Luttrell v. Novartis Pharmaceuticals Corp.
894 F. Supp. 2d 1324
E.D. Wash.2012Background
- Luttrell filed a 2007 complaint in the Eastern District of Washington alleging ONJ from Aredia and Zometa; the case was MDL-transferred to the Middle District of Tennessee before remand to this Court in 2012.
- Luttrell conceded dismissal of manufacturing defect and express warranty claims and abandoned implied warranty; remaining claims are strict liability and failure to warn.
- Novartis moved to exclude causation testimony and for summary judgment; arguments were heard August 10, 2012.
- ONJ is defined for BRONJ as bone exposure with eight weeks’ duration in the maxillofacial region, with potential contributing factors including cancer, chemotherapy, corticosteroids, infection, and trauma.
- Luttrell’s treating physicians and a retained causation expert (Dr. Jackson) testified or were designated as experts, but the court found multiple causation opinions inadmissible under Rule 702/Daubert; the court ultimately granted summary judgment to Novartis on causation and related claims.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Admissibility of causation testimony by treating physicians | Luttrell argues treating doctors can testify on causation if formed during treatment (Goodman standard) | Novartis contends treating doctors lack Daubert qualifications and causation opinions | Admissibility limited to opinions formed during treatment; causation testimony excluded |
| Whether Luttrell can prove causation under Washington law | Sufficient evidence exists through Dr. Jackson and others that bisphosphonates caused ONJ | No admissible causation evidence; failure to show proximate causation | No genuine issue of material fact; proximate causation not proven; summary judgment for defendant |
| Product identification—Aredia vs. generic pamidronate | Luttrell likely received Aredia early in treatment; six doses could be contestable | Purchasing records show generic pamidronate; insufficient to prove Aredia actually given | Genuine issue of material fact whether Luttrell received six initial doses of Aredia vs. generic pamidronate; part of summary judgment denial on this issue |
| Adequacy of warning under Washington law (learned intermediary doctrine) | Warning was inadequate and buried in label; prescriber would have treated differently | Brady was aware of potential BRONJ; adequate warning under comment k; warning was sufficient | Warning adequacy contested; court found no genuine issue on Brady’s definitive awareness; summary judgment for defendant on warning issue |
Key Cases Cited
- Fielden v. CSX Transp., Inc., 482 F.3d 866 (6th Cir. 2007) (causation testimony of treating physician discussed as integral to treatment or litigation preparation)
- Goodman v. Staples The Office Superstore, LLC, 644 F.3d 817 (9th Cir. 2011) (treating physicians may testify to causation formed during treatment; exception to 26(a)(2)(B) report requirements)
- Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (U.S. 1993) (gatekeeper of expert testimony; reliability and relevance required)
- Kumho Tire Co., Ltd. v. Carmichael, 526 U.S. 137 (U.S. 1999) (extension of Daubert gatekeeping to all expert testimony)
- Ayers By and Through Smith v. Johnson & Johnson Baby Products Co., 59 Wash.App. 287, 797 P.2d 527 (Wash. Ct. App. 1990) (proximate causation and warning analysis under Washington law)
- Laisure-Radke v. Par Pharmaceutical, Inc., 426 F.Supp.2d 1163 (W.D. Wash. 2006) (learned intermediary doctrine and warning analysis in Washington)
- Terhune v. A.H. Robins Co., 90 Wash.2d 9, 577 P.2d 975 (Wash. 1978) (Restatement 402A comment k on warnings for prescription drugs)
- McLaughlin v. Cooke, 112 Wash.2d 829, 774 P.2d 1171 (Wash. 1989) (medical certainty standard for causation evidence)