Judge David R. Herndon recently granted a plaintiffs’ motion in the Pradaxa side effects lawsuits against Boehringer Ingelheim Pharmaceuticals, Inc., ordering the company to produce documents related to off-label promotion, doctor kickbacks, earlier lawsuits, and wrongful activities of the company’s other medications. Lawsuits have been consolidated into a multidistrict litigation in the U.S. District Court for the Southern District of Illinois.

Pradaxa lawsuits are filed by patients who took the anti-coagulant drug and suffered from severe and possibly fatal side effects such as excessive bleeding. The drug was approved by the FDA in 2010, the first new blood-thinner drug to be introduced in the U.S. in decades. It was marketed as an improvement over warfarin, the anticoagulant that had long been on the market. However, Pradaxa bleeding cannot be easily reversed and may turn out fatal, whereas there is an antidote to stop warfarin bleeding problems. Pradaxa lawsuits allege that:

  • Pradaxa can cause an increased risk of serious or deadly bleeding
  • Pradaxa does not have an effective reversal agent or protocol
  • Pradaxa is less safe than similar anticoagulant, Warfarin
  • Pradaxa places certain patient populations at an increased risk for serious bleeding
  • It is difficult to assess the degree of anticoagulation in patients taking Pradaxa.

The lawsuits seek to hold the manufacturer responsible for failing to warn patients about Pradaxa bleeding risks, especially concerning because the uncontrolled bleeding cannot be stopped. As a result, more than 540 Pradaxa deaths and 3,781 Pradaxa adverse event reports have been submitted to the FDA.

Pradaxa Bleeding Side Effects Lawsuits Continue

Plaintiffs in the Pradaxa litigation requested documents on an earlier qui tam suit alleging off-label marketing of four BIPI products. The company had entered into a Corporate Integrity Agreement as part of the settlement of the action, which governs the company’s conduct as related to all of its drugs, including Pradaxa. Plaintiffs argued that the materials related to other BIPI drugs may reveal evidence of overpromotion and improper conduct that may be relevant to the Pradaxa lawsuits. The court agreed: “it is entirely possible that the marketing policies and strategies at issue in the qui tam action extended to BIPI’s marketing of Pradaxa.”

Approximately 176 Pradaxa lawsuits have been filed in federal court. If you took Pradaxa and experienced Pradaxa bleeding or other serious side effects, consider filing a lawsuit to seek compensation for your injuries, including medical expenses, lost wages, and more. Speak to a Pradaxa lawyer at our firm today to learn more about your legal rights. Call (877) 779-1414 for a free and confidential case review.

Published February 5, 2013 by