Formula makers cannot use US government statement in trial over preterm baby illness
By Brendan Pierson
Oct 23 (Reuters) -Abbott ABT.N and Reckitt's RKT.L Mead Johnson will not be allowed to show jurors a statement by U.S. government agencies and a government-commissioned report to defend themselves against a lawsuit by a mother who says her son got a severe intestinal illness from the companies' baby formula for premature infants.
The ruling by Missouri Circuit Judge Michael Noble in St. Louis, Missouri, state court on Wednesday comes in the middle of a trial that began in late September and is expected to last five weeks. Noble said the statement and report were not new research and rejected the companies' argument that they should be allowed in court because they are "authoritative."
Plaintiff Elizabeth Whitfield says that her son, Kaine, developed necrotizing entercolitis (NEC) as a result of being fed the companies' formulas after he was born premature at less than 28 weeks, weighing just over 1,000 grams, or 2.2 pounds. The disease required Kaine to have surgery and left him with developmental delays, malnutrition and other health problems, Whitfield says.
Abbott declined to comment on Wednesday's ruling. Reckitt and a lawyer for Whitfield did not immediately respond to requests for comment.
Whitfield's case is one of close to 1,000 similar cases nationwide, and comes after two previous trials that resulted in verdicts of $60 million against Reckitt and $495 million against Abbott. Plaintiffs claim that the formula companies failed to warn that their products can cause NEC in babies weighing less than 1,500 grams, or about 3.3 pounds.
Both companies have said that their products do not cause NEC but rather that mother's milk or donated human milk protects against it, and that this protective effect has long been known to doctors and incorporated into hospital feeding practices.
To support that position, they sought to have their expert witnesses testify at the trial about a recent statement by the U.S. National Institute of Health (NIH), Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) that formula is "part of the standard of care" for preterm infants when milk is not available or insufficient, and that there is "no conclusive evidence that preterm infant formula causes NEC."
They also sought to introduce a report released last month by a working group of doctors and researchers convened by the NIH, which states that available evidence "supports the hypothesis that it is the absence of human milk - rather than the exposure to formula - that is associated with an increase in the risk of NEC."
Noble, however, ruled that there was no case law "directly on point for authoritativeness of a press release by a governmental regulatory body or a working group's report."
While neither document directly mentions the litigation, the working group was convened less than a month after the blockbuster $495 million verdict against Abbott. The verdicts have raised widespread alarm from doctors who fear that the lawsuits could jeopardize the formulas' availability or inappropriately influence medical decisions.
Abbott CEO Robert Ford told investors in a call earlier this month that it would be "very difficult for any company to remain on the market with these products" in the face of "indefinite liability." Reckitt in July said it was "considering options" for Mead Johnson, and CEO Kris Licht did not rule out a sale.
Unlike most of the NEC plaintiffs, Whitfield is suing not only the formula makers but also the hospital where her son was born, St. Louis Children's Hospital, for malpractice. The hospital has denied the claim.
The case is K.W. by and through Next Friend Elizabeth Whitfield v. St. Louis Children's Hospital et al, Missouri Circuit Court, 22nd Judicial Circuit, No. 2222-CC-06214.
For Whitfield: Tim Cronin of The Simon Law Firm
For Abbott: Jim Hurst of Kirkland & Ellis
For Mead Johnson: Phyllis Jones of Covington & Burling
For St. Louis Children's: Teresa Bartosiak of Bartosiak Makepeace
Read more:
Abbott, Reckitt face trial over premature baby formula amid alarm from doctors
Reckitt unit hit with $60 million verdict in Enfamil baby formula case in Illinois
Abbott must pay $495 million in premature infant formula trial, jury finds
Reckitt to offload homecare brands, consider nutrition options
(Reporting By Brendan Pierson in New York)
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