`
`UNITED STATES DISTRICT COURT
`MIDDLE DISTRICT OF LOUISIANA
`
`
`
`
`
`
`
`Case No.
`
`COMPLAINT
`
`DEONDRICK BROWN, SR., Individually
`and on behalf of THE ESTATE OF
`DEONDRICK W. BROWN, JR.; and
`REBEKAH ETIENNE, Individually and on
`behalf of THE ESTATE OF DEONDRICK
`W. BROWN, JR.
`
`
`Plaintiffs,
`
`
`v.
`
`
`ABBOTT LABORATORIES, INC.; MEAD
`JOHNSON & COMPANY, LLC,
`
`
`Defendants.
`
`
`
`
`
`
`COMPLAINT
`
`Plaintiffs bring this Complaint and Demand for Jury Trial (“the Complaint”) against Abbott
`
`
`
`Laboratories, Inc. and Mead Johnson & Company, LLC (“Defendants”). As more specifically set
`
`forth below, Plaintiffs allege the following based upon personal knowledge as to Plaintiffs’ own
`
`acts and experiences and upon information and belief, including investigation conducted by
`
`Plaintiffs’ attorneys, as to all other matters.
`
`This is a survival claim and wrongful death action as well as individual actions brought by
`
`DEONDRICK W. BROWN, SR. and REBEKAH ETIENNE the biological parents and legal heirs
`
`of DEONDRICK W. BROWN, JR., as a direct and proximate result of Defendants’ negligent and
`
`wrongful conduct in connection with the design, development, manufacture, testing, packaging,
`
`promoting, marketing, distribution, labeling, and/or sale of Similac products and Enfamil products
`
`(at
`
`times
`
`referred
`
`to herein as “the
`
`subject products”), which products were
`
`
`
`1
`
`
`
`Case 3:21-cv-00687-SDD-EWD Document 1 11/28/21 Page 2 of 28
`
`prescribed/administered to and consumed by their minor child, DEONDRICK W. BROWN, JR.,
`
`and which products caused the suffering and death of DEONDRICK W. BROWN, JR.
`
`
`
`1.
`
`PARTIES, JURISDICTION, AND VENUE FACTS
`
`Plaintiff Deondrick Brown, Sr., individually and on behalf of the Estate of Deondrick
`
`W. Brown, Jr., is an adult and resident of New Iberia, Iberia Parish, Louisiana. He is the biological
`
`and legal father of Deondrick W. Brown, Sr., who was a minor and is now deceased, and sues as
`
`his successor-in-interest for causes of action that survive Deondrick W. Brown, Jr.’s death.
`
`Deondrick Brown, Sr. also brings this suit individually, for all causes of action and damages
`
`outlined herein.
`
`2.
`
`Plaintiff Rebekah Etienne, individually and on behalf of the Estate of Deondrick W.
`
`Brown, Jr., is an adult and resident of New Iberia, Iberia Parish, Louisiana. She is the biological
`
`and legal mother of Deondrick W. Brown, Jr., who was a minor and is now deceased, and sues as
`
`his successor-in-interest for causes of action that survive Deondrick W. Brown Jr.’s death.
`
`Rebekah Etienne also brings this suit individually, for all causes of action and damages outlined
`
`herein.
`
`3.
`
`On July 7, 2021, Deondrick Willie Brown, Jr. (“the baby” or “Deondrick, Jr.”) was
`
`born at Our Lady of Lourdes Hospital in Lafayette, Louisiana.
`
`4.
`
`The baby, Deondrick Jr., was the son of Deondrick Brown, Sr. (“the father”) and
`
`Rebekah Etienne (“the mother”) (collectively, the “Plaintiffs”).
`
`5.
`
`On September 16, 2021, baby Deondrick Jr. died at Lady of Lourdes Hospital in
`
`Lafayette, Louisiana as a result of ingesting Defendants’ fortified milk baby formula for infants
`
`and preemies, namely Similac Special Care (all varieties), Similac NeoSure Enfamil Human Milk
`
`fortifier, EnfaCare Powders and Enfamil Human Milk Fortifiers.
`
`
`
`2
`
`
`
`Case 3:21-cv-00687-SDD-EWD Document 1 11/28/21 Page 3 of 28
`
`6.
`
`Defendant, Abbott Laboratories, Inc. (“Abbott”) manufactures, designs, formulates,
`
`prepares, tests, provides instructions, markets, labels, packages, places into the stream of
`
`commerce in all fifty states, including Louisiana, and sells premature infant formula including
`
`Similac Special Care and Similac NeoSure formulas. At all material times herein, including from
`
`2016 through present, Abbott solely or jointly designed, developed, manufactured, 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 Fortifiers, 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.
`
`7.
`
`Defendant, Mead Johnson & Company, LLC (“Mead Johnson”) manufactures, designs,
`
`formulates, prepares, tests, provides instructions, markets, labels, packages, places into the stream
`
`of commerce in all fifty states, including Louisiana, and sells premature infant formula including
`
`Enfamil Human Milk Fortifiers and EnfaCare formulas. At all material times herein, including
`
`from 2016 through present, Abbott solely or jointly designed, developed, manufactured, packaged,
`
`labeled, promoted, marketed, distributed and/or sold Enfamil products specifically targeting
`
`medical providers and parents of preterm infants, including but not limited to Enfamil Human Milk
`
`Fortifiers including, Enfamil A+, Enfamil NeuroPro, Enfamil Enspire and EnfaCare Power.
`
`8.
`
`The Court has original jurisdiction pursuant to 28 U.S.C. § 1332(a) because complete
`
`diversity exists between Plaintiffs and Defendant, and the matter in controversy, exclusive of
`
`interest and costs, exceeds the sum or value of $75,000.
`
`9.
`
`The Court has personal jurisdiction over Defendants, because they conduct business in
`
`Louisiana, purposefully direct and/or directed their actions toward Louisiana, consented to being
`
`
`
`3
`
`
`
`Case 3:21-cv-00687-SDD-EWD Document 1 11/28/21 Page 4 of 28
`
`sued in Louisiana by registering an agent for service of process in Louisiana, and/or consensually
`
`submitted to the jurisdiction of Louisiana when obtaining a manufacturer or distributor license,
`
`and have the requisite minimum contacts with Louisiana necessary to constitutionally permit this
`
`Court to exercise jurisdiction. Moreover, Defendants’ actions and/or inactions described herein
`
`were purposefully directed at and/or within the State of Louisiana, the damages were sustained by
`
`Plaintiff within the State of Louisiana, and the damages sustained by Plaintiff were a result of
`
`Defendants’ actions and/or inactions—described herein—that were purposefully directed at and/or
`
`within the State of Louisiana.
`
`10.
`
`Venue is appropriate in this court, as defendants herein are registered to do business in
`
`the judicial district in which this matter is filed, may be served in this judicial district, conduct the
`
`business activities described herein in this judicial district, and various actions and/or inactions
`
`sued upon occurred in this judicial district. 28 U.S.C. §1391(b)(2).
`
`BACKGROUND FACTS
`
`The protein ingredients most often found in Defendants’ infant formulas are nonfat
`
`11.
`
`milk and whey protein concentrate from cow’s milk. In recent years, there has been a growing
`
`scientific link between the use of cow’s milk in infant formulas like Similac and Enfamil and an
`
`increased risk of necrotizing enterocolitis (“NEC”).
`
`12.
`
`13.
`
`If developed in premature infants, NEC can result in serious injuries, including death.
`
`NEC causes the intestinal tissues to become inflamed, then perforated, which allows
`
`bacteria to leak into the abdomen or infiltrate the bloodstream. Once NEC develops, the condition
`
`can progress rapidly from mild intolerance to fatal sepsis.
`
`14.
`
`Preterm and low-birth-weight infants are especially susceptible to NEC because of their
`
`underdeveloped digestive systems. Scientific research, including randomized controlled trials, has
`
`
`
`4
`
`
`
`Case 3:21-cv-00687-SDD-EWD Document 1 11/28/21 Page 5 of 28
`
`confirmed that cow’s milk-based feeding products cause NEC in preterm and low-birth-weight
`
`infants.
`
`15.
`
`According to the American Academy of Pediatrics, premature infants should be fed
`
`human breast milk, in part because premature babies fed human breast milk have lower incidences
`
`of NEC.
`
`16.
`
`In 2010 the Journal of Pediatrics published a study that established premature babies
`
`fed exclusive diets of mother’s milk, donor milk, and human milk fortifier 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. (J Pediatr 2010; 156:562-7, doi: 10.1016/j.jpeds.2009.10.040)
`
`17.
`
`The Surgeon General’s Call to Action to Support Breastfeeding, 2011, warned that,
`
`“[f]or vulnerable premature infants, formula feeding is associated with higher rates of necrotizing
`
`enterocolitis (NEC).” U.S. Department of Health and Human Services. The Surgeon General’s
`
`Call to Action to Support Breastfeeding. Washington, DC: U.S. Department of Health and Human
`
`Services, Office
`
`of
`
`the
`
`Surgeon General;
`
`2011,
`
`p.
`
`1,
`
`available
`
`at
`
`https://www.ncbi.nlm.nih.gov/books/NBK52682/.
`
`18.
`
`A 2014 published study reported that diets for extremely premature babies that
`
`exclusively consisted of human milk “should be considered as an approach to nutritional care of
`
`these infants.” Abrams, Steven, et al. Greater Mortality and Morbidity in Extremely Preterm
`
`Infants Fed a Diet Containing Cow Milk Protein Products. (Breastfeeding Medicine. 2014, Jul-
`
`Aug.; 9(6):281-285, doi: 10.1089/bfm.2014).
`
`19.
`
`Another 2014 study observed, “Necrotizing enterocolitis (NEC) is the most frequent
`
`and lethal gastrointestinal disorder affecting preterm infants [1,2], and is characterized by intestinal
`
`
`
`5
`
`
`
`Case 3:21-cv-00687-SDD-EWD Document 1 11/28/21 Page 6 of 28
`
`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 [1-3]. 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 [3,4].” “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 medical journal articles reviewing the timing
`
`of administration and rate of advancement of enteral feedings in the premature infant 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 [11–13]. 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.” Good, et al., Evidence Based Feeding Strategies Before and
`
`After the Development of Necrotizing Enterocolitis. (Expert Rev Clin Immunol. 2014 July; 10 (7):
`
`875-884. doi: 10.1586/1744666X.2014.913481).
`
`20.
`
`Again, in 2016, a study observed the health benefits of exclusive human milk diets in
`
`extreme premature infants and within those findings noted that there was a significant decrease of
`
`both medical and surgical NEC. The authors concluded that “the use of an exclusive HUM [human
`
`milk] diet is associated with significant benefits for extremely premature infants” and “while
`
`evaluating the benefits of using an exclusive HUM-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, 2016 Nov.; 11(2), doi: 10.1089/bfm.2015.0134).
`
`
`
`6
`
`
`
`Case 3:21-cv-00687-SDD-EWD Document 1 11/28/21 Page 7 of 28
`
`21.
`
`In a study published in 2017, it was reported (using the acronym “HM” to stand for
`
`human milk): “In summary, HM has been acknowledged as the best source of nutrition for preterm
`
`infants and those at risk for NEC. Two RCTs 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.” Shulhan, et al., Current Knowledge of Necrotizing Entercolitis in Preterm Infants and the
`
`Impact of Different Types of Enteral Nutrition Products. (Adv. Nutr. 2017, Jan.; 8(1):80-91, doi:
`
`10.3945/an.116.013193).
`
`MISLEADING MARKETING FACTS
`
`Despite strong medical and scientific evidence describing the dangers and risks that
`
`22.
`
`cow-based milk products pose for premature infants; during the period in question, including but
`
`not limited to throughout the last five (5) years and through September 16, 2021, Defendants have
`
`marketed their cow-milk based formulas and powdered products, including their respective
`
`Similac and Enfamil products, as equally safe alternatives to breast milk.
`
`23.
`
`Defendants, Abbott Laboratories and Mead Johnson, manufacture, design, formulate,
`
`prepare, test, provide instructions, market, label, package, and place into the stream of commerce
`
`in all fifty states, including Louisiana, and sell premature infant formula including Similac Special
`
`Care Formulas and Enfamil Formulas.
`
`24.
`
`From 2016 through September 16, 2021, Abbott’s aggressive marketing for its Similac
`
`products included and still includes targeting medical providers and parents of preterm infants with
`
`messages that Abbott’s cow’s milk formulas are necessary for the growth and development of their
`
`premature children. Indeed, it is believed that these marketing practices discourage some mothers
`
`from breastfeeding. All the while, Abbott’s promotional websites have been and still are silent as
`
`
`
`7
`
`
`
`Case 3:21-cv-00687-SDD-EWD Document 1 11/28/21 Page 8 of 28
`
`to the growing science that describes the risks cow’s milk formulas, including its Similac formulas,
`
`pose to premature infants.
`
`25.
`
`From 2016 through September 16, 2021, Abbott marketed and sold (and still does
`
`market and sell) multiple products specifically targeting medical providers and parents of preterm
`
`infants, including 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 (collectively “Similac
`
`Special Care”).
`
`26.
`
`From 2016 through September 16, 2021, Abbott specifically targeted medical providers
`
`and parents of premature infants in their marketing. Numerous web-based advertisements tout
`
`phrases like “Similac is the #1 Pediatrician Recommended Brand for Immune Support” and “you
`
`can be confident in the nourishment of Similac”. Yet, searches of Abbott’s webpages yield no
`
`results or reference to necrotizing enterocolitis or NEC.
`
`27.
`
`From 2016 through September 16, 2021, Abbott’s website includes several promises
`
`to mothers and their premature babies with zero warning as to NEC or death resulting from NEC.
`
`28.
`
`From 2016 through September 16, 2021, Abbott’s infant formulas including 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 did not include labels that warned parents or
`
`healthcare providers over the risks of NEC.
`
`29.
`
`Abbott’s misleading marketing campaign which occurred during the time-period in
`
`question, including through the present day, deceive(s) medical providers and parents to believe
`
`that: (1) cow’s milk-based formulas are safe; (2) cow’s milk-based formulas are equal substitutes
`
`to human breast milk; and (3) health care professionals prefer cow’s milk-based formulas. Abbott
`
`
`
`8
`
`
`
`Case 3:21-cv-00687-SDD-EWD Document 1 11/28/21 Page 9 of 28
`
`has marketed its products for premature infants as necessary for growth, and perfectly safe for
`
`premature infants, despite knowing of the extreme risk of NEC and death.
`
`30.
`
`From 2016 through September 16, 2021, Mead Johnson’s aggressive marketing for its
`
`Enfamil infant baby products included and still includes targeting medical providers and parents
`
`of preterm infants with messages that Mead Johnson’s cow’s milk formulas are necessary for the
`
`growth and development of their premature children. Indeed, it is believed that these marketing
`
`practices discourage some mothers from breastfeeding. All the while, Mead Johnson’s promotional
`
`websites have been and still are silent as to the growing science that describes the risks cow’s milk
`
`formulas, including its Similac formulas, pose to premature infants.
`
`31.
`
`From 2016 through September 16, 2021, Mead Johnson marketed and sold (and still
`
`does market and sell) multiple products specifically targeting medical providers and parents of
`
`preterm infants, including Enfamil infant Human Milk Fortifiers such as Enfamil Human Milk
`
`Fortifier Liquid High Protein, Enfamil NeuroPro EnfaCare, Enfamil Premature 20 Cal, Enfamil
`
`Premature 24 Cal, Enfamil Premature 30 Cal, and Enfamil Human Milk Fortifier Powder.
`
`32.
`
`From 2016 through September 16, 2021, Mead Johnson specifically targeted medical
`
`providers and parents of premature infants in their marketing. Numerous web-based
`
`advertisements tout phrases like “Discover Your Baby’s Trusted Formula with over 100 Years of
`
`Pediatric Nutrition Experience” and “Enfamil: What a baby needs”. Yet, searches of Mead
`
`Johnson’s webpages yield no results or reference to necrotizing enterocolitis or NEC.
`
`33.
`
`From 2016 through September 16, 2021, Mead Johnson’s website includes several
`
`promises to mothers and their premature babies with zero warning as to NEC or death resulting
`
`from NEC.
`
`
`
`9
`
`
`
`Case 3:21-cv-00687-SDD-EWD Document 1 11/28/21 Page 10 of 28
`
`34.
`
`From 2016 through September 16, 2021, Mead Johnson’s infant formulas including
`
`Enfamil infant Human Milk Fortifiers such as Enfamil Human Milk Fortifier Liquid High Protein,
`
`Enfamil NeuroPro EnfaCare, Enfamil Premature 20 Cal, Enfamil Premature 24 Cal, Enfamil
`
`Premature 30 Cal, and Enfamil Human Milk Fortifier Powder did not include labels that warned
`
`parents or healthcare providers over the risks of NEC.
`
`35. Mead Johnson’s misleading marketing campaign which occurred during the time-
`
`period in question, including through the present day, deceive(s) medical providers and parents to
`
`believe that: (1) cow’s milk-based formulas are safe; (2) cow’s milk-based formulas are equal
`
`substitutes to human breast milk; and (3) health care professionals prefer cow’s milk-based
`
`formulas. Mead Johnson has marketed its products for premature infants as necessary for growth,
`
`and perfectly safe for premature infants, despite knowing of the extreme risk of NEC and death.
`
`36.
`
`The subject products made from cow’s milk, specifically for premature infants such as
`
`Similac and Enfamil, are unsafe to premature infants and are avoidable for use in that there is
`
`human donor milk available and/or human milk derived fortifier products available made from
`
`human milk instead of cow’s milk.
`
`37.
`
`Despite knowing that its cow’s milk-based Similac and Enfamil products were causing
`
`NEC, devastating injuries, and death in premature infants, Defendants did not recommend to the
`
`FDA, hospitals, NICUs or physicians that they should discuss the risks of NEC or death with the
`
`parents.
`
`38.
`
`There are human milk based formulas and fortifier products which are feasible
`
`alternatives to the subject Similac and Enfamil products offered by Defendants.
`
`
`
`
`
`
`
`10
`
`
`
`Case 3:21-cv-00687-SDD-EWD Document 1 11/28/21 Page 11 of 28
`
`SPECIFIC ALLEGATIONS
`
`Baby Deondrick, Jr. was born prematurely on July 7, 2021, weighing between 750-999
`
`39.
`
`grams (1.6-2.2 lbs.) and was the product of a 25 to 26-week pregnancy.
`
`40.
`
`Baby Deondrick, Jr. was placed in the Neonatal Intensive Care Unit (NICU) at Lady of
`
`Lourdes Women and Children Hospital.
`
`41.
`
`Baby Deondrick, Jr. received donor breast milk for several weeks before transitioning
`
`to Similac Special Care Formula, Similac Human Milk Fortifier, and/or other Similac-branded
`
`formulas on or around September 11, 2019, which meant Baby Deondrick, Jr. was fed with both
`
`breast milk and formula.
`
`42.
`
`Rebekah Etienne and Deondrick Brown, Sr., mother and father to Baby Deondrick, had
`
`no knowledge that Similac Special Care, Similac Human Milk Fortifier, and/or other Similac-
`
`branded formulas would increase the risk of their baby developing necrotizing enterocolitis.
`
`43.
`
`On or about September 15, 2021, Baby Deondrick, Jr. was scheduled to, and did,
`
`primarily receive one or more of Defendants’ subject products for his infant feeding regimen.
`
`44. Within a matter of hours, Baby Deondrick, Jr. was referred to pediatric surgery based
`
`on findings suspicious of necrotizing enterocolitis.
`
`45.
`
`Prior to baby Deondrick, Jr. being fed Similac and/or Enfamil formula, Rebekah
`
`Etienne, Deondrick Brown, Sr. and Deondrick Brown, Jr.’s healthcare providers were exposed to
`
`marketing for Defendants’ products, including Similac Special Care Formula, Similac Human
`
`Milk Fortifier, Enfamil Human Milk Fortifier and/or other Similac or Enfamil cow’s milk-based
`
`formulas, which marketing represented that these products were safe and necessary to the growth
`
`and nutrition of premature infants.
`
`
`
`11
`
`
`
`Case 3:21-cv-00687-SDD-EWD Document 1 11/28/21 Page 12 of 28
`
`46.
`
`Although Abbott promotes an aggressive marketing campaign designed to make
`
`parents and healthcare providers believe that Similac Special Care, Similac Human Milk Fortifier,
`
`and/or other Similac-branded formulas are safe and necessary for growth of a premature infant,
`
`the products are in fact extremely dangerous for premature infants. Similac Special Care, Similac
`
`Human Milk Fortifier, and/or other Similac-branded formulas substantially increase the chances
`
`of a premature infant getting NEC and of dying.
`
`47.
`
`Defendants’ Similac and Enfamil products are commercially available at retail
`
`locations and online.
`
`48.
`
`Despite knowing of the risk of NEC, Defendants did not properly warn parents
`
`(including Deondrick Brown, Jr.’s parents) of the risk of NEC or dying associated with Similac
`
`Special Care Formula, Similac Human Milk Fortifier, Enfamil Human Milk Fortifier and/or other
`
`Similac or Enfamil cow’s milk-based formulas.
`
`49.
`
`Despite knowing of the risk of NEC, Defendants did not warn doctors, hospital, nurses
`
`and medical staff (including Deondrick Brown, Jr.’s healthcare providers) of the risk of NEC or
`
`dying associated with Similac Special Care Formula, Similac Human Milk Fortifier, Enfamil
`
`Human Milk Fortifier and/or other Similac or Enfamil cow’s milk-based formulas.
`
`50.
`
`Defendants failed to properly warn parents (including Deondrick Brown, Jr.’s parents)
`
`and medical providers (including Deondrick Brown, Jr.’s healthcare providers) that its cow’s milk-
`
`based formulas, including Similac Special Care Formula, Similac Human Milk Fortifier, Enfamil
`
`Human Milk Fortifier and/or other Similac or Enfamil cow’s milk-based formulas can significantly
`
`increase the risk that the premature infant will develop NEC and/or death, failed to design said
`
`products such as to make them safe, and deceived the public, parents (including Deondrick Brown,
`
`Jr.’s parents), physicians and medical staff (including Deondrick Brown, Jr.’s healthcare
`
`
`
`12
`
`
`
`Case 3:21-cv-00687-SDD-EWD Document 1 11/28/21 Page 13 of 28
`
`providers) into believing that the products were a safe and necessary alternatives, supplements
`
`and/or and substitutes to human milk.
`
`51.
`
`Baby Deondrick, Jr. developed Necrotizing enterocolitis after transfer from the NICU
`
`and died on September 16, 2021 at only 71 days old.
`
`52.
`
`Despite knowing that its subject products were being fed to premature infants without
`
`the parents’ informed consent, Defendants failed to require or recommend that Hospitals inform
`
`the parents of the significant risks, and to require that the consent of the parent be obtained prior
`
`to feeding it to babies.
`
`53.
`
`Defendants’ cow’s milk-based formula products did cause Baby Deondrick, Jr. to
`
`develop NEC, which resulted in his death.
`
`FIRST CAUSE OF ACTION
`DESIGN DEFECT UNDER LA. R.S. 9:2800.56
`(PRODUCTS LIABILITY)
`
`Plaintiffs incorporate by reference each of the paragraphs of this Complaint as if fully
`
`54.
`
`set forth herein.
`
`55.
`
`Defendants’ subject products which were consumed by DEONDRICK W. BROWN,
`
`JR. and which caused his death, were defective in its design or formulation in that they are not
`
`reasonably fit, suitable, or safe for their intended purpose and/or the foreseeable risks exceed the
`
`benefits associated with their design and formulation. The subject products were unreasonably
`
`dangerous in design as provided by La. R.S. 9:2800.56.
`
`56.
`
`At all times material to this action, Defendants’ subject products expected to reach, and
`
`did reach, consumers in the State of Louisiana and throughout the United States, including
`
`Plaintiffs herein, without substantial change in the condition in which it was sold.
`
`
`
`13
`
`
`
`Case 3:21-cv-00687-SDD-EWD Document 1 11/28/21 Page 14 of 28
`
`57.
`
`At all times relevant, Defendants’ subject products were designed, developed,
`
`manufactured, tested, packaged, promoted, marketed, distributed, labeled, and/or sold by
`
`Defendants in a defective and unreasonably dangerous condition at the time placed in the stream
`
`of commerce in ways which include, but are not limited to, one or more of the following
`
`particulars:
`
`a) When placed in the stream of commerce, Defendants’ Similac Special Care Formula,
`
`Similac Human Milk Fortifier, Enfamil Human Milk Fortifier and/or other Similac or
`
`Enfamil cow’s milk-based formulas contained unreasonably dangerous design defects
`
`and were not reasonably safe as intended to be used, subjecting Baby Deondrick, Jr. to
`
`risks that exceeded the benefits of the subject product, including personal injury and
`
`death;
`
`b) When placed in the stream of commerce, Defendants’ Similac Special Care Formula,
`
`Similac Human Milk Fortifier, Enfamil Human Milk Fortifier and/or other Similac or
`
`Enfamil cow’s milk-based formulas were defective in design and formulation, making
`
`the use of Defendants’ products more dangerous than an ordinary consumer would
`
`expect, and more dangerous than other risks associated with non-cow’s milk-based
`
`formulas;
`
`c) The design defects with Defendants’ Similac Special Care Formula, Similac Human
`
`Milk Fortifier, Enfamil Human Milk Fortifier and/or other Similac or Enfamil cow’s
`
`milk-based formulas existed before they left the control of the Defendants;
`
`d) Defendants’ Similac Special Care Formula, Similac Human Milk Fortifier, Enfamil
`
`Human Milk Fortifier and/or other Similac or Enfamil cow’s milk-based formulas
`
`harmful side effects outweighed any potential utility;
`
`
`
`14
`
`
`
`Case 3:21-cv-00687-SDD-EWD Document 1 11/28/21 Page 15 of 28
`
`e) Defendants’ Similac Special Care Formula, Similac Human Milk Fortifier, Enfamil
`
`Human Milk Fortifier and/or other Similac or Enfamil cow’s milk-based formulas were
`
`not accompanied by adequate instructions and/or adequate warnings to fully apprise
`
`consumers, including Plaintiffs, of the full nature and extent of the risks and side effects
`
`associated with its use, thereby rendering Defendants liable to Plaintiffs;
`
`f)
`
` At the time Defendants’ Similac Special Care Formula, Similac Human Milk Fortifier,
`
`Enfamil Human Milk Fortifier and/or other Similac or Enfamil cow’s milk-based
`
`formulas left Defendant’s control, there existed one or more alternative designs for said
`
`products, with such alternative design(s) capable of preventing the claimant's damage,
`
`and the danger of the damage from Defendants’ subject products outweighed the
`
`burden on Defendants of adopting the alternative design(s).
`
`58.
`
`Defendants did foresee or should have foreseen that its respective products would be
`
`used in situations similar to Baby Deondrick, Jr. and that such use would significantly increase the
`
`risk of NEC and death in Baby Deondrick, Jr.
`
`59.
`
`60.
`
`Defendants took no steps to prevent the use of its cow’s milk-based formulas.
`
`The products, Similac Special Care, Similac Human Milk Fortifier, Enfamil Human
`
`Milk Fortifier and/or other Similac or Enfamil cow’s milk-based formulas were designed,
`
`manufactured, and distributed respectively by Defendants Abbott Laboratories and Mead Johnson.
`
`61.
`
`Defendants’ subject products were not safe to be used as they were in the case of Baby
`
`Deondrick, Jr. and the Defendants knew or should have known they was unsafe, yet they failed to
`
`provide any instructions or guidelines on when and how its products would be safe to
`
`administer/use to or with a premature infant like Baby Deondrick, Jr.
`
`
`
`15
`
`
`
`Case 3:21-cv-00687-SDD-EWD Document 1 11/28/21 Page 16 of 28
`
`62.
`
`Defendants marketed their respective products as safe and beneficial for premature
`
`infants like Baby Deondrick, Jr.
`
`63.
`
`As a result of the foregoing acts and omissions, Defendants’ Similac Special Care
`
`and/or Enfamil Human Milk Fortifier products were a substantial factor in causing Baby
`
`Deondrick, Jr.’s NEC and death.
`
`64.
`
`As a result of the foregoing acts and omissions, Plaintiffs Rebekah Etienne and
`
`Deondrick Brown, Sr., suffered and are suffering physical pain and mental anguish, as well as the
`
`other damages outlined herein.
`
`SECOND CAUSE OF ACTION
`INADEQUATE WARNING UNDER LA. R.S. 9:2800.57
`(PRODUCTS LIABILITY)
`
`Plaintiffs incorporate by reference each of the paragraphs of this Complaint as if fully
`
`65.
`
`set forth herein.
`
`66.
`
`Defendants’ Similac Special Care Formula, Similac Human Milk Fortifier, Enfamil
`
`Human Milk Fortifier and/or other Similac or Enfamil cow’s milk-based formulas which were
`
`consumed by DEONDRICK W. BROWN, JR. and which caused his death, were defective and
`
`unreasonably dangerous when it left the possession of the Defendants in that it contained warnings
`
`insufficient to alert consumers, including Plaintiffs and DEONDRICK W. BROWN, JR.’s health
`
`care providers, of the dangerous risks and reactions associated with the subject products, including
`
`but not limited to heightened risk of developing NEC that could result in death. Thus, the subject
`
`products were unreasonably dangerous because an adequate warning was not provided as required
`
`pursuant to La. R.S. 9:2800.57.
`
`67.
`
`Defendants, as manufacturers and/or distributors of the subject products, are held to the
`
`level of knowledge of an expert in the field.
`
`
`
`16
`
`
`
`Case 3:21-cv-00687-SDD-EWD Document 1 11/28/21 Page 17 of 28
`
`68.
`
`Defendants had a continuing duty but failed to warn users (including the parents of
`
`DEONDRICK W. BROWN, JR.) and the medical field (including DEONDRICK W. BROWN,
`
`JR.’s healthcare providers) of all of the known and/or potential dangers associated with the subject
`
`products, including NEC and death.
`
`69.
`
`Scientific studies establish that Defendants’ cow’s milk-based formulas pose
`
`significant risk and dangers to premature infants, yet Defendants did not properly change its
`
`product, packaging, guidelines, instructions, and warnings.
`
`70.
`
`Despite that it knew or should have known that their products were linked to NEC and
`
`death, Defendants failed to properly collect data from doctors and hospitals in order to develop
`
`evidence-based strategies, instructions, and warnings to reduce or prevent its product from causing
`
`NEC and death.
`
`71.
`
`Despite that they knew or should have known that their respective cow’s milk-based
`
`products were causing NEC and death in premature infants, Defendants did not conduct any
`
`testing, data analysis, or research to determine when its products should not be used or when and
`
`how its products were safe for use.
`
`72.
`
`Defendants did not contact the FDA, NICUs, hospitals, or health care providers to
`
`inform them that their products at issue were linked to causing NEC and death.
`
`73.
`
`The subject products, Similac Special Care Formula, Similac Human Milk Fortifier,
`
`Enfamil Human Milk Fortifier and/or other Similac or Enfamil cow’s milk-based formulas,
`
`manufactured and supplied by Defendants, were defective due to inadequate post-marketing
`
`