Pradaxa Bleeding Warnings Not Enough to Get Cases Dismissed: Judge

A federal judge in Illinois has denied an attempt by Boehringer Ingelheim to get several Pradaxa lawsuits dismissed, finding that the prior warnings about the risk of fatal bleeds associated with the medication were not sufficient to overcome the allegations raised in the complaints.

While a panel of federal judges is considering whether to consolidate the Pradaxa litigation pending in U.S. District Courts throughout the country, individual cases continue to move forward in various courts.

At least 17 of the currently pending lawsuits over bleeding problems with Pradaxa are currently before U.S. District Judge David R. Herndon in the Southern District of Illinois, representing about half of the cases filed throughout the federal court system.

After refusing the stay the proceedings while the U.S. Judicial Panel on Multidistrict Litigation considers whether to transfer all cases to a Pradaxa MDL, Judge Herndon has also denied a motion to dismiss filed by Boehringer Ingelheim in several cases.

Pradaxa Warnings Insufficient to Overcome Lawsuits

Pradaxa (dabigitran) is an anticoagulant that was introduced by Boehringer Ingelheim in October 2010 for prevention of strokes in patients with atrial fibrillation. The medication was promoted as a superior alternative to warfarin, because it is easier to take and requires less monitoring. However, if bleeding problems develop on warfarin, patients can be given a reversal agent to quickly stop the bleeding, but no such antidote is available to stop Pradaxa bleeding.

In response to several early lawsuits filed, Boerhinger Ingelheim filed a Motion to Dismiss pursuant to Federal Rule 12(b)(g), claiming that the lawsuits failed to state a valid claim upon which they could be successful.

One of the central arguments raised by the drug maker was that the medication warning label contained information that side effects of Pradaxa may cause serious and sometimes fatal bleeding, arguing that the complaints should therefore be dismissed.

In an order (PDF) issued on July 25, which was filed in several cases, Judge Herndon denied this motion, pointing out that the failure to warn claims also allege that the drug maker did not adequately inform users or the medical community about the lack of a reversal agent and that there is an alleged increased risk of excessive or uncontrollable bleeding with Pradaxa. Therefore, Judge Herndon found that “including a warning about the risk of serious or fatal bleeding does not justify dismissal of plaintiff’s claims.”

Judge Herndon May Be Assigned to Preside Over Entire Pradaxa Litigation

The order denying Boehringer Ingelheim’s attempt to dismiss the lawsuits was entered the same week the U.S. Judicial Panel on Multidistrict Litigation (JPML) heard oral arguements over whether all complaints filed over bleeding problems in federal district courts throughout the country should be transferred to Judge Herndon in the Southern District of Illinois, or to a different venue.

In May 2012, plaintiff Vera Lee Sellers filed a motion to consolidate all Pradaxa litigation during pretrial proceedings as part of an MDL. Sellers and several other plaintiffs who filed supporting motions proposed that the Pradaxa MDL be assigned to Judge Herndon, as he is already proceeding over most of cases pending in the country.

In a June response filed by Boehringer Ingelheim, the drug maker agreed to MDL centralization, but disagreed about the most appropriate venue. The primary argument raised against assigning the cases to Judge Herndon was the existing docket of Yaz lawsuits and Yasmin lawsuits currently pending in his court. However, the drug maker also suggested that plaintiffs’ attorneys had selectively filed a number of cases in that district and pushed those cases forward in an attempt to pursuade the U.S. JPML to transfer the litigation to Judge Herndon.

It is widely expected that the an order will be issued in the next few weeks establishing an MDL for the Pradaxa lawsuits, and determining where the litigation will be transferred.