New Pradaxa Lawsuits To Be Pursued After Settlement Outside MDL

Although Boehringer Ingelheim agreed to pay more than $650 million last year to settle thousands of Pradaxa lawsuits, it appears that the drug maker will face a new round of cases alleging that users suffered severe and often fatal bleeding problems after using the controversial anticoagulant.

Pradaxa (dabigatran) is a member of a new generation of oral anticoagulants, which was introduced in October 2010 for prevention of strokes among patients with atrial fibrillation. However, the drug has been plagued by reports of complications involving uncontrollable bleeding, which lawsuits allege may have been prevented if the manufacturer had provided adequate warnings or identified an effective reversal agent before marketing the drug.

Following several years of centralized proceedings in a federal multidistrict litigation (MDL), Boehringer Ingelheim agreed to settle about 4,000 product liability lawsuits in May 2014, paying an average of about $150,000 per case. The deal was reached just as the first cases were set to go to trial, resolving essentially all cases pending at the time.

Last week, the U.S. District Judge David Herndon, who has presided over the federal MDL since August 2012, issued an order (PDF) to disband the Plaintiffs’ Steering Committee, agreeing that attorneys previously appointed to leadership roles in the litigation should be resolved of their duties and obligations, since they have no active cases pending outside of the global settlement.

The order comes as a growing number of new complaints have been filed in various courts in recent months by other attorneys, who have indicated that they intend to pursue a “second wave” of litigation outside of the MDL. The complaints raise similar allegations, claiming that Boehringer Ingelheim has continued to provide inadequate warnings about the risk of bleeding from Pradaxa side effects.

However, Judge Herndon has determined that plaintiffs in those post-settlment cases will not be entitled to receive the discovery obtained by the PSC or their work product in preparing earlier cases for trial.

Pradaxa Discovery and Documents in MDL

The U.S. Judicial Panel on Multidistrict Litigation established centralized proceedings in the federal court system for all Pradaxa cases filed in U.S. District Courts nationwide in August 2012, centralizing the litigation before Judge Herndon to oversee coordinated discovery and to avoid conflicting pretrial rulings from different judges.

As part of the coordinated proceedings, a group of attorneys were appointed to serve on a Plaintiffs’ Steering Committee (PSC), coordinating discovery, negotiating with Boehringer Ingelheim and taking other actions that benefited all plaintiffs in the litigation.

Following the conclusion of the May 2014 settlement, a motion (PDF) was filed by the PSC asking to be relieved its duties and obligations, since the law firms involved no longer have any individual cases in the MDL.

“The PSC recently has learned that there is a certain group of lawyers with a handful of post-settlement Pradaxa plaintiffs and additional Pradaxa claimants that have an interest in pursuing a second wave of litigation, although they have asserted an intention of not litigating those cases in this MDL,” wrote plaintiffs’ leadership attorneys in a brief submitted May 5.

Members of the PSC asked to be relieved of responsibility for managing and maintaining the Document Dispository, involving information obtained during the discovery phase of the litigation.

In a response (PDF) filed by attorneys for Boehringer Ingelheim on May 8, the drug maker argued that along with the dissolution of the PSC, all confidential work product and discovery should be returned or destroyed, indicating that the information will be preserved by Boehringer Ingelheim and reproduced on a case-by-case basis as needed.

Although some attorneys representing post-settlement Pradaxa plaintiffs argued that they should be entitled to receive the previously produced documents and information, Judge Herndon agreed with the drug maker and denied the request to transfer all defense document productions and PSC work product, indicating that the information will only be preserved for the benefit of cases originally brought in the MDL that are pending on appeal.

Anticoagulant Bleeding Lawsuits

The second wave of Pradaxa litigation is being pursued at the state court level, coming as a number of similar Xarelto lawsuits are also being pursued on behalf of individuals who suffered uncontrollable bleeding after using that similar blood thinner.

Pradaxa was the first member of a new class of novel oral anticoagulants introduced in the United States, approved in late 2010 for prevention of strokes among patients with atrial fibrillation. The medication quickly became a blockbuster drug, and has been followed by the introduction of Xarelto and Eliquis, in 2011 and 2012 respectively.

All of the novel anticoagulants have been promoted as superior alternatives to warfarin, which has been the go-to blood thinner for prevention of strokes among atrial fibrillation patients for decades. Amid aggressive marketing that suggested the drugs are easier to use and just as effective, combined sales of the new-generation drugs have grown to more than $2 billion a year. However, concerns have emerged about the risk of severe bleeding problems with Pradaxa, Xarelto and Eliquis.

While all blood thinners carry a risk of bleeding, as the medications are designed to prevent clotting, which can make bleeds difficult to control, the effects of warfarin can be quickly reversed with the use of vitamin K and fresh frozen plasma in the event. However, there is no similar antidote currently available for Pradaxa, Xarelto or Eliquis, causing many doctors to report incidents of severe and uncontrollable bleeding among users of the newer drugs.

When Pradaxa was first released it quickly became associated with a high number of adverse event reports to the FDA and hundreds of bleeding deaths in the U.S. alone.

As concerns about the safety of Pradaxa mounted, Xarelto has grown to become the most widely used of the new-generation blood thinners. However, similar reports of Xarelto bleeding problems have surfaced, with users experiencing uncontrollable gastrointestinal hemorrhaging and death.

Bayer Healthcare and Johnson & Johnson’s Janssen subsidiary now face a growing number of product liability lawsuits over side effects of Xarelto, raising similar claims that the drug makers failed to adequately explore all potential reversal agents. Many plaintiffs also claim that Xarelto should be removed from the market until a safe and effective antidote for bleeding problems is identified.

The makers of Pradaxa, Xarelto and Eliquis are now racing to release a reversal agent to stop bleeding events for their drugs, knowing that the first to do so could gain an edge on its competitors.