United States District Court, D. Arizona
G. Campbell, United States District Judge
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.
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.
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.
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
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.
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.
Federal Rules of Evidence 401, 402, and 403.
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).
The FDA's Clearance of the G2 Filter Under 501(k)
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.
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