As the federal litigation established for Pradaxa lawsuits began to pick up steam late last year, Boehringer Ingelheim Pharmaceuticals, the manufacturer of the controversial blood thinner, was trying to resolve yet another headache.  In October, the drug maker agreed to pay $95 million to settle charges with the U.S. Department of Justice that it illegally promoted four of its drugs.  While none of those drugs included Pradaxa, it turns out the settlement still had implications for the scores of Pradaxa bleeding lawsuits pending in federal litigation in Illinois.

Pradaxa Bleeding Lawsuits

Pradaxa is a blood thinner used to prevent strokes in people with atrial fibrillation, a heart rhythm disorder.  Approved by the U.S Food & Drug Administration (FDA) in October 2010, Pradaxa was named in 542 deaths and 3,781 side-effect reports made to the agency in 2011.  The drug was touted by Boehringer Ingelheim as an improvement over warfarin, a decades-old blood thinner.  But while both Pradaxa and warfarin can cause serious, internal bleeding in some patients, there is no readily-available antidote for Pradaxa bleeding, while hemorrhaging from warfarin can be stopped with vitamin K.  Earlier this year, an analysis published in the QuarterWatch Report from the Institute for Safe Medicine Practices (ISMP) found that Pradaxa bleeding is 5 times more likely to result in death compared to warfarin bleeding.

More than 170 Pradaxa bleeding claims are pending in a multidistrict litigation underway in U.S. District Court, Southern District of Illinois.  All of the Pradaxa lawsuits allege Boehringer Ingelheim sold the blood thinner despite knowing it could cause fatal bleeding in some patients, and failed to adequately warn that there was no readily-available antidote for Pradaxa bleeding. Judge David Herndon, who is overseeing the federal Pradaxa lawsuits, has expressed his intent to expedite the litigation, and has scheduled its first bellwether trial for September 2014.

Boehringer Ingelheim Whistleblower Lawsuit

The Boehringer Ingelheim whistleblower lawsuit was originally filed by a former company sales representative who accused the drug maker of promoting the use the use of Combivent and Atrovent, both used to treat pulmonary disease, at doses exceeding those covered by federal health care program.  The company was also accused of paying doctors kickbacks to use those medications, as well as Aggrenox, used in the prevention of strokes; and its blood pressure drug, Micardis.  According to a Bloomberg.com report, $78.4 million of the $95 million settlement was slated go to the federal government, with state Medicaid programs taking a $16.5 million share.  The whistleblower who originally filed the claim was to receive $17 million.

Among other things, Pradaxa lawsuits allege Boehringer Ingelheim improperly marketed the blood thinner.   As discovery in the federal Pradaxa lawsuits got underway, Plaintiffs requested documents and other information about any lawsuits involving similar promotional or marketing conduct, including the whistleblower lawsuit the company settled in October.    For its part, Boehringer Ingelheim sought a protective order from the court to prevent it from responding to the Plaintiffs’ requests, claiming, among other things, that they were not relevant to any pending Pradaxa bleeding lawsuit, and would subject the company to undue burden and expense.

In an Order issued in January, Judge Herndon turned down Boehringer Ingelheim’s request for a protective order, pointing out that Plaintiffs had clearly asserted allegations related to the way Pradaxa was marketed.  “Accordingly, discovery into issues related to the marketing of Pradaxa, whether there was off-label promotion, over-promotion, misleading promotion, and the like is clearly relevant,” he wrote.    However, he did find that the Plaintiffs’ requests were overly broad, and limited them to lawsuits filed during the year 1990 or later.

Injured by Pradaxa Bleeding?  Contact an Attorney Today.

If you took Pradaxa and experienced Pradaxa bleeding or other serious side effects, consider filing a lawsuit to seek compensation for your injuries, including medical expenses, lost wages, and more. To speak to an attorney about filing a Pradaxa lawsuit, please call (877) 779-1414 for a free and confidential case review.

Published March 11, 2013 by