GranuFlo is a powder concentrate used in thousands of kidney dialysis centers around the United States for hemodialysis. It is marketed as an easier, cost effective alternative to pre-mixed liquid solutions, allowing clinics to mix their own dialysate on site.
Although Granuflo itself is not a dangerous product, its chemical formulation can lead to improper mixing or administration, causing serious injury or death. Potential Granuflo side effects include:
In March, 2012, the FDA issued a Class I recall of the product after learning that its maker, Fresenius Medical Care (FMC), knew of the risk of these Granuflo side effects, but did not inform outside doctors, patients or the FDA.
Although Granuflo remains on the market for dialysis, lawyers are helping those affected file claims based on FMC’s failure to properly warn of the dangers.
If you or a loved one suffered cardiopulmonary arrest, heart attack or death after dialysis treatment with Granuflo, you may be entitled to substantial compensation. It is important to speak with a lawyer about your legal options. Contact us today.
Dialysis cleanses the blood of toxic waste when damaged or failed kidneys can no longer do this naturally. Part of the process uses bicarbonate to neutralize built-up acid in the bloodstream.
Granuflo contains more of an ingredient which the body converts to bicarbonate, a property that many doctors weren’t advised of by FMC. This may have led to patients receiving higher separate bicarbonate prescriptions, which could contribute to severe Granuflo side effects.
In 2010, FMC conducted a widespread study due to higher-than-expected rates of patient heart problems at its clinics. The study found that 941 patients during that time suffered cardiopulmonary arrest, which was six times the normal level.
In November of 2011, FMC alerted doctors at its own clinics of possible Granuflo side effects, but failed to warn outside clinics, patients or the FDA. After the FDA received an anonymous copy of the FMC internal memo, the company moved quickly to add warning labels to the product in March of 2012.
Due to the attempts of FMC to hide the potential side effects of Granuflo, hundreds of thousands of dialysis patients were put at risk. Lawyers are currently helping those affected file claims for their loss.
Due to the number of Granuflo lawsuits expected, a federal judicial panel is consolidating all claims to a special Multi-District Litigation court. A lawyer can explain the current litigation, as well as whether your case may qualify and how long you have to take action.
Before choosing a lawyer, make sure they are qualified for this type of lawsuit and have experience fighting large drug companies. The DrugRisk Resource Center only recommends law firms that specialize in medical device injuries and have handled Granuflo claims.
For more information on the side effects, recall and legal action related to Granuflo, or to speak with a lawyer, contact us today. We are available 24 hours a day to provide help.