Medicolegal Issues

Genetic testing and the future of cerebral palsy malpractice cases

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Negligence

Malpractice cases require not only damages (which clearly there are with CP) but also negligence and causation. (A more complete discussion of the elements of professional liability are included in a recent “What’s the Verdict?” column within OBG Management.)17 CP cases are somewhat unusual in that, frequently, both negligence and causation are bitterly disputed. In a CP case, even where negligence is obvious (and it usually is not), causation may not be obvious and is likely to become a key to the defense of a very big case.

Several areas of negligence are common in CP related to delivery, including failure to monitor properly or ignoring, or not responding to, fetal heart rate (FHR) monitoring.18,19 For FHR monitoring, the claim is that problems can lead to asphyxia, resulting in HIE. Electronic fetal monitoring (EFM) has been an especially contentious matter. On one hand, the evidence of its efficacy is doubtful, but it has remained a standard practice, and it is often a centerpiece of delivery.20 Attorney Thomas Sartwelle has been prolific in suggesting that it not only has created legal problems for physicians but also results in unnecessary cesarean deliveries (CDs), which carry attendant risks for mother and infant.21 (It should be noted that other attorneys have expressed quite different views.22) He has argued that experts relying on EFM should be excluded from testifying because the technology is not based on sufficient science to meet the standard criteria used to determine the admissibility of expert witness (the Daubert standard).23 This argument is a difficult one so long as EFM is standard practice. Other claims of negligence include improper use of instruments at delivery, resulting in physical damage to the baby’s head, neck, or shoulders or internal hemorrhage. In addition, failure to deal with neonatal infection may be the basis for negligence.24

Causation

The question of whether or not the negligence (no matter how bad it was) caused the CP still needs to be addressed. Because a number of factors may cause CP, it has often been difficult to determine for any individual what the cause, or contributing causes, were. This fact would ordinarily work to the advantage of defendant-physicians and hospitals because the plaintiff in a malpractice case must prove by a preponderance of the evidence that the defendant’s negligence caused the CP. “Caused” is a term of art in the law; at the most basic level it means that the harm would not have occurred (or would have been less severe) but for the negligence.

In most CP cases the real cause is unknowable. It is, therefore, important to understand the difference between the certainty required in negligence cases and the certainty required in scientific studies (eg, 95% confidence). Negligence and causation in civil cases (including malpractice) must only be demonstrated by a preponderance of the evidence, which means “more likely than not.” For recovery in malpractice cases, states may require only that negligence be a “substantial factor.”

The theory that this lack of knowledge means that the plaintiff cannot prove causation, however, does not always hold.25 The following is what a jury might see: a child who will have a lifetime of medical, social, and financial burdens. Clear negligent practice by the physician coupled with severe injury can create considerable sympathy for the family. Then there are experts on both sides claiming that it is reasonably certain, in their opinions, that the injury was/was not caused by the negligence of the physician and health care team. The plaintiff’s witnesses will start eliminating other causes of CP in a form of differential diagnosis, stating that the remaining possibilities of causation clearly point to malpractice as the cause of CP. At some point, the elimination of alternative explanations for CP makes malpractice more likely than not to be a substantial factor in causing CP. On the other hand, the defense witnesses will stress that CP occurs most often without any negligence, and that, in this case, there are remaining, perhaps unknown, possible causes that are more likely than malpractice.

In this trial mix, it is not unthinkable that a jury or judge might find the plaintiff’s opinions more appealing. As a practical matter, and contrary to the technical rules, the burden of proof can seem to shift. The defendant clinician may, in effect, have to prove that the CP was caused by something other than the clinician’s negligence.

The role of insurance in award amounts

One reason that malpractice insurance companies settle CP cases for millions of dollars is that they face the possibility of judgements in the tens of millions. We saw even more than $100 million, in the 2019-2020 CP cases reported above. Another risk for malpractice insurance companies is that, if they do not settle, they may have liability beyond the policy limits. (Policy limits are the maximum an insurance policy is obligated to pay for any occurrence, or the total for all claims for the time covered by the premium.) For example, assume a malpractice policy has a $5 million policy limit covering Dr. Defendant, who has been sued for CP resulting from malpractice. There was apparently negligence during delivery in monitoring the fetus, but on the issue of causation the best estimate is that there is a 75% probability a jury would find no causal link between the negligence and the CP. If there is liability, damages would likely range from $5 to $25 million. Assume that the plaintiff has signaled it would settle for the policy limits ($5 million). Based purely on the odds and the policy limits, the insurance company should go to trial as opposed to settling for $5 million. That is because the physician personally (as opposed to the insurance company) is responsible for that part of a verdict that exceeds $5 million.

To prevent just such abuse (or bad faith), in most states, if the insurance company declines to settle the case for $5 million, it may become liable for the excess verdict above the policy limits. One reason that the cases that result in a verdict on damages—the 4 cases reported above for 2019‒2020—are interesting is that they help establish the risk of failing to settle a CP case.

Genetic understanding of causation

Given the importance of defendant-clinicians to be able to find a cause other than negligence to explain CP, the recent research of Moreno-De-Luca and colleagues may be especially meaningful.9 Using exome sequencing, the researchers found that 32.7% of pediatric-aged CP patients had pathogenic variance in the sequencing. In theory, this might mean that for about one-third of the CP plaintiffs, there may be genomic (rather than malpractice) explanations for CP, which might ultimately result in fewer cases of CP.

As significant as these findings are, caution is warranted. As the authors note, “this was an observational study and a causal relationship between detected gene variants and phenotypes in participants was not definitively established.”9 Until the causal relationship is established, it is not clear how much influence such a study would have in CP malpractice cases. Another caveat is that, at most, the genetic variants accounted for less than a third of CP cases studied, leaving many cases in which the cause remains unknown. In those cases in which a genomic association was not found, the case may be stronger for the “malpractice was the cause” claim. The follow-up research will likely shed light on some of these issues. Of course, if the genetic research demonstrates that in some proportion of cases there are genetic factors that contribute to the probability of CP, then the search will be for other triggering elements, which could possibly include poor care (that might well be a substantial factor for malpractice). Therefore, the preliminary genetic research likely represents only a part of the CP puzzle in malpractice cases.

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