Granuflo is a popular kidney failure drug manufactured by Fresenius Medical Care (FMC) and used in numerous dialysis centers around the world. FMC is the largest operator of hemodialysis clinics in the United States, and is also the leading supplier of dialysis machines and dialysis drugs like GranuFlo to clinics throughout the U.S. and Europe. GranuFlo first garnered FDA approval in 2003 and has since been used to treat patients suffering from a loss of kidney function due to renal failure. Despite the popularity of its dialysis medication though, Fresenius has come under fire recently for failing to warn dialysis clinics about the risk of cardiac arrest side effects linked to GranuFlo. If you have suffered from cardiac arrest and you believe GranuFlo to be the cause, contact a knowledgeable GranuFlo attorney to discuss your legal options.
Cardiac arrest occurs when the body’s normal circulation of blood is interrupted due to the failure of the heart to contract effectively. Cardiac arrest is often confused with a heart attack, in which blood flow to the heart muscle is impaired, although the two heart conditions are very different in presentation. According to the FDA, FMC’s GranuFlo can lead to elevated bicarbonate levels in dialysis patients, possibly leading to a condition called hemodialysis metabolic alkalosis, which is a major risk factor for cardiac arrest and other serious heart side effects. Although FMC became aware of the potential link between GranuFlo and cardiac arrest side effects back in November 2011 and alerted its dialysis centers of this risk via internal memo, the company failed to notify non-FMC dialysis centers. It wasn’t until March 2012 that the FDA received a copy of the internal memo and launched an investigation into Fresenius Medical Care’s GranuFlo medication, warning all dialysis centers about the risk of cardiac arrest side effects.
Cardiac arrest is a medical emergency and the effects of the condition can sometimes be reversed if diagnosed and treated early. Possible treatments for individuals who suffer cardiac arrest include CPR, defibrillation and therapeutic hypothermia, among others. Unfortunately, because impaired blood circulation prevents oxygen from being delivered to the rest of the body, the complications associated with cardiac arrest are often severe. A lack of oxygen supplied to the brain causes loss of consciousness, for example, and may result in abnormal or absent breathing. The prognosis for cardiac arrest is poor, and the survival rate of cardiac arrest victims who receive initial emergency care by ambulance is only 2%, with 15% experiencing return of spontaneous circulation. In some cases, cardiac arrest can lead to brain injury if the condition remains untreated for more than five minutes.
According to the 2011 FMC memo, as many as 941 GranuFlo patients had suffered from cardiac arrest associated with the improper administration of the drug. Cardiac arrest is an extremely serious heart side effect associated with a high mortality rate. Unfortunately, even for those who survive a cardiac arrest event, the long-term effects of the condition can be devastating and costly. For those individuals who suffer from brain injury caused by cardiac arrest, it is likely that life-long medical care will be required, which can lead to extensive medical bills. In the event of a cardiac arrest death, the victim’s surviving family members will likely suffer from emotional loss as well as costly funeral and burial expenses. If you have experienced cardiac arrest, or if you lost a loved one to cardiac arrest, and you believe GranuFlo to be the cause, consult an experienced GranuFlo lawyer to explore your compensation options. You may be entitled to financial compensation for your injuries, medical bills and pain and suffering, or funeral and burial costs, which you can pursue by filing a GranuFlo lawsuit against Fresenius Medical Care.