Naturalyte, a dialysis treatment product manufactured by Fresenius Medical Care, has been linked to an increased risk of heart attack, cardiopulmonary arrest, and death. In 2012, Naturalyte was recalled over safety concerns. Fresenius is now facing hundreds of lawsuits from plaintiffs who allege that they were not adequately warned about these side effects.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting NaturaLyte induced injury cases in all 50 states. If you or somebody you know has been diagnosed with a heart attack, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.
UPDATE: Fresenius Settles NaturaLyte Lawsuits for $250 Million
February 18, 2016 — Fresenius Medical Care has offered $250 million to settle over 4,300 lawsuits involving dialysis patients who had heart attacks after they were given GranuFlo or NaturaLyte. The securities filing states that 97% of all plaintiffs must opt-in to the agreement by July to receive payment by August 2016.
NaturaLyte Recalled for Bacterial Contamination
In May 2014, the FDA issued a Class I recall for Naturalyte because it may be contaminated with bacteria. Patients could develop life-threatening bacterial infections, sepsis, and bacteremia (blood poisoning). One month later, the FDA updated the recall after finding that two injuries and one death may have been caused by the products.
NaturaLyte Lawsuits and Multi-District Litigation
In 2013, a panel of federal judges has created a Multi-District Litigation (MDL No. 2428) to centralize lawsuits involving GranuFlo and NaturaLyte into one court. DaVita HealthCare, another dialysis company that used NaturaLyte on their patients, was also hit with several class actions. However, most lawsuits were filed by individuals or their family members, such as:
- Louisiana man filed a lawsuit after suffering a heart attack, stroke, and severe pain after treatment at a Fresenius dialysis clinic. Click here to read more.
- Wrongful death lawsuit filed on behalf of a man from Texas who died of a sudden cardiac arrest after being treated with GranuFlo and Naturalyte. Click here to read more.
- Wrongful death lawsuit has been filed in Georgia on behalf of a woman who died of a cardiovascular event during dialysis treatment in 2010. Click here to read more.
- Two wrongful death lawsuits filed in the U.S. District Court for Alabama by women whose husbands died of heart attacks after being given GranuFlo or Naturalyte during dialysis. Click here to read more.
What is Naturalyte?
NaturaLyte is a liquid called dialysate that is used to balance blood chemistry of patients undergoing hemodialysis. It contains acetic acid plus sodium diacetate. It is made by Fresenius Medical Care, the world’s largest provider of dialysis treatment clinics and products. The company operates more than 5,700 dialysis centers, providing care for approximately 400,000 patients in the U.S. alone.
What is the problem?
Unlike most dialysate products, NaturaLyte contains sodium diacetate, which is metabolized into bicarbonate by a patient’s tissues and liver. If a doctors does not adjust the dose to compensate for the “extra” bicarbonate in Naturalte, the patient could easily suffer from an overdose. Unfortunately, doctors may be unaware of the risk because most other dialysates consist primarily of acetic acid. Bicarbonate is also often added to the dialysate solution.
Metabolic Alkalosis
Patients with too much bicarbonate in their body can suffer from metabolic alkalosis, a condition that occurs when blood chemistry becomes too basic. It is associated with a number of life-threatening cardiovascular side effects, such as:
- Heart attack (myocardial infarction)
- Cardiac arrest
- Low blood pressure
- Cardiopulmonary arrest
- Irregular heartbeat
- Stroke
- Low potassium
- Low oxygen levels
- Excessive carbon dioxide
- Loss of consciousness
- Seizures
- Severe breathing difficulties
- Death
FDA Issues Class I Recall for NaturaLyte
March 29, 2012 — Fresenius has issued a Class 1 recall of the NaturaLyte and GranuFlo dialysis treatments, with the following warning:
“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.”
Failure to Warn About Side Effects
On November 4, 2011, Fresenius sent an internal memo (PDF) to doctors at their dialysis clinics. The memo warned that they had seen a sharp increase in the number of patient deaths who were treated with GranuFlo and NaturaLyte.
Fresenius found a six-fold increased risk of heart attack and death for patients who had high levels of bicarbonate before dialysis treatment. There were 941 dialysis patients who died of cardiac arrest at 667 Fresenius facilities between January 1, 2010 and December 31, 2010. The company issued a memo warning doctors to check bicarbonate levels before dialysis. Furthermore, they warned doctors to be careful with the dosage of NaturaLyte and GranuFlo.
Fresenius only sent this memo to doctors at their own clinics. They did not warn the FDA, doctors at other clinics, or the public, despite the fact that more than 100,000 patients at other clinics were also being treated with GranuFlo and NaturaLyte. The FDA only became aware of the memo from an anonymous source. When confronted, Fresenius executives were forced to issue an urgent warning and recall the products on March 29, 2012.
Do I have a NaturaLyte Lawsuit?
The Schmidt Firm, PLLC is currently accepting NaturaLyte induced injury cases in all 50 states. If you or somebody you know has been diagnosed with a heart attack, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.
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