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The defendants in Mixson v. C.R. Bard, Inc., ___ F. Supp.3d ___, (N.D. Fla. Sept. 16, 2022) (“Mixson I”), and Mixson v. C.R. Bard, Inc., 2022 WL 7581737 (N.D. Fla. Sept. 23, 2022) (“Mixson II”), by no means won everything, but what they won was more important than what they didn’t, so we’re OK with the results.

Starting with the to-be-published Mixson I, this IVC filter case presented rather complex choice of law issues because the plaintiff implantee was in the military when the surgery in question occurred, and the army sent him to Texas for treatment, even though he was a Florida resident.  2022 WL 4364153, at *2. The defendant was based in Arizona, which also matters for some of the claims.

The defendant lost on the overall statute of limitations, with Mixson I deciding (under Florida choice of law rules) that plaintiff’s presence in Texas was involuntary, and therefore happenstance.  Id. at *2-3.  But for us, individual statute of limitations issues are fact-bound and state-specific, and thus tend not to be of great interest.  We can’t even tell from Mixson I what about the Texas statute would have barred any claims.

The rest of Mixson I is more useful.  Summary judgment was granted against plaintiff’s failure to warn claims for one of our favorite reasons – causation under the learned intermediary rule.  Here, Florida law was every bit as good as Texas law for the defendants.  Plaintiff failed to come up with any evidence that the implanting surgeon ever saw the purportedly inadequate warnings:

[The] implanting physician testified that he “can’t say for sure” if he read the filter’s instructions for use.  Though he said he’d “probably seen it,” he did not believe he had “read it cover to cover,” and he testified he had “probably not” read it before implanting [plaintiff’s] filter.

Id. at *4 (citation omitted).  This is the causation variant that we described here as “not quite physician failure to read,” since the pertinent testimony was in the nature of a failure to remember reading the relevant information rather than an absolute “never read it” from the implanter.  Such testimony requires plaintiffs to do more to avoid summary judgment on causation – and this plaintiff couldn’t come up with the necessary additional evidence.

Plaintiff did try, however, “point[ing] to the physician’s general conversations with [defendant’s] sales representatives.”  Id.  Not good enough:

[T]he passing reference to those conversations did not include specific discussions about the instructions for use, let alone explain why those conversations would impact the application of Florida’s basic proximate cause standards.

Id. (citation omitted).  Nor would application of Texas law have helped plaintiff.  Id. at *4 n.4 (“The outcome would be the same under Texas law.”) (citation omitted).

Since the learned intermediary rule applies to misrepresentation and fraud claims – and plaintiffs did not claim any personal reliance – those claims also failed on causation grounds.  Id.

The other interesting issue was punitive damages.  The defendants won again, on two different grounds depending on choice of law.  Mixson I did “not decide” which of Florida’s or Arizona’s law applied to punitive damages because defendants won either way.

Punitive damages failed under Florida’s “one bite” law – that only a single punitive damages award is allowed for the same alleged conduct.  “[P]unitive damages may not be awarded against a defendant in a civil action if that defendant establishes, before trial, that punitive damages have previously been awarded against that defendant in any state or federal court in any action alleging harm from the same act or single course of conduct.”  Fla. Stat. §768.73(2)(a).  Plaintiff tried to get around this by arguing that the prior award was “insufficient” – representing only a fraction of a percent of various measures of the defendants’ wealth.  Mixson I, 2022 WL 4364153, at *5.  But the raw amount of the prior award was not clearly insufficient, and the mere fact that defendants’ product “sales are ongoing” was “insufficient as a matter of law.”  Id.

Punitive damages also failed as a matter of law under Arizona’s compliance defense.

In Arizona, a manufacturer is not liable for punitive damages when “[t]he product alleged to have caused the harm was designed, manufactured, packaged, labeled, sold or represented in relevant and material respects according to the terms of an approval, conditional approval, clearance, license or similar determination of a government agency.”  It is undisputed here that the filter received FDA approval.

Id. (quoting Ariz. Rev. Stat. § 12-689(A)(1)).  Plaintiff’s response was puny.  First, since “clearance” was right there in the statute, arguments that clearance was not approval failed.  Id.  Second, no “retroactivity” argument could succeed because “any claim for punitive damages does not vest until suit is filed.”  Id.  Finally, warning letters issued after plaintiff’s implantation could not trigger a statutory exception.  Id.

Mixson II decided a series of motions in limine plaintiff had filed involving the testimony of a particular defense expert.  Of the 13 motions – several of which addressed issues more properly brought under Rule 702 − the defendants won 12½.  The expert was qualified to testify about possible effects on plaintiff’s “lifestyle,” nor was testimony about plaintiff’s modified “truck” and “use of concealed carry” unduly prejudicial.  2022 WL 7581737, at *1.  Alternative cause evidence (“lung problems”) was admissible.  Id.  The defense expert was also allowed to testify to the “possibility” that plaintiff’s prior fall, not a defect, caused any problems with the filter.  This testimony was not “too speculative” (defense witnesses need not meet the same certainty standards):

[R]elevance is a very low bar, requiring only that the evidence have “any tendency” to make a fact of consequence more probable.  Testimony that the fall was a potential cause − even if a remote possibility − is not irrelevant.  And testimony is not speculative just because it does not specify the level of probability.

Id. at *2 (citation omitted).  Another piece of case-specific testimony could not “confuse” the jury.  Id.  Nor could plaintiff preclude this defense expert” from describing IVC filters as “lifesaving” – because they are.  Any request for “an order precluding . . . discussi[on of] the filter’s lifesaving attributes or pulmonary embolism-stopping abilities . . . is denied.”  Id.

The defense expert could also offer unspecified “opinions about other IVC filters” because they are neither irrelevant nor confusing.  Id.  Along the same lines, the expert could also testify about the availability of “other treatment options” involving IVC filters.  Id. at *3.  He could also testify to the percentage “mortality rate had [plaintiff] not received an IVC filter.  Id.  Nor could plaintiffs exclude the expert’s testimony that, whatever his problems, plaintiff was “asymptomatic” since whether mere “anxiety” is a “symptom” was for the jury to decide.  Id.

Various other uninteresting motions in limine were also largely denied, id., but Mixson II saved the best for last – rejecting plaintiff’s attempt to bar the expert “from referencing the FDA 510(k) process – or the FDA generally.”  Id.  Not only was the witness qualified to offer these opinions, but “just because the 510k process does not certify safety and efficacy does not mean that the 510k process isn’t evidence of safety and efficacy.”  Id.

So while the defendants in the Mixson litigation did not win everything, we’re quite happy with what they did win.