Various plaintiff-side consortia have taken it into their heads to sue every manufacturer of so-called “novel oral anticoagulants” because these products, gasp, can cause serious, and sometime fatal, bleeding incidents. Fortunately, on the whole the plaintiffs haven’t done so well with these cases – losing almost all the trials – because jurors can be taught the dictionary definition of “anticoagulant.” Thus, it was initially disturbing to us to read that a Connecticut state court recently upheld a plaintiff’s verdict in a Pradaxa case, Roberto v. Boehringer Ingelheim Pharmaceuticals, Inc., No. CPL-HHD CV16-6068484S, slip op. (Conn. Super. Sept. 11, 2019) (yeah, we sent it to Westlaw, but it hasn’t shown up there yet).

Then we read it.

Sure, the plaintiff scraped by with somewhat oddball verdict in a somewhat oddball case – the plaintiff had a history of gastroesophageal reflux disease (“GERD”) − but on two major issues, preemption and punitive damages, the plaintiff didn’t get what he wanted at all. Thus, here’s another dictionary definition:

Pyrrhic victory n. A victory that is offset by staggering losses. [After Pyrrhus]

American Heritage College Dictionary, at 1115 (3d ed. 2000).

On the merits of the underlying claim, plaintiff received a ridiculously high half million dollars on a warning claim that was almost certainly bogus. He tried to get around the learned intermediary rule with a self-serving (and uncorroborated) claim that:

while waiting at the doctor’s office, . . . he saw a pamphlet on [the drug] and asked a nurse about it. Ultimately, the plaintiff had a discussion with [the prescriber] and decided to change to Pradaxa.

Slip op. at 8. That didn’t succeed in ousting the rule altogether – since it is still a prescription drug – but it conveniently provided plaintiff a second bite at the causation apple:

[A]ccording to the evidence, if the plaintiff had known that there was an increased risk of bleeding for a patient with a history of GERD, he would not have asked to switch to Pradaxa. Although this testimony relied on the benefit of hindsight, the testimony was admissible and the jury was entitled to credit it.

Id.

The prescriber, of course knew all about the risks of bleeding – knowledge that usually precludes warning causation − but from his “general” (that is, “not specifically mention[ing] GERD”) description of his informed consent practices, “the jury could have reasonably inferred from it that [the prescriber] would have mentioned the increased bleed risks for patients with a history of GERD if the label had disclosed that risk.” Id. at 10-11. It was a “close call,” but there was “minimally sufficient evidence” to establish a basis for a jury to believe that a different warning could have made a difference.” Id. at 11. Significantly, plaintiff failed to prove the usual claim that we see advanced in this type of case:

In contrast, there is no similar testimony from the plaintiff that he would have rejected [the drug] if he learned that its label required blood monitoring. Thus, there is insufficient evidence to sustain the verdict on the theory that the absence of warnings about blood concentration and monitoring was a cause in fact of the plaintiff’s injury.

Id. at 12 n.5.

The plaintiff also supposedly proved medical causation – although we think the result in Roberto was simply wrong under Connecticut law. The bleed was caused by plaintiff’s GERD (specifically, by an ulcer) and there was no evidence that the drug caused the ulcer. The Court held that but for causation didn’t matter; that plaintiff could recover “by showing that [the drug], even if not the original cause of the bleed, made it more severe.” Id. at 14. Plaintiff had expert testimony that plaintiff “at least was less likely to develop” a bleed compared to some unstated “different anticoagulant” – the drug “[m]ade it worse, exacerbated it.” Id.

Roberto tellingly cited nothing to support this reasoning, and in fact the Connecticut Supreme Court has rejected just such “increased risk” causation testimony. We discussed in this post how that dumbed down approach to causation is not sufficient in product liability, where the product must actually cause the risk, and remains controversial even in “lost chance” medical malpractice cases where it originated. We cited Boone v. William W. Backus Hospital, 864 A.2d 1 (Conn. 2005), as one of the decisions refusing to permit mere “increased risk” causation in any circumstance. Boone held:

[The plaintiff] must show . . . that the decreased chance for successful treatment more likely than not resulted from the defendant’s negligence.” Thus, in order to satisfy the elements of a lost chance claim, the plaintiff must first prove that prior to the defendant’s alleged negligence, the decedent had a chance of survival of at least 51 percent. Once this threshold has been met, the plaintiff must then demonstrate that the decedent had a decreased chance for successful treatment and that this decreased chance more likely than not resulted from the defendant’s negligence. Accordingly, it is not sufficient for a lost chance plaintiff to prove merely that a defendant’s negligent conduct has deprived him or her of some chance; in Connecticut, such plaintiff must prove that the negligent conduct more likely than not affected the actual outcome.

Id. at 18 (citations and quotation marks omitted) (emphasis original). Plaintiff’s “at least was less likely” thus shouldn’t cut it in Connecticut. Roberto cites no testimony indicating that Boone’s more likely than not standard was satisfied, so we think the entire verdict should have fallen on causation grounds. We’re not even sure the court in Roberto realized it was being asked to allow a Boone-barred increased risk causation theory.

So through the first 15 pages of Roberto, we were not happy at all. Then we got to punitive damages.

The jury found that punitive damages were appropriate. Id. at 3. But under Connecticut law, the court decides how much to award. Id. at 18 (citing Conn. Gen. Stat. §52-240b). The court awarded the princely sum of one dollar, explaining that the jury had been hoodwinked, calling out the expert that did it, and finding no evidence to justify such damages.

[T]he court must state that it simply does not credit the testimony of Dr. Plunkett. . . . Although Plunkett was entitled to review company documents . . ., the court believes that Plunkett engaged in unreliable mind-reading in concluding that the company put sales over safety. The court views the company’s documents and emails very differently. . . . [T]t is entirely appropriate for employees of a for-profit company . . . to consider topics such as cost and sales. If a pharmaceutical company cannot make a profit selling a drug, the company would likely withdraw the drug, with all its attendant benefits, from the market.

Roberto, slip op. at 18-19 (footnote omitted). The court utterly rejected the opinions of plaintiff’s expert on this issue:

This case is not one in which a company, motivated by greed, proceeded to ignore safety standards, defy government regulations, or disregard scientific literature in order to put an unreasonably dangerous or socially worthless product on the market. On the contrary, all experts agreed that [the drug] provides significant benefits in reducing the risk of a stroke, with all its devastating consequences. Fortunately, the plaintiff himself achieved this benefit and did not suffer a stroke.

Id. at 20 (footnote omitted). That “[t]he FDA has never recalled the product and instead has approved the label some eighteen times . . . without more . . . should preclude an award of any significant punitive damages. Id. at 21. But there was more, and the court surveyed the evidence, concluding:

Unless the defendants are required to ignore all of these experts, articles, authorities, and examples, there is no basis for any significant punitive damages. Accordingly, the court awards [punitive damages] in the amount of $1.

Id. at 22 (citations omitted). Given this conclusion, it may have been more appropriate to grant judgment n.o.v. against the claim for punitive damages, but the $1 award is the functional equivalent – and the appellate standard of review is probably abuse of discretion.

And then we come to preemption. As already mentioned, plaintiff pursued two warning-related claims, the plaintiff-peculiar GERD claim on which the court found sufficient evidence to support the verdict, and the blood monitoring claim typically advanced by all plaintiffs, which failed. The preemption ruling in Roberto was similar.

First, “three days after the verdict,” Albrecht was decided, meaning that the excuse that preemption was for the “jury’s consideration” vanished. Id. at 23 n.16. Thus, the court had to decide the issue itself:

[T]he court views it as its obligation to decide the preemption issue in the first instance rather than merely pass it on to the appellate courts or have the parties waste resources taking an appeal that would result in a remand to this court to decide the very matter that the court can decide today.

Id.

In so doing, Roberto made a number if interesting preemption-related legal rulings. Preemption in prescription drug cases involves a “two-pronged” test, the first requiring the plaintiff to establish that prerequisites to use of the CBE regulation, such as “newly acquired information” were satisfied, and the second being the so-called “clear evidence” directly at issue in Albrecht.

Post-FDA approval preemption analysis proceeds in two stages. . . . “[I]f the plaintiff can point to the existence of “newly acquired information” to support a labeling change under the CBE regulation, the burden then shifts to the manufacturer to show by “clear evidence” that the FDA would not have approved the labeling change made on the basis of this newly acquired information.

Id. at 27-28 (quoting Utts v. Bristol-Myers Squibb Co., 251 F. Supp.3d 644, 661 (S.D.N.Y. 2017), aff’d, 919 F.3d 699 (2d Cir. 2019)). See Id. at 28 n.9 (discussing burden of proof issues and concluding “it is fair to expect the plaintiff to come forward with the newly acquired information in question”).

The court (correctly, we believe) viewed Albrecht as applying to all preemption questions presented by either prong. Thus whether “newly acquired information” existed was also a question of law. Id. at 29-30.

The phrase “newly acquired information” is the key component of the CBE regulation. . . . [I]f there is no newly acquired information, then the manufacturer is under no duty to change its label and related state failure to warn claims are preempted.

Id. at 25-26 (citations omitted).

Although the issues and analysis on the first prong of the preemption test, involving newly acquired information, are not identical to those involved in the second, clear evidence prong, it seems unlikely that the Supreme Court would hold that the first prong is triable to the jury while the second prong is not. Both prongs involve complicated legal analysis.

Id. at 30 (footnote omitted). The court also demurred on the supposed “presumption against preemption,” concluding that after Albrecht, it was “unclear whether the presumption applies in this situation,” particlarly since “the FDA contemplated that the CBE regulation would be used ‘sparingly.’” Id. at 31 (citation omitted).

Reviewing the case law, Roberto arrived at some conclusions concerning what could, and could not, be “newly acquired information”:

Information previously known to the manufacturer, but not submitted to the FDA, may constitute “newly acquired information,” provided that the information meets the other CBE requirements. And, as the regulation suggests, “[n]ewly acquired information” can include either new data or new analyses of previously submitted data. However, any claim that a drug label should be changed based solely on information previously submitted to the FDA is preempted because the CBE regulation cannot be used to make a label change based on such information.

Id. at 30-31 (citations and quotation marks omitted). Further, because the FDA does “not allow a change to labeling to add a warning in the absence of reasonable evidence of an association between the product and an adverse event,” the Agency “contemplate[s] that the CBE regulation would be used sparingly.” Id. at 32 (citation and quotation marks omitted).

Finally, the CBE regulation’s “newly acquired information” prerequisite was not predicated on a contemporaneous request for a label change:

First, the regulation itself does not require a specific request for a label change. . . . Second, one can assume that the FDA, as a public agency, will . . . request a label change if the circumstances warrant. Indeed, . . . the FDA has a statutory obligation to do so. Third, the defendants cannot be faulted if they exercise caution in submitting a study to the FDA even though they are not sure whether it merits a labeling change.

Id. at 54-55 (citations omitted).

As to the claims most Pradaxa plaintiffs bring – concerning some blood plasma concentrations and the monitoring of same – the court held that no “newly acquired information” existed to permit the manufacturer’s resort to the FDA’s CBE regulation, as of plaintiff’s January, 2014 claimed injury. Roberto, slip op. at 50. “The opinion goes through a plethora of Pradaxa-specific information, that anyone interested in the details can read, but:

In sum, after review of the numerous articles and reports identified by the parties in their briefs, the court concludes that there was no newly acquired information that would have allowed the defendants to make a label change on their own on the topics of Pradaxa blood concentration levels or blood monitoring. Accordingly, the court finds these claims preempted.

Id. at 34-50.

But as discussed at the beginning of this post, the plaintiff had a second warning claim specific to his situation – lack of a warning about greater bleed risks to GERD sufferers like himself – indeed, that GERD claim “was the only claim for which there was sufficient evidence to prove causation in fact.” Id. at 50. As to this claim, the timing of the defendant’s submission to the FDA was “unclear.” Id. at 55. Thus, “the court cannot conclude that the GERD information was previously submitted to the FDA.” Id. at 56. The second prong of preemption also was not satisfied. “[T]he defendants’ argument amounts to a second prong ‘clear evidence’ claim” that lacked either proof of what information the FDA received or a definitive FDA disapproval of a warning change. Id. at 56-57. Since it does not appear that the defendant asserted a “clear evidence” defense to plaintiff’s GERD claim, that claim survived preemption.

Thus, the favorable preemption holding in Roberto is applicable to the majority of Pradaxa plaintiffs asserting claims concerning blood concentration and monitoring (at least for injuries predating January, 2014). Only those few Pradaxa plaintiffs with GERD-related claims can make use of the second, adverse ruling. A Pyrrhic plaintiff’s victory indeed.

Finally, for those who are gluttons for punishment, Roberto rejected largely case-specific new trial arguments concerning non-FDA-approved drug dosages, misconduct by plaintiff’s counsel, and evidence of foreign GERD labeling. Id. at 57-62. The defense also lost a Connecticut-specific “phantom damages” argument concerning recovery of medical charges that were billed but then written off by the government. Id. at 62-65.