Fresenius is Accused of Withholding Information of the Dangers of their Dialysis Products GranuFlo and NaturaLyte
Fresenius provides products and services for people with kidney problems. They provide dialysis treatments at their own labs, and provide such products as GranuFlo and NaturaLyte. These products were the subject of an FDA recall earlier this year following the agency receiving evidence through anonymously leaked internal company memos that the dangers were not disclosed by Fresenius to patients who were undergoing treatment. These patients, unaware of the risks, were subjected to cardiac problems and possible death.
Metabolic alkalosis may occur as a result of NaturaLyte and GranuFlo
Medical experts have linked NaturaLyte and GranuFlo related side effects to metabolic alkalosis. These products may result in high bicarbonate levels in the bloodstream which, in turn, can lead to metabolic alkalosis. The symptoms of metabolic alkalosis may include sudden drops in blood pressure, irregular heartbeat, nausea, and vomiting.
The FDA orders a Class I recall—the most serious kind—of Fresenius products
The report stated that patients who received GranuFlo and NaturaLyte had experienced cardiac at rates that were significantly higher that those who had used other hemodialysis products. Fresenius allegedly knew this in November of 2011, but it did not take any steps to notify customers until nearly four months later. The FDA conducted an investigation and implemented a Class I recall of the products.
A Class I recall is the most serious level recall and can only be ordered by the FDA when the product exposes the public to the risk of death.
Those injured or put at risk are contacting GranuFlo attorneys to gauge the viability of their cases against Fresenius.
More than 940 deaths were related to these products in 2010
In the United States each year, around 400,000 people undergo hemodialysis treatments. It is estimated by some experts that as many as one-third of these patients were exposed to Fresenius’s products GranuFlo and NaturaLyte. More than 940 deaths were related to these products in 2010.
Amid allegations that they knew of the dangers of their products and failed to notify clients and patients, the value of Fresenius is in decline. Daily Finance has reported that the stock of Fresenius Medical Center was down 2.7% last week.
[SmartLink granuflolawsuit]