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The estate of a Tennessee woman who died of gastrointestinal bleeding after taking is suing the drug makers Janssen, Bayer and Johnson & Johnson for wrongful death.
The uncontrollable bleeding lawsuit alleges that the deceased Phyllis L. took the drug and suffered severe medical complications and expenses leading up to her death. The lawsuit claims that the drug makers were aware of the additional risks presented by , but did not disclose them to doctors, patients or the public.
According to the lawsuit, is an anticoagulant marketed to doctors and patients to reduce the risk of strokes, systemic embolism and other medical complications after hip and knee replacement surgery. , along with other drugs, are marketed as the “next generation” of blood thinning drugs to replace warfarin. Warfarin, says the lawsuit, is an established safe treatment for preventing stroke and systemic embolism and has been in use for 60 years.
is the second most commonly prescribed drug for treatment of atrial fibrillation, states the lawsuit. It made $2 billion in sales in 2013.
The uncontrollable bleeding lawsuit alleges that the drug was introduced to the market in 2011, but its use was based on flawed research that dismissed the bleeding risks that lead to the death of the plaintiff. The lawsuit points out that the Food and Drug Administration scolded the drug makers for their research design in 2009.
“FDA Official Action Indicated…rated inspections in 2009 disclosed rampant violations including, ‘systemic discarding of medical records,’ unauthorized unblinding, falsification, and ‘concerns regarding improprieties in randomization,” alleges the lawsuit. “As a result, the FDA found that the RECORD 4 studies were so flawed that they were deemed unreliable.”
Further, the lawsuit states that the drug makers pushed a marketing scheme they called “the Difference” that flew in the face of research that would reduce the risks of taking the drug. The marketing included once-a-day dosing of , contrary to evidence that multiple doses reduced the risk of uncontrollable bleeding.
Additionally, drug makers allegedly wanted to market as not requiring blood monitoring, as required by the safe alternative, warfarin, again in the face of evidence that blood monitoring reduced the risk of medical complications.
“Defendants’ promotional materials fail to similarly highlight the increased risk of gastrointestinal bleeding and bleeding that required transfusion, among other serious bleeding concerns,” the uncontrollable bleeding lawsuit claims.
The lawsuit alleges that the drug makers failed to warn patients and doctors in the face of evidence that has double the risk of a bleeding death than the alternative, warfarin. Instead, they continued to market the drug as a simpler alternative with no additional risks.
If you or a loved one took after a knee or hip replacement surgery and has experienced problems with uncontrollable bleeding, consider contacting an experienced attorney today.
Patients using have been experiencing severe complications and the attorneys at McDonald Worley are working hard to hold drug makers responsible. Contact them today for a FREE case evaluation.