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`Case 2:22-cv-00624 Document 1 Filed 05/09/22 Page 1 of 37
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`UNITED STATES DISTRICT COURT
`WESTERN DISTRICT OF WASHINGTON
`AT SEATTLE
`
`
`JESSICA ABIGAIL LEAK, and BRIAN
`JEROME CUNNINGHAM, Individually
`and as next of friends of L. J. C., a minor,
`
`
`Plaintiffs,
`
`v.
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`
`
`
`ABBOTT LABORATORIES, INC.,
`
`
`Defendant.
`
`
`No.
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`COMPLAINT FOR A CIVIL CASE
`
`JURY TRIAL REQUESTED
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`
`
`
`
`
`COME NOW, Plaintiffs, JESSICA ABIGAIL LEAK, and BRIAN JEROME
`
`CUNNINGHAM, Individually and as parent of L. J. C., a minor, by and through the
`
`undersigned counsel, for causes of action against the above-named Defendant, and hereby
`
`allege as follows:
`
`Plaintiffs
`
`I. PARTIES
`
`1.
`
`Plaintiffs, JESSICA ABIGAIL LEAK, the mother of L.J.C. (hereinafter
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`“Mother” or collectively as “Plaintiffs”), and BRIAN JEROME CUNNINGHAM, the father
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`
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`COMPLAINT FOR A CIVIL CASE − 1
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`S C H R O E T E R , G O L D M A R K & B E N D E R
`401 Union Street ● Suite 3400 ● Seattle, WA 98101
`Phone (206) 622-8000 ● Fax (206) 682-2305
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`Case 2:22-cv-00624 Document 1 Filed 05/09/22 Page 2 of 37
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`of L.J.C., a minor, (hereinafter “Father” or collectively as “Plaintiffs”), are citizens of the
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`State of Washington, and reside in Edmonds in Snohomish County, Washington.
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`2.
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`Plaintiff L.J.C. was born prematurely at Swedish Medical Center – First Hill
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`Campus in Seattle, Washington (hereinafter “Swedish Medical”) on
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` 2012. L.J.C.
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`developed necrotizing enterocolitis (hereinafter “NEC”) after being fed Similac Special Care
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`Advance 20 calorie, 22 calorie, and 24 calorie Defendant’s cow’s milk-based products
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`(hereinafter “Cow’s Milk-Based Formula,” “Cow’s Milk-Based Fortifier,” or collectively
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`“Cow’s Milk-Based Products”) while in the newborn intensive care unit (hereinafter
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`“NICU”) at Swedish Medical. At all times material hereto, L.J.C. is a resident a citizen of the
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`State of Washington and resides with her parents in Edmonds in Snohomish County,
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`Washington.
`
`Defendant
`
`3.
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`Defendant, ABBOTT LABORATORIES, INC. (hereinafter “Abbott” or
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`“Defendant”) was at all times material hereto and is now a corporation duly organized, and
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`existing under the laws of the State of Illinois, with its principal place of business and
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`headquarters located at 100 Abbott Park Road, Abbott Park, IL 60064-350 and is thus a
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`resident, citizen, and domiciliary of the State of Illinois. Abbott may be served via its
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`registered agent at:
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`CT Corporation System
`711 Capitol Way S., Suite 204
`Olympia, WA 98501-1267
`
`
`4.
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`Abbott manufactures, designs,
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`formulates, prepares,
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`tests, provides
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`instructions for, markets, labels, packages, sells, and/or places into the stream of commerce
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`in all fifty (50) states, including the State of Washington, and sells premature infant formula
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`
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`COMPLAINT FOR A CIVIL CASE − 2
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`S C H R O E T E R , G O L D M A R K & B E N D E R
`401 Union Street ● Suite 3400 ● Seattle, WA 98101
`Phone (206) 622-8000 ● Fax (206) 682-2305
`
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`Case 2:22-cv-00624 Document 1 Filed 05/09/22 Page 3 of 37
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`products including but not limited to Similac Sensitive, Similac NeoSure, and Similac
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`Special Care Advance 20 calorie, 22 calorie, and 24 calorie.
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`II. JURISDICTION AND VENUE
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`
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`5.
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`This Court has jurisdiction over Defendant and this action pursuant to
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`28 U.S.C. § 1332 because the amount in controversy exceeds $75,000, exclusive of interest
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`and costs and, because there is complete diversity of citizenship between Plaintiffs and
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`Defendant.
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`
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`6.
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`Venue is proper in this Court pursuant to 28 U.S.C. § 1391; at all times
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`material, plaintiff was a resident of Washington State and Defendants at all times material
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`transacted business in Washington selling, marketing, and/or distributing Cow’s Milk-Based
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`Products.
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`III. STATEMENT OF FACTS
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`The Science and Scope of the Problems
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`7.
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`According to the World Health Organization (“WHO”), babies born
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`prematurely, or “preterm,” are defined as being born alive before 37 weeks of pregnancy are
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`completed. L.J.C. was born prematurely at 32.5 weeks. The WHO estimates that
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`approximately 15 million babies are born preterm every year and that this number is rising.
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`8.
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`Nutrition for preterm babies, especially those who have a very low birth
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`weight (under 1500 grams) or extremely low birth weight (under 1000 grams), is critical.
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`Since the United States ranks in the top ten countries in the world with the greatest number of
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`preterm births, the market of infant formula and fortifiers is particularly vibrant.
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`9.
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`Science and research have advanced in recent years confirming strong links
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`between cow’s milk-based products and NEC causing and/or substantially contributing to
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`
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`COMPLAINT FOR A CIVIL CASE − 3
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`S C H R O E T E R , G O L D M A R K & B E N D E R
`401 Union Street ● Suite 3400 ● Seattle, WA 98101
`Phone (206) 622-8000 ● Fax (206) 682-2305
`
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`Case 2:22-cv-00624 Document 1 Filed 05/09/22 Page 4 of 37
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`death in preterm and severely preterm, low-weight infants, along with many other health
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`complications and long-term risks to these babies. Additionally, advances in science have
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`created alternative fortifiers that are derived from human milk and non-cow’s milk-based
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`products. However, the manufacturers of the Cow’s Milk-Based Products continue to
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`promote and sell the Cow’s Milk-Based Product versions.
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`10.
`
`To illustrate the danger posed to preterm infants, this image below is a
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`diagram of the normal layers of the baby’s intestinal wall1:
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`
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`
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`1
`All of the medical illustrations are provided to assist the Court in understanding this devastating
`disease and are subject to a copyright by MediVisuals, Inc. As such, they cannot be reproduced, reprinted, or
`used without permission of the copyright holder.
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`
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`COMPLAINT FOR A CIVIL CASE − 4
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`S C H R O E T E R , G O L D M A R K & B E N D E R
`401 Union Street ● Suite 3400 ● Seattle, WA 98101
`Phone (206) 622-8000 ● Fax (206) 682-2305
`
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`Case 2:22-cv-00624 Document 1 Filed 05/09/22 Page 5 of 37
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`11.
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`Normal absorption in the small intestine looks like the diagram below. The
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`cells lining the lumen of the intestines have microvilli that magnify the surface area available
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`for uptake. Nutrients, which are color-coded in light blue, are absorbed by these cells, then
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`transported through the cells, and released where they are then transported to the rest of the
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`body through the bloodstream and lymphatic system. The cells keep out the bacteria and
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`toxins that are present in the intestines which would be harmful if absorbed into the other
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`tissues of the body. The tight junctions between each cell play a major role in preventing the
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`bacteria and toxins from entering the body.
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`12.
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`The diagram below shows how the absorption is significantly altered
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`following the intake of Cow’s Milk-Based Products:
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`COMPLAINT FOR A CIVIL CASE − 5
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`
`S C H R O E T E R , G O L D M A R K & B E N D E R
`401 Union Street ● Suite 3400 ● Seattle, WA 98101
`Phone (206) 622-8000 ● Fax (206) 682-2305
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`Case 2:22-cv-00624 Document 1 Filed 05/09/22 Page 6 of 37
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`Specifically, this figure demonstrates what the breakdown of the tight junctions looks like
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`after a preterm baby ingests the Cow’s Milk-Based Products. As a result, the harmful bacteria
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`and toxins are able to enter the baby’s bloodstream and lymphatics, which induces an
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`inflammatory response (not pictured) in the baby’s intestinal walls.
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`13.
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`The figure below demonstrates the intestinal veins and lymphatics that
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`transport the harmful bacteria and toxins that have entered the baby’s intestinal wall
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`following the ingestion of the Cow’s Milk-Based Products.
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`COMPLAINT FOR A CIVIL CASE − 6
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`S C H R O E T E R , G O L D M A R K & B E N D E R
`401 Union Street ● Suite 3400 ● Seattle, WA 98101
`Phone (206) 622-8000 ● Fax (206) 682-2305
`
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`Case 2:22-cv-00624 Document 1 Filed 05/09/22 Page 7 of 37
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`14.
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`The image above is a simplified view of the major organs of the baby’s chest
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`and abdomen, as well as her circulatory system. The box at the top shows a magnified view
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`of the normal functioning of small blood vessels and capillaries of the tissues throughout the
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`body. As shown, tight intercellular junctions lining the capillaries prevent plasma from
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`escaping into the surrounding tissues. By contrast, the baby depicted to the right is in distress,
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`COMPLAINT FOR A CIVIL CASE − 7
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`S C H R O E T E R , G O L D M A R K & B E N D E R
`401 Union Street ● Suite 3400 ● Seattle, WA 98101
`Phone (206) 622-8000 ● Fax (206) 682-2305
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`Case 2:22-cv-00624 Document 1 Filed 05/09/22 Page 8 of 37
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`as is illustrated by her capillary bed where bacteria and toxins (shown in green) were
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`transported from the intestines and spread to the rest of her body. These toxins further
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`breakdown and weaken the tight, intercellular junctions, and as a result, bacteria, toxins, and
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`plasma escape into the surrounding interstitial spaces resulting in a condition known as
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`“third-spacing,” and sepsis.
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`15.
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`This harmful process is further illustrated in the series of images below. This
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`process all begins with the administration of Cow’s Milk-Based Products and as shown in the
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`illustration, can lead to sepsis, multi-system organ failure, surgery to remove necrosed
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`intestine, developmental injuries in later life, including death.
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`S C H R O E T E R , G O L D M A R K & B E N D E R
`401 Union Street ● Suite 3400 ● Seattle, WA 98101
`Phone (206) 622-8000 ● Fax (206) 682-2305
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`COMPLAINT FOR A CIVIL CASE − 8
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`Case 2:22-cv-00624 Document 1 Filed 05/09/22 Page 9 of 37
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`16.
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`This chart below illustrates many of the classic signs and symptoms of NEC
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`experienced by these vulnerable preterm babies after ingesting Cow’s Milk-Based Products.
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`
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`17.
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`As far back as 1990, a prospective, multicenter study on 926 preterm infants
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`
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`found that NEC was six to ten times more common in exclusively formula-fed babies than
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`in those fed breast milk alone and three times more common than in those who received
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`formula plus breast milk. Studies of babies born at more than 30 weeks gestation confirmed
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`that NEC was rare in those whose diet included breast milk, but it was 20 times more
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`common in those fed formula only. A. Lucas, T. Cole, Breast Milk and Neonatal Necrotizing
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`Enterocolitis, LANCET, 336: 1519-1523 (1990)
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`18.
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`A study published in 2009 evaluated the health benefits of an exclusively
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`human milk-based diet as compared to a diet with both human milk and cow’s milk-based
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`COMPLAINT FOR A CIVIL CASE − 9
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`S C H R O E T E R , G O L D M A R K & B E N D E R
`401 Union Street ● Suite 3400 ● Seattle, WA 98101
`Phone (206) 622-8000 ● Fax (206) 682-2305
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`Case 2:22-cv-00624 Document 1 Filed 05/09/22 Page 10 of 37
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`products in extremely premature infants. The results show that preterm babies fed an
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`exclusively human milk-based diet were 90% less likely to develop surgical NEC as
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`compared to a diet that included some cow’s milk-based products. S. Sullivan, et al, An
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`Exclusively Human Milk-Based Diet Is Associated with a Lower Rate of Necrotizing
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`Enterocolitis than a Diet of Human Milk and Bovine Milk-Based Products, JOURNAL OF
`
`PEDIATRICS, 156: 562-7 (2010).
`
`19.
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`In 2011, the U.S. Surgeon General published a report titled, “The Surgeon
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`General's Call to Action to Support Breastfeeding.” In it, the Surgeon General warned that
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`“for vulnerable premature infants, formula feeding is associated with higher rates of
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`necrotizing enterocolitis (NEC)." U.S. Dep’t of Health & Human Serv., Off. of Surgeon
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`Gen., “The Surgeon General's Call to Action to Support Breastfeeding,” p.1, (2011)
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`(emphasis added). This same report stated that premature infants who are not breastfed are
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`138% more likely to develop NEC. Id. at Table 1.
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`20.
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`In 2012, the American Academy of Pediatrics issued a policy statement that
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`all premature infants should be fed an exclusive human milk diet because of the risk of NEC
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`associated with the consumption of Cow’s Milk-Based Products. The Academy stated that
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`"[t]he potent benefits of human milk are such that all preterm infants should receive human
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`milk... If the mother's own milk is unavailable ...pasteurized donor milk should be used.''
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`Breastfeeding and the Use of Human Milk, PEDIATRICS, 129:e827-e84l (2012).
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`21.
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`Further, a study published in 2013 showed that all 104 premature infants
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`participating in the study receiving an exclusive human-milk based diet exceeded targeted
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`growth standards and length and weight and head circumference gain. The authors concluded
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`that "this study provides data showing that infants can achieve and mostly exceed targeted
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`COMPLAINT FOR A CIVIL CASE − 10
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`S C H R O E T E R , G O L D M A R K & B E N D E R
`401 Union Street ● Suite 3400 ● Seattle, WA 98101
`Phone (206) 622-8000 ● Fax (206) 682-2305
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`Case 2:22-cv-00624 Document 1 Filed 05/09/22 Page 11 of 37
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`growth standards when receiving an exclusive human milk-based diet." A. Hair, et al,
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`Human Milk Feeding Supports Adequate Growth in Infants ≤1250 Grams Birthweight, BMC
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`RESEARCH NOTES, 6:459 (2013) (emphasis added). Thus, preventing or countering
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`inadequate growth was proven to be a poor excuse for feeding preterm infants Cow’s Milk-
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`Based Formula, but the practice has largely continued due to extensive and aggressive
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`marketing campaigns conducted by infant formula makers such as the Defendant.
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`22.
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`Another study published in 2013 reported the first randomized trial in
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`extremely premature infants of exclusive human milk versus preterm cow’s milk-based
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`formula. The study found a significantly higher rate of surgical NEC in infants receiving
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`the cow’s milk-based preterm formula and supported the use of exclusive human milk diet to
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`nourish extremely preterm infants in the NICU (Newborn Intensive Care Unit). E.A.
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`Cristofalo, et al, Randomized Trial in Extremely Preterm Infants, J PEDIATR., 163(6):1592-
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`1595 (2013).
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`23.
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`In another study published in 2014, it was reported that NEC is “a devastating
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`disease of premature infants and is associated with significant morbidity and mortality.
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`While the pathogenesis of NEC remains incompletely understood, it is well established that
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`the risk is increased by the administration of infant formula and decreased by the
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`administration of breast milk." Misty Good, et al., Evidence Based Feeding Strategies Before
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`and After the Development of Necrotizing Enterocolitis, EXPERT REV. CLIN. IMMUNOL.,
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`10(7): 875-884 (2014 July) (emphasis added). The same study found that NEC “is the most
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`frequent and lethal gastrointestinal disorder affecting preterm infants and is characterized
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`by intestinal barrier disruption leading to intestinal necrosis, multi-system organ failure and
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`death.” Id. (emphasis added). The study noted that “NEC affects 7-12% of preterm infants
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`COMPLAINT FOR A CIVIL CASE − 11
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`S C H R O E T E R , G O L D M A R K & B E N D E R
`401 Union Street ● Suite 3400 ● Seattle, WA 98101
`Phone (206) 622-8000 ● Fax (206) 682-2305
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`Case 2:22-cv-00624 Document 1 Filed 05/09/22 Page 12 of 37
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`weighing less than 1500 grams, and the frequency of disease appears to be either stable or
`
`rising in several studies. The typical patient who develops NEC is a premature infant who
`
`displays a rapid progression from mild feeding intolerance to systemic sepsis, and up to 30%
`
`of infants will die from this disease.” Id. (emphasis added). Advances in formula
`
`development have made it possible to prevent necrotizing enterocolitis, and the “exclusive
`
`use of human breast milk is recommended for all preterm infants and is associated with a
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`significant decrease in the incidence of NEC.” Id.
`
`24.
`
`In yet another study published in 2014 it was reported that an exclusive
`
`human milk diet, devoid of Cow’s Milk-Based Products, was associated with “lower
`
`mortality and morbidity” in extremely preterm infants without compromising growth and
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`should be considered as an approach to nutritional care of these infants. Steven Abrams, et
`
`al., Greater Mortality and Morbidity in Extremely Preterm Infants Fed a Diet Containing
`
`Cow Milk Protein Products, BREASTFEEDING MEDICINE, 9(6):281-286 (2014).
`
`25.
`
`In 2016, a large study supported previous findings that an exclusive human
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`milk diet in extreme preterm infants dramatically decreased the incidence of both medical
`
`and surgical NEC. This was the first study to compare rates of NEC after a feeding protocol
`
`implementation at multiple institutions and years of follow-up using an exclusive human
`
`milk diet. The authors concluded that the use of an exclusive human milk diet is associated
`
`with “significant benefits” for extremely preterm infants and while evaluating the benefits
`
`of using an exclusive human milk-based protocol, “it appears that there were no feeding-
`
`related adverse outcomes.” Hair, et al, Beyond Necrotizing Enterocolitis Prevention:
`
`Improving Outcomes with an Exclusive Human Milk Based Diet, BREASTFEEDING MEDICINE,
`
`11-2 (2016) (emphasis added).
`
`
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`COMPLAINT FOR A CIVIL CASE − 12
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`S C H R O E T E R , G O L D M A R K & B E N D E R
`401 Union Street ● Suite 3400 ● Seattle, WA 98101
`Phone (206) 622-8000 ● Fax (206) 682-2305
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`Case 2:22-cv-00624 Document 1 Filed 05/09/22 Page 13 of 37
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`26.
`
`A publication by the American Society for Nutrition, in 2017, noted that
`
`human milk has “been acknowledged as the best source of nutrition for preterm infants and
`
`those at risk for NEC.” The study compared the results from two randomized clinical trials
`
`on preterm infants with severely low weight (between 500 and 1250 grams at birth) and
`
`compared the effect of cow’s milk-based preterm infant formula to human milk as to the rate
`
`of NEC. Both trials found that an exclusive human milk diet resulted in a much lower
`
`incidence of NEC. While the study noted that cow’s milk-based preterm formulas provided
`
`consistent calories and were less expensive than human milk-based products, the cow’s milk-
`
`based products significantly increase the risk of NEC and death. The study also noted the
`
`“exponential” health care costs associated with NEC and noted data from the U.S. from
`
`2011-2012 that showed that the cost of NEC is $180,000 to $198,000 per infant and nearly
`
`doubles to $313,000 per infant for surgically treated NEC. Further, NEC survivors accrue
`
`substantially higher outpatient costs. Jocelyn Shulhan, et al, Current Knowledge of
`
`Necrotizing Enterocolitis in Preterm Infants and the Impact of Different Types of Enteral
`
`Nutrition Products, ASN ADV. NUTR., 8(1):80-91 (2017).
`
`27.
`
`The WHO and United Nation’s International Children’s Emergency Fund
`
`(UNICEF) held a meeting more than two decades ago to address concerns over the marketing
`
`of breast-milk substitutes. The WHO Director concluded the meeting with the following
`
`statement, “In my opinion, the campaign against bottle-feed advertising is unbelievably
`
`more important than the fight against smoking advertisement.” Jules Law, The Politics
`
`of Breastfeeding: Assessing Risk, Dividing Labor, JSTOR SIGNS, vol. 25, no. 2: 407-50
`
`(2000) (emphasis added).
`
`
`
`COMPLAINT FOR A CIVIL CASE − 13
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`
`
`
`
`
`
`
`S C H R O E T E R , G O L D M A R K & B E N D E R
`401 Union Street ● Suite 3400 ● Seattle, WA 98101
`Phone (206) 622-8000 ● Fax (206) 682-2305
`
`
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`Case 2:22-cv-00624 Document 1 Filed 05/09/22 Page 14 of 37
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`28.
`
`Recognizing the abuses and dangers of the marketing of infant formula, in
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`1981, the World Health Assembly (“WHA”), the decision-making body of the world's
`
`Member States, developed the International Code of Marketing of Breast-milk Substitutes
`
`(“the Code”), which required companies to acknowledge the superiority of breast milk and
`
`outlawed any advertising or promotion of breast milk substitutes to the general public.
`
`Pursuant to Article 5.1 of the Code, advertising of breast-milk substitutes is specifically
`
`prohibited: “There should be no advertising or other form of promotion to the general
`
`public [of breast milk substitutes].” (emphasis added). In Article 5.2, the Code states that
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`“manufacturers and distributors should not provide, directly or indirectly, to pregnant
`
`women, mothers or members of their families, samples of products within the scope of this
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`Code.” In addition, the Code expressly prohibits, “point-of-sale advertising, giving of
`
`samples, or any other promotion device to induce sales directly to the consumer at the retail
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`level, such as special displays, discount coupons, premiums, special sales…” See Int’l Code
`
`of Marketing of Breast-Milk Substitutes, May 21, 1981, WHA 34/1981/REC/2, Art.5.3
`
`(emphasis added).
`
`29.
`
`The World Health Organization’s 2018 Status Report on this issue noted that
`
`“despite ample evidence of the benefits of exclusive and continued breastfeeding for
`
`children, women, and society, far too few children are breastfed as recommended.” The
`
`Status Report states that “a major factor undermining efforts to improve breastfeeding
`
`rates is continued and aggressive marketing of breast-milk substitutes,” noting that in
`
`2014, the global sales of breast-milk substitutes amounted to US $44.8 billion and “is
`
`expected to rise to US $70.6 billion by 2019.” Marketing of Breast-milk Substitutes: Nat’l
`
`
`
`COMPLAINT FOR A CIVIL CASE − 14
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`
`
`
`
`
`
`
`S C H R O E T E R , G O L D M A R K & B E N D E R
`401 Union Street ● Suite 3400 ● Seattle, WA 98101
`Phone (206) 622-8000 ● Fax (206) 682-2305
`
`
`

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`Case 2:22-cv-00624 Document 1 Filed 05/09/22 Page 15 of 37
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`Implementation of the Int’l Code, Status Report 2018. Geneva: World Health Org., 2018,
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`p.21 (emphasis added).
`
`30.
`
`Recognizing a shift in the medical community towards an exclusive human-
`
`based diet for preterm infants, the Defendant began heavily promoting “human milk
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`fortifiers,” a name which misleadingly suggests that the product is derived from human milk,
`
`instead of being derived from Cow’s Milk.
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`COMPLAINT FOR A CIVIL CASE − 15
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`S C H R O E T E R , G O L D M A R K & B E N D E R
`401 Union Street ● Suite 3400 ● Seattle, WA 98101
`Phone (206) 622-8000 ● Fax (206) 682-2305
`
`
`

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`Case 2:22-cv-00624 Document 1 Filed 05/09/22 Page 16 of 37
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`31.
`
`The Defendant has separately designed competing, systematic, powerful, and
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`misleading marketing campaigns to persuade physicians and parents to believe that:
`
`(1) Cow’s Milk-based formula and fortifiers are safe; (2) Cow’s Milk-Based Products are
`
`equal, or even superior, substitutes to breastmilk; and (3) physicians consider their Cow’s
`
`Milk-Based Products a first choice. Similarly, the Defendant markets its products for preterm
`
`infants as necessary for growth, and are perfectly safe for preterm infants, despite knowing of
`
`the extreme risks posed by Cow’s Milk-Based Products and failing to warn of the deadly
`
`disease of NEC and other serious injuries, including the risk of death.
`
`32.
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`Thus, despite the existence of alternative and safe human milk-based formulas
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`and fortifiers, Defendant continues to market and/or sell the Cow’s Milk-Based Products
`
`under the guise of being a safe product for their newborns and despite knowing the
`
`significant health risk posed by ingesting these products, especially to preterm, low weight
`
`infants, like L.J.C.
`
`The Inadequate Warnings
`
`33.
`
`Defendant promotes the use of its preterm infant Cow’s Milk-Based Products
`
`to parents, physicians, hospitals, and medical providers as safe products that are specifically
`
`needed by preterm infants for adequate growth.
`
`34.
`
`Despite the knowledge of the significant health risks posed to preterm infants
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`ingesting the Cow’s Milk-Based Products, including the significant risk of NEC,
`
`developmental injuries in later life, and death, Defendant did not warn parents or medical
`
`providers of the risk of NEC, nor did Defendant provide any instructions or guidance on how
`
`to properly use its Cow’s Milk-Based Products so as to lower the risk or avoid NEC or other
`
`serious injuries, including death.
`
`
`
`COMPLAINT FOR A CIVIL CASE − 16
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`S C H R O E T E R , G O L D M A R K & B E N D E R
`401 Union Street ● Suite 3400 ● Seattle, WA 98101
`Phone (206) 622-8000 ● Fax (206) 682-2305
`
`
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`Case 2:22-cv-00624 Document 1 Filed 05/09/22 Page 17 of 37
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`35.
`
`In fact, the Defendant does not provide any warning in its labeling, websites,
`
`or marketing of these products that discusses the risk of NEC or serious bodily injury,
`
`including death, with use in preterm infants.
`
`36.
`
`Defendant’s Similac products contained only the following packaging
`
`information guidelines, instructions, and warnings:
`
`“Similac Special Care 20 – Precautions:
`
`
`•
`
`•
`
`•
`
`•
`
`•
`
`•
`
`particularly
`are
`infants
`low-birth-weight
`Very
`susceptible to gastrointestinal complications; therefore,
`feeding should be initiated cautiously.
`
`Tolerance to enteral feedings should be confirmed by
`initially offering small volumes of formula followed by
`cautious progression to higher caloric feedings.
`
`Spitting up, abdominal distention, abnormal stools or
`stool patterns, excessive gastric residuals, or other signs
`of intestinal dysfunction have been associated with
`enteral feeding before the intestinal tract is ready to
`accommodate the regimen. At the first sign of these
`problems, enteral
`feeding should be slowed or
`discontinued.
`
`infants are particularly
`low-birth weight
`Very
`susceptible to gastrointestinal complications; therefore,
`feeding should be initiated cautiously.
`
`Tolerance to enteral feedings should be confirmed by
`initially offering small volumes of formula followed by
`cautious progression to higher caloric feedings.
`
`Spitting up, abdominal distention, abnormal stools or
`stool patterns, excessive gastric residuals, or other signs
`of intestinal dysfunction have been associated with
`enteral feeding before the intestinal tract is ready to
`accommodate the regimen. At the first sign of these
`problems, enteral
`feeding should be slowed or
`discontinued.
`
`
`
`
`COMPLAINT FOR A CIVIL CASE − 17
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`S C H R O E T E R , G O L D M A R K & B E N D E R
`401 Union Street ● Suite 3400 ● Seattle, WA 98101
`Phone (206) 622-8000 ● Fax (206) 682-2305
`
`
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`Case 2:22-cv-00624 Document 1 Filed 05/09/22 Page 18 of 37
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`•
`
`Not intended for feeding low-birth-weight infants after
`they reach a weight of 3600 g (approximately 8 lbs.) or
`as directed by a physician.”
`
`“Similac Special Care 24 High Protein – Precautions:
`
`
`•
`
`•
`
`•
`
`•
`
`particularly
`are
`infants
`low-birth-weight
`Very
`susceptible to gastrointestinal complications; therefore,
`feeding should be initiated cautiously.
`
`Tolerance to enteral feedings should be confirmed by
`initially offering small volumes of formula followed by
`cautious progression to higher caloric feedings.
`
`Spitting up, abdominal distention, abnormal stools or
`stool patterns, excessive gastric residuals, or other signs
`of intestinal dysfunction have been associated with
`enteral feeding before the intestinal tract is ready to
`accommodate the regimen. At the first sign of these
`problems, enteral
`feeding should be slowed or
`discontinued.
`
`Not intended for feeding low-birth-weight infants after
`they reach a weight of 3600 g (approximately 8 lbs.) or
`as directed by a physician.
`
`
`
`“Similac Special Care Premature 20 calorie and 24 calorie and High Protein
`Precaution:
`
`
`•
`
`•
`
`If signs of intolerance develop, slow feeding, or
`discontinue.
`
`Not intended for low-birth-weight infants after they
`reach a weight of 3600 grams (approximately 8 lbs.) or
`as directed by a doctor.”
`
`“Similac Special Care Premature 30 calorie – Precaution:
`
`
`•
`
`•
`
`•
`
`Use once feeding tolerance is established.
`
`If signs of intolerance develop, slow feeding, or
`discontinue.
`
`Hydration status should be monitored.
`
`
`
`
`COMPLAINT FOR A CIVIL CASE − 18
`
`
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`
`
`
`
`S C H R O E T E R , G O L D M A R K & B E N D E R
`401 Union Street ● Suite 3400 ● Seattle, WA 98101
`Phone (206) 622-8000 ● Fax (206) 682-2305
`
`
`

`

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`Case 2:22-cv-00624 Document 1 Filed 05/09/22 Page 19 of 37
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`•
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`Not intended for low-birth-weight infants after they
`reach a weight of 3600 grams (approximately 8 lbs.) or
`as directed by a doctor.”
`
`
`
`37.
`
`Thus, Defendant did not warn the users, the parents, or the medical providers
`
`and staff that these Cow’s Milk-Based Products can cause NEC and other serious injuries,
`
`including death, nor do Defendant provide any guidance on how to avoid or reduce the risks
`
`of NEC or other serious injuries, including death, while using their products.
`
`L.J.C. and the Dangerous, Defective Products
`
`38.
`
`L.J.C. was born at Swedish Medical in Seattle, Washington on
`
`
`
`2012. L.J.C. was born preterm at 33-weeks and 2-days gestational age with a low birth
`
`weight of 3 pounds 7 ounces.
`
`39.
`
`After she was born, L.J.C. was placed on a ventilator in the NICU at Swedish
`
`Medical.
`
`40.
`
`Following her birth, her mother was unsuccessful in pumping her own breast
`
`milk for her baby’s nutrition.
`
`41.
`
`L.J.C. was fed Similac Infant Formula, Defendant’s Cow’s Milk-Based
`
`formula from August 25, 2012, to November 6, 2012, while at Swedish Medical.
`
`42.
`
`On August 28, 2012, L.J.C. was evaluated for the possibility of NEC. The
`
`doctors indicated that there was no indication for surgery at this time but would monitor
`
`L.J.C.’s condition over the next 24 hours.
`
`43.
`
`L.J.C. was diagnosed wit