Paul Decker v. GE Healthcare Inc.
770 F.3d 378
6th Cir.2014Background
- Paul Decker (ESRD patient) received a single dose of Omniscan (a GE Healthcare GBCA) during an MRI in 2005 and later developed Nephrogenic Systemic Fibrosis (NSF).
- The Deckers sued GE Healthcare in 2012 in the N.D. Ohio as part of MDL No. 1909 alleging multiple Ohio products-liability and tort claims; this was the first MDL case to proceed to trial.
- Plaintiffs presented a “free (dechelated) gadolinium” theory: prolonged retention in renally impaired patients permits dechelation and tissue deposition, triggering NSF; plaintiffs relied on published studies, animal/human tissue evidence, and adverse event reports (AERs).
- GEHC defended with an alternative chelated-gadolinium theory, sought to introduce evidence of alleged gadolinium‑naïve NSF cases, and challenged plaintiffs’ use of AERs and certain expert testimony; GEHC also raised discovery/spoliation issues over late/missing GEHC documents (Muller materials).
- Jury found for the Deckers on failure-to-warn, awarding $5 million; district court denied GEHC’s Rule 59 motion for a new trial. GEHC appealed various evidentiary rulings, jury-instruction refusals, and Judge Polster’s partial recusal.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Judge Polster’s partial recusal | Polster’s limited recusal from ruling on prejudgment interest did not affect trial impartiality | Partial recusal required vacatur/new trial or full recusal under 28 U.S.C. § 455 | Partial recusal permitted; no abuse of discretion and no new trial required |
| Admissibility of "free gadolinium" causation expert testimony (Daubert) | Free‑gadolinium theory is supported by peer-reviewed studies, tissue findings, and is generally accepted | Theory speculative; should be excluded as unreliable under Daubert/Kumho | District court properly admitted free‑gadolinium testimony; no abuse of discretion |
| Admissibility of pharmacovigilance/AER testimony | Blume (pharmacovigilance expert) could reliably testify that four AERs constituted a safety signal | Gaspari (dermatologist) and others not qualified to opine on AER significance; AERs are unreliable for causation | Court properly admitted Blume and excluded Gaspari on AER‑signal issues; district court did not abuse discretion |
| Evidence of gadolinium‑naïve NSF cases (rebuttal) | GEHC offered studies and Patient 5 (Lemy) to rebut foreseeability and causation | Studies were methodologically flawed and irrelevant to what GEHC knew in 2005 | Court permissibly excluded unreliable gadolinium‑naïve evidence and limited Lemy unless directly comparable; no new trial |
| Causation for failure‑to‑warn (but‑for/proximate) | Plaintiffs’ experts and treating radiologist would have altered treatment had they received an adequate warning | Even with a better label, clinicians (practice) would not have changed; jury’s design‑defect verdict undermines warning causation | Sufficient evidence supported jury’s finding that inadequate warnings caused Decker’s injury; no new trial |
| Jury instructions (AERs and spoliation/ lost documents) | Request limiting instruction on AERs and instruction downplaying missing documents were required to avoid prejudice | Instructions would have been confusing or overemphasized marginal issues | Court did not abuse discretion in refusing both instructions; refusal did not warrant a new trial |
Key Cases Cited
- Daubert v. Merrell Dow Pharm., 509 U.S. 579 (court must assess reliability and relevance before admitting expert scientific testimony)
- Kumho Tire Co. v. Carmichael, 526 U.S. 137 (trial court has broad latitude to assess expert reliability under Rule 702)
- In re Aetna Cas. & Sur. Co., 919 F.2d 1136 (6th Cir.) (addressing judge disqualification concerns in consolidated cases)
- Ellis v. United States, 313 F.3d 636 (1st Cir. 2002) (approving limited/partial judicial recusals in appropriate circumstances)
- Liteky v. United States, 510 U.S. 540 (judicial bias/prejudice standard; deep‑seated favoritism/antagonism required for disqualification)
- Cummins v. BIC USA, Inc., 727 F.3d 506 (6th Cir. 2013) (standards for new trial review and harmless‑error evaluation of evidentiary rulings)