Federal Judge Orders $931,500 Fine for Failure to Produce Pradaxa Files

The manufacturer of Pradaxa has been order to pay a fine of almost $1 million. The company had Pradaxa sales of more than $1 billion in 2012.

The manufacturer of Pradaxa has been ordered to pay a fine of almost $1 million. The company had Pradaxa sales of more than $1 billion in 2012.

A federal judge has ordered Boehringer Ingelheim, manufacturer of the blood-thinning drug, Pradaxa, to pay a $931,500 fine for its failure to preserve or produce important documents sought by patients and their families who are suing the company.

The number of consolidated federal Pradaxa lawsuits pending against the German pharmaceutical has grown to 1,883 cases, according to the December report of the Judicial Panel for Multidistrict Litigation. That is an increase from 1,748 a month ago. The first federal case is set for a jury trial in August 2014.

U.S. District Judge David Herndon, who is overseeing the multidistrict litigation in the Southern District of Illinois, ordered the fine earlier this month. The judge said in his ruling that Boehringer Ingelheim had committed “egregious” wrongs, that its file preservation system was a “gross inadequacy,” that the company had acted “in bad faith,” and that company representatives had made “misrepresentations” about the requested documents.

Plaintiffs are seeking the documents to prove their contention that Boehringer Ingelheim knew about the life-threatening dangers of Pradaxa use when they placed the anticoagulant on the market in 2010. Pradaxa (dabigatran etexilate) was approved by the FDA in October 2010 for use in the U.S. as an alternative to the blood thinner, warfarin. It is prescribed for people with atrial fibrillation (irregular heartbeat) to reduce the risk of blood clots and strokes.

However, there is no antidote to counteract Pradaxa’s anti-coagulating effect. When a Pradaxa patient experiences internal bleeding, such as gastrointestinal bleeding or a cerebral hemorrhage, due to injury or disease, doctors may be unable to stop the bleeding. Thousands of Pradaxa patients have experienced severe bleeding and more than 1,100 Pradaxa patients in the U.S. have died since the drug was made available.

The FDA received 6,981 serious adverse event reports related to Pradaxa during 2011 and 2012, including a total of 1,124 deaths during the two-year period. The FDA receives more adverse event reports about Pradaxa than about any other prescription drug.

In addition to the almost 2,000 federal lawsuits, lawsuits are pending in state courts in California, Illinois, Connecticut and Delaware. Plaintiffs contend that Boehringer Ingelheim failed to warn doctors and prospective patients about the lack of an antidote and the possibility that the drug’s anti-clotting effects could not be reversed in the event of internal bleeding related to an injury or illness.

The nearly $1 million fine Boehringer has been ordered to pay is small compared to the multi-million-dollar award a jury could award if it was convinced by the evidence that Boehringer knew about the life-threatening risks of Pradaxa use when it put the drug on the market.

Boehringer Ingelheim had Pradaxa sales of $829 million in 2011 and more than $1 billion in 2012.


For more information about Pradaxa, including information about your legal rights if you or a loved one in Oklahoma have experienced severe bleeding after using Pradaxa, see our webpage: “Pradaxa Use Can Lead to Severe, Irreversible, Sometimes Fatal Bleeding.”

Or contact the Hasbrook & Hasbrook law firm for a free consultation. Contact us by telephone (866-416-4737), email (cth@hasbrooklaw.com) or by using our Contact Form.