We are going to Peoria next week. On an airplane. Ordinarily, this would not be newsworthy, but we are irrationally excited to be taking this step toward normalcy. We have long comforted apprehensive young lawyers by assuring them that any event provoking fear would soon recede into the past tense. The last year did not lend itself to that advice, and we are overjoyed and grateful to be looking backward at it.
Perhaps this mood contributed to our pleasure when we read today’s case. But we think Johnson v. C.R. Bard Inc., 2021 U.S. Dist. LEXIS 97665 (W.D. Wisc. May 24, 2021) would have made us happy in any event. Johnson is a decision on motions in limine in a remanded IVC (inferior vena cava) filter case. Both sides filed motions, most of which will sound familiar to anyone working in the mass tort space, and many of the holdings are really good, with some nice rhetoric to boot. Here are some highlights:
- Motion to Exclude Evidence of Reports of Deaths Associated with a Different Filter and Evidence of Marketing, Communications, and “Bad Acts” Related to That Filter
The defendants moved to exclude evidence related to reports that their earlier first-generation filter (this case involved the fifth-generation filter) allegedly caused death by migrating to patients’ hearts. The defendants argued that the plaintiff was not implanted with the implicated filter and that her filter had not migrated to her heart or to any other organ, making any reference to the earlier filter “both irrelevant and highly prejudicial.” Johnson, 2021 U.S. Dist. LEXIS 97665 at *4. The plaintiffs countered that the implicated filter was “the first in a series of [the defendant’s] filters that failed in ‘substantially similar’ migrations.” Id. (Under Wisconsin law, a court may admit evidence of “other accidents” but only if the accident occurred under ‘substantially similar’ circumstances.) Citing a string of cases holding that reports of deaths caused by migration of the earlier filter were not ‘substantially similar’ to claims of non-fatal fracture of later generations of filters, the court “likewise concluded” that the alleged migration deaths and the plaintiff’s alleged injuries “did not occur under substantially similar circumstances. As such, “any marginal relevance would be outweighed by the danger of unfair prejudice to defendants,” and the court denied the motion unless the defendants opened the door by disputing notice of the potential for the plaintiff’s filter to migrate.
The defendants filed a related motion to exclude “irrelevant and prejudicial” evidence of marketing, communications, and other purported ‘bad acts’ responding to deaths allegedly involving the earlier filter. The court concluded, “Having decided that [the earlier] deaths are not substantially similar to the incident in the present case, the court will not admit efforts to explain them away, however ham-handed the attempt, given the prejudicial confusion that would likely engender.” Id. at *8-9. We love “ham-handed.” Even more, like everyone who represents medical device manufacturers with long histories of marketed products, we love this result.
- Motion to Exclude References to Other Lawsuits and Trials
The defendants moved to exclude evidence of other lawsuits involving its filters, along with evidence that witnesses had testified in multiple cases. The plaintiff objected, arguing that this evidence would be relevant to show that [the] defendants knew or should have known about the risks associated with their filter “and to explore the credibility of witnesses by using their prior statements.” Id. at *9-10. The court held, “Plaintiff’s argument is not just disingenuous but bolsters defendants’ motion. . . . The mere existence of other related lawsuits, including ones in which no judgment was entered against defendants, has minimal if any probative value as to the foreseeable risk of harm posed by the . . . filter, although the risk of unfair prejudice is great.” Id. at *10. Moreover, the court held, the parties could explore witnesses’ credibility by making general references to their “prior testimony,” without mentioning specific prior lawsuits.
- Motion to Exclude Testimony Related to Damages During the Liability Phase of Trial
Earlier, the magistrate judge had bifurcated the trial into liability and damages phases. The defendants moved to preclude the plaintiff from introducing evidence about her alleged damages during the liability phase. The court held, “Although seemingly unnecessary given [the magistrate’s] earlier ruling, defendant’s motion is perhaps wise, as plaintiff’s opposition indicates that she believes that the bifurcation extends only to the issue of punitive damages.” Motion granted.
- Motion to Preclude Any Suggestion that the Defendant’s Filter Saved the Plaintiff’s Life or that the Filter Was a “Lifesaving Device”
The plaintiff moved to preclude the defendants from arguing that the filter was a “lifesaving device,” because she was implanted with the defendant’s filter “as a precaution,” and there was no evidence that the filter ever caught a blood clot. The defendants countered that they “should be able to reference the . . . [filter’s] general ability to save lives to contextualize the product and to establish the medical benefits of the filter, as well as to introduce evidence of [the plaintiff’s] medical history and the reason the filter was implanted.” Id. at *23. The court agreed, holding, “. . . [D]efendants’ proposed evidence is probative and is not outweighed by unfair prejudice or other considerations. . . . [E]vidence is not irrelevant and unduly prejudicial merely because it conflicts with one party’s side of the story.” Id. at *23-24 (internal punctuation and citation omitted). Motion denied.
In a related motion, the plaintiff moved to preclude the defendants from introducing evidence that their filter “save[d] lives or provided a clinical benefit.” The defendants countered that they should be permitted to reference the filter’s “ability to save lives to contextualize the product and to establish the medical benefits of the filter.” Id. at *39. The court sided with the defendant, holding the defendants should be permitted to respond the plaintiff’s “design defect” and “inadequate warnings” arguments with evidence of the filter’s medical benefits. The court went on to comment that the plaintiff had not demonstrated that the probative value of the evidence was outweighed by unfair prejudice, and that the alleged weakness of the “medical benefit” evidence went to the evidence’s weight and not to its admissibility.
- Motion to Preclude Medical Witnesses’ Anecdotal Testimony
The plaintiff moved to exclude anecdotal testimony by medical witnesses “about their experience with patients who have died of pulmonary embolism,” the condition the filter is designed to prevent. The court denied what it characterized as “another vague motion,” holding that, “since an issue in the case [was] whether the [filter] was ‘unreasonably dangerous,’ the benefit of the filter,” along with “the clinical experience of physicians or experts of patients dying of pulmonary embolisms,” were “directly relevant to this issue.” Id. at *25.
- Motion to Preclude References to Plaintiffs’ Experts’ Testimony in Cases Against Other Filter Manufacturers
The plaintiff argued that “any reference to the number of times an expert [had] testified in cases against other medical device manufacturers” was irrelevant. The court disagreed, holding that the information might be relevant to the bias of the plaintiff’s experts.
- Motion to Preclude Reference to Fault or Negligence of Non-Parties
The plaintiff moved to preclude the defendants from suggesting that non-parties, including plaintiff’s physicians, “had any responsibility” for the plaintiff’s injuries. The court denied the motion, holding that “the medical treatment that [the plaintiff] received [was] highly relevant to the jury’s determination of causation” and would not be excluded. Id. at *34-35. The court also held that Wisconsin law permitted the defendants to blame an “empty chair.”
- Motion to Preclude Evidence of the Surgeon General’s “Call to Action”
The plaintiff moved to exclude references to the Surgeon General’s 2008 “Call to Action to Prevent Deep Vein Thrombosis and Pulmonary Embolism,” arguing that the publication was hearsay and that it was irrelevant and prejudicial. Guided by earlier decisions, the court held that the document was not hearsay, because it fell within the “public records” exception to the hearsay rule. Moreover, the publication was “relevant to the plaintiff’s claim that the filter was not reasonably safe, which necessarily involve[d] a risk-benefit analysis.” Id. at *41.
- Motion to Preclude Reference to Plaintiff’s Surgical Consent Form
Finally, the plaintiff argued that any probative value of her signed surgical consent form was outweighed by unfair prejudice, since the judge had held, in an earlier summary judgment decision, that the learned intermediary doctrine governed the warnings analysis and rendered irrelevant the question of what warnings the defendants had provided to the plaintiff herself. The judge (who called it “refreshing” that the plaintiff referenced the summary judgment order) held that the consent form was relevant to what the plaintiff’s doctors knew about the risks of the filter, “which, at least indirectly, [spoke] to the sufficiency of the warning provided to the physician and . . . to the physician’s understanding of [those] risks.” Id. at *42-43.
There are other rulings, and not all fall into the “win” column for the defendants. Notably, identifying a split of authority, the court reserved its rulings on the admissibility of evidence that the FDA cleared the filter for marketing through its 510(k) process and that there were no FDA enforcement actions against the defendants. But there are nuggets of victory even in some of the ostensible defeats. For example, though the judge precluded the defendants from arguing that they couldn’t issue warning letters without the FDA’s consent (the defendants did not contest this), he refused to preclude them from presenting evidence that warnings about failure rates and increased risks could not be based only on anecdotal medical device reports (“MDR”) or on data from the FDA Manufacturer and User Facility Device Experience (“MAUDE”) database that collects these reports. The opinion is carefully reasoned throughout, and we love its unapologetic betrayal of the judge’s impatience with the plaintiff’s lawyers and of his determination to shield the jury from ubiquitous mass-tort-plaintiff tactics.
We will let you know if we hear more about this trial. Meanwhile, we haven’t worn “work shoes” in fifteen months, and we need to go find them for Peoria. Stay safe out there.