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The Granuflo Lawsuit Drug Lawsuit

Granuflo is a dry acid product containing sodium diacetatein which is used as an additive in conjunction with the hemodialysis machine and dialyzer for patients who have renal failure. In June 2012, the FDA issued a Class I Recall notice for Fresenius Medical Care North America Naturalyte Liquid Acid Concentrate and Naturalyte GranuFlo (powder) Acid Concentrate.


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What is Granuflo Lawsuit?

Patients with renal failure do not have kidneys which perform their natural functions. Specifically, their kidneys may be incapable of removing excess fluids, toxins, and wastes from their body. Their kidneys also fail to produce the chemical bicarbonate which helps maintain the body’s pH by neutralizing the acidity in the body. Granuflo is an additive used with the dialysis process to personalize the serum bicarbonate concentration levels. Unfortunately, when doctors use dialysate concentrates containing acetic acid and acetate (such as Granuflo) as an additive with dialysis, some patients experience an increase in their levels of high serum bicarbonate. The increase in serum bicarbonate can cause metabolic alkalosis, leading to a variety of severe health conditions including death, heart attack, low blood pressure, low potassium in the blood, low levels of oxygen, cardiac arrhythmia, and excessive carbon dioxide in the blood.

What is Granuflo Lawsuit used for?

In 2012, given the issues listed above, the U.S. Food and Drug Administration (FDA) issued a Class I Recall for Granuflo. This classification is the most serious type of recall and is only used for products in which “there is a reasonable probability that the use of these products will cause serious adverse health consequences or death.” After the FDA recall notice, Granuflo lawsuits were filed against the manufacturer Fresenius Medical Care alleging that they failed in their duty to sufficiently label their products and did not adequately warn users about the risks posed by Granuflo.

  • Granuflo is manufactured by Fresenius Medical Care, the largest provider of dialysis services and products in the world. The company began years ago in one of Frankfurt's oldest pharmacies, the Hirsch Apotheke. Now, after years of acquisitions and mergers, the company is focused on helping patients with chronic kidney disease, including the designing, manufacturing, and selling of its own dialysis machines.

Granuflo Lawsuit Usage and Statistics

Fresenius Medical Care has expanded to several major countries throughout the world, employing an estimated 45,000 employees in North America. According to the company’s mission statement they “not only want to provide products; they also want to create connections with patients and their families through caring treatment, guidance and comfort.”

How Granuflo Lawsuit Works

Companies who decide to manufacture, market, and sell medications have the legal responsibility to educate users about the side-effect of their medications. Users of Granuflo suggest Fresenius Medical Care North America (FMCNA) may have failed in their responsibility to notify users of all of the serious side-effects of Granuflo. Although the medication was approved by the FDA in 2003, claimants allege Fresenius Medical Care North America (FMCNA) has not done enough to notify the Granuflo users of the most dangerous side-effect of Granuflo.

Side Effects of Granuflo Lawsuit

  • If you have experienced injury due to a heart attack, low blood pressure, low potassium in the blood, low levels of oxygen, cardiac arrhythmia, or excessive carbon dioxide in the blood from the use of Granuflo, you may be eligible for compensation. To win your injury claim you will have to prove certain elements of your claim. For example, you may have to prove not only that you were injured, but that your injuries were the result of the manufacturer’s failure to properly warn consumers about the dangers of their medication. Granuflo lawsuits are handled on a contingency fee basis, which means that there are no out-of-pocket costs to hire a Granuflo lawyer, and lawyers are only paid if they win your case. If you win your Granuflo lawsuit you may be entitled to the following types of compensation:
  • Pain and Suffering
  • Current medical expenses
  • Lost Wages

Granuflo Lawsuit Medical Studies


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