91 F.4th 538
1st Cir.2024Background
- Edmund Ward suffered from familial LCAT deficiency, a rare genetic disorder leading to kidney failure.
- Dr. Ernst Schaefer, after diagnosing FLD, arranged for Ward's participation in an NIH experimental enzyme therapy, ACP-501, with hopes to delay—rather than cure—dialysis.
- Ward eventually sued Dr. Schaefer and others, alleging fraud and failure to obtain informed consent after the experimental treatment did not improve his condition and possibly worsened it.
- The case against Dr. Schaefer proceeded to trial on the issues of fraud and informed consent and resulted in a jury verdict for Dr. Schaefer; post-trial and appellate review followed.
- The appeal concerns whether various trial errors (exclusion of evidence and jury instructions) warranted a new trial.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Exclusion of ACP-501 Patent | Patent shows ACP-501 not designed for Ward's condition—relevant to fraud/informed consent | No proper foundation, minimal relevance, risk of confusing jury | No abuse of discretion; exclusion affirmed |
| Jury instruction on doctor-patient relationship/informed consent | Broader instruction needed: Dr. Schaefer's monitoring sufficed for duty | Instruction tracked SJC case law; sufficient as given | Instruction legally correct and not inadequate |
| Res ipsa loquitur instruction (inference of negligence from circumstances) | Due to experimental nature, jury should infer negligence for atrial fibrillation episode | Doctrine inapplicable; no sole control or inference of negligence | District court properly rejected res ipsa instruction |
| Jury instruction: titles (principal/co-investigator) create duty | Jury should be told Dr. Schaefer’s study role imposed consent duty | Relevant law focuses on actual patient interaction, not title | District court’s refusal to give requested instruction was correct |
Key Cases Cited
- United States v. Kilmartin, 944 F.3d 315 (1st Cir. 2019) (addresses standards for reviewing the facts supporting a verdict)
- Schubert v. Nissan Motor Corp., 148 F.3d 25 (1st Cir. 1998) (abuse of discretion standard for evidentiary rulings)
- Harnish v. Children's Hospital Medical Center, 439 N.E.2d 240 (Mass. 1982) (defines doctor-patient relationship for informed consent)
- Halley v. Birbiglia, 458 N.E.2d 710 (Mass. 1983) (duty of disclosure based on doctor-patient relationship)
- Wilson v. Honeywell, Inc., 569 N.E.2d 1011 (Mass. 1991) (requirements for res ipsa loquitur in Massachusetts)