Gudel counters that the Nap Nanny has been unfairly blamed. She says all the deaths have been linked to improper use of the recliner, "such as when used in a crib where the child could suffocate on a crib bumper or a blanket."
So is this a case, as Gudel and her lawyers seem to suggest, of the "nanny state" run amok? Or are federal regulators simply doing their job, unpleasant though it may sometimes seem?
With infants' safety at stake, the highest standards are called for - although this case itself doesn't appear black and white. If it were, it likely wouldn't have become such a pitched battle, even at a time when our politics and courts are deeply polarized over the proper role of government.
For the fourth time in a year, but only the fifth time since 2001, the CPSC has asked an administrative judge to order a recall that a company has refused to do voluntarily. The three cases in 2012 all involved companies that distribute small, powerful magnets marketed as adult "desk toys" that caused serious gastrointestinal damage when children swallowed them.
In most cases - including more than 450 in 2012 - companies weigh the accumulating evidence and decide to do what the CPSC asks.
Gudel can rightly argue that her product violated no safety standards - since none apply - and that four of the five deaths occurred when the Nap Nanny was placed in a crib, despite a specific warning on the product's label against such use. She could also point out that in all but one of the deaths, caregivers had apparently failed to connect the Nap Nanny's harness.
"My heart is broken for those families," Gudel told me when we spoke last week. But her frustration with the CPSC is palpable. She believes, in essence, that the agency has repeatedly moved the goal posts - pushing for costly reengineering and relabeling before finally seeking a recall of even the latest version, the Nap Nanny Chill.
"If they didn't like the product, they should have determined that two years ago," she says.
Neither Gudel nor the CPSC is willing to discuss details of the dispute while it's pending before the agency - and, potentially, headed to federal court.
Have CPSC officials performed perfectly in this case? I don't know enough to say. But while I can understand Gudel's frustration, it's also possible that rather than shifting the goal posts, the agency was trying to help keep the Nap Nanny on the market before it concluded that a recall was necessary.
Which gets us back to those deaths, and why it's so important for the CPSC - to use a different sports metaphor - to keep its eye on the ball: protecting consumers, particularly the babies and children most vulnerable to product risks.
There's no doubt that Gudel set out to make a safe and helpful device - and has the testimonials, celebrity and non-celebrity, to prove the helpful part. An infant's sleeplessness can make any parent desperate.
But is it safe enough? After five deaths and more than 90 incidents in which babies were found "nearly falling out of the product" despite use of the safety harness, the CPSC said no.
One unanswered question is the performance of the Nap Nanny's latest redesign, which includes an improved harness and a deeper, bucket seat. Although one death has been linked to a baby left to sleep in the Chill - in a crib and without the harness attached - a CPSC spokesman said Friday that he could not confirm whether any of the 90 nonfatal incidents, in which babies wormed their way partially out of an attached harness, occurred in the new design.
Ironically, the real problem facing a company such as Baby Matters may be underregulation, not overregulation.
Well-considered safety standards now protect babies from faulty designs in cribs, bassinets and portable cribs and play yards. So far, no such standard applies to the kind of recliner Gudel created.
"A sleeping environment for a baby should be a safe haven," says Rachel Weintraub, general counsel of the Consumer Federation of America. Weintraub is skeptical of the notion that a device meant for an infant's sleep can be made safe by a warning to place it on the floor and never in a crib.
A Fisher-Price entry in the market, the Rock 'n Play Sleeper, for instance, has large legs. It's hard to imagine anyone putting it anyplace other than the floor, unlike the Nap Nanny.
"It's totally foreseeable that someone would put a product like this in a crib, whether it's intended for that or not," Weintraub says.
Safety standards are the result, in part, of trial and error - sometimes tragic errors. For more than two years, an industry committee has been working on a new, voluntary standard for "inclined sleep products."
Gudel herself is lending a hand.
Contact Jeff Gelles at 215-854-2776 or email@example.com.