274 F. Supp. 3d 922
D. Neb.2017Background
- Plaintiff Jan Vallejo (individually and as representative of decedent Steve Vallejo) sued Amgen, Pfizer, and Wyeth alleging Enbrel caused the decedent’s myelodysplastic syndrome (MDS) and death, asserting design-defect, failure-to-warn, negligence, breach of warranty, wrongful death, and loss-of-consortium claims.
- Decedent took Enbrel beginning in 2004 and died in 2011; Vallejo contends Enbrel caused or contributed to MDS that led to death.
- The magistrate ordered phased discovery limited initially to general medical causation (whether Enbrel can cause MDS); Amgen produced adverse event reports and deposed its safety officer.
- Vallejo failed to disclose any qualified retained expert on general or specific causation, instead identifying a non‑specific “John Doe (Pfizer Employee)” and relying on a MedWatch adverse event report and a few literature items.
- Amgen moved for summary judgment on grounds that Vallejo has no admissible expert proof of causation; the court evaluated whether anecdotal adverse reports and the proffered materials could substitute for expert testimony.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether plaintiff may prove medical causation without expert testimony | Vallejo says a 2016 MedWatch report (and other documents) effectively admits causation, eliminating need for expert testimony | Amgen contends causation is a complex medical/scientific issue requiring reliable expert proof and Vallejo offered no admissible expert | Court held expert testimony was required; MedWatch report and cited articles do not substitute for reliable expert proof, so plaintiff failed to prove causation |
| Admissibility/weight of adverse event (MedWatch) reports as proof of general causation | Vallejo treats the report as an admission that etanercept (Enbrel) caused MDS | Amgen argues such reports are anecdotal, unreliable, and insufficient to establish general or specific causation | Court held MedWatch reports are uncontrolled anecdotal evidence, unreliable for establishing causation and cannot replace expert evidence |
| Sufficiency of plaintiff’s expert disclosure (John Doe Pfizer employee) | Vallejo designated a “John Doe (Pfizer Employee)” as an expert on general causation | Amgen asserts the disclosure lacks qualification, substance, and reliability to be admissible expert evidence | Court found the designation inadequate to meet Rule 56 burden; no showing the testimony would be scientifically valid |
| Whether cited literature and product monograph establish causation | Vallejo relies on two dermatology articles and the Canadian Product Monograph listing MDS as an observed adverse event | Amgen argues these show at most association or uncertainty, not causation | Court held literature and monograph at best show association/uncertainty and do not satisfy the burden without expert analysis |
Key Cases Cited
- Glastetter v. Novartis Pharm. Corp., 252 F.3d 986 (8th Cir. 2001) (MedWatch/adverse reports are uncontrolled anecdotal evidence and unreliable proof of causation)
- Torgerson v. City of Rochester, 643 F.3d 1031 (8th Cir. 2011) (summary judgment standards and nonmovant’s burden to produce specific evidentiary materials)
- Celotex Corp. v. Catrett, 477 U.S. 317 (U.S. 1986) (party with no proof on an essential element cannot survive summary judgment)
- Marmo v. Tyson Fresh Meats, Inc., 457 F.3d 748 (8th Cir. 2006) (courts must ensure scientific testimony is reliable and relevant)
- Grant v. Pharmative, LLC, 452 F. Supp. 2d 903 (D. Neb. 2006) (plaintiff must prove both general and specific causation in pharmaceutical product cases)
Disposition: Amgen’s motion for summary judgment granted; Vallejo’s complaint dismissed.