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In re Bard IVC Filters Products Liability Litigation

United States District Court, D. Arizona

March 1, 2018

IN RE Bard IVC Filters Products Liability Litigation,
C. R. Bard, Inc., a New Jersey corporation; and Bard Peripheral Vascular, Inc., an Arizona corporation, Defendants. Sherr-Una Booker, an individual, Plaintiff,



         The parties have filed various motions in limine (“MIL”) in advance of the Booker bellwether trial. The Court ruled on some of the motions in an earlier order. Doc. 10075. This order will rule on the remaining motions.

         A. Defendants' MIL No. 1 (Recovery filter complications).

         Plaintiff Booker was implanted with a Bard G2 filter in June 2007. The filter later tilted, migrated, and fractured. Ms. Booker had surgeries to remove the filter and several fractured struts, but one strut remains embedded in the wall of her inferior vena cava (“IVC”). Defendants seek to exclude evidence of complications with an earlier version of the Bard IVC filter - the Recovery filter - arguing that those complications are not “substantially similar” to the issues with Ms. Booker's G2 filter. Doc. 9862 at 5-7.

         The Recovery was Bard's first generation of retrievable IVC filters, and was on the market from the beginning of 2003 to the fall of 2005. The Recovery was followed by the G2. As Defendants explain in their motion: “Based on clinical experience with the Recovery Filter, Bard made several significant changes to the G2 Filter: the filter hook wire diameter was increased, the filter arm tips were curved, the curvature radius of the filter arms at the sleeve were increased, and the spline was modified to accommodate the other dimensional changes.” Id. at 4. Because Ms. Booker received a G2 filter, and that filter had been changed significantly from the Recovery filter, Defendants argue that problems with the Recovery have “absolutely no relevance to the issues in this case.” Id. The Court does not agree.

         Plaintiffs claim that Bard negligently and defectively designed the G2 filter, failed to warn of its risks, and did so with a mindset worthy of punitive damages. In response, Defendants will argue, among other points, that the FDA cleared the G2 filter for market. Defendants vigorously opposed Plaintiffs' motion to exclude evidence of the FDA's 510(k) clearance process, arguing that the steps a manufacturer must take before a product is cleared by the FDA are “highly relevant to a case . . . like this one, ” and that compliance with the 510(k) process “is certainly probative under Georgia law on the issues of reasonableness of the design, manufacture, and warnings of the G2 Filter, as well as whether Bard's conduct rises to the level justifying punitive damages[.]” Doc. 9690 at 3. The Court agreed with Defendants, noting that the FDA grants 510(k) clearance “only where the device ‘is as safe and effective as a [predicate device] and does not raise different questions of safety and efficacy than the predicate device.'” Doc. 9529 at 4 (citation omitted).

         Bard identified the Recovery filter as the predicate device for the G2, and avowed to the FDA that the “design, material, components, fundamental technology (mode of device function/operation) and intended use featured with the [G2]” are “substantially equivalent to those featured with the predecessor Recovery Filter System[.]” Doc. 10068-1 at 25. Defendants assert that “one of Bard's goals in developing the G2 Filter was to reduce the number of incidents of filter fracture and migration that Bard had observed with the Recovery Filter.” Doc. 9862 at 4.

         Given these facts, the Court concludes that Bard's knowledge of problems with the Recovery filter is relevant to central issues in this case - whether Bard properly designed the G2 to correct those problems, whether Bard failed to warn physicians and patients about problems shared by the Recovery and G2, and whether Bard's alleged failure to correct or warn about known problems justifies an award of punitive damages. The Court also concludes that it would be difficult to try this case without evidence of the Recovery filter and the problems it encountered. Defendants' evidence regarding FDA clearance will necessarily include the fact that the Recovery filter was the predicate device for the G2 and was substantially equivalent to the G2. In showing Bard's care in designing the G2, Defendants almost certainly will argue that Bard carefully tracked problems encountered by the Recovery, dutifully reported those problems to the FDA, and took specific steps to correct those problems in the G2. Defendants will use this evidence to show that Bard did not negligently or defectively design the G2 and did not fail to warn of its risks. It is only fair that Plaintiffs be permitted to present evidence to support their claim that the Recovery was known to be more hazardous than Bard admitted publicly or to the FDA, and that it involved problems that were not corrected in the G2 and Bard failed to warn physician and patients of those known problems.

         Defendants cite a number of cases for the proposition that other instances of product failure are admissible only if the instances are substantially similar to the product failure at issue in this case. Id. at 5. For example, the Ninth Circuit has held that “[a] showing of substantial similarity is required when a plaintiff attempts to introduce evidence of other accidents as direct proof of negligence, a design defect, or notice of the defect.” Cooper v. Firestone Tire & Rubber Co., 945 F.2d 1103, 1105 (9th Cir. 1991). For three separate reasons, the Court does not find this case law controlling.

         First, Ms. Booker alleges that her G2 filter tilted, perforated her IVC, fractured, and migrated. Doc. 10068 at 7. These methods of failure include virtually all of the known methods of failure for the Recovery filter.

         Second, the facts of this case distinguish it from many of the cases cited by Defendants. This is not simply a product defect case in which Plaintiffs seek to introduce evidence of other potentially unrelated product failures. As already noted, the Recovery was the predicate for the G2 and Bard sought FDA clearance on the basis that the G2 was substantially equivalent to the Recovery. Bard intends to present evidence of that FDA clearance during trial. Defendants surely will note that the clearance required an FDA determination that the G2 was as safe and effective as the Recovery. In this context, evidence regarding the safety and effectiveness of the Recovery filter is plainly relevant, particularly where Plaintiffs claim that the Recovery was not as safe and effective as Bard represented to the FDA. Further, Defendants claim to have designed the G2 to overcome known defects in the Recovery, making the extent and severity of those defects relevant to the adequacy of Bard's design of the G2.

         Third, although substantial similarity is required by the Ninth Circuit for direct evidence of negligence, design defect, or notice, it is not required when other examples of product failure are used to impeach an expert's testimony that a product is safe. Cooper, 945 F.2d at 1105. The parties do not address whether the evidence in this case would be used for impeachment or direct evidence.

         Defendants also seek to exclude evidence of complications involving cephalad migration (toward the heart), asserting that such evidence is irrelevant because Ms. Booker's filter migrated in a caudal direction (away from the heart). Doc. 9862 at 7-8. Plaintiffs respond that Bard combined caudal and cephalad migration in tracking adverse events internally and in reporting migration rates to the FDA. Doc. 10068 at 9 (citing Doc. 10068-9 at 2-4). On this record, however, the Court cannot determine whether evidence of cephalad migration is relevant to Ms. Booker's claims. The parties should be prepared to address this issue at the final pretrial conference - specifically, what instances of cephalad migration Plaintiffs intend to present at trial, and why those instances are relevant.

         Finally, Defendants contend that the probative value of the Recovery filter evidence is substantially outweighed by the risks of unfair prejudice, misleading and confusing the jury, and wasting time. Doc. 9862 at 8-9; Fed.R.Evid. 403. Defendants claim that admission of such evidence will require Bard to introduce its own evidence regarding the design of the Recovery, the technology available at the time, and Bard's investigation of adverse event reports. Id. at 9. This may be true, but that often is the result of admitting relevant evidence. With the possible exception of cephalad migration, the Court concludes that known complications with the Recovery filter are plainly relevant to this case. It will not, in the Court's view, mislead or confuse the jury, waste time, or result in unfair prejudice. The motion in limine (Doc. 9862) is denied, subject to the Court's consideration of cephalad migration at the final pretrial conference.

         B. Defendants' MIL No. 2 (development of the Recovery).

         Defendants seek to exclude specific evidence relating to the development of the Recovery device: (1) migration resistance tests, (2) testimony from Dr. Asch regarding his clinical trial of the Recovery, and (3) testimony from Bard employee Kay Fuller regarding the 510(k) submission to the FDA. Doc. 9863 at 2-3. Defendants claim that this “bad act” evidence is irrelevant and inadmissible under Rules 404 and 403. Id. at 3-4.

         The Court cannot conclude that development of the Recovery filter is irrelevant to the G2 filter claims in this case. Bard based its request for FDA clearance of the G2 on the claim that it was substantially equivalent to, and as safe and effective as, the Recovery. Defendants intend to argue at trial that the resulting FDA approval shows that Bard acted responsibly and produced a safe and effective filter. In this context, evidence that the Recovery filter was itself the result of inadequate and incomplete testing, that a doctor involved in the testing concluded that it was inadequate and incomplete, and that a Bard employee reached the same conclusion, is plainly relevant. After considering the Ninth Circuit's four-part test, see Duran v. City of Maywood, 221 F.3d 1127, 1132-33 (9th Cir. 2000), the Court concludes that such evidence is admissible under Rule 404(b) as probative of Bard's knowledge, intent, and lack of mistake, and that its probative value is not substantially outweighed by the potential dangers set forth in Rule 403. Defendants' motion in limine (Doc. 9863) is denied.

         C. Defendants' MIL No. 3 (FDA warning letter).

         Defendants seek to exclude a 2015 FDA warning letter, contending that it is irrelevant because it constitutes an informal advisory statement by the FDA issued more than seven years after Ms. Booker received her G2 filter. Doc. 9864 at 2-3. Defendants also contend that specific topics in the warning letter are not related to the G2 filter or any other issues in this case. Plaintiffs counter that the letter is an essential piece of evidence to rebut Bard's suggestion that the FDA took no action against Bard and expressed no concerns about Bard filters. Doc. 9927 at 2. Other than one sentence, however, Plaintiffs do not address Defendants' argument that topics in the letter are not related to issues in this case. That sentence argues only that deficiencies in Bard's handling and reporting of filter failures are relevant to this case. Id.

         Many topics in the warning letter lack probative value. Topics 1 and 2 concern the Recovery Cone retrieval system, which is not at issue in this case. See Doc. 9864-1. Topic 4(a) concerns the filter cleaning process, which does not appear to be at issue here. Topics 4(b), 5, and 6 concern the Denali filter, a generation of filter developed after the G2 received by Ms. Booker. Topics 3, 7, and 8 concern Bard's complaint handling and reporting processes, but Plaintiffs have not shown why the specific issues raised in those three topics are relevant to this case.

         The Court concludes that topics 1, 2, 4(a), 4(b), 5, and 6 are not relevant to this case, and will grant the motion in limine with respect to them. The Court cannot tell on the present record whether topics 3, 7, and 8 are relevant; that decision must be made at trial. To avoid the potential prejudice that will result if the warning letter is mentioned but irrelevant, the Court directs Plaintiffs to raise the potential admissibility of topics 3, 7, and 8 outside the hearing of the jury before mentioning the warning letter to the jury.

         A few other comments are warranted. Plaintiffs argue that Defendants intend to present evidence of the lack of FDA enforcement actions, and to argue that the “FDA's decision not to take any enforcement actions against Bard is probative as to whether Bard acted reasonably in its design and manufacture of the G2 line of filters.” Doc. 9690 at 9. In response, Plaintiffs argue, they should be allowed to show that the FDA did issue a warning letter to Bard. But Plaintiffs' statement of Defendants' position is too broad. Defendants argue that they should be permitted to present evidence of “FDA's lack of enforcement action regarding Bard's G2 line of filters.” Doc. 9690 at 8 (emphasis added). The warning letter did not concern the G2 line of filters, and was issued in 2015, long after Ms. Booker received her G2 filter in 2007. If Defendants open the door at trial by arguing generally that the FDA has never taken enforcement action of any ...

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