Pradaxa Class Action Dismissed, Individual Failure to Warn to Proceed

A federal judge has dismissed class action allegations from a lawsuit filed against the makers of Pradaxa, but will allow the plaintiff to continue with individual claims for injuries allegedly caused by the drug makers’ failure to adequately warn about the risk of bleeding from side effects of Pradaxa.

In an Order (PDF) issued July 18, Chief District Judge David R. Herndon denied a motion filed by Boehringer Ingelheim to dismiss all counts in a Pradaxa lawsuit filed by Mark A. Jackson, of Louisiana.

Although Judge Herndon did dismiss the Pradaxa class action claims included in the complaint and some other counts related to the Louisiana Product Liability Act, the lawsuit will be permitted to move forward on claims for failure to warn and defects associated with the design and marketing of the controversial anticoagulant.

Jackson filed the complaint (PDF) in May 2012, alleging that he suffered a serious bleeding event in February 2012, after starting to take Pradaxa in 2010 at the direction of his doctor.

In addition to claims for damages associated with his own “severe and life altering injuries”, Jackson included allegations relating to a class action for Pradaxa, seeking to establish a medical monitoring program, among other damages.

In dismissing the class action claim, Judge Herndon said the allegations were deficient, but dismissed them without prejudice and said the plaintiff could amend the lawsuit and request class action status again later. However, he noted that given the nature of the case, it is “highly unlikely” that the requirements for a statewide class under the law of Louisiana would be met and that a nationwide class is likely unmanageable.

Pradaxa Litigation Continues to Grow

Judge Herndon is presiding over more than 1,100 Pradaxa injury lawsuits that have been filed in U.S. District Courts throughout the country, which are centralized for pretrial proceedings as part of an MDL, or Multi-District Litigation.

All of the individual Pradaxa cases involve similar allegations that plaintiffs suffered serious or fatal injuries when doctors were unable to reverse the blood thinning effects of Pradaxa, which has been heavily promoted as a superior alternative to Coumadin or warfarin.

Pradaxa (dabigatran) was introduced by Boehringer Ingelheim in October 2010, as the first member of a new class of anticoagulants promoted as a superior alternative to warfarin for stroke prevention, as it is easier to take and requires less medical monitoring.

Plaintiffs argue that Boehringer Ingelheim failed to adequately warn about the hemorrhage risk or disclose that there is no reversal agent for Pradaxa to allow doctors to stop bleeding events that may develop.

Warfarin, sold under the brand name Coumadin, has been the go-to anticoagulant for decades. While Pradaxa does require less monitoring, concerns have emerged about the lack of an effective reversal agent to stop the blood thinning effects of the medication.

Unlike warfarin, which can be quickly reversed with a dose of vitamin K and plasma, there is no available reversal agent for Pradaxa. While some studies have shown that the chances of bleeding may be about the same with the two drugs, evidence continues to emerge highlighting how Pradaxa bleeding problems may pose a more serious risk, since hemorrhages are typically harder to stop.

In the Pradaxa MDL, a small group of cases are being prepared for early trial dates, known as “bellwether” trials, which are scheduled to begin between August 2013 and February 2015. These trials are designed to help the parties gauge how juries are likely to respond to certain evidence and testimony that may be repeated throughout the litigation.

The preparation for these trials and any verdicts may influence potential Pradaxa settlement negotiations in a large number of cases. Starting next month, Judge Herndon has ordered the parties to meet with a mediator at least once a month to discuss settling cases.