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A recent article published in Bloomberg takes a critical look at how FDA policies allowing companies to select which data they share with the agency effects the likelihood of approval even if evidence exists suggesting otherwise. The author specifically looks at the approval process for the drug, Pradaxa.
According to the article, “Selective disclosure of Pradaxa information may have camouflaged a serious safety signal, according to an assessment report from European Medicines Agency’s Committee for Medicinal Products for Human Use in August 2012. That agency is the European Union’s drug regulator.”
Pharmaceutical companies often produce and market their products to consumers before the proper safety guidelines have been established through extensive clinical trials. If injuries result as a result of drug maker negligence, victims may file suit and recover costs related to past and future health care, lost wages and damages related to pain and suffering.
Joe Lyon is an experience pharmaceutical injury lawyer and drug defect attorney representing injured plaintiffs nationwide in drug injury cases.
Pradaxa Injury & Lawsuits
In addition, the New York Times reported that unsealed legal documents, showed Boehringer Ingelheim, the manufacturer of Pradaxa, suppressed safety studies showing the potential for Pradaxa injury and the drugs inefficacy. The company, faced “thousands of lawsuits” for a variety of bleeding complications allegedly caused by the drug.
Pradaxa was approved in 2010 and racked up $2 billion in sales. Since being introduced to the market, “it has been prescribed to 850,000 patients and has been linked to more than 1,000 deaths.”
The Lyon Firm focuses on product liability cases where consumers have been injured by defective products like pharmaceutical and medical devices. Large drug companies must be held accountable for their failure to protect patients. Those injured by Pradaxa or other recalled drugs can file claims and recover compensation related to their respective injuries.
