United States District Court, D. Arizona
G. CAMPBELL SENIOR UNITED STATES DISTRICT JUDGE.
case brought by Plaintiffs Lisa and Mark Hyde is set for a
bellwether trial later this month. The parties have filed
motions in limine (“MILs”) in advance of trial.
This order will rule on Plaintiffs' MILs Nos. 4 and 5,
which seek to exclude evidence regarding the Bard IVC
filter's instructions for use (“IFU”) and
certain guidelines published by the Society of Interventional
Radiologists (“SIR”). Docs. 12100, 12101.
Lisa Hyde received a Bard IVC filter implant in 2011. In
2014, she learned that the filter had tilted, perforated the
IVC wall, and fractured. The filter and fractured limbs were
removed three months later.
Hyde and her husband assert various claims. Doc. 364; Doc. 1,
No. CV-16-00893. Applying Wisconsin law, the Court granted
summary judgment on their failure to warn claims (Counts II
and VII). Doc. 12007. Plaintiffs continue to assert claims
for strict liability design defect (Count III), negligent
design (Count IV), negligence per se (Count IX), loss of
consortium (Count XV), and punitive damages. Id. at
Wisconsin's product liability statute, Wis.Stat. §
895.047, a product is defective in design if its foreseeable
risks of harm could have been reduced or avoided by the
adoption of a reasonable alternative design, and the omission
of the alternative design renders the product not reasonably
safe. § 895.047(1)(a). Plaintiffs argue that, consistent
with the statute, the focus of their case will be on the
design of the Bard filter and alternative designs that would
have made the filter safe. Doc. 12100 at 2. Plaintiffs argue
that because the IFU says nothing about the filter's
design, and because the failure to warn claims have been
dismissed, the instructions and warnings set forth in the IFU
are no longer relevant to any issue in the case and should be
excluded under Rules 401 and 402 of the Federal Rules of
Evidence. Id. at 2-3. Plaintiffs further argue that
evidence regarding the IFU should be excluded under Rule 403
because it would only confuse the jury. Id. at 3.
seek exclusion of the SIR guidelines for similar reasons.
Doc. 12101. They argue that the purpose for which the SIR
guidelines were previously admitted - to show knowledge of
IVC filter complications in the medical community - is no
longer relevant now that the failure to warn claims have been
dismissed. Id. at 2. Plaintiffs contend that any
defense based on the learned intermediary doctrine is moot
without a failure to warn claim, and that the defense
otherwise does not apply because Mrs. Hyde, not the
implanting physician, is the “ultimate consumer”
under Wisconsin product liability law. Id.; Doc.
12100 at 3 (citing Green v. Smith & Nephew AHP,
Inc., 629 N.W.2d 727, 752 (Wis. 2001) (holding that a
product is defective if it is in a condition “not
contemplated by the ultimate consumer”)).
assert that the language of § 895.047(a)(1) reflects
Wisconsin's adoption of § 2(b) of the Restatement
(Third) of Torts (1998) (“§ 2(b)”). Docs.
12384 at 2, 12385 at 2. The IFU and SIR guidelines are
relevant to the design defect claim, Defendants argue,
because § 2(b) involves a risk-utility balancing test
and consideration of a broad range of factors, including the
instructions and warnings accompanying the product.
Id. (citing § 2, cmts. d & f). Defendants
further argue that Plaintiffs' reliance on Green
and the “consumer contemplation” test is
misplaced because the test has been abrogated by
Wisconsin's adoption of § 895.047 and § 2(b).
Doc. 12385 at 2 n.2.
Wisconsin's Product Liability Law.
1967, Wisconsin adopted the rule of strict product liability
set forth in the Restatement (Second) of Torts § 402A
(1965) (“§ 402A”). See Dippel v.
Sciano, 155 N.W.2d 55, 63-65 (1967). Eight years later,
the state explicitly adopted a “consumer
contemplation” test. See Vincer v. Esther Williams
All-Aluminum Swimming Pool Co., 230 N.W.2d 794, 797
(Wis. 1975) (adopting § 402A, cmts. g & i);
Green, 629 N.W.2d at 738-39. Under this test, a
product “is defective and unreasonably dangerous when
it is in a condition not contemplated by the ultimate
consumer and unreasonably dangerous to that consumer.”
Beacon Bowl, Inc. v. Wis. Elec. Power Co., 501
N.W.2d 788, 809 (Wis. 1993) (citing Vincer).
consumer contemplation test was challenged in Green.
The defendant argued that a pure consumer contemplation test,
without consideration of the risks and benefits of the
product, would unnecessarily cause many useful products to be
taken off the market. Green, 629 N.W.2d at 742. The
defendant further argued that foreseeability of the risk of
harm should be an element of product liability claims in
order to avoid imposing absolute liability on manufacturers.
Id. at 744. The defendant urged the court to adopt
Restatement § 2(b), which includes an element of
[A product] is defective in design when the foreseeable risks
of harm posed by the product could have been reduced or
avoided by the adoption of a reasonable alternative design[,
] . . . and the omission of the ...