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We write in a state of annoyed frustration (so different from our normal sunshiny sweetness – lol).  We have a bat mitzvah to attend next weekend – dear friend’s daughter.  And we knew exactly what to wear to the evening festivities:  a great dress with a skirt is slightly poufed, because it has a bit of a petticoat underneath.  Or had, we should say.  When we picked the dress up from the alterations shop, the petticoat was missing.  The [talented] seamstress is not a native English speaker, so we learned nothing from our reconnaissance efforts.  Best we could exact was a promise to sew in something similar, if we so chose, in time for the event.  

But what is similar enough?  That is also the root of the dispute in today’s case.  In Banks v. C.R. Bard, Inc., 2023 WL 1100446 (M.D. La. Jan. 30, 2023), the plaintiff was implanted with the defendants inferior vena cava (“IVC”) filter in October 2007.  (IVC filters are designed to catch blood clots before they travel to the heart and lungs.  The filter remained in place until March 2016, when it failed by “tilting, migrating downward, and perforating” the plaintiff’s IVC and adjacent structures.  Today’s decision involves the defendant’s motion in limine to exclude evidence of adverse events associated with an earlier filter and of the company’s marketing and communications related to those adverse events.  Let us back up and explain.

From 2003 to 2005, the defendant marketed its first-generation retrievable IVC filter. (The plaintiff’s filter was the later second-generation filter).  During that time, the defendant received reports that the first-generation filter migrated to the heart and caused deaths.  The defendant created communication materials to respond to media inquiries about these adverse events and sent materials to its sales force for use in responding to questions about the deaths, and there were internal emails addressing the events and the company’s response.  The defendant sought to exclude all of this evidence.

Evidence of Deaths Associated with the First-Generation Filter

In the Fifth Circuit, as Banks explains, the proponent of evidence of “other accidents or occurrences,” offered “for any purpose other than to show notice,” must “show that the facts and circumstances of the other accidents or occurrences are ‘closely similar to the facts and circumstances at issue’ – otherwise known as the ‘substantial similarity’ requirement for admissibility.”  Banks, 2023 WL 1100446 at *2 (internal punctuation and citations omitted).  Applying that standard, Banks held:

The circumstances in this case sharply differ from those surrounding the . . . migrations [of the first-generation filter].   For one, this case does not involve complications resulting in death.  Nor does it involve . . . migration of the entire [filter] to the heart.  Instead, [the plaintiff’s] own evidence shows that her filter migrated in the opposite direction, “downward” towards her feet.

Id.  The court concluded, “. . . [I]nstances of migration [to the heart] resulting in death are not substantially similar to complications experienced by the [second-generation filter the plaintiff received].”  Moreover, in the one MDL bellwether trial in which similar evidence was admitted “to understand the issues that prompted the creation and design of the” second-generation filter, the court did not apply the Fifth Circuit “substantial similarity” standard.  Banks also pointed out that, even if the plaintiff could establish “substantial similarity,” the court had broad discretion to exclude the evidence under Fed. R. Civ. P. 403.  In that vein, Banks found “that the probative value of the [first-generation filter] evidence, if any, [was] substantially outweighed by the risk of prompting an emotional reaction from the jury based on injuries that are more severe than those [the plaintiff] experienced,” and also “risk[ed] confusing the issues and misleading the jury” by “putting . . . separate filters on trial.”  Id. at *3.   And so the court held that the evidence of deaths related to migration of the first-generation filter was not admissible to support the plaintiff’s design defect claim.

Nor was the evidence admissible as “notice” evidence to support the plaintiff’s failure-to-warn claim, because it did not involve “similar products failing in a similar manner.”  Because migrations into the heart had “largely ceased due to changes made to the [second-generation] filters, and deaths due to such migrations had stopped, the court “fail[ed] to discern how instances of [such] migration, addressed and corrected by [the defendant] enabled [the defendant] to predict a different form of migration from a different filter.”  Finally, the court held that this evidence did not reveal anything about the defendant’s state of mind that was not apparent from evidence already in the record – the defendant had disclosed the possibility of migration in the second-generation filter’s Instructions for Use and had stipulated to notice of potential migration.  Bottom line: the court excluded all evidence of deaths associated with the earlier filter.

Marketing and Communications Evidence

The defendant also sought to exclude marketing and communications materials responding to the deaths associated with the first-generation filter.  These included a draft crisis communication plan related to the deaths, sales communications, and an email from a sales representative including an unflattering characterization of the company’s response to the deaths.  The court held that the evidence was “irrelevant and inadmissible propensity evidence,” id. at *4, explaining:

[The defendant] stopped selling the [first-generation filter] after it introduced the [second-generation filter], so [the defendant’s] communications and warnings surrounding the [earlier] filter have no bearing on whether [the defendant], years later, provided adequate warnings for a completely different filter with its own unique design and complications.  The [challenged materials] are an impermissible attempt to establish a propensity by [the defendant] to downplay complications with all of its filters, without actually establishing that the [second-generation] filter . . . was accompanied by an inadequate warning.

Id.  Nor would Rule 403 permit introduction of the evidence to illuminate the second-generation filter’s design history – this could be established in a less-prejudicial fashion.  Banks held that the plaintiff could admit evidence of the first-generation filter’s “complications, testing, and design to the extent it helps to explain the” testing and design of the second-generation filter, but she could not mention the deaths or the materials generated in response.

We like Banks.  In our corner of the jurisprudential universe, we defend medical device manufacturers.  Our job would be easier if all plaintiffs were required to prove liability with reference to their own devices and without resorting to irrelevant past events and their atmospheric negative implications. 

We will talk to you next week, after a slightly-less-poufy bat mitzvah appearance.  In the meantime, stay safe out there.