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Cause No.: 

UNITED STATES DISTRICT COURT 

FOR THE SOUTHERN DISTRICT OF FLORIDA 

FORT LAUDERDALE DIVISION 

 

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 ) Civil Action No. __________ 

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 ) 

 ) 

 ) JURY TRIAL DEMANDED 

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COMPLAINT 

Plaintiff Jordyn O’Brien (“Plaintiff”), individually and on behalf of her minor child, H.O., 

files this Complaint against Defendant Abbott Laboratories, Inc. D/B/A Abbott Nutrition. 

(“Abbott” or “Defendant”), and in support state the following: 

NATURE OF THE ACTION 

1. Plaintiff, Jordyn O’Brien, is the mother of H.O., a minor. 

2. Defendant Abbott Laboratories, Inc., manufactures, labels, markets, distributes, 

and sells infant formulas under the Similac, Alimentum, and EleCare brands that have been 

recalled due to bacterial contamination. 

3. On February 17, 2022, the U.S. Food and Drug Administration (“FDA”), along 

with the Center for Disease Control (“CDC”), announced that it was investigating Defendant 

Abbott’s Similac, Alimentum, and EleCare infant formula products manufactured at Defendant 

Abbott’s facility in Sturgis, Michigan (“Sturgis Facility”), following several consumer complaints 

of Cronobacter sakazakii and Salmonella Newport contamination. The FDA’s advisory notice told 

consumers to avoid purchasing or using Defendant Abbott’s Similac, Alimentum, and EleCare, 

and Defendant Abbott subsequently initiated a voluntary recall of those products. 

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Cause No.: 

4. Plaintiff, H.O., consumed Defendant’s Recalled Product and suffered injury as a 

result of the contamination of Defendant’s product. 

JURISDICTION AND VENUE 

5. This Court has jurisdiction over this action pursuant to 28 U.S.C. § 1332, as there 

is complete diversity of the parties, and the amount in controversy exceeds $75,000. 

6. Venue is proper in this district because a substantial portion of the acts and conduct 

giving rise to the claims occurred within this district. 

THE PARTIES 

7. Plaintiff is a citizen and resident of Broward County, Florida, and at all times 

relevant hereto, has been a resident of Escambia County. In or around November 2021, Plaintiff 

purchased Similac 360 Total Care infant formula for H.O. from Publix, CVS, and Target. Based 

on the false and misleading claims by Defendant, Plaintiff was unaware that Defendant’s 

Alimentum product may be adulterated with Salmonella, Cronobacter sakazakii, and other 

contaminants. Plaintiff used the Defendant’s product on the assumption that the labeling of 

Defendant’s products were accurate and that the products were unadulterated, safe and effective. 

Plaintiff would not have used Defendant’s Similac, Alimentum, and EleCare products had she 

known there was a risk the products may contain Salmonella, Cronobacter sakazakii, and other 

contaminants. 

8. Defendant ABBOTT LABORATORIES, INC. D/B/A ABBOTT NUTRITION, is 

a Delaware Corporation with its principal place of business in 100 Abbott Park Road, Abbott Park, 

Illinois. Defendant manufactures, markets, advertises, labels, distributes and sells the Recalled 

Product at issue in this litigation. 

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Cause No.: 

9. This Court has specific personal jurisdiction over Defendant because Defendant 

has purposefully availed itself of the privileges and benefits of doing business in Florida. 

10. Defendant subjected itself to jurisdiction in Florida by doing business in Florida 

and by contracting with Florida businesses and by performing such contracts in part in Florida and 

by committing torts where one or more elements of the tort or one or more of the tortious acts 

occurred in Florida. 

INTRODUCTION 

11. The following infant formulas are manufactured, marketed, and sold by Defendant 

Abbott Laboratories: 

 Similac. Similac is a brand of powdered infant formula produced by Abbott which 

Abbott promises will “give babies a strong start by helping to keep them fed, happy, 

and healthy.” See Why Similac, https://www.similac.com/why-similac.html (last 

visited February 18, 2022). According to Abbott, Similac “is the #1 Pediatrician 

Recommended Brand for Immune Support.” Id.

 Alimentum. Alimentum is a brand of powdered infant formula produced by Abbott for 

infants with lactose sensitivity which Abbott claims is “the #1 infant formula brand fed 

for cow’s milk protein allergy in the US.” See Alimentum Product Description, 

https://www.similac.com/products/baby-formula/alimentum-powder/19-8oz-can4pack.html (last visited February 18, 2022). 

 EleCare. EleCare is a brand of powdered infant formula produced by Abbott for infants 

who cannot tolerate intact or hydrolyzed protein due to conditions such as severe food 

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Cause No.: 

allergies or short bowel syndrome. See EleCare Product Information, 

https://elecare.com/ (last visited February 18, 2022). 

12. Abbott distributes these powdered infant formula products both nationwide and 

internationally. 

13. As mentioned above, on February 17, 2022, the FDA, in conjunction with the CDC, 

announced a warning to consumers to not purchase or use Recalled Product, stating: “Do not use 

recalled Similac, Alimentum and EleCare powdered infant formulas produced in Sturgis, 

Michigan.”1

14. As part of the warning, the FDA Deputy Commissioner for Food Policy and 

Response stated, “As this is a product used as the sole source of nutrition for many of our nation’s 

newborns and infants, the FDA is deeply concerned about these reports of bacterial infections. We 

want to reassure the public that we’re working diligently with our partners to investigate 

complaints related to these products, which we recognize include infant formula produced at this 

facility, while we work to resolve this safety concern as quickly as possible.”2

15. Specifically, the FDA announced that it is investigating consumer complaints of 

Cronobacter sakazakii and Salmonella Newport infections connected to powdered infant formula 

products produced by Abbott. 

16. The FDA has so far linked two infant deaths and multiple illnesses to Cronobacter 

sakazakii contamination of its Similac, Alimentum, and EleCare powdered infant formulas 

produced in the Sturgis, Michigan plant. 

 

1 https://www.fda.gov/consumers/powdered-infant-formula-recall-what-know (last visited March 16, 2022). 

2 https://thehill.com/policy/healthcare/public-global-health/594856-three-kinds-of-baby-formula-recalled-by-abbott/

(last visited April 28, 2022). 

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17. The initial recall notice included Similac, Alimentum, and EleCare powdered 

infant formula with the following characteristics: 

 the first two digits of the code are 22 through 37; and 

 the code on the container contains K8, SH or Z2; and 

 the expiration date is 4-1-2022 (APR 2022) or later. 

18. On February 17, 2022, Abbott announced a recall of its powdered infant formulas. 

However, the recall does not include a refund, reimbursement, or replacement for consumers who 

purchased or used Recalled Products.3 

19. On February 28, 2022, the recall was expanded to include one lot of Similac PM 

60/40 (Lot # 27032K80 (can) / Lot # 27032K800 (case)), which was also manufactured in 

Abbott’s Sturgis, Michigan facility. 

20. These products may contain Cronobacter sakazakii bacteria and Salmonella. 

21. Per the CDC website, Cronobacter sakazakii is a germ that can live in very dry 

places. The germs can live in dry foods, such as powdered infant formula. 

22. Cronobacter bacteria can get into formula powder if contaminated raw materials 

are used to make the formula or if the formula powder touches a contaminated surface in the 

manufacturing environment. 

23. Cronobacter bacteria can cause severe, life-threatening infections, meningitis, and 

symptoms include: poor feeding, irritability, temperature changes, jaundice, grunting, and 

abnormal body movements. As set forth by the Centers for Disease Control and Prevention: 

Infants (<12 months old): In infants, Cronobacter usually causes sepsis or severe 

meningitis. Some infants may experience seizures. Those with meningitis may 

 

3

 Recall Notice, https://www.similacrecall.com/us/en/home.html (last visited March 16, 2022) 

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develop brain abscesses or infarcts, hydrocephalus, or other serious complications 

that can cause long-term neurological problems. The mortality rate for Cronobacter 

meningitis may be as high as 40%.4

Other sources have described the mortality rate reaching as high as 80%.5

24. The FDA also received one complaint of an infant with Salmonella infection who 

consumed formula from Abbott’s Sturgis, Michigan facility. However, they later concluded there 

is not enough information available to definitively link the illness with the recalled infant formula. 

25. The FDA then conducted several inspections, which uncovered numerous, 

egregious violations of statutes and regulations set forth herein in Defendant’s manufacture, 

processing, packing, and holding of Similac, Alimentum and EleCare powdered infant formulas. 

26. As documented in the FDA Form 483 issued on September 24, 2019, Defendant 

failed to test a representative sample of an infant formula production aggregate of powered infant 

formula at the final product stage and before distribution to ensure that the production aggregate 

met the required microbiological quality standards. 

27. Subsequent inspections establish a pattern of Defendant’s disregard of reasonable, 

responsible industry practices, as well as applicable statutes and regulations, with respect to 

manufacture, processing, packing, and holding of Similac, Alimentum and EleCare powdered 

infant formulas. As documented in the FDA Form 483 issued on September 24, 2021: 

a. Defendant failed to maintain a building used in the manufacture, processing, 

packing, or holding of infant formula in a clean and sanitary condition; and 

 

4

 CDC.gov, https://www.cdc.gov/cronobacter/technical.html (last accessed on March 25, 2022). 

5

 Norberg S, Stanton C, Ross RP, Hill C, Fitzgerald GF, Cotter PD. Cronobacter spp. in powdered 

infant formula. J Food Prot. 2012 Mar;75(3):607-20. doi: 10.4315/0362-028X.JFP-11-285. 

PMID: 22410240. 

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Cause No.: 

b. Defendant personnel working directly with infant formula, its raw materials, 

packaging, or equipment or utensil contact surfaces did not wash hands 

thoroughly in a hand washing facility at a suitable temperature after the hands 

may have become soiled or contaminated. 

28. As documented in the FDA Form 483 issued on March 18, 2022: 

a. Defendant failed to set in place and/or maintain a system of process controls 

that cover all stages of infant formula processing to ensure the product does not 

become adulterated due to the presence of microorganisms (such as 

Cronobacter) in the formula or in the processing environment; 

b. Defendant further failed to ensure that all surfaces that contacted infant formula 

were maintained to protect infant formula from being contaminated with 

microorganisms, (such as Cronobacter); 

c. Defendant failed to document any determination as to whether a hazard to 

health exists due to contamination with microorganisms (such as Cronobacter); 

d. Defendant’s personnel that worked directly with infant formula, its raw 

materials, packaging, equipment, or utensil contact surfaces failed to wear 

necessary protective apparel. 

29. Additionally, Abbott’s own records indicate that, in June 2020, it destroyed 

products because of a previous Cronobacter contamination. 

30. This establishes that Abbott, at various times: 

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Cause No.: 

a. Had knowledge that its powdered infant formula manufactured, processed, and 

packaged at its Sturgis, Michigan plant had been contaminated with 

microorganisms, (such as Cronobacter); 

b. Failed to adequately test for Cronobacter in its powdered infant formula; 

c. Failed to ensure numerous controls were in place to prevent contamination of 

its powdered infant formula manufactured, processed, and packaged at its 

Sturgis, Michigan plant. 

31. The results of these investigations demonstrate a pattern of Defendant not only 

failing to take adequate, reasonable measures to protect the health and lives of infants consuming 

its powered infant formula products, but also failing to take even the common sense measures, 

such as washing hands, upon learning of the risk of contamination of its products with 

microorganisms. 

32. Defendant demonstrates an unwillingness or incapability to learn from its own 

misconduct, and from the historical misconduct of others engaged in the manufacture, processing, 

packing, and holding of infant formula that resulted in widespread, serious and often fatal harm to 

the same vulnerable population, such as the “swill milk” scandal during the 1850s in New York 

City.6 Thousands of infants were reported to have died from bacterial infection after ingesting 

contaminated milk sold to their poor and middle class parents by unscrupulous distillers who fed 

the grain distillation byproduct to dairy cattle kept in fetid conditions. 

 

6

 Tyler Moss, “The 19th-Century Swill Milk Scandal That Poisoned Infants With Whiskey 

Runoff,” AtlasObscura.com (November 27, 2017) available at 

https://www.atlasobscura.com/articles/swill-milk-scandal-new-york-city (last accessed on Mar. 25, 2022). 

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Cause No.: 

33. More recently, in September 2008, the deaths of infants and sickness of over 

300,000 babies were traced to contamination of infant formula with melamine believed to have 

been used as a protein additive.7 

34. Further, a whistleblower report dated October 19, 2021, noted that violations taking 

place at the Sturgis Facility were “neither inadvertent nor minor in nature.”8 Attached as Exhibit 

A to this Complaint. Further findings from that report include: 

 “On multiple occasions, and in various ways, records have been knowingly falsified... 

This included testing seals on empty cans...” 

 “The Sturgis site performed a time code removal after the discovery of microorganisms 

(“micros”) in a batch of infant formula. The remaining portion of the batch outside the 

time code removal was released without additional testing. On another occasion 

product was not re-called from the market even after management became aware of a 

nonconformity (“NC”). 

 “Aside from the mandate of FDA regulations, Abbott’s inaction is directly at odds with 

the mandate of Sarbanes-Oxley mandating adequate internal controls and the 

Department of Justice’s policy mandating effective compliance programs.” 

 

7

 Gossner CM, Schlundt J, Ben Embarek P, Hird S, Lo-Fo-Wong D, Beltran JJ, Teoh KN, 

Tritscher A. The melamine incident: implications for international food and feed safety. Environ 

Health Perspect. 2009 Dec;117(12):1803-8. doi: 10.1289/ehp.0900949. Epub 2009 Aug 6. PMID: 

20049196; PMCID: PMC2799451. 

8 https://www.marlerblog.com/files/2022/04/Redacted-Confidential-Disclosure-re-Abbott-Laboratories-10-19-

2021_Redacted-1.pdf (last visited May 4, 2022) 

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Cause No.: 

35. Defendant’s conduct therefore represents a repeated, conscious disregard for the 

safety and lives of among the most vulnerable individuals—infants—that rises to the level of 

recklessness, wantonness, and malice. 

36. Beginning in November 2021, Plaintiff started purchasing Similac 360 Total Care 

for her infant son. 

37. Upon information and belief, the container used by Plaintiff for her minor child 

match the tainted lots identified by the FDA advisory and subsequently recalled by Defendant. 

38. Plaintiff’s infant child consumed the tainted infant product. 

39. Shortly after starting the tainted formula, Plaintiff’s infant suffered immediate and 

severe injury as a result of consuming the tainted product. 

40. Plaintiff’s infant child became irritable and displayed problems sleeping after 

consuming the tainted product necessitating medical intervention. 

41. Plaintiff’s infant child’s stool became discolored and bloody after consuming the 

tainted formula. He also suffered a 103 degree fever and vomiting. 

42. Plaintiff took her infant son to the hospital where cultures confirmed a diagnosis 

of Salmonella. 

43. Plaintiff’s infant son was placed on antibiotics, probiotics, and anti-nausea 

medication for at least ten (10) days. 

44. Plaintiffs have incurred substantial medical bills as a result of many doctor visits 

and the recent hospital stay. 

45. As a direct and proximate result of ingesting the contaminated formula, Plaintiff 

H.O. has suffered injuries in the past and will continue in the future. 

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Cause No.: 

First Cause of Action: Negligent Misrepresentation/Omission 

 

46. Plaintiff incorporates by reference and re-alleges each and every allegation 

contained above, as though fully set forth herein. 

47. Through its labeling and advertising, Defendant made representations to Plaintiff 

concerning the safety of their Similac, Alimentum, and EleCare Products. 

48. Defendant has a duty to provide accurate information to consumers with respect to 

their Similac, Alimentum, and EleCare Products as detailed above. 

49. Additionally, Defendant has a duty to not make false representations with respect 

to the safety of their Products. 

50. Defendant failed to fulfill its duty when it made false representations regarding the 

quality and safety of the Products as detailed above. 

51. Such failures to disclose on the part of Defendant amount to negligent omission 

and the representations regarding the quality and safety of the product amount to negligent 

misrepresentation. 

52. Plaintiff reasonably relied upon such representations and omissions to their 

detriment. 

53. By reason thereof, Plaintiff H.O. has suffered damages in an amount to be proven 

at trial. 

Second Cause of Action: Breach of Express Warranty 

35. Plaintiff incorporates by reference and re-alleges each and every allegation 

contained above, as though fully set forth herein.

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Cause No.: 

36. As detailed above, Defendant, through its written literature, packaging and 

labeling, and written and media advertisement, expressly warranted that the Similac, Alimentum, 

and EleCare Products were safe and fit for the purposes intended, that they were of merchantable 

quality, and that they did not pose dangerous health risks. 

37. Plaintiff read and relied on these express warranties provided by Defendant in the 

packaging and written advertisements, including that the “infant formula” was a “ready to feed” 

formula that “starts reducing excessive crying and colic symptoms in most babies within 24 hours, 

so your baby can start feeling better today.” 

38. Defendant breached its express warranties because Similac, Alimentum, and 

EleCare Products were defective and not reasonably safe for their intended use. 

39. Defendant knew or should have known that the Similac, Alimentum, and EleCare 

Products did not conform to its express warranties and representations and that, in fact, the 

Products are not safe and pose serious health risks because they contain microorganisms, such as 

Cronobacter sakazakii and Salmonella. 

40. Plaintiff H.O. has suffered harm as a result of Defendant’s breach of its express 

warranty regarding the fitness for use and safety of these Products and is entitled to damages to 

be determined at trial. 

Third Cause of Action: Breach of Implied Warranty 

41. Plaintiff incorporates by reference and re-alleges each and every allegation 

contained above, as though fully set forth herein. 

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Cause No.: 

42. Because the Similac, Alimentum, and EleCare Products contained Cronobacter 

sakazakii and salmonella, they were not of the same quality as those generally acceptable in the 

trade and were not fit for the ordinary purposes for which such infant formula products are used. 

43. Plaintiff used these Products in reliance upon Defendant’s skill and judgment and 

the implied warranties of fitness for the purpose. 

44. The Defendant’s Similac, Alimentum, and EleCare Products were not altered by 

Plaintiff. 

45. Plaintiff was a foreseeable user of the Products. 

46. Plaintiff used the Products in the manner intended. 

47. As alleged, the Defendant’s Similac, Alimentum, and EleCare Products were not 

adequately labeled and did not disclose that they contain harmful microorganisms, such as 

Cronobacter sakazakii and salmonella. 

48. The Products did not measure up to the promises or facts stated in the written 

literature, media advertisement and communications by and from Defendant. 

49. Defendant impliedly warranted that the Products were merchantable, fit and safe 

for ordinary use. 

50. Defendant further impliedly warranted that the Products were fit for the particular 

purposes for which they were intended and sold. 

51. Contrary to these implied warranties, the Products were defective, unmerchantable, 

and unfit for their ordinary use when sold, and unfit for the particular purpose for which they were 

sold. 

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52. By reason thereof, Plaintiff H.O. has suffered damages in an amount to be proven 

at trial. 

Fourth Cause of Action: Strict Product Liability – Failure to Warn 

53. Plaintiff incorporates by reference and re-alleges each and every allegation 

contained above, as though fully set forth herein. 

54. Defendant knew or should have known that the Defendant’s Similac, Alimentum, 

and EleCare Products contained Cronobacter sakazakii and Salmonella. 

55. Defendant had a duty to warn Plaintiff about the presence of microorganisms, such 

as Cronobacter sakazakii and Salmonella, in its Products. 

56. In addition, Defendant had a duty to warn Plaintiff about the dangers of the 

presence of harmful microorganisms, such as Cronobacter sakazakii and Salmonella, in its 

Products. 

57. Defendant knew that the risk of infection of microorganisms, such as Cronobacter 

sakazakii and Salmonella, from use of its products was not readily recognizable to an ordinary 

consumer and that consumers would not inspect the product for harmful microorganisms such as 

Cronobacter sakazakii and Salmonella. 

58. Defendant did not warn Plaintiff that Defendant’s Similac, Alimentum, and 

EleCare Products contain harmful microorganisms, such as Cronobacter sakazakii and 

Salmonella, or about the dangers of the presence of microorganisms, such as Cronobacter 

sakazakii bacteria, in its Products. 

59. Plaintiff H.O. suffered damages by purchasing the Defendant’s Similac, 

Alimentum, and EleCare Products in a manner promoted by Defendant, and in a manner that was 

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Cause No.: 

reasonably foreseeable by Defendant. Plaintiff would not have used Defendant’s Similac, 

Alimentum, and EleCare Products had she known they contained harmful microorganisms, such 

as Cronobacter sakazakii bacteria and Salmonella. 

60. Plaintiff was justified in her reliance on Defendant’s labeling and advertising of 

the product for use as a safe infant formula. 

61. Plaintiff H.O. has suffered damages in an amount to be proven at trial. 

Fifth Cause of Action: Strict Product Liability – Manufacturing Defect 

62. Plaintiff incorporates by reference and re-alleges each and every allegation 

contained above, as though fully set forth herein. 

63. The Defendant’s Similac, Alimentum, and EleCare Products contained a 

manufacturing defect when they left the possession of Defendant. Specifically, the Products differ 

from Defendant’s intended result or from other lots of the same product line because they contain 

harmful microorganisms, such as Cronobacter sakazakii bacteria and Salmonella. 

64. Plaintiff H.O. used the Products in a way that was reasonably foreseeable to 

Defendant. 

65. As a result of the defects in the manufacture of the Defendant’s Similac, 

Alimentum, and EleCare Products, Plaintiff H.O. suffered damages. 

66. Accordingly, Plaintiff H.O. suffered damages in an amount to be proven at trial. 

Sixth Cause of Action: Negligence Per Se

67. Plaintiff incorporates by reference and re-alleges each and every allegation 

contained above, as though fully set forth herein. 

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68. As documented in the FDA Form 483 issued on September 24, 2019, Defendant 

failed to test a representative sample of an infant formula production aggregate of powered infant 

formula at the final product stage and before distribution to ensure that the production aggregate 

met the required microbiological quality standards. 

69. As documented in the FDA Form 483 issued on September 24, 2021, Defendant 

failed to maintain a building used in the manufacture, processing, packing, or holding of infant 

formula in a clean and sanitary condition. 

70. As documented in the FDA Form 483 issued on September 24, 2021, Defendant 

personnel working directly with infant formula, its raw materials, packaging, or equipment or 

utensil contact surfaces did not wash their hands thoroughly in a hand washing facility at a suitable 

temperature after their hands may have become soiled or contaminated. 

71. As documented in the FDA Form 483 issued on March 18, 2022, Defendant failed 

to set in place and/or maintain a system of process controls that cover all stages of infant formula 

processing to ensure the products do not become adulterated due to the presence of 

microorganisms, including Cronobacter, in the formula or in the processing environment. 

72. As documented in the FDA Form 483 issued on March 18, 2022, Defendant further 

failed to ensure that all surfaces that contacted infant formula were maintained to protect infant 

formula from being contaminated with microorganisms, including Cronobacter and Salmonella. 

73. As documented in the FDA Form 483 issued on March 18, 2022, Defendant failed 

to document any determination as to whether a hazard to health exists due to contamination with 

microorganisms, including Cronobacter. 

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74. As documented in the FDA Form 483 issued on March 18, 2022, Defendant’s 

personnel that worked directly with infant formula, its raw materials, packaging, equipment, or 

utensil contact surfaces failed to wear necessary protective apparel. 

75. The conduct set forth herein, including that documented in the FDA Form 483 

reports represent Defendant’s conduct in violation of the following statutes or regulations that 

caused Plaintiff H.O.’s injury, including the risk of infection and infection of life-threatening 

microorganisms: 

a. 21 U.S.C. § 331 - “The following acts and the causing thereof are 

prohibited: (a) The introduction or delivery . . . of any food . . . that is 

adulterated or misbranded. (b) The adulteration or misbranding of any 

food . . . .(g) The manufacture . . . of any food . . . that is adulterated or 

misbranded;”9

b. 21 CFR § 106.5 (failing to maintain good manufacturing practices that 

are to be used in, and the facilities or controls that are to be used for, 

the manufacture, processing, packing, or holding of infant formula);10

c. 21 CFR § 106.10 (failing to ensure personnel washed hands); 

 

9 See 21 U.S.C. § 342 (A food shall be deemed to be adulterated (1) If it bears or contains any 

poisonous or deleterious substance which may render it injurious to health . . . or (4) if it has been 

prepared, packed, or held under insanitary conditions . . . .); and 21 U.S.C. § 343 (A food shall be 

deemed to be misbranded . . . if (1) its labeling is false or misleading. . . ). 

10 See 21 CFR 106.5(b) (The failure to comply with any regulation in this subpart in the 

manufacture, processing, packing, or holding of an infant formula shall render such infant formula 

adulterated under section 412(a)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

350a(a)(3)) . . . .) 

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Cause No.: 

d. 21 CFR § 106.20(a) (failing to maintain building in a clean, sanitary 

condition); 

e. 21 CFR § 106.30(d) (failing to maintain instruments used to measure, 

regulate, control parameter); 

f. 21 CFR § 106.30(e)(5) (failing to monitor the temperature in thermal 

processing equipment at a frequency as is necessary to maintain 

temperature control); and 

g. 21 CFR § 106.30(g) (failing to install a filter capable of retaining 

particles 0.5 micrometer or smaller when compressed gas is used at a 

product filling machine). 

76. Under 21 U.S.C. § 350a, an infant formula, including an infant formula powder, 

shall be deemed to be adulterated if such infant formula does not meet the quality factor 

requirements prescribed by the Secretary under subsection (b)(1), or (3) the processing of such 

infant formula is not in compliance with the good manufacturing practices and the quality control 

procedures prescribed by the Secretary under subsection (b)(2). 

77. The injury caused to plaintiffs by Defendant’s conduct, which violated these 

statutes and regulations, was the type of injury that the statutes and regulations were designed to 

prevent. 

78. Additionally, Plaintiff H.O. was a member of the class of persons these statutes 

and regulations were intended to protect. Indeed, as set forth in 21 C.F.R. § 106.5, “compliance 

with these provisions is necessary to ensure that such infant formula ... is manufactured in a 

manner designed to prevent its adulteration.” 

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Cause No.: 

79. As a result of Defendant’s conduct in the manufacture of the Defendant’s Similac, 

Alimentum, and EleCare Products violating the foregoing statutes and regulations, Plaintiff H.O. 

suffered damages in an amount to be proven at trial.

Seventh Cause of Action: Violation of Florida’s Deceptive and Unfair Trade Practices Act 

Fla. Stat. §§ 501.201-213 

80. Plaintiff incorporates by reference and re-alleges each and every allegation 

contained above, as though fully set forth herein. 

81. Plaintiff H.O. was a consumer who used Defendant Abbott’s contaminated 

Similac, Alimentum, and EleCare powdered infant formula primarily for personal use and thereby 

suffered ascertainable losses, including mental anguish, as a result of Defendant Abbott’s acts and 

omissions in violation of the applicable consumer protection laws. 

82. The Florida Deceptive and Unfair Trade Practices Act (“FDUTPA”) renders 

unlawful unfair methods of competition, unconscionable acts or practice, and unfair or deceptive 

acts or practices in the conduct of any trade or commerce. Fla. Stat. § 501.204. 

83. Among other purposes, FDUTPA is intended “[t]o protect the consuming public 

and legitimate business enterprises from those who engage in unfair methods of competition, or 

unconscionable, deceptive, or unfair acts or practices in the conduct of any trade or commerce.” 

Fla. Stat. § 501.202. 

84. As alleged herein, Plaintiff has suffered injury in fact and lost money as a result of 

Defendant’s conduct because they purchased infant formula Products from Defendant in reliance 

on Defendant’s representation that the ingredients in their infant formula Products were safe and 

effective and were not contaminated with microorganisms, such as Cronobacter sakazakii and 

Salmonella. 

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Cause No.: 

85. Defendant has engaged, and continue to engage, in conduct that is likely to deceive 

members of the public. This conduct includes representing in their labels that their infant formula 

Products contain only the ingredients listed in the label, which is untrue, and failing to make any 

mention that the infant formula Products are adulterated with microorganisms, such as 

Cronobacter sakazakii and Salmonella. 

86. Florida Statutes, Section 501.204, makes unfair and/or deceptive trade practices in 

the conduct of any trade or commerce illegal. 

87. Florida Statutes, Section 501.211, creates a private right of action for individuals 

who are aggrieved by an unfair and/or deceptive trade practice by another person. 

88. Florida Statutes, Section 501.2105, provides that the prevailing party in litigation 

arising from a cause of action pursuant to Chapter 501 shall be entitled to recover attorney’s fees 

within the limitations set forth therein form the non-prevailing party. 

89. Florida Statutes, Section 501.213, provides that any remedies available under 

Chapter 501 are in addition to any other remedies otherwise available for the same conduct under 

state or local law. 

90. Florida Statutes, Section 501.203 (3)(c), states that a person has violated the 

FDUTPA if he violates “any law, statute, rule, regulation, or ordinance which proscribes unfair, 

deceptive, or unconscionable acts or practices.” 

91. Defendant is engaged in the practice of manufacturing, marketing, distributing, 

selling and otherwise placing into the stream of commerce infant formula Products which 

constitutes trade and commerce as defined by Sections 501.203(8) Fla. Stat., and is therefore 

subject to FDUPTA. 

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Cause No.: 

92. As a result of Defendant’s unfair and deceptive trade practices, Plaintiff is entitled 

to an award of attorney’s fees pursuant to FDUTPA, Florida Statutes, Section 501.2105, if they 

prevail. 

93. Defendant’s conduct with respect to the labeling, advertising, marketing, and sale 

of their infant formula Products is unfair because Defendant’s conduct was immoral, unethical, 

unscrupulous, or substantially injurious to consumers and the utility of its conduct, if any, does 

not outweigh the gravity of the harm to its victims. 

94. In accordance with FDUTPA, Plaintiff seeks an order enjoining Defendant from 

continuing to conduct business through fraudulent or unlawful acts and practices and to commence 

a corrective advertising campaign. Defendant’s conduct is ongoing and continuing, such that 

prospective injunctive relief is necessary. 

95. Plaintiffs also seeks an order entitling them to recover all monies spent on the 

Defendant’s infant formula Products, which were acquired through acts of fraudulent, unfair, or 

unlawful competition. In addition, the measure of restitution should be full refund of the purchase 

price insofar as the infant formula Products and their associated labels are worthless. But for 

Defendant’s misrepresentations and omissions, Plaintiff would have paid nothing for infant 

formula Products that have a risk of containing microorganisms such as Cronobacter sakazakii

and Salmonella. Indeed, there is no discernible “market” for an infant formula product that may 

be adulterated with harmful bacteria. As a result, the Defendant’s infant formula Products are 

rendered valueless. 

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Cause No.: 

96. As a result of Defendant’s conduct in the manufacture of the Defendant’s Similac, 

Alimentum, and EleCare Products violating the foregoing statutes and regulations, Plaintiff H.O. 

suffered damages in an amount to be proven at trial. 

Eighth Cause of Action: Plaintiffs Claim for Damages Incurred on Behalf of her Minor 

Child, H.O. 

97. Plaintiff incorporates by reference and re-alleges each and every allegation 

contained above, as though fully set forth herein. 

98. Plaintiff, H.O. was a minor at all times referenced in this Complaint. 

99. As a direct and proximate result of Defendant’s acts and/or omissions, Plaintiff 

H.O. suffered physical injuries. 

100. Plaintiff Jordyn O’Brien has a derivative claim for damages because her minor 

child, H.O., has sustained physical injuries due to the Defendant’s conduct. 

101. As a result, Plaintiff Jordan O’Brien has a legally recognized claim for damages 

and seeks reimbursement for medical expenses and other expenses incurred because of Plaintiff 

H.O.’s injuries. 

102. As a result of Defendant’s conduct in the manufacture of the Defendant’s Similac, 

Alimentum, and EleCare Products violating the foregoing statutes and regulations, Plaintiff 

suffered damages in an amount to be proven at trial. 

PRAYER FOR RELIEF 

WHEREFORE, Plaintiff, on behalf of herself and her minor child, H.O. pray for 

judgment against the Defendant as to each and every count, including: 

a. Actual damages in the amount to be determined at trial; 

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Cause No.: 

b. Exemplary damages sufficient to punish Defendant Abbott and deter it and others 

from future wrongful conduct; 

c. Treble damages as allowed by law; 

d. Attorneys’ fees as allowed by law; 

e. Costs and expenses as allowed by law; 

f. Pre- and post- judgment interest as allowed by law; 

g. Any other relief the Court may deem just and proper. 

DEMAND FOR JURY TRIAL 

Plaintiff demands a trial by jury on all issues so triable. 

DATED: August 22, 2022 AYLSTOCK, WITKIN, KREIS &

OVERHOLTZ, PLLC 

BY: /s/ E. Samuel Geisler 

E. Samuel Geisler, Fla. Bar No. 83817 

sgeisler@awkolaw.com 

Bryan F. Aylstock, Fla. Bar No. 78263 

baylstock@awkolaw.com 

Caitlyn P. Miller, Fla. Bar No. 126097 

cmiller@awkolaw.com 

Aylstock, Witkin, Kreis & Overholtz, PLLC 

17 East Main Street, Suite 200 

Pensacola, FL 32502 

Phone: (850) 202-1010 

WALSH LAW 

Alexandra Walsh, pro hac vice to be submitted 

awalsh@alexwalshlaw.com 

Kim Channick, pro hac vice to be submitted 

kchannick@alexwalshlaw.com 

1050 Connecticut Ave., NW, Suite 500 

Washington, DC 20036 

(202) 780-3014 

 ATTORNEYS FOR PLAINTIFFS 

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