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  • BIOETHICS FORUM ESSAY

The SUPPORT Study Case: Not Vindication

Last week’s New England Journal of Medicine featured, and had an editorial about, a short opinion piece by John Lantos about the recent decision in Looney v. Moore. In that case, a Federal District judge dismissed the claims for damages brought by families of babies who had suffered injuries while enrolled in the controversial SUPPORT study. The SUPPORT study was designed to help determine optimal blood-oxygen levels for infants in the NICU. Lantos’ piece characterized the judge’s opinion as a “vindication” of the study.

In the New York Times, NEJM editor-in-chief Jeffrey Drazen was quoted as saying that the judge in Looney “was saying . . .  that being in the trial didn’t cause the bad outcomes for these kids.” But the opinion was no vindication, and that isn’t what the judge was saying.

To be clear: in this post, I will express no opinion about whether the researchers in the SUPPORT study exposed patients to risks beyond those they’d have faced outside the study; and if they did, whether they knew or should have known about any such additional risks when they framed their study. Furthermore, I express no opinion about whether the researchers adequately disclosed risks to patients’ families in the informed consent process. In these particulars, I exactly resemble Judge Bowdre, who, not having conducted a trial on any of these issues, naturally made no findings with regard to any of them.

When a plaintiff sues a defendant in a civil tort case for damages (as in a medical or legal malpractice case or a car-crash case or a toxic-exposure case), the plaintiff must prove four things: First, that the defendant had some duty to the plaintiff. Second, that the defendant breached that duty. Third, that plaintiff was harmed. Fourth, that plaintiff’s harm was caused by defendant’s breach. Each of these “elements” of the case must be proved, separately, by a “preponderance of the evidence”—that is, each must be shown to have been more probable than not.  Roughly speaking, in the Looney case, plaintiffs were alleging that defendant researchers owed them a duty of informed consent, and breached that duty by failing to inform them adequately of risks. Plaintiffs then alleged two sorts of harm: the abstract harm of being exposed to increased levels of risk, and the concrete harms of retinopathy and neural damage. Finally, plaintiffs alleged that their harms were caused by the researchers because, absent their breach of duty of informed consent, plaintiffs wouldn’t have enrolled their babies in the study, and their babies wouldn’t have been harmed.

The defendants moved to have the case dismissed without any trial. When defendants move for such “summary judgment,” the law requires the judge to assume, for the sake of argument, that everything alleged by the plaintiffs is true. She must then decide whether the plaintiff’s case fails as a matter of law, even under those favorable assumptions. Judge Bowdre decided for the defendants in this case, for two reasons having nothing to do with the adequacy of the consent process or the researchers’ awareness of any increased risk. Her holdings dealt, instead, with plaintiffs’ allegations about harm and about causation.

Plaintiffs alleged that the SUPPORT study exposed them to additional risks of harm of which the researchers hadn’t informed them. One part of the judge’s decision rejected the claim that exposure to additional risk of harm is itself a kind of (compensable) harm. This rejection was in line with many other similar decisions, and, to my mind at least, it’s common sense. You may be upset at your neighbor for doing chemistry experiments that expose you to risk of explosion-related injury; your neighbor may have behaved negligently or even immorally in exposing you to those risks; but unless something actually blows up, you don’t get compensation, because (luckily) you haven’t actually been harmed.

The judge’s decision about proof of causation, though, is the heart of the matter. Three babies whose families brought suit were actually harmed during the trial—one got retinopathy, and two suffered neurological damage. With regard to them, the judge ruled that plaintiffs had not alleged enough facts to show that the babies’ injuries likely resulted from their participation in the SUPPORT trial, rather than from their underlying condition of prematurity. The plaintiffs’ expert witness did allege that the study increased the participant babies’ risk of retinopathy and neural damage compared to the risk faced by non-participants, but that, said the judge, only shows that the study could possibly have been the cause of their injuries, not that it probably caused them. And causation, like all other elements in a tort suit for damages, has to be proved by a preponderance of the evidence. It has to be probable—that is, more likely than not—that a plaintiff’s damages were caused by the breach of duty. And the plaintiffs failed to allege enough facts to show that probability.

To see why this holding is nothing like a “vindication” of the SUPPORT study, consider for a moment what the plaintiffs would have to have claimed in order to adequately allege that the study, and not the babies’ condition of prematurity, probably caused the injuries. Many courts—in toxic-tort cases, in drug exposure cases, in medical malpractice cases—have held that a plaintiff can only make such an allegation stick by showing that defendant’s breach more than doubled plaintiff’s risk of injury. The reasoning goes this way: It is only if babies were more than twice as likely to be injured in the study than out of it that we can conclude that any given baby’s injury was probably caused by the study rather than by their underlying condition.

Cases relying on such reasoning—and there are many—are in some ways troubling. Consider a couple of cases where such reasoning might be (and has been) applied. Suppose that Fair City has some steady background rate of cancer. Then DarkCo Petroceutical Company dumps chemical waste into Fair City’s water-table. Thereafter, the city’s cancer rate leaps up by 80 percent. Even if plaintiffs can establish a biological theory linking cancer to exposure to DarkCo’s waste, they won’t be able to get to a jury. That 80 percent leap still isn’t enough to establish that any one person’s cancer was probably caused by DarkCo’s dumping rather than being just an ordinary, background case of cancer. Their case will be dismissed by a judge on summary judgment, following the reasoning followed in Looney. The plaintiffs would need to show a cancer-rate leap of over 100 percent to establish the necessary probability—and then, of course, DarkCo would find itself on the hook for damages for everyone’s cancer, even though many people would have gotten cancer without DarkCo’s dumping.

Or imagine a different study, SUPPORT-like but worse than anything that any SUPPORT-study critic has actually alleged. Suppose the researchers in that study knew or should have known that their study would impose risks on babies—indeed, that the risk of harms to babies in their study would be nearly double those of babies not in the study. And suppose that their informed consent procedures utterly failed to make this clear to parents. And then suppose that during the study, nearly twice as many babies get injured in the study group than statistics suggest would have been injured if the study hadn’t been done. In this case of a plainly unethical study—a study that imposed risks and did real harm beyond what would otherwise have occurred, with wholly inadequate informed consent–the injured babies’ families still couldn’t get to trial, and for the very same reasons articulated by Judge Bowdre. No plaintiff could show that any given baby’s injury was probably caused by the study unless risks were more than doubled.

Looney is therefore no vindication of the SUPPORT study. Judge Bowdre did not say that no babies were injured in the study, or that any were; only that even if some were, no individual plaintiff could prove that his own injury was more likely a study-injury rather than a background injury. The opinion is in fact completely neutral on the core ethical issues in the case—whether the researchers made the correct ex ante assessment of study-related risks; whether any babies were injured by the study; whether risks were adequately disclosed  to families; and whether IRB oversight failed. The case instead shows how difficult it is for an injured party to get a case to a jury if their main evidence of injury causation is statistical elevation of some already-existing risk.

Stephen R. Latham, JD, PhD, is director of Yale University’s Interdisciplinary Center for Bioethics.

Posted by Susan Gilbert at 09/10/2015 02:54:05 PM |

Published on: September 10, 2015
Published in: Children and Families, Clinical Trials and Human Subjects Research

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