Following a May 25, 2012 FDA warning, many kidney dialysis patients are considering a consultation with a GranuFlo lawyer.
The FDA warned healthcare professionals of dosing errors occurring with hemodialysis products GranuFlo and NaturaLyte, both made by Fresenius Medical Care. According to an internal Fresenius memo, these products have been linked with serious cardiovascular side effects, including heart rhythm problems and cardiopulmonary arrest.
Reports indicate, however, that Fresenius may have put thousands of patients at risk of GranuFlo side effects by failing to adequately warn dialysis centers of the dangers associated with GranuFlo.
FDA Questions Company About GranuFlo Side Effects
Fresenius alerted doctors at company run dialysis centers of the risks of GranuFlo in 2011. It was not until the FDA anonymously received a copy of a Fresenius company memo that Fresenius issued a broader warning about GranuFlo side effects on March 29, 2012.
In the memo, Fresenius warned its own doctors of problems they were seeing in their dialysis centers. After examining the data from 941 deaths by cardiac arrest that occurred in Fresenius centers in 2010, the company determined that an elevated bicarbonate level was an independent risk factor in these deaths. They noted GranuFlo as a potential cause, since the product can create higher levels of bicarbonate than similar products.
GranuFlo May Blame Fresenius for Failing to Warn
GranuFlo and NaturaLyte are acid concentrates made by Fresenius. Both products are used during hemodialysis procedures to help control acid levels in the blood. They are designed differently than similar products, however, and according to the November 2011 memo, doctors were not always aware of this.
Some kidney patients are prescribed bicarbonate outside of dialysis procedures to help control acid in the blood. When GranuFlo is used during dialysis, bicarbonate levels may climb high enough to create a condition known as metabolic alkalosis, which is a pH imbalance in the body.
According to the FDA warning dated May 25, 2012, metabolic alkalosis is a significant risk factor for low blood pressure, low blood oxygen, high carbon dioxide in the blood, cardiac arrhythmia, and cardiac arrest that can result in death. A GranuFlo lawyer is likely to claim Fresenius was negligent in warning physicians of this connection.
FDA Issues a Class I Recall
On June 27, 2012, the FDA issued a Class I recall for both GranuFlo and NaturaLyte, stating that these products can cause œserious adverse health consequences, including death. The agency added that Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious health problems.
Free Consultation with a GranuFlo Lawyer
Patients who suffered a serious cardiovascular injury after going through dialysis with GranuFlo may be eligible to recover damages through a GranuFlo lawsuit. A thorough review of your case with a GranuFlo lawyer may reveal claims that can be made against the manufacturer. Contact Chaffin Luhana LLP for a free and confidential case evaluation at 1-888-480-1123.