Hemodialysis patients are at greater risk of serious health complications, but according to a case-control study by Fresenius Medical Care, the use of GranuFlo or NaturaLyte acid concentrates had the potential to increase the risk of a heart attack by 6.3 times. During the course of the study between January 2010 and December 2010, there were 941 identified patients who suffered heart attacks that may have been related to the GranuFlo dialysate.
GranuFlo and NaturaLyte Recall
In March 29 of 2012, Frsenius Medical Care (FMC) issued a Class I recall for the NaturaLyte and GranuFlo acid concentrates. The recall cautioned clinicians of the potential for inappropriate prescriptions caused by the high bicarbonate conversion levels. The concentration of acetate and acetic acid contained in Fresenius’ NaturaLyte and Granuflo has been found to convert into bicarbonate at greater rates than other acid concentrates, thus potentially leaving patients at risk of high bicarbonate levels. Increased levels of bicarbonate may contribute to metabolic alkalosis, a significant risk factor associated with a number of serious complications, including:
- Hypoxemia
- Hypercapnia
- Cardiac arrhythmia
- Low blood pressure
- Hypokalemia
- Cardiopulmonary arrest (heart attack).
2010 GranuFlo Case Control Study
Having been linked to a greater number of heart complications, FMC conducted a case-control study on all GranuFlo patients. The study found that patients with bicarbonate levels greater than 28mEq/L before dialysis treatment were 4.7 times more likely to suffer cardiac arrest. In addition, patients with a pre-dialysis potassium level less than 4mEq/L faced a 6.3 times higher risk of a heart attack. While the data suggesting GranuFlo and NaturaLyte patients faced an unusually high risk of heart attacks had been available since 2010, the Fresenius waited until 2011 to inform FMC operated clinics of the dangerous risk of inaccurate prescriptions and waited until 2012 before alerting the wide public of the issue.
Nationwide Impact on Dialysis Patient Health
Some 240,000 patients receive hemodialysis treatment either at FMC dialysis centers or facilities operating with FMC devices. Of that number, approximately 125,000 patients are treated using GranuFlo dialysate in non-FMC clinics. FMC defends its decision to delay informing the FDA by claiming that there was not enough evidence until 2012. However, the internal memo that was distributed to FMC operated centers indicates the manufacturers were aware of the very serious risks linked to the GranuFlo formulation. Their decision to withhold information may have cost hundreds of lives that may otherwise have been prolonged through proper dialysis treatment.
Securing Financial Compensation
Revenue from U.S. GranuFlo sales alone is estimated at a minimum of $80 million per year. When a company makes a decision to endanger the public’s health for its profits, product liability laws provide legal options for the wrongfully harmed patients. Speaking with an aggressive trial lawyer knowledgeable in product liability law, particularly someone experienced in handling cases against medical device manufacturers, can ensure your receive the total financial compensation you deserve after being injured by a defective device. GranuFlo or NaturaLyte patients and their families are encouraged to contact a knowledgeable attorney to evaluate their legal rights to compensation.