby products should be regulated into making their products as safe as possible. By the time Fisher Price issued this recall, they had been able to sell nearly 5 million of these devices without so much as an okay from a qualified pediatrician, and that seems wrong, somehow.