ST. LOUIS — The July decision in Abbott v. Margo Gill Laboratories raises concerns about the potential impact on the availability of products essential for the care of premature infants, and with another trial scheduled to begin soon, there are worries about Abbott's ability to remain afloat.
Abbott's post-trial filings claim that procedural irregularities occurred during the trial, contributing to concerns about the fairness of the proceedings in St. Louis and the second necrotizing enterocolitis (NEC) trial is scheduled in the same courtroom to begin soon.
In June 2023, Margo Gill filed a lawsuit in Missouri against Abbott Laboratories over their cow’s milk-based infant formula, Similac, which was fed to her premature daughter, R.D., at Cardinal Glennon Children’s Hospital.
Born in August 2021, R.D. developed NEC, a gastrointestinal condition that affects premature babies, after consuming Similac.
Gill’s lawsuit accused Abbott and its sales reps of aggressively marketing Similac as safe for premature babies, despite knowing it allegedly increased the risk of NEC.
The company also allegedly failed to provide clear warnings about the risks and falsely promoted the formula as essential for premature infants' development, her suit claimed.
The case sought compensation for R.D.’s medical bills, ongoing health issues and the emotional distress and financial losses suffered by Gill. Punitive damages were also requested.
During the trial, Gill’s attorney, Jake Plattenberger, argued that Abbott did not make doctors fully aware of the alleged NEC risk associated with Similac, despite knowing about studies that linked the formula to the disease.
Abbott’s defense, led by James Hurst, argued that R.D.’s condition was caused by birth complications, not the formula.
Hurst maintained that the product had saved many lives and was necessary for many premature infants, adding that the warnings provided were sufficient.
During the trial, no hard evidence was presented to confirm that the products in question cause NEC — no scientific research or reliable expert testimony supported the claim. The plaintiff's key witness, Dr. Jonathan Swanson, a neonatal doctor, admitted that neither he nor anyone else knows how formula could cause NEC, and no studies or government agencies have concluded that it does.
Other experts, including Dr. Randal Buddington and Dr. Noah Hillman, also agreed there is no proof that formula causes NEC. Dr. Hillman, the only physician who treated the plaintiff and testified, stated he would still use formula based on medical literature, not manufacturer warnings. None of the plaintiff’s witnesses could provide any data or studies connecting the formula to NEC or determine the amount of formula needed to cause NEC.
The court also restricted any mention of human milk fortifiers during the proceedings. When Abbott's first expert took the stand and presented a slide approved earlier that day by the court, the plaintiff's counsel objected, accusing Abbott of misleading the jury.
The plaintiff's counsel also argued, for the first time, that Abbott’s experts should not discuss studies involving human milk fortifiers, despite their own experts having previously done so.
This situation raised concerns about fairness, as human milk fortifiers are a recognized part of the standard care for preterm infants and relevant in comparing warnings, risks and study outcomes.
The plaintiff's counsel repeatedly questioned the entire category of milk-based preterm formula, which, according to Abbott, may not align with Missouri law.
There were also no examples provided to suggest that physicians would have chosen not to use formula if warned it was less protective against NEC than breast milk, as formula is often the only option in such cases.
The jury, however, found Abbott responsible for failing to warn about the risks of NEC from its formula.
Gill was awarded $95 million in compensatory damages for medical expenses and suffering, plus $400 million in punitive damages, totaling $495 million.
This trial sought punitive damages that were four times the awarded compensatory damages that some feel don't meet Missouri's high legal standard of "clear and convincing evidence" for punitive damages and feel the jury was influenced by emotion rather than facts.
The punitive damages awarded in this case raise concerns about potential unconstitutionality and the impact on the industry.
The Missouri Supreme Court has stated that excessive punitive damages can lead to arbitrary deprivation of property, emphasizing the importance of adhering to the Due Process Clause.
In this instance, the ratio of punitive to compensatory damages exceeds 4:1, which is viewed by many as excessive, especially given the already substantial compensatory award of $95 million.
Courts often find compensatory awards of around half a million dollars to be substantial, suggesting that even a large company like Abbott may struggle under multiple large judgments, particularly as this case is one of many similar lawsuits.
There are worries about over-deterrence, prompting calls for a more nominal punitive award. Concerns have been voiced by the American Academy of Pediatrics and the NEC Society, which have stated that such verdicts could jeopardize the availability of essential nutrition for infants and lead to unintended harmful consequences.
Research from experts at Dell Medical School and Texas Children's Hospital highlights the significant challenges and risks associated with a lack of preterm infant formula and fortifiers, noting that without proper nutrition, preterm infants face serious risks to their growth and development. The National Institutes of Health's NEC Working Group has identified the protective components in human milk and expressed uncertainty about the potential detrimental effects of formula.