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In re Bard IVC Filters Products Liability Litigation

United States District Court, D. Arizona

May 8, 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. Doris Jones, an individual, Plaintiff,


          David G. Campbell, United States District Judge.

         The Court has entered two previous orders finding that evidence of deaths caused by cephalad migration of Recovery filters is marginally relevant to this case, and that the limited relevance is substantially outweighed by the danger of unfair prejudice. Docs. 10819, 10920. As a result, the Court has concluded that the death evidence is inadmissible under Rule 403.

         In the second order, which ruled on a motion for reconsideration filed by Plaintiff, the Court addressed a new argument: that cephalad migration death evidence cannot reasonably be extracted from the overall Recovery filter complication evidence, and that eliminating the death evidence would hamstring Plaintiff's ability to prove that the Eclipse filter lacked the design changes necessary to make it a safe filter. Doc. 10920 at 5. Because the Court could not resolve that issue on the existing record, the Court instructed the parties to address it more fully at the final pretrial conference on May 4, 2018. Id. at 6. Plaintiff's counsel presented six exhibits and three deposition excerpts at the conference, and argued extensively. Defense counsel presented four of the same exhibits with death evidence redacted, and also argued.

         A. General Observations.

         The Court previously held that evidence regarding the complications, testing, and design of the Recovery filter are relevant to Plaintiff's claims in this case. Docs. 10819, 10920. As the Court explained:

Those events help explain the testing, development, and design of the G2, and Plaintiff contends that the G2 was essentially the filter she received. The history of the Recovery and how it led to the G2 tends to make a fact in dispute - the allegedly defective design of the Eclipse - more probable.

Doc. 10819 at 2 (citing Fed.R.Evid. 401).

         The Court also concluded, however, that evidence of deaths from cephalad migration was only marginally relevant. This is because cephalad migration did not continue in any significant degree beyond the Recovery filter; cephalad migration deaths all occurred before the Recovery filter was taken off the market in late 2005; the deaths say nothing about three of Ms. Jones' four claims in this case: strict liability design defect, strict liability failure to warn, or negligent failure to warn; although the evidence may add some weight to her fourth claim - negligent design - it is not central to proof of design negligence; and instances of cephalad migration resulting in death are not substantially similar to complications experienced by Ms. Jones and therefore do not meet the Georgia standard for evidence on punitive damages. Id. at 3-4. Given the limited relevancy of the cephalad migration death evidence, the Court found that its probative value was substantially outweighed by the danger of unfair prejudice and therefore was inadmissible under Rule 403. Id. at 5-6.

         When the Court agreed to hear more of Plaintiff's arguments regarding the difficulty of excising death evidence from other relevant evidence, it specifically advised the parties that this would not be another opportunity to argue the Rule 403 ruling:

The purpose of considering this issue on May 4 is not to reconsider whether Plaintiff may make the cephalad migration deaths a component of her case - the Court's Rule 403 ruling stands. The purpose will be to consider whether some references to death must remain in the evidence in order for Plaintiff to effectively present evidence of Recovery filter complications, testing, and design.

Doc. 10920 at 6 (emphasis in original). At the final pretrial conference, Plaintiff's counsel nonetheless felt compelled to argue again that the cephalad death evidence is relevant to her claims. The Court will address briefly some of the arguments made.

         Plaintiff's counsel argued that the 2004-2005 cephalad migration deaths show that the Recovery filter was not performing as advertised, that is was adulterated and misbranded, that it was therefore being marketed illegally, and that Defendants should have removed it from the market. If the Recovery filter was removed from the market, Plaintiff argues, it could not have served for the predicate device for the G2 filter, and, without the G2, Plaintiff's Eclipse filter never would have been sold by Defendants.

         But this case does not include a claim that Defendants negligently failed to recall the Recovery filter. It includes claims that the Eclipse filter was defectively designed and that Defendants failed to warn about the risks of the Eclipse filter. The Court can see no clear connection between the design of and warnings about the Eclipse filter in 2010, and Defendants' alleged failure to remove the Recovery filter from the market in 2004 and 2005. Plaintiff may have an attenuated “but for” argument - that but for Defendants' failure to remove the Recovery filter from the market, the G2 and G2X never would have been marketed, and the Eclipse never would have been available to hurt her - but such a domino-like causal link does not help prove that the Eclipse was designed defectively or that Defendants' 2010 warnings about the Eclipse were inadequate. Thus, the Court cannot conclude that Plaintiff should be permitted to present evidence of Recovery filter cephalad migration deaths in order to convince the jury that Defendants should have removed the Recovery filter from the market years before Plaintiff received her later-generation filter.

         Plaintiff's counsel argued that the medical community should have been warned about the cephalad migration deaths - that Defendants should have described the deaths in the Instruction for Use (IFU) that accompany each Bard IVC filter. Plaintiff's counsel further argued that such a warning should have carried forward into the G2 and Eclipse filters. But as noted in the Court's two prior orders, cephalad migration deaths stopped with the Recovery and did not recur in the G2-line of filters. Docs. 10819 at 3, 10920 at 3. Thus, even if Plaintiff could credibly argue that users of the Recovery filter should have been warned of cephalad migration deaths, that argument has no relevancy with respect a later-generation filter that was not causing cephalad migration or such deaths. Plaintiff cannot plausibly claim that the jury should find Defendants liable to her for failure to warn of deaths that occurred five years earlier, from a filter she did not receive, and by a means of migration she did not experience.

         Plaintiff's counsel argued that Defendants' failure to warn Recovery users about the cephalad migration deaths - and failure to warn G2-line users about the Recovery deaths - is a basis for punitive damages. The Court might agree if cephalad migration deaths continued with the G2-line of filters, but they did not. The Court cannot conclude that Defendants should be punished for their sale of an Eclipse filter to Plaintiff because they failed to warn Recovery patients about cephalad migration deaths five years earlier. Nor can the Court conclude that Recovery cephalad migration deaths are “substantially similar” to Plaintiff's injury from embolization of an Eclipse filter fragment, as required by Georgia law with respect to punitive damages. See Gen. Motors Corp. v. Moseley, 447 S.E.2d 302, 306 (Ga.Ct.App. 1994).

         Plaintiff's counsel argued that they should be able to show the jury “[h]ow incredibly unreasonable it was that they put out another device only having done bench testing, less bench testing and less animal testing than they did with the Recovery filter[.]” Court's Livenote Transcript, 5-4-18. But the Court's ruling does not prevent Plaintiff from making this showing. The Court's exclusion of cephalad migration death evidence does not limit her ability to show what testing was done or not done on the G2 filter.

         Plaintiff's counsel argued that Defendants will assert at trial that IVC filters save lives, and “we're not going to be able to establish that these things could actually cause people to lose their lives.” Id. Not so. The Court has not ruled that Plaintiff is precluded from asserting that filter migration, tilt, fracture, and perforation can cause serious health effects including death. The Court has not barred Plaintiff from asking her experts what consequences could arise from the complications seen in the G2-line of filters. ...

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