Jean Adams v. Merck Sharp & Dohme Corp.
15-56997
| 9th Cir. | Dec 6, 2017Background
- Plaintiffs (including Jean Adams) sued over alleged failure-to-warn claims linking incretin drugs to pancreatic cancer; consolidated multidistrict litigation.
- Defendants invoked federal preemption, citing Wyeth v. Levine and Buckman-related principles.
- District court concluded Buckman implicated the case, limited discovery (adverse-event source files, foreign regulatory files) and granted summary judgment on preemption grounds.
- Plaintiffs discovered “new safety information” (Health Canada signal assessment, animal and trial data) in allowed discovery and argued it was material to whether FDA would have acted.
- District court partially disqualified plaintiffs’ regulatory expert, Dr. Fleming, as having been exposed to confidential information and as a “competitor” under the protective order.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Buckman justified limiting discovery into adverse-event/foreign regulatory files | Buckman does not apply because claims are state-law failure-to-warn parallel to federal duties; requested data is relevant to causation and to feasibility of complying with both duties | Buckman shields FDA-policing issues and discovery about reporting is preempted/fraud-on-FDA territory | Reversed: Buckman was misapplied; discovery into adverse-event and foreign regulatory files is relevant and should not have been barred |
| Whether production of adverse-event source files was unduly burdensome | Production was feasible (defendants already maintain databases; small volume; redaction only) | Production would be burdensome and costly | Reversed: defendants failed to show undue burden; denial to compel was abuse of discretion |
| Whether district court properly disregarded plaintiffs’ “new safety information” at summary judgment | New information could be material to FDA’s decision; disputed by experts — creates triable issue on preemption/clear-evidence standard | Argued the new data was immaterial or not considered by FDA so it cannot defeat preemption | Reversed: court erred to deem the evidence irrelevant; uncertainty whether FDA considered it makes material fact disputes that defeat summary judgment |
| Whether partial disqualification of plaintiffs’ regulatory expert (Dr. Fleming) and finding he was a "competitor" was proper | Fleming attested he did not rely on confidential consulting materials; defendants offered no specific evidence of relevant disclosures; Exsulin relationship did not violate protective order | Claimed Fleming had exposure to confidential information and his involvement with Exsulin made him a competitor under the protective order | Reversed: defendants failed to show specific, unambiguous disclosures; protective-order competitor finding unsupported; partial disqualification was abuse of discretion |
Key Cases Cited
- Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (preemption of state fraud-on-the-FDA claims)
- Wyeth v. Levine, 555 U.S. 555 (clear-evidence preemption framework for FDA-regulated drugs)
- Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir. en banc) (state failure-to-warn claims paralleling federal duties not preempted)
- McClellan v. I-Flow Corp., 776 F.3d 1035 (9th Cir.) (failure-to-warn claims not fraud-on-the-FDA where claims do not arise solely from federal law)
- Gaeta v. Perrigo Pharm. Co., 630 F.3d 1225 (9th Cir.) (discussing applicability of Buckman reasoning to drugs)
- Hewlett-Packard Co. v. EMC Corp., 330 F. Supp. 2d 1087 (N.D. Cal.) (standard for showing specific and unambiguous disclosures to disqualify an expert)
Vacated and remanded.