Case: 1:22-cv-01190 Doc #: 1 Filed: 07/06/22 1 of 42. PageID #: 1
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF OHIO
`EASTERN DIVISION
`
`ANASTASIA HAGERMAN, individually, and
`NAOMI HAGERMAN, individually and on
`behalf of STEVEN HAGERMAN, her deceased
`minor child,
`
`
`CASE NO.:
`
`JUDGE:
`
`
`
`
`
`
`COMPLAINT
`JURY TRIAL DEMANDED
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`
`Plaintiffs,
`
`
`vs.
`
`ABBOTT LABORATORIES,
`
`
`SERVE:
`CT Corporation System
`208 So. Lasalle Street, Suite 814
`Chicago, IL 60604
`
`ABBOTT LABORATORIES, INC.,
`
`SERVE:
`CT Corporation System
`208 So. Lasalle Street, Suite 814
`Chicago, IL 60604
`
`MEAD JOHNSON & COMPANY, LLC,
`
`
`SERVE:
`Illinois Corporation Service Company
`801 Adlai Stevenson Drive
`
`
`Springfield, IL 62703
`
`and
`
`MEAD JOHNSON NUTRITION COMPANY,
`
`
`SERVE:
`Illinois Corporation Service Company
`801 Adlai Stevenson Drive
`
`
`Springfield, IL 62703
`
`
`
`
`
`
`Defendants.
`
`1
`
`

`

`Case: 1:22-cv-01190 Doc #: 1 Filed: 07/06/22 2 of 42. PageID #: 2
`
`PLAINTIFFS’ COMPLAINT
`
`
`
`Plaintiffs hereby bring this Complaint against Defendants Abbott Laboratories, Abbott
`
`Laboratories, Inc., Mead Johnson & Company, LLC, and Mead Johnson Nutrition Company
`
`(collectively “Defendants”) and state and allege as follows:1
`
`INTRODUCTION
`
`1.
`
`This action arises out of injuries suffered by premature infant twins, Plaintiff
`
`Anastasia Hagerman and decedent Steven Hagerman (together, the “Injured Infants”). The
`
`Injured Infants were given Defendants’ cow’s milk-based infant feeding products which caused
`
`the Injured Infants to develop necrotizing enterocolitis (“NEC”), a life-altering and potentially
`
`deadly disease that largely affects premature infants who are given cow’s milk-based feeding
`
`products. As a result, the Injured Infants were seriously injured, resulting in injurious long-term
`
`health impacts on Anastasia Hagerman. the injury and death of decedent Steven Hagerman, and
`
`harm to the Injured Infants’ parent (“Plaintiff Parent”).
`
`2.
`
`Plaintiffs bring this cause of action against Defendants to recover for injuries and
`
`harm that are the direct and proximate result of the Injured Infants’ consumption of Defendants’
`
`unreasonably dangerous cow’s milk-based infant feeding products.
`
`PARTIES
`
`3.
`
`Plaintiff Anatasia Hagerman is a natural person and adult who is domiciled in and
`
`a citizen of the State of West Virginia.
`
`4.
`
`Plaintiff Naomi Hagerman is a natural person and adult who is domiciled in and a
`
`citizen of the State of West Virginia. Plaintiff Naomi Hagerman is the natural mother of Anatasia
`
`
`1 The allegations in this Complaint are made upon personal knowledge as to Plaintiffs’ own acts and experiences
`and upon information and belief, including investigation conducted by Plaintiffs’ attorneys.
`
`2
`
`

`

`Case: 1:22-cv-01190 Doc #: 1 Filed: 07/06/22 3 of 42. PageID #: 3
`
`Hagerman and decedent Steven Hagerman. Plaintiff Naomi Hagerman brings this suit in her
`
`personal capacity and on behalf of her deceased minor child.
`
`5.
`
`Defendant Abbott Laboratories was at all times material hereto and is now a
`
`corporation duly organized, incorporated, and existing under the laws of the State of Delaware
`
`with its principal place of business and headquarters in the State of Illinois and is thus a resident,
`
`citizen and domiciliary of Delaware and Illinois.
`
`6.
`
`Defendant Abbott Laboratories, Inc. was at all times material hereto and is now a
`
`corporation duly organized, incorporated, and existing under the laws of the State of Delaware
`
`with its principal place of business and headquarters in the State of Illinois and is thus a resident,
`
`citizen and domiciliary of Delaware and Illinois.
`
`7.
`
`Defendants Abbott Laboratories and Abbott Laboratories, Inc. (collectively,
`
`“Abbott”) manufacture, design, formulate, prepare, test, provide instructions for, market, label,
`
`package, sell, and/or place into the stream of commerce in all fifty states, including Ohio,
`
`premature infant formula including Similac Human Milk Fortifier, Similac Special Care, Similac
`
`NeoSure, and Liquid Protein Fortifier. At all material times hereto, Abbott solely or jointly
`
`designed, developed, formulated, prepared, manufactured, provided instructions for, packaged,
`
`labeled, promoted, marketed, distributed and/or sold Similac products specifically targeting
`
`medical providers and parents of preterm infants, including but not limited to Liquid Protein
`
`Fortifier, Similac NeoSure, Similac Human Milk Fortifier, and “Similac Special Care Formulas”
`
`such as Similac Special Care 20, Similac Special Care 24, Similac Special Care 24 High Protein,
`
`and Similac Special Care 30.
`
`8.
`
`Defendants Abbott advertise that it provides the “#1 Formula Brand, Backed by
`
`Science” and claims to have “over 90 years of innovations” in infant formula.
`
`3
`
`

`

`Case: 1:22-cv-01190 Doc #: 1 Filed: 07/06/22 4 of 42. PageID #: 4
`
`9.
`
`Defendants Mead Johnson & Company, LLC, and Mead Johnson Nutrition
`
`Company (“collectively Mead”) are companies based in Illinois that manufacture, design,
`
`formulate, prepare, test, provide instructions for, market, label, package, sell, and/or place into the
`
`stream of commerce in all fifty states, including Ohio, premature infant formula including Enfamil
`
`and Enfamil Human Milk Fortifiers, including Enfamil A+, Enfamil NeuroPro, Enfamil Enspire,
`
`and EnfaCare Powder.2
`
`10. Mead Johnson Nutrition Company was at all times material hereto and is now a
`
`corporation duly organized, incorporated, and existing under the laws of the State of Delaware
`
`with its principal place of business and global headquarters in the State of Illinois and is thus a
`
`resident, citizen, and domiciliary of Delaware and Illinois.
`
`11. Mead Johnson & Company, LLC was at all times material hereto and is now a
`
`limited liability company duly organized and existing under the laws of the State of Delaware with
`
`its principal place of business and headquarters in the State of Illinois. Mead Johnson &
`
`Company’s sole member is Mead Johnson Nutrition Company and thus is a resident, citizen, and
`
`domiciliary of Delaware and Illinois.
`
`12. Mead Johnson Nutrition Company self-proclaims to be recognized as “a world
`
`leader in pediatric nutrition” and traces its history back to the company’s founding in 1905 by
`
`Edward Mead Johnson, Sr. It claims to be the “only global company focused primarily on infant
`
`and child nutrition” and that its “singular devotion has made our flagship ‘Enfa’ line the leading
`
`infant nutrition brand in the world.” Boasting “more than 70 products in over 50 countries,” it
`
`claims that its “products are trusted by millions of parents and healthcare professionals around the
`
`
`2 Defendants’ premature infant formula products at issue are collectively referred to herein as “Cow’s Milk Products.”
`
`4
`
`

`

`Case: 1:22-cv-01190 Doc #: 1 Filed: 07/06/22 5 of 42. PageID #: 5
`
`world.” It is this trust that Defendants Mead have intentionally exploited for their own pecuniary
`
`gain at the expense of vulnerable families throughout the United States and the world.
`
`JURISDICTION AND VENUE
`
`13.
`
`This is an action for damages which exceed the sum of $75,000.00, exclusive of
`
`costs, interest, and attorneys’ fees.
`
`14.
`
`This Court has jurisdiction over this case pursuant to 28 U.S.C. §1332, as complete
`
`diversity exists between Plaintiffs and the Defendants, and the matter in controversy, exclusive of
`
`interest and costs, exceeds the sum or value of $75,000.00.
`
`15.
`
`This Court has personal jurisdiction over Defendants because Defendants are
`
`authorized to conduct business and do conduct business in the State of Ohio, purposefully direct
`
`and/or directed their actions toward and/or within Ohio, and this action is related to the actions
`
`and/or inactions of Defendants in Ohio. Moreover, Defendants’ actions and/or inactions described
`
`herein were purposefully directed at and/or within the State of Ohio, the damages were sustained
`
`by Plaintiffs within the State of Ohio, and the damages sustained by Plaintiffs were a result of
`
`Defendants’ actions and/or inactions, described herein, that were purposefully directed at and/or
`
`within the State of Ohio. Further, Defendants have marketed, promoted, distributed, and/or sold
`
`their products described herein in the State of Ohio. Defendants have sufficient minimum contacts
`
`with this state and/or sufficiently avail themselves of the markets in the state through their
`
`promotion, sales, distribution, and marketing within this state to render exercise of jurisdiction by
`
`this Court permissible.
`
`16.
`
`Venue of this action is proper in this Court pursuant to 28 U.S.C. §1391(b) because
`
`a substantial part of the events or omissions giving rise to Plaintiffs’ claims occurred in this judicial
`
`district.
`
`5
`
`

`

`Case: 1:22-cv-01190 Doc #: 1 Filed: 07/06/22 6 of 42. PageID #: 6
`
`FACTUAL ALLEGATIONS
`
`The Hagerman Twins’ NEC Diagnosis
`
`1.
`
`The Injured Infants were born prematurely on July 10, 2002 at MetroHealth
`
`Medical Center in Cleveland, Ohio.
`
`2.
`
`The Injured Infants were fed Defendants’ Cow’s Milk Products Similac and/or
`
`Enfamil starting shortly after birth.
`
`3.
`
`Shortly after being fed Defendants’ Cow’s Milk Products, the Injured Infants
`
`developed NEC.
`
`4.
`
`Due to the NEC, which was directly and proximately caused by Defendants’ Cow
`
`Milk Products, the Injured Infants suffered severe complications and injuries that ultimately led
`
`to decedent’s death on June 30, 2002.
`
`5.
`
`As a result of Injured Infants’ NEC and resulting injuries, Plaintiff Parent has
`
`suffered financial and economic loss and emotional harm and distress.
`
`6.
`
`Plaintiff Parent was not informed that Defendants’ Cow’s Milk Products carried
`
`the risk of NEC (and resulting medical conditions and/or death).
`
`7.
`
`If Plaintiff Parent had been informed that Defendants’ Cow’s Milk Products were
`
`associated with health risks, including NEC, she would not have allowed the Injured Infants to be
`
`fed Defendants’ Cow’s Milk Products.
`
`The Science and Scope of the Problem
`
`8.
`
`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
`
`the Injured Infants. The WHO estimates that approximately 15 million babies are born preterm
`
`every year and that this number is rising.
`
`6
`
`

`

`Case: 1:22-cv-01190 Doc #: 1 Filed: 07/06/22 7 of 42. PageID #: 7
`
`9.
`
`Nutrition for preterm babies, like the Injured Infants, 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.
`
`10.
`
`Historically, there are three types of nutrition for preterm babies: parenteral
`
`nutrition for feed intolerance such as a feeding tube, human milk whether it is the mother’s own
`
`milk or donor milk, and cow’s milk-based formulas and fortifiers. Cow’s milk-based products
`
`(“Cow’s Milk Products”) were believed to be good for the growth of premature, low birth weight
`
`babies. While the Cow’s Milk Products were good for bulking up these babies quickly, science
`
`and research have advanced in recent years confirming strong links between cow-based products
`
`and Necrotizing Enterocolitis (“NEC”) causing 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 these babies. Additionally, advances in science have created alternative
`
`fortifiers that are derived from human milk and non-bovine based products. Despite knowledge of
`
`a causal connection between Cow’s Milk Products and NEC, the manufacturers of the Cow’s Milk
`
`Products, including Defendants, did nothing to change their product, packaging, guidelines,
`
`instructions, and/or warnings and continue to promote and sell the Cow’s Milk Product versions.
`
`11.
`
`NEC is a deadly intestinal disease characterized by inflammation and injury of the
`
`gut wall barrier that may advance to necrosis and perforation of the gut.
`
`12. With normal absorption in the small intestine, the cells lining the lumen of the
`
`intestines have microvilli that magnify the surface area available for uptake. Nutrients are
`
`absorbed by these cells, then transported through the cells, and released where they are then
`
`transported to the rest of the body through the bloodstream and lymphatic system. The cells keep
`
`out the bacteria and toxins that are present in the intestines which would be harmful if absorbed
`
`7
`
`

`

`Case: 1:22-cv-01190 Doc #: 1 Filed: 07/06/22 8 of 42. PageID #: 8
`
`into the other tissues of the body. The tight junctions between each cell play a major role in
`
`preventing the bacteria and toxins from entering the body.
`
`13.
`
`If these tight junctions are broken down, harmful bacteria and toxins are able to
`
`enter the baby’s bloodstream and lymphatics, which induces an inflammatory response in the
`
`baby’s intestinal walls. These toxins further breakdown and weaken the tight, intercellular
`
`junctions, and as a result, bacteria, toxins, and plasma escape into the surrounding interstitial
`
`spaces resulting in a condition known as “third-spacing” and sepsis. This process all begins with
`
`the administration of Cow’s Milk Products and can lead to sepsis, multi-system organ failure, and
`
`death.
`
`14.
`
`The classic signs and symptoms of NEC experienced by vulnerable preterm babies
`
`after ingesting the Cow’s Milk Products include, but are not limited to: irritability, crying, pain,
`
`abdominal distention, hyperthermia, tachycardia, decreased bowel sounds, lethargy, reduced urine
`
`output, shock, free air in the abdomen, elevated white blood count, tenderness, portal venous gas,
`
`greenish discoloration, worsening or persistent thrombocytopenia, completely gasless abdomen,
`
`repeated feeding intolerance, intestinal strictures, passage of meconium through patent processus
`
`vaginalitis, and fixed and dilated loop on serial abdominal radiographs.
`
`15.
`
`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).
`
`16.
`
`A study published in 2010 evaluated the health benefits of an exclusively human
`
`8
`
`

`

`Case: 1:22-cv-01190 Doc #: 1 Filed: 07/06/22 9 of 42. PageID #: 9
`
`milk-based diet as compared to a diet with both human milk and bovine milk-based products in
`
`extremely premature infants. The results show that preterm babies fed an exclusively human milk-
`
`based diet were 90% less likely to develop surgical NEC as compared to a diet that included some
`
`bovine milk-based products. S. Sullivan, et al., An Exclusively Human Milk-Based Diet Is
`
`Associated with a Lower Rate of Necrotizing Enterocolitis than a Diet of Human Milk and Bovine
`
`Milk-Based Products, JOURNAL OF PEDIATRICS, 156: 562-7 (2010).
`
`17.
`
`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 necrotizing
`
`enterocolitis (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.
`
`18.
`
`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 Products. The Academy stated that "[t]he potent
`
`benefits of human milk are such that all preterm 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-e84l (2012).
`
`19.
`
`A study published in 2013 showed that all 104 premature infants participating in
`
`the study receiving an exclusive human-milk based diet 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 Feeding Supports
`
`9
`
`

`

`Case: 1:22-cv-01190 Doc #: 1 Filed: 07/06/22 10 of 42. PageID #: 10
`
`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 Cow’s Milk Products, but
`
`the practice has largely continued due to extensive and aggressive marketing campaigns conducted
`
`by infant formula companies such as Defendants.
`
`20.
`
`Another study published in 2013 reported the first randomized trial in extremely
`
`premature infants of exclusive human milk versus preterm bovine-based formula. The study found
`
`a significantly higher rate of surgical NEC in infants receiving the bovine preterm formula and
`
`supported the use of exclusive human milk diet to nourish extremely preterm infants in the NICU
`
`(Newborn Intensive Care Unit). E.A. Cristofalo, et al, Randomized Trial in Extremely Preterm
`
`Infants, J PEDIATR., 163(6):1592-1595 (2013).
`
`21.
`
`In a study published in 2014, it was reported that 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." Misty Good, et al., Evidence Based Feeding Strategies Before and After the Development
`
`of Necrotizing Enterocolitis, EXPERT REV. CLIN. IMMUNOL., 10(7): 875-884 (2014 July).
`
`22.
`
`The same study found that 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.” Id. The study noted: “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.” Id. The study further found that advances in formula
`
`10
`
`

`

`Case: 1:22-cv-01190 Doc #: 1 Filed: 07/06/22 11 of 42. PageID #: 11
`
`development have made it possible to prevent necrotizing enterocolitis, and the “exclusive use of
`
`human breast milk is recommended for all preterm infants and is associated with a significant
`
`decrease in the incidence of NEC.” Id.
`
`23.
`
`In another study published in 2014, it was reported that an exclusive human milk
`
`diet, devoid of Cow’s Milk Products, was associated with “lower mortality and morbidity” in
`
`extremely preterm infants without compromising growth and should be considered as an approach
`
`to nutritional care of these infants. Steven Abrams, et al., Greater Mortality and Morbidity in
`
`Extremely Preterm
`
`Infants Fed a Diet Containing Cow Milk Protein Products,
`
`BREASTFEEDING MEDICINE, 9(6):281-286 (2014).
`
`24.
`
`In 2016, a large study supported previous findings that an exclusive human milk
`
`diet in extreme preterm infants dramatically decreased the incidence of both medical and surgical
`
`NEC. This was the first study to compare rates of NEC after a feeding protocol implementation at
`
`multiple institutions and years of follow-up using an exclusive human milk diet. The authors
`
`concluded that the use of an exclusive human milk diet is associated with “significant benefits”
`
`for extremely preterm infants and while evaluating the benefits of using an exclusive human milk-
`
`based protocol, “it appears that there were no feeding-related adverse outcomes.” Hair, et al,
`
`Beyond Necrotizing Enterocolitis Prevention: Improving Outcomes with an Exclusive Human
`
`Milk Based Diet, BREASTFEEDING MEDICINE, 11-2 (2016).
`
`25.
`
`In 2017, a publication by the American Society for Nutrition noted that human milk
`
`has “been acknowledged as the best source of nutrition for preterm infants and those at risk for
`
`NEC.” The study compared the results from two randomized clinical trials on preterm infants with
`
`severely low weight (between 500 and 1250 grams at birth) and compared the effect of bovine
`
`milk-based preterm infant formula to human milk as to the rate of NEC. Both trials found that an
`
`11
`
`

`

`Case: 1:22-cv-01190 Doc #: 1 Filed: 07/06/22 12 of 42. PageID #: 12
`
`exclusive human milk diet resulted in a much lower incidence of NEC. While the study noted that
`
`bovine milk-based preterm formulas provided consistent calories and were less expensive than
`
`human milk-based products, the bovine-based products significantly increase the risk of NEC and
`
`death. Jocelyn Shulhan, et al., Current Knowledge of Necrotizing Enterocolitis in Preterm Infants
`
`and the Impact of Different Types of Enteral Nutrition Products, ASN ADV. NUTR., 8(1):80-91
`
`(2017).
`
`26.
`
`The FDA requires manufacturers of prescription medications to study their
`
`medications and perform drug trials and collect data to determine the safety and efficacy of their
`
`drugs and to determine the likelihood of side effects, and to continuously study the drug’s use to
`
`review adverse outcomes and create proper warnings and instructions. However, because baby
`
`products, such as Defendants’ Cow’s Milk Products, are not drugs,3 Defendants have not
`
`performed such trials and have not collected data on when and how the products should be fed.
`
`Despite knowing for decades that their Cow’s Milk Products are associated with and are
`
`significantly increasing NEC and death in premature infants, and are far more dangerous than
`
`most prescription drugs, Defendants have done nothing to stop or lessen NEC or death.
`
`27.
`
`If Defendants had performed
`
`the pharmacovigilance required by drug
`
`manufacturers for their premature infant formulas and fortifiers, which a reasonably prudent
`
`manufacturer would have done, Defendants’ Cow’s Milk Products would not have been fed to the
`
`Injured Infants, they would not have developed NEC, and they would not have suffered the
`
`devastating effects of NEC.
`
`28.
`
`There are human milk-based formulas and fortifier products which are safer
`
`feasible alternatives to Defendants’ Cow’s Milk Products.
`
`
`3 Defendants’ Cow’s Milk Products do not require a prescription from a healthcare provider; rather, they are readily
`available to the average consumer.
`
`12
`
`

`

`Case: 1:22-cv-01190 Doc #: 1 Filed: 07/06/22 13 of 42. PageID #: 13
`
`The Marketing
`
`29.
`
`Notwithstanding strong and overwhelming medical evidence establishing the
`
`extreme dangers that Cow’s Milk Products pose for preterm infants, Defendants Abbott and Mead
`
`have marketed their Cow’s Milk Products as an equally safe alternative to breast milk and have
`
`promoted these products as necessary for additional nutrition and growth. Defendants have
`
`specifically marketed their formulas and fortifiers as necessary to the growth and development of
`
`preterm infants, when instead, these products pose a known and substantial risk to these babies.
`
`30.
`
`Defendants have also engaged in tactics reminiscent of tobacco manufacturers by
`
`trying to “hook” moms when they are most vulnerable. They often offer free formula and other
`
`freebies and coupons in “gift baskets” given to mothers in hospitals, medical clinics, and even left
`
`at residential charities where out-of-town families have to stay when their babies are being treated
`
`for a substantial amount of time in the neonatal intensive care units of hospitals. By doing this,
`
`Defendants are able to create brand loyalty under the guise of a “medical blessing” so that these
`
`vulnerable parents continue to use formula to feed their babies after they leave the hospital,
`
`resulting in great expense to parents, significant risk to the babies, and substantial profit to
`
`Defendants.
`
`31.
`
`Defendants are also able to hook a customer base for other products they
`
`manufacture as the customer base ages. For example, Abbott’s Similac website also advertises its
`
`products Ensure and Zone Perfect as “healthy living” and markets its “therapeutics,” such as
`
`Glucerna, Alliance, Mi Glucerna, and Nepro, which are products largely marketed to aging and
`
`geriatric populations.
`
`32.
`
`Defendants’ self-serving and nefarious tactics go back decades, as these companies
`
`continue to fight for their respective market share by scaring mothers with newborn infants,
`
`13
`
`

`

`Case: 1:22-cv-01190 Doc #: 1 Filed: 07/06/22 14 of 42. PageID #: 14
`
`especially those who are higher risk because they are born preterm. Defendants falsely advertise
`
`that their products are healthier or even necessary for adequate nutrition and that formula is the
`
`only appropriate choice for modern mothers. In fact, these tactics are purposefully designed to
`
`encourage parents to buy into the myth that formula is best, which further discourages mothers
`
`from breastfeeding at all and which further reduces the supply of available breast milk and ensures
`
`that more of their formula will be purchased.
`
`33.
`
`The WHO and United Nation’s International Children’s Emergency Fund
`
`(UNICEF) held a meeting more than two decades ago to address concerns over the marketing of
`
`breast-milk substitutes. The WHO Director concluded the meeting with the following statement,
`
`“In my opinion, the campaign against bottle-feed advertising is unbelievably more important than
`
`the fight against smoking advertisement.” Jules Law, The Politics of Breastfeeding: Assessing
`
`Risk, Dividing Labor, JSTOR SIGNS, vol. 25, no. 2: 407-50 (2000).
`
`34.
`
`Recognizing the abuse and dangers of the marketing of infant formula, in 1981, the
`
`World Health Assembly (WHA) developed the International Code of Marketing of Breast- milk
`
`Substitutes (“the Code”), which required companies to acknowledge the superiority of breast milk
`
`and outlawed any advertising or promotion of breast milk substitutes to the general public.
`
`Pursuant to Article 5.1 of the Code, advertising of breast-milk substitutes is specifically
`
`prohibited: “There should be no advertising or other form of promotion to the general public [of
`
`breast milk substitutes].” In Article 5.2, the Code states that “manufacturers and distributors
`
`should not provide, directly or indirectly, to pregnant women, mothers or members of their
`
`families, samples of products within the scope of this Code.” In addition, the Code expressly
`
`prohibits, “point-of-sale advertising, giving of samples, or any other promotion device to induce
`
`sales directly to the consumer at the retail level, such as special displays, discount coupons,
`
`14
`
`

`

`Case: 1:22-cv-01190 Doc #: 1 Filed: 07/06/22 15 of 42. PageID #: 15
`
`premiums, special sales.…” See Int’l Code of Marketing of Breast-Milk Substitutes, May 21,
`
`1981, WHA 34/1981/REC/2, Art.5.3.
`
`35. While Defendants have publicly acknowledged the Code since its adoption and
`
`claim to support the effort to educate mothers to breastfeed, they insidiously undermine
`
`breastfeeding efforts and flout the Code. See “Don’t Push It: Why the Formula Milk Industry Must
`
`Clean up its Act,” SAVE THE CHILDREN, 2018. In the decades since adoption of the Code,
`
`Defendants continue to aggressively market and exploit the vulnerabilities of these families by
`
`advertising directly to the new parents’ darkest fears – that by not buying and using these products,
`
`they will somehow hurt their newborns by not giving them the very best chance of survival. In
`
`fact, in the WHO’s 2018 Status Report on this issue, it was noted that “despite ample evidence of
`
`the benefits of exclusive and continued breastfeeding for children, women, and society, far too
`
`few children are breastfed as recommended.” The Status Report states that “a major factor
`
`undermining efforts to improve breastfeeding rates is continued and aggressive marketing of
`
`breast-milk substitutes,” noting that in 2014, the global sales of breast-milk substitutes amounted
`
`to US $44.8 billion and “is expected to rise to US $70.6 billion by 2019.” Marketing of Breast-
`
`milk Substitutes: Nat’l Implementation of the Int’l Code, Status Report 2018. Geneva: World
`
`Health Org., 2018, p. 21.
`
`36.
`
`These companies continue to aggressively market because it works, especially
`
`since they consistently employ unfair and deceptive tactics from the inception of the Cow’s Milk
`
`Products. For example, the name “Similac,” as in, it is “similar to lactation,” is deceptively
`
`designed to perpetuate a false sense that its product is similar to human breast milk.
`
`37. Moreover, an advertisement for Similac on the back cover of the April 2004 issue
`
`of American Baby Magazine makes repeated references and comparisons to breast milk for brain
`
`15
`
`

`

`Case: 1:22-cv-01190 Doc #: 1 Filed: 07/06/22 16 of 42. PageID #: 16
`
`and visual development, along with greater calcium absorption and greater bone density. See
`
`Angela B. Hyderkhan, Mammary Malfunction: A Comparison of Breastfeeding and Bottlefeeding
`
`Product Ads with Magazine Article Content, (2005) LSU MASTER’S THESES, 667,
`
`https://digitalcommons.lsu.edu/gradschool_theses/667/.
`
`38.
`
`In addition to perpetuating the myth that these Cow’s Milk Products are similar to
`
`breast milk, Defendants have also intentionally deceived the public into believing that healthcare
`
`providers believe these products are superior to breast milk or even ideal and that physicians and
`
`institutions endorse the Cow’s Milk Products.
`
`39.
`
`A marketing report commissioned by Abbott in March 1998 summarized consumer
`
`reactions to several informational advertising pamphlets on Similac. Abbott found that the
`
`advertisements that scored highest in terms of whether consumers would actually buy the product
`
`included the claims about being the “1st Choice of Doctors.” Defendants Abbott found that using
`
`doctor recommendations and the supposed “science” behind the formula further drove consumer
`
`interest and purchases.
`
`40.
`
`Another study found that direct-to-consumer advertising increased request rates of
`
`brand choices and the likelihood that physicians would prescribe those brands. R.S. Parker, Ethical
`
`Considerations in the Use of Direct-to-Consumer Advertising and Pharmaceutical Promotions:
`
`The Impact on Pharmaceutical Sales and Physicians, J. OF BUS. ETHICS, 48, 279-290 (2003).
`
`Thus, by a company marketing in advance to the public that a product is recommended by
`
`physicians, the public buys more of the product, and then the physicians are actually more likely
`
`to recommend the product in the future, further perpetuating and fueling a deceptive cycle.
`
`41. Manufacturers have also repeatedly used their relationships with hospitals and the
`
`discharge process to encourage mothers to substitute Cow’s Milk Products for human breastmilk
`
`16
`
`

`

`Case: 1:22-cv-01190 Doc #: 1 Filed: 07/06/22 17 of 42. PageID #: 17
`
`even after they leave the hospital. K.D. Rosenberg, C.A. Eastham, et al, Marketing Infant Formula
`
`Through Hospitals: The Impact of Commercial Hospital Discharge Packs on Breastfeeding, AM
`
`J PUBLIC HEALTH, 98(2):290-295 (2008).
`
`42.
`
`Indeed, most hospitals in the U.S. distribute “commercial discharge bags packaged
`
`as smart diaper bags containing various coupons, advertisements, baby products, and infant
`
`formula samples.” Yeon Bai, et al, Alternative Hospital Gift Bags and Breastfeeding Exclusivity,
`
`ISRN NUTR., article ID 560810: 2 (2013). Providing commercial gift bags to breastfee