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.
Why does Granuflo increase the risk of cardiac arrest?
Dialysis is required when an individual’s kidneys can no longer properly filter waste, salt and water from the blood. Part of this process involves neutralizing acid in the blood by giving the patient an alkaline substance, called bicarbonate. However, physicians weren’t factoring in the fact that Granuflo already had higher levels of bicarbonate, exposing patients to excessive amounts which has been linked to the following complications:
- Low blood pressure.
- Cardiac arrhythmia.
- Low potassium levels.
- A high concentration of carbon dioxide in the blood.
When these complications occur, they may lead to serious medical problems, including cardiac arrest and even death.
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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.
What damages can you recover from a lawsuit against Fresenius?
If you or a loved one has experienced serious medical complications or even death after being treated with Granuflo, you may be able to file a lawsuit against the manufacturer. If you win, you may be entitled to recover damages for the following:
- Pain and suffering.
- Mental anguish.
- Past, future and current medical bills.
- Lost wages and loss of future earning capacity.
- In the event of a death, funeral expenses, loss of the deceased’s future earning capacity and loss of love and companionship.