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Pradaxa Maker Settles With the United States Government and States for Over $600 Million

Filed May 28th, 2014 Cynthia Diaz-Shephard

Boehringer Ingelheim, the maker of the blood thinner, Pradaxa, just announced that it agreed to a comprehensive settlement of U.S. Pradaxa (dabigatran etexilate mesylate) litigation.

Boehringer Ingelheim announced the settlement resolves state and federal cases in the United States litigation regarding Pradaxa for a total of $650 million; the settlement will resolve about 4,000 claims. The drug maker also indicated that it expects that this proposed settlement will resolve most of the claims brought over Pradaxa.

Recently, Boehringer Ingelheim was concerned over how the release of internal research might impact sales of its popular blood thinner medication. According to a The New York Times report, employees at Boehringer Ingelheim allegedly pushed the study’s author to revise or suppress the research, according to recently unsealed legal documents. In fact, the federal Illinois judge overseeing thousands of lawsuits filed by Pradaxa patients and their families made the documents public. Lawsuits allegations included that the drug maker did not sufficiently warn about risks associated with Pradaxa.

Pradaxa received U.S. Food and Drug Administration (FDA) approval in 2010, bringing in more than $2 billion in sales in the United States to Boehringer, according to research firm, IMS Health. Since it was approved, Pradaxa has been prescribed to approximately 850,000 patients and has been tied to more than 1,000 deaths, according to The New York Times.

For about 50 years, the anticoagulant, Coumadin (warfarin), has been used in patients diagnosed with atrial fibrillation (AF), which is an irregularity of the heartbeat, and is also prescribed to people who are at increased risk for developing potentially fatal blood clots. Pradaxa is prescribed to reduce stroke and blood clots risks in patients who are diagnosed with non-valvular AF. Pradaxa inhibits thrombin, which, according to News-Medical, is the central coagulation activator in the body’s blood clotting system.

While both warfarin and Pradaxa may cause internal bleeding, antidotes are readily available for warfarin bleeds. Increasing Pradaxa bleeding lawsuits allege that the medication caused serious, uncontrollable bleeding side effects, including GI bleeding and cerebral hemorrhaging, for which no possible reversal or reversal agent exists. Also, not all patients, particularly older patients, metabolize Pradaxa in the same way. There are also fewer dosing options available for Pradaxa and there are no monitoring tests available for the drug in the U.S.

Boehringer was also recently charged with a nearly $1 million fine for withholding or failing to preserve files sought in Pradaxa litigation, according to the judge’s ruling. The “countless” files were sought by patients who brought lawsuits over Pradaxa, Bloomberg News recently reported. Judge Herndon concluded that Boehringer executives acted “in bad faith” by neglecting to ensure that the documents and files, which involved the development and marketing of Pradaxa, were preserved. “The wrongs here are egregious,” Judge Herndon said in the ruling. “The gross inadequacy” of the company’s efforts to protect the documents warranted a sanction of more than $931,000, the judge added, according to Bloomberg News.

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