Injured families and families of lost loved ones have filed lawsuits against Fresenius, the German-based manufacturer of GranuFlo and NaturaLyte, chemicals used in dialysis machines to help clean blood. The suit alleges that the chemicals significantly 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 cardiac arrest, cardiac arrhythmia and death. NaturaLyte and GranuFlo contain acetate, which can increase blood pH levels and lead to metabolic alkalosis, which also can cause cardiac arrest.
In March 2012, the U.S. Food and Drug Administration (FDA) issued a Class I recall of GranuFlo and NaturaLyte after receiving an anonymous tip regarding the chemicals’ dangerous side effects. The tip was based on an internal memo written and issued by Fresenius in 2011 and distributed only to its branded dialysis facilities, describing the issues with GranuFlo and NaturaLyte as “potentially serious.”
But, 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 claim 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 instead, the company rushed the products onto the market.
The GranuFlo lawsuit asserts that Fresenius knew, or reasonably should have known, that their products could potentially cause serious health complications. The lawsuit also contends that Fresenius had a legally enforceable duty to monitor clinical reports, peer-reviewed journals and other forms of post market surveillance. The manufacturer should have been aware of these risks.
In addition, the lawsuit further asserts that not only was Fresenius aware of these risks, but that they actively concealed them, preventing patients and healthcare workers from having enough information to make informed decisions regarding their medical care. The GranuFlo lawsuit refers to an internal Fresenius memo from 2011 that refers to “previous communications.” This memo speaks of the risks of the risk of cardiac arrest and death during dialysis with GranuFlo and NaturaLyte. Fresenius only sent this memo to Fresenius-owned dialysis clinics, even though other unaffiliated clinics also used GranuFlo and NaturaLyte. The internal memo was eventually leaked to the FDA. The GranuFlo/NaturaLyte lawsuit holds that this memo proves that Fresenius knew about the risks, and the fact that they only issued it to their own dialysis clinics was an act of concealment.
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
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 about 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. Many people lost their lives as a result of Fresenius’ negligence. So many others suffered heart attacks and other cardiac events after undergoing dialysis.
If you or a loved one has suffered a heart attack to sudden cardiac events after undergoing dialysis, you should consult with an attorney. Contact one of our experienced Gacovino Lake attorneys at 1-800-246-HURT (4878).