For more information or confidential assistance
Call 800-306-3180

A Missouri Lawsuit Against Boehringer Ingelheim is Considered a Tag-Along Action to the Pradaxa MDL

A new lawsuit was filed against the anti-coagulant drug Pradaxa was filed on August 23, 2012 in the U.S. District Court for the Western District of Missouri (St. Joseph Division). Shirley Jean Higdon’s filing a Pradaxa lawsuit against Boehringer Ingelheim Pharmaceuticals is considered a tag-along action to the Pradaxa products liability multidistrict litigation (MDL No. 2385). An MDL is similar to a class action lawsuit in that it consolidates plaintiff complaints into one court, but all cases are tried on an individual basis.

According to Higdon’s attorney, Boehringer Ingelheim “overstated the efficacy of Pradaxa” with respect to preventing stroke and systemic embolism, and failed to adequately disclose to patients that there is no drug, agent, or means to reverse the anticoagulation effects of Pradaxa. Additionally, such irreversibility could have permanent disabling, life-threatening and fatal consequences.

Boehringer Ingelheim spent $464 million to market Pradaxa in 2011

Pradaxa (dabigatran etexilate mesylate) is a direct thrombin inhibitor that is indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. Pradaxa first received FDA approval on October 19, 2010 and is the first anticoagulation medication approved in the U.S. in more than 50 years for patients with non-valvular atrial fibrillation. It is a direct competitor for Coumadin, or warfarin, which requires dietary restrictions and regular monitoring of blood levels (INR) by undergoing blood tests and potentially adjusting the dose of their medication. Pradaxa is marketed as a one-size-fits-all drug—an easier, simpler, and more effective alternative to warfarin. In 2010 alone, Boehringer Ingelheim spent $67 million on Pradaxa marketing. This sum increased to $464 million in 2011.

The plaintiff suffers internal bleeding and requires hospitalization after using Pradaxa

Shirley Higdon was prescribed Pradaxa on July 1, 2011. Higdon’s attorney emphasizes that at the time, Higdon and her physicians were “unaware, and could not have reasonably known or have learned through reasonable diligence that {the plaintiff} would be exposed to the risk of excessive and/or uncontrollable bleeding and the other risks and injuries.” On July 28, 2011, Higdon experienced a severe Pradaxa internal bleeding requiring hospitalization and blood transfusion.

As do other cases included in the class action lawsuit and MDL, Higdon alleges strict liability and failure to warn, design defect, negligence, negligent misrepresentation and/or fraud, breach of express and implied warranties, negligence per se, fraudulent concealment, and violation of the Missouri Merchandising Practices Act. She requests punitive, compensatory, and other economic damages.

Pradaxa’s label doesn’t disclose the information that there is no means to reverse its anticoagulation effects

From October 2010 through March 2011, the FDA received 120 reports of death resulting from Pradaxa use and more than 500 reports of severe, life-threatening bleeding. From April through June 2011, there were an additional 117 reported incidents of death and 510 life-threatening bleeding events. Nevertheless, the drug’s original labeling and prescribing information failed to disclose that there are no means to reverse the anticoagulation effects of Pradaxa.

[SmartLink pradaxalawsuit]