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We have seen a few decisions on discovery issues out of the In re Pradaxa MDL.  By and large, they have been pretty bad.  Sanctions of almost $1 million and other “remedies yet to be addressed” bad.  The latest decision on a Pradaxa discovery dispute is not so bad and, important to us in the middle of a hectic week of litigation and DRI drinking, is not too long.

We try not to write on decisions just because they come from a litigation we have written about before or because they are short. When it comes to discovery decisions, we try not to write on them at all, unless there is an interesting issue or we are incensed by the burden imposed on defendants—that is, the party that did not initiate litigation.  The decision in In re Pradaxa (Dabigatran Etexilate) Prods. Liab. Litig., MDL No. 2385, 3:12-md-02385-DRH-SCW, 2014 U.S. Dist. LEXIS 62664 (S.D. Ill. May 1, 2014), falls in the former category.  It is interesting to us because plaintiffs wanted access to on-going scientific research before it was done or, failing that, in time to incorporate it into expert reports.  Scientific research sponsored by the manufacturer, particularly after the onset of litigation always faces a catch-22 from plaintiff’s perspective. If aspects of the research support the defendant’s position in litigation, then the plaintiff can say it was litigation-driven pseudo-science that should be disregarded.  If aspects of the research support the plaintiff’s position in litigation, then “defendant’s own research shows” what plaintiff contends otherwise.  If this all happens for a drug that is still on the market when the litigation is on-going, then some other dynamics also apply.  Plaintiffs will say the defendant desperately wants to keep the drug on the market and would skew the science to make it so.  The defendant will say the plaintiffs would skew the science, if possible, to get the drug off the market and improve their chances in litigation. Pradaxa is on the market. Research sponsored by defendants has been on-going since litigation began.  And, apparently, plaintiffs may have the ability to influence that research.

Without delving too deep—the opinion certainly does not—we can see that the pending “re-examination of the RE-LY study” at issue in the order relates to a study the results of which were first published in the New England Journal of Medicine in 2009 and have been the subject of a fair amount of medical literature since.  It makes sense that a re-analysis could matter in the litigation. It also makes sense, from plaintiff’s perspective, that they wanted to see data from the re-analysis in “real time.” The court had rejected that request a few months ago on the grounds that such access “would hinder the scientific integrity of the re-examination process.”  Id. at *2.  Since then, the defendant had reported on multiple occasions that the final results of the re-analysis were taking longer than anticipated.  With expert report deadlines approaching, the plaintiffs filed a motion seeking a range of “sanctions” and schedule adjustments due to defendant’s alleged litigation tactic of trying to get plaintiffs’ expert reports “to reveal missed bleeding events allegedly uncovered by the [plaintiffs] before the defendants reveal the results of their re-examination.”  Id. at **3-4.  Plaintiffs also contended that the re-analysis itself was “nothing more than a litigation tool and that results would be forthcoming at a time that was advantageous for the defendants.”  Id. at *5.  In turn, the defendants contended plaintiffs wanted to withhold information about fatal bleeding events from the original study—something plaintiffs’ counsel had “taunt[ed] defendants’ witnesses” about—until after the re-analysis was finalized to be able to attack its integrity. Id. at **5-6.  Juicy stuff.

Rather than force the defendant to finish the re-analysis by a certain date or allow the real time access previously denied, the court essentially tweaked the schedule for expert discovery to provide for supplementation to account for the re-analysis when it becomes available. In so doing, the court urged respect for the scientific process while endorsing the role of litigation in skewing the regulatory process:

From the Court’s perspective, it is clear that the plaintiffs are holding onto evidence as a litigation strategy.  However, if they are right, it may well go a long way toward proving a much greater issue and ultimately assisting the regulators with invaluable information that they can use if they choose.  The Court still believes it is right, even though the plaintiffs continue to disagree with it, to avoid an argument that the scientists were inappropriately interfered with.  The scientists must be left to conduct their scientific business at their pace and in their own time.

Id. at *6.  We do not quite get how the scientific process should be independent of litigation but the regulatory process should not.  Ideally, the FDA’s regulation of drugs should be driven by an honest evaluation of scientific information.  The suggestion that litigation have a say in how a specific drug is regulated is troubling to us.

We are also troubled by the court’s linking “the litigation strategy that these defendant companies have pursued in the past” with doubt about whether the timing of the finalization of the re-analysis was litigation-driven. Id. at **6-7.  Linkages like that often seem to have a way of foreshadowing future rulings.