You, or a loved one, can be at risk. The German company manufacturing GranuFlo, Fresenius Medical Care, was aware of the potential dangers associated with their product used for dialyses, but decided to hide information in order to maintain their market share. Fresenius did not warn patients and physicians of the risks of cardiovascular injuries or cardiac deaths linked to GranuFlo. Fresenius was aware of these risks when the product was introduced and despite potential GranuFlo lawsuits, the company is still aggressively marketing the product.
Know Your Rights
If you or a loved one has been injured by GranuFlo, or suffered cardiac arrest or other sicknesses following dialysis, please feel free to contact us. A reputable drug injury attorney can answer your questions and provide the advice necessary to prevent further loss related to your GranuFlo injury. We will fight aggressively on your behalf to ensure you receive full reimbursement for your harms and losses.
GranuFlo – Facts That You Should Know
Dialyses is used for patients with chronic kidney diseases, kidney failures or other issues related to renal function. There is an estimated two million people worldwide suffering from chronic kidney diseases or failure, of which more than 400,000 are treated in dialysis centers in the United States. It is found that more than a third of these patients receiving dialyses are treated with GranuFlo, a product manufactured by Fresenius Medical Care.
Dialysis is used to artificially filter a patient’s blood by pumping it through the dialyzer. The blood is treated with a chemical, often GranuFlo, to remove impurities, or toxic waste, from the blood. Dialysis replaces the important kidney function of waste removal and fluid removal. Without dialysis the toxic waste in the blood increases to levels that can lead to coma and death. Once the filtering process is done, the blood is pumped back into the patient’s body.
GranuFlo Linked to Cardiovascular Injuries and Deaths
Metabolic alkalosis is caused by too much bicarbonate in the blood, a condition that can cause cardiovascular injuries or sudden cardiac deaths. The dialysis process involves neutralizing the acid built-up in a patient’s blood. To neutralize the acid, bicarbonate is provided during the dialysis. Granuflo contains more of the bicarbonate ingredient than any other dialysis product and is used in the United States by various dialysis centers.
GranuFlo is linked to cardiopulmonary arrest and sudden cardiac deaths as a result of bicarbonate overdose. Evidence surfaced that Fresenius withheld information about the dangers of GranuFlo. An internal company memo from November 4th, 2011, confirmed that a staggering amount of 900 patients experienced heart attacks in Fresenius clinics during that past year. The memo stated that the company’s medical experts reached the conclusion that patients with high levels of bicarbonate in their blood are facing increased risk of heart attacks. Most importantly, the memo also linked GranuFlo to increased bicarbonate levels. The memo clearly confirmed that Fresenius was fully aware of the potential dangers of Granuflo and did not share this vital information.
Class 1 Recall Issued by the Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services. The main goal of the Food and Drug Administration is to promote and protect public health. The Food and Drug Administration recently issued a Class 1 Recall notice for Fresenius Medical Care, which is the most severe recall for situations involving a reasonable chance that the use of the recalled product will result in serious health issues or death.
Dialysis and Cardiac Side Effects of GranuFlo
Dialysis is typically performed three times a week on patients with chronic kidney diseases, kidney failures or other issues related to renal function. During dialysis, the patient’s blood is pumped through the dialyzer, where the blood is treated with a chemical solution, often GranuFlo, to remove impurities, or toxic waste, from the blood. The blood is then pumped back into the patient’s body. Granuflo, a chemical solution, creates excessive bicarbonate builds up and serious health problems can occur. RenalWEB found that GranuFlo contains sodium diacetate. Sodium acetate is traditionally used. The composition of GranuFlo causes the production of higher levels of bicarbonate, which lead to metabolic alkalosis.
Metabolic alkalosis occurs when the pH level in the blood leans toward the alkaline end of the scale. Maintaining the balance of acid and alkaline in the blood is an important part of dialysis. Acidosis (excessive acid) can cause damage to internal organs and excessive bicarbonate in the bloodstream can cause severe heart problems and even death.
Claims by Injured Parties
There are several complaints filed against Fresenius, such as:
- Fresenius intentionally did not inform physicians and clinics about the risks of GranuFlo;
- Fresenius did not warn patients and physicians of the risks of cardiovascular injuries or cardiac deaths linked to GranuFlo. Fresenius was aware of these risks when the product was introduced;
- Fresenius did not report the dangers and risks of Granuflo to the public or the Food and Drug Administration. Fresenius decided to mislead patients and health care centers by putting profits ahead of safety;
- Serious cases of patients receiving dialysis were not warned about the risks involved;
- Fresenius continued to sell GranuFlo even though the company was aware of the health risks;
- The company did not provide product-related warnings and instructions;
- Consumers were misled by GranuFlo as it remained on the market;
- Fresenius showed a disregard for public safety;
- The company showed no interest in addressing the defects of GranuFlo prior to selling it to consumers.
GranuFlo Research Findings
The high bicarbonate levels that are linked to GranuFlo can result in serious health problems, such as heart problems, metabolic alkalosis, cardiopulmonary arrest, heart attack, stroke or death. It is found that fifty-nine percent of deaths of dialysis patients were caused by cardiac death.
How to Hire a Lawyer for a GranuFlo Lawsuit?
If you, or a loved one, are a victim of GranuFlo, we can help provide information and aggressive legal representation with respect to your legal rights. Please contact us immediately to discuss your case. As an injury lawyer, we operate on a contingent fee basis, meaning there is NO FEE unless we win your case. We offer a unique blend of compassionate and aggressive legal representation. A phone call is all that is required to get started.
Injured parties and the families of those wrongfully killed by GranuFlo may contact a GranuFlo lawyer and case intake specialists for a FREE Case Consultation by calling 855-55-BAD-DRUG or (314) 409-7060 24 hours a day, 7 days a week.