Pradaxa Gastrointestinal Bleed Lawsuit Filed in Texas

A man from Texas has filed a lawsuit against Boehringer Ingelheim, alleging their blood-thinning medication Pradaxa resulted in severe gastrointestinal bleeding. Filed on May 2nd in the U.S. District Court for the Eastern District of Texas, it’s the latest Pradaxa gastrointestinal bleed lawsuit in which Boehringer Ingelheim is accused of failing to warn consumers of the hemorrhage risk associated with the anticoagulant.

The plaintiff began taking Pradaxa in early 2011. In August of the same year, he suffered a severe gastrointestinal bleed that required emergency treatment at Overton Brooks VA Medical Center in Shreveport, Louisiana, and later hospitalization at Nacogdoches Memorial Hospital in Texas.

The lawsuit contends that Boehringer Ingelheim “knew or should have known” of the defective nature of Pradaxa. Echoing other claims filed against the firm, the plaintiff alleges he was not warned of the dangers at the time of prescription.

Pradaxa sales have exceeded $1 billion

Pradaxa has generated more than a billion dollars for Boehringer Ingelheim since first reaching the market in 2011. In 2013, projected sales are worth $603,000,000.

Pradaxa’s success has been largely attributed to an aggressive marketing campaign by Boehringer Ingelheim, conducted at a cost of $67,000,000 during the year leading up to its release. Pradaxa was promoted as a more effective alternative to the widely-used warfarin, which requires frequent blood monitoring and dosage adjustments.

According to the Pradaxa gastrointestinal bleed lawsuit filed in Texas, there were 272,119 prescriptions written between October 2012 and March 2011. During the same period, 932 “adverse event reports” were submitted to the FDA, including 120 Pradaxa related deaths and 500 cases of severe internal bleeding. A further 856 adverse event reports were filed in the subsequent three months, 117 of them pertaining to death.

Pradaxa side effects warning varies according to region

The lawsuit details the discrepancies between Pradaxa’s labeling around the world. In New Zealand, a lower dosage is recommended for patients over the age of 80. In a letter published in the New England Journal of Medicine, two Kiwi doctors expressed concern that “the potential risks of this medication are not generally appreciated”. In Japan, Pradaxa carries a “black box warning” to alert patients to the risk of severe hemorrhages.

In March 2012, Canadian Health authorities advised healthcare providers of certain risks associated with the drug, but despite these global concerns about Pradaxa side effects, Boehringer Ingelheim failed to warn American consumers about the severity of the risks.

Pradaxa gastrointestinal bleed lawsuit cases expected to rise

There are more than 200 lawsuits currently pending against Boehringer Ingelheim, but a recent Bloomberg report indicated that legal experts anticipate as many as 4,000 lawsuits involving Pradaxa bleeding to be filed in federal and state courts. Complaints have emerged from California, Illinois, Delaware, Alabama and Connecticut, among other states.

Pradaxa multidistrict litigation (MDL no.2385) has been established at the U.S. District Court for the Southern District of Illinois. Initially scheduled to begin in August 2014, the MDL has been moved forward by U.S. District Court Judge David Herndon. It is now set to begin in March 2014.

In a recent communication, Judge Herndon said the consolidated Pradaxa litigation is making “steady progress.”