After Fisher-Price’s Rock ’n Play sleeper was linked to multiple infant deaths, the company and a government regulator issued a joint warning to consumers about the product on Friday, stopping short of a recall.
But on Tuesday, the American Academy of Pediatrics called on Fisher-Price to withdraw the Rock ’n Play immediately. The group’s president, Dr. Kyle Yasuda, said in a statement that the sleeper, which rocks babies to sleep in a cloth-covered cradle, was “deadly” because it could cause asphyxiation.
Fisher-Price, which stood by the safety of the Rock ’n Play and said a recall was not necessary, can keep selling the product. Here’s why.
The potential danger
In issuing the safety alert, the consumer commission said it was aware of 10 deaths since 2015 of children 3 months or older linked to the Rock ’n Play. Each of the children had rolled from their backs to their stomachs or sides while in the sleeper without being secured in the product’s harness restraint.
The warning recommended that consumers not use the Rock ’n Play with children older than 3 months or those who can roll over, according to the federal regulator, the Consumer Product Safety Commission.
Chuck Scothon, Fisher-Price’s general manager, said in a statement on Wednesday that the Rock ’n Play “meets all applicable safety standards.”
“It is essential that the product warnings and instructions are always followed,” he said.
But the warning that was issued “did not go far enough to ensure safety and protect infants,” the pediatricians’ group said. Citing reporting by Consumer Reports, the group said the sleeper had been linked to 32 infant deaths from 2011 to 2018, including some involving children under 3 months.
The commission said Wednesday that it was investigating other deaths connected the Rock ‘n Play, and that a recall was possible in the future.
“C.P.S.C. has requirements it must follow for any decisions concerning recalls,” said Patty Davis, an agency spokeswoman. “If the evidence shows the need for a recall, we will take that step.”
The path to a recall
Before seeking any recall, the commission must conclude there is a “substantial product hazard.” To make such a finding, it considers factors like whether the risk of injury is obvious to consumers, the severity of that risk and how many people are exposed to the product.
Most recalls are voluntary and prompted either by companies contacting the commission with concerns about a product or agreeing to stop selling a product after being approached by regulators.
Issuing a recall is a collaborative process. The commission works with companies to decide a recall’s parameters, including the number of affected units and whether consumers should get refunds.
In rare cases, the commission can seek a mandatory recall by suing companies that refuse to agree to a voluntary recall, threatening to lay out its case publicly in legal filings.
Other federal agencies have their own recall policies. Last month, the Food and Drug Administration said it had found asbestos in cosmetics sold by Claire’s, a retailer focused on products for teenagers. The agency, which said Claire’s had refused to recall the products, urged consumers not to use them.
The company later said it had stopped selling the cosmetics at issue and similar items “out of an abundance of caution.”
A shifting regulatory landscape?
The commission has recently been leaning more heavily on warnings than on recalls, according to Pamela Gilbert, the agency’s executive director from 1995 to 2001.
In March, the commission’s website listed 20 recalls for products including an electric bicycle, a riding saddle and a sauté pan. In March 2018, there were 29 such listings.
Ms. Gilbert said the shift away from recalls was a “very dangerous trend.”
“Consumers react to product recalls with more urgency and more care and attention than they do for warnings,” she said. “When deaths are involved, especially for babies and children, warnings are really not the appropriate remedy.”
Joseph Martyak, a spokesman for the safety commission, said that a warning or a safety alert could precede a voluntary recall. He added that the number of safety alerts issued by the agency “is much less than the number of voluntary recalls we achieve every year.”
The Washington Post reported this month that a leadership change at the commission under President Trump had allowed Britax, a British manufacturer of child care products, to avoid a recall of its popular BOB stroller, which the regulator had linked to hundreds of accidents.
Britax said in a statement last week that it did not agree to a recall of certain strollers because “they are not defective and are safe when used as instructed.”
Scrutiny outside the U.S.
The Rock ’n Play has faced scrutiny outside of the United States. The Australian Competition and Consumer Commission warned parents to keep the product away from children, according to The Sydney Morning Herald.
In Canada, the Rock ‘n Play is classified as a “soother” rather than as a “sleeper.” Canadian regulations do not allow the product to be used for unattended sleep, according to Fisher-Price.
Ms. Gilbert, who is now a consumer safety lawyer, said that parents in the United States should be better informed about the product’s risks.
“This is a discretionary product — if consumers knew that their babies could die, they wouldn’t buy it,” she said. “The penalty for a caregiver failing to use a restraint should not be the baby’s death.”