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We tend to favor a “glass half full” outlook.  We are preternaturally sunshiny during our daily “how was your day” calls from the 86-year-old Drug and Device Law Dowager Countess.  (We have not mentioned, for example, that our aging dog has begun sleeping most of the day and barking most of the night, resulting in an exponential escalation of the coffee intake required for even marginal function.)  On a larger scale, while we have not been immune to sadness and frustration over choices lost during the past thirteen months, we have tried to concentrate on the continued health of everyone we love and on our ability to work from home – and to work at all – during a time of hardship for so many.

But we don’t discharge our obligation to the readers of this blog by Pollyanna-esque avoidance of bad decisions in favor of reporting only on the good.  In that vein, today’s decision has full complements of both.  Nolen v. C.R. Bard, Inc., et al., 2021 WL 1264539 (M.D. Tenn. Apr. 6, 2021) is an IVC (inferior vena cava) filter case.  The plaintiff suffered from deep vein thrombosis (“DVT”), a condition that increased the likelihood of a pulmonary embolism (a blood clot that travels to the lungs).  His physician implanted the defendant’s IVC filter to mitigate this risk.  Sometime after the implant surgery, the doctor died – much more on the implications of that in a moment.

Years passed, and the plaintiff had no symptoms suggesting that anything was wrong with the IVC filter.  Eventually, his cardiologist recommended testing to evaluate whether the filter should be removed.  He ordered a CT scan, which revealed that the filter had tilted and that some of its legs were protruding through the IVC.  The cardiologist attempted to remove the filter but did not succeed, and the filter remains implanted today.   The plaintiff’s suit alleged that he was at greater risk of future adverse events and that he will be required to undergo “recurrent, expensive imaging to detect any dangerous worsening of the situation.”  Nolen, 2021 WL 1264539 at *2.  He asserted the usual product liability claims, and the defendant moved for summary judgment.   For purposes of today’s post, we will concentrate on the court’s decisions on the punitive damages claim (good) and the failure-to-warn claim (very, very bad).

Failure to Warn

In Tennessee, like everywhere else, a plaintiff can prevail on a failure-to-warn claim only by proving both that the defendant did not provide adequate warnings and that the inadequate warning proximately caused his alleged injuries.  In a case involving a prescription medical device, in which the duty to warn is framed by the learned intermediary doctrine, Tennessee law provides that a plaintiff proves proximate causation by producing “evidence that the omitted warning would have altered the doctor’s actions and that the change in the doctor’s actions would have averted the [plaintiff’s] injury.”  Id. at *5 (internal punctuation and citation omitted).   Causation is an element of the claim, and the plaintiff has the burden of proving it – it is not the defendant’s burden to prove the absence of a causal link.  The inquiry on summary judgment, then, is whether a plaintiff has adduced any evidence that a different or stronger warning would have caused the doctor to change his behavior in a manner that would have prevented the plaintiff’s injury. In a “normal” case, that evidence comes from the doctor’s testimony.  In the absence of any such testimony, if the judge is applying the standard correctly, the defendant is entitled to summary judgment on the failure-to-warn claim.

But this was not a “normal” case.   As we mentioned, the plaintiff’s implanting physician was deceased, and he died without being deposed.  Tough luck for the plaintiff, right?  As we have discussed in previous posts, here and here, for example, there is a whole body of case law (including a case from Tennessee) holding that, in the absence of prescriber testimony, a plaintiff can’t prevail on a failure-to-warn claim because he can’t satisfy the causation element of the claim.  So, check and mate, right?

Nope.  The plaintiff’s expert opined that “no reasonable person” would have used the filter if the defendant had provided adequate warnings.   Now, proving causation is not subject to a “reasonable person” standard.  The correct standard, as the court itself articulated, is entirely subjective:  would a different warning have affected the plaintiff’s own doctor’s behavior.  But the court didn’t care.  It held,

Obviously, it would have been preferable to have [the implanter]’s own testimony regarding why he chose the filter that he did and what he would have done in response to more information.  However, [the] testimony about what a reasonable physician would have done is potentially persuasive evidence that [the doctor] would have acted differently.  There is, moreover, nothing in the record to suggest that [the doctor] . . . would depart from the ordinary concerns depicted by [the expert].”  Id. at *5.   The court concluded, “[The plaintiff’s] strategy,” in the face of the implanter’s death, “of recreating the options [the implanter] faced and setting forth evidence of how a reasonable physician would have reacted is an acceptable course of action and sufficient to defeat summary judgment in this instance.

Id. at *6.  Do we even have to tell you how much we hate this?  By allowing an expert’s “reasonable person” speculation to create a fact issue in the complete absence of record evidence, the court applied the incorrect standard and shifted the burden of proving the causation element of the failure-to-warn claim, all in one fell swoop.  We can hope only that judges facing similar cases are as incredulous as we are and that this absurd reasoning spreads no further.

Punitive Damages

But here’s the good part.   The defendant moved for summary judgment on the plaintiff’s punitive damages claim on basis of a “safe harbor” in Tennessee’s punitive damages statute, which bars awards of punitive damages for injuries caused by drugs and devices that were “manufactured and labeled in relevant and material respects in accordance with the terms of an approval or license” issued by FDA.  Id  at *7, citing Tenn. Code Ann. § 29-39-104(d)(1).  The filter was a Class II medical device, cleared for marketing through FDA’s § 510(k) process.  As most of you know, the 510(k) process does not involve the full premarket approval (“PMA”) process to which Class III devices are subject; instead, it clears devices for marketing when they are “substantially similar” to predicate devices.  The plaintiff argued that § 510(k) clearance of the filter did not constitute an “approval or license” issued by FDA.   This issue – the admissibility and weight of evidence that a Class II device was “cleared” – has huge implications for all of us who defend medical device manufacturers.  We most recently blogged about it here, in a post about a case that made our “Best of 2020” list.

And just as in that case, the Nolen court got it right, holding,

[I]t seems clear that authorization to market a product pursuant to the § 510(k) process is, in fact, a form of approval.  Indeed, as [the defendant] points out, the U.S. Supreme Court has referred to § 510(k) approval in its opinions.”  Id. at *8 (citations to Riegel and Buckman omitted).  The court underscored this conclusion with a careful discussion of statutory construction, emphasizing, “The only way that the General Assembly could have intended to use “approval” narrowly here would have been if that legislative body had specifically had the distinction between PMA and lesser forms of FDA review in mind.  But if the General Assembly was that far “into the weeds” of federal pharmaceutical law, why did it not more clearly indicate that it was drawing such a distinction?  Why did it not just say “premarket approval” or cite the relevant subsections as opposed to merely saying “approval” and citing generally to the [FDCA] as a whole?

Id. at *9.  The court concluded that “a defense to punitive damages . . . can be satisfied by establishing that the device at issue was “approved” by the FDA through the §510(k) process.”  Id. 

The defendant had one more hurdle to surmount, because the same statutory section that establishes a safe harbor for “approved devices” includes an exception stating that the defense does not apply to a device when the manufacturer withheld material information from the FDA at any time before the plaintiff’s injury.  The defendant argued that this provision was preempted by federal law because, under Buckman, policing of fraud on the FDA is reserved for the FDA.  The court held that the defendant was partly right:  under Sixth Circuit law, federal law preempts a court’s finding of fraud on the FDA; however, “a state statute [can] include a distinction based on wrongdoing before the FDA as long as it relie[s] solely on the FDA’s own finding of wrongdoing to determine whether the provision applie[s].”  Id., at *10 (emphasis in original).

In other words, “a provision like Tenn. Code Ann. § 29-39-104(d)(2) could permit punitive damages in a case arising out of an FDA-approved device based on the fact that the FDA itself made a determination that manufacturer withheld information, but the same provision could not allow punitive damages based solely on the court’s independent finding that such withholding had occurred.”  Id. (internal punctuation and citation omitted, emphasis in original).   Because the FDA had made no such determination before Nolen’s injury, the exception did not apply, the safe harbor did, and the court granted summary judgment for the defendant on the punitive damages claim.  And this holding is every bit as good as the failure-to-warn holding is bad.

As for us, we look forward with excitement to our second shot next week and, a couple weeks later, to hugging the Dowager Countess on Mothers’ Day.  The sun’ll come out tomorrow.  In the meantime, stay safe out there.