Fields v. Eli Lilly & Co., 116 F. Supp. 3d 1295

Fields gave birth to D.F. with tetralogy of Fallot and congenital defects; she alleges Prozac use during pregnancy caused it.
Lilly moves for summary judgment on whether Fields took Prozac during pregnancy and causation.
Warning label in 1996 stated teratogenic risk with limited animal data and no adequate human studies.
No documentary or pharmaceutical records confirm Prozac prescription; sole proffered evidence is Ms. Fields’s and her husband’s testimony.
Dr. Durden allegedly prescribed Prozac in May 1996; Dr. Garrard treated Fields during pregnancy with no indication of Prozac use.
Court must decide if Fields’s self‑serving testimony suffices to create a fact dispute and whether Alabama’s learned‑intermediary doctrine supports causation.

Issue	Plaintiff's Argument	Defendant's Argument	Held
Whether Fields took Prozac during pregnancy	Fields and husband testimony show use	No hard evidence; no prescription records	Disputed fact; testimony supports use
Causation under learned‑intermediary doctrine	Adequate warning would alter physician's prescribing	Physician decision governed; no proof of altered behavior	Genuine issue of material fact on factual causation under Toole
Evidence source for physician behavior (Rule 406)	Ledbetter shows physician habit of warning patients	Ledbetter testimony insufficient for habit evidence	Summary judgment denied on habit-based causation theory
Adequacy of Lilly’s warnings and impact on ingestion	Stronger warning would have prevented ingestion	Difficulty showing warning would change physician’s action	Fact dispute exists; not entitled to summary judgment

Toole v. McClintock, 999 F.2d 1430 (11th Cir.1993) (learned‑intermediary focus on physician‑level causation)
Wyeth, Inc. v. Weeks, 159 So.3d 649 (Ala.2014) (warning sufficiency measured by effect on physician)
Thomas v. Hoffman‑LaRoche, Inc., 949 F.2d 806 (5th Cir.1992) (objective vs. subjective proof of physician response to warnings)