Top Class Actions’s website and social media posts use affiliate links. If you make a purchase using such links, we may receive a commission, but it will not result in any additional charges to you. Please review our Affiliate Link Disclosure for more information.
GranuFlo Recall Puts Fresenius Medical Care Deaths in Spotlight
By Christina Drury
Â
GranuFlo along with its powder form, NaturaLyte, were used to treat patients with kidney problems – those on dialysis. GranuFlo was approved by the US Food and Drug Administration (FDA) in 2003 for use in hemodialysis treatments. The drug was used for several years before Fresenius Medical Care (FMC) carried out a study that showed 941 patients had suffered from cardiac arrest while undergoing care in 667 different Fresenius clinics. Instead of making this information public knowledge, or alerting the FDA, FMC simply sent an internal message to its own Fresenius clinics warning them of GranuFlo heart attacks. Thousands of other dialysis clinics who were using GranuFlo along with NaturaLyte were not informed of these events, nor were they given any warning.
FDA Receives Anonymous Notification
Four months after FMC notified its internal clinics of the dangers associated with GranuFlo and NaturaLyte, the FDA received a copy of the memo. The memo was sent anonymously and sparked an FDA investigation into NaturaLyte and GranuFlo side effects. Shortly after their investigation was initiated, the FDA issued a Class I recall – the most serious recall – to remove the dialysis products from the market in the interest of patient safety. Despite the recall and the notification sent to the internal clinics managed by FMC, there were numerous patients who experienced GranuFlo side effects such as cardiac arrest and heart attack.
NaturaLyte & GranuFlo Side Effects
The main problem that was experienced with GranuFlo is that the drug contained higher levels of acetate than its competing drugs in the same market. As a result, the body was producing higher levels of bicarbonate which, in turn, caused serious GranuFlo side effects – and in some cases, even death. The most common GranuFlo side effects experienced by those who are filing GranuFlo lawsuits are:
* Heart problems
* Cardiac arrest
* Low blood pressure
* Metabolic alkalosis
Each of these GranuFlo side effects can cause medical complications that would not otherwise be experienced in most instances.
Patients Begin Filing GranuFlo Lawsuits
When the public was made aware of the potential complications that may have been caused by the use of GranuFlo, they began filing lawsuits against FMC to recover compensation for injuries sustained. NaturaLyte and GranuFlo are no longer on the market, but the action taken by the FDA came too late for some patients who had already experienced serious GranuFlo side effects.
Seeking the Legal Help You Need
If you have been injured or someone you know has been injured through the use of GranuFlo or its powder form, NaturaLyte, it is recommended that you seek professional legal advice to explore your options. You can view your possibilities and submit your information simply by visiting our Kidney Dialysis Heart Attack, GranuFlo & NaturaLyte Recall Class Action Lawsuit Settlement Investigation page. Your information will be sent to attorneys who are actively investigating the lawsuits pertaining to GranuFlo side effects. You may be eligible to receive compensation for your pain and suffering, wrongful death, negligence and fraud complaints if your GranuFlo side effects limited the capacity of your life.
Â
Updated December 26th, 2012
Â
All medical device, dangerous drug and medical class action and lawsuit news updates are listed in the Drug and Medical Device section of Top Class Actions.
Â
Top Class Actions Legal Statement