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Enfamil & NEC lawsuit


chandas

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Many colleagues would be aware of the recent lawsuit in Illinois against Mead Johnson alleging Enamel causing NEC in a preterm baby which the US Court found in the family's favour with an award of $60 million. Whilst the allegation that any cow's milk-based formula CAUSES NEC (rather than saying that human milk protects against NEC) may not be widely held view here, I wondered if colleagues are seeing any fallout from this lawsuit. Clearly this would raise parental concerns and the professionals would find it difficult to recommend any cow's milk-based formula for a preterm baby if the mother can not or does not wish to provide her own breast milk.

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Adding some links for context:

Reckitt charged with $60 million verdict:

https://www.reuters.com/legal/reckitt-unit-hit-with-60-million-verdict-enfamil-baby-formula-case-illinois-2024-03-14/

The legal turns:

https://www.law.com/2024/03/14/mead-johnson-hit-with-60m-verdict-in-first-nec-trial-over-preterm-infant-formula/?slreturn=20240224133119

As I’ve understood it they are fined for not warning about the increased risk for NEC compared to breast milk.

As for breast milk, there are a number of ways to set up programmes for donor breast milk, wouldn’t that be the most reasonable approach?

 

 

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  • 1 month later...

The ICU in question appears to be licensed only to care for babies >32 weeks on CPAP or lower respiratory support. Based on my best inference from various articles, he was born in 2020 or 2021 and transferred from a high risk perinatal center as a 10-12 day old ex-31 to 31 6/7 week twin boy, probably on CPAP or HFNC, probably on full enteral feeds. It is unclear if he was transitioned to formula feeds at the birth hospital or upon transfer to the local unit.

There is probably significant variation in when babies are transitioned to formula feeds both internationally and within the US, but in my experience in multiple regions of the USA, transitioning at ~33weeks corrected is not unusual.

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34 minutes ago, Bimal said:

The ICU in question appears to be licensed only to care for babies >32 weeks on CPAP or lower respiratory support. Based on my best inference from various articles, he was born in 2020 or 2021 and transferred from a high-risk perinatal center as a 10–12-day old ex-31 to 31 6/7 week twin boy, probably on CPAP or HFNC, probably on full enteral feeds. It is unclear if he was transitioned to formula feeds at the birth hospital or upon transfer to the local unit.

There is probably significant variation in when babies are transitioned to formula feeds both internationally and within the US, but in my experience in multiple regions of the USA, transitioning at ~33weeks corrected is not unusual.

Before transition enteral feed than breast milk, the GIT has to be primed before any non-breast milk enteral feed, as non-priming increases the risk of NEC.

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2 hours ago, Manohar said:

Before transition enteral feed than breast milk, the GIT has to be primed before any non-breast milk enteral feed, as non-priming increases the risk of NEC.

 Still, medical care is about balancing benefits and risks. When preterm infants are fed formula, the other alternative is not always breast milk (being unavailable), so there would be no “choice”.  IMHO this legal case is just a bad example of a legal culture with few, if any, benefits. I sincerely hope we will never see anything of this in Europe.

BTW, we also transition to formula around 32-33 weeks if there is insufficient mother’s own milk.

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  • 2 weeks later...

Interesting, this litigation was bound to happen one day.

In the unit I work in, we do not use formula feds for preterm babies.

We have not had a case of NEC since change of the policy.

Majority of the babies are fed mothers own milk (MOM).

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  • 1 month later...

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