In re Pradaxa (Dabigatran Etexilate) Products Liability Litigation Lawsuit

In re Pradaxa (Dabigatran Etexilate) Products Liability Litigation

Pradaxa (dabigatran etexilate) is an oral anticoagulant made by Boehringer Ingelheim and the first of the direct thrombin inhibitors. It is used to prevent stroke in patients with nonvalvular atrial fibrillation, to treat and prevent deep vein thrombosis and pulmonary embolism, and to prevent clots after major hip or knee surgery. A defining commercial feature was that, unlike warfarin, it did not require routine monitoring by blood tests. The European Medicines Agency first authorized the drug in 2008, and the U.S. Food and Drug Administration approved it in October 2010 for stroke prevention in nonvalvular atrial fibrillation, after an advisory committee had recommended approval. At the time, no specific antidote existed to reverse dabigatran's anticoagulant effect — a gap later filled by idarucizumab, which received FDA approval in 2015.

The alleged harm

Bleeding is the principal adverse effect of dabigatran, and in the pivotal trial data gastrointestinal bleeding occurred at a meaningfully higher rate than with warfarin. The products liability claims alleged that Pradaxa caused severe — and, as the case caption reflects, "unusual" — bleeding events in patients, particularly elderly patients. The dispute took on a regulatory dimension in 2014, when a series of press investigations accused the privately held Boehringer Ingelheim group of withholding critical information about the need for monitoring to protect patients from severe bleeding. Review of internal company communications by the FDA and the European Medicines Agency reportedly revealed that Boehringer's own researchers had found evidence that serum levels of dabigatran vary widely between patients — data that conflicted with the drug's extensive marketing as a monitor-free anticoagulant.

The litigation: MDL No. 2385, Southern District of Illinois

The Pradaxa claims filed in U.S. federal courts were centralized in 2012. The JPML centralization order is dated August 8, 2012 (reported at 883 F. Supp. 2d 1355), and the consolidated actions were docketed as MDL No. 2385 in the United States District Court for the Southern District of Illinois, under master docket 3:12-md-02385-DRH-SCW, and assigned to Chief Judge David R. Herndon. In the consolidated docket, the common questions — the drug's bleeding profile, the adequacy of warnings to patients and prescribers, and the no-monitoring marketing claim — were addressed through coordinated pretrial proceedings while individual injury claims were held for case-by-case resolution.

While the MDL proceeded, the scientific record continued to develop. In May 2014 the FDA reported the results of a large comparative study of more than 130,000 Medicare patients, concluding that dabigatran was associated with a lower risk of overall mortality, ischemic stroke, and intracranial bleeding than warfarin, with more gastrointestinal bleeding and a similar heart-attack risk, and reiterating that the drug's overall risk–benefit ratio remained favorable. In July 2014 the press investigations into the monitoring data added further pressure on the pending claims.

Outcome

In May 2014, Boehringer Ingelheim and the plaintiffs announced a settlement covering roughly 3,900 claimants. The MDL was wound down thereafter; the docket is recorded as terminated, with the litigation resolved in 2014.