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We typically write about product liability cases, not medical malpractice actions. But the two are not mutually exclusive, and similar issues arise in those cases. Medical causation is an issue we often see in both. Capacity to execute a release is not.

The facts in Bentley v. Highlands Hospital Corp., et al., 2016 U.S. Dist. LEXIS 178688 (E.D. Kentucky Dec. 27, 2016), are sad and scary. The plaintiff showed up in a hospital emergency room, complaining of nausea, back pain, and a tingling sensation in the legs. A CT scan showed no serious problems, and the plaintiff was discharged, with instructions to follow up with her family doctor. Her condition deteriorated significantly. The next day, she went to another hospital, where an MRI was performed. The radiologist, it is alleged, missed a shadow in the image of the spinal cord. The plaintiff’s conditions got steadily worse, and she was sent to another hospital. Ultimately, she was permanently paralyzed from the chest down. It turned out that she had suffered serious inflammation of the spinal cord. The triggering event might have been a bout of strep throat a week earlier.  We are told that the strep throat “tricked” the plaintiff’s immune system into attacking nerve cells in her spinal cord, and that the resulting inflammation “climbed up both sides of her lower spinal cord, destroying the myelin sheathing on her nerve cell fibers, and disrupting communication between her spinal cord and the remainder of her central nervous system.”

To support her malpractice action, the plaintiff retained three medical experts who opined that one of the hospitals could have stopped the progression of the plaintiff’s paralysis if it had administered steroids when she still had motor control and sensation in her legs. These experts also opined that the plaintiff was cognitively impaired when she signed a hospital release form because she was on central nervous system depressant and an opioid painkiller at the time.

The defendant hospital moved to exclude these expert opinions. There was no issue as to whether the opinions were relevant to issues in the case. They were. There was also no issue as to the experts’ qualifications. The only dispute was whether the expert opinions were sufficiently reliable as to pass Fed. R. Evid. 702 and the Daubert test. The court applied the Daubert test conscientiously, recognized that the plaintiff bore the burden of proving by a preponderance of the evidence that the opinions were admissible, and concluded that the plaintiff carried that burden for the medical causation opinions, but not for the mental capacity opinions.

Here is why the Bentley court held that the medical causation opinions made the grade:

1. The experts explained how the inflammatory process works and how steroids can arrest that process.
2. The experts cited evolving literature on inflammatory conditions of the central nervous system. Observational studies demonstrated that early steroid intervention improved neurological outcomes in patients with spinal inflammation.
3. The experts’ own clinical experiences confirmed the power of steroids to combat neurological decline in patients with inflammatory myelopathies.
4. The course of the plaintiff’s own treatment was probative. Steroids actually did help her, even if that help came too late to save much of her neurological function.

The defendants argued that the plaintiff experts had misread some of the medical records, but the court deemed that a factual dispute best sent to the jury. The defendants also argued that the scientific literature was insufficiently strong to support the plaintiff’s position. The American Academy of Neurology concluded in 2011 that there was insufficient evidence to determine the utility of steroids in alleviating the condition suffered by the plaintiff in Bentley.  Reading between the lines, it seems to us that the gravamen of the plaintiff’s complaint in Bentley was that a hospital had committed medical malpractice by failing to resort to an off label use.  To our defense hack eyes, this is rich stuff, given how many cases we encounter where plaintiffs assail our clients for supposedly supporting off label uses of their products.

Off label or not, the court had no problem with the plaintiff’s position or the expert opinions. The court acknowledged that there are no double-blind studies or epidemiological evidence that firmly made the case. But the court reasoned that the defendants’ concerns were “overblown,” that the defendants were raising the bar too high, that the plaintiff experts had accounted for any gaps in the literature, and that those experts had reinforced their reading of the literature by looking to clinical experience and the particular experience of the plaintiff herself. Moreover, to the extent the plaintiff experts had extrapolated from other literature, such extrapolation seemed logical. Finally, it was significant that the plaintiff experts’ opinions did not seem litigation-driven; at least one of those experts had been taking a similar position for years prior to this case.

The court allowed that the jury might end up disagreeing with the plaintiff experts. But it was convinced that the jury should at least hear them.

By contrast, the Bentley court held that the jury should not hear the plaintiff expert opinions that the medications taken by the plaintiff could cause “mental fogginess and fatigue” such as to invalidate her execution of the hospital release. The experts could testify about possible side effects from those medications. But only a minority of patients taking those medications suffer such side effects, and the experts simply lacked a basis to “explain how they know that these effects would have been so severe as to deprive [the plaintiff] of the mental capacity necessary to exercise independent and informed judgment.”