L-R: Alan M. Feldman, Daniel J. Mann and Edward S. Goldis of Feldman Shepherd Wohlgelernter Tanner Weinstock Dodig.

In the early hours of May 3, 2017, Jayme Minnich put his 3-month-old son Cayson down to sleep in a "Napper," an inclined sleeper that was part of the Chicco Lullaby Dream Portable Playard. Minnich then fell asleep on a nearby couch. When he awoke about 30 minutes later, Cayson was not moving and did not appear to be breathing. Despite life-saving measures by his parents, first responders and medical personnel, Cayson died later that day.

The tragedy that played out in Minnich's home was not a "freak" occurrence. It was a predictable outcome of a sleep environment that was unsafe for newborn infants. The defective design of inclined sleepers results in infants being able to move into positions that cause asphyxia. Newborns do not have sufficient neck strength and head control to prevent these injuries from occurring.

On Oct. 31, the Consumer Product Safety Commission (CPSC) warned consumers to stop using infant inclined sleepers—such as the Chicco "Napper"—citing reports of 73 deaths and more than 1,000 incidents from January 2005 to June 2019. The warning was issued after an independent study commissioned by the CPSC of 14 inclined infant sleep products found that none of them were safe for infant sleep.

The CPSC's warning also followed four recalls by three infant product manufacturers of more than 5 million inclined sleepers:

• On April 12, Fisher-Price recalled 4.7 million Rock 'n Play sleepers after the product was tied to more than 30 infant fatalities. The Washington Post reports that Fisher-Price brought the product to market in 2009 without any clinical research into whether it was safe, and that the first time it hired a pediatrician to evaluate the sleeper's safety was eight years later to defend itself in a products liability lawsuit. On June 27, Fisher-Price also recalled about 71,000 inclined sleeper accessories that were included with all models of its Ultra-Lite Day & Night Play Yards, which were sold nationwide from October 2014 through June 2019.
• On April 26, Kids II recalled 694,000 Rocking Sleepers, citing five infant fatalities since the product's introduction in 2012.
• On July 31, Dorel Juvenile Group USA recalled about 24,000 inclined sleepers that were sold nationwide from November 2014 through February 2017 under two names: Eddie Bauer Slumber and Soothe Rock Bassinet/Rocker; Disney Baby Doze and Dream Bassinet/Rocker.

Why are so many infants getting hurt? Inclined sleepers, by design, place infants in positions that disregard the safe sleeping recommendations of the American Academy of Pediatrics (AAP). The AAP recommends that infants be put to sleep on their backs, on a separate, flat and firm sleep surface without any bumpers, loose bedding or stuffed toys. Instead, inclined sleepers position babies at an angle between 10 and 30 degrees, potentially interfering with the baby's ability to breathe.

Still on the Market

Despite the danger, many inclined sleepers remain on the market with manufacturers refusing to issue voluntary recalls. On Nov. 4, Marta L. Tellado, president and CEO of Consumer Reports, sent letters to multiple manufacturers of infant products—including big names such as Mattel, Graco, Evenflo, Baby Delight and others—asking that they recall their inclined infant sleepers. To date, there have been no recalls following Tellado's letter-writing campaign.

Recently, though, retailers have taken the lead to protect infants, filling the void left by infant product manufacturers who allow the death toll to continue to mount.

On Dec. 4, Amazon and eBay announced that they were ending the sale of all inclined sleepers on their platforms. Walmart and Buy Buy Baby quickly followed with commitments that they too would pull inclined sleepers from their stores and websites.

Additionally, in October the CPSC issued a supplemental notice of proposed rulemaking that proposes to limit the seatback angle for products intended for infant sleep to 10 degrees or less. If enacted, the new regulation would essentially ban inclined sleep products by requiring that all future sleepers meet the same standards as bassinets. The proposed rule will be open for public comment until Jan. 27, 2020.

Federal lawmakers are also getting involved. On June 10, Rep. Tony Cárdenas, D-California, introduced the Safe Sleep for Babies Act, which would prohibit the sale of inclined sleepers with an inclined surface of greater than 10 degrees that is intended, marketed or designed to provide sleeping accommodations for infants up to a year old. Sen. Richard Blumenthal, D-Connecticut, introduced a companion bill in the Senate.

Since inclined sleeper tragedies can, and likely will, continue until these products are removed from the marketplace and are out of homes and child care facilities, we offer an action plan for when a family contacts you about a potential inclined sleeper case.

Gather Key Information

First, you must gather some key information:

• Get all information about the inclined sleeper, including the model, instruction manual, where it was purchased and the receipt. Note that the manual may be available online.
• Determine whether there are any warnings in the manual, on the sleeper or on the box in which it was sold, if still available.
• Take possession of the sleeper and any related products sold with the sleeper, and store them in a secure facility. Preserve the sleeper in the manner in which it was acquired.
• Conduct an in-depth interview with the parents or caregivers about the events leading up to the incident and how they learned of it.
• Check the CPSC website to ascertain whether the sleeper has been subject to a recall.

Retain Experts

Experts to consider in an inclined sleeper case include:

• Product design and human factors experts.
• Causation expert/airway specialist.
• Forensic pathologist.

Notify the CPSC

After you have conducted your initial investigation, report the incident to the CPSC. The CPSC will provide notice to the manufacturer if you have not already done so.

The CPSC may commence an in-depth investigation (IDI), which will include interviews of your clients. You should be present for any interviews to ensure that the questions are appropriate and not adversarial. If the CPSC was notified of the incident before you were retained, your clients may have already been interviewed. You should also make a Freedom of Information Act request to the CPSC for claims and reports associated with the subject sleeper, as well as for the IDI if it was already done. Be aware that the records furnished are often highly redacted, and there is typically a significant delay associated with this request.

Documents, Records and Depositions to Seek in Discovery

Plaintiffs counsel should request the following information from the inclined sleeper manufacturer:

• History of internal testing.
• Warnings and instructions supplied with the subject inclined sleeper and other inclined sleepers sold by the manufacturer.
• Reports of all prior incidents involving the inclined sleeper, regardless of whether it resulted in injury or death.
• Memoranda arising from representatives of the manufacturer's attendance at meetings of the Juvenile Products Subcommittee (F15) of ASTM International, which publishes voluntary safety standards for juvenile products. Note that the ASTM does not presently have a safety standard for inclined sleepers.

After reviewing the information received from the manufacturer and other sources, notice the depositions of all persons involved in the design and compliance testing of the inclined sleeper. A corporate designee involved in the receipt and documentation of consumer complaints and accidents should also be deposed.

Causation Issues

Proof of legal causation can be challenging in cases involving inclined sleepers, with the catch-all diagnosis of Sudden Infant Death Syndrome (SIDS) often made as opposed to asphyxiation from the design of the product. Remember that SIDs is a diagnosis of exclusion, that can only be made when all mechanical means of asphyxiation have been removed as a potential cause. Obtain the autopsy report as soon as possible and determine if the medical examiner was aware that the death occurred in an inclined sleeper product. Learn whether the medical examiner filed a Medical Examiners and Coroners Alert Project (MECAP) report, which is designed to collect timely information from coroners and medical examiners on product-related deaths.

Legal Claims Available

Possible legal claims include:

• Unsafe design, meaning that the sleeper is not safe for its intended or expected use. These claims can be asserted under negligence or products liability theories. In Pennsylvania, products liability claims are evaluated under a risk-utility test or a consumer expectation test pursuant to Tincher v. Omega Flex, 104 A.3d 328 (Pa. 2014).
• Failure-to-warn, which is based upon the absence of clear instructions and adequate warnings about the safe use of the product, pursuant to Section 402A of the Restatement (Second) of Torts.
• Whether a post-sale duty to warn exists in Pennsylvania for products like inclined sleepers is problematic under current law, but in our view warrants a fresh look, given the state of industry knowledge of significant risks, and the law of other jurisdictions permitting these types of claims.

Punitive damages may be possible when there is evidence that a manufacturer recklessly failed to consult with medical specialists in designing the sleeper, or received notice or was otherwise aware of injuries or deaths occurring in inclined sleeper products, and did little or nothing to investigate such incidents.

Settlements That Prevent Tragedies

A common motivation among parents who lose a child to a dangerous product is that they want to spare other families from similar tragedies. We submit that plaintiffs counsel can play an important role in achieving this objective.

When settling inclined sleeper cases, be mindful that you can achieve fair compensation for your clients while also negotiating terms that promote recalls, public awareness and design practices that will help keep other infants safe.

Alan M. Feldman is co-managing shareholder and Daniel J. Mann and Edward S. Goldis are partners at Feldman Shepherd Wohlgelernter Tanner Weinstock Dodig. They represent Cayson's parents in products liability litigation filed against Chicco in the Philadelphia Court of Common Pleas. They can be contacted at [email protected], [email protected] and [email protected].