983 F.3d 1223
11th Cir.2020Background
- Karen Hubbard, long-time user of Bayer fourth-generation COCs (Yasmin, YAZ, then Beyaz), suffered a catastrophic venous sinus thrombosis (VTE) stroke in Oct. 2012; she and her husband sued Bayer alleging inadequate warnings about stroke/VTE risk.
- Beyaz contains drospirenone (DRSP); medical literature and FDA communications (2011) and an April 2012 Bayer label update reported studies showing DRSP pills may carry higher VTE risk (estimates ranged up to a three-fold increase).
- Dr. Lawrence Rowley was Karen’s prescribing physician; he had long-standing knowledge that COCs and DRSP-containing pills carried some elevated VTE risk and had prescribed Bayer DRSP pills for years without incident.
- At deposition Dr. Rowley testified unambiguously that even with the 2012 label information (or the most current research/FDA warnings) he would still have prescribed Beyaz to Karen in Dec. 2011 and that he considered that original decision appropriate.
- The district court granted Bayer summary judgment for lack of proximate causation under Georgia’s learned intermediary doctrine; the Eleventh Circuit affirmed, finding no genuine fact dispute that an updated warning would not have changed the prescribing decision.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether an allegedly inadequate drug warning proximately caused Karen’s injury | The pre-2012 warnings were inadequate; an adequate warning would have changed Dr. Rowley’s prescribing decision | Dr. Rowley already knew the risk and testified he would have prescribed Beyaz anyway | Plaintiff must prove proximate cause; doctor’s unambiguous testimony defeats causation; summary judgment for Bayer |
| Whether Georgia’s learned intermediary doctrine governs duty to warn | Plaintiffs argued inadequate manufacturer warning to intermediaries harmed patient | Bayer: duty runs to physicians, not patients; physician knowledge is dispositive | Learned intermediary applies; duty owed to physician, not patient |
| Whether an evidentiary presumption of causation applies when a warning is inadequate | Hubbards sought presumption (argued irrebuttable or at least rebuttable) that inadequate warning caused injury | Bayer relied on Dietz and record to show plaintiff bears burden and evidence rebuts any presumption | No irrebuttable presumption; under Dietz plaintiff bears burden; even if rebuttable, Bayer rebutted it |
Key Cases Cited
- Dietz v. SmithKline Beecham Corp., 598 F.3d 812 (11th Cir. 2010) (plaintiff bears burden to prove inadequate warning proximately caused injury; physician testimony that he would still prescribe breaks causal chain)
- McCombs v. Synthes (U.S.A.), 587 S.E.2d 594 (Ga. 2003) (Georgia adopted learned intermediary doctrine for prescription drugs)
- Sanders v. Lull Int’l, Inc., 411 F.3d 1266 (11th Cir. 2005) (court may decide proximate cause as a matter of law where evidence is plain and undisputed)
- Tesoriero v. Carnival Corp., 965 F.3d 1170 (11th Cir. 2020) (standard of review for summary judgment)
- EmbroidMe.com, Inc. v. Travelers Prop. Cas. Co. of Am., 845 F.3d 1099 (11th Cir. 2017) (panel bound by prior circuit interpretations of state law absent contrary state authority)
- Ackermann v. Wyeth Pharm., 526 F.3d 203 (5th Cir. 2008) (discussion of effect of rebuttable presumptions in failure-to-warn cases)
- Eck v. Parke, Davis & Co., 256 F.3d 1013 (10th Cir. 2001) (example of rebuttable-presumption analysis under another jurisdiction)