Lawsuit Claims Pradaxa Manufacturer Knew of Drug’s Risks

A new lawsuit against Pradaxa manufacturer Boehringer Ingelheim Pharmaceuticals alleges that the company was aware of the risk of internal bleeding from Pradaxa, but failed to warn patients, the public, or the medical community. The lawsuit was filed by Thelma Hawthorne in the U.S. District Court, Eastern District of Louisiana in New Orleans and is being overseen by the Honorable Judge Jay C. Zainey.

Pradaxa is an anticoagulant that is prescribed to help prevent strokes in patients with non-valvular atrial fibrillation. Patients with this condition have an increased risk of stroke because blood clots can escape and move through the patient’s body.

Pradaxa was approved by the FDA in 2010 and was heavily marketed as a convenient alternative to Warfarin, which had been on the market for 50 years. Unlike Warfarin, Pradaxa does not require patients to adhere to a restricted diet or monitor their blood levels every one to four weeks, and Pradaxa can be used in combination with other heart medications.

FDA receives hundreds of reports of internal bleeding from Pradaxa

However, patients who use Pradaxa are at risk of internal bleeding. Warfarin carries this risk as well, but bleeding from Warfarin can be controlled with Vitamin K. Bleeding from Pradaxa does not have a known effective antidote.

In November 2011, Boehringer Ingelheim confirmed that the company had received 260 reports of Praxada-related deaths caused by bleeding. The following month, the FDA launched an investigation. Ultimately the FDA received more than 500 reports of Praxada-related deaths, along with more than 900 cases of gastrointestinal bleeding, more than 300 cases of rectal bleeding, and more than 200 cases of cerebrovascular accidents among Pradaxa users.

Hawthorne’s lawsuit claims that despite overwhelming evidence of life-threatening internal hemorrhage caused by the drug, the manufacturer failed to warn patients about the serious side effects of Pradaxa.

First Pradaxa lawsuits filed in March 2012

The initial three lawsuits alleging bleeding from Pradaxa were filed in March 2012 in the  U.S. District Court for the Eastern District of Tennessee, the U.S. District Court for the Western District of Louisiana and the U.S. District Court for the Eastern District of Kentucky. More Pradaxa litigation soon followed in Illinois and Connecticut. Given the severity and frequency of bleeding from Pradaxa, many further lawsuits are expected to follow.

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