Although the CPSC, an independent regulatory body, has asked retailers not to sell the Nap Nanny until an administrative law judge rules on its complaint, Wolfson would not say whether parents should stop using the high-density-foam recliners modeled after a car seat.
He said: "We want parents to understand that the government is filing the lawsuit because we believe the product to be a substantial hazard and we want parents to know that we allege that there have been five deaths associated with the products."
That the recliners seem to have been used contrary to manufacturer's instructions does not absolve Baby Matters, Wolfson said.
In four of the five deaths, none of them local, the Nap Nanny was placed in a crib - precisely what the warning labels on the seats say should not be done. Those instructions say the seats are to be used on the floor, with babies strapped into the three-point harness.
"A company needs to anticipate the ways in which consumers will use their products," Wolfson said.
Describing herself as "truly heartbroken" over the infant deaths, Gudel, the mother of two young children - one whose sleeping difficulties inspired her entrepreneurial endeavor - rejected the CPSC's contention that businesses are responsible for their products' misuse.
In a statement posted on her company's website Wednesday, she said "the fact that infants have died 'while using' the Nap Nanny improperly, such as when used in a crib where the child could suffocate on a crib bumper or a blanket, does not mean our product caused the child's death or is hazardous."
Calling the CPSC's complaint without merit, Gudel said her company stood "behind the safety of our product when used as instructed."
Not that she plans to produce any more.
Gudel shut down her company three weeks ago, blaming, in part, the legal costs stemming from protracted negotiations with the CPSC. The company had 13 employees, had sold more than 160,000 Nap Nannys, and was on track to exceed $6 million in revenue this year - a 65 percent increase over last year, Gudel said.
She also cited rising product-liability insurance costs as a factor in the closing. One wrongful-death lawsuit has been filed against Baby Matters in U.S. District Court in Detroit.
Though not expecting to fight the CPSC action given Gudel's financial constraints, her Washington attorney, Raymond G. Mullady Jr., accused the agency Wednesday of having "elected to target a safe and beneficial infant sleep product and a small business for extinction based on a handful of cases involving product misuse."
Selling for $129.99, the Nap Nanny had attracted a broad following. Scores of parents posted testimonials on Nap Nanny's Facebook page about the seat's sleep-inducing powers and its perceived help with their babies' digestion and breathing problems.
Gudel and her lawyers have been in talks with the CPSC for months, working toward what they hoped would be a corrective-action plan that would keep Nap Nanny on the market. They had opposed a recall. Gudel said she had proposed an enhanced education and social-media campaign on the chair's proper use.
In July 2010, the agency and Gudel agreed to a recall of two earlier versions of Nap Nanny upon the CPSC's learning of an infant death and hearing of babies managing to get themselves sideways while in a Nap Nanny. Improved warnings and instructions were issued for the Gen2 model, and customers were asked to discontinue using Gen1.
Earlier this year, the CPSC became aware of three other deaths with some alleged connection to the first or second generation of Nap Nanny. That led to discussions with Gudel and her lawyers on a plan to remind consumers how to use the Nap Nanny properly.
While those talks were going on, a fifth death occurred in July involving the latest version of the product, Nap Nanny Chill, launched in January 2011 with slightly higher sides and a snugger contour. That prompted the CPSC's move for a full recall and refunds.
Katie Reczek, a spokeswoman for retailer Babies R Us, said Wednesday afternoon the company was removing Nap Nanny from its website and store shelves.
Contact Diane Mastrull at 215-854-2466, email@example.com, or follow @mastrud on Twitter.