Granuflo is a drug used during kidney dialysis – however a large number of patients experienced heart problems after receiving the medication. With evidence suggesting that the drug manufacturer was aware of the dangers but failed to adequately warn physicians and consumers, individuals who have experienced serious medical issues after being exposed to Granuflo may be entitled to legal recourse.
An Overview of the Granuflo Recall
The FDA issued a Class I recall on Granuflo after it was found that the product put patients at a heightened risk for cardiac arrest.
It’s been alleged that the manufacturer of the drug, Fresenius Medical Care, failed to adequately warn physicians that Granuflo contains more of an ingredient that the body converts to bicarbonate, which has been linked to heart problems.
According to an internal company memo, 941 patients treated at Fresenius’ dialysis centers experienced cardiac arrest in 2010. An analysis of the data showed that a patient’s risk of cardiac arrest was six times higher if they had high pre-dialysis bicarbonate levels. Even with this knowledge, Fresenius continued to market Granuflo and did not warn outside clinics that the drug seemed to contribute to a heightened risk of cardiac arrest. This became public knowledge in March 2012, after the FDA leaked Fresenius’ internal memo.
Fresenius is currently facing a number of serious allegations, including that the manufacturer knew or should have known that Granuflo leads to an increased risk of death and serious injuries. The lawsuits claim that Granuflo substantially heightens a patient’s risk of potentially fatal cardiovascular injuries, and that Fresenius concealed and misrepresented those risks. While Granuflo was being marketed as a safe medication for dialysis, the manufacturer had reason to believe it could cause serious medical problems.
In addition, Fresenius is being sued for failing to adequately warn doctors, nurses and clinicians about the risks associated with Granuflo. The reality is drug manufacturers have a responsibility to ensure that their product is used in a safe and effective manner – and the lawsuits claim that Fresenius did not do this by failing to alert the medical community that the medication led to significantly increased bicarbonate levels that put patients at risk for sudden cardiac arrest and even death.
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If you or a loved one have been the victim of negligence or misconduct, please do not hesitate to contact among the best attorneys Miami has available at Goldberg & Rosen today to receive expert guidance about your legal options, as well as a free and confidential case evaluation.