After a warning by the Food and Drug Administration (FDA) on May 25th, 2012, many patients who frequently undergo dialysis for kidney function are looking to speak with a professional about a GranuFlo Dialysis Injuries Lawsuit.
The Food and Drug Administration (FDA) cautioned medical professionals that numerous dosing errors have occurred while using Fresenius Medical Center’s dialysis products: GranuFlo and NaturaLyte. Fresenius actually released an internal memo linking their products to severe cardiovascular injuries including heart attacks. Disappointingly, however, Fresenius only released this memo internally and failed to warn the broader public of the potential GranuFlo dialysis injuries.
The memo which Fresenius released warned doctors within their own centers about the serious risks of GranuFlo and NaturaLyte back in 2011. The only reason that this information has come to light is that somebody leaked the internal memo to the FDA. The FDA subsequently decided to launch an investigation into potential injuries caused by GranuFlo and NaturaLyte.
In Fresenius’ internal memo, they warned their own doctors that they were noticing potential problems inside their dialysis centers. After reviewing data of more than 941 deaths caused by cardiac arrest occurring in Fresenius’ centers during 2010, they determined that higher levels of bicarbonate was likely the cause of these GranuFlo dialysis deaths. They noted in the memo that GranuFlo in particular contains higher levels of bicarbonate than rival products which is likely the cause of all the GranuFlo dialysis injuries.
Both GranuFlo and NaturaLyte are hemodialysis products made by Fresenius used during dialysis to help maintain proper levels of acid in the blood during dialysis. They have a different makeup and many doctors were unaware of the potential dangers caused by GranuFlo dialysis products. Doctors outside of Fresenius’ own medical centers were unaware of the higher levels of bicarbonate in GranuFlo and as a result did not factor that into their dosing.
FDA Class I Recall
On June 27, 2012, the United States Food and Drug Administration (FDA) issued a Class I recall for both of Fresenius’ Products: GranuFlo and NaturaLyte. The FDA stated that GranuFlo and NaturaLyte may cause ‘serious adverse health consequences, including death.’ Class I recalls are the most severe type of FDA recall and only occur in situations where the FDA believes that there is a high probability that continuing to use the product may pose significant health risks.
Granuflo & Naturalyte Recall
Fresenius is currently under investigation by the FDA to see whether the company violated federal regulations by not alerting all customers of GranuFlo & NaturaLyte of the health risks. The FDA issued a Class 1 recall of GranuFlo & NaturaLyte from all clinics on June 27, 2012.
GranuFlo & NaturaLyte Lawsuit
If you or a loved one has experienced cardiac arrest, heart attack, stroke following dialysis with GranuFlo or Naturalyte, please contact the Willis Law Firm for a free consultation for a potential dialysis lawsuit. Call 1-800-883-9858 to speak to lawyer or CLICK HERE