We have blogged before about the Mirena IUD litigation. Cases alleging injuries from device migration and uterine perforation were centralized in an MDL in the Southern District of New York, but, as we reported here, summary judgment was granted for the defendants in all of those cases when Daubert motions disposed of the plaintiffs’ causation experts. There is another group of Mirena plaintiffs, this time alleging that Mirena caused them to develop idiopathic intracranial hypertension (“IIH”), a serious brain disorder marked by increased pressure in the brain and central nervous system.
Exactly one published study has ever linked Mirena to IIH. The lead author was Mahyar Etminan, Pharm. D. – much more about him in a minute. You can read the Etminan article here. The Etminan article reported the results of two analyses: an epidemiological study and an analysis of adverse events reported in the FAERs database. The epidemiological study – that is to say, the unbiased statistics – did not demonstrate an increased risk of IIH associated with Mirena use when compared to combined oral contraceptives. But the article reported that the FAERs analysis demonstrated a higher-than-expected proportion of IIH reports with Mirena as compared to all other products in the FAERS database. (We’ve devoted an entire post (and cheat sheet) to why adverse event reporting doesn’t, and can’t, demonstrate causation.)
The Etminan article was published in 2015 and included a standard “no conflict of interest” statement. In the ensuing months, Mirena IIH plaintiffs in a half-dozen district courts disclosed their experts. Among them was none other than Mahyar Etminan, who, it turns out, had been on plaintiffs’ payroll all along in a blatant conflict of interest not disclosed in his article. Etminan, along with three other causation experts, cherry-picked the results of the FAERs analysis to allege a causal relationship between Mirena and IIH but never dealt with the conflicting epidemiological data from the same article.
And it gets even better. In December 2016, Etminan executed an affidavit, which you can see here. In it, Etminan explained that the methodology of the FAERs analysis was flawed and did not support its conclusion. Specifically, in comparing the proportion of IIH reports among Mirena users with the proportion among non-users in his FAERs analysis, Etminan failed to limit the comparator groups to women of reproductive age. Because women of reproductive age have a higher background incidence of IIH than other age groups, failing to limit the comparator groups to these women introduced a bias against the Mirena group. When the analysis was re-done with the correct comparator groups, the affidavit explains, the results did not support a claim that Mirena increases the risk of IIH.
And so Etminan, the source of the only published study claiming that Mirena causes IIH, publicly renounced his published conclusions. (Earlier, when the flaws in the FAERs analysis came to light, Etminan withdrew from the seven cases in which he’d been named as an expert.) We don’t know that we have ever seen anything like this in all of our days litigating mass torts. And we love watching the collapse of a house of cards erected on a foundation of paid (and undisclosed) advocacy.
But the story isn’t over yet. None of plaintiffs’ other causation experts – all of whom also relied on Etminan’s published FAERs analysis – has yet withdrawn. And, just days ago, IIH cases were centralized in an MDL in the Southern District of New York. (Plaintiffs had sought such an MDL in 2014, but the JPML rejected that request.) Regular blog readers are familiar with our views of many MDL plaintiffs and their lawyers, spawned during countless hours fighting hordes of meritless claims that MDL judges allow to remain pending. By rights, with no evidence of causation, plaintiffs should be out of court. And, certainly, some threshold determination of merit should precede the formation of an MDL. But mass torts exist for the masses, who queue up for settlement handouts that don’t depend on meritorious claims. Can the new IIH MDL proceed very far down the litigation path when the plaintiffs’ causation claim has been debunked by its primary supporter? Back in November, we learned never to say never. So stay tuned.