192 A.3d 847
Md. Ct. Spec. App.2018Background
- Decedent Dennis Allen, with end-stage liver disease and renal failure, experienced hyperkalemia while admitted at UMMC; Dr. Burks ordered emergency hyperkalemia treatment including Kayexalate premixed with 35.8% sorbitol and dialysis was started later the same day.
- Shortly after Kayexalate, Allen developed ischemic colitis progressing to colonic necrosis; extensive colectomy was performed and he died the next day. Autopsy/pathology noted findings "suggestive of Kayexalate colitis."
- Plaintiffs sued for wrongful death and survival, alleging Kayexalate with sorbitol caused the ischemic colitis and that Dr. Burks breached the standard of care and failed to obtain informed consent.
- Six weeks before trial Dr. Burks requested a Frye-Reed hearing to exclude plaintiffs’ general-causation experts, arguing the causal link between Kayexalate (as given) and ischemic colitis is not generally accepted. The trial court denied a separate evidentiary Frye-Reed hearing and alternatively ruled Frye-Reed was satisfied.
- A jury returned a plaintiff verdict and large noneconomic damages award; the trial court later reduced the award under Maryland’s statutory cap. Defendants appealed challenging (1) denial of a Frye-Reed hearing and admissibility, (2) certain informed-consent evidence rulings, and (3) admission of evidence about calcium administration and blood draws. Plaintiffs cross-appealed the constitutionality of the damages cap.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether a pretrial evidentiary Frye-Reed hearing was required before admitting general-causation expert testimony that Kayexalate+sorbitol can cause ischemic colitis | Plaintiffs: the literature, FDA warnings, hospital guidelines and experts show the causal theory is generally accepted or at least admissible without further hearing | Defendants: the causation link is controversial; conflicting studies and different formulations/modes (powder vs suspension, 70% vs 35.8% sorbitol, enema vs oral) mean Frye-Reed applies and an evidentiary hearing was required | Court: assuming Frye-Reed applied, no prejudicial error in deciding the issue without live evidentiary hearing given comprehensive written record; alternatively, Frye-Reed was satisfied and testimony admissible |
| Whether plaintiffs’ experts satisfied Frye-Reed on general causation (Kayexalate+35.8% sorbitol causes ischemic colitis in critically ill patients) | Plaintiffs: FDA black-box warnings, UMMC guidelines, pathology, case reports, and expert opinions support general acceptance of a causal link in the relevant medical community | Defendants: literature is inconclusive and conflicted; association ≠ causation; many adverse reports involve different formulations/modes so causation for the exact preparation here is not generally accepted | Held: On de novo review court concluded the total record supported general acceptance (not unanimity) that Kayexalate with sorbitol can cause ischemic colitis in critically ill patients; Frye-Reed satisfied |
| Whether expert testimony on the risk of ischemic colitis was admissible for informed-consent claim | Plaintiffs: the risk is material; patient would have withheld consent if informed | Defendants: if causation is not established then the risk is fortuitous and immaterial | Held: Because court found general acceptance of causal link, the risk was material and testimony admissible for informed consent |
| Whether evidence that calcium gluconate/calcium chloride were not administered and that a blood draw was not requested was admissible | Plaintiffs: admissible as relevant to credibility and to show Dr. Burks did not act meticulously in the emergency, undermining defense that he used every available measure | Defendants: irrelevant because lack of those drugs caused no separate injury; collateral and prejudicial | Held: Evidence admitted—relevant to credibility and treatment decisions; exclusion not warranted (blood-draw challenge was waived by failure to object) |
Key Cases Cited
- Frye v. United States, 293 F. 1013 (D.C. Cir. 1923) (original articulation of the general-acceptance test for novel scientific evidence)
- Reed v. State, 283 Md. 374 (Md. 1978) (Maryland adoption of Frye general-acceptance test)
- Myers v. Celotex Corp., 88 Md. App. 442 (Md. Ct. Spec. App. 1991) (discussion of medical-diagnosis testimony versus novel scientific techniques)
- CSX Transp., Inc. v. Miller, 159 Md. App. 123 (Md. Ct. Spec. App. 2004) (same distinction between routine medical etiology opinions and novel scientific techniques)
- Chesson v. Montgomery Mut. Ins. Co., 399 Md. 314 (Md. 2007) (Frye-Reed applied to novel medical causation theories and tests; remand for hearing)
- Blackwell v. Wyeth, 408 Md. 575 (Md. 2009) (applying Frye-Reed to medical causation and emphasizing the analytical-gap inquiry)
- Clemons v. State, 392 Md. 339 (Md. 2006) (preference for pretrial Frye-Reed hearings but appellate review permitted where hearing did not occur)
- Rochkind v. Stevenson, 454 Md. 277 (Md. 2017) (Rule 5-702 sufficiency discussion: expert must have adequate factual basis for general-causation opinions)
- Sissoko v. State, 236 Md. App. 676 (Md. Ct. Spec. App. 2018) (recent review of Frye-Reed evolution and analytical-gap principles)