Enfamil Linked to Preemie Blindness, Cerebral Palsy

Evansville, INOn April 17, Sandra Hayes sued Mead Johnson & Company, alleging that the baby formula manufacturer was responsible for injuring Adam Hayes shortly after his birth. The necrotizing enterocolitis lawsuit details baby Adam’s injuries including partial blindness and cerebral palsy brought on by his consumption of Enfamil Premature 24, a cow’s milk-based formula in the days after his early birth.

Hayes v. Mead Johnson & Company seeks damages for Baby Adam on the grounds that the baby formula was unreasonably dangerous and that the company failed to exercise reasonable care to design, test, manufacture, inspect, and/or to distribute a product free of unreasonable risk of harm to children. In addition, the Complaint alleges that Mead Johnson failed to warn the general public that the product is dangerous.

Tiny baby gets sicker

Adam Hayes was born on April 17, 2003, at just 24 weeks of gestational age. He weighed less that a pound and a half. Within the first month of his life, Adam was fed Enfamil Premature 24 as many as 28 times.

Two days after his birth, Adam began to throw up bile, -- an early sign of necrotizing enterocolitis (NEC). Adam developed an esophageal perforation on May 5, 2003. Thereafter, the hospital where he was born began to add intravenous feedings to oral Enfamil Premature 24 feedings. By May 9, 2003, Adam had developed:

• abdominal distention;
• dilated bowel loops;
• ileal perforation; and
• observable free air in abdominal x-rays.

On May 10, 2003, Adam was transferred to St. Christopher’s Children’s Hospital in Philadelphia, PA because of his worsening condition. He was diagnosed Stage IIIA NEC.

On July 17, Adam’s eye exam reported a pre-threshold Retinopathy of Prematurity, and he eventually required laser eye surgery for both eyes, Additionally, and as a result of his development of NEC, Adam developed cerebral palsy. The Complaint alleges that he will live for the remainder of his life with the chronic and permanent effects of his exposure to Enfamil Premature 24.

Special issues with feeding preterm or low weight babies

As set forth in the Complaint, “[c]aring for preterm, low-weight babies is challenging because they typically have metabolic immaturity, poor gut function, [and] cannot coordinate sucking with breathing, so it is not safe to feed them by mouth.” They also have special nutrient needs. There are four basic options:

• parenteral nutrition, such as a feeding tube for feeding intolerance;
• human milk – either the mother’s or a donor’s;
• cow’s milk-based formulas or fortifiers; and
• human milk and non-cow’s-milk based formulas.

Donor milk became scarce during the HIV and AIDs crisis, and nutritional companies invested in cow’s milk-based products, to the neglect of human and non-bovine products. NEC appears to be six to ten times more common in exclusively formula-fed babies than in those fed breast milk alone. It is three times more common than in those who received formula plus breast milk. The manufacturers’ marketing campaigns directed at hospitals and new mothers appear to have exacerbated the problem.

As early as 2018, the World Health reported that “despite ample evidence of the benefits of exclusive and continued breastfeeding for children, women, and society, far too few children are breastfed as recommended.” The WHO Report further states that “a major factor undermining efforts to improve breastfeeding rates is continued and aggressive marketing of breast-milk substitutes,” noting that in 2014, the global sales of breast-milk substitutes amounted to US $44.8 billion and “is expected to rise to US $70.6 billion by 2019.”

Strict liability

The Complaint sets forth three legal theories under which Mead Johnson could be found liable for Adam’s injuries. The first of these, strict liability, posits that Enfamil Premature 24 is defectively designed and/or unreasonably dangerous to consumers. Mead, the plaintiff asserts, knew or should have known that the use of their cow’s milk products with preterm infants significantly increased the risk of NEC. Based on scientific data and well-researched studies, the risks of NEC appeared to outweigh the products’ benefits for extremely premature infants like Adam.

Negligence

The second of these theories argues that Mead, as the manufacturer and seller, had a duty to have the knowledge and skill of an expert and was obliged to keep abreast of any scientific discoveries concerning the product that it introduced into commerce. Among other things, the company appears to have failed to:

• collect data to determine if the products were safe for preterm infants;
• utilize the significant peer reviewed research to develop instructions;
• stop or deter the products from being fed to extremely preterm infants like Adam Hayes;
• adopt an adequate or sufficient quality control program; and/or
• inspect or test their products with sufficient care.

Adam’s serious injuries were the direct and foreseeable result of these failures.

Failure to warn

Finally, Mead owed a duty to the consuming public in general, and Adam Hayes in particular, to properly warn and provide adequate warnings or instructions about the dangers and risks associated with the use of cow’s milk products with preterm infants, specifically including but not limited to the risk of NEC. Instead, the company appears to have marketed the product aggressively hospitals and anxious parents, at a particularly vulnerable time in their lives.

The possible outcome

This is a civil lawsuit, of course, so the remedy will be monetary. But it may do something to make Adam’s life easier in the years to come. Further, the deterrent effect of monetary damages may prompt Mead to change its future practices.