Booker v. C. R. Bard, Inc. (In re Bard IVC Filters Prods. Liab. Litig.)
289 F. Supp. 3d 1045
D. Ariz.2018Background
- MDL involving thousands of personal-injury claims over C.R. Bard IVC filters (Recovery, G2, G2 Express, G2X, Eclipse, Meridian, Denali); Booker is a bellwether plaintiff with a G2 implanted in 2007.
- Plaintiffs allege Bard filters have higher rates of tilt, perforation, fracture/migration and that Bard failed to warn; remaining claims: design defect, failure to warn, punitive damages under Georgia law.
- Each disputed Bard filter received FDA 510(k) clearance (showing substantial equivalence to a predicate device), not premarket approval (PMA).
- Plaintiffs moved in limine to exclude evidence of (1) FDA 510(k) clearance and (2) lack of FDA enforcement action, arguing irrelevance and prejudice under Fed. R. Evid. 402/403.
- Court reviewed relevance under Georgia risk-utility/reasonableness framework and Rule 401–403 principles and denied the motion, allowing 510(k)-related evidence with limits to prevent misleading the jury.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether FDA 510(k) clearance evidence is admissible | 510(k) clearance is irrelevant to state-law claims and will mislead jury into thinking device was found "safe and effective"; should be excluded under Rules 402/403 | 510(k) compliance is relevant to reasonableness under Georgia risk-utility analysis and to punitive-damages inquiry; admissible with proper limits | Admissible. 510(k) evidence is probative of reasonableness and punitive-damage issues but cannot be presented as FDA "approval" or a finding that device is "safe and effective." Limiting instruction/expert explanation may be used. |
| Whether absence of FDA enforcement action is admissible | Irrelevant and prejudicial if used to imply FDA found device safe | May be probative depending on context and other evidence (e.g., FDA warning letters) | Context-dependent; court will rule at trial. |
Key Cases Cited
- United States v. Scholl, 166 F.3d 964 (9th Cir.) (trial court has discretion to limit or exclude evidence under Rules 402/403)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (U.S. 1996) (510(k) focuses on equivalence, not the same standard as PMA safety/efficacy determinations)
- Banks v. ICI Americas, 450 S.E.2d 671 (Ga. 1994) (Georgia risk-utility analysis; compliance with federal regulations is a factor for reasonableness)
- Doyle v. Volkswagenwerk Aktiengesellschaft, 481 S.E.2d 518 (Ga. 1997) (compliance with federal standards is probative of manufacturer reasonableness)
- Duren v. Paccar, Inc., 549 S.E.2d 755 (Ga. Ct. App. 2001) (federal compliance probative under risk-utility analysis)
- Stone Man, Inc. v. Green, 435 S.E.2d 205 (Ga. 1993) (compliance with regulations generally not behavior that supports punitive damages)
- Barger v. Garden Way, Inc., 499 S.E.2d 737 (Ga. Ct. App. 1998) (same as to punitive damages)
- Block v. Woo Young Med. Co., 937 F. Supp. 2d 1028 (D. Minn. 2013) (permitting expert testimony on FDA regulatory process and defendant's regulatory conduct)