OPINION:
Two years ago, as we were emerging from the worst of the COVID-19 pandemic, a new health crisis — an infant formula shortage — gripped the nation. The good news was that families across the country worked with friends, churches, synagogues, mosques, community groups and milk banks to ensure their babies got the nutrition they needed.
Now, new litigation involving preterm infant formula and human milk fortifiers threatens to upend access to these critical products. Once again, tort lawyers, sensing a big payday, have put greed before civic duty by putting at risk one of our most at-risk populations — premature infants.
Lawsuits alleging a link between necrotizing enterocolitis, or NEC, preterm infant formula and human milk fortifiers have popped up across the country. In March, an Illinois jury awarded $60 million to a woman whose premature infant died from NEC, an intestinal disease afflicting premature and low-birth-weight babies, finding that Mead Johnson (the manufacturer of Enfamil formula) failed to warn her about the potential risk of NEC.
These “failure to warn” claims are odd and out of place because parents don’t buy preterm infant formula or human milk fortifiers at the grocery store. These are highly specialized products that neonatal doctors in hospitals direct for specific use for infants. Preterm baby formula and milk fortifiers carry mandatory labeling language that is strictly regulated by the Food and Drug Administration.
These products are accompanied by product guides developed for medical professionals. Doctors, nurses and other hospital professionals work around the clock to ensure that premature babies get the extra calories, protein and essential nutrients they need for growth and bone development. These decisions are extremely complex and happen in real time.
If the FDA felt it needed to take action, it would. And in fact, it did. Last year, the FDA ordered medical staff to stop administering probiotics to premature infants when an infant died after the bacteria in one probiotic was found in the baby’s bloodstream. The infant formula shortage of two years ago found parents across the country scrambling to find formula to meet their babies’ needs. Rather than allowing the tort bar to create a new feeding frenzy, we should instead focus on strengthening the baby formula supply chain and investing in new and innovative technologies to support babies most at risk.
Physicians across the country rely on preterm infant formula and human milk fortifiers for at-risk premature babies because they are effective and safe. The FDA has continued to allow preterm infant formula or human milk fortifier product to support the standard of care, and they have not necessitated any further labeling.
The most effective way to increase positive outcomes rather than drive more greed-driven litigation is to ensure decisions about neonatal nutrition continue to be made in conversations between medical professionals and their patients’ parents and guardians. More lawsuits will inevitably lead to more formula shortages as more companies pull out of this specialized market segment completely. “Failure to warn” is a direct threat to the lives of America’s preterm infants.
• Peter J. Pitts is president of the Center for Medicine in the Public Interest, a visiting professor at the University of Paris School of Medicine, and a former associate commissioner of the Food and Drug Administration.
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