Abbott Laboratories: The Silence Behind $670 Million -By Fransiscus Nanga Roka

Abbott Laboratories has now rebooted a $670 million deal — and its not even the actual money payout. It is a stunning public indictment of all the ways American medicine, corporate power and neonatal care can come together at their lowest point: in the NICU where premature infants are at their most vulnerable and parents least capable of resisting whatever they are told.

The obvious who: Abbott, which faces roughly 2,000 claims and Mead Johnson is still battling related litigation. The what is bombshell: a huge settlement, much of it related to the 2024 Margo Gill verdict in St. Louis, with Abbott facing a $495 million judgment that was said to have grown to about $600 million with interest. The when is right now, at a time when the national litigation has gained speed, rather than waning. Where: Missouri courtrooms and MDL 3026 in federal court, Chicago. The actual scandal resides in the why that some rumors ZThey did not warn it well enoughZ that cow’s milk-based formula as well as fortifiers may increase the risk of necrotizing enterocolitis, or NEC–compared with human milkZ for premature babies stuck around. The how, of course, is second nature across corporate America: big settlement, no admission of wrongdoing and brand protection.

That last point matters. A no-liability deal is court-ready, but the ethical issue does not go away. If these products are as critical as manufacturers and some health care authorities assert, why was the debate about warnings not front-and-center for parents, clinicians and hospitals from the very beginning? A product can be clinically beneficial and still require much more honest risk disclosure.

And this is what makes the case so disturbing. It is not a mantra found in supermarket formula. This October 2023 it is well past the Cronobacter crisis of 2022 in Micigan. It relates to hospital products that are used on premature infants during the critical early development period of the intestines. NEC is a horrible disease — it is not just a technical footnote; it can lead to bowel tissue death, perforation, septicemia and death. When the patient is that vulnerable, vague labeling and institutional complacency does not amount to neutrality. They are dangerous.

The science is neither politically convenient for the right, nor for the left. The major institutions that have weighed in include the FDA, CDC and NIH as well as the American Academy of Pediatrics — all of which believe that specialized preterm-infant formula remains an important clinical role. Numerous experts contend that the underlying cause of NEC risk is typically indeed not formula “poisoning” those infants, but actually the absence of mother’s milk or donor milk. But even that defense does not address the heart of the matter. If risk differs depending on modality of feeding then informed consent ought to be laid out in no uncertain terms, particularly in critical care.

And this deluge of litigation is only just getting started. According to reports, thousands of claims are still pending and Mead Johnson remains on the hook with further bellwether trials continuing. Hence there is no closing with the Abbott deal at all. It is a warning flare.

If health systems are serious about saving preterm babies rather than simply caring for them, then three reforms are no longer optional.

The first is that we must ensure stronger warning labels on cow’s milk-based premature infant formula and fortifiers. These labels should never be couched in sterile, industry-friendly language that sacrifices risk for reassurance. They must be clear to all audiences, clinicians and parents alike: what it is, for whom it is indicated, what the known concerns are, and where uncertainty remains. The blurred line in the NICU isn’t innocuous A weak label is not a neutral oversight but rather a failure of moral and clinical clarity, particularly when the patient is a preterm infant with an immature gut. There is no way meaningful choice can come to play if the warning just backdates into some technical language designed to protect liability as opposed to informing.

Second, there should be documented informed consent for each NICU where these products are used. It is common to see making decisions about feeding premature infants as routine, like a simple hospital Operation instead of treating it as choices with possibly dire consequences. That logic is unacceptable. The rationale for donor human milk, enumeration of alternatives and the clear explanation of the risk that use of NEC poses can be highly reproached at by a family. Consent should not be a signature squeezed out of someone at some point under duress, or handed over post factum as a formality. That parents were indeed updates, that they understood their options, and that they were given a choice. Otherwise, it’s just a euphemism for institutional convenience disguised as consent language.

Third, governments need to fund human milk infrastructure at the national level. That translates into growing donor milk banks, bolstering lactation support and setting hospital policies that lower reliance on formula wherever feasible. This is not sentimentality. It is public health strategy. If formula is easier to acquire than donor milk, we are subtly giving the system incentives for what is convenient and not what is safe. This in-balance is particularly cruel in the NICU, where that relationship between access and non-access have a huge impact in survival, complications and long-term outcomes.

These recommendations are important, because they speak to the underlying failure: not what products exist or even how they are regulated, but how risk is communicated and decision making occurs within our health system at its most vulnerable stages. Families should not have to place their trust first and understand second in a NICU. They should be a standard of care where transparency, consent, and safer feeding alternatives are built in to all the options.

The real scandal is not what transpired in court. What it is that in one of the most sophisticated health systems on planet Earth, parents might still be forced into learning the harshest realities not through honesty but litigation.

Fransiscus Nanga Roka

Faculty of Law University 17 August 1945 Surabaya and Managing Partner Law Firm Victorious Indonesia