Fresenius Medical Care, the manufacturer of GranuFlo (and similar product NaturaLyte), has agreed to multidistrict litigation (MDL) consolidation for all federal Granuflo and NaturaLyte lawsuits. The plaintiffs allege that the products distributed by Fresenius Medical Care administered during dialysis procedures caused patients to suffer heart attacks, cardiac arrest and in some cases, sudden death.
NaturaLyte and GranuFlo are dialysis treatments used in clinics across the U.S. Both products have sodium acetate that converts to bicarbonate at higher levels. When the blood bicarbonate level or blood alkalosis becomes too high, it can cause cardiac arrest and sudden death. The FDA issued a Class I recall of NaturaLyte and GranuFlo in March 2012. A Class I recall is issued only when there is “reasonable probability that the use of or exposure to the product will cause serious negative health consequences or death.” These types of recalls are the most serious.
Evidence shows that Fresenius Medical Care sent out an internal memo advising that those patients who underwent GranuFlo treatment were 6 to 8 times more likely to suffer sudden cardiac death or heart attack. The internal memo was created on November 4, 2011. It also stated that patients could suffer heart attacks from the moment they were hooked up to the dialysis treatment machine all the way up to 48 hours after undergoing the treatment. This memo was not disclosed to the FDA until a whistleblower leaked it.
Given this non-disclosure, patients affected by the treatments have filed lawsuits against Fresenius Medical Care on the grounds that the company failed to provide warnings to doctors and patients. Many patients claim that the company should have known or knew about the risk of problems with GranuFlo and NaturaLyte dialysis treatments.
In December 2011 a request was submitted to the U.S. Judicial Panel on Multidistrict Litigation (JPML) that all GranuFlo and NaturaLyte federal lawsuits to be consolidated for pretrial proceedings as part of an MDL. There have been some objections to centralizing the cases in Massachusetts. There are currently 37 Fresenius dialysis lawsuits filed in federal courts in Pennsylvania, Ohio, New York, New Jersey, Mississippi, Massachusetts, Louisiana, Georgia, Florida, California, and Alabama.
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.