The Court of Special Appeals of Maryland (“Maryland Appellate Court”), which is Maryland’s intermediate appellate court, affirmed a Maryland medical malpractice wrongful death verdict in its opinion filed on August 29, 2018.
The Underlying Facts
The decedent was admitted to the defendant hospital (University of Maryland Medical Center (“UMMC”)) with multi-system diagnoses, including renal and liver failure. When he experienced an episode of bradycardia, the defendant doctor treated him for presumed hyperkalemia, which was later confirmed. The treatment included Kayexalate given in a suspension with sorbitol and hemodialysis. Shortly thereafter, the decedent developed ischemic colitis which quickly progressed to necrosis of the colon. Surgical intervention failed and the decedent died.
Maryland survival and wrongful death actions were brought alleging medical malpractice. The plaintiffs’ expert witnesses testified that the decedent’s ischemic colitis was caused by the Kayexalate with sorbitol and opined that the standard of care required treatment with dialysis alone.
Six weeks prior to trial, defense counsel filed a request for a Frye-Reed hearing, arguing that it was not generally accepted in the relevant medical community that Kayexalate with sorbitol, as given in this case, can cause ischemic colitis, and therefore the plaintiffs’ experts should be precluded from testifying on causation. The plaintiffs filed an opposition and supplements were filed. The assignment office did not schedule a hearing.
The request was addressed on the morning of trial, by the judge who had just been assigned the case. The judge held a hearing on whether a Frye-Reed hearing should be held and ruled that the causation issue did not warrant a Frye-Reed hearing and, alternatively, if Frye-Reed was implicated, the Frye-Reed general acceptance test was satisfied.
Frye-Reed Test
In Frye v. United States, 293 F.1013 (D.C. Cir. 1923), the District of Columbia Court of Appeals held that for expert testimony predicated on a novel scientific principle or discovery to be admissible, the principle or discovery must be generally accepted in the relevant scientific field. When the Maryland Court of Appeals adopted the Frye general acceptance test in Reed v. State, 283 Md. 374 (1978), it explained that the test governs the admissibility of novel scientific evidence.
Until the 2000s, the Frye-Reed test was not applied outside that context. In the meantime, in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), the United States Supreme Court held that Federal Rule of Evidence 702 had superseded Frye and established, in its place, a nonexclusive list of factors, including general acceptance, for federal district courts to consider in ruling on the admissibility of scientific expert testimony.
A few years later, in General Electric Co. v. Joiner, 522 U.S. 136, 146 (1997), the Supreme Court upheld the exclusion of expert testimony that PCBs caused a plaintiff’s lung cancer because there was “too great an analytical gap between the data and the opinion proffered.”
In the mid-2000s, the Maryland Court of Appeals expanded the Frye-Reed general acceptance test to include techniques that are not novel and also to include scientific conclusions, as well as techniques. Now, under Frye-Reed, the admissibility issue is whether “the expert[s] bridged the ‘analytical gap’ between accepted science and [their] ultimate conclusions in [this] particular case.” Savage v. State, 455 Md. 138, 160 (2017).
In the present case, the Maryland Appellate Court stated that in a nutshell, the Frye-Reed issue is whether it is generally accepted in the relevant medical community that the drug Kayexalate, given orally in a formulation with 35.8% sorbitol, can cause ischemic colitis in a patient such as the decedent. General acceptance under Frye-Reed does not equate to unanimity of opinion within a scientific community, nor universality, and is not subject to a quantum analysis. The Maryland Appellate Court stated: “There was substantial evidence offered by the [the plaintiffs] in opposition to [the defendant doctor’s] motion that strongly supports a finding that, while there may be some disagreement among experts in the field, there is not a “‘fundamental division in the scientific community'” that necessitated exclusion of the [the plaintiffs’] expert witness testimony.”
In the present case, the Maryland medical malpractice jury found that the defendant doctor had breached the standard of care by treating the decedent with “Kayexalate Sorbitol mixture”; that that breach was a cause of injury to the decedent and was the cause of his death; that the defendant doctor had a duty to obtain informed consent before treating the decedent with Kayexalate; that a reasonably prudent person in the decedent’s position would have withheld his consent to that course of treatment had he been informed of the risks; and that the failure to obtain informed consent also was a cause of the decedent’s injury and was the cause of his death.
The Maryland medical malpractice jury awarded the Estate $2 million in non-economic damages and awarded his wife and his seven biological children $1 million each in non-economic damages. The trial court later reduced the damages award in accordance with Maryland’s statutory cap on non-economic damages. The reduced damages award totaled $906,250 and was apportioned as follows: $181,250 to the Estate and $90,625 to the wife and to each of the seven children. The defendant doctor and the defendant hospital appealed.
The Maryland Appellate Court stated that ordinarily, when the admissibility of proposed expert testimony is challenged under Frye-Reed, and Frye-Reed is implicated, an evidentiary hearing should be held to decide whether the testimony satisfies the Frye-Reed test. The Maryland Appellate Court assumed without deciding that Frye-Reed applied to the proposed expert testimony and affirmed the trial court’s alternative ruling, made without holding an evidentiary hearing, that that testimony satisfied the Frye-Reed test.
The Maryland Appellate Court stated that the materials submitted to the court in support of and opposition to the request for Frye-Reed hearing comprehensively addressed the substance of the Frye-Reed issue and included medical and scientific articles, FDA warning labels, UMMC Guidelines for Treatment of Hyperkalemia, medical records of the decedent, and deposition testimony of the relevant experts. The arguments made in the written submissions and to the court on the first day of trial focused not on whether a hearing was needed but on the substance of the Frye-Reed; practically nothing was said about what a Frye-Reed hearing would include that was not already before the court to consider. The Maryland Appellate Court stated that in that circumstance, with the trial about to commence, the court did not err or abuse its discretion by deciding the Frye-Reed issue without holding an evidentiary hearing.
The Maryland Appellate Court held that on the merits, the evidence before the trial court, in the request for Frye-Reed hearing and opposition, supported a legally correct conclusion that, although the causal connection between Kayexalate with sorbitol and ischemic colitis is not considered definitive, i.e., beyond question, Kayexalate with sorbitol is generally recognized by the relevant medical community as a cause of ischemic colitis in critically ill patients, such as the decedent.
Source Burks v. Allen, No. 2361, September Term, 2016.
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