IN RE: Bard IVC Filters Products Liability Litigation, 2:15-md-02641

Background

Plaintiff Sherr-Una Booker received a Bard G2 retrievable IVC filter in 2007 that later tilted, migrated, fractured, and required surgeries; one fractured strut remains embedded in her IVC wall.
Plaintiff alleges Bard negligently designed the G2, failed to warn, and seeks punitive damages; Bard will rely in part on FDA 510(k) clearance and substantial-equivalence to its predicate Recovery filter.
The Recovery (Bard’s first-generation retrievable filter) was marketed 2003–2005; Bard made multiple design changes for the G2 and used Recovery as the 510(k) predicate.
Bard moved to exclude evidence about the Recovery and certain FDA materials; Plaintiffs opposed, asserting relevance to design, warnings, and punitive-damages issues and to rebut Bard’s FDA-clearance defense.
The court balanced relevance (including the predicate relationship in FDA 510(k) submissions) against hearsay, prejudice, and Rule 403 concerns, resolving multiple MILs addressing Recovery-related testing and FDA materials, third-party fault, professional statements, and FDA involvement in warnings/recalls.

Issues

Issue	Plaintiff's Argument	Defendant's Argument	Held
Admissibility of evidence about the Recovery filter (predicate device)	Recovery problems show Bard knew of risks, did not correct/warn, and are relevant to G2 design, warnings, and punitive damages	Recovery was substantially redesigned; its problems are not substantially similar or relevant to Booker’s G2 failures	Denied: Recovery evidence admissible (subject to later limitation re: cephalad migration); predicate relationship makes Recovery probative of knowledge, design choices, and warnings
Admission of Recovery-development evidence (tests, investigator testimony, Bard employee statements)	Such evidence shows inadequate testing and Bard’s knowledge—relevant to 510(k) predicate and G2 safety	Evidence is improper "bad acts" and unfairly prejudicial under Rules 404/403	Denied: admissible under Rule 404(b) for knowledge/intent; probative value not substantially outweighed by prejudice
Admissibility of 2015 FDA warning letter	Plaintiffs say it rebuts Bard’s implication of no FDA action	Defendants say letter is irrelevant (post-dates implantation, mostly concerns other devices/topics)	Granted in part: topics unrelated to G2 excluded; topics 3,7,8 may be admissible if shown relevant at trial; letter not excluded as hearsay (803(8) public records)
Whether Bard may argue filters are "lifesaving" or part of medical standard of care	Plaintiffs sought to bar "lifesaving" characterization	Bard contends filters prevent fatal pulmonary embolism and evidence of benefit is relevant to risk-utility	Denied: evidence that filters can be lifesaving admissible for risk-utility; parties should distinguish medical standard of care vs. design/marketing standard
Use of professional society statements/guidelines (e.g., SIR)	Plaintiffs argue hearsay, hearsay-within-hearsay, or Daubert-avoidance through lay witnesses	Defendants say statements can be admitted non-hearsay (for notice/publicity), under Rule 803(18) via experts, or as lay witness fact testimony about Bard discussions	Denied: motion to exclude broadly; admissibility depends on specific statements and foundation at trial; Rule 703/803(18) constraints noted
Whether Bard needed FDA consent to add warnings or recall	Plaintiffs: Bard could have voluntarily sent warnings or recalled without FDA consent	Defendants: contend some labeling/recall actions implicate FDA processes	Granted in part: Defendants precluded from arguing they needed FDA consent to add warnings, send warning letters, or recall; may explain FDA involvement and limitations of MDR/MAUDE data
Nonparty fault and intervening causation (Dr. Amer, Dr. Kang)	Plaintiffs: limit Defendants’ nonparty-fault evidence to Dr. Amer (the only timely-noticed nonparty)	Defendants: want to apportion fault to others and/or argue intervening cause (e.g., Dr. Kang’s retrieval caused heart injury)	Granted in part/Denied in part: jury may apportion fault under Georgia statute only to Dr. Amer (timely notice). Defendants may assert intervening-cause defense re: other providers (must prove not foreseeable, not triggered by Bard, and sufficient alone to cause injury). Jury instructions will reflect these limits
Sufficiency of expert support to blame Dr. Amer	Plaintiffs: no expert causation connects Dr. Amer’s alleged breach to injuries	Defendants: combined expert testimony (one on standard of care, one on causation) suffices	Denied: court finds combined expert opinions create jury question; evidence admissible for jury to decide causation

Key Cases Cited

Cooper v. Firestone Tire & Rubber Co., 945 F.2d 1103 (9th Cir. 1991) (other-accident evidence requires showing of substantial similarity when offered as direct proof of negligence or notice)
Duran v. City of Maywood, 221 F.3d 1127 (9th Cir. 2000) (four‑part test for admission of uncharged misconduct under Rule 404(b))
Banks v. ICI Ams., Inc., 450 S.E.2d 671 (Ga. 1994) (Georgia risk-utility framework for design-defect analysis)
Zaldivar v. Prickett, 774 S.E.2d 688 (Ga. 2015) (definition of "fault" and standard for intervening cause under Georgia law)
Jordan v. Everson, 806 S.E.2d 533 (Ga. 2017) (intervening cause need not be negligent or wrongful)
Monitronics Int’l, Inc. v. Veasley, 746 S.E.2d 793 (Ga. Ct. App.) (strict compliance required for Georgia nonparty-at-fault statutory notice)
Vega v. La Movida, Inc., 670 S.E.2d 116 (Ga. Ct. App. 2008) (statute § 51-12-33 concerns apportionment of damages and does not preclude intervening-cause defenses)
Moore v. Singh, 755 S.E.2d 319 (Ga. Ct. App. 2014) (causation questions are for the jury unless the record is clear and undisputed)
Sabel v. Mead Johnson & Co., 737 F. Supp. 135 (D. Mass. 1990) (FDA letters admissible as public records under Rule 803(8) when based on an agency investigation)