In the second court case to find against an infant formula company in the US this year, Abbott has been fined $495 million ($95 m punitive damages, $400 compensatory damages) for not informing doctors of the increase risk of Necrotizing enterocolitis (NEC –  a serious gastrointestinal problem that mostly affects premature babies). from its Similac infant formula. Meanwhile the share price of UK rival Reckitt Benkiser fell to a 10-year low after $60 m was awarded to the family of a baby who died after being fed with preterm formula.

The importance of mothers milk for premature babies has been known for many years, and donor milk can play an important role in providing a bridge to breastfeeding as part of a programme of optimal lactation support. So why has there been so little investment in training, staffing, infrastructure and research into donor milk banking or Kangaroo Mother Care ? The raised risk of NEC has been suspected for several decades, since the 1980s, and meta-analyses confirming the association have been published since 2014.

July 26/27 2024  (Reuters) A jury found that Abbott Laboratories’ specialized formula Similac for premature infants caused an Illinois girl to develop a dangerous bowel disease, ordering the healthcare company to pay $495 million in damages.  The verdict in St. Louis, Missouri state court comes in the first trial against the company out of hundreds of similar claims over the formula pending in courts around the country, which Reuters viewed via Courtroom View Network.  

According the Just Food Abbott Laboratories  hid the risk that its infant formula for premature babies can cause serious illness. A jury sitting in a state court in St Louis on Friday (26 July) voted nine to three against US-based Abbott, which was then fined $95m to compensate the Gill family, whose experience was at the centre of the allegations, for its losses and $400m in punitive damages.

In a post on LinkedIn after the verdict was handed down, TorHoerman Law, the legal firm representing the family, said: “Robynn Gill suffered severe, irreversible brain damage due to Abbott’s misconduct.”

Prevention Strategies and Management of Necrotizing Enterocolitis

What is behind this story?

It is well documented that prematurely born infants who receive a diet of human milk supplemented with cow’s milk-based protein products experience significantly higher rates of necrotizing enterocolitis (NEC) compared to premature infants who receive a human milk diet only^1-13.   For this reason both global and national authoritative bodies all recommend the feeding of human milk for premature babies.

The American Academy of Pediatrics in its policy statement Breastfeeding and the Use of Human Milk¹² has for years recommended that all preterm infants should receive human milk.  The Academy has supported its recommendation with research documenting, those fed an exclusive diet of human milk compared to those supplemented with cow’s milk based products to have reduction of NEC as high as 77% ^10,11,13. The US Department of Health and Human Services similarly in its 2011 Call to Action¹⁴ notes the risk of NEC when premature infants are not receiving breastmilk.

Similarly, the World Health Organization (WHO)’s numerous policy recommendations on infant and young child feeding^15,16 emphasize the critical importance of all infants to receive exclusively their own mothers’ milk or donor milk to achieve optimal health outcomes and survival.

Despite such evidence and policy recommendations, infant formula manufacturers aggressively and  systematically market their products for the feeding of premature infants with unsubstantiated promotional claims, while failing to inform of the risks.

On Friday (26 July), in the first of these cases, US infant-formula major Abbott Laboratories was ordered to pay almost $500m in damages after a jury agreed by a majority that it hid the risks associated with its Similac Special Care 24 cow’s milk-based formula for premature babies.  Premature baby girl Robynn Gill suffered brain damage as a result of contracting necrotizing enterocolitis (NEC) after being fed with the formula.

Reckitt’s share price is said to have fallen to a 10-year low.

Reckitt Benckiser’s shares slump after Abbott baby formula ruling over bowel disease link

British group says claims products cause serious bowel condition NEC are ‘not supported by science’

The Guardian 30th July 2024.  Jack Simpson

Reckitt Benckiser’s share price has dropped to a 10-year low after a US court ruled that a formula produced by rival Abbott Laboratories had caused a baby girl to develop a serious bowel disease.Shares in the British consumer goods group, which is facing similar legal action over its Enfamil formula, saw its shares plunge by about 9% to roughly £40.75 a share on Monday after Abbott was ordered to pay $495m (£385m) in damages by a court in Missouri on Friday.

Analysts Jefferies said the Abbott ruling was likely to “depress sentiment” for Abbott and Reckitt, and has already estimated a discount for the legal liability of £3bn for Reckitt. “With [Reckitt’s]   own new individual trial due to start on 30 September and multidistrict litigation action gaining momentum, that risk may be extended this week we think.”

According to Reuters, there are now 1,000 cases that have been filed against each, or both, of the companies in US federal or state courts.

The lawsuits claim the companies did not warn doctors that infants receiving formula had a greater risk of a deadly disease than infants who are breastfed or given donor milk or human milk-derived formula. Abbott and Reckitt have denied the claims and say there is no evidence their products cause NEC.

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References:

1. Cortez, J., Makker, K., Kraemer, D. et al.Maternal milk feedings reduce sepsis, necrotizing enterocolitis and improve outcomes of premature infants. J Perinatol 38, 71–74 (2018).
2. Steven A. Abrams, Richard J. Schanler, Martin L. Lee, David J. Rechtman, and the Prolacta Study Group. Greater Mortality and Morbidity in Extremely Premature Infants fed a Diet Containing Cow Milk Based Products. Breastfeeding Medicine.9, 281-285 (2014). http://doi.org/10.1089/bfm.2014.0024
3. Shulhan, Jocelyn et al. “Current Knowledge of Necrotizing Enterocolitis in Preterm Infants and the Impact of Different Types of Enteral Nutrition Products.” Advances in nutrition (Bethesda, Md.) 8,1 80-91. 17 Jan. 2017, doi:10.3945/an.116.013193
4. Lucas A, Cole TJ. Breast milk and neonatal necrotising enterocolitis. 1990;336(8730):1519–1523.Describes the strong relationship of the protective effect of breast milk on NEC.
5. Good, M., Sodhi, C. P., & Hackam, D. J. (2014). Evidence-based feeding strategies before and after the development of necrotizing enterocolitis. Expert review of clinical immunology, 10(7), 875–884.https://doi.org/10.1586/1744666X.2014.913481
6. McGuire, W., and M. Y. Anthony. “Formula milk versus preterm human milk in preterm or LBW infants (Cochrane Review).” The Cochrane Library(2001).
7. Taylor S. Solely human milk diets for preterm infants. Semin Perinatol. 2019;43(7):151158.

8. Maffei D, Schanler RJ. Human milk is the feeding strategy to prevent necrotizing enterocolitis! Semin Perinatol. 2017 Feb;41(1):36-40. doi: 10.1053/j.semperi.2016.09.016. Epub 2016 Nov 8. PMID: 27836421.
9. Maffei D, Schanler RJ. Human milk is the feeding strategy to prevent necrotizing enterocolitis! Semin Perinatol. 2017 Feb;41(1):36-40. doi: 10.1053/j.semperi.2016.09.016. Epub 2016 Nov 8. PMID: 27836421.
10. Sullivan S. Schandler RJ, Kim JH, An exclusive human milk based diet associate with a lower rate of necrotizing enterocolitis than a diet of human milk and bovine milk-based products. J Pediar, 2010:156:362-267.
11. Cristofalo EA, Schandler RJ, Blanco CL, Sullivan S, Trawoeger R, Kiechl-Kohlendorfer U, Dudell G, Rechtman DJ, Lee ML, Lucas A, et al. Randomized triel of exclusive human milk versus preterm fprmula diets in extremely premature infants. J Pediatr 2013;163:1592-1505.
12. pediatrics.org/cgi/doi/10.1542/peds.2011-3552 doi:10.1542/peds.2011-3552
    PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098-4275). Copyright © 2012 by the American Academy of Pediatrics
13. Ip S, Chung M, Raman G,et al. Tufts-New England Medical Centre Evidence-based Practice Centre. Breastfeeding and maternal and infant health outcomes in developed countries. Evid Rep Technol Access 207;153(153):1
14. S. Dept of Health and Human Services. The Surgeon General’s Call to Action to Support Breastfeeding. 2011.
15. Edmond K, Bahl K. Optimal feeding of low-birth-weight infants: technical review. WHO, Geneva 2006.
16. WHO,UNICEF. Global Strategy for Infant and Young Child Feeding. WHO, Geneve, 2003.

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Baby Milk Action – BMA