In re Bard IVC Filters Products Liability Litigation

          ORDER

          DAVID G. CAMPBELL SENIOR UNITED STATES DISTRICT JUDGE.

         The 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.

         I. Background.

         Plaintiff 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.^[1]

         Mrs. 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 19.

         II. Discussion.

         A. Parties' Arguments.

         Under 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.

         Plaintiffs 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”)).^[2]

         Defendants 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.^[3]

         B. Wisconsin's Product Liability Law.

         In 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).

         The 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 foreseeability:

[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 ...