R.T. v. Knobeloch
111 N.E.3d 588
Ohio Ct. App.2018Background
- Six‑year‑old S.T. was treated by pediatrician Dr. William Knobeloch in 2012 for behavioral problems; he switched her from Prozac to Lamictal after consulting a counselor and diagnosing possible pediatric bipolar disorder.
- Knobeloch initially prescribed 25 mg/day Lamictal (off‑label for pediatric bipolar) and then increased it to 50 mg/day by phone; the prescribed initial dosing exceeded manufacturer's recommendations.
- Within days S.T. developed a target rash, oral ulcers, eye involvement, fever, and was diagnosed with Stevens‑Johnson Syndrome (SJS); she required hospitalization and a medically induced coma.
- R.T. (mother) testified Knobeloch did not discuss risks, alternatives, dosage specifics, or the FDA "black box" warning; Knobeloch testified he discussed risks but not that he was using Lamictal off‑label and had no written record.
- Plaintiffs sued for medical malpractice and lack of informed consent; a jury found Knobeloch negligent and lacking informed consent and awarded damages (reduced by remittitur).
- On appeal, defendants raised seven assignments of error challenging jury instructions, expert qualification/admissibility, trial court questioning, exclusion of a defense expert, sufficiency of causation evidence, and failure‑to‑mitigate instruction; the appellate court affirmed.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether a lack‑of‑informed‑consent instruction was properly given | R.T. argued Dr. Knobeloch failed to disclose material risks of Lamictal and alternatives | Defendants argued no expert established the proper disclosure standard and instruction misstated law | Court: Instruction proper; sufficient evidence (mother's testimony + experts) supported submitting claim to jury |
| Whether FDA "black box" warning instruction was improper evidence of causation | Plaintiffs used FDA warning as evidence that Lamictal can cause SJS | Defendants argued FDA warnings only indicate possibilities and cannot substitute for proximate‑cause proof | Court: Instruction correct — FDA warnings cannot alone prove causation but may be considered in causation analysis |
| Whether expert testimony (causation/standard) was admissible/reliable (Evid.R.702/Daubert) | Plaintiffs relied on expert Dr. Kaye to link Lamictal dosing/failure to stop to SJS | Defendants argued Dr. Kaye lacked direct prescribing experience and opinions rested on FDA warnings | Court: Dr. Kaye qualified within limits; his methodology and testimony admissible to show causal connection and dosage risk |
| Whether trial court questioning and comments showed bias (Evid.R.614(B)) | Plaintiffs contended court’s clarifying questions aided truth seeking | Defendants claimed the court’s interrogation revealed partiality and influenced jurors | Court: No abuse of discretion; questioning was impartial clarifying and did not demonstrate bias |
Key Cases Cited
- Murphy v. Carrollton Mfg. Co., 61 Ohio St.3d 585 (standard for requested jury instructions)
- Kokitka v. Ford Motor Co., 73 Ohio St.3d 89 (review of jury instruction errors — analyze charge as whole)
- Nickell v. Gonzalez, 17 Ohio St.3d 136 (elements of lack of informed consent tort)
- White v. Leimbach, 131 Ohio St.3d 21 (expert testimony required to establish material risks; jury decides what a reasonable patient would do)
- Daubert v. Merrell Dow Pharm., 509 U.S. 579 (factors for evaluating scientific expert reliability)
- Miller v. Bike Athletic Co., 80 Ohio St.3d 607 (adoption of Daubert factors in Ohio)
- Groob v. KeyBank, 108 Ohio St.3d 348 (standard for directed verdict review)