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In re Bard IVC Filters Products Liability Litigation

United States District Court, D. Arizona

January 29, 2018

IN RE Bard IVC Filters Products Liability Litigation
C. R. Bard, Inc., et al. Defendants. Sherr-Una Booker, an individual, Plaintiff,


          David G. Campbell, United States District Judge

         This multidistrict litigation proceeding (“MDL”) involves thousands of personal injury cases related to inferior vena cava (“IVC”) filters manufactured and marketed by Defendants C. R. Bard, Inc. and Bard Peripheral Vascular, Inc. (collectively, “Bard”). Plaintiff Sherr-Una Booker, who had a Bard filter implanted ten years ago, brought one of the MDL cases. Plaintiff Booker's case has been selected as one of several bellwether cases and is set for trial in March 2018.

         Plaintiffs have filed a motion in limine based on Federal Rules of Evidence 402 and 403 to preclude evidence of (1) the premarket clearance of Bard IVC filters by the Food and Drug Administration (“FDA”), and (2) the lack of FDA enforcement action against Bard. Doc. 9529. The motion is fully briefed, and the parties agree that oral argument is not necessary. The Court will deny the motion.

         I. Background.

         The IVC is a large vein that returns blood to the heart from the lower body. IVC filters are small metal devices implanted in the IVC to catch blood clots before they reach the heart and lungs. Seven different versions of Bard IVC filters are at issue in this MDL - the Recovery, G2, G2 Express, G2X, Eclipse, Meridian, and Denali.

         IVC filters and other medical devices must be approved or cleared for market by the FDA. The FDA may approve a medical device that is shown to be safe and effective through a process known as “premarket approval[.]” 21 U.S.C. § 360e(a). Such approval is not required, however, for most medical devices. Through a less rigorous process known as section “510(k)” review, a manufacturer can obtain “clearance” to market a device by showing that it is substantially equivalent to a device already on the market. 21 U.S.C. § 360c(f)(1)(A). Each Bard IVC filter at issue in this MDL received FDA clearance through 510(k) review.[1]

         Plaintiffs allege that Bard filters are more dangerous than other IVC filters because they have a higher risk of tilting, perforating the IVC, or fracturing and migrating to neighboring organs. Plaintiffs further allege that Bard failed to warn physicians and patients about these higher risks. Doc. 303-1. Bard disputes Plaintiffs' allegations, contending that overall complication rates for Bard filters are comparable to those of other IVC filters and that the medical community is aware of IVC filter risks.

         Plaintiff Booker was implanted with a G2 filter in June 2007 and suffered injuries from the filter's failure. She asserts various claims against Defendants under Georgia law. Doc. 1, CV-16-00474-PHX-DGC. The following claims remain for trial: design defect, failure to warn, and punitive damages. See Doc. 8874 at 22.

         II. Federal Rules of Evidence 401, 402, and 403.

         The relevance and admissibility of evidence at trial is governed in part by Rules 401, 402, and 403. Evidence is relevant under Rule 401 if it has any tendency to make a material fact more or less probable. Fed.R.Evid. 401(a)-(b). Rule 402 provides that relevant evidence is admissible unless otherwise excluded by the rules, a federal statute, or the Constitution; irrelevant evidence is not admissible. Fed.R.Evid. 402. Under Rule 403, relevant evidence may be excluded if its probative value is substantially outweighed by the danger of “unfair prejudice, confusing the issues, misleading the jury, undue delay, wasting time, or needlessly presenting cumulative evidence.” Fed.R.Evid. 403. Trial courts have discretion to limit or exclude evidence under Rules 402 and 403. United States v. Scholl, 166 F.3d 964, 971 (9th Cir. 1999).

         III. Discussion.

         A. The FDA's Clearance of the G2 Filter Under 501(k) Review.

         Plaintiffs argue that Defendants intend to assert an “FDA defense” at trial by implying that the 510(k) clearance process demonstrates filter “safety and effectiveness” and the reasonableness of Bard's conduct. Plaintiffs contend that such evidence is not relevant to any issue in the case and should be excluded under Rule 402. Doc. 9529 at 1-2. The Court does not agree.

         Georgia courts have adopted a risk-utility analysis for design defect claims like those asserted by Plaintiff Booker. This analysis incorporates negligence principles and the “concept of ‘reasonableness, ' i.e., whether the manufacturer acted reasonably in choosing a particular product design[.]” Banks v. ICI Ams., Inc., 450 S.E.2d 671, 673 (Ga. 1994). One of the many factors a jury may consider in its reasonableness determination is the manufacturer's compliance with federal regulations. Id. at 675 & n.6. Compliance with the regulations may not render a manufacturer's design choice immune from liability, but it can be a “piece of the evidentiary puzzle.” Doyle v. Volkswagenwerk Aktiengesellschaft, 481 S.E.2d 518, 521 (Ga. 1997); see Duran v. Paccar, Inc., 549 S.E.2d 755, 762 (Ga.Ct.App. 2001) (“[C]ompliance with federal standards or regulations is probative of Paccar's reasonableness under the risk-utility analysis.”). Given these ...

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