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`Case: 1:22-cv-01089 Document #: 1 Filed: 03/02/22 Page 1 of 21 PageID #:1
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`IN THE UNITED STATES DISTRICT COURT FOR THE
`NORTHERN DISTRICT OF ILLINOIS
`CHICAGO DIVISION
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`JUSTIN DE LOS SANTOS,
`as PARENT, NATURAL GUARDIAN
`AND NEXT FRIEND OF RYAN J.
`DE LOS SANTOS,
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`
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`Plaintiff,
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`v.
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`ABBOTT LABORATORIES,
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`Defendant.
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`Case No.
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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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`Defendant’s cow’s milk-based infant formula and/or fortifier. Defendant’s 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
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`barrier that may advance to necrosis and perforation of the gut. Advanced cases of NEC often lead
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`to surgery and even death. Significantly higher rates of NEC have been found in premature or
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`preterm babies with low birth weights who are fed cow’s milk-based formula or fortifier products.
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`The companies who manufacture these products often intentionally mislabel and misrepresent the
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`contents of the products both to the public at-large and to the health care community, passing off
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`these deadly products as something similar or even superior to human breast milk. Tragically, baby
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`Ryan J. De Los Santos, 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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`Case: 1:22-cv-01089 Document #: 1 Filed: 03/02/22 Page 2 of 21 PageID #:2
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`Plaintiff, Justin De Los Santos, as Parent, Natural Guardian, and Next Friend of Ryan J.
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`De Los Santos, brings this cause of action against Defendant for claims arising from the direct and
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`proximate result of Defendant’s negligent, willful, and wrongful conduct in connection with the
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`design, development, manufacture, testing, packaging, promoting, marketing, distribution,
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`labeling, failure to warn, and/or sale of the Defendant’s cow’s milk-based products (hereinafter
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`“Cow’s milk-based Formula,” “Cow’s milk-based Fortifier,” or collectively “Cow’s Milk-Based
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`Products”).
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`GENERAL ALLEGATIONS
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`Plaintiff, Justin De Los Santos, as Parent, Natural Guardian, and Next Friend of Ryan J.
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`De Los Santos, (hereinafter “Plaintiff”), by and through the undersigned counsel, brings this
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`Complaint against Defendant, Abbott Laboratories; and upon information and belief and based
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`upon the investigation of counsel to date, would set forth as 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
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`costs, 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 Defendant, 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 Defendant because Defendant resides in
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`this District and is incorporated under the laws of Illinois and is authorized to conduct business
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`and does conduct business in the State of Illinois. Defendant has marketed, promoted, distributed,
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`and/or sold its Cow’s Milk-Based Products in the States of Illinois and Texas, and Defendant has
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`sufficient minimum contacts with these states and/or sufficiently avails itself of the markets in
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`the state through its promotion, sales, distribution, and marketing within these states to render
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`Case: 1:22-cv-01089 Document #: 1 Filed: 03/02/22 Page 3 of 21 PageID #:3
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`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
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`(b) because a substantial part of the events or omissions giving rise to Plaintiff’s claims occurred
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`in this judicial district. Venue is also proper under 18 U.S.C. §1965 (a) because Defendant
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`transacts substantial business in this District.
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`PLAINTIFF
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`5.
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`Ryan J. De Los Santos was born prematurely at Driscoll Children’s Hospital in
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`Corpus Christi, Texas on October 22, 2019. Upon information and belief, Ryan J. De Los Santos
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`developed NEC after being fed Abbott’s Similac Cow’s Milk-Based Products while at Driscoll
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`Children’s Hospital in Corpus Christi, Texas. At all times material hereto, Ryan J. De Los Santos
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`was domiciled in and was a citizen of the State of Texas.
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`6.
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`Plaintiff, Justin De Los Santos, the father of Ryan J. De Los Santos, was domiciled
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`in and was a citizen of the State of Texas at all relevant times. Ryan J. De Los Santos’s father
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`brings this action against Defendant to recover for Ryan J De Los Santos’s injuries, which are the
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`direct and proximate result of consumption of Defendant’s unreasonably dangerous cow’s milk-
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`based products.
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`DEFENDANT
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`Defendant, Abbott Laboratories (“Abbott”) was at all times material hereto and is now a
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`corporation duly organized, incorporated, and existing under the laws of the State of Texas with its
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`principal place of business and headquarters in the State of Illinois and is thus a resident, citizen
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`and domiciliary of Illinois. Abbott manufactures, designs, formulates, prepares, tests, provides
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`instructions for, markets, labels, packages, sells, and/or places into the stream of commerce in all
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`fifty states premature infant formula and premature infant milk fortifier under the Similac brand
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`name, including Similac Advance Formula.
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`7.
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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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`FACTUAL ALLEGATIONS
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`The Science and Scope of the Problem
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`8.
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`According to the World Health Organization (“WHO”), babies born prematurely,
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`or “preterm,” are defined as being born alive before 37 weeks of pregnancy are completed. The
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`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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`9.
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`Nutrition for preterm babies, especially those who have a very low birth weight
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`(under 1500 grams) or extremely low birth weight (under 1000 grams) is significantly important.
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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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`10.
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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 death in
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`preterm and severely preterm, low-weight infants, along with many other health complications and
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`long-term risks to these babies. Additionally, advances in science have created alternative fortifiers
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`that are derived from human milk and non-cow’s milk-based products; however, the manufacturers
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`of the Cow’s Milk-Based Products continue to promote and sell the Cow’s Milk-Based versions.
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`11.
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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
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`whose diet included breast milk but was 20 times more common in those fed cow’s milk-based
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`formula only. A. Lucas, T. Cole, Breast Milk and Neonatal Necrotizing Enterocolitis, LANCET,
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`336: 1519-1523 (1990) (emphasis added).
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`12.
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`A study published in 2009 evaluated the health benefits of an exclusively human
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`milk-based diet as compared to a diet with both human milk and cow’s milk-based products in
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`extremely premature infants. The results show that preterm babies fed an exclusively human milk-
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`based diet were 90% less likely to develop surgical NEC as compared to a diet that included some
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`cow’s milk-based products. S. Sullivan, et al., An Exclusively Human Milk-Based Diet Is
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`Associated with a Lower Rate of Necrotizing Enterocolitis than a Diet of Human Milk and Bovine
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`Milk-Based Products, JOURNAL OF PEDIATRICS, 156: 562-7 (2010) (emphasis added).
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`13.
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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
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`to Action to Support Breastfeeding,” p.1, (2011) (emphasis added). This same report stated that
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`premature infants who are not breast-fed are 138% more likely to develop NEC. Id.
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`14.
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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
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`associated with the consumption of Cow’s Milk-Based Products. The Academy stated that "[t]he
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`potent benefits of human milk are such that all preterm infants should receive human milk... If the
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`mother's own milk is unavailable ...pasteurized donor milk should be used.'' Breastfeeding and the
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`Use of Human Milk, PEDIATRICS, 129:e827-e84l (2012).
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`15.
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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 growth
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`standards and length and weight and head circumference gain. The authors concluded that "this
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`study provides data showing that infants can achieve and mostly exceed targeted growth
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`Case: 1:22-cv-01089 Document #: 1 Filed: 03/02/22 Page 6 of 21 PageID #:6
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`standards when receiving an exclusive human milk-based diet." A. Hair, et al., Human Milk
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`Feeding Supports Adequate Growth in Infants ≤1250 Grams Birthweight, BMC RESEARCH NOTES,
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`6:459 (2013) (emphasis added). Thus, inadequate growth was proven to be a poor excuse for
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`feeding Cow’s Milk-Based Formula, but the practice has largely continued due to extensive and
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`aggressive marketing campaigns conducted by infant formula companies such as the Defendant.
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`16.
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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
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`preterm formula and supported the use of exclusive human milk diet to nourish extremely preterm
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`infants in the NICU (Newborn Intensive Care Unit). E.A. Cristofalo, et al., Randomized Trial in
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`Extremely Preterm Infants, J PEDIATR., 163(6):1592-1595 (2013) (emphasis added).
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`17.
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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. While
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`the pathogenesis of NEC remains incompletely understood, it is well established that the risk is
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`increased by the administration of infant formula and decreased by the administration of breast
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`milk." Misty Good, et al., Evidence Based Feeding Strategies Before and After the Development
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`of Necrotizing Enterocolitis, EXPERT REV. CLIN. IMMUNOL., 10(7): 875-884 (2014 July)
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`(emphasis added). The same study found that NEC “is the most frequent and lethal
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`gastrointestinal disorder affecting preterm infants and is characterized by intestinal barrier
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`disruption leading to intestinal necrosis, multi-system organ failure and death. Id. The study noted
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`that “NEC affects 7- 12% of preterm infants weighing less than 1500 grams, and the frequency of
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`disease appears to be either stable or rising in several studies. Id. The typical patient who develops
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`NEC is a premature infant who displays a rapid progression from mild feeding intolerance to
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`systemic sepsis, and up to 30% of infants will die from this disease.” Id. Advances in formula
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`Case: 1:22-cv-01089 Document #: 1 Filed: 03/02/22 Page 7 of 21 PageID #:7
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`development have made it possible to prevent necrotizing enterocolitis, and the “exclusive use of
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`human breast milk is recommended for all preterm infants and is associated with a significant
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`decrease in the incidence of NEC.” Id.
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`18.
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`In 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”
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`in extremely preterm infants without compromising growth and should be considered as an
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`approach to nutritional care of these infants. Steven Abrams, et al., Greater Mortality and
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`Morbidity in Extremely Preterm Infants Fed a Diet Containing Cow Milk Protein Products,
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`BREASTFEEDING MEDICINE, 9(6):281-286 (2014).
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`19.
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`In 2016, a large study supported previous findings that an exclusive human milk
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`diet in extreme preterm infants significantly decreased the incidence of both medical and surgical
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`NEC. This was the first study to compare rates of NEC after a feeding protocol implementation
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`at multiple institutions and years of follow-up using an exclusive human milk diet. The authors
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`concluded that the use of an exclusive human milk diet is associated with “significant benefits”
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`for extremely preterm infants and while evaluating the benefits of using an exclusive human milk-
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`based protocol, “it appears that there were no feeding-related adverse outcomes.” Hair, et al.,
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`Beyond Necrotizing Enterocolitis Prevention: Improving Outcomes with an Exclusive Human Milk
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`Based Diet, BREASTFEEDING MEDICINE, 11-2 (2016) (emphasis added).
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`20.
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`A publication by the American Society for Nutrition, in 2017, noted that human
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`milk has “been acknowledged as the best source of nutrition for preterm infants and those at risk
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`for NEC.” The study compared the results from two randomized clinical trials on preterm infants
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`with severely low weight (between 500 and 1250 grams at birth) and compared the effect of cow’s
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`milk-based preterm infant formula to human milk as to the rate of NEC. Both trials found that an
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`exclusive human milk diet resulted in a much lower incidence of NEC. While the study noted
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`that cow’s milk-based preterm formulas provided consistent calories and were less expensive than
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`human milk-based products, the cow’s milk-based products significantly increase the risk of
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`NEC and death. The study also noted the “exponential” health care costs associated with NEC
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`and noted data from the U.S. from 2011-2012 that showed that the cost of NEC is $180,000 to
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`$198,000 per infant and nearly doubles to $313,000 per infant for surgically treated NEC. Further,
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`NEC survivors accrue substantially higher outpatient costs. Jocelyn Shulhan, et al., Current
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`Knowledge of Necrotizing Enterocolitis in Preterm Infants and the Impact of Different Types of
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`Enteral Nutrition Products, ASN ADV. NUTR., 8(1):80-91 (2017) (emphasis added).
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`21.
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`The WHO and United Nation’s International Children’s Emergency Fund
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`(UNICEF) held a meeting more than two decades ago to address concerns over the marketing of
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`breast-milk substitutes. The WHO Director concluded the meeting with the following statement,
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`“In my opinion, the campaign against bottle-feed advertising is unbelievably more important
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`than the fight against smoking advertisement.” Jules Law, The Politics of Breastfeeding:
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`Assessing Risk, Dividing Labor, JSTOR SIGNS, vol. 25, no. 2: 407-50 (2000) (emphasis added).
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`22.
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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
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`or other form of promotion to the general public [of breast milk substitutes].” (Emphasis added).
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`In 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
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`the scope of this Code.” In addition, the Code expressly prohibits, “point-of-sale advertising,
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`giving of samples, or any other promotion device to induce sales directly to the consumer at the
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`retail level, such as special displays, discount coupons, premiums, special sales…” See Int’l Code
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`of Marketing of Breast-Milk Substitutes, May 21, 1981, WHA 34/1981/REC/2, Art.5.3.
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`23.
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`The World Health Organization’s 2018 Status Report on this issue noted that
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`“despite ample evidence of the benefits of exclusive and continued breastfeeding for children,
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`women, and society, far too few children are breastfed as recommended.” The Status Report states
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`that “a major factor undermining efforts to improve breastfeeding rates is continued and
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`aggressive marketing of breast-milk substitutes,” noting that in 2014, the global sales of breast-
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`milk substitutes amounted to US $44.8 billion and “is expected to rise to US $70.6 billion by
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`2019.” Marketing of Breast-milk Substitutes: Nat’l Implementation of the Int’l Code, Status Report
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`2018. Geneva: World Health Org., 2018, p.21 (emphasis added).
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`24.
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`Recognizing a shift in the medical community towards an exclusive human milk-
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`based diet for preterm infants, the Defendant began heavily promoting “human milk fortifiers,” a
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`name which misleadingly suggests that the product is derived from human milk, instead of being
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`derived from Cow’s Milk.
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`25.
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`The Defendant has designed a systematic, powerful, and misleading marketing
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`campaign to persuade physicians and parents to believe that: (1) Cow’s Milk-based formula and
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`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,
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`Defendant markets its 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
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`failing to warn of the deadly disease of NEC and risk of death.
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`26.
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`Thus, despite the existence of alternative and safe human milk-based fortifiers,
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`Defendant continues 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.
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`The Inadequate Warnings
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`27.
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`Defendant promotes the use of its 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
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`by preterm infants for adequate growth.
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`28.
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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,
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`Defendant did not warn parents or medical providers of the risk of NEC in preterm infants, nor did
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`Defendant provide any instructions or guidance on how to properly use its Cow’s Milk-Based
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`Products so as to lower the risk or avoid NEC or death.
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`29.
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`In fact, the Defendant does not provide any warning in its labeling, websites, or
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`marketing that discusses the risk of NEC and death with use of its Cow’s Milk-Based Products
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`with preterm infants.
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`30.
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`Thus, Defendant does 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
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`guidance on how to avoid or reduce the risks of NEC or death while using its products.
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`Ryan J. De Los Santos and the Dangerous, Defective Products
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`31.
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`Ryan J. De Los Santos was born prematurely at Driscoll Children’s Hospital in
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`Corpus Christi, Texas on October 19, 2019. Ryan J. De los Santos was born preterm at 37 weeks.
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`32.
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`33.
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`On October 22, 2019, Ryan J. De Los Santos was admitted to the Neonatal ICU.
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`On October 28, 2019, Ryan J. De Los Santos started trophic feeds with Similar
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`Advance formula.
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`34.
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`From October 28, 2019 to November 8, 2019, Ryan J. De Los Santos received
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`Similar Advance formula.
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`35.
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`36.
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`On November 8, 2019, Ryan J. De Los Santos was worked up for a bloody stool.
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`On November 8, 2019, an exploratory laparotomy was conducted on Ryan J. De
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`Los Santos. Necrotizing enterocolitis (NEC) with substantial pneumatosis and abdominal free air
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`was noted.
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`37.
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`On November 22, 2019, Ryan J. De Los Santos completed a 14-day regime of
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`antibiotics for NEC.
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`38.
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`On November 25-26, 2019, Ryan J. De Los Santos received abdominal x-rays
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`concerning residual pneumatosis and NEC follow-up.
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`39.
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`On December 24, 2019, Ryan J. De Los Santos was discharged from Driscoll
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`Children’s Hospital.
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`40.
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`At the time he was diagnosed with and treated for NEC, Ryan J. De Los Santos’s
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`parents were unaware of the fact that the Defendant’s Cow’s Milk-Based Products he was fed
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`caused or substantially contributed to his development of NEC and resulting injuries.
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`COUNT I: STRICT LIABILITY AS TO DEFENDANT ABBOTT’S DESIGN
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`41.
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`Plaintiffs incorporate by reference each of the preceding paragraphs as if fully set
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`forth herein.
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`42.
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`At all times material to this action, Defendant Abbott was engaged in the sale,
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`and/or marketing and/or design, and/or manufacture, and/or distribution of Cow’s Milk-Based
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`Products, which are defectively designed and/or unreasonably dangerous to consumers.
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`43.
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`Defendant Abbott, as a manufacturer, has a duty to hold the knowledge and skill of
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`an expert and is obliged to keep abreast of any scientific discoveries and are presumed to know
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`the result of all such advances.
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`44.
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`At all times material to this action, the Cow’s Milk-Based Products manufactured,
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`distributed and/or sold by Defendant Abbott, were in a defective and/or unreasonably dangerous
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`condition at the time the products were placed in the stream of commerce for nutritional use for
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`preterm infants.
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`45.
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`Defendant Abbott specifically marketed and created its Cow’s Milk-Based
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`Products for use as nutrition and nutritional supplements for preterm infants.
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`46.
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`Defendant Abbott’s Cow’s Milk-Based Products are expected to and do reach the
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`user without substantial change affecting that defective and/or unreasonably dangerous condition.
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`47.
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`Prior to Plaintiff’s birth, Defendant Abbott was aware or should have been aware
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`that its Cow’s Milk-Based Products were not safe for use, as they were used, as nutrition or
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`nutritional support in preterm infants, yet they took no steps to prevent the use of these products
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`in such situations.
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`48.
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`Defendant Abbott knew or should have known that the use of its Cow’s Milk-Based
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`Products with preterm infants was unreasonably dangerous in that its Cow’s Milk-Based Products
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`significantly increased the risk of NEC.
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`49.
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`Furthermore, scientific data and well-researched studies have concluded that the
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`Cow’s Milk-Based Products of the Defendant carried unreasonable risks of NEC and death, which
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`far outweighed the products’ benefits for preterm infants.
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`50.
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`Despite the foregoing, the Defendant continued to sell and market its defective
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`and/or unreasonably dangerous products to preterm infants.
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`51.
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`The products were defectively manufactured and/or designed and/or unreasonably
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`dangerous, including, but not limited to the following particulars:
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`a.
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`The products did not perform as safely as an ordinary consumer would expect when
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`used in the intended or reasonably foreseeable manner, such that the use of Cow’s
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`Milk-Based Products as nutrition or nutritional supplements in preterm infants
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`significantly increased the risk of NEC;
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`b.
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`The products contained hidden and dangerous design defects and were not
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`reasonably safe as intended to be used, subjecting preterm infants, to risks of serious
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`bodily injury;
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`c.
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`The products failed to meet legitimate, commonly held, minimum safety
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`expectations of that product when used in an intended or reasonably foreseeable
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`manner;
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`d.
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`Defendant failed to utilize economical and technically available safer design
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`alternatives for preterm infant formula and fortifiers;
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`e.
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`The products were manifestly unreasonable in that the risk of harm so clearly
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`exceeded the products’ utility that a reasonable consumer, informed of those risks
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`and utility, would not purchase the product;
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`f.
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`g.
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`Defendant failed to adopt an adequate or sufficient quality control program; and/or
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`Defendant failed to inspect or test its products with sufficient care.
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`52.
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`As a direct and proximate cause of the Cow’s Milk-Based Product’s unreasonable
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`dangerous condition, Plaintiff suffered serious bodily injury.
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`WHEREFORE, Plaintiff, by and through undersigned counsel, demands judgment against
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`Defendant Abbott Laboratories for all applicable damages, costs of this action, post-judgment
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`interest, and trial by jury.
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`COUNT II: NEGLIGENCE AS TO DEFENDANT ABBOTT
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`53.
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`Plaintiff incorporates by reference each of the preceding paragraphs as if fully set
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`forth herein.
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`54.
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`Defendant Abbott, as the manufacturer and/or seller of Cow’s Milk-Based
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`Products, owed a duty to the consuming public in general, and Plaintiff in particular, to exercise
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`reasonable care to design, test, manufacture, inspect, and distribute a product free of unreasonable
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`risk of harm to users and patients, when said product is used in its intended manner.
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`55.
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`Defendant Abbott, as a manufacturer, has a duty to hold the knowledge and skill of
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`an expert and is obliged to keep abreast of any scientific discoveries and are presumed to know
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`the result of all such advances.
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`56.
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`Defendant Abbott, directly or indirectly, negligently, and/or defectively made,
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`created, manufactured, designed, assembled, tested, marketed and/or sold the subject Cow’s Milk-
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`Based Products.
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`57.
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`Defendant breached the duty owed to Plaintiff and acted negligently in its actions,
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`including, but not limited to, the following:
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`a.
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`Designed the products such that there are latent and not obvious dangers for
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`consumers and patients while the products are being used in a foreseeable and
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`intended manner;
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`b.
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`The products contained hidden and dangerous design defects and were not
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`reasonably safe as intended to be used, subjecting preterm infants to risks of serious
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`bodily injury and death in that the products’ design and/or manufacture amounted
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`to and/or resulted in a defect failure mode of the products;
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`c.
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`d.
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`e.
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`f.
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`Failing to collect data to determine if its products were safe for preterm infants;
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`Failing to collect data to determine when and how its products could be used safely;
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`Failing to utilize the significant peer reviewed research to develop instructions;
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`Failing to develop evidence-based guidelines or instructions to decrease the risk of
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`its products causing NEC and death;
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`g.
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`Failing to provide evidence-based guidelines or instructions to decrease the risk of
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`its products causing NEC and death;
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`h.
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`Failing to stop or deter its products from being fed to preterm infants like Baby
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`Mason;
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`i.
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`j.
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`Failing to provide evidence-based instructions or guidance on when or how a
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`preterm infant should be transitioned to the products;
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`Failing to update its warnings and/or instructions based upon currently available
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`data, research, and studies;
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`k.
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`Failing to take reasonable steps to prevent preterm infants from developing NEC
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`and/or death
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`l.
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`Failing to take reasonable precautions to prevent preterm infants from developing
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`NEC and/or death
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`m.
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`Improperly creating agreements with hospitals whereby its products would be over
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`utilized to the detriment of the preterm infants; and/or
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`n.
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`Improperly promoting continued use of its product in hospitals despite knowing of
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`the great harm it was causing; and/or
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`o.
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`Failing to develop comprehensive mitigation strategies to reduce the risk of NEC
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`and/or death in its products; and/or
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`p.
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`Intentionally promoting a culture of silence whereby the harmful effects of its
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`products were never being communicated to the parents or the public; and/or
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`q.
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`Failing to insert a warning or instruction to healthcare professionals in the NICU
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`that parents should be provided information necessary to make an informed choice
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`about whether to allow their babies to be fed cow’s milk-based products; and/or
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`r.
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`Failing to continuously and vigorously study its cow’s milk-based products in order
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`to avoid NEC and death in premature infants;
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`s.
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`Failing to utilize economical and technically available safer manufacturing and/or
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`design alternatives for the preterm infant formula and fortifier;
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`Failing to adopt an adequate or sufficient quality control program; and/or
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`Failing to inspect or test their products with sufficient care.
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`t.
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`u.
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`58.
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`Defendant Abbott knew or should have known that its products were to be used as
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`nutrition and nutritional supplements with preterm infants.
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`59.
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`Defendant Abbott knew or should have known that the use of its Cow’s Milk-Based
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`Products with preterm infants was unreasonably dangerous in that its Cow’s Milk-Based Products
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`significantly increased the risk of NEC.
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`60.
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`Furthermore, scientific data and well researched studies have concluded that the
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`Cow’s Milk-Based Products of the Defendant carried unreasonable risks of NEC and death, which
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`far outweighed the products’ benefits for extremely premature infants.
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`61.
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`As a direct and proximate result of the negligence of Defendant Abbott, Plaintiff
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`suffered serious bodily injury.
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`WHEREFORE, Plaintiff, by and through undersigned counsel, demands judgment against
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`Defendant Abbott Laboratories for all applicable damages, costs of this action, post-judgment
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`interest, and trial by jury.
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`COUNT III: FAILURE TO WARN AS TO DEFENDANT ABBOTT
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`62.
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`Plaintiff incorporates by reference each of the preceding paragraphs as if fully set
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`forth herein.
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`63.
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`Defendant Abbott, as the manufacturer and/or seller of Cow’s Milk-Based
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`Products, owed a duty to the consuming public in general, and Plaintiff in particular, to properly
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`warn and provide adequate warnings or instructions about the dangers and risks associated with
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`the use of Cow’s Milk-Based Products with preterm infants, specifically including but not limited
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`to the risk of NEC.
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`64.
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`Defendant Abbott, as the manufacturer and/or seller of Cow’s Milk-Based
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`Products, was unreasonable in relying upon any intermediary, including physicians, other health
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`care providers or health care staff, to fully warn the end user of the hidden dangers and risks in its
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`Cow’s Milk-Based Products, as the magnitude of the risk involved is using Defendant’s Cow’s
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`Milk-Based Products with preterm infants is significant and involves the real danger of serious
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`bodily injury and death.
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`65.
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`Defendant Abbott, as the manufacturer and