IN RE: Bard IVC Filters Products Liability Litigation
2:15-md-02641
D. Ariz.Dec 21, 2017Background
- MDL alleging thousands of injuries from seven Bard IVC filter models; plaintiffs claim design defects, perforation, fracture/migration, and inadequate warnings; Bard obtained FDA 510(k) clearance for the filters.
- Plaintiffs designated two FDA regulatory experts: Dr. Suzanne Parisian (former FDA medical officer, pathologist) and Dr. David Kessler (former FDA Commissioner, MD/JD).
- Bard moved to exclude or limit both experts under Fed. R. Evid. 702/Daubert, challenging methodology, scope, and impermissible legal conclusions or advocacy.
- Court reviewed lengthy Parisian report (257 pages) and Kessler reports, finding both experts qualified on FDA regulatory processes but identifying problems with narrative, opinions outside expertise, and legal conclusions.
- Court largely permitted FDA-process testimony from both experts, limited testimony on intent, corporate motives, design/testing, medical causation, and ultimate legal conclusions; reserved finer line-drawing for trial.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Admissibility of Dr. Parisian’s regulatory testimony | Parisian will educate jury on FDA 510(k), Bard duties, pre/post-market responsibilities, and specific regulatory failures | Parisian is an advocate: report is unfocused narrative, lacks methodology, offers opinions beyond FDA expertise (design, causation, intent) | Admitted in part: may testify on FDA process and Bard’s compliance within disclosed opinions; excluded from narrative, intent, design, testing, medical causation, and legal conclusions; court to police testimony at trial |
| Parisian’s methodology/reliability | Plaintiffs: Parisian relied on FDA-style document analysis from her FDA experience; methodology is sufficient | Defendants: report lacks clear, reliable methodology and analytical bridge from facts to opinions | Court: methodology description thin but, given her FDA background and report, sufficient for FDA-process opinions under Rule 702; other methodological gaps may be addressed at trial |
| Legal conclusions & preemption (both experts) | Plaintiffs: experts will explain regulatory context; not offering legal conclusions on state law; FDA evidence is relevant and not preempted | Bard: experts attempt to usurp jury on ultimate issues; Buckman/other preemption concerns | Court: Experts may not give ultimate legal conclusions on state-law claims or opine on intent/ethics; Buckman does not bar use of FDA evidence here (Wyeth controls on compliance evidence) |
| Admissibility of Dr. Kessler’s opinions (scope) | Kessler is qualified to explain 510(k), what FDA would do with disclosures, and Bard’s compliance; will not opine on state-law ultimate issues | Bard: Kessler offers narrative, speculates about FDA actions, opines beyond regulatory expertise on design, causation, and motive | Admitted in part: may testify about FDA regulatory process, Bard’s disclosures, and what a reasonable FDA official might do; barred from offering ultimate legal conclusions, intent/ethics opinions, and improperly narrating or testifying outside his expertise; objections to be raised at trial |
Key Cases Cited
- Daubert v. Merrell Dow Pharm., 509 U.S. 579 (gatekeeping role for expert testimony under Rule 702)
- Kumho Tire Co. v. Carmichael, 526 U.S. 137 (Rule 702 gatekeeping applies to non-scientific experts)
- Wyeth v. Levine, 555 U.S. 555 (manufacturer’s compliance with FDA is admissible evidence; does not preempt state failure-to-warn claims)
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (fraud-on-the-FDA preemption principle distinguishes claim-preemption from use-of-FDA-evidence issues)
- Lust v. Merrell Dow Pharm., 89 F.3d 594 (proponent bears burden to show admissibility of expert testimony)
- In re C. R. Bard, Inc. Pelvic Repair Sys. Prods. Liab. Litig., 948 F. Supp. 2d 589 (district court permitting regulatory experts to testify about FDA 510(k) framework and defendant’s actions)
- In re Vioxx Prod. Liab. Litig., 401 F. Supp. 2d 565 (Buckman does not bar a qualified expert from opining on FDA’s regulatory balancing)