NaturaLyte Lawsuits Centralized in Class Actions and Federal Court
With hundreds of NaturaLyte lawsuits pending against Fresenius Medical Care, a panel of federal judges has ordered that this nationwide litigation must be centralized in one federal court. The Multi-District Litigation (MDL No. 2428) is located in the U.S. District Court for the District of Massachusetts, In re: Fresenius Granuflo/NaturaLyte Dialysate Products Liability Litigation.
What is the problem?
NaturaLyte lawsuits accuse Fresenius of failing to provide warnings to doctors and patients about severe, life-threatening cardiovascular side effects. Plaintiffs allege that NaturaLyte is defectively designed and manufactured, Fresenius knew or should have known about the propensity of NaturaLyte to cause severe side effects, including metabolic alkalosis and cardiopulmonary arrest.
NaturaLyte and Dialysis Heart Attacks
NaturaLyte Liquid Acid Concentrate is a product that is used to balance the acidity of blood in patients with end-stage kidney failure who are undergoing hemodialysis (mechanical cleaning of the blood). Although most acid concentrate products contain primarily acetic acid, NaturaLyte is unique because it contains acetic acid plus sodium acetate. When the liver metabolizes these chemicals, a small percentage is metabolized into bicarbonate.
Because doctors typically administer NaturaLyte with a bicarbonate concentrate, they must carefully adjust the dose to compensate for the “extra” metabolized bicarbonate. If they do not, the patient may suffer a bicarbonate overdose, which lowers the pH of blood below the tolerable range of 7.35-7.45. This condition is called metabolic alkalosis, and it can cause a sudden, deadly heart attack in the dialysis clinic.
NaturaLyte and Failure to Warn
In March 2012, the FDA and Fresenius issued a Class 1 recall of Granuflo. Soon afterward, the New York Times reported that the recall was issued after an anonymous source leaked an internal company memo from Fresenius.
The memo, dated November 4, 2011, reported that NaturaLyte was a factor in 941 deaths at Fresenius clinics in 2010. Patients with high pre-dialysis bicarbonate levels were 6- to 8-times more likely to die from cardiopulmonary arrest in the dialysis clinic. This important risk information was only sent to doctors at Fresenius clinics — not the FDA or doctors at other dialysis clinics who were also using NaturaLyte.
NaturaLyte Side Effects
- Cardiopulmonary arrest
- Heart attack
- Cardiac arrest
- Low blood pressure
- Metabolic alkalosis
- Low potassium (hypokalemia)
- Low oxygen (hypoxemia)
- High carbon dioxide (hypercapnia)
- Irregular heart rhythm (cardiac arrhythmia)
Do I have a NaturaLyte Class Action 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 NaturaLyte lawsuits. We are handling individual litigation nationwide and currently accepting new cases in all 50 states.
Free NaturaLyte Lawsuit Evaluation: Again, if you or a loved one was injured by NaturaLyte, you should contact our law firm immediately. You may be entitled to compensation by joining a NaturaLyte class action lawsuit or by filing a NaturaLyte lawsuit, and we can help.