Los Angeles, CAFresenius Medical Care, the maker of Granuflo and Naturalyte, is facing a wrongful death class action lawsuit filed by the widow of Earin Blossom. The lawsuit, filed in the Northern District of California, alleges the makers of Granuflo and Naturalyte, and their subsidiaries “failed to exercise reasonable care in manufacturing and selling defective dialysis products known as Granuflo and and Naturalyte.”
Tina Nunn, who filed the lawsuit on behalf of herself, her late husband, and those similarly situated, alleges that the dialysates caused fatal complications and sudden death, and caused her husband to incur substantial medical expenses prior to his death.
According to court documents, Earin Blossom began hemodialysis treatments in November 2010. During the course of those treatments, which took place three times a week at a Fresenius dialysis clinic in Fremont, he received both Granuflo and Naturalyte additives. Then, on April 6, 2011, just a few hours after completing a dialysis treatment at the clinic, Blossom suffered a massive heart attack and died.
The lawsuit alleges that Blossom’s metabolic alkalosis, cardiac arrest and subsequent demise were a direct and proximate result of his use of Granuflo and/or Naturalyte. The lawsuit also claims that the defendant knew its products resulted in excess bicarbonate levels in patients, often leading to metabolic alkalosis, a dangerous condition associated with heightened risks for heart attack, cardiac arrhythmia and sudden death.
Both Fresenius Medical Care products - Naturalyte and GranuFlo- are used in the treatment of acute and chronic renal failure during hemodialysis. The concentrate is formulated to be used with a three-stream hemodialysis machine, which is calibrated for acid and bicarbonate concentrates, according to the FDA safety recall initiated in March 2012. The recalled Naturalyte Liquid Acid Concentrate and Naturalyte GranuFlo (powder) Acid Concentrate was manufactured and distributed from January 2008 through June 2012.
An internal memo issued by Fresenius on November 4, 2011 warns that the GranuFlo and NaturaLyte products could lead to a greater risk of cardiac arrest and other heart problems. The memo, which was anonymously leaked to the FDA earlier this year, warned doctors working in Fresenius dialysis centers only that 941 dialysis patients suffered cardiac arrest in 2010 from GranuFlo use. Dangerously high biocarbonate levels would put their patients at a risk of cardiac arrest up to six times higher than that of patients using competing products.
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