Susan Orrell v. Astrazeneca Pharmaceuticals Lp
662 F. App'x 528
| 9th Cir. | 2016Background
- Plaintiffs (MDL) sued AstraZeneca alleging Nexium (a PPI) caused reduced bone mineral density and fractures; plaintiffs offered only general-causation expert Dr. Sonny Bal.
- Dr. Bal prepared a three-page report, reviewed 13 references, and posited three biological mechanisms by which PPIs could increase fracture risk.
- Dr. Bal formed his opinion for litigation, his theory was not peer reviewed, and he relied on epidemiological studies and meta-analyses that did not themselves conclude causation.
- The district court excluded Dr. Bal’s testimony under Federal Rule of Evidence 702 and Daubert, finding his causal analysis thin and inadequately tied to the scientific literature.
- With no other general-causation evidence, the district court granted summary judgment for AstraZeneca and awarded costs to the defendants; the Ninth Circuit affirmed.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Admissibility of expert testimony under Rule 702/Daubert | Dr. Bal’s review and explanation suffice to show reliable methodology linking Nexium to fractures | Dr. Bal’s opinion was litigation-driven, not peer-reviewed, and failed to reliably apply epidemiological methods | Excluded: Dr. Bal’s testimony was unreliable and properly excluded |
| Sufficiency of general-causation evidence for summary judgment | Dr. Bal was adequate general-causation proof | Without admissible expert proof, plaintiffs cannot prove general causation | Summary judgment for defendants affirmed |
| Application of Bradford Hill factors | Dr. Bal considered some factors to infer causation | Dr. Bal analyzed only a few factors and did so thinly; he failed to reconcile heterogeneity in studies | Court found analysis inadequate to support causation opinion |
| Award of costs under Fed. R. Civ. P. 54(d)(1) | Plaintiffs sought relief from costs | Defendants sought presumptive costs as prevailing parties | Costs awarded to appellees; district court did not abuse discretion |
Key Cases Cited
- Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (1993) (principles for admissibility of expert scientific testimony under Rule 702)
- Gen. Elec. Co. v. Joiner, 522 U.S. 136 (1997) (deference standard: exclusion of expert testimony reviewed for abuse of discretion)
- Lust ex rel. Lust v. Merrell Dow Pharm., Inc., 89 F.3d 594 (9th Cir. 1996) (expert must show objective basis and scientific method when not relying on peer-reviewed pre-litigation research)
- Kennedy v. Collagen Corp., 161 F.3d 1226 (9th Cir. 1998) (review standard for excluding expert testimony in summary judgment context)
- Milward v. Acuity Specialty Prods. Grp., Inc., 639 F.3d 11 (1st Cir. 2011) (use of Bradford Hill factors to assess causation from epidemiological evidence)
- Save Our Valley v. Sound Transit, 335 F.3d 932 (9th Cir. 2003) (presumption favoring awarding costs to prevailing parties under Rule 54(d)(1))
- Miles v. California, 320 F.3d 986 (9th Cir. 2003) (award of costs reviewed for abuse of discretion)