CLASS-ACTION LAWSUIT FILED AGAINST THE UNIVERSITY OF ALABAMA AT BIRMINGHAM OVER NEGLIGENCE AND INADEQUATE WARNINGS INVOLVED IN A STUDY OF PREMATURE BABIES
By Sheff Law on May 9, 2013
The parents of premature babies involved in a study filed a lawsuit over negligence and inadequate warning of the risks involved. The suit was filed against the University of Alabama at Birmingham. UAB conducted a study to find the optimum oxygen level to sustain premature babies. The lawsuit was filed in the U.S. District Court in Birmingham, Alabama. The lawsuit is pursuing a class action status for all of the study's participants. It said that damages would be larger than $5 million. Reginald McDaniel, a Birmingham attorney, filed the lawsuit. The parents of five of the children involved said that the study led to a variety of severe health issues, such as respiratory disease, eyesight disorders and even permanent brain damage. The lawsuit said that "As a result of the careless, negligent, and reckless conduct of the defendants the plaintiffs and the class were caused to suffer excruciating and agonizing pain, physical discomfort and emotional distress." The Surfactant, Positive Pressure and Oxygenation Randomized Trial (SUPPORT) ran from 2004 and 2009. Carried out at 23 hospitals, 1,300 premature infants participated in the study. It was conducted to find what oxygen saturation level would be the best to sustain premature babies. Both too much and too little oxygen can cause severe health problems. High levels of oxygen can result in blindness from retinopathy; while too little, can cause brain damage and even death. The Office for Human Research Protections sent a letter to the UAB in March of this year criticizing them for not warning the involved parents of all the risks of the study. The letter said that, "It would have been appropriate for the consent form to explain that the study involves substantial risks, and that there is significant evidence from past research indicating that the level of oxygen provided to an infant can have an important effect on many outcomes, including whether the infant becomes blind, develops serious brain injury, and even possibly whether the infant dies." This office is a federal agency that runs under the Department of Health and Human Services. The medical community has fought back against criticism, like this letter and accusations from the group Public Citizen, which deemed the study unethical. One piece of support came from an op-ed article in the New England Journal of Medicine that said the Office for Human Research Protections was incurred for "suggesting that the parents were duped into enrolling their frail infants in dangerous research."
The op-ed was written by representatives of the Center for Biomedical Ethics at Standford University and the Division of Medical Ethnics at New York University Langone Medical Center. It said that "Not only is that not true, but it also poses substantial risk to the conduct of valuable comparative effectiveness research both for premature infants and for the general public who continue to face too many treatments where uncertainty prevails about what is best." Dr. Waldermar Carlo, the principal investigator for the SUPPORT study wrote a letter with other investigators to the journal that said, "Ill-informed allegations create unwarranted apprehension that serves no one. Our consent forms were conscientiously drafted according to the Code of Federal Regulations and were based on the best available evidence."
Carlo is a defendant in the suit, along with members of UAB's Institutional Review Board. The plaintiffs include 5 children that were born during the time of the study at UAB Hospital. The lawsuit states, "The experiment exclusively targeted those who are among the most vulnerable members of the population: very premature, extremely low-birth-weight neonates, many of whom come from difficult economic backgrounds." According to Jim Bakken, a spokesman for UAB, the university is not commenting on the lawsuit.