Formula For Tragedy

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Nov 13, 2008 9:16 pm US/Central

Investigators: Formula For Tragedy

Powdered Baby Formula Could Be Dangerous For Some Infants

Dave Savini

CHICAGO (CBS) ― A warning for parents: Milk-based powdered formula
could put premature babies at risk.

And it is a possible cause for the death of an infant born at Rush-
Copley Medical Center in Aurora and other babies across the country.

Connor McGray and his twin brother, Logan, were born prematurely on
Nov. 16, 2007, at Rush-Copley.

Connor appeared to be the healthier of the two — until a week later
when their parents, Amanda Carlin and Tim McGray of Somonauk, received
a call from a doctor at the hospital, saying the infant was lethargic
and refusing to eat.

Doctors discovered Connor had meningitis, McGray said, and "they
basically told us, all we could do (was) pray."

The baby died at home on May 3, 2008, five months after he was born.
The cause of death listed on the baby's death certificate is
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 baby while he was
being cared for in the Neo-Natal Intensive Care Unit at Rush-Copley.
In a statement released Thursday, Rush-Copley said, "We have the
utmost compassion for the baby and his family.

"Rush-Copley delivers 4,000 babies a year and the procedures followed
here are consistent with the standards of care provided to prematurely
born infants in the U.S."

The danger with powdered formula is that, unlike the liquid kind, it
cannot be sterilized, making it vulnerable to bacteria growing in it,
according to the Centers for Disease Control and Prevention.

The most severe cases involve babies exposed to a bacteria called
Enterobacter sakazakii, or E-sak, which can lead to raging infections,
severe brain damage, and ultimately death, according to the CDC.
Amanda Carlin said son Connor died after the E-sak bacteria led to an
infection which caused the deadly form of meningitis.

The baby suffered from seizures and brain abscess. And his blood and
cerebral spinal fluid tested positive for the organism, the Health
Department document says.

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

The powdered formula used by the hospital was Enfamil by Mead Johnson.
Connor consumed the product from Nov. 20 through Nov. 24 orally and
through a nasogastric tube, the Health Department says. The report
said 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, McGray said, the family wanted the twin
boys together. Logan was being treated at the University of Chicago
for an intestinal condition.

Infants born prematurely, or those with weak immune systems, are at
greatest risk of being infected, according to the U.S. Department of
Health and Human Services. 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."

Carlin 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 said. "That's the only way we
knew."

A CBS2/Beacon News investigation 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.

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

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."

The FDA also said there are sterilized liquid fortifiers on the market
that can be used as an alternative. The FDA would not put a complete
ban on the powder and said it may be used in the NICU when no
appropriate liquid product is available.

Five years after this FDA warning, Connor McGray was given the
powdered formula, according to the Health Department document.
His family says he was getting stronger and doing well until he got
the powder.

Similar to Connor, Daniel Korte was born prematurely last year. He,
too, 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 under-reported.
There may be other infants diagnosed with meningitis that have not
been checked for E-sak.

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,'" said
Meyers. "Especially if it comes in a hospital gift bag."

Mead Johnson, manufacturer of powdered formula including Enfamil, 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
said.
Both manufacturers have been sued by formula victims.

The parents of Connor McGray and Daniel Korte are also 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.

Christine Moyer of the Aurora Beacon News and Michele Youngerman and
Michelle Diotallevi of CBS2 contributed to this report.

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