New GranuFlo Fatal Heart Attack Lawsuit Filed in Federal Court
By Courtney Coren
A GranuFlo lawsuit was filed in May by the daughter of a woman who suffered a fatal cardiac arrest after GranuFlo and NaturaLyte were used in her dialysis treatment.
The GranuFlo/NaturaLyte lawsuit was filed on May 17 in the U.S. District Court for the District of Massachusetts. The lawsuit claims that the additives used in the woman’s kidney dialysis caused the heart attack that took her life.
A similar lawsuit was filed in April by the child of a different woman who suffered a fatal heart attack just a few hours after receiving her hemodialysis treatment at a Fresenius medical center. Fresenius is the maker of both GranuFlo and NaturaLyte.
On May 14, the U.S. Judicial Panel on Multi-District Litigation said that there are now 161 lawsuits pending in the GranuFlo/NaturaLyte lawsuit MDL in the U.S. District Court for the District of Massachusetts, and more are expected to be added. All of the GranuFlo/NaturaLyte lawsuits have similar claims that the patients suffered serious injury or death after the additives were used in their kidney dialysis treatments.
GranuFlo is used in kidney dialysis to help neutralize the acid in the blood by providing bicarbonate. For kidney dialysis treatment to work and do the job of filtering the blood that is normally done by the kidneys, an acid concentrate such as GranuFlo or NaturaLyte need to be used. When the acid concentrate enters the bloodstream they are naturally converted to bicarbonate. Bicarbonate is how more than 90 percent of carbon dioxide takes form in the bloodstream — keeping the blood from becoming too acidic — a job normally done by healthy kidneys.
The problem with GranuFlo and NaturaLyte is that they were not properly dosed an were linked to a potential rapid increase of bicarbonate, leading to a condition known as alkalosis — meaning that the blood has become too alkaline. If a person develops alkalosis, the risk of a catastrophic heart side effect becomes 6 to 8 times more likely and can lead to sudden death.
The lawsuits claim that Fresenius knew about the dangers these additives caused and they failed to properly notify the doctors and clinics where the products were used of the potential dangers.
This claim is based on a memo Fresenius sent out in November 2011 to its own clinics — not all of the clinics that use GranuFlo and NaturaLyte — stating that GranuFlo was responsible for 941 deaths due to cardiac arrest at clinics in 2010. They notified all of the clinics where the acid concentrates were used in March 2012 after Fresenius was questioned by the U.S. Food & Drug Administration upon receiving an anonymous copy of November 2011 memo.
In June 2012, the FDA issued a Class I recall of NaturaLyte and GranuFlo — the most serious recall they can issue — restricted only for products that may result in severe injury or death.
If you or someone you know experienced a negative side effect after GranuFlo or NaturaLyte were used during kidney dialysis, legal options are available. Learn more and get a free consultation regarding a claim’s eligibility at the Kidney Dialysis Heart Attack, GranuFlo & NaturaLyte Recall Class Action Lawsuit Settlement Investigation. Experienced legal professionals acid concentrates played a roll in your complications, so act now.
Updated June 3rd, 2013
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.
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