United States: Summary Judgment For All Pending Cases In The Mirena MDL

Last Updated: August 3 2016
Article by Eric Alexander

We often lament, in our curmudgeonly way, that plaintiffs in obviously lacking cases get chance after chance to keep going, all the while imposing costs and risks on the defendants and a burdens on court dockets.  Plaintiffs tend to get three strikes on complaints that fail to plead cognizable claims or cannot help but plead right into a clear defense.  Plaintiffs are sometimes allowed to offer extra experts after Daubert wipes out their first wave or two.  Summary judgment is denied on the pretense that a jury could find for the plaintiff based on tenuous and speculative liability or causation arguments.  The reality, particularly in cases where hundreds or thousands of plaintiffs sue over the same drug or device, is that the calculus of the number of pending cases, the time they have been pending, and the proximity to trial plays into the likelihood of large settlements.  Even where the manufacturer has good reason to believe that the cases against it should not succeed, the cost of pursuing them to the bitter end can weigh in favor of paying to settle cases.  So, when we see a drug or device manufacturer take a litigation to its end (or the end for one of the major fronts), we applaud its determination.

For the In re Mirena IUD Products Liability Litigation MDL, the litigation looks to be fairly short-lived as far as such litigations go.  In April 2013, the JPML consolidated cases because of the common issues of "the alleged risks of uterine perforation and migration associated with Mirena and the adequacy of the product's warning label."  In less than three years, the parties did fact discovery, selected bellwether cases, did expert discovery, and filed dueling Daubert motions.  We discussed the lengthy ruling on those motions here, noting that the court "was not afraid to shut down entire theories on which the plaintiffs based their claims."  All of the plaintiffs with pending cases after the Daubert decision apparently agreed that their cases required them to prove that the product can cause "secondary perforation"—definition discussed below—which was something the plaintiffs' experts could not support with admissible opinions.  The plaintiffs also agreed that the product liability law of each of their home jurisdictions generally required admissible expert evidence on general causation.  In opposing defendant's motion for summary judgment, plaintiffs offered two arguments:  1) the injury here makes general causation something that the jury can decide without supporting expert testimony from plaintiff despite the general requirement; and 2) a series of purported admissions from the product's label and elsewhere can establish general causation.  In rejecting both arguments, the court was up front that it was doing so "reluctantly, knowing that it will doom hundreds of cases," which showed as each proffered decision and statement was analyzed patiently. In re Mirena IUD Prods. Liab. Litig., Nos. 13-MD-2434 (CS), 13-MC-2434 (CS), 2016 U.S. Dist. LEXIS 99221, **67-68 (S.D.N.Y. July 28, 2016).  We, of course, have no such reluctance in seeing the decision as correct and the basis for bringing the cases as dubious from the start.

The product at issue is a combination drug-device approved for contraception with a label that always warned of perforation of the uterus or cervix.  Specifically, when the product was approved, it said "An IUD may perforate the uterus or cervix, most often during insertion although the perforation may not be detected until some time later" and, in the years leading up to the establishment of the MDL, it said "Perforation or penetration of the uterine wall or cervix may occur during insertion although the perforation may not be detected until some time later." Id. at *7.  In 2014, this was changed to "Perforation (total or partial, including penetration/embedment of Mirena in the uterine wall or cervix) may occur most often during insertion, although the perforation may not be detected until sometime later." Id. at **7-8.  Plaintiffs contended that there is a risk of "secondary perforation," where the product starts to move through tissue after insertion when the insertion procedure produced no injury, and that the labels—at least when they were prescribed the product—inadequately warned of that risk.  Those versed in product liability cases should see some immediate problems with plaintiffs' positions.  If what they claim happened to them was just a perforation that began or progressed after insertion, then the label always warned of that.  If what they claim happened to them was different than something set in motion by injuries sustained during the insertion process, then it would be hard to ever rule out that an injury during insertion progressed over time and was detected later.  In either case, it would be hard to see how plaintiffs would prove that a relevant different warning was required and would have changed anything a prescribing physician would have done or how plaintiffs would dispute that FDA would not have accepted such a different warning.  In other words, this looks like a very weak warnings claim.  The manufacturer, by contrast, took the simple position that there is no "secondary perforation"—rather, perforations always start with some injury during insertion—and there was never a need to say more about a non-existent risk.  The Daubert ruling held, in part, that plaintiffs' experts' opinions that there was a risk of "secondary perforation" were unreliable.  Unless plaintiffs could prove general causation for "secondary perforation" without admissible expert testimony, they would be unable to prove any claim.  Lack of proof of a risk means the warning cannot be inadequate and that an individual plaintiff's alleged injury cannot be linked to a risk of the product.  (Based upon the broader allegations suggested by the JPML order and the narrow issues presented in summary judgment, it must be that plaintiffs originally pursued other theories of liability but recognized that they were all dead ends.)

Plaintiffs' attempt to argue that they did not really need experts to establish general causation was hampered by the facts that they had named experts to opine on general causation and opposed Daubert by arguing that the jury needed expert testimony to understand the issues here. Id. at *20.  We will not belabor it, but the court walked through extensive authority that drug and medical device causation requires expert testimony because it is beyond the understanding of lay jurors and they should not be invited to speculate.  Thus, when plaintiffs offered the disingenuous claim that these were "simple soft-tissue cases that do not require experts for general causation," we would not have been surprised if the response had been the judicial equivalent of a laugh. Id. at **20-21.  Instead, the court reasoned that "an analysis of the anatomy and physiology of the uterus, the strength of its muscles, the types of injuries that could be caused by the Mirena insertion procedure, and whether and how such injuries can be detected with existing technology" would be "well beyond the common understanding of lay jurors," meaning that expert on general causation testimony would be required. Id. at **22-23.  Rather than rule that expert testimony on general causation would be required for all device cases under the law of every state, the court had "no serious doubt that all jurisdictions would treat this issue as one requiring expert testimony to prove causation." Id. at *24.

Because plaintiffs did not have expert testimony to prove causation, the court might have stopped there.  Instead, it devoted lots of ink to rejecting the argument that a series purported party admissions under 801(d)(2) can substitute for the required expert proof.  This logically has two parts:  1) "whether as a matter of substantive products liability law admissions can substitute for expert evidence of causation" and 2) whether the statements that plaintiffs offered were actually admissions on general causation for "secondary perforation."  Again, the court did not lay down a blanket rule that admissions could never suffice.  After walking through every case plaintiff cited with a level of detail we will not repeat—but would be worth a read if a similar issue comes up in your case—the court noted:  "None of these cases hold what Plaintiffs wish the Court to hold here:  that a defendant's admission can substitute for expert testimony on general causation." Id. at *40.  As such, the court avowed that it would not be the first to so hold, but it—again, consistent with its avowed reluctance—noted that any admission allowed to substitute for expert testimony would need to be "the clearest and most unambiguous admission that the product or device in question can cause the alleged injury." Id. at **41-42 & 44.  They would also need to satisfy the reliability requirements of Rule 702.

The statements here did not come close.  "The alleged admissions offered by Plaintiffs here do not suffice, because they are not clear or concrete or detailed enough either individually or collectively, to permit a jury to consider intelligently the existence, or not, of secondary perforation." Id. at *45.  Still, the court walked through each purported admission with far more patience than we will have in recounting them.  First, plaintiff said that the statement in another company's IUD's label that "Partial or total perforation of the uterus may occur at the time of or after [the product's] insertion" was somehow adopted by the manufacturer from the approval process.  But it was rejected, rather than adopted, by the proposal of different language for its own product and it did not acknowledge that secondary perforation occurs anyway.  Second, in what strikes us as supremely disingenuous, plaintiffs contended that the 2014 label was an admission because it suggested that some perforations could happen after insertion.  But it did not acknowledge that "secondary perforation," as plaintiffs defined it to get around always having an adequate warning, existed.  We will just quote the rest on this:

Plaintiffs argue that it should be up to the jury to assess the meaning of Defendants' statements, but the problem is that in the absence of expert testimony, the jury would have no scientific basis on which to do so, and would doing just what the requirement of expert testimony is designed to avoid: speculating about a complex medical process without any specialized information with which to make an intelligent decision as to whether it capable of causing Plaintiffs' injuries.

Id. at *52 (citations omitted).  Third, labeling language for another of the manufacturer's IUDs that was very similar to the 2014 label's language was also not an admission about "secondary perforation."  Fourth, language in a letter to health care providers in Canada that "Uterine perforation may occur with Mirena at the time of insertion or after the insertion with limited clinical symptoms" was not an admission of "secondary perforation"—and would have been hard to reconcile with plaintiffs' position that similar language in the U.S. label from 2008 on was inadequate.  Fifth, various emails discussing reports of late perforations did not adopt the position that "secondary perforations" occur.  Sixth, and perhaps closest, was a powerpoint presentation that had a bullet point saying "Migration into the abdomen (spontaneous perforation unrelated to insertion) can occur."  In context, however, it was not clear that this was describing plaintiffs' precise version of "secondary perforation" or that it was endorsing that it happens as opposed to that it had been reported. Id. at **62-63.  Last, plaintiffs pointed to two pages of testimony from the deposition of one company witness about a hypothetical situation where movement of the device was possible, but he was 99% sure that there would need to be injury with insertion to start the movement. Id. at *64.  So, that was not a pertinent admission either.  "With all of these alleged admissions, a jury would have to read between the lines to discern the speaker's intended meaning, with any scientific or other basis to sort out the ambiguities." Id. at *65.

With all that, plaintiffs had nothing to show they could carry their burden on general causation and summary judgment was appropriate as to about 1300 cases.  We cannot help but note that this is yet another in a series of plaintiff losses on dispositive motions in contraceptive cases.  If this is the best plaintiffs can do with this product, then we hope to hear about the state litigation coming to a similar conclusion soon.  Maybe the plaintiff bar's seemingly reflexive desire to gather up cases and sue over just about every new contraceptive to be approved will be suppressed at least somewhat going forward.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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