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`
`DIXON DIAB & CHAMBERS LLP
`DEBORAH S. DIXON (SBN 248965)
`ddixon@theddcfirm.com
`TARINA MAND (SBN 316477)
`tarina@theddcfirm.com
`501 West Broadway, Suite 800
`San Diego, California 92101
`Telephone: (619) 354-2662
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`GOMEZ TRIAL ATTORNEYS
`JOHN H. GOMEZ (SBN 171485)
`jgomez@thegomezfirm.com
`
`655 W. Broadway Suite 1700
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`San Diego, California 92101
`Telephone: (619) 237-3490
`Facsimile: (619) 237-3496
`
`Counsel for Plaintiff
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`UNITED STATES DISTRICT COURT
`
`CENTRAL DISTRICT OF CALIFORNIA
`
`EASTERN DIVISION
`
`
`Case No: 5:21-cv-2146
`
`COMPLAINT
`
`
`
`
`
`
`
`LASHANAE LITTLES, individually
`and on behalf of THE ESTATE OF
`MAKAI SANDERS,
`
`
`
`
`v.
`
`Plaintiff,
`
`ABBOTT LABORATORIES, INC.;
`MEAD JOHNSON & COMPANY,
`LLC and/or MEAD JOHNSON
`NUTRITION COMPANY,
`
`
`Defendants.
`
`
`
`
`
`
`
`
`
`LaShanae Littles, et al. v. Abbott Laboratories, Inc., Case No. 5:21-CV-2146
`COMPLAINT
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`Case 5:21-cv-02146 Document 1 Filed 12/27/21 Page 2 of 32 Page ID #:2
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`PARTIES, JURISDICTION, AND VENUE
`1.
`Plaintiff LaShanae Littles, individually and on behalf of the Estate of
`Makai Sanders, is an adult and resident of San Bernardino County, California. She
`is the mother of Makai Sanders, who was a minor and is now deceased, and sues as
`his successor-in-interest for causes of action that survive her baby’s death.
`2.
`On December 25, 2020, Makai Sanders (“Baby Sanders”) was born at
`Community Hospital of San Bernardino in San Bernardino, California.
`3.
`Baby Sanders, is the son of LaShanae Littles (“Plaintiff” or “the
`mother”).
`4.
`The Defendant, Mead Johnson & Company, LLC and/or Mead Johnson
`Nutrition Company (“Mead”) manufactures, designs formulates, prepares, tests,
`provides instructions, markets, labels, packages, places into the stream of commerce
`in all fifty states, including California, and sells premature infant formula products
`including Enfamil Human Milk Fortifier and Enfacare Powder.
`5.
`The Defendant, Abbott Laboratories, Inc. (“Abbott,” together with
`Mead, the “Defendants”) manufactures, designs, formulates prepares, tests, provides
`instructions, markets, labels, packages, places into the stream of commerce in all
`fifty states, including California, and sells premature infant formula including
`Similac Special Care.
`6.
`This Court has original jurisdiction pursuant to 28 U.S.C. § 1332(a)
`because complete diversity exists between Plaintiff and Defendants, and the matter
`in controversy, exclusive of interest and costs, exceeds the sum or value of $75,000.
`7.
`This Court has personal jurisdiction over Defendants because
`Defendants are authorized to conduct and do conduct business in the State of
`California and Defendants have sufficient minimum contacts with this State and/or
`sufficiently avails itself of the markets in this State through its promotion, sales,
`distribution and marketing within this State to render the exercise of jurisdiction by
`this Court permissible.
`
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`LaShanae Littles, et al. v. Abbott Laboratories, Inc., Case No. 5:21-CV-2146
`COMPLAINT
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`Case 5:21-cv-02146 Document 1 Filed 12/27/21 Page 3 of 32 Page ID #:3
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`8.
`Venue is proper in this Court pursuant to 28 U.S.C. §§ 1391(a) and (b)
`because a substantial part of the events or omissions giving rise to Plaintiff’s claims
`occurred in this judicial district.
`GENERAL ALLEGATION
`9.
`On December 25, 2020, Baby Sanders was born prematurely with a low
`birth weight of 4 pounds and 2 ounces.
`10. Following the birth, Makai Sanders, was placed in the Neonatal
`Intensive Care Unit (NICU) at Community Hospital of San Bernardino.
`11. Baby Sanders, was intravenously fed Similac Special Case 20Fe,
`Enfamil HMF High Protein, Enfamil Premature, and Enfamil Premium, while in the
`NICU.
`12. On January 25, 2021, after being fed Defendants products, Baby
`Sanders developed Necrotizing Enterocolitis (“NEC”).
`13. On January 27, 2021, at only 34 days old, Baby Sanders passed away
`from medical complications after developing NEC, which are the direct and
`proximate result of consumption of Defendants unreasonably dangerous cow’s milk-
`based products.
`
`THE SCIENCE
`14. According to the World Health Organization (“WHO”), babies born
`prematurely, or “preterm,” are defined as being born alive before 37 weeks of
`pregnancy are completed, like Makai Sanders. The WHO estimates that
`approximately 15 million babies are born preterm every year and that number is
`rising.
`15. Nutrition for preterm babies, like Makai Sanders, is significantly
`important. Since the United States ranks in the top ten countries in the world with
`the greatest number of preterm births, the market of infant formula and fortifiers is
`particularly vibrant.
`/ / /
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`LaShanae Littles, et al. v. Abbott Laboratories, Inc., Case No. 5:21-CV-2146
`COMPLAINT
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`Case 5:21-cv-02146 Document 1 Filed 12/27/21 Page 4 of 32 Page ID #:4
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`16. Originally, cow’s milk-based products were believed to be good for the
`growth of premature, low birth weight babies; however, science and research have
`advanced for decades confirming the significant dangers of the Defendants’ cow’s
`milk-based products
`in causing Necrotizing Enterocolitis (“NEC”) and/or
`substantially contributing to death in preterm and severely preterm, low-weight
`infants, along with many other health complications and long-term risks to babies,
`yet, the Defendants did nothing to change their product, packaging, guidelines,
`instructions, and/or warnings. Additionally, advances in science have created
`alternative formulas and fortifiers that are derived from human milk and non-bovine
`based products; however, the Defendants continue to promote and sell their defunct
`cow’s milk-based products.
`17. As early as 1990, a prospective, multicenter study on 926 preterm
`infants found that NEC was six to ten times more common in exclusively formula-
`fed babies than in those fed breast milk alone and three times more common than in
`those who received formula plus breast milk. Babies born at more than 30 weeks
`gestation confirmed that NEC was rare in those whose diet included breast milk, but
`it was 20 times more common in those fed formula only. A. Lucas, T. Cole, Breast
`Milk and Neonatal Necrotizing Enterocolitis, LANCET, 336: 1519-1523 (1990).
`18.
`In a study published in 2007 it was reported: “The use of an
`exclusive HUM [Human] diet is associated with significant benefits for
`extremely premature infants <1259 g BW. The benefits include decreased NEC
`rates, mortality, late-onset sepsis, PDA, BPD, ventilator days, and ROP.
`Importantly, while evaluating the benefits of using an exclusive HUM-based
`protocol, it appears that there were no feeding-related adverse outcomes. This
`study demonstrates that an exclusive HUM diet provides important benefits
`beyond NEC.” Hair, Amy, et al. Beyond Necrotizing Enterocolitis Prevention:
`Improving Outcomes with an Exclusive Human Milk-Based Diet. (Breastfeeding
`Medicine. 2016, Nov 2., 11(2):70-75.)
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`COMPLAINT
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`Case 5:21-cv-02146 Document 1 Filed 12/27/21 Page 5 of 32 Page ID #:5
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`19. A study published in 2010 established that when premature babies were
`fed an exclusive diet of mother’s milk, donor milk, and human milk fortifier, these
`babies were 90% less likely to develop surgical NEC. Sullivan, S., et al., An
`Exclusively Human Milk-Based Diet Is Associated with a Lower Rate of Necrotising
`Enterocolitis than a Death of Human Milk and Bovine Milk-Based Products.
`(Journal of Pediatrics 2010; 156:562-7.)
`20.
`In 2011, the U.S. Surgeon General published a report titled, “The
`Surgeon General’s Call to Action to Support Breastfeeding.” In it, the Surgeon
`General warned that “for vulnerable premature infants, formula feeding is associated
`with higher rates of [NEC].” U.S. Dep’t. of Health & Human Serv., Off. of Surgeon
`Gen., “The Surgeon General’s Call to Action to Support Breastfeeding,” p. 1, (2011).
`This same report stated that premature infants who are not breast fed are 138% more
`likely to develop NEC. Id., Table 1, p. 2.
`21.
`In 2012, the American Academy of Pediatrics issued a policy statement
`that all premature infants should be fed an exclusive human milk diet because of the
`risk of NEC associated with the consumption of cow’s milk-based products. The
`Academy stated that “[t]he potent benefits of human milk are such that all pre-term
`infants should receive human milk … If
`the mother’s own milk
`is
`unavailable…pasteurized donor milk should be used.” Breastfeeding and the Use
`of Human Milk, PEDIATRICS, 129:e827-e841 (2012).
`22. A study published in 2013 showed that, out of 104 the premature infants
`participating in the study receiving an exclusive human-milk based diet, all 104
`exceeded targeted growth standards, as well as length, weight, and head
`circumference gain. The authors concluded that “this study provides data showing
`that infants can achieve and mostly exceed targeted growth standards when receiving
`an exclusive human milk-based diet.” A. Hair, et al., Human Milk Feed Supports
`Adequate Growth in Infants <1250 Grams Birthweight, BMC RESEARCH NOTES,
`6- 459 (2013). Thus, inadequate growth was proven to be a poor excuse for feeding
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`LaShanae Littles, et al. v. Abbott Laboratories, Inc., Case No. 5:21-CV-2146
`COMPLAINT
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`Case 5:21-cv-02146 Document 1 Filed 12/27/21 Page 6 of 32 Page ID #:6
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`cow’s milk-based products, but the practice continued largely due to extensive and
`aggressive marketing campaigns conducted by infant formula companies.
`23.
`In another study published in 2013 it was reported: “This is the first
`randomized trial in EP [Extremely Premature] infants of exclusive HM [Human
`Milk] vs. PF [Preterm Formula]. The significantly shorter duration of TPN and
`lower rate of surgical NEC support major changes in the strategy to nourish EP
`infants in the NICU.” Cristofalo, E.A., et al., Exclusive Human Milk vs. Preterm
`Formula: Randomized Trial in Extremely Preterm Infants. (J Pediatr 2013 Dec;
`163(6): 1592-1595.)
`24.
`In a study published in 2014, it was reported: “Necrotizing enterocolitis
`(NEC) is a devastating disease of premature infants and is associated with significant
`morbidity and mortality. While the pathogenesis of NEC remains incompletely
`understood, it is well established that the risk is increased by the administration of
`infant formula and decreased by the administration of breast milk.” Good, Misty, et
`al., Evidence Based Feeding Strategies Before and After the Development of
`Necrotizing Enterocolitis. (Expert Rev Clin Immunol. 2014 July; 10 (7): 875-884.)
`25.
`In that same article it was reported: “Necrotizing enterocolitis (NEC) is
`the most frequent and lethal gastrointestinal disorder affecting preterm infants, and
`is characterized by intestinal barrier disruption leading to intestinal necrosis, multi-
`system organ failure and death. NEC affects 7-12% of preterm infants weighing less
`than 1500 grams, and the frequency of disease appears to be either stable or rising
`in several studies. The typical patient who develops NEC is a premature infant who
`displays a rapid progression from mild feeding intolerance to systemic sepsis, and
`up to 30% of infants will die from this disease.”
`26.
`In that same article it was reported: “A wide variety of feeding practices
`exist on how to feed the premature infant in the hopes of preventing necrotizing
`enterocolitis. There have been several meta-analysis reviewing the timing of
`administration and rate of advancement of enteral feedings in the premature infant
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`LaShanae Littles, et al. v. Abbott Laboratories, Inc., Case No. 5:21-CV-2146
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`Case 5:21-cv-02146 Document 1 Filed 12/27/21 Page 7 of 32 Page ID #:7
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`as reviewed above, but there is no consensus on the precise feeding strategy to
`prevent this disease. The exclusive use of human breast milk is recommended for
`all premature infants and is associated with a significant decrease in the incidence of
`NEC. By determining the specific ingredients in breast milk that are protective
`against NEC, it is our hope that this devastating disease will one day be preventable.”
`27.
`In a study published in 2016 it was reported: “Extremely premature
`infants who received an exclusive HUM diet had a significantly lower incidence
`of NEC and mortality. The HUM group also had a reduction in late-onset sepsis,
`BPD, and ROP. This multicenter study further emphasizes the many benefits of
`an exclusive HUM diet, and demonstrates multiple improved outcomes after
`implementation of such a feeding protocol.” Hair, Amy, et al. Beyond
`Necrotizing Enterocolitis Prevention: Improving Outcomes with an Exclusive
`Human Milk-Based Diet. (Breastfeeding Medicine. 2016, Nov. 2, 11(2):70-75.)
`28.
`In a study published in 2017, it was reported: “Human milk is the
`preferred diet for preterm infants as it protects against a multitude of NICU
`challenges, specifically necrotizing enterocolitis. Infants who receive greater
`than 50% of mother’s own milk (MOM) in the 2 weeks after birth have a
`significantly decreased risk of NEC. An additional factor in the recent declining
`rates of NEC is the increased utilization of donor human milk (DHM). This
`creates a bridge until MOM is readily available, thus decreasing the exposure to
`cow milk protein. Preterm infants are susceptible to NEC due to the immaturity
`of their gastrointestinal and immune systems. An exclusive human milk diet
`compensates for these immature systems in many ways such as lowering gastric
`pH, enhancing intestinal motility, decreasing epithelial permeability, and
`altering the composition of bacterial flora. Ideally, preterm infants should be fed
`human milk and avoid bovine protein. A diet consisting of human milk-based
`human milk fortifier is one way to provide the additional nutritional supplements
`necessary for adequate growth while receiving the protective benefits of a human
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`LaShanae Littles, et al. v. Abbott Laboratories, Inc., Case No. 5:21-CV-2146
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`Case 5:21-cv-02146 Document 1 Filed 12/27/21 Page 8 of 32 Page ID #:8
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`milk diet.” Maffei, Diana, Schanler, Richard J., Human milk is the feeding
`strategy to prevent necrotizing enterocolitis! (Semin Perinatol. 2017 Feb;
`41(1):36-40.).
`29.
`In another study published in 2017, it was reported: “In summary,
`HM [Human Milk] has been acknowledged as the best source of nutrition for
`preterm infants and those at risk for NEC. Two RCTs [Randomized Clinical
`Trials] on preterm infants weighing between 500 and 1250 g at birth compared
`the effect of bovine milk-based preterm infant formula to MOM or DHM on the
`incidence of NEC. Both trials found that an exclusive HM diet results in a lower
`incidence of NEC. A Cochrane systematic review that evaluated the effect of
`DHM or bovine milk-based formula on health outcomes for preterm infants also
`determined that formula significantly increases the risk of NEC.” Shulhan,
`Jocelyn, et al., Current Knowledge of Necrotizing Enterocolitis in Preterm
`Infants and the Impact of Different Types of Enteral Nutrition Products. (ASN.
`ADV Nutr 2017; 8:8-0.91.)
`30. Yet another study that analyzed the data from a 12-center randomized
`trial concluded that fortification of breast milk with a cow’s milk-based fortifier
`resulted in a 4.2-fold increased risk of NEC and a 5.1-fold increased risk of surgical
`NEC or death, compared to fortification with a breast milk-based fortifier.
`31. Another study conducted a randomized comparison of extremely
`preterm infants who were given either (a) a diet of breast milk fortified with a breast
`milk-based fortifier or (b) a diet containing variable amounts of cow’s milk-based
`products. The babies given exclusively breast milk products suffered NEC 5% of the
`time. The babies given cow’s milk products suffered NEC 17% of the time.
`32. Further, when Defendants recognized a shift in the medical community
`towards an exclusive breast milk-based diet for premature infants, Abbott developed
`a product called “Similac Human Milk Fortifier.” Similar to the “Human Milk”
`formula, these names are misleading in that they suggest that the products are
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`Case 5:21-cv-02146 Document 1 Filed 12/27/21 Page 9 of 32 Page ID #:9
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`derived from breast milk, when, in fact, they are cow’s milk-based products. One
`study, for example, found that 91.2 percent of parents surveyed in the NICU
`interpreted “human milk fortifier” as potentially meaning breast milk-based product.
`33. Abbott’s packaging directs users to: “Add only to human milk—do not
`add water.” This direction is convoluted by Abbott’s misleading use of the term
`human milk. The fortifier can be added to Abbott’s “Human Milk” formula, as well
`as breast milk. There is no indication that the fortifier is only meant to be added to
`breast milk, and even if this was the intended direction, the widespread
`misapplication of the fortifier to Abbott’s “Human Milk” formula would be its own
`doing by deliberately conflating and misdirecting the delineation of “human milk.”
`The packaging appears as:
`
`
`
`34. Defendants have designed powerful misleading marketing campaigns
`to deceive parents into believing that: (1) cow’s milk-based products are safe,
`including for preterm infants; (2) cow’s milk-based products are equal, or even
`superior, substitutes to breast milk; (3) cow’s milk-based products are necessary for
`proper growth and development of preterm infants; and (4) physicians consider
`Defendants’ cow’s milk-based products a first choice. This marketing scheme is
`employed despite Defendants knowing of and failing to warn of the extreme risk of
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`Case 5:21-cv-02146 Document 1 Filed 12/27/21 Page 10 of 32 Page ID #:10
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`NEC and death that cow’s milk-based products pose to preterm infants like Baby
`Sanders.
`35. The products Abbott markets specifically for premature infants are
`available at retail locations and online. No prescription is necessary. As seen above,
`Abbott’s packaging failed to give any precaution to use the product under the
`direction of a physician, however, newer packaging includes such a caution: “To be
`used only under the supervision of a doctor.” The packaging seems to be changed
`recently to include this warning and products with the older packaging are still
`widely available to buy online.
`36. Despite knowing of the risk of NEC, Abbott did not warn of the
`significantly increased risk of NEC (and resulting medical conditions, and/or death)
`associated with its products, or of the magnitude of this increased risk. Abbott
`likewise did not provide instructions or guidance for how to avoid NEC.
`37. Abbott deceived the public, parents, physicians, other medical
`professionals, and medical staff into believing that its products were a safe and
`necessary alternative, supplement and/or substitute to breast milk.
`38. Despite knowing that its products were being fed to premature infants,
`often without the parents’ informed consent, Abbott failed to require or recommend
`that medical professionals or hospitals inform parents of the significant risk of NEC
`or to require that parental consent be obtained prior to the products being fed to their
`babies.
`39. On information and belief, Abbott was aware of the significantly
`increased risk of NEC and death associated with their cow’s milk-based products,
`and instead of warning of the dangers, or removing them altogether, Abbott has
`continued to use cow’s milk as the foundation of their products. Abbott fails to
`mention “cow’s milk” anywhere on its packaging, and surreptitiously refers to cow’s
`milk under its ingredients as “Nonfat Milk.” The words “cow’s milk” or “cow” are
`nowhere to be found on any of the packaging or marketing for its product.
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`Case 5:21-cv-02146 Document 1 Filed 12/27/21 Page 11 of 32 Page ID #:11
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`Abbott’s Failure to Provide Adequate Warnings, Instructions or Guidelines
`40. Defendant Abbott Laboratories,
`Inc. manufactures, designs,
`formulates, prepares, tests, provides instructions, markets, labels, packages, places
`into the stream of commerce in all fifty states, including California, and sells
`premature infant formula and fortifier.
`41. Abbott’s Similac product contained only the following packaging
`information guidelines, instructions and warnings:
`“Similac Special Care 20 – Precautions:
`• Very low-birth-weight infants are particularly susceptible to
`gastrointestinal complications; therefore, feeding should be initiated
`cautiously
`• Tolerance to enteral feedings should be confirmed by initially offering
`small volumes of formula followed by cautious progression to higher
`caloric feedings
`• Spitting up, abdominal distention, abnormal stools or stool patterns,
`excessive gastric residuals, or other signs of intestinal dysfunction have
`been associated with enteral feeding before the intestinal tract is ready
`to accommodate the regimen. At the first sign of these problems, enteral
`feeding should be slowed or discontinued
`• Not intended for feeding low-birth-weight infants after they reach a
`weight of 3600 g (approximately 8 lb) or as directed by a physician”
`“Similac Special Care 24 – Precautions:
`• Very low-birth weight infants are particularly susceptible to
`gastrointestinal complications; therefore, feeding should be initiated
`cautiously
`• Tolerance to enteral feedings should be confirmed by initially offering
`small volumes of formula followed by cautious progression to higher
`caloric feedings
`• Spitting up, abdominal distention, abnormal stools or stool patterns,
`excessive gastric residuals, or other signs of intestinal dysfunction have
`been associated with enteral feeding before the intestinal tract is ready
`to accommodate the regimen. At the first sign of these problems, enteral
`feeding should be slowed or discontinued
`• Not intended for feeding low-birth-weight infants after they reach a
`weight of 3600 g (approximately 8 lb) or as directed by a physician”
`“Similac Special Care 24 High Protein – Precautions:
`
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`Case 5:21-cv-02146 Document 1 Filed 12/27/21 Page 12 of 32 Page ID #:12
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`• Very low-birth-weight infants are particularly susceptible to
`gastrointestinal complications; therefore, feeding should be initiated
`cautiously
`• Tolerance to enteral feedings should be confirmed by initially offering
`small volumes of formula followed by cautious progression to higher
`caloric feedings
`• Spitting up, abdominal distention, abnormal stools or stool patterns,
`excessive gastric residuals, or other signs of intestinal dysfunction have
`been associated with enteral feeding before the intestinal tract is ready
`to accommodate the regimen. At the first sign of these problems, enteral
`feeding should be
`slowed or discontinued.
`• Not intended for feeding low-birth-weight infants after they reach a
`weight of 3600 g (approximately 8 lb) or as directed by a physician
`
`“Similac Special Care 30 – Precautions:
`• Very low-birth-weight infants are particularly susceptible to
`gastrointestinal complications; therefore, feeding should be initiated
`cautiously
`• Use this product only after feedings of lower caloric density are well-
`established. For improved tolerance, it is best to increase caloric density
`slowly, by 2- to 4-Cal/fl oz increments
`• Hydration status should be monitored
`• Spitting up, abdominal distention, abnormal stools or stool patterns,
`excessive gastric residuals, or other signs of intestinal dysfunction have
`been associated with enteral feeding before the intestinal tract is ready
`to accommodate the regimen. At the first sign of these problems, enteral
`feeding should be slowed or discontinued
`• Not intended for feeding low-birth-weight infants after they reach a
`weight of 3600 g (approximately 8 lb) or as directed by a physician”
`“Similac Special Care Premature 20 calorie and 24 calorie and High Protein
`Precaution:
`• If signs of intolerance develop, slow feeding or discontinue.
`• Not intended for low-birth-weight infants after they reach a weight of
`3600 grams (approx.. 8 lb) or as directed by a doctor.”
`
`“Similac Special Care Premature 30 calorie – Precaution:
`• Use once feeding tolerance is established
`• If signs of intolerance develop, slow feeding or discontinue.
`• Hydration status should be monitored
`12
`LaShanae Littles, et al. v. Abbott Laboratories, Inc., Case No. 5:21-CV-2146
`COMPLAINT
`
`
`
`Case 5:21-cv-02146 Document 1 Filed 12/27/21 Page 13 of 32 Page ID #:13
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`• Not intended for low-birth-weight infants after they reach a weight of
`3600 grams (approx.. 8 lb) or as directed by a doctor.”
`
`42. Defendant Abbott’s product, Similac Alimentum and Similac
`Alimentum Expert Care, contain only the following packaging information warnings
`and instructions:
`
`Safety Precautions: Never use a microwave oven to warm
`mixture. Serious burns can result.
`Warning: Powdered infant formulas 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.
`
`43. Defendant Abbott’s range of Human Milk Fortifiers contain only the
`following packaging information warnings and instructions:
`Similac Human Milk Fortifier Concentrated Liquid: 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
`
`
`Similac Human Milk Fortifer Hydrolyzed Protein Concentrated Liquid:
`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 Hydrolyzed Protein Concentrated Liquid can be added
`to human milk
`• Not intended for feeding low-birth-weight infants after they
`reach a weight of 3600 g (approximately 8 lb) or as directed by
`a physician
`
`
`
`Similac Human Milk Fortifier Powder: Precautions
`• Add only to human milk—do not add water
`
`13
`LaShanae Littles, et al. v. Abbott Laboratories, Inc., Case No. 5:21-CV-2146
`COMPLAINT
`
`
`
`Case 5:21-cv-02146 Document 1 Filed 12/27/21 Page 14 of 32 Page ID #:14
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`• 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 Power can be added to human milk (see Preparation,
`page 29)
`• Not intended for feeding low-birth-weight infants after they
`reach a weight of 3600 g (approximately 8 lb) or as directed by
`a physician
`1. Barrett-Reis B, et al. Pediatrics. 2000;106:581-588.
`2. Chan GM. J Perinatol. 2003;23:620-623.
`3. *Escherichia coli, Staphylococcus, Group B Streptococcus, and
`Enterobacter sakazakii (now Cronobacter sakazakii).
`
`Liquid Protein Fortifier: Precaution
`• If signs of intolerance develop, slow feeding or discontinue.
`
`44. Science and research have advanced in recent years confirming the
`dangers of the defendant’s cow’s milk-based product in causing NEC and death in
`premature infants, yet the Defendant did nothing to change its product, packaging,
`guidelines, instructions and warnings.
`45. The warnings and instructions are overly broad and vague, and do not
`ever mention that the product significantly increases the risk of NEC and death, nor
`provide any detailed instructions or evidence on when and how to feed the infants
`and how to avoid NEC and death when feeding its products.
`46. None of this medical literature properly warns the user that its product
`causes NEC and death nor does it provide guidance on how to avoid NEC or death
`while using its product.
`47. Despite knowing that its product significantly increases the risk of NEC
`and death, Abbott Laboratories, Inc. deliberately chose to omit a specific warning of
`NEC or death, and deliberately failed to provide any detailed instructions or
`guidance on how to avoid NEC or death when feeding Similac.
`48. The cow’s milk-based product, Similac, is dangerous to premature
`infants in that it significantly increases the risk that the baby will develop NEC.
`
`14
`LaShanae Littles, et al. v. Abbott Laboratories, Inc., Case No. 5:21-CV-2146
`COMPLAINT
`
`
`
`Case 5:21-cv-02146 Document 1 Filed 12/27/21 Page 15 of 32 Page ID #:15
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`49. The cow’s milk-based product, Similac, is dangerous to premature
`infants in that it significantly increases the risk that the baby will die.
`50. The Defendant, Abbott Laboratories, Inc., failed to properly warn that
`its product, Similac, can significantly increase the risk that the premature infant will
`develop NEC and suffer catastrophic injuries as occurred to Makai Sanders.
`51. Based on information and belief, Abbott Laboratories, Inc.’s cow’s
`milk-based product, Similac, did cause Baby Sanders, to develop NEC, which
`caused his unfortunate and untimely death.
`52. Prior to February 2019, the Defendant, Abbott Laboratories, Inc. was
`aware, or should have been aware, that its product was not safe for use, as it was
`used, in the premature infant, Makai Sanders, yet they took no steps to prevent its
`use in such a situation.
`53. The Defendant, Abbott Laboratories, Inc. did foresee, or should have
`foreseen, that its product would be used as it was in the case of Makai Sanders and
`knew or should have known, that such use would significantly increase the risk of
`NEC in Makai Sanders, yet it took no steps to prevent such use.
`54. The product, Similac, was not safe to be used as it was in the case of
`Makai Sanders, and the Defendant knew, or should have known, it was unsafe, yet
`it failed to properly instruct, or warn the FDA, NICUs, hospitals, doctors and parents
`that its product was not safe.
`55. The product, Similac, was not safe to be used as it was in the case of
`Makai Sanders and the Defendant knew or should have known it was unsafe, yet it
`failed to provide detailed instructions or guidelines on when and how its product
`would be safe to use in a premature infant like Makai Sanders.
`56. The Defendant, Abbott Laboratories, Inc, has marketed its products as
`safe and beneficial for premature infants like Makai Sanders.
`57. Because the Defendant Abbott Laboratories, Inc.’s product is specially
`designed as food for