Lawsuit: Life-Threatening Bleeding Risk Was Hidden

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A Wayne County, Michigan, couple has filed a life-threatening bleeding lawsuit, alleging that the widely popular blood-thinner caused the wife to suffer severe internal bleeding.

Plaintiffs F. and J. Felicia Anderson have joined thousands of other users who accuse the drug’s makers, Johnson & Johnson and Bayer, of knowing the risks of internal bleeding while on  but failing to sufficiently warn the Food and Drug Administration, physicians, patients or the public at large.

Introduced in the U.S. in July 2011, is part of a class of drugs known as New Oral Anticoagulants. It is marketed as being more effective and easier to use than warfarin (Coumadin), which has been on the market for six decades.

Unlike Coumadin, which requires regular blood monitoring and avoiding foods that contain vitamin K, does not require either.

However, and its next-generation competitors, Pradaxa and Eliquis, do not have an antidote in the event of an internal bleeding episode. Bleeding episodes can be reversed for Coumadin patients by the administration of vitamin K, which acts as an antidote.

According to her life-threatening bleeding lawsuit, Mrs. Anderson took the drug from May 2014 to August 2014 and subsequently suffered “severe, internal bleeding in addition to other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, diminished enjoyment of life, and financial expenses for medical treatment.”

Their case is one of some 13,000 life-threatening bleeding lawsuits pending in a multidistrict litigation created in New Orleans.

Lawsuits Allege Failure to Warn

Anderson and the other plaintiffs accuse Johnson & Johnson and Bayer of failing to provide adequate safety warnings, including the absence of a reversal agent for life-threatening bleeding episodes.

“Despite being aware of: (1) serious, and sometimes fatal, irreversible bleeding events associated with the use of ; and (2) 2,081 SAE Medwatch reports filed with the FDA in 2012 alone, including at least 151 deaths, Defendants nonetheless failed to provide adequate disclosures or warnings in their label,” the lawsuit states.

’s aggressive marketing campaign resulted in $2 billion in sales in 2013, according to Anderson’s complaint.

And in its direct-to-consumer marketing efforts, the “Defendants overstated the efficacy of with respect to preventing stroke and systemic embolism, failed to disclose the need for dose adjustments, failed to disclose the need for blood monitoring, and failed to adequately disclose to patients that there is no drug, agent, or means to reverse the anticoagulation effects of , and, that such irreversibility could have permanently disabling, life- threatening and fatal consequences,” Anderson alleges.

is intended to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation; to treat Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE); to reduce the risk of recurring DVT and/or PE; and to prevent DVT in patients undergoing hip and knee replacement surgery.

At least 370 deaths have been linked to the medication, according to the Chicago Tribune, citing the Food and Drug Administration.

Get Legal Help

If you or a loved one took and suffered an internal bleeding episode that left you hospitalized, you may have a legal claim.

Thousands of lawsuits have been filed by patients seeking compensation for failure to warn about the risks of life-threatening bleeding. This compensation could help you cover expenses related to hospital stays, medical bills, pain and suffering, and more. Fill out the form on this page now for a FREE case evaluation.