GranuFlo Injury Lawsuit
On March 29, 2012, Fresenius Medical Care of North America issued a Class 1 Recall, the most serious type of recall, for its products GranuFlo and NaturaLyte. The Class I recall was implemented because the increased risk with these two products involve a reasonable probability that use of these products will cause serious adverse health consequences or death. These products are used in the treatment of acute and chronic renal failure during dialysis. The reason for the recall lies in the increased risk for high serum bicarbonate level in patients undergoing hemodialysis with these products. A high serum bicarbonate level may contribute to metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which, if not appropriately treated, may result in cardiopulmonary arrest or even death. On May 25, 2012, the FDA issued a Safety Communication to nephrology doctors and nurses using dialysis equipment about the risks associated with acetate, acetic acid and/or citrate levels in dialysate concentrates such as GranuFlo and NaturaLyte. On June 27, 2012, the FDA issued a a Class 1 Recall notice for Fresenius Medical Care of North America’s GranuFlo and NaturaLyte.
How Bailey & Galyen Can Help You with Injury Lawsuit
The attorneys of Bailey & Galyen are currently investigating GranuFlo and NaturaLyte induced heart attack for victims and for families of victims. If you or somebody you know was injured from use of GranuFlo and NaturaLyte dialysis, call our attorneys immediately to receive a free case review. Call 844-402-2992 or complete the injury form to speak with our Pharmaceutical Litigation Department.
GRANUFLO INJURY UPDATE
Nov. 29, 2012 – An Ohio GranuFlo lawsuit was filed by the family of a man who suffered cardiac arrest and death in 2010 following being administered GranuFlo. Nov. 12 – A Georgia GranuFlo death lawsuit was filed on behalf of one GranuFlo patient who suffered a heart attack suddenly and died during GranuFlo dialysis treatment during 2010.
Sep. 27, 2012 – A Georgia GranuFlo wrongful death case was filed for a woman which died from a lethal cardiovascular event while receiving dialysis treatment.
Sep. 4, 2012 – Two Fresenius wrongful death suits were filed in Alabama. Both cases were filed on behalf of husbands who died from heart attacks following administration of GranuFlo or Naturalyte while receiving dialysis treatment.
May 25, 2012 – The FDA has issued a safety alert and Class 1 recall of the dialysis treatments GranuFlo & Naturalyte because of risk for death, bicarbonate overdose, heart attack, metabolic alkalosis, and sudden cardiac arrest.
GranuFlo Failure to Warn
The United States Food & Drug Administration has placed Fresenius Medical Care under investigation for their failure to adequately and properly warn patients regarding life-threatening risks of serious complications linked to dialysis treatment using GranuFlo.
In the month of November in 2011, Fresenius Medical sent out an internal company memo warning its own doctors who work in Fresenius dialysis centers. At the same time, they did not warn doctors providing care at non-Fresenius dialysis centers. The internal Fresenius memo warned its own doctors that improper GranuFlo dosage administration had been linked to a drastic increase in the number of GranuFlo patient deaths.
This memo indicated that 941 GranuFlo patients had suffered from cardiac arrest while receiving treatment in Fresenius dialysis centers since the year 2010. Staff of Fresenius had concluded that its dialysis patients who had high bicarbonate levels were at more than six times the risk for cardiac arrest when compared with patients at low levels of bicarbonate.
Yet, Fresenius made not efforts to notify FDA officials regarding this dangerous finding. The company also did not immediately notify any other non-Fresenius dialysis clinics which used its dialysis supplies. Only after an anonymous tip to the FDA did the problem come to light as the company’s own internal memo was forwarded by this source to the FDA several months later in March of 2011.
GranuFlo Complications & Injuries
Serious GranuFlo complications can include the following:
- Heart attack
- Metabolic alkalosis
- Cardiopulmonary arrest
- Cardiac arrest
- Low blood pressure
- Hypokalemia (potassium reaches dangerously low levels)
- Hypoxemia (oxygen reaches dangerously low levels in blood)
- Hypercapnia (carbon dioxide reaches dangerously high levels in blood)
- Cardiac arrhythmia
If you or a loved one has been injured from GranuFlo and NaturaLyte dialysis treatment, call our dialysis injury attorneys at Bailey & Galyen today — you could be eligible to receive compensation through a GranuFlo and NaturaLyte injury lawsuit. Through a dialysis lawsuit, you could be entitled to receive significant financial damages for pain and suffering, lost income, medical expenses, disability, or in the additionally extreme situation of wrongful death of a loved one.
How to Know If You have a GranuFlo Injury Case
Bailey & Galyen is currently investigating GranuFlo and NaturaLyte – caused injury cases throughout all 50 states. Did you or a loved one suffer a heart attack while receiving dialysis with GranuFlo and NaturaLyte? If you were taken to the emergency room and admitted to the hospital for treatment for a heart attack, our GranuFlo and NaturaLyte dialysis lawyers can be reached immediately and will give you a free case evaluation. Please call 844-402-2992 or complete our intake form to reach our Pharmaceutical Litigation Department.
Our phones are answered 24 hours a day, seven days a week 844-402-2992