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

Background

MDL involving thousands of personal-injury suits alleging design, manufacturing, and warning defects in Bard retrievable IVC filters (Recovery, G2, G2 Express, G2X, Eclipse, Meridian, Denali). Plaintiffs claim elevated risks of tilt, perforation, fracture, migration.
Plaintiffs disclosed Robert McMeeking, Ph.D., a mechanical engineer/materials scientist, as an expert on filter design; he submitted a detailed report and a rebuttal report addressing design, stress/strain, testing, and failure modes for Bard filters and comparing the Simon Nitinol Filter (SNF) to Bard devices.
Bard moved (Daubert) to exclude categories of McMeeking opinions: (1) that Bard failed to eliminate risks through design, (2) that Bard was not frank with the FDA, (3) that complication rates are “dangerous,” and (4) that the SNF is a safer alternative.
The parties largely dispute the scope and basis of McMeeking’s opinions; Bard challenges some opinions as beyond his expertise or unsupported by reliable methodology; Plaintiffs represent McMeeking will limit certain opinions at trial.
Court reviewed McMeeking’s reports, deposition, and briefing and ruled: grant in part — exclude the “frank and honest” FDA opinion; otherwise deny pretrial exclusion of the identified categories but limit certain testimony (e.g., no opinion that SNF was safer for specific plaintiffs; McMeeking won’t opine on complication rates as a statistician).

Issues

Issue	Plaintiff's Argument	Defendant's Argument	Held
Whether McMeeking may opine generally that Bard failed to eliminate risks via design/process	McMeeking may rely on engineering analyses, FEA, testing review to identify design defects and design-process failures	Bard says specific assertions (e.g., Bard didn’t go far enough) lack reliable basis and are unsupported by the reports	Court declined to exclude broadly; parties must identify specific trial objections — trial will resolve context-specific objections
Whether McMeeking may opine that Bard was not “frank and honest” with the FDA	Plaintiffs rely in part on other experts (e.g., Dr. Parisian) and documents to support assertions about Bard’s communications	Bard contends McMeeking lacks FDA-regulatory expertise and merely parrots other experts without independent verification	Excluded: McMeeking cannot offer the ‘‘frank and honest’’ opinion; he may point out technical inaccuracies in Bard documents from an engineering perspective but not opine on FDA compliance/conduct
Whether McMeeking may state that complication rates make Bard filters “dangerous”	Plaintiffs state McMeeking will not present statistical/epidemiological rate opinions and will only say literature is consistent with his engineering analysis	Bard seeks to exclude any opinion that filters are ‘‘dangerous’’ (statistical/medical conclusion)	Court accepts Plaintiffs’ representation that McMeeking will not offer rate opinions; Defendants may object at trial if he strays into statistical/medical rate opinions
Whether McMeeking may opine that the SNF is a safer device than Bard retrievable filters	McMeeking offers an engineering-based comparison concluding SNF is substantially better for migration, tilt, fracture, perforation; not offered for specific-plaintiff causation	Bard argues design-function differences or law (cited NY cases) may bar asserting SNF as a feasible safer alternative and that McMeeking lacks qualification to opine about suitability for particular plaintiffs	Court permitted the general engineering safety-comparison opinion; disallowed any opinion that SNF would have been a safer alternative for any specific plaintiff; admissibility as to law/feasibility left for trial/jury under applicable state law

Key Cases Cited

Lust v. Merrell Dow Pharm., Inc., 89 F.3d 594 (9th Cir.) (proponent bears burden to show expert qualification and admissibility)
Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (1993) (trial court gatekeeping role under Fed. R. Evid. 702)
McCarthy v. Olin Corp., 119 F.3d 148 (2d Cir.) (expert showing product feature was necessary to function; feasibility-defense precedent)
Felix v. Akzo Nobel Coatings, 262 A.D.2d 447 (N.Y. App. Div.) (expert admitted formulation necessity; infeasibility of safer alternative)
Voss v. Black & Decker Mfg. Co., 450 N.E.2d 204 (N.Y.) (risk-utility / feasible safer-design requirement discussion)
In re Toyota Motor Corp. Unintended Acceleration Mktg., Sales Practices, & Prods. Liab. Litig., 978 F. Supp. 2d 1053 (C.D. Cal.) (expert may not merely repeat other experts without independent verification)
Mascarenas v. Cooper Tire & Rubber Co., 643 F. Supp. 2d 1363 (S.D. Ga.) (Georgia risk-utility framework; jury typically weighs factors)