Baby Matters, LLC; Complaint, 73621-73626 [2012-29760]
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Federal Register / Vol. 77, No. 238 / Tuesday, December 11, 2012 / Notices
Service Networks (VISNs) 1, 3, 4, 5, 6,
7, and 8, as aggregated by Service Area
Office (SAO) East, Veterans Health
Administration, Department of Veterans
Affairs, Pittsburgh, PA, with an effective
date of November 26, 2012. This Notice
is to clarify that the Committee’s
decision to add the referenced eyewear
requirement to the Procurement List
does not affect current contracts or
option years exercised under those
contracts. Nor does the Committee’s
decision preclude the Department of
Veterans Affairs from implementing its
Veterans First Program in awarding
prime contracts for optical products and
services in accordance with their
published procedures.
Further, the Committee is temporarily
suspending the November 26, 2012
effective date for the following
locations: VISNs 1, 3, 4, 5, 6 and those
portions of VISN 8 that have existing
commercial contracts as of November
26, 2012. Concurrently, pursuant to 41
CFR 51–2.4, the Committee will
reconsider the decision in order to
determine whether it had all
appropriate information for
consideration when the Committee
extended to SAO East its decision that
the products were suitable for
procurement by the Government.
Interested parties may submit
comments pertaining to the eyewear
addition for the Committee’s
consideration no later than 5 p.m. on
January 28, 2013. Comments received
after this date will not be considered.
Comments should be submitted to Barry
S. Lineback at the address above.
Dated: December 6, 2012.
Barry S. Lineback,
Director, Business Operations.
[FR Doc. 2012–29873 Filed 12–10–12; 8:45 am]
BILLING CODE 6353–01–P
CONSUMER PRODUCT SAFETY
COMMISSION
[CPSC Docket No. 13–1]
Baby Matters, LLC; Complaint
Consumer Product Safety
Commission
AGENCY:
Publication of a Complaint
under the Consumer Product Safety Act.
ACTION:
Under provisions of its Rules
of Practice for Adjudicative Proceeding
(16 CFR part 1025), the Consumer
Product Safety Commission must
publish in the Federal Register
Complaints which it issues. Published
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SUMMARY:
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below is a Complaint: In the Matter of
Baby Matters, LLC.1
SUPPLEMENTARY INFORMATION: The text of
the Complaint appears below.
Dated: December 5, 2012.
Todd A. Stevenson,
Secretary.
UNITED STATES OF AMERICA
CONSUMER PRODUCT SAFETY
COMMISSION
In the Matter of BABY MATTERS LLC,
Respondent.
CPSC DOCKET NO. 13–1
Complaint
Nature of Proceedings
1. This is an administrative
enforcement proceeding pursuant to
Section 15 of the Consumer Product
Safety Act (‘‘CPSA’’), as amended, 15
U.S.C. 2064, and Section 15 of the
Federal Hazardous Substances Act
(‘‘FHSA’’), as amended, 15 U.S.C. 1274,
for public notification and remedial
action to protect children from the
substantial risks of injury and death
presented by infant recliners known as
the Nap Nanny® and the Nap Nanny®
ChillTM (collectively, the ‘‘Subject
Products’’), imported, distributed and
sold by Baby Matters LLC (‘‘Baby
Matters’’ or ‘‘Respondent’’).
2. This proceeding is governed by the
Rules of Practice for Adjudicative
Proceedings before the Consumer
Product Safety Commission (the
‘‘Commission’’), 16 CFR part 1025.
Jurisdiction
3. This proceeding is instituted
pursuant to the authority contained in
Sections 15(c), (d) and (f) of the CPSA,
15 U.S.C 2064 (c), (d) and (f), and
Sections 15(c), (d) and (e) of the FHSA,
15 U.S.C. 1274(c), (d) and (e).
Parties
4. Complaint Counsel is the staff of
the Division of Compliance within the
Office of the General Counsel of the
Commission (‘‘Complaint Counsel’’).
The Commission is an independent
federal regulatory agency established
pursuant to Section 4 of the CPSA, 15
U.S.C. 2053.
5. Respondent is a Pennsylvania
limited liability company with its
principal place of business located at
531 Winston Way, Berwyn,
Pennsylvania, 19312.
6. From January 2009 until November
2012, Respondent was an importer,
1 Commissioner Nancy A. Nord issued a
statement regarding this issue. The statement is
available on the Commission Web site,
www.cpsc.gov or from the Office of the Secretary.
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73621
distributor, and retailer of the Subject
Products, as those terms are defined in
CPSA Sections 3(a)(5), (7), (8), (11) and
(13) of the CPSA, 15 U.S.C. 2052(a)(5),
(7), (8), (11) and (13).
7. As an importer, from January 2009
until November 2012 Respondent was a
‘‘manufacturer’’ as that term is defined
in CPSA Section 3(a)(11), 15 U.S.C.
2052(a)(11).
The Consumer Product
8. From January 2009 until November
2012, Respondent imported and
distributed the Subject Products in U.S.
commerce and offered them for sale to
consumers for their personal use in or
around a permanent or temporary
household or residence, in recreation or
otherwise.
9. The Subject Products are sold
under the brand names Nap Nanny®
(‘‘Nap Nanny’’), and The Nap Nanny®
ChillTM’’ (the ‘‘Chill’’).
10. Upon information and belief, three
models of the Nap Nanny have been
introduced in U.S. commerce.
11. Upon information and belief, one
model of the Nap Nanny (‘‘Generation
One’’) was sold between January 2009
and August 2009.
12. Upon information and belief, the
Generation One consists of a shaped
foam seat base covered by a removable
fabric shell, and is equipped with a
three-point harness.
13. Upon information and belief, the
harness on each Generation One
Product is attached to the fabric cover
only and is not secured to the foam base
underneath.
14. Upon information and belief, a
second model of the Nap Nanny
(‘‘Generation Two’’) was sold between
August 2009 and as late as April 2012.
15. Upon information and belief, the
Generation Two consists of a shaped
foam seat base covered by a removable
fabric shell and is equipped with a
three-point harness.
16. Upon information and belief, the
contour of the foam seat base of the
Generation Two is identical to that of
the Generation One.
17. Upon information and belief, the
harness system in the Generation Two is
sewn to the fabric cover but also can be
secured to two ‘‘D’’-shaped rings
embedded in the foam base by means of
VelcroTM tabs.
18. Upon information and belief, a
third model of the Nap Nanny, the Chill,
has been sold since January 2011.
19. Upon information and belief, the
Chill consists of a shaped foam seat base
covered by a removable fabric shell and
is equipped with a three-point harness.
20. Upon information and belief, the
contour of the Chill model’s foam base
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has been modified from those of the
Generation One and Generation Two
versions of the Subject Products.
21. Upon information and belief, the
contour of the Chill forms a more
narrow space around the infant’s hip
area and provides a higher side wall on
either side of the infant than do either
the Generation One or Generation Two
models of the Subject Products.
22. Upon information and belief, the
harness in the Chill is permanently
attached to the foam base, in contrast to
the design of the Generation One and
Generation Two Subject Products.
23. Upon information and belief, the
foam core components of the Subject
Products were, and continue to be,
manufactured by G&T Industries, of
Reading, Pennsylvania.
24. Upon information and belief, the
fabric covers of the Generation One and
a portion of fabric covers of the
Generation Two were manufactured by
Ricochet Manufacturing, of
Philadelphia, Pennsylvania.
25. Upon information and belief, the
fabric covers for a portion of the
Generation Two are manufactured by
Jiaxing Jiayi Garment Co. Ltd., of
Jiazing, Zhejiang, in China.
26. Upon information and belief, the
fabric covers for the Chill are
manufactured by Jiaxing Jiayi Garment
Co. Ltd., of Jiazing, Zhejiang, in China.
27. Upon information and belief,
Respondent imports these fabric covers
into the United States.
28. Upon information and belief, the
Subject Products have been, and
continue to be, sold for a retail price of
approximately $130.
29. Upon information and belief,
approximately 5,000 units of the
Generation One and 50,000 units of the
Generation Two have been sold to
consumers in the United States.
30. Upon information and belief,
approximately 100,000 units of the Chill
have been sold to consumers in the
United States.
31. Upon information and belief,
Respondent advised the public on its
Web site in November 2012 that
Respondent has ‘‘closed [its] doors,’’
and directed consumers to Respondent’s
retail partners that continued to sell the
Chill.
32. Upon information and belief,
subsequently, on or about November 27,
2011, Respondent removed the message
that it had ‘‘closed [its] doors’’ and
replaced it with links to the Chill’s User
Guide and registration. Respondent
retained the message directing
consumers to Respondent’s retail
partners that continued to sell the Chill.
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The Subject Products are Substantial
Product Hazards Under Section 15(a)(2)
of the CPSA, 15 U.S.C. 2064(a)(2),
Because They Contain Product Defects
That Create a Substantial Risk of Injury
to the Public
The Subject Products Contain a Design
Defect
33. Paragraphs 1 through 32 are
hereby realleged and incorporated by
reference as though fully set forth
herein.
34. A product may contain a defect
even if a product is manufactured in
exact accordance with its design and
specifications, if the design presents a
risk of injury to the public. 16 CFR
§ 1115.4.
35. Upon information and belief,
because the restraint system in the
Generation One is designed such that
the harness straps are secured only to
the fabric cover and cannot be attached
to the foam seat base, the fabric cover
can move freely over the seat base so
that there is no means of anchoring the
harness to any fixed point.
36. Upon information and belief, this
defective design allows the infant to
have significant movement within the
Generation One even when the harness
is used.
37. Upon information and belief, the
harness straps of the Generation One
slide easily through the buckles when
the infant user moves, preventing a
secure, snug fit around the infant’s
waist.
38. Upon information and belief, this
defective design allows freedom of
movement such that the infant is able to
maneuver over the side walls of the
Generation One and into other
compromised positions. This hazardous
scenario exists even while the harness is
in use.
39. Upon information and belief, the
restraint system in the Generation Two
is designed such that the two harness
straps that encircle the infant’s waist are
sewn to the fabric cover but also could
be secured, via VelcroTM tabs, to two
‘‘D’’-shaped rings embedded in the foam
seat base. The third point of the harness
is sewn to the fabric cover between the
infant user’s legs with no means of
attaching it to a fixed point on the foam
seat base, causing the harness straps to
slide easily through the buckles and
prevent a secure, snug fit around the
infant’s waist.
40. Upon information and belief,
when the harness is not attached to the
‘‘D’’-shaped rings, the Generation Two
harness moves freely with the fabric
cover.
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41. Upon information and belief, this
defective design allows an infant to fall
or hang over the side of a Generation
Two even while the harness is in use,
which can result in injury or death.
42. Upon information and belief,
parents and caregivers who remove the
fabric cover of the Generation Two are
directed in Respondent’s instructions
that failure to secure the harness around
the ‘‘D’’ shaped rings can allow the
infant to turn and contact the floor.
43. Upon information and belief, the
VelcroTM tabs in the Generation Two
loosen as the infant user moves in the
seat.
44. Upon information and belief, over
time, due to the nature of VelcroTM, the
tabs gradually detach with ease, thereby
rendering the restraint system
ineffective, posing a risk of injury and
death to the infant.
45. Upon information and belief,
parents or other caregivers using a
Generation Two are not likely to
immediately know that the VelcroTM
tabs have detached from the ‘‘D’’-shaped
ring.
46. Upon information and belief,
parents or other caregivers, may be
unaware of the importance of ensuring
that the VelcroTM tabs are secured
around the ‘‘D’’-shaped rings after
replacing the cover and before every
use.
47. Upon information and belief,
because the restraint system in the Chill
is permanently attached to three points
on the foam seat base, this design makes
it difficult for caregivers to adjust the
waist straps.
48. Upon information and belief,
because it is difficult to adjust the waist
straps in the Chill, parents and other
caregivers are less likely to use the
harness.
49. Upon information and belief, due
to difficulty of use in the case of the
Chill and ineffectiveness in the case of
the other models, parents and other
caregivers are unlikely to use the
harness on any of the Subject Products.
50. Upon information and belief, even
if the harness is used, the harness may
fail to prevent the infant user from
moving into a compromised position if
it is not adequately tightened around the
infant.
51. These defective designs pose a
risk of injury and death to infant users.
The Subject Products Are Defective
Because the Risk of Injury Occurs as a
Result of Their Operation or Use
52. A design defect may also be
present if the risk of injury occurs as a
result of the operation or use of the
product. 16 CFR § 1115.4.
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53. Upon information and belief, the
Subject Products have been advertised
and marketed by Respondent as devices
that promote a full night’s sleep for
infants.
54. Upon information and belief, the
risk of injury occurs as a result of the
use of the Subject Products by parents
and caregivers who, contrary to the onproduct warnings, are likely to use the
product, regardless of the version, in
cribs and other traditional sleep
environments in order to ensure the
child’s safety during a full night’s sleep.
55. Upon information and belief, the
risk of injury occurs as a result of the
foreseeable use and/or misuse of the
Subject Products by parents and
caregivers.
56. Upon information and belief,
infants who are not adequately
restrained in the Subject Products may
move into compromised positions on
the side or inside the seat well of the
recliner, which can result in injury or
death.
57. Upon information and belief,
when a Subject Product is used in a
crib, an infant may be able to maneuver
its head over the side of the Subject
Product and become entrapped between
the Subject Product and a bumper pad
of a crib or the side of a crib, which can
result in injury or death.
58. The Subject Products contain a
design defect because they fail to
operate as intended and present a
substantial risk of injury to the public.
The Subject Products Are Defective
Because Their Instructions and
Warnings Are Inadequate
59. A defect can occur in a product’s
contents, construction, finish,
packaging, warnings and/or
instructions. 16 CFR § 1115.4.
60. A defect can occur when
reasonably foreseeable consumer use or
misuse, based in part on the lack of
adequate instructions and safety
warnings, could result in injury, even
where there are no reports of injury. 16
CFR § 1115.4.
61. Upon information and belief, from
approximately January 2009 through
July 2010, all of the Generation One and
Generation Two models had a warning
label that read as follows: ‘‘Safety
guidelines to prevent injury or death:
FALL HAZARD: ALWAYS use on the
floor. This product should not be used
inside a crib. NEVER place product on
countertops, tables, steps or other
elevated surfaces. SUFFOCATION
HAZARD: NEVER use on soft or uneven
surface (sofa, bed cushion), as seat may
tip over and cause suffocation. NEVER
use with blankets, towels, pillows, or
other soft objects while child is in seat.
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Intended for infants 8 pounds or 3.6
kilograms and above. NEVER leave
child in the seat when straps are loose
or undone. Adjust the straps provided
so they fit snugly around the infant.
NEVER move or carry unit while child
is in seat. Not intended for carrying a
baby.’’
62. Upon information and belief, this
warning was printed in extremely small
(approximately 6-point) font on the
underside of the product, which would
be placed on the floor or other surface
and thus not visible to consumers
during use.
63. Upon information and belief, on
or about April 17, 2010, a six-month-old
girl died when she suffocated while
using a Generation Two model of the
Subject Products. Not secured in the
harness, the infant was found with her
face pressed between the Nap Nanny
and the crib bumper. The medical
examiner ruled the cause of death as
probable positional asphyxia.
64. Upon information and belief, on
or about July 9, 2010, a four-month-old
girl died when she suffocated between
a Generation Two Nap Nanny and the
bumper in her crib. Although the
harness had been secured around the
infant, it failed to adequately restrain
her in the seat. She was found by her
mother in the Nap Nanny, with the
harness secured but with her head tilted
back and her neck hyperextended. Her
face was pressed against the bumper
pad of her crib. The medical examiner
ruled the cause of death as position/
compression asphyxia.
65. On July 26, 2010, the Commission
and the Respondent issued a joint press
release announcing a recall of the
Generation One and the Generation Two
models of the Subject Products: Baby
Matters Recalls Nap Nanny ® Recliners
Due to Entrapment, Suffocation and
Fall Hazards; One Infant Death
Reported.
66. Upon information and belief, on
or about July 26, 2010, Respondent
executed a corrective action plan in
cooperation with the U.S. Consumer
Product Safety Commission. As part of
this corrective action plan, Respondent
modified the warnings, instructions,
and labeling on the Generation Two
products that were in Respondent’s
inventory at the time and on the Subject
Products imported, sold, and distributed
thereafter by Respondent.
67. Upon information and belief, as
part of the corrective action, Respondent
relocated the warning label from the
underside of the Generation Two model
to the front of the Generation Two
model, increased the font size of the
warning, and changed the text of the
warning label to read as follows:
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‘‘ALWAYS use on floor. NEVER use in
crib. ALWAYS secure buckles on
harness. NEVER use with infant under
8 pounds (3.6 kilograms). When infant
can sit up, do not use for sleep.
Suffocation hazards:—Do not place
inside crib, other contained areas, or on
the floor next to other vertical surfaces
(e.g., walls, dresser). An infant who
leans over side can become entrapped
between the product and another
object.—Never use on soft surfaces (e.g.,
bed, sofa, cushion) where product can
tip over and cause suffocation in soft
surfaces.—Do not add blankets, towels,
or other soft objects that can cover face.
Fall hazards:—Never use on counter
tops, tables or other elevated surfaces
from which infant can fall.—Never carry
product with infant in it.—ALWAYS
secure infant snugly in harness or infant
may turn sideways and fall.
Strangulation hazards:—Head/neck can
get caught in loosely fastened seatbelt if
infant tries to get out of product.—Head/
neck can get caught in a fastened
seatbelt not in use if active infant tries
to climb in and out of product
unassisted.’’
68. Upon information and belief, the
change in warning did not address the
Subject Products that had already been
purchased by consumers or that
remained in retailers’ inventory.
69. Upon information and belief, for
products already purchased by
consumers or those that remained in
retailers’ inventory, Respondent
directed retailers with Generation Two
products to place a sticker on the plastic
bag covering the product.
70. Upon information and belief, the
sticker directed users to a website,
www.napnanny.com/recall, which
contained the revised warnings and
instructions that were part of the recall
and corrective action plan.
71. Upon information and belief, at
the time of the recall, Respondent knew
of the July 9, 2010 fatality, one injury,
and 21 other incidents resulting from
the failure of the harness systems on the
Generation One and the Generation Two
to properly secure the infant.
72. Upon information and belief,
since the Chill was first introduced into
commerce in January 2011, the warning
label read as follows: ‘‘To avoid serious
injury or death, read and follow the
warnings and instructions provided
below: ALWAYS use on floor. NEVER
use in crib. ALWAYS secure buckles on
harness. NEVER use with clothing or
blankets that interfere with the use of
the harness. Harness must always be
snug against your child. NEVER use
with infant under 8 pounds (3.6
kilograms). When infant can sit up, do
not use for sleep. For infants who
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cannot sit up, use for sleep, feeding and
play time. ALWAYS secure infant
snugly in harness or infant may turn
sideways and fall. Suffocation hazards—
Do not place inside crib, other
contained areas, or on the floor next to
other vertical surfaces (e.g., walls,
dresser). An infant who leans over side
can become entrapped between the
product and another object.—Never use
on soft surface (e.g., bed, sofa, cushion)
where product can tip over and cause
suffocation in soft surfaces.—Do not add
blankets, towels, or other soft objects
that can cover face. Fall hazards—Never
use on counter tops, tables, or other
elevated surfaces from which infant can
fall.—Never carry product with infant in
it.—ALWAYS secure infant snugly in
harness or infant may turn sideways and
fall. Strangulation hazards—Head/neck
can get caught in loosely fastened
seatbelt if infant tries to get out of
product.—Head/neck can get caught in
a fastened seatbelt not in use if active
infant tries to climb in and out of
product unassisted.’’
73. Upon information and belief,
subsequent to the July 2010 recall, and
despite enhanced warnings and revised
instructions on the Subject Products,
parents and caregivers continue to use
the Subject Products inside of cribs and
other sleeping environments, contrary to
the warnings on the Subject Products.
74. Upon information and belief,
subsequent to the July 2010 recall, and
despite enhanced warnings and revised
instructions on the Subject Products,
parents and caregivers continue to use
the Subject Products without using the
harness or ensuring that the harness is
firmly secured around the infant.
75. Upon information and belief,
since the July 2010 recall, at least three
additional fatalities of infants using the
Subject Products have been reported.
76. Upon information and belief, one
of those fatalities involved an infant
sleeping in the Chill.
77. Upon information and belief, over
70 other incidents have been reported of
children nearly falling out of the Subject
Products.
78. The warnings and instructions on
the Subject Products are inadequate and
defective because they do not and
cannot effectively communicate to
parents and caregivers the hazard
associated with use of the Subject
Products inside cribs and other sleep
enclosures.
79. The warnings and instructions on
the Subject Products are inadequate and
defective because they do not and
cannot effectively communicate to
parents and caregivers the hazard
associated with the Subject Products if
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the harness is not used or is not snugly
secured around the infant.
80. Because the warnings and
instructions on the Subject Products are
inadequate and defective, parents will
continue to use the Subject Products in
cribs or other enclosures.
81. Because the warnings and
instructions on the Subject Products are
inadequate and defective, parents will
not use the harness provided or will not
secure it snugly around the infant.
82. Parents and caregivers cannot and
do not appreciate the hazard associated
with using the Subject Products in
locations other than the floor, and it is
thus foreseeable that they will use the
Subject Products in cribs, play yards, or
other enclosures. These uses can and do
result in infant death and injury.
83. Parents and caregivers cannot and
do not appreciate the hazard associated
with not using the harness or not
securing the harness snugly, and it is
foreseeable that they will use the
Subject Products without securing the
harness or without securing it snugly
around the infant. These uses can and
do result in infant death and injury.
84. The warnings on the Subject
Products are inadequate and defective
because while they warn against use of
the Subject Products in a crib and
advise users to secure the infant with
the three point harness, they do not
convey the gravity of the consequences
of non-compliance. Specifically, the
warnings and instructions do not
communicate that an infant can die if
placed in a Subject Product used in a
crib or other enclosure, or if the harness
is not used or adequately secured. These
uses can and do result in infant injury
and death.
85. In addition, the warnings and
instructions on the Generation Two are
inadequate and defective because they
do not convey the importance of
ensuring, before each use, that the
VelcroTM tabs are attached to the ‘‘D’’shaped rings embedded in the foam
seat. The VelcroTM tabs can loosen with
time and normal use of the Generation
Two, allowing a child to extend his or
her head over the side of the product or
to fall down inside the well of the seat.
It is not obvious to caregivers when
these rings become loosened or
unattached.
86. The effectiveness of the warnings
on the Subject Products is further
diminished by the advertising and
marketing of the Subject Products.
87. Upon information and belief, in
2009 and thereafter, Respondent
advertised the Subject Products as sleep
products.
88. Upon information and belief, the
advertisements encouraged consumers
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to use them for unattended, overnight
sleep, advancing the tagline,
‘‘Everybody Sleeps!’’
89. Upon information and belief,
Respondent’s advertisements further
encouraged consumers to use the
Subject Products as a traditional sleep
environment, contending that the
product is, ‘‘Better than a bassinet, more
effective than a wedge.’’
90. Upon information and belief,
Respondent’s advertisements also
promoted the Subject Products as a safe
environment for infant sleep, by
characterizing the Subject Products as,
‘‘The only portable infant recliner
designed for sleep, play—and peace of
mind.’’
91. Upon information and belief,
advertising for the Chill promotes the
Chill as having ‘‘a 3-point safety harness
anchored to the foam—no D-rings or
loose cover to worry about—a contoured
bucket for maximum containment and a
large foam base for total stability.’’
92. Upon information and belief, that
advertisement suggests that the Chill is
safer than the Generation Two.
93. Upon information and belief,
Respondent’s retail partners advertised
and marketed the Subject Products as a
solution for babies with gastroesophageal reflux disease that have
difficulty sleeping comfortably on flat
surfaces. Respondents knew or should
have known that its retail partners
advertised and marketed the Subject
Products in this manner.
94. The advertising and marketing of
the Subject Products conflict with the
current warnings and instructions that
the Subject Products should not be used
for unattended overnight sleep.
95. The advertising and marketing of
the Subject Products conflict with the
current warnings and instructions that
the Subject Products not be used if the
infant can sit up unaided.
96. Because the advertising and
marketing of the Subject Products
conflict with the weight, age, and usage
restrictions described on the label, the
effectiveness of the warning label is
diminished.
97. Even if the warnings and
instructions on the Subject Products
were enhanced, and the attendant
advertising were changed, it is
foreseeable that parents and caregivers
would continue to use the products in
cribs, bassinettes, and other sleep
environments.
98. Parents and caregivers are likely to
continue to use the Subject Products in
enclosed spaces such as cribs in order
to create a barrier to older siblings, pets,
or pests in the home.
99. Parents and caregivers are likely to
continue to use the Subject Products in
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cribs because cribs are traditionally
viewed as safe sleeping environments.
100. Because of the lack of adequate
instructions and safety warnings, a
substantial risk of death and injury
occurs as a result of the foreseeable use
and misuse of the Subject Products.
The Type of the Risk of Injury Renders
the Subject Products Defective
101. The risk of injury associated with
a product may render the product
defective. 16 CFR § 1115.4.
102. The nature of the risk of injury
includes death if a child becomes
trapped between the side of the Subject
Products and the bumper pad or the
side of a crib.
103. The nature of the risk of injury
also includes death if a child is not
restrained in the seat of the Subject
Products and suffocates on the interior
wall or well of the seat.
104. Infants, a vulnerable population
protected by the CPSA and FHSA, are
exposed to risk of injury by the Subject
Products.
105. The risk of injury associated with
use of the Subject Products in a crib is
neither obvious nor intuitive.
106. The risk of injury associated with
use of the Subject Products without the
harness or without tightly securing the
harness is neither obvious nor intuitive.
107. Warnings and instructions
cannot adequately mitigate the risk of
injury and death associated with use of
the Subject Products.
108. Because Respondent promoted
the use of the Subject Products for
unsupervised, overnight sleep, use of
the Subject Products in a crib or other
enclosed areas is foreseeable.
109. Use of the Subject Products
without securing the harness around the
infant is foreseeable.
110. The type of the risk of injury
renders the Subject Products defective.
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The Subject Products Create a
Substantial Risk of Injury to the Public
111. The Subject Products pose a risk
of injury or death to infants who may,
consistent with developmentally
appropriate behavior, maneuver to
compromised positions either within
Subject Products or partially outside
Subject Products used in cribs.
112. Therefore, because the Subject
Products are defective and create a
substantial risk of injury, the Subject
Products present a substantial product
hazard within the meaning of Section
15(a)(2) of the CPSA, 15 U.S.C.
2064(a)(2).
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Relief Sought
The Subject Products Are Intended for
Use by Children and Contain Defects
Which Create a Substantial Risk of
Injury to Children Under Section
15(c)(1) of the FHSA
Wherefore, in the public interest,
Complaint Counsel requests that the
Commission:
A. Determine that the Subject
Products present a ‘‘substantial product
hazard’’ within the meaning of Section
15(a)(2) of the CPSA, 15 U.S.C.
2064(a)(2), and/or present a ‘‘substantial
product hazard’’ within the meaning of
Section 15(a)(1) of the CPSA, 15 U.S.C.
2064(a)(1).
B. Determine that the Subject
Products contain a defect, which creates
a substantial risk of injury to children
because of the pattern of defect, the
number of such articles distributed in
commerce, the severity of the risk, or
otherwise, within the meaning of
Section 15(c)(1) of the FHSA, 15 U.S.C.
1274(c)(1).
C. Determine that extensive and
effective public notification under
Section 15(c) of the CPSA, 15 U.S.C.
2064(c), is required to protect the public
and children adequately from the
substantial product hazard presented by
the Subject Products, and order
Respondent under Section 15(c) of the
CPSA, 15 U.S.C. 2064(c) to:
(1) Cease any remaining distribution
of the product to other distributors,
wholesalers or retailers;
(2) Notify all persons that transport,
store, distribute or otherwise handle the
Subject Products, or to whom such
products have been transported, sold,
distributed or otherwise handled, to
immediately cease distribution of the
Subject Products;
(3) Notify appropriate state and local
public health officials;
(4) Give prompt public notice of the
defects in the Subject Products,
including the incidents and injuries
associated with use of the Subject
Products including posting clear and
conspicuous notice on Respondent’s
Web site, and providing notice to any
third party Web site on which
Respondent has placed the Subject
Products for sale, and provide further
announcements in languages other than
English and on radio and television;
(5) Mail notice to each distributor or
retailer of the Subject Products; and
(6) Mail notice to every person to
whom the Subject Products were
delivered or sold;
D. Determine that extensive and
effective public notification under
Section 15(c)(1)(A) of the FHSA, 15
U.S.C. 1274(c)(1), is required to protect
the public and children adequately from
the substantial product hazard
presented by the Subject Products, and
order Respondent under Section 15(c) of
the FHSA, 15 U.S.C. 1274(c)(1)(A) to:
113. Paragraphs 1 through 112 are
hereby realleged and incorporated by
reference as though fully set forth
herein.
114. Upon information and belief, the
Subject Products are an article intended
for use by children as young as
newborns. Respondent has marketed,
and continues to promote, the Subject
Products as appropriate for use by
infants weighing eight pounds or more
until the infant can sit up unassisted.
115. The Subject Products contain a
design defect that is present in all
models of the Subject Products.
116. The harness designs in the
Generation One and the Generation Two
are defective because each design fails
to adequately restrain the infant user.
117. The harness design in the
Generation Two is also defective
because the ‘‘D’’-shaped ring in the foam
base must be secured after the cover is
changed, and can also become loose
with regular use of the product.
Caregivers are not informed adequately
of the importance of securing the
harness straps to the ‘‘D’’-shaped rings
embedded in the foam seat base and
may use the product without securing
the ‘‘D’’-shaped rings or ensuring that
they are adequately tightened before
each use.
118. The harness design in the Chill
is defective because the double-threaded
buckles inhibit a caregiver’s ability to
secure the harness around the infant
user, thereby reducing the effectiveness
of the harness and the likelihood of use
of the harness by the caregiver.
119. Upon information and belief,
Respondent has distributed over
150,000 Subject Products into U.S.
commerce and the Chill continues to be
available for purchase through
Respondent’s retail partners.
120. Upon information and belief, the
severity of the risk associated with use
of all of the Subject Products is
extremely high, as five infants have died
while using the Subject Products.
121. The Subject Products contain a
defect, which creates a substantial risk
of injury to children because of the
pattern of defect, the number of such
defective articles distributed in
commerce and the severity of the risk
within the meaning of Section 15(c)(1)
of the FHSA, 15 U.S.C. § 1274(c)(1).
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Federal Register / Vol. 77, No. 238 / Tuesday, December 11, 2012 / Notices
(1) To give public notice that such
defective toy or article contains a defect
which creates a substantial risk of injury
to children;
(2) To mail such notice to each person
who is a manufacturer, distributor, or
dealer of such toy or article; and
(3) To mail such notice to every
person to whom the person giving
notice knows such toy or article was
delivered or sold.
E. Determine that action under
Section 15(d) of the CPSA, 15 U.S.C.
2064(d) and Section 15(c)(2) of the
FHSA, 15 U.S.C. 1274(c)(2), is in the
public interest and additionally order
Respondent to:
(1) Refund consumers the purchase
price of the Subject Products;
(2) Make no charge to consumers and
to reimburse consumers for any
reasonable and foreseeable expenses
incurred in availing themselves of any
remedy provided under any
Commission Order issued in this matter,
as provided by Section 15 U.S.C.
2064(e)(1) of the CPSA and Section 15
U.S.C. 1274(d)(1) of the FHSA;
(3) Reimburse retailers for expenses in
connection with carrying out any
Commission Order issued in this matter,
including the costs of returns, refunds
and/or replacements, as provided by
Section 15(e)(2) of the CPSA, 15 U.S.C.
2064(e)(2) and Section 15(d)(2) of the
FHSA, 15 U.S.C. 1274(d)(2);
(4) Submit a corrective action program
satisfactory to the Commission, within
ten (10) days of service of the Final
Order, directing that actions specified in
Paragraphs C(1) through (6) and D(1)
through (3) above be taken in a timely
manner;
(5) To submit monthly reports, in a
format satisfactory to the Commission,
documenting the progress of the
corrective action program;
(6) For a period of five (5) years after
issuance of the Final Order in this
matter, to keep records of its actions
taken to comply with Paragraphs C(1)
through (6) and D(1) through (3) above,
and supply these records to the
Commission for the purpose of
monitoring compliance with the Final
Order; and
(7) For a period of five (5) years after
issuance of the Final Order in this
matter, to notify the Commission at least
sixty (60) days prior to any change in its
business (such as incorporation,
dissolution, assignment, sale, or petition
for bankruptcy) that results in, or is
intended to result in, the emergence of
a successor corporation, going out of
business, or any other change that might
affect compliance obligations under a
Final Order issued by the Commission
in this matter.
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Jkt 229001
F. Order that Respondent shall take
other and further actions as the
Commission deems necessary to protect
the public health and safety and to
comply with the CPSA and FHSA.
Issued By Order of the Commission:
Dated this l day of December, 2012.
chapter 3501 et seq.), ED is proposing an
extension of an existing information
collection.
DATES: Interested persons are invited to
submit comments on or before January
10, 2013.
ADDRESSES: Comments submitted in
lllllllllllllllllllll
response to this notice should be
BY: Marc Schoem
submitted electronically through the
Acting Assistant Executive Director for
Federal eRulemaking Portal at https://
Compliance and Field Operations
www.regulations.gov by selecting
U.S. Consumer Product Safety
Docket ID number ED–2012–ICCD–0030
Commission, Bethesda, MD 20814,
or via postal mail, commercial delivery,
Tel: (301) 504–7520.
or hand delivery. Please note that
Mary B. Murphy, Assistant General
comments submitted by fax or email
Counsel, Division of Compliance,
and those submitted after the comment
Office of General Counsel, U.S.
period will not be accepted. Written
Consumer Product Safety
requests for information or comments
Commission, Bethesda, MD 20814,
submitted by postal mail or delivery
Tel: (301) 504–7809.
should be addressed to the Director of
lllllllllllllllllllll
the Information Collection Clearance
Kelly Moore, Trial Attorney, Complaint
Division, U.S. Department of Education,
Counsel, Division of Compliance,
400 Maryland Avenue SW, LBJ, Room
Office of the General Counsel, U.S.
2E105, Washington, DC 20202–4537.
Consumer Product Safety
FOR FURTHER INFORMATION CONTACT:
Commission, Bethesda, MD 20814,
Electronically mail
Tel: (301) 504–7447.
ICDocketMgr@ed.gov. Please do not
Certificate of Service
send comments here.
I hereby certify that on December l,
SUPPLEMENTARY INFORMATION: The
2012, I served the foregoing Complaint
Department of Education (ED), in
and List of Summary and Documentary
accordance with the Paperwork
Evidence upon all parties of record in
Reduction Act of 1995 (PRA) (44 U.S.C.
these proceedings by hand-delivering
3506(c)(2)(A)), provides the general
and mailing, certified mail, postage
public and Federal agencies with an
prepaid, a copy to each at their
opportunity to comment on proposed,
principal place of business, and
revised, and continuing collections of
courtesy copy to counsel, as follows:
information. This helps the Department
assess the impact of its information
Baby Matters LLC, 531 Winston Way,
collection requirements and minimize
Berwyn, PA 19312.
the public’s reporting burden. It also
Raymond G. Mullady, Jr., BLANK
helps the public understand the
ROME LLP, Watergate, 600 New
Department’s information collection
Hampshire Avenue NW.,
Washington, DC 20037, Counsel for requirements and provide the requested
data in the desired format. ED is
Baby Matters LLC.
Mary B. Murphy, Complaint Counsel for soliciting comments on the proposed
information collection request (ICR) that
U.S. Consumer Product Safety
is described below. The Department of
Commission.
Education is especially interested in
[FR Doc. 2012–29760 Filed 12–10–12; 8:45 am]
public comment addressing the
BILLING CODE 6355–01–P
following issues: (1) Is this collection
necessary to the proper functions of the
Department; (2) will this information be
DEPARTMENT OF EDUCATION
processed and used in a timely manner;
[Docket No. ED–2012–ICCD–0030]
(3) is the estimate of burden accurate;
(4) how might the Department enhance
Agency Information Collection
the quality, utility, and clarity of the
Activities; Submission to the Office of
information to be collected; and (5) how
Management and Budget for Review
might the Department minimize the
and approval; Comment Request;
burden of this collection on the
Student Assistance General
respondents, including through the use
Provisions—Non-Title IV Revenue
of information technology. Please note
Requirements (90/10)
that written comments received in
response to this notice will be
AGENCY: Department of Education (ED),
considered public records.
Federal Student Aid (FSA).
Title of Collection: Student Assistance
ACTION: Notice
General Provisions—Non-Title IV
SUMMARY: In accordance with the
Revenue Requirements (90/10).
OMB Control Number: 1845–0096.
Paperwork Reduction of 1995 (44 U.S.C.
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Agencies
[Federal Register Volume 77, Number 238 (Tuesday, December 11, 2012)]
[Notices]
[Pages 73621-73626]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-29760]
=======================================================================
-----------------------------------------------------------------------
CONSUMER PRODUCT SAFETY COMMISSION
[CPSC Docket No. 13-1]
Baby Matters, LLC; Complaint
AGENCY: Consumer Product Safety Commission
ACTION: Publication of a Complaint under the Consumer Product Safety
Act.
-----------------------------------------------------------------------
SUMMARY: Under provisions of its Rules of Practice for Adjudicative
Proceeding (16 CFR part 1025), the Consumer Product Safety Commission
must publish in the Federal Register Complaints which it issues.
Published below is a Complaint: In the Matter of Baby Matters, LLC.\1\
---------------------------------------------------------------------------
\1\ Commissioner Nancy A. Nord issued a statement regarding this
issue. The statement is available on the Commission Web site,
www.cpsc.gov or from the Office of the Secretary.
---------------------------------------------------------------------------
SUPPLEMENTARY INFORMATION: The text of the Complaint appears below.
Dated: December 5, 2012.
Todd A. Stevenson,
Secretary.
UNITED STATES OF AMERICA
CONSUMER PRODUCT SAFETY COMMISSION
In the Matter of BABY MATTERS LLC, Respondent.
CPSC DOCKET NO. 13-1
Complaint
Nature of Proceedings
1. This is an administrative enforcement proceeding pursuant to
Section 15 of the Consumer Product Safety Act (``CPSA''), as amended,
15 U.S.C. 2064, and Section 15 of the Federal Hazardous Substances Act
(``FHSA''), as amended, 15 U.S.C. 1274, for public notification and
remedial action to protect children from the substantial risks of
injury and death presented by infant recliners known as the Nap
Nanny[supreg] and the Nap Nanny[supreg] ChillTM
(collectively, the ``Subject Products''), imported, distributed and
sold by Baby Matters LLC (``Baby Matters'' or ``Respondent'').
2. This proceeding is governed by the Rules of Practice for
Adjudicative Proceedings before the Consumer Product Safety Commission
(the ``Commission''), 16 CFR part 1025.
Jurisdiction
3. This proceeding is instituted pursuant to the authority
contained in Sections 15(c), (d) and (f) of the CPSA, 15 U.S.C 2064
(c), (d) and (f), and Sections 15(c), (d) and (e) of the FHSA, 15
U.S.C. 1274(c), (d) and (e).
Parties
4. Complaint Counsel is the staff of the Division of Compliance
within the Office of the General Counsel of the Commission (``Complaint
Counsel''). The Commission is an independent federal regulatory agency
established pursuant to Section 4 of the CPSA, 15 U.S.C. 2053.
5. Respondent is a Pennsylvania limited liability company with its
principal place of business located at 531 Winston Way, Berwyn,
Pennsylvania, 19312.
6. From January 2009 until November 2012, Respondent was an
importer, distributor, and retailer of the Subject Products, as those
terms are defined in CPSA Sections 3(a)(5), (7), (8), (11) and (13) of
the CPSA, 15 U.S.C. 2052(a)(5), (7), (8), (11) and (13).
7. As an importer, from January 2009 until November 2012 Respondent
was a ``manufacturer'' as that term is defined in CPSA Section
3(a)(11), 15 U.S.C. 2052(a)(11).
The Consumer Product
8. From January 2009 until November 2012, Respondent imported and
distributed the Subject Products in U.S. commerce and offered them for
sale to consumers for their personal use in or around a permanent or
temporary household or residence, in recreation or otherwise.
9. The Subject Products are sold under the brand names Nap
Nanny[supreg] (``Nap Nanny''), and The Nap Nanny[supreg]
ChillTM'' (the ``Chill'').
10. Upon information and belief, three models of the Nap Nanny have
been introduced in U.S. commerce.
11. Upon information and belief, one model of the Nap Nanny
(``Generation One'') was sold between January 2009 and August 2009.
12. Upon information and belief, the Generation One consists of a
shaped foam seat base covered by a removable fabric shell, and is
equipped with a three-point harness.
13. Upon information and belief, the harness on each Generation One
Product is attached to the fabric cover only and is not secured to the
foam base underneath.
14. Upon information and belief, a second model of the Nap Nanny
(``Generation Two'') was sold between August 2009 and as late as April
2012.
15. Upon information and belief, the Generation Two consists of a
shaped foam seat base covered by a removable fabric shell and is
equipped with a three-point harness.
16. Upon information and belief, the contour of the foam seat base
of the Generation Two is identical to that of the Generation One.
17. Upon information and belief, the harness system in the
Generation Two is sewn to the fabric cover but also can be secured to
two ``D''-shaped rings embedded in the foam base by means of
VelcroTM tabs.
18. Upon information and belief, a third model of the Nap Nanny,
the Chill, has been sold since January 2011.
19. Upon information and belief, the Chill consists of a shaped
foam seat base covered by a removable fabric shell and is equipped with
a three-point harness.
20. Upon information and belief, the contour of the Chill model's
foam base
[[Page 73622]]
has been modified from those of the Generation One and Generation Two
versions of the Subject Products.
21. Upon information and belief, the contour of the Chill forms a
more narrow space around the infant's hip area and provides a higher
side wall on either side of the infant than do either the Generation
One or Generation Two models of the Subject Products.
22. Upon information and belief, the harness in the Chill is
permanently attached to the foam base, in contrast to the design of the
Generation One and Generation Two Subject Products.
23. Upon information and belief, the foam core components of the
Subject Products were, and continue to be, manufactured by G&T
Industries, of Reading, Pennsylvania.
24. Upon information and belief, the fabric covers of the
Generation One and a portion of fabric covers of the Generation Two
were manufactured by Ricochet Manufacturing, of Philadelphia,
Pennsylvania.
25. Upon information and belief, the fabric covers for a portion of
the Generation Two are manufactured by Jiaxing Jiayi Garment Co. Ltd.,
of Jiazing, Zhejiang, in China.
26. Upon information and belief, the fabric covers for the Chill
are manufactured by Jiaxing Jiayi Garment Co. Ltd., of Jiazing,
Zhejiang, in China.
27. Upon information and belief, Respondent imports these fabric
covers into the United States.
28. Upon information and belief, the Subject Products have been,
and continue to be, sold for a retail price of approximately $130.
29. Upon information and belief, approximately 5,000 units of the
Generation One and 50,000 units of the Generation Two have been sold to
consumers in the United States.
30. Upon information and belief, approximately 100,000 units of the
Chill have been sold to consumers in the United States.
31. Upon information and belief, Respondent advised the public on
its Web site in November 2012 that Respondent has ``closed [its]
doors,'' and directed consumers to Respondent's retail partners that
continued to sell the Chill.
32. Upon information and belief, subsequently, on or about November
27, 2011, Respondent removed the message that it had ``closed [its]
doors'' and replaced it with links to the Chill's User Guide and
registration. Respondent retained the message directing consumers to
Respondent's retail partners that continued to sell the Chill.
Count 1
The Subject Products are Substantial Product Hazards Under Section
15(a)(2) of the CPSA, 15 U.S.C. 2064(a)(2), Because They Contain
Product Defects That Create a Substantial Risk of Injury to the Public
The Subject Products Contain a Design Defect
33. Paragraphs 1 through 32 are hereby realleged and incorporated
by reference as though fully set forth herein.
34. A product may contain a defect even if a product is
manufactured in exact accordance with its design and specifications, if
the design presents a risk of injury to the public. 16 CFR Sec.
1115.4.
35. Upon information and belief, because the restraint system in
the Generation One is designed such that the harness straps are secured
only to the fabric cover and cannot be attached to the foam seat base,
the fabric cover can move freely over the seat base so that there is no
means of anchoring the harness to any fixed point.
36. Upon information and belief, this defective design allows the
infant to have significant movement within the Generation One even when
the harness is used.
37. Upon information and belief, the harness straps of the
Generation One slide easily through the buckles when the infant user
moves, preventing a secure, snug fit around the infant's waist.
38. Upon information and belief, this defective design allows
freedom of movement such that the infant is able to maneuver over the
side walls of the Generation One and into other compromised positions.
This hazardous scenario exists even while the harness is in use.
39. Upon information and belief, the restraint system in the
Generation Two is designed such that the two harness straps that
encircle the infant's waist are sewn to the fabric cover but also could
be secured, via VelcroTM tabs, to two ``D''-shaped rings
embedded in the foam seat base. The third point of the harness is sewn
to the fabric cover between the infant user's legs with no means of
attaching it to a fixed point on the foam seat base, causing the
harness straps to slide easily through the buckles and prevent a
secure, snug fit around the infant's waist.
40. Upon information and belief, when the harness is not attached
to the ``D''-shaped rings, the Generation Two harness moves freely with
the fabric cover.
41. Upon information and belief, this defective design allows an
infant to fall or hang over the side of a Generation Two even while the
harness is in use, which can result in injury or death.
42. Upon information and belief, parents and caregivers who remove
the fabric cover of the Generation Two are directed in Respondent's
instructions that failure to secure the harness around the ``D'' shaped
rings can allow the infant to turn and contact the floor.
43. Upon information and belief, the VelcroTM tabs in
the Generation Two loosen as the infant user moves in the seat.
44. Upon information and belief, over time, due to the nature of
VelcroTM, the tabs gradually detach with ease, thereby
rendering the restraint system ineffective, posing a risk of injury and
death to the infant.
45. Upon information and belief, parents or other caregivers using
a Generation Two are not likely to immediately know that the
VelcroTM tabs have detached from the ``D''-shaped ring.
46. Upon information and belief, parents or other caregivers, may
be unaware of the importance of ensuring that the VelcroTM
tabs are secured around the ``D''-shaped rings after replacing the
cover and before every use.
47. Upon information and belief, because the restraint system in
the Chill is permanently attached to three points on the foam seat
base, this design makes it difficult for caregivers to adjust the waist
straps.
48. Upon information and belief, because it is difficult to adjust
the waist straps in the Chill, parents and other caregivers are less
likely to use the harness.
49. Upon information and belief, due to difficulty of use in the
case of the Chill and ineffectiveness in the case of the other models,
parents and other caregivers are unlikely to use the harness on any of
the Subject Products.
50. Upon information and belief, even if the harness is used, the
harness may fail to prevent the infant user from moving into a
compromised position if it is not adequately tightened around the
infant.
51. These defective designs pose a risk of injury and death to
infant users.
The Subject Products Are Defective Because the Risk of Injury Occurs as
a Result of Their Operation or Use
52. A design defect may also be present if the risk of injury
occurs as a result of the operation or use of the product. 16 CFR Sec.
1115.4.
[[Page 73623]]
53. Upon information and belief, the Subject Products have been
advertised and marketed by Respondent as devices that promote a full
night's sleep for infants.
54. Upon information and belief, the risk of injury occurs as a
result of the use of the Subject Products by parents and caregivers
who, contrary to the on-product warnings, are likely to use the
product, regardless of the version, in cribs and other traditional
sleep environments in order to ensure the child's safety during a full
night's sleep.
55. Upon information and belief, the risk of injury occurs as a
result of the foreseeable use and/or misuse of the Subject Products by
parents and caregivers.
56. Upon information and belief, infants who are not adequately
restrained in the Subject Products may move into compromised positions
on the side or inside the seat well of the recliner, which can result
in injury or death.
57. Upon information and belief, when a Subject Product is used in
a crib, an infant may be able to maneuver its head over the side of the
Subject Product and become entrapped between the Subject Product and a
bumper pad of a crib or the side of a crib, which can result in injury
or death.
58. The Subject Products contain a design defect because they fail
to operate as intended and present a substantial risk of injury to the
public.
The Subject Products Are Defective Because Their Instructions and
Warnings Are Inadequate
59. A defect can occur in a product's contents, construction,
finish, packaging, warnings and/or instructions. 16 CFR Sec. 1115.4.
60. A defect can occur when reasonably foreseeable consumer use or
misuse, based in part on the lack of adequate instructions and safety
warnings, could result in injury, even where there are no reports of
injury. 16 CFR Sec. 1115.4.
61. Upon information and belief, from approximately January 2009
through July 2010, all of the Generation One and Generation Two models
had a warning label that read as follows: ``Safety guidelines to
prevent injury or death: FALL HAZARD: ALWAYS use on the floor. This
product should not be used inside a crib. NEVER place product on
countertops, tables, steps or other elevated surfaces. SUFFOCATION
HAZARD: NEVER use on soft or uneven surface (sofa, bed cushion), as
seat may tip over and cause suffocation. NEVER use with blankets,
towels, pillows, or other soft objects while child is in seat. Intended
for infants 8 pounds or 3.6 kilograms and above. NEVER leave child in
the seat when straps are loose or undone. Adjust the straps provided so
they fit snugly around the infant. NEVER move or carry unit while child
is in seat. Not intended for carrying a baby.''
62. Upon information and belief, this warning was printed in
extremely small (approximately 6-point) font on the underside of the
product, which would be placed on the floor or other surface and thus
not visible to consumers during use.
63. Upon information and belief, on or about April 17, 2010, a six-
month-old girl died when she suffocated while using a Generation Two
model of the Subject Products. Not secured in the harness, the infant
was found with her face pressed between the Nap Nanny and the crib
bumper. The medical examiner ruled the cause of death as probable
positional asphyxia.
64. Upon information and belief, on or about July 9, 2010, a four-
month-old girl died when she suffocated between a Generation Two Nap
Nanny and the bumper in her crib. Although the harness had been secured
around the infant, it failed to adequately restrain her in the seat.
She was found by her mother in the Nap Nanny, with the harness secured
but with her head tilted back and her neck hyperextended. Her face was
pressed against the bumper pad of her crib. The medical examiner ruled
the cause of death as position/compression asphyxia.
65. On July 26, 2010, the Commission and the Respondent issued a
joint press release announcing a recall of the Generation One and the
Generation Two models of the Subject Products: Baby Matters Recalls Nap
Nanny [supreg] Recliners Due to Entrapment, Suffocation and Fall
Hazards; One Infant Death Reported.
66. Upon information and belief, on or about July 26, 2010,
Respondent executed a corrective action plan in cooperation with the
U.S. Consumer Product Safety Commission. As part of this corrective
action plan, Respondent modified the warnings, instructions, and
labeling on the Generation Two products that were in Respondent's
inventory at the time and on the Subject Products imported, sold, and
distributed thereafter by Respondent.
67. Upon information and belief, as part of the corrective action,
Respondent relocated the warning label from the underside of the
Generation Two model to the front of the Generation Two model,
increased the font size of the warning, and changed the text of the
warning label to read as follows: ``ALWAYS use on floor. NEVER use in
crib. ALWAYS secure buckles on harness. NEVER use with infant under 8
pounds (3.6 kilograms). When infant can sit up, do not use for sleep.
Suffocation hazards:--Do not place inside crib, other contained areas,
or on the floor next to other vertical surfaces (e.g., walls, dresser).
An infant who leans over side can become entrapped between the product
and another object.--Never use on soft surfaces (e.g., bed, sofa,
cushion) where product can tip over and cause suffocation in soft
surfaces.--Do not add blankets, towels, or other soft objects that can
cover face. Fall hazards:--Never use on counter tops, tables or other
elevated surfaces from which infant can fall.--Never carry product with
infant in it.--ALWAYS secure infant snugly in harness or infant may
turn sideways and fall. Strangulation hazards:--Head/neck can get
caught in loosely fastened seatbelt if infant tries to get out of
product.--Head/neck can get caught in a fastened seatbelt not in use if
active infant tries to climb in and out of product unassisted.''
68. Upon information and belief, the change in warning did not
address the Subject Products that had already been purchased by
consumers or that remained in retailers' inventory.
69. Upon information and belief, for products already purchased by
consumers or those that remained in retailers' inventory, Respondent
directed retailers with Generation Two products to place a sticker on
the plastic bag covering the product.
70. Upon information and belief, the sticker directed users to a
website, www.napnanny.com/recall, which contained the revised warnings
and instructions that were part of the recall and corrective action
plan.
71. Upon information and belief, at the time of the recall,
Respondent knew of the July 9, 2010 fatality, one injury, and 21 other
incidents resulting from the failure of the harness systems on the
Generation One and the Generation Two to properly secure the infant.
72. Upon information and belief, since the Chill was first
introduced into commerce in January 2011, the warning label read as
follows: ``To avoid serious injury or death, read and follow the
warnings and instructions provided below: ALWAYS use on floor. NEVER
use in crib. ALWAYS secure buckles on harness. NEVER use with clothing
or blankets that interfere with the use of the harness. Harness must
always be snug against your child. NEVER use with infant under 8 pounds
(3.6 kilograms). When infant can sit up, do not use for sleep. For
infants who
[[Page 73624]]
cannot sit up, use for sleep, feeding and play time. ALWAYS secure
infant snugly in harness or infant may turn sideways and fall.
Suffocation hazards--Do not place inside crib, other contained areas,
or on the floor next to other vertical surfaces (e.g., walls, dresser).
An infant who leans over side can become entrapped between the product
and another object.--Never use on soft surface (e.g., bed, sofa,
cushion) where product can tip over and cause suffocation in soft
surfaces.--Do not add blankets, towels, or other soft objects that can
cover face. Fall hazards--Never use on counter tops, tables, or other
elevated surfaces from which infant can fall.--Never carry product with
infant in it.--ALWAYS secure infant snugly in harness or infant may
turn sideways and fall. Strangulation hazards--Head/neck can get caught
in loosely fastened seatbelt if infant tries to get out of product.--
Head/neck can get caught in a fastened seatbelt not in use if active
infant tries to climb in and out of product unassisted.''
73. Upon information and belief, subsequent to the July 2010
recall, and despite enhanced warnings and revised instructions on the
Subject Products, parents and caregivers continue to use the Subject
Products inside of cribs and other sleeping environments, contrary to
the warnings on the Subject Products.
74. Upon information and belief, subsequent to the July 2010
recall, and despite enhanced warnings and revised instructions on the
Subject Products, parents and caregivers continue to use the Subject
Products without using the harness or ensuring that the harness is
firmly secured around the infant.
75. Upon information and belief, since the July 2010 recall, at
least three additional fatalities of infants using the Subject Products
have been reported.
76. Upon information and belief, one of those fatalities involved
an infant sleeping in the Chill.
77. Upon information and belief, over 70 other incidents have been
reported of children nearly falling out of the Subject Products.
78. The warnings and instructions on the Subject Products are
inadequate and defective because they do not and cannot effectively
communicate to parents and caregivers the hazard associated with use of
the Subject Products inside cribs and other sleep enclosures.
79. The warnings and instructions on the Subject Products are
inadequate and defective because they do not and cannot effectively
communicate to parents and caregivers the hazard associated with the
Subject Products if the harness is not used or is not snugly secured
around the infant.
80. Because the warnings and instructions on the Subject Products
are inadequate and defective, parents will continue to use the Subject
Products in cribs or other enclosures.
81. Because the warnings and instructions on the Subject Products
are inadequate and defective, parents will not use the harness provided
or will not secure it snugly around the infant.
82. Parents and caregivers cannot and do not appreciate the hazard
associated with using the Subject Products in locations other than the
floor, and it is thus foreseeable that they will use the Subject
Products in cribs, play yards, or other enclosures. These uses can and
do result in infant death and injury.
83. Parents and caregivers cannot and do not appreciate the hazard
associated with not using the harness or not securing the harness
snugly, and it is foreseeable that they will use the Subject Products
without securing the harness or without securing it snugly around the
infant. These uses can and do result in infant death and injury.
84. The warnings on the Subject Products are inadequate and
defective because while they warn against use of the Subject Products
in a crib and advise users to secure the infant with the three point
harness, they do not convey the gravity of the consequences of non-
compliance. Specifically, the warnings and instructions do not
communicate that an infant can die if placed in a Subject Product used
in a crib or other enclosure, or if the harness is not used or
adequately secured. These uses can and do result in infant injury and
death.
85. In addition, the warnings and instructions on the Generation
Two are inadequate and defective because they do not convey the
importance of ensuring, before each use, that the VelcroTM
tabs are attached to the ``D''-shaped rings embedded in the foam seat.
The VelcroTM tabs can loosen with time and normal use of the
Generation Two, allowing a child to extend his or her head over the
side of the product or to fall down inside the well of the seat. It is
not obvious to caregivers when these rings become loosened or
unattached.
86. The effectiveness of the warnings on the Subject Products is
further diminished by the advertising and marketing of the Subject
Products.
87. Upon information and belief, in 2009 and thereafter, Respondent
advertised the Subject Products as sleep products.
88. Upon information and belief, the advertisements encouraged
consumers to use them for unattended, overnight sleep, advancing the
tagline, ``Everybody Sleeps!''
89. Upon information and belief, Respondent's advertisements
further encouraged consumers to use the Subject Products as a
traditional sleep environment, contending that the product is, ``Better
than a bassinet, more effective than a wedge.''
90. Upon information and belief, Respondent's advertisements also
promoted the Subject Products as a safe environment for infant sleep,
by characterizing the Subject Products as, ``The only portable infant
recliner designed for sleep, play--and peace of mind.''
91. Upon information and belief, advertising for the Chill promotes
the Chill as having ``a 3-point safety harness anchored to the foam--no
D-rings or loose cover to worry about--a contoured bucket for maximum
containment and a large foam base for total stability.''
92. Upon information and belief, that advertisement suggests that
the Chill is safer than the Generation Two.
93. Upon information and belief, Respondent's retail partners
advertised and marketed the Subject Products as a solution for babies
with gastro-esophageal reflux disease that have difficulty sleeping
comfortably on flat surfaces. Respondents knew or should have known
that its retail partners advertised and marketed the Subject Products
in this manner.
94. The advertising and marketing of the Subject Products conflict
with the current warnings and instructions that the Subject Products
should not be used for unattended overnight sleep.
95. The advertising and marketing of the Subject Products conflict
with the current warnings and instructions that the Subject Products
not be used if the infant can sit up unaided.
96. Because the advertising and marketing of the Subject Products
conflict with the weight, age, and usage restrictions described on the
label, the effectiveness of the warning label is diminished.
97. Even if the warnings and instructions on the Subject Products
were enhanced, and the attendant advertising were changed, it is
foreseeable that parents and caregivers would continue to use the
products in cribs, bassinettes, and other sleep environments.
98. Parents and caregivers are likely to continue to use the
Subject Products in enclosed spaces such as cribs in order to create a
barrier to older siblings, pets, or pests in the home.
99. Parents and caregivers are likely to continue to use the
Subject Products in
[[Page 73625]]
cribs because cribs are traditionally viewed as safe sleeping
environments.
100. Because of the lack of adequate instructions and safety
warnings, a substantial risk of death and injury occurs as a result of
the foreseeable use and misuse of the Subject Products.
The Type of the Risk of Injury Renders the Subject Products Defective
101. The risk of injury associated with a product may render the
product defective. 16 CFR Sec. 1115.4.
102. The nature of the risk of injury includes death if a child
becomes trapped between the side of the Subject Products and the bumper
pad or the side of a crib.
103. The nature of the risk of injury also includes death if a
child is not restrained in the seat of the Subject Products and
suffocates on the interior wall or well of the seat.
104. Infants, a vulnerable population protected by the CPSA and
FHSA, are exposed to risk of injury by the Subject Products.
105. The risk of injury associated with use of the Subject Products
in a crib is neither obvious nor intuitive.
106. The risk of injury associated with use of the Subject Products
without the harness or without tightly securing the harness is neither
obvious nor intuitive.
107. Warnings and instructions cannot adequately mitigate the risk
of injury and death associated with use of the Subject Products.
108. Because Respondent promoted the use of the Subject Products
for unsupervised, overnight sleep, use of the Subject Products in a
crib or other enclosed areas is foreseeable.
109. Use of the Subject Products without securing the harness
around the infant is foreseeable.
110. The type of the risk of injury renders the Subject Products
defective.
The Subject Products Create a Substantial Risk of Injury to the Public
111. The Subject Products pose a risk of injury or death to infants
who may, consistent with developmentally appropriate behavior, maneuver
to compromised positions either within Subject Products or partially
outside Subject Products used in cribs.
112. Therefore, because the Subject Products are defective and
create a substantial risk of injury, the Subject Products present a
substantial product hazard within the meaning of Section 15(a)(2) of
the CPSA, 15 U.S.C. 2064(a)(2).
Count 2
The Subject Products Are Intended for Use by Children and Contain
Defects Which Create a Substantial Risk of Injury to Children Under
Section 15(c)(1) of the FHSA
113. Paragraphs 1 through 112 are hereby realleged and incorporated
by reference as though fully set forth herein.
114. Upon information and belief, the Subject Products are an
article intended for use by children as young as newborns. Respondent
has marketed, and continues to promote, the Subject Products as
appropriate for use by infants weighing eight pounds or more until the
infant can sit up unassisted.
115. The Subject Products contain a design defect that is present
in all models of the Subject Products.
116. The harness designs in the Generation One and the Generation
Two are defective because each design fails to adequately restrain the
infant user.
117. The harness design in the Generation Two is also defective
because the ``D''-shaped ring in the foam base must be secured after
the cover is changed, and can also become loose with regular use of the
product. Caregivers are not informed adequately of the importance of
securing the harness straps to the ``D''-shaped rings embedded in the
foam seat base and may use the product without securing the ``D''-
shaped rings or ensuring that they are adequately tightened before each
use.
118. The harness design in the Chill is defective because the
double-threaded buckles inhibit a caregiver's ability to secure the
harness around the infant user, thereby reducing the effectiveness of
the harness and the likelihood of use of the harness by the caregiver.
119. Upon information and belief, Respondent has distributed over
150,000 Subject Products into U.S. commerce and the Chill continues to
be available for purchase through Respondent's retail partners.
120. Upon information and belief, the severity of the risk
associated with use of all of the Subject Products is extremely high,
as five infants have died while using the Subject Products.
121. The Subject Products contain a defect, which creates a
substantial risk of injury to children because of the pattern of
defect, the number of such defective articles distributed in commerce
and the severity of the risk within the meaning of Section 15(c)(1) of
the FHSA, 15 U.S.C. Sec. 1274(c)(1).
Relief Sought
Wherefore, in the public interest, Complaint Counsel requests that
the Commission:
A. Determine that the Subject Products present a ``substantial
product hazard'' within the meaning of Section 15(a)(2) of the CPSA, 15
U.S.C. 2064(a)(2), and/or present a ``substantial product hazard''
within the meaning of Section 15(a)(1) of the CPSA, 15 U.S.C.
2064(a)(1).
B. Determine that the Subject Products contain a defect, which
creates a substantial risk of injury to children because of the pattern
of defect, the number of such articles distributed in commerce, the
severity of the risk, or otherwise, within the meaning of Section
15(c)(1) of the FHSA, 15 U.S.C. 1274(c)(1).
C. Determine that extensive and effective public notification under
Section 15(c) of the CPSA, 15 U.S.C. 2064(c), is required to protect
the public and children adequately from the substantial product hazard
presented by the Subject Products, and order Respondent under Section
15(c) of the CPSA, 15 U.S.C. 2064(c) to:
(1) Cease any remaining distribution of the product to other
distributors, wholesalers or retailers;
(2) Notify all persons that transport, store, distribute or
otherwise handle the Subject Products, or to whom such products have
been transported, sold, distributed or otherwise handled, to
immediately cease distribution of the Subject Products;
(3) Notify appropriate state and local public health officials;
(4) Give prompt public notice of the defects in the Subject
Products, including the incidents and injuries associated with use of
the Subject Products including posting clear and conspicuous notice on
Respondent's Web site, and providing notice to any third party Web site
on which Respondent has placed the Subject Products for sale, and
provide further announcements in languages other than English and on
radio and television;
(5) Mail notice to each distributor or retailer of the Subject
Products; and
(6) Mail notice to every person to whom the Subject Products were
delivered or sold;
D. Determine that extensive and effective public notification under
Section 15(c)(1)(A) of the FHSA, 15 U.S.C. 1274(c)(1), is required to
protect the public and children adequately from the substantial product
hazard presented by the Subject Products, and order Respondent under
Section 15(c) of the FHSA, 15 U.S.C. 1274(c)(1)(A) to:
[[Page 73626]]
(1) To give public notice that such defective toy or article
contains a defect which creates a substantial risk of injury to
children;
(2) To mail such notice to each person who is a manufacturer,
distributor, or dealer of such toy or article; and
(3) To mail such notice to every person to whom the person giving
notice knows such toy or article was delivered or sold.
E. Determine that action under Section 15(d) of the CPSA, 15 U.S.C.
2064(d) and Section 15(c)(2) of the FHSA, 15 U.S.C. 1274(c)(2), is in
the public interest and additionally order Respondent to:
(1) Refund consumers the purchase price of the Subject Products;
(2) Make no charge to consumers and to reimburse consumers for any
reasonable and foreseeable expenses incurred in availing themselves of
any remedy provided under any Commission Order issued in this matter,
as provided by Section 15 U.S.C. 2064(e)(1) of the CPSA and Section 15
U.S.C. 1274(d)(1) of the FHSA;
(3) Reimburse retailers for expenses in connection with carrying
out any Commission Order issued in this matter, including the costs of
returns, refunds and/or replacements, as provided by Section 15(e)(2)
of the CPSA, 15 U.S.C. 2064(e)(2) and Section 15(d)(2) of the FHSA, 15
U.S.C. 1274(d)(2);
(4) Submit a corrective action program satisfactory to the
Commission, within ten (10) days of service of the Final Order,
directing that actions specified in Paragraphs C(1) through (6) and
D(1) through (3) above be taken in a timely manner;
(5) To submit monthly reports, in a format satisfactory to the
Commission, documenting the progress of the corrective action program;
(6) For a period of five (5) years after issuance of the Final
Order in this matter, to keep records of its actions taken to comply
with Paragraphs C(1) through (6) and D(1) through (3) above, and supply
these records to the Commission for the purpose of monitoring
compliance with the Final Order; and
(7) For a period of five (5) years after issuance of the Final
Order in this matter, to notify the Commission at least sixty (60) days
prior to any change in its business (such as incorporation,
dissolution, assignment, sale, or petition for bankruptcy) that results
in, or is intended to result in, the emergence of a successor
corporation, going out of business, or any other change that might
affect compliance obligations under a Final Order issued by the
Commission in this matter.
F. Order that Respondent shall take other and further actions as
the Commission deems necessary to protect the public health and safety
and to comply with the CPSA and FHSA.
Issued By Order of the Commission:
Dated this -- day of December, 2012.
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BY: Marc Schoem
Acting Assistant Executive Director for Compliance and Field Operations
U.S. Consumer Product Safety Commission, Bethesda, MD 20814, Tel: (301)
504-7520.
Mary B. Murphy, Assistant General Counsel, Division of Compliance,
Office of General Counsel, U.S. Consumer Product Safety Commission,
Bethesda, MD 20814, Tel: (301) 504-7809.
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Kelly Moore, Trial Attorney, Complaint Counsel, Division of Compliance,
Office of the General Counsel, U.S. Consumer Product Safety Commission,
Bethesda, MD 20814, Tel: (301) 504-7447.
Certificate of Service
I hereby certify that on December --, 2012, I served the foregoing
Complaint and List of Summary and Documentary Evidence upon all parties
of record in these proceedings by hand-delivering and mailing,
certified mail, postage prepaid, a copy to each at their principal
place of business, and courtesy copy to counsel, as follows:
Baby Matters LLC, 531 Winston Way, Berwyn, PA 19312.
Raymond G. Mullady, Jr., BLANK ROME LLP, Watergate, 600 New Hampshire
Avenue NW., Washington, DC 20037, Counsel for Baby Matters LLC.
Mary B. Murphy, Complaint Counsel for U.S. Consumer Product Safety
Commission.
[FR Doc. 2012-29760 Filed 12-10-12; 8:45 am]
BILLING CODE 6355-01-P