UPDATE: Plaintiffs have filed an appeal in the U.S. Court of Appeals for the Eleventh Circuit. Their brief is due on October 19.
The district court has granted summary judgment (opinion pdf) for all remaining defendants as to all of plaintiffs’ remaining claims in Looney v. Moore, the lawsuit arising out of the controversial SUPPORT trial, which I last discussed here. This therefore ends the lawsuit, pending possible appeal by the plaintiffs.
Plaintiff infants include two who were randomized to the low oxygen group and survived, but suffer from “neurological issues,” and one who was randomized to the high oxygen group who developed ROP, but not permanent vision loss. In their Fifth Amended Complaint (pdf), plaintiffs alleged negligence, lack of informed consent, breach of fiduciary duty, and product liability claims against, variously, individual IRB members, the P.I., and the pulse oximeter manufacturer. What unites all of these claims is the burden on plaintiffs to show (among other things) that their injuries were caused by their participation in the trial.
The court held that plaintiffs had not created a genuine issue of material fact on that issue. To recover under Alabama law, plaintiffs had to show that participation in the trial “probably” caused their injuries. Defendants’ three experts testified that the infants’ injuries were probably caused instead by their prematurity. Plaintiffs’ only relevant expert opined merely that participating in the trial “increased the risk” that they would suffer their current injuries, which the court found to be tantamount to an opinion that the trial could “possibly” have caused their injuries, which is insufficient under Alabama law.
As for plaintiffs’ claims that trial infants in each arm were at heightened risk relative to those in the opposite arm and those outside of the trial, an increased risk of harm that doesn’t materialize is not cognizable under law (and indeed presents serious case-or-controversy standing problems).
Where the dignitary torts that are so often really at issue in human subjects research lawsuits are deemed non-cognizable, the need to show that participation in research caused actual, compensable injury obviously becomes critical. That requirement has always been difficult for research participant-plaintiffs to meet when they are ill patients for whom conventional therapy has often already failed by the time they enroll in a study. To be successful on a lack of informed consent claim, for instance, such a plaintiff would usually have to show both that, had the informed consent process been adequate, she would have chosen not to participate in the study and that participating in the study resulted in actual harm that she would have avoided by not participating (that is, that research participation probably resulted in a different clinical outcome).
But these hurdles may be doubly difficult for ill participant-patients who participate in standard-of-care research. To be sure, some standard-of-care research involves comparing two of more standards of care that are qualitatively different and, hence, pose qualitatively different risks (e.g., a surgical intervention versus drug therapy or psychotherapy versus an SSRI). If a plaintiff in such a situation can convincingly show that, with better informed consent, she would have chosen not to participate in a trial but instead to have opted for the alternative form of standard care (say, a drug) than the one to which she was randomized (say, a surgical intervention), then any harm that uniquely resulted from the randomized intervention (say, infection at the incision site) ought to be compensable (as opposed to an adverse clinical outcome that is consistent with the alternative form of care and/or the underlying disease).
But where, as here, a study compares two qualitatively similar interventions—oxygen saturation between 85 and 89% versus oxygen saturation between 91 and 95%, where everyone in both arms of the trial and eligible patients outside of it are at significant risk of the same suite of adverse clinical outcomes (ROP/blindness and death/neurological damage)—showing that the trial “probably” caused one of these clinical outcomes whereas the particular standard care the plaintiff would have chosen outside of the trial would not have done so seems very unlikely.