Use of Fresenius Medical Care’s popular dialysis treatment product GranuFlo has been linked to a six-fold increased risk of cardiopulmonary arrest and sudden cardiac death. It has recently come to the public’s attention that Fresenius was aware of these potential complications, but that it chose to withhold this information until the U.S. Food & Drug Administration (FDA) launched an investigation into the company’s activities. The GranuFlo Lawyers at Schmidt & Clark, LLP, are currently offering free, no-obligation consultations to individuals injured by GranuFlo side effects.
July 2013 – Schmidt & Clark, LLP Attorney Michael Schmidt Elected to Plaintiffs’ Steering Committee For Granuflo and Naturalyte for Injury Claims Throughout The Country
Free GranuFlo Lawsuit Evaluation: If you were seriously injured after undergoing dialysis treatment with GranuFlo, or if a loved one died following treatment with GranuFlo, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of GranuFlo and we can help.
What’s the Problem with GranuFlo?
Manufactured and marketed by Fresenius Medical Care (FMC), GranuFlo is a dry acid product used during dialysis treatment procedures. GranuFlo is used at the company’s own clinics, which treat more than a third of all dialysis patients in the U.S., as well as an estimated 125,000 patients in clinics operated by other providers. According to Fresenius’ website, GranuFlo is the “most-widely prescribed dry acid product in the dialysis industry.”
Dialysis is a process that clears toxic waste from the body in individuals suffering from kidney failure. During the procedure, bicarbonate is added to neutralize the acid that accumulates in the bloodstream. GranuFlo is an alkaline product that contains acetate, a substance the body converts into bicarbonate. The product is designed to be given to patients together along with additional bicarbonate products. However, unbeknownst to many healthcare providers who performed dialysis procedures, GranuFlo has more acetate than rival products, which results in significantly elevated levels of bicarbonate in the body. This can lead to metabolic alkalosis, a condition that has been associated with a number of severe, potentially life-threatening cardiovascular complications.
GranuFlo Side Effects
Serious side effects reported in patients treated with GranuFlo during hemodialysis procedures have been reported to include:
- Low blood pressure
- Cardiopulmonary arrest
- Cardiac arrhythmia
- Sudden heart attack
- Hemodialysis cardiopulmonary arrest
- Cardiopulmonary death
FDA Recall of GranuFlo
In March 2012, the FDA recalled GranuFlo and NaturaLyte (another widely-used dialysis treatment product manufactured by Fresenius) nationwide due to their potential to cause adverse cardiovascular complications. According to the FDA, Fresenius failed to disclose vital information to healthcare providers about the risk of elevated bicarbonate levels when administering the products. The recall announcement states:
“The manufacturer is cautioning clinicians to be aware of the concentration of acetate or sodium diacetate (acetic acid plus acetate) contained in Fresenius’ Naturalyte Liquid and Granuflo Dry Acid Concentrate. Inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis. This may contribute to metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which, if not appropriately treated, may culminate in cardiopulmonary arrest. This product may cause serious adverse health consequences, including death.”
Did Fresenius Withhold GranuFlo Safety Data?
In November 2011, an internal memo circulated to doctors at Fresenius’ own clinics warned that at least 941 of its dialysis patients had suffered cardiac arrests in the year 2010 alone. According to the communication, physicians’ failure to use GranuFlo and NaturaLyte correctly appeared to be contributing to the spike in dialysis patient complications. The products are designed to be prescribed together with bicarbonate, and doctors were apparently not accounting for the higher bicarbonate contribution from GranuFlo and NaturaLyte when deciding how much of the product to prescribe separately. FMC did not issue any type of warning to its customer clinics until March 2012, and only did so after the FDA was leaked a copy of the company’s secret memo from an anonymous source.
When Fresenius decided not to warn the public and medical communities about the potential side effects associated with GranuFlo, it may have led to numerous preventable heart attacks and other serious health complications. If you’ve suffered one or more of the injuries listed above after undergoing dialysis treatment with GranuFlo, contact the GranuFlo Lawyers at Schmidt & Clark, LLP, today. We are currently offering free, no-obligation consultations to individuals injured by GranuFlo side effects. If we determine that you have a valid claim, compensation may be available for medical expenses, lost wages, pain and suffering, and other damages.
GranuFlo Lawsuit Update
As of Jan. 2015, more than 2,000 GranuFlo and NaturaLyte lawsuits have been included in the multidistrict litigation (MDL) currently pending in Massachusetts Federal Court before U.S. District Judge Douglas P. Woodlock. The first trial is schedule to begin in Jan. 2016., with the next beginning a month later.
Do I Have a GranuFlo Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in GranuFlo lawsuits. We are handling individual litigation nationwide and currently accepting new GranuFlo injury and death cases in all 50 states.
Free GranuFlo Lawsuit Evaluation: If you were seriously injured after undergoing dialysis treatment with GranuFlo, or if a loved one died following treatment with GranuFlo, you should contact our law firm immediately. You may be entitled to compensation by filing a GranuFlo suit and we can help.