Fresenius Medical Care’s popular dialysis treatments GranuFlo and NaturaLyte have recently been linked to heart attacks, strokes, arrhythmias, cardiac arrest and sudden death. Due to an abnormally high number of adverse event reports submitted to the U.S. Food & Drug Administration (FDA) by patients treated with GranuFlo and NaturaLyte, these products were the subject of a nationwide recall in March 2012. The Defective Drug Lawyers at Schmidt & Clark, LLP, are currently pursuing potential lawsuits for individuals who have been injured by GranuFlo or NaturaLyte 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
GranuFlo Lawsuit Update 5/8/14: Lawyers involved in the nationwide GranuFlo litigation are expected to meet this week with a U.S. district judge to review proposals regarding preparation for the upcoming bellwether trials. Fresenius Medical Care (FMC), the company that manufactured GranuFlo, currently faces about 1,500 federal complaints from patients who allegedly suffered cardiac arrest or sudden death after undergoing dialysis treatment with the product. Click here to learn more.
GranuFlo / NaturaLyte Lawsuit Update 3/12/13: At least four separate GranuFlo and NaturaLyte class action lawsuits have been filed against DaVita Healthcare, alleging that the company should have known about the dialysis products’ potential to cause severe, potentially life-threatening side effects. The complaints seek class action status to include all patients who underwent hemodialysis treatment with GranuFlo or NaturaLyte at a DaVita clinic. Click here to learn more.
Free GranuFlo / NaturaLyte Lawsuit Evaluation: If you or a loved one has been injured by GranuFlo of NaturaLyte, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of GranuFlo and NaturaLyte and we can help.
What’s the Problem with GranuFlo and NaturaLyte?
NaturaLyte and Granuflo Dry Acid Concentrate are used in the treatment of acute and chronic renal failure, and are formulated to be used with a three-stream hemodialysis machine, which is calibrated for acid and bicarbonate concentrates. Dialysis is a procedure that clears toxic waste from the blood in patients whose kidneys have failed. During this process, bicarbonate is administered to neutralize the acid that builds up in the blood. Both GranuFlo and NaturaLyte contain an ingredient that converts bicarbonate at higher levels than its rival products, which may lead to serious side effects in certain patients.
Side Effects of GranuFlo and NaturaLyte
Over the past several years, GranuFlo and NaturaLyte have been increasingly linked to metabolic alkalosis, a condition associated with an increase in severe cardiovascular complications. The FDA has received a large number of adverse event reports (AERS) describing alkali dosing errors that occurred during hemodialysis using GranuFlo and NaturaLyte. When metabolized, these products can contribute to metabolic alkalosis, which is a significant risk factor for the following side effects:
- Low blood pressure
- Cardiopulmonary arrest
- Cardiac arrhythmia
- Sudden heart attack
- Hemodialysis cardiopulmonary arrest
- Cardiopulmonary death
A 2010 study found that patients with pre-dialysis bicarbonate levels greater than 28mEq/L were nearly five times more likely to experience cardiac arrest. The research also found that individuals with pre-dialysis potassium levels lower than 4 mEq/L had a 6.3 times higher risk of suffering a cardiac arrest. In response to these findings, in May 2012 the FDA recommended healthcare providers consider the presence and quantity of acetate, citrate, and/or acetic acid in dialysate concentrates like GranuFlo and NaturaLyte when determining a patient’s dialysate prescription.
GranuFlo and NaturaLyte FDA Recall
On March 29, 2012, the FDA issued a Class I recall of GranuFlo and NaturaLyte dialysis products due to their potential to cause metabolic alkalosis. Class I recalls are the most serious type of recall, and involve situations in which there is a reasonable probability that the use of these products will result in adverse reactions or even death. The recall states that Fresenius Medical Care (FMC) failed to disclose vital information to the FDA and healthcare providers about the possible risk of high bicarbonate levels when administering GranuFlo and NaturaLyte. 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.”
FMC Withheld Crucial GranuFlo and NaturaLyte Safety Information
On its product website, FMC refers to GranuFlo as the “most-widely prescribed dry acid product in the dialysis industry today,” and claims that “With GranuFlo’s distinctive proportional component blend in each bag, you have made the safest choice for onsite concentrate mixing.”
However, an internal memo sent to doctors operating FMC’s own clinics contradicts these safety claims. The November 2011 communication warned that 941 patients had suffered cardiac arrest inside FMC clinics in 2010. According to the memo, physicians’ failure to use GranuFlo and NaturaLyte correctly appeared to be contributing to the spike in patients dying suddenly from cardiac arrest. The products are prescribed together with bicarbonate, and doctors were apparently not accounting for the higher bicarbonate contribution from GranuFlo and NaturaLyte when deciding how much bicarbonate to prescribe separately. Fresenius did not issue any type of warning to its customer clinics until March 2012, and only did so after the FDA received a copy of the company’s internal memo from an anonymous source and questioned the company about it.
Do I Have a GranuFlo / NaturaLyte 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 and NaturaLyte lawsuits. We are handling individual litigation nationwide and currently accepting new injury cases in all 50 states.
Free GranuFlo / NaturaLyte Lawsuit Evaluation: If you or a loved one has been injured by GranuFlo or Naturalyte, you should contact our law firm immediately. You may be entitled to compensation by filing a GranuFlo / NaturaLyte injury suit and we can help.