Case 1:22-cv-00711 Document 1 Filed 03/15/22 Page 1 of 31
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF COLUMBIA
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`Civil Action No.:
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`
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`ALYHANA CHILDS,
`as PARENT, NATURAL GUARDIAN
`AND NEXT FRIEND OF S.S., a minor,
`5469 Grove Ridge Way,
`Rockville, MD 20852.
`
`
` Plaintiff,
`
`
`
`
`
`
`v.
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`ABBOTT LABORATORIES,
`100 Abbott Park Road,
`Abbott Park, IL 60064
`
`SERVE:
`CT Corporation System
`1015 15th Street NW, Suite 1000
`Washington, DC 20005
`
`and
`
`
`MEAD JOHNSON & COMPANY, LLC,
`225 North Canal Street, 24th Floor,
`Chicago, IL 60606
`
`SERVE:
`Corporation Service Company
`1090 Vermont Avenue, NW
`Washington, DC 20005
`
`and
`
`MEAD JOHNSON NUTRITION
`COMPANY,
`225 North Canal Street, 24th Floor,
`Chicago, IL 60606
`
`SERVE:
`Corporation Service Company
`1090 Vermont Avenue, NW
`Washington, DC 20005
`
`
` Defendants.
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`Case 1:22-cv-00711 Document 1 Filed 03/15/22 Page 2 of 31
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`PLAINTIFF’S COMPLAINT AND JURY DEMAND: PRODUCTS LIABILITY
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`INTRODUCTION
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`This action arises out of the injuries suffered by Plaintiff’s premature infant, who was fed
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`Defendants’ cow’s-milk-based infant formula and/or fortifier. Defendants’ products caused the
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`injured infant to develop Necrotizing Enterocolitis (hereinafter “NEC”), a life-threatening and
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`potentially deadly intestinal disease characterized by inflammation and injury of the gut wall barrier
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`that may advance to necrosis and perforation of the gut. Advanced cases of NEC often lead to surgery
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`and even death. Significantly higher rates of NEC have been found in premature or preterm babies
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`with low birth weights who are fed cow’s milk-based formula or fortifier products. The companies
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`who manufacture these products often intentionally mislabel and misrepresent the contents of the
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`products both to the public at-large and to the health care community, passing off these deadly
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`products as something similar to or even superior to human breast milk. Tragically, baby S.S.
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`(hereinafter “Baby S.S.”), who was premature at birth, was fed these cow’s milk-based products,
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`developed NEC, and suffered significant injuries as a result.
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`
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`Plaintiff, Alyhana Childs, as Parent, Natural Parent, and Next Friend of Baby S.S., brings this
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`cause of action against Defendants for claims arising from the direct and proximate result of
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`Defendants’ negligent, willful, and wrongful conduct in connection with the design, development,
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`manufacture, testing, packaging, promoting, marketing, distribution, labeling, failure to warn, and/or
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`sale of the Defendants’ cow’s milk-based products (hereinafter “Cow’s milk-based Formula,” “Cow’s
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`milk-based Fortifier,” or collectively “Cow’s Milk-Based Products”).
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`GENERAL ALLEGATIONS
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`
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`Plaintiff, Alyhana Childs, as Parent, Natural Parent, and Next Friend of Baby S.S. (hereinafter
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`“Plaintiff”), by and through the undersigned counsel, brings this Complaint against Defendants,
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`Case 1:22-cv-00711 Document 1 Filed 03/15/22 Page 3 of 31
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`Abbott Laboratories; Mead Johnson and Company, LLC; and Mead Johnson Nutrition Company; and
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`upon information and belief and based upon the investigation of counsel to date, would set forth as
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`grounds the following:
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`JURISDICTION AND VENUE
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`1.
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`This is an action for damages which exceeds the sum of 75,000.00, exclusive of costs,
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`interest, and attorneys’ fees.
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`2.
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`This Court has jurisdiction over this case pursuant to 28 U.S.C. §1332, as complete
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`diversity exists between Plaintiff and the Defendants, and the matter in controversy, exclusive of
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`interest and costs, exceeds the sum or value of $75,000.00.
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`3.
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`This Court has personal jurisdiction over Defendants because Defendants are
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`authorized to conduct business and do conduct business in the District of Columbia. Defendants
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`have marketed, promoted, distributed, and/or sold their Cow’s Milk-Based Products in the District
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`of Columbia and Defendants have sufficient minimum contacts with this state and/or sufficiently
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`avail themselves of the markets in the state through their promotion, sales, distribution, and marketing
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`within this state to render exercise of jurisdiction by this Court permissible.
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`4.
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`Venue of this action is proper in this Court pursuant to 28 U.S.C. §§1391 (a) and (b)
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`because a substantial part of the events or omissions giving rise to Plaintiff’s claims occurred in this
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`judicial district. Venue is also proper under 18 U.S.C. §1965 (a) because Defendants transact
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`substantial business in this District.
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`PLAINTIFF
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`5.
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`Baby S.S. was born prematurely at George Washington University Hospital in
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`Washington, District of Columbia. Upon information and belief, Baby S.S. developed NEC after
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`being fed Similac and Enfamil Cow’s Milk-Based Products while in the NICU at George Washington
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`University Hospital in Washington, District of Columbia.
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`Case 1:22-cv-00711 Document 1 Filed 03/15/22 Page 4 of 31
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`6.
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`At the time of Baby S.S.’s birth and subsequent NICU treatment, he domiciled in and
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`was a citizen of the District of Columbia.
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`7.
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`Plaintiff, Alyhana Childs, the mother of Baby S.S., (hereinafter “Baby S.S.’s Mother”),
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`domiciled in and was a citizen of the District of Columbia at the time of Baby S.S.’s birth. Baby S.S.
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`and Baby S.S.’s Mother currently domicile in and are citizens of the State of Maryland, and reside in
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`Rockville in Montgomery County, Maryland. Baby S.S.’s Mother brings this action against Defendants
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`to recover for Baby S.S.’s injuries, which are the direct and proximate result of consumption of
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`Defendants’ unreasonably dangerous cow’s milk-based products.
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`DEFENDANTS
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`8.
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`Defendant, Abbott Laboratories (“Abbott”) was at all times material hereto and is now
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`a corporation duly organized, incorporated, and existing under the laws of the State of Delaware with
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`its principal place of business and headquarters in the State of Illinois and is thus a resident, citizen
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`and domiciliary of Delaware and Illinois. Abbott manufactures, designs, formulates, prepares, tests,
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`provides instructions for, markets, labels, packages, sells, and/or places into the stream of commerce
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`in all fifty states, including the District of Columbia, premature infant formula and premature infant
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`milk fortifier under the Similac brand name.
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`9.
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`Defendant Abbott advertises that it provides the “#1 Formula Brand, Backed by
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`Science” and claims to have “over 90 years of innovations” in infant formula.
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`10.
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`Defendants, Mead Johnson & Company, LLC, and Mead Johnson Nutrition
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`Company, (collectively “Mead Johnson”) are companies based in Illinois that manufacture, design,
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`formulate, prepare, test, provide instructions, market, label, package, sell, and/or place into the stream
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`of commerce in all fifty states, including the District of Columbia, premature infant formula and
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`premature infant milk fortifier under the Enfamil brand name. Mead Johnson Nutrition Company
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`was at all times material hereto and is now a corporation duly organized, incorporated, and existing
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`Case 1:22-cv-00711 Document 1 Filed 03/15/22 Page 5 of 31
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`under the laws of the State of Delaware with its principal place of business and global headquarters in
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`the State of Illinois, and is thus a resident, citizen, and domiciliary of Delaware and Illinois. Mead
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`Johnson & Company, LLC was at all times material hereto and is now a limited liability company duly
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`organized and existing under the laws of the State of Delaware with its principal place of business and
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`headquarters in the State of Illinois. Upon information and belief, at all times material hereto, the sole
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`member of Mead Johnson & Company, LLC is Mead Johnson Nutrition Company.
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`11. Mead Johnson Nutrition Company self-proclaims to be recognized as “a world leader
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`in pediatric nutrition” and traces its history back to the company’s founding in 1905 by Edward Mead
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`Johnson, Sr. It claims to be the “only global company focused primarily on infant and child nutrition”
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`and that its “singular devotion has made our flagship ‘Enfa’ line the leading infant nutrition brand in
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`the world.” Boasting “more than 70 products in over 50 countries,” it claims that its “products are
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`trusted by millions of parents and healthcare professionals around the world.”
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`FACTUAL ALLEGATIONS
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`The Science and Scope of the Problem
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`12.
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`According to the World Health Organization (“WHO”), babies born prematurely, or
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`“preterm,” are defined as being born alive before 37 weeks of pregnancy are completed, like Baby S.S.
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`The WHO estimates that approximately 15 million babies are born preterm every year and that this
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`number is rising.
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`13.
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`Nutrition for preterm babies, especially those who have a very low birth weight (under
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`1500 grams) or extremely low birth weight (under 1000 grams), is significantly important. Since the
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`United States ranks in the top ten countries in the world with the greatest number of preterm births,
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`the market of infant formula and fortifiers is particularly vibrant.
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`14.
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`Science and research have advanced in recent years confirming strong links between
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`cow’s milk-based products and NEC causing and/or substantially contributing to death in preterm
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`Case 1:22-cv-00711 Document 1 Filed 03/15/22 Page 6 of 31
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`and severely preterm, low-weight infants, along with many other health complications and long-term
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`risks to these babies. Additionally, advances in science have created alternative fortifiers that are
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`derived from human milk and non-cow’s milk-based products, however, the manufacturers of the
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`Cow’s Milk-Based Products continue to promote and sell the Cow’s Milk-Based versions.
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`15.
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`As far back as 1990, a prospective, multicenter study on 926 preterm infants found
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`that NEC was six to ten times more common in exclusively formula-fed babies than in those fed
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`breast milk alone and three times more common than in those who received formula plus breast
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`milk. The study also found that NEC was rare in babies born at more than 30 weeks gestation whose
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`diet included breast milk but was 20 times more common in those fed cow’s milk-based formula
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`only. A. Lucas, T. Cole, Breast Milk and Neonatal Necrotizing Enterocolitis, LANCET, 336: 1519-1523 (1990)
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`(emphasis added).
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`16.
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`A study published in 2009 evaluated the health benefits of an exclusively human milk-
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`based diet as compared to a diet with both human milk and cow’s milk-based products in extremely
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`premature infants. The results show that preterm babies fed an exclusively human milk-based diet
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`were 90% less likely to develop surgical NEC as compared to a diet that included some cow’s milk-
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`based products. S. Sullivan, et al, An Exclusively Human Milk-Based Diet Is Associated with a Lower Rate of
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`Necrotizing Enterocolitis than a Diet of Human Milk and Bovine Milk-Based Products, JOURNAL OF
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`PEDIATRICS, 156: 562-7 (2010) (emphasis added).
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`17.
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`In 2011, the U.S. Surgeon General published a report titled, “The Surgeon General's
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`Call to Action to Support Breastfeeding.” In it, the Surgeon General warned that “for vulnerable
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`premature infants, formula feeding is associated with higher rates of necrotizing enterocolitis
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`(NEC)." U.S. Dep’t of Health & Human Serv., Off. of Surgeon Gen., “The Surgeon General's Call to
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`Action to Support Breastfeeding,” p.1, (2011) (emphasis added). This same report stated that premature
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`infants who are not breast­fed are 138% more likely to develop NEC. Id.
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`18.
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`In 2012, the American Academy of Pediatrics issued a policy statement that all
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`premature infants should be fed an exclusive human milk diet because of the risk of NEC associated
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`with the consumption of Cow’s Milk-Based Products. The Academy stated that "[t]he potent benefits
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`of human milk are such that all preterm infants should receive human milk... If the mother's own milk
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`is unavailable ...pasteurized donor milk should be used.'' Breastfeeding and the Use of Human Milk,
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`PEDIATRICS, 129:e827-e84l (2012).
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`19.
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`Further, a study published in 2013 showed that all 104 premature infants participating
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`in the study receiving an exclusive human-milk based diet exceeded targeted growth standards and
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`length and weight and head circumference gain. The authors concluded that "this study provides data
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`showing that infants can achieve and mostly exceed targeted growth standards when receiving
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`an exclusive human milk-based diet." A. Hair, et al, Human Milk Feeding Supports Adequate Growth in
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`Infants ≤1250 Grams Birthweight, BMC RESEARCH NOTES, 6:459 (2013) (emphasis added). Thus,
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`inadequate growth was proven to be a poor excuse for feeding Cow’s Milk-Based Formula, but the
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`practice has largely continued due to extensive and aggressive marketing campaigns conducted by
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`infant formula such as the Defendants.
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`20.
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`Another study published in 2013 reported the first randomized trial in extremely
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`premature infants of exclusive human milk versus preterm cow’s milk-based formula. The study
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`found a significantly higher rate of surgical NEC in infants receiving the cow’s milk-based preterm
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`formula and supported the use of exclusive human milk diet to nourish extremely preterm infants in
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`the NICU (Newborn Intensive Care Unit). E.A. Cristofalo, et al, Randomized Trial in Extremely Preterm
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`Infants, J PEDIATR., 163(6):1592-1595 (2013) (emphasis added).
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`21.
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`In another study published in 2014, it was reported that NEC is “a devastating disease
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`of premature infants and is associated with significant morbidity and mortality. While the
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`pathogenesis of NEC remains incompletely understood, it is well established that the risk is increased
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`by the administration of infant formula and decreased by the administration of breast milk." Misty
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`Good, et al., Evidence Based Feeding Strategies Before and After the Development of Necrotizing Enterocolitis,
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`EXPERT REV. CLIN. IMMUNOL., 10(7): 875-884 (2014 July) (emphasis added). The same study found
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`that NEC “is the most frequent and lethal gastrointestinal disorder affecting preterm infants and
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`is characterized by intestinal barrier disruption leading to intestinal necrosis, multi-system organ failure
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`and death. Id. The study noted that “NEC affects 7-12% of preterm infants weighing less than 1500
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`grams, and the frequency of disease appears to be either stable or rising in several studies. Id. The
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`typical patient who develops NEC is a premature infant who displays a rapid progression from mild
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`feeding intolerance to systemic sepsis, and up to 30% of infants will die from this disease.” Id.
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`Advances in formula development have made it possible to prevent necrotizing enterocolitis, and the
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`“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.
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`22.
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`In yet another study, published in 2014, it was reported that an exclusive human milk
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`diet, devoid of Cow’s Milk-Based Products, was associated with “lower mortality and morbidity” in
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`extremely preterm infants without compromising growth and should be considered as an approach to
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`nutritional care of these infants. Steven Abrams, et al., Greater Mortality and Morbidity in Extremely Preterm
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`Infants Fed a Diet Containing Cow Milk Protein Products, BREASTFEEDING MEDICINE, 9(6):281-286 (2014).
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`23.
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`In 2016, a large study supported previous findings that an exclusive human milk diet
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`in extreme preterm infants dramatically decreased the incidence of both medical and surgical NEC.
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`This was the first study to compare rates of NEC after a feeding protocol implementation at multiple
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`institutions and years of follow-up using an exclusive human milk diet. The authors concluded that
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`the use of an exclusive human milk diet is associated with “significant benefits” for extremely
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`preterm infants and while evaluating the benefits of using an exclusive human milk-based protocol,
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`“it appears that there were no feeding-related adverse outcomes.” Hair, et al, Beyond Necrotizing
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`Enterocolitis Prevention: Improving Outcomes with an Exclusive Human Milk Based Diet, BREASTFEEDING
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`MEDICINE, 11-2 (2016) (emphasis added).
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`24.
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`A publication by the American Society for Nutrition, in 2017, noted that human milk
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`has “been acknowledged as the best source of nutrition for preterm infants and those at risk for NEC.”
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`The study compared the results from two randomized clinical trials on preterm infants with severely
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`low weight (between 500 and 1250 grams at birth) and compared the effect of cow’s milk-based
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`preterm infant formula to human milk as to the rate of NEC. Both trials found that an exclusive
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`human milk diet resulted in a much lower incidence of NEC. While the study noted that cow’s
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`milk-based preterm formulas provided consistent calories and were less expensive than human milk-
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`based products, the cow’s milk-based products significantly increase the risk of NEC and
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`death. The study also noted the “exponential” health care costs associated with NEC and noted
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`data from the U.S. from 2011-2012 that showed that the cost of NEC is $180,000 to $198,000 per
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`infant and nearly doubles to $313,000 per infant for surgically treated NEC. Further, NEC survivors
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`accrue substantially higher outpatient costs. Jocelyn Shulhan, et al, Current Knowledge of Necrotizing
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`Enterocolitis in Preterm Infants and the Impact of Different Types of Enteral Nutrition Products, ASN ADV.
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`NUTR., 8(1):80-91 (2017) (emphasis added).
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`25.
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`The WHO and United Nation’s International Children’s Emergency Fund (UNICEF)
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`held a meeting more than two decades ago to address concerns over the marketing of breast-milk
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`substitutes. The WHO Director concluded the meeting with the following statement, “In my
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`opinion, the campaign against bottle-feed advertising is unbelievably more important than
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`the fight against smoking advertisement.” Jules Law, The Politics of Breastfeeding: Assessing Risk,
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`Dividing Labor, JSTOR SIGNS, vol. 25, no. 2: 407-50 (2000) (emphasis added).
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`26.
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`Recognizing the abuse and dangers of the marketing of infant formula, in 1981, the
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`World Health Assembly (“WHA”), the decision-making body of the world's Member States,
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`developed the International Code of Marketing of Breast-milk Substitutes (“the Code”), which
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`required companies to acknowledge the superiority of breast milk and outlawed any advertising or
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`promotion of breast milk substitutes to the general public. Pursuant to Article 5.1 of the Code,
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`advertising of breast-milk substitutes is specifically prohibited: “There should be no advertising or
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`other form of promotion to the general public [of breast milk substitutes].” (emphasis added). In
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`Article 5.2, the Code states that “manufacturers and distributors should not provide, directly or
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`indirectly, to pregnant women, mothers or members of their families, samples of products within the
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`scope of this Code.” In addition, the Code expressly prohibits, “point-of-sale advertising, giving of
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`samples, or any other promotion device to induce sales directly to the consumer at the retail level,
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`such as special displays, discount coupons, premiums, special sales…” See Int’l Code of Marketing of
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`Breast-Milk Substitutes, May 21, 1981, WHA 34/1981/REC/2, Art.5.3.
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`27.
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`The World Health Organization’s 2018 Status Report on this issue noted that “despite
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`ample evidence of the benefits of exclusive and continued breastfeeding for children, women, and
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`society, far too few children are breastfed as recommended.” The Status Report states that “a major
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`factor undermining efforts to improve breastfeeding rates is continued and aggressive
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`marketing of breast-milk substitutes,” noting that in 2014, the global sales of breast-milk
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`substitutes amounted to US $44.8 billion and “is expected to rise to US $70.6 billion by 2019.”
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`Marketing of Breast-milk Substitutes: Nat’l Implementation of the Int’l Code, Status Report 2018. Geneva: World
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`Health Org., 2018, p.21 (emphasis added).
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`28.
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`Recognizing a shift in the medical community towards an exclusive human milk-based
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`diet for preterm infants, the Defendants began heavily promoting “human milk fortifiers,” a name
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`which misleadingly suggests that the product is derived from human milk, instead of being derived
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`from Cow’s Milk.
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`29.
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`The Defendants have designed competing, systematic, powerful, and misleading
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`Case 1:22-cv-00711 Document 1 Filed 03/15/22 Page 11 of 31
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`marketing campaigns to persuade physicians and parents to believe that: (1) Cow’s Milk-based formula
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`and fortifiers are safe; (2) Cow’s Milk-Based Products are equal, or even superior, substitutes to
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`breastmilk; and (3) physicians consider their Cow’s Milk-Based Products a first choice. Similarly, the
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`Defendants market their products for preterm infants as necessary for growth, and perfectly safe for
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`preterm infants, despite knowing of the extreme risks posed by Cow’s Milk-Based Products and failing
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`to warn of the deadly disease of NEC and risk of death.
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`30.
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`Thus, despite the existence of alternative and safe human milk-based products, these
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`Defendants continue to market and/or sell the Cow’s Milk-Based Products under the guise of being
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`a safe product for their newborns and despite knowing the significant health risk posed by ingesting
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`these products, especially to preterm, low weight infants, like Baby S.S.
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`The Inadequate Warnings
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`31.
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`Defendants promote the use of their preterm infant Cow’s Milk-Based Products to
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`parents, physicians, hospitals, and medical providers as safe products that are specifically needed by
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`preterm infants for adequate growth.
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`32.
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`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 and death, Defendants
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`did not warn parents or medical providers of the risk of NEC in preterm infants, nor did Defendants
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`provide any instructions or guidance on how to properly use its Cow’s Milk-Based Products so as to
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`lower the risk or avoid NEC or death.
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`33.
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`In fact, neither of the Defendants provide any warning in their labeling, websites, or
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`marketing that discusses the risk of NEC and death with use of their Cow’s Milk-Based Products with
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`preterm infants.
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`34.
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`The warning on Similac Human Milk Fortifier, an Abbott Cow’s Milk-Based Product
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`specifically marketed for use with preterm infants states:
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`Precautions
`• Add only to human milk—do not add water
`• This product is nutritionally incomplete by itself and is designed to be added to
`human breast milk
`• Additional iron may be necessary
`• Tolerance to enteral feedings should be confirmed by offering small volumes of
`unfortified human milk
`• Once enteral feeding is well established, Similac Human Milk Fortifier Concentrated
`Liquid can be added to human milk
`• Not intended for feeding low-birth-weight infants after the reach a weight of 3600 g
`(approximately 8 lb) or as directed by a physician
`Preparation and Use
`Follow directions as specified on carton. Improper dilution may be harmful.
`
`35.
`
`The warning on Enfamil Human Milk Fortifier, a Mead Johnson Cow’s Milk-Based
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`Product specifically marketed for use with preterm infants states:
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`WARNING: Your baby’s health depends on carefully following the instructions below. Use
`only as directed by a medical professional. Improper hygiene, preparation, dilution, use or
`storage may result in severe harm. Although this powder is formulated for premature infants,
`nutritional powders are not sterile and should not be fed to premature infants or infants who
`might have immune problems unless directed and supervised by your baby’s doctor.
`Follow hospital rules or your baby’s doctor’s instructions for the safe handling of human milk.
`To aid mixing, agitate the human milk well. Pour the desired amount into a sterile container
`and warm to feeding temperature.
`1. Remove vials from foil pouch and separate number of vials needed.
`2. Store remaining vials in foil pouch at room temperature. Once pouch has been opened,
`vials must be used within 24 hours.
`3. Shake vigorously to mix contents. Firmly hold vial UPRIGHT by bottom tab and
`slowly twist top off completely. Add fortifier to breast milk.
`Some liquid may remain in cap and vial; disregard [sic] this liquid. Discard opened vial and cap
`promptly. Do not use product that has unusual characteristics.
`1. Failure to follow these instructions could result in severe harm. Once prepared,
`fortified breast milk can spoil quickly. Either feed fortified breast milk immediately
`or cover and store in refrigerator at 35-40°F (2-4°C) for no longer than 24 hours.
`Agitate before each use.
`2. For bottle feeding: Pour only the amount of fortified breast milk to be fed into a
`feeding container and feed immediately. Do not use fortified breast milk if it is
`unrefrigerated for more than a total of 2 hours. After feeding begins, use fortified
`breast milk within one hour or discard.
`3. For tube feeding: Once fortified breast milk is prepared, it can remain at room
`temperature for no longer than a total of 4 hours.
`Warning: Do not use a microwave oven to warm the fortified human milk. Serious burns may
`result.
`Storage: Store unopen pouches in carton at room temperature. Avoid excessive heat. Do not
`freeze.
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`Warning: Not for parental (I.V.) use. Fortifier is designed to be mixed with breast milk; do
`not administer directly.
`36.
`The warning on Enfamil Premature Formula, a Mead Johnson Cow’s Milk-Based
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`Product specifically marketed for use with preterm infants states:
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`Your baby’s health depends on carefully following the instructions below.
`Proper hygiene, preparation, use and storage are important when preparing infant formula.
`Use as directed by your baby’s doctor. Ask your baby’s doctor about the need to boil a clean
`nipple in water before use. Inspect each bottle for signs of damage.
`1. Wash hands thoroughly with soap and water before preparing bottle for feeding.
`2. SHAKE BOTTLE WELL and remove cap.
`3. Attach nipple unit (not included).
`WARNING: Do not use a microwave oven to warm formula. Serious burns may result.
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`Failure to follow these instructions could result in severe harm. Opened bottles can spoil
`quickly. Either feed immediately or replace cap and store in refrigerator at 35-40°F (2-4°C) for
`no longer than 24 hours. Do not use opened bottle if it is unrefrigerated for more than a total
`of 2 hours. Do not freeze. After feeding begins, use formula within one hour or discard.
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`Storage: Store unopened bottles at room temperature.
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`Avoid excessive heat and prolonged exposure to light. Do not freeze.
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`DO NOT ACCEPT IF PACKAGE HAS BEEN OPENED. DO NOT USE IF CAP RING
`IS BROKEN OR MISSING.
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`USE BY DATE ON CARTON AND BOTTLE LABEL.
`
`37.
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`Thus, Defendants do not warn the users, the parents, or the medical providers and
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`staff that these Cow’s Milk-Based Products can cause NEC or death, nor do they provide any guidance
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`on how to avoid or reduce the risks of NEC or death while using their products.
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`Baby S.S. and the Dangerous, Defective Products
`
`38.
`
`Baby S.S. was born at George Washington University Hospital on May 12, 2007. Baby
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`S.S. was born preterm at 30 weeks gestation age with a low birth weight of 1265 grams (2 pounds 12.6
`
`ounces) and a length of 15 inches.
`
`39.
`
`After he was born, Baby S.S. was sent to the Neonatal Intensive Care Unit (NICU) at
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`George Washington University Hospital.
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`Case 1:22-cv-00711 Document 1 Filed 03/15/22 Page 14 of 31
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`40.
`
`Following his birth, his mother successfully pumped her own breast milk for her
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`baby’s nutrition.
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`41.
`
`From May 13, 2007 until May 26, 2007, Baby S.S. was fed with his mother’s breast
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`milk, fortified breast milk, or Enfamil Premature Infant Formula.
`
`42.
`
`On May 27, 2007, Baby S.S. developed bright red stools with increasing abdominal
`
`distention.
`
`43.
`
`Baby S.S. was diagnosed with NEC on May 27, 2007. He was put on bowel rest and
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`was started on triple antibiotics.
`
`44.
`
`45.
`
`On June 11, 2007, oral feeds were restarted slowly after 14 days of bowel rest.
`
`
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`Baby S.S. was fed Enfamil Premature Infant Formula and breast milk between June
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`11, 2007, and June 14, 2007.
`
`46.
`
`On June 15, 2007, Baby S.S. again developed a distended abdomen, and he was put on
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`bowel rest. Over the next few days, Baby S.S.’s condition did not improve. He was diagnosed with
`
`NEC a second time.
`
`47.
`
`Due to the imminent need for surgical consultation, Baby S.S. was transferred to
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`Children’s National Hospital in Washington, District of Columbia, on June 22, 2007.
`
`48.
`
`On June 30, 2007, Baby S.S. was forced to undergo an exploratory laparotomy.
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`Multiple perforations in the bowel and a severe stricture were discovered. He underwent a resection
`
`of the terminal ileum and cecum.
`
`49.
`
`At the time he was diagnosed with and treated for NEC, Baby S.S.’s parents were
`
`unaware of the fact that the Defendants’ Cow’s Milk-Based Products he was fed caused or substantially
`
`contributed to his development of NEC and resulting injuries.
`
`50.
`
`As a result of developing NEC, Baby S.S. lost large portions of his bowel, causing
`
`permanent injury. He continues to suffer today with chronic bowel-related distress, pain, suffering,
`
`14
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`Case 1:22-cv-00711 Document 1 Filed 03/15/22 Page 15 of 31
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`mental and emotional anguish and distress.
`
`COUNT I: STRICT LIABILITY AS TO DEFENDANT ABBOTT’S DESIGN
`
`51.
`
`Plaintiff incorporates by reference each of the preceding paragraphs as if fully set forth
`
`herein.
`
`52.
`
`At all times material to this action, Defendant Abbott was engaged in the sale, and/or
`
`marketing and/or design, and/or manufacture, and/or distribution of Cow’s Milk-Based Products,
`
`which are defectively designed and/or unreasonably dangerous to consumers, including Baby S.S.
`
`53.
`
`Defendant Abbott, as a manufacturer, has a duty to hold the knowledge and skill of
`
`an expert and is obliged to keep abreast of any scientific discoveries and are presumed to know the
`
`result of all such advances.
`
`54.
`
`At all times material to this action, the Cow’s Milk-Based Products manufactured,
`
`distributed and/or sold by Defendant Abbott, were in a defective and/or unreasonably dangerous
`
`condition at the time the products were placed in the stream of commerce for nutritional use for
`
`preterm infants.
`
`55.
`
`Defendant Abbott specifically marketed and created its Cow’s Milk-Based Products
`
`for use as nutrition and nutritional supplements for preterm infants, like Baby S.S..
`
`56.
`
`Defendant Abbott’s Cow’s Milk-Based Products are expected to and do reach the user
`
`without substantial change affecting that defective and/or unreasonably dangerous condition.
`
`57.
`
`Prior to May 12, 2007, Defendant Abbott was aware or should have been aware that
`
`its Cow’s Milk-Based Products were not safe for use, as they were used, as nutrition or nutritional
`
`support in preterm infants, yet they took no steps to prevent the use of these products in such
`
`situations.
`
`58.
`
`Defendant Abbott knew or should have known that the use of its Cow’s Milk-Based
`
`Products with preterm infants was unreasonably dangerous in that its Cow’s Milk-Based Products
`
`15
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`Case 1:22-cv-00711 Document 1 Filed 03/15/22 Page 16 of 31
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`significantly increased the risk of NEC.
`
`59.
`
`Furthermore, scientific data and well-researched studies have concluded that the
`
`Cow’s Milk-Based Products of the Defendant carried unreasonable risks of NEC and death, which
`
`far outweighed the products’ benefits for preterm infants like Baby S.S.
`
`60.
`
`Despite the foregoing, the Defendant continued to sell and market its defective and/or
`
`unreasonably dangerous products to preterm infants.
`
`61.
`
`The products were defectively manufactured and/or designed and/or unreasonably
`
`dangerous, including, but not limited to the following particul