Injured families and families of lost loved ones have filed lawsuits again Fresenius, the German-based manufacturer of GranuFlo and NaturaLyte, chemicals used in dialysis machines to help clean blood. The suits allege that the chemicals sharply increase the risk of cardiopulmonary arrest and sudden cardiac death.
GranuFlo and NaturaLyte are products mixed with water by the dispensing dialysis provider for use in kidney dialysis. They contain bicarbonate, a substance used to prevent the buildup of acid in the blood. Labeling problems with GranuFlo manufactured between 2003 and June 2012 resulted in higher levels of bicarbonate in the bloodstreams of dialysis patients, at times resulting in cardio arrest, cardiac arrhythmia and death. NaturaLyte and GranuFlo both contain acetate, which can increase blood pH levels and lead to metabolic alkalosis, which can also cause cardiac arrest.
The FDA issued a Class I recall of GranuFlo and NaturaLyte in March 2012 after it received an anonymous tip regarding the chemicals’ dangerous side effects. The tip was based on an internal memo composed and issued by Fresenius in 2011 and distributed only to its branded dialysis facilities, describing the issues with GranuFlo and NaturaLyte as “potentially serious.”
However, Fresenius elected not to publish these findings based on the company’s view that the results were preliminary and more time was needed to verify them. Critics of that decision maintain that Fresenius had a duty to inform all users of GranuFlo and NaturaLyte of these concerns in an effort to protect them from potential harm, but the company rushed the products onto the market instead.
According to the FDA, these side effects may be seen during or within 24 hours of dialysis treatment where GranuFlo or NaturaLyte were used:
- Cardiopulmonary arrest
- Cardiac arrhythmia
- Sudden Cardiac Death
- Heart problems
- Metabolic alkalosis
- Low blood pressure
- Sudden myocardial infarction or heart attack
Court records indicate that more than 3,000 GranuFlo lawsuits are pending in Massachusetts federal and state courts alleging that Fresenius failed to provide adequate warnings regarding the risks associated with the use of GranuFlo and NaturaLyte, and that the company continued to aggressively market the products, even after it became aware of those risks.
If you have suffered a heart attack or if you have lost a family member to sudden cardiac event after undergoing dialysis, we can help. Contact the attorneys of Childers, Schlueter & Smith for a free case evaluation and consultation. Our experienced attorneys will work closely with you and fight for the maximum compensation on your behalf.