Special Report-Birmingham Times
Parents of three premature babies involved in a clinical research experiment led by the University of Alabama at Birmingham filed a class-action lawsuit in U.S. District Court. The class action lawsuit is still in the early stages of litigation according to federal court documents. United States Federal Court Judge, Karon Bowdre, is the named judge in the case.
The suit claims the nationwide study, which included 23 hospitals and aimed to determine the best amount of oxygen to treat premature babies, was “unethical by design” and accused defendants of negligence and a failure to properly disclose the risks of the study.
The lawsuit claims participants in the study born between 24-28 weeks, suffered visual and respiratory issues, brain damage, other permanent impairments and even death as a result of wrongdoing in the study, known as the Surfactant, Positive Pressure and Oxygenation Randomized Trial (SUPPORT). The wrongful death claim of one plaintiff has been dismissed by Judge Bowdre under Alabama law which only allows two years to bring a lawsuit against a defendant. The SUPPORT study ran from 2005-2009, although information regarding the alleged wrong doing by UAB, was not publicly known until March 2013.
Concerns about the failure to disclose the health risks of the experiment to parents who enrolled their premature babies were first expressed in a March 2013 to Richard B. Marchase, Ph.D., V.P. for Research & Economic Development, University of Alabama at Birmingham (UAB) from the Department of Health and Human Services, which stated in part:
“In the SUPPORT study, the intervention differed from such standard care (as UAB described it). Half of the subjects were assigned to values that put them in the upper end of that range (91-95%), and the other half were assigned to values that put them in the lower end of that range (85-89%). The purpose of the study was to find out whether there was a difference between the infants assigned to receive a higher or lower range of oxygen saturation in terms of likelihood of dying, experiencing neurological problems, or developing ROP. By assuring that the infants in the two groups were receiving different levels of oxygen, the study design made it more likely that differences in the outcomes of the two groups could be detected.
According to the study design, on average, infants assigned to the upper range received more oxygen than average infants receiving standard care, and infants assigned to the lower range received less. Thus the anticipated risks and potential benefits of being in the study were not the same as the risks and potential benefits of receiving standard of care. For the infants assigned to the upper range, based upon the premises of the researchers, the risk of ROP was greater, while for the infants assigned to the lower range the risk of ROP was lower. And, as described above, there were also risks relating to neurological development and possibly death. The SUPPORT study involved changing the treatment of enrolled infants from the treatment of infants according to standard care, with attendant changes in the risks and potential benefits.”
HHS further determined the following as stated in the March 2013 letter:
“It was alleged, and we determine, that the UAB IRB approved informed consent documents for this study failed to include or adequately address the following basic element required by HHS regulations at 45 CFR 46.116(a): Section 46.116(a)(2): “A description of any reasonably foreseeable risks and discomforts. “
Another part of the letter states that some 237 babies enrolled in the experiment died. The letter states in part, “On the other hand, the low oxygen group had a higher percentage of deaths before discharge. 130 out of the 654 infants in that group died (19.9%), in comparison to the 107 out of 662 infants who died in the high oxygen group (16.2%). This difference was not as large as that seen with regard to developing eye disease, but it was nonetheless statistically significant. There were about 1316 premature babies enrolled in the UAB led experiment.
The lawsuit also claims, Masimo Inc., rigged the pulse oximeter machines, used to measure oxygen saturation levels in the babies’ blood so that the actual oxygen levels would not be displayed and the alarm would not sound when oxygen levels were too low or too high.
Birmingham attorney Reginald D. McDaniel filed the suit for the plaintiffs. Attorneys for the Defendants include Starnes Davis Florie, LLP and Lightfoot Franklin and White.
