Formula For Tragedy: Milk-Based Powdered Formula

Infant Formula Notification
Every week I get news stories that are gathered from Google searches on prematurity. This morning I was looking though the stories and found a series of alarming stories on the use of Enfamil powdered breast milk fortifier

Formula For Tragedy: Milk-Based Powdered Formula
Powdered Baby Formula Could Be Dangerous For Some Infants
CHICAGO (CBS News) ― Connor McGray and his twin brother, Logan, were born prematurely on Nov. 16, 2007 at an Illinois hospital.

Connor appeared to be the healthier of the two. It wasn't until their parents, Amanda Carlin and Tim McGray of Somonauk, Ill., received a call from a doctor at the hospital a week later saying the infant was lethargic and refusing to eat.

Doctors discovered Connor had meningitis and "they basically told us, all we could do was pray," their parents recall.

On May 3, 2008, their baby died at home.

"He knows there's something missing," Amanda Carlin says of their surviving child, Logan, who turned 1 last week.

Officials listed the cause of death as hydrocephalus and bacterial meningitis. The bacterial infection, according to a memo from the Illinois Department of Public Health, "may be associated with the consumption of a powdered breast milk fortifier."


The Enfamil brand powdered formula was fed to the Connor during his time in the the Neo-Natal Intensive Care Unit at Rush-Copley Medical Center.

In a statement released on Nov. 13, 2008, Rush-Copley said: "We have the utmost compassion for the baby and his family."

Hospital officials noted 4,000 babies are born at the facility each year and "the procedures followed here are consistent with the standards of care provided to prematurely born infants in the U.S."

"There was nothing I could do. I felt helpless and part of me was gone forever," Carlin said.

During an investigation by the CBS station in Chicago, research found Connor's death was not the only associated with the tainted baby formula claim.

The Centers for Disease Control and Prevention says the danger with powdered formula is that -- unlike the liquid kind -- it cannot be sterilized, which makes it vulnerable to bacteria growing in it, CBS station KTVT-TV reported.

The most severe cases involve babies exposed to a bacteria called Enterobacter sakazakii, or E-sak. The CDC notes e-sak can lead to raging infections, severe brain damage and ultimately death, as in Connor McGray's case.

The baby suffered from seizures and brain abscess. According to official health records, his blood and cerebral spinal fluid tested positive for the organism.

Premature Infants or those with weak immune systems are at greatest risk of getting infections, the U.S. Department of Health and Human Services reports.

There is even a warning on powdered formula containers. One brand warns: "... powdered infant formulas are not sterile and should not be fed to premature infants or infants who might have immune problems unless directed and supervised by your baby's doctor."

During the week before Connor's illness, a health department memo notes he was fed ready-to-feed liquid formula, as well as, breast milk with powdered infant fortifier.

Hospital records show the powdered formula the hospital used was Enfamil by Mead Johnson.

From Nov. 20 to Nov. 24, Connor was fed the product orally and through a nasogastric tube.

The same health department report noted the product was prepared at the hospital in a prep area/station, not a dedicated formula preparation room.

On Dec. 3, 2007, Connor was transferred from Rush-Copley to the University of Chicago because, Tim McGray said, the family wanted the twin boys together. Logan was being treated at the University of Chicago for an intestinal condition.

His mother said the hospital did not tell her about the risks of powdered formula.

She said she also didn't learn about her son being given the powder, until she hired The Collins Law firm in Naperville.

"We didn't find out until afterward, when we got a hold of whatever medical records we could get," McGray adds. "That's the only way we knew."

The CBS2 investigation also uncovered other cases in which powdered formula was blamed for causing brain damage or death in infants. There have been at least two Illinois cases and cases in at least 17 other states, including Texas.

Ed Manzke, one of the attorneys hired in Connor McGray's case said it's not an isolated problem.

"There have been deaths all across the country related to powder infant formulas. And what is so shocking about it, is hardly anyone knows it. It's like leaving a loaded gun in a nursery."

A 2001 E-Sak outbreak in Tennessee led to a 2002 U.S. Food and Drug Administration warning to health professionals.

In a letter the FDA wrote: "FDA recommends that powdered infant formulas not be used in neonatal intensive care settings unless there is no alternative available."

FDA officials also said there are sterilized liquid fortifiers on the market that can be used as an alternative.

The FDA stopped short of issuing a complete ban on the powder, but said it may be used in the NICU when no appropriate liquid product is available.

Despite the warning, five years later Connor McGray was given the powdered formula. His family says he was getting stronger and doing well until he got the powder.

Daniel Korte also was fed powdered infant formula and was struck with the same infection and meningitis. His parents said the contaminated formula was fed to him at Mercy Medical Center in Des Moines, Iowa.

Daniel survived, but is living in a nursing facility on a ventilator.

"It basically turned his brain to mush," said Michelle Korte, Daniel's mother. "He is ventilated and his upper brain is destroyed."

Korte said the hospital in this case also never warned her about the risk associated with the formula.

An attorney she hired, Andy Weisbecker, said powdered formula manufacturers need to do a better job of informing doctors and parents about the danger.

"More needs to be done to increase the level of knowledge about this deadly bug," Weisbecker said. "Who knows how many parents are out there with affected children who may still not be aware of a possible connection between these illnesses and contaminated formula."

Federal regulators believe the number of cases are underreported. There may be other infants diagnosed with meningitis that have not been checked for E-sak.

"They pretty much just want to sweep it under the rug and it's not an issue you can just sweep under the rug. I mean it took a baby's life," Copley stresses.

Babies are not just being sickened by formula in hospitals, however. Parents unknowingly are buying the powdered formula for at-risk babies.

Stephen Meyer, an attorney at the Law Office of Nick Stein in Indiana, has spent nine years working on E-sak cases. He said the FDA's warning should have gone to consumers.

"Most moms would think 'If it's marketed to me, it's safe' … especially if it comes in a hospital gift bag."

Mead Johnson officials said its products are safe as long as they are used according to label directions.

The company said it has "taken the position that powdered infant formula should not be used in neonatal intensive care settings unless no alternative is available."

Tracey Noe, a spokesman for Abbott, which manufactures formula including Similac, said it uses rigorous testing procedures, including bacterial testing, on its powdered formulas.

"Abbott agrees with the U.S. Food and Drug Administration/Centers for Disease Control and Prevention joint recommendation that powdered formula should not be used in hospital neonatal intensive care units — unless no nutritionally suitable alternative is available," Noe responded.

Both manufacturers have been sued by families who say they were affected by the tainted formula.

The parents of Connor McGray and Daniel Korte also are planning to file lawsuits. In the meantime, they are talking about what happened in hopes of warning — and educating — doctors, hospital staff and other parents about the potential danger of powdered formula.

"I want other people to be aware of it so they don't have to go through what I did," Amanda Carlin said.