969 F.3d 1067
9th Cir.2020Background
- Bard manufactured the G2 inferior vena cava (IVC) filter, which received FDA 510(k) clearance in 2005 after the agency reclassified IVC filters from Class III to Class II and issued three "special controls" in 2000.
- Booker received a G2 implant in 2007; years later the filter fractured and perforated her vena cava, requiring surgeries that left a fragment embedded.
- Booker sued Bard in Georgia state-law product‑liability claims (design defect and negligent failure to warn); the case was tried in MDL proceedings in Arizona.
- The district court denied Bard's omnibus summary‑judgment bid that the Medical Device Amendments (MDA) preempted state claims and denied Bard's motion to bar Booker’s comparative‑risk failure‑to‑warn theory.
- A jury found Bard liable for negligent failure to warn, awarding $1.6 million compensatory and $2 million punitive damages; the district court denied Bard’s renewed JMOL on punitive damages.
- On appeal, the Ninth Circuit affirmed: it held the FDA special controls did not create device‑specific preemptive requirements, Georgia law permits comparative‑risk warning claims for submission to a jury, and the punitive award was supported by substantial evidence.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| 1) Is the denial of summary judgment on preemption reviewable after trial? | Booker: Preemption denial presents a legal issue subject to review under the Banuelos exception. | Bard: Ordinarily summary‑judgment denials are not appealable after trial (Ortiz). | The court held the purely legal preemption question is reviewable; Banuelos exception survives Ortiz. |
| 2) Do the FDA's Class II "special controls" preempt Booker's state failure‑to‑warn claim? | Booker: The special controls are not device‑specific requirements that preempt state law. | Bard: Reclassification and special controls impose specific federal requirements that preempt conflicting state duties. | The court held special controls were not "specific requirements applicable to a particular device" and/or not relevant to the comparative‑warning claim, so no express preemption. |
| 3) Does Georgia law permit failure‑to‑warn claims based on lack of comparative‑risk information? | Booker: Georgia law imposes a manufacturer duty to warn physicians (learned intermediary) and does not categorically bar comparative warnings; adequacy is for the jury. | Bard: Georgia does not require manufacturers to compare their product risks to competitors; no duty to provide comparative risk warnings. | The court held Georgia law does not categorically bar comparative‑risk warnings and the adequacy of warnings was properly left to the jury. |
| 4) Was the punitive damages award supported by sufficient evidence? | Booker: Evidence showed Bard knew G2 posed greater risks, downplayed them, and failed to warn—supporting punitive damages. | Bard: Compliance with FDA process and allegedly adequate labeling preclude punitive damages; insufficient evidence of willful or conscious indifference. | The court held substantial evidence supported punitive damages under Georgia law (clear and convincing standard facts for jury). |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) (premarket approval creates device‑specific federal requirements that can preempt state law)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) (510(k) substantial‑equivalence review and generic federal requirements do not automatically preempt state law)
- Ortiz v. Jordan, 562 U.S. 180 (2011) (orders denying summary judgment generally not reviewable after trial; left open the "purely legal" exception)
- Banuelos v. Constr. Laborers’ Tr. Funds for S. Cal., 382 F.3d 897 (9th Cir. 2004) (Ninth Circuit recognizes reviewability of purely legal denials of summary judgment)
- Miller v. Gammie, 335 F.3d 889 (9th Cir. 2003) (en banc) (governs circuit precedent rules and application of prior Ninth Circuit decisions)
- Papike v. Tambrands Inc., 107 F.3d 737 (9th Cir. 1997) (preemption limited to instances where FDA has established specific requirements applicable to a particular device)
- Harper v. City of Los Angeles, 533 F.3d 1010 (9th Cir. 2008) (standard for reviewing denial of renewed JMOL — substantial evidence suffices)