First trial against Abbott over premature infant formula commences in Missouri

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-07-11T16:00:49+05:30 | Updated On 16 July 2024 8:34 PM IST

Abbotts Plea Alleging NPPA Used Outdated PTR Data for Metoprolol Pricing Rejected by DoP

In a legal battle, the first trial against Abbott, the maker of Similac baby formula, commenced on Tuesday amidst allegations that its formula for preterm infants, used in neonatal intensive care units (NICUs), contributes to a potentially deadly bowel disease. Opening statements marked the beginning of proceedings, where a lawyer representing a mother who is suing Abbott emphasized the lifelong injuries sustained by her child. The lawyer urged jurors to consider holding Abbott accountable for the alleged role of its formula in causing the debilitating condition.

Jake Plattenberger of TorHoerman, a lawyer for Illinois resident Margo Gill, told the St. Louis, Missouri state court jury that Abbott made "no attempt to tell physicians in a clear and direct way" that its products could cause necrotizing enterocolitis (NEC) in premature babies.

"They've known for a long time that there's a problem with this product," Plattenberger told the jury, saying the company was aware of studies showing that it increased the risk of the disease. Reuters watched the proceeding through Courtroom View Network.

NEC, which causes the death of bowel tissue, mostly affects premature newborns and has a fatality rate of between 15% and 40%. Gill's child, Robynn Davis, who developed NEC after being given Abbott premature infant formula while in a neonatal intensive care unit in 2021, survived, but suffered irreversible neurological damage because of her illness and will require long-term care, Plattenberger said.

According to Reuters, James Hurst of Kirkland & Ellis, representing Abbott, said in his opening statement that Robynn's condition was caused by trauma at birth that deprived her brain of oxygen, long before she received formula. He said that formulas like Abbott's had saved many lives, and were in many cases necessary.

Like all of the lawsuits over NEC, the case involves formula and products for fortifying mother's milk given to infants in hospital settings, not ordinary formula available to consumers in stores.

Close to 1,000 lawsuits have been filed against Abbott and Enfamil formula maker Reckitt Benckiser both in federal or state courts alleging that cow's milk-based formula products for premature infants caused NEC. More than 500 are centralized in an Illinois federal court, with others pending in Illinois, Missouri and Pennsylvania.

The lawsuits claim that the companies failed to warn that infants given their products are at greater risk of NEC compared to infants who are breast-fed or given donor milk or human milk-derived formula.

Reckitt, like Abbott, has said that its products for premature infants are life-saving and called the lawsuits meritless.

The first lawsuit to go to trial, against Reckitt in Illinois, ended with a $60 million jury verdict in March. Reckitt is appealing that verdict and has argued that the plaintiff's case relied on unsound expert testimony.

The litigation has concerned investors. Reckitt's share price fell about 15% after the verdict, and Abbott's about 4%. Both stocks have remained depressed, although analysts at JPMorgan and Barclays have said they believe the companies' ultimate liability is likely to be small.

The NEC Society, a patient-led non-profit organization working to combat the disease, has criticized the lawsuits, saying that "feeding decisions should be made at patients' bedsides, not in courtrooms."

NEC Society executive director Jennifer Canvasser, who founded the group after losing her own son to complications of NEC, said that the group has no financial relationship with Abbott or Reckitt.

The NEC lawsuits are separate from ongoing litigation against Abbott over the shutdown of its Sturgis, Michigan, plant and subsequent recall of batches of baby formula for possible contamination, which contributed to a nationwide formula shortage in 2022. There have been no trials in those cases.

The case is Gill v. Abbott Laboratories, 22nd Judicial Circuit of Missouri, No. 2322-CC01251.

For Gill: Jake Plattenberger of TorHoerman and others

For Abbott: James Hurst of Kirkland & Ellis and others

SimilacAbbottAbbott newsnecrotizing enterocolitisbowel disease

Source : with inputs

Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751