687 F.3d 947
8th Cir.2012Background
- Schilfs sued Lilly for failure-to-warn and deceit causing their son Peter’s death; district court granted Lilly’s summary judgment motion; FDA black box warning issued days before and then added to Cymbalta literature after Peter’s death; Dr. Briggs prescribed Cymbalta to Peter after discussing risks; Cymbalta had five suicides in Lilly-sponsored trials not disclosed to doctors; warning language and FDA advisories were evolving in 2004; the district court concluded Dr. Briggs’ knowledge rebutted any warning duty; this court reverses and remands for further proceedings.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether an adequate warning would have changed Dr. Briggs’s prescribing decision | Schilf argues a stronger warning would have altered prescribing | Lilly argues Dr. Briggs would have prescribed anyway | Genuine issue of material fact; remand needed |
| Whether the learned intermediary doctrine and heeding presumption apply to Lilly’s duty to warn | Schilfs rely on heeding presumption that prescribing physician would follow adequate warnings | Lilly contends district court correctly limited warnings to physician knowledge | Issue of material fact remains, warranting reversal on warning issue |
| Whether Dr. Briggs’ knowledge of FDA/PHA warnings defeats the heeding presumption | Schilfs contend Dr. Briggs lacked full understanding of PHA warnings | Lilly contends Dr. Briggs was aware of FDA warnings and PHA content | Genuine fact questions about Dr. Briggs’s knowledge survive; not dispositive preclusion of presumption |
| Whether federal pre-emption precludes the state-law failure-to-warn claim | Schilfs argue state-law warning duties not pre-empted by FDA labeling decisions | Lilly asserts preemption based on FDA labeling decisions | Preemption not controlling on the remaining factual questions; not dispositive |
Key Cases Cited
- In re Prempro Prods. Liab. Litig., 586 F.3d 547 (8th Cir. 2009) (learned intermediary and warning causation principles apply to causation questions)
- Thom v. Bristol-Myers Squibb Co., 353 F.3d 848 (10th Cir. 2003) (warning adequacy and causal link considerations in tort claims)
- Ehlis v. Shire Richwood, Inc., 367 F.3d 1013 (8th Cir. 2004) (heeding presumption and causal link considerations in failure-to-warn claims)
- McElhaney v. Eli Lilly, 739 F.2d 340 (8th Cir. 1984) (state-law warning duties and learned intermediary doctrine relevance)
- Christopher v. Cutter Labs., 53 F.3d 1184 (11th Cir. 1995) (causation and warning sufficiency principles in tort warnings)