There are thousands of patients estimated to have suffered fatal cardiac arrests related to the Fresenius Medical Care (FMC) GranuFlo and NaturaLyte Acid Concentrate products. Approximately 240,000 patients receive hemodialysis treatment using GranuFlo dry acid concentrate, a dialysate that has been linked to higher rates of cardiac arrest and other serious side effects. Although both products have been recalled in March 29, 2012, an internal memo circulated amongst FMC facilities indicate that the medical device manufacturer may have been aware of the problems long before the recall was issued.
GranuFlo Case-Control Study
An End-Stage Renal Disease conference in 2009 identified that cardiac death as the number one cause of death for dialysis patients and that the deaths were primarily due to uremic cardiomyopathy, a side effect of dialysis. Following the results of this conference, FMC conducted a yearlong case-control study and found 941 patients in 667 FMC facilities with records of cardiac arrest between January 1st and December 31st of 2010. The study concluded that GranuFlo patients faced greater risk of cardiac arrest, especially those with sodium levels higher than 28mEq/L. The risks were even greater for patients with lower potassium levels, 6.3 times greater.
Concerns Regarding GranuFlo Safety
Before the study was published in November, FMC began to alert its staff of the risks associated with GranuFlo as early as January of 2011. In the Medical Staff Newsletter, the higher risk of heart attack was presented as a working hypothesis. In early November, internal data analysis supported the conclusion that GranuFlo significantly increased the risk of cardiopulmonary arrest. The internal memos that were published warned FMC facilities of the dangers of causing alkalosis through incorrect prescription of GranuFlo.
2012 Recall and Public Warning
Despite having the data on hand since November 2011, FMC failed to notify the FDA until March 29, 2012. While GranuFlo and NaturaLyte have both been recalled, the delayed action may have caused hundreds more unnecessary cardiac arrests in dialysis patients. Thousands of patients have been unnecessarily put at risk between the period when FMC had conclusive evidence indicating the deadly GranuFlo side effects and until the FDA were finally notified. Although the firm denies allegations of conflict of interest, GranuFlo is estimated to raise over $80 million a year in revenue, a significant portion of FMC profits.
Screening Cases Against FMC
The loss or suffering of a loved one is always difficult. When coupled with the knowledge that the devastating cardiac event could have been prevented if FMC decided to conduct a study earlier or even release their study findings earlier, coping with the life-long damages are even more difficult. For such cases, Estey & Bomberger attorneys are offering free case evaluations and contingency fee based legal representation to help grieving families secure compensation and justice from FMC. Schedule a free consultation today to learn whether your GranuFlo or NaturaLyte caused event may be eligible for compensation.