MDL 2428 (In re: Fresenius GranuFlo/NaturaLyte Dialysate Products Liability Litigation)

A panel of judges have recently agreed to consolidate all GranuFlo lawsuits, according a press release issued April 1, 2013. The U.S. Judicial Panel on Multidistrict Litigation on March 29, 2013 issued a transfer order consolidating 11 federal claims to MDL 2428 (In re: Fresenius GranuFlo/NaturaLyte Dialysate Products Liability Litigation). These and future federally filed cases will now be consolidated in the U.S. District Court for the District of Massachusetts.These GranuFlo lawsuits assert claims against Fresenius Medical Care claiming the company failed to adequately warn patients about the 6 to 8 fold increase in the risk of cardio events such as cardio arrest, heart attacks and sudden cardiac death.

GranuFlo and NaturaLyte are dialysis treatments used across the United States in dialysis clinics. Fresenius Medical Care is the manufacturer of GranuFlo and NaturaLyte. According to an internal memo that was first circulated within Fresenius on November 4, 2011, patients who undergoGranuFlo treatment are 6 to 8 times more likely to suffer heart attack or sudden cardiac death. Patients may suffer heart attack from the moment they are hooked up to the dialysis machine and up to 48 hours after undergoing treatment. Fresenius Medical care treats more than a third of the Americans who receive dialysis.

In an internal memo sent by Fresenius Medical to its own dialysis centers, the company warned them that “failure to properly use one of the company’s products appeared to be contributing to a sharp increase in the risk of patients dying suddenly from cardiac arrest,” according to an article in the NY Times. Fresenius did not tell the FDA about this information and failed to tell other dialysis centers that used its GranuFlo and NaturaLyte products. Instead, it was kept secret until an internal document was anonymously leaked to the FDA. In March 2012, the FDA issued a Class I recall of GranuFlo and NaturaLyte. This is the most serious type of recall the FDA can issue and signifies there is a “reasonable probability that the use of or exposure to the product will cause serious negative health consequences or death.”

Childers, Schlueter & Smith continue to investigate and file dialysis injury lawsuits on a nationwide basis. 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 dialysis injury attorneys will work closely with you and fight for legal rights.