In federal courts throughout the U.S., GranuFlo lawsuits have been filed against the world’s largest dialysis group, Fresenius Medical Care, for injuries and deaths allegedly caused by the company’s GranuFlo and NaturaLyte products, which are used to treat dialysis patients.
GranuFlo lawsuits allege the claimants or their loved ones suffered heart attacks, which were often fatal, after being treated with GranuFlo or NaturaLyte at dialysis centers owned by Fresenius Medical Care or other companies. The lawsuits also claim the products’ labeling and warnings did not adequately warn users about the risks posed by these drugs.
GranuFlo & NaturaLyte Might Cause Heart Attacks & Death
GranuFlo and Naturalyte were recalled in March 2012 because, compared to rival products, they contained more of an ingredient that the human body converts into bicarbonate and, according to the New York Times, doctors had “not been accounting for this extra bicarbonate contribution from GranuFlo when deciding how much bicarbonate to prescribe separately. The result can be, in effect, an overdose of bicarbonate, which some recent studies have suggested could lead to heart problems.”
Overdoses of bicarbonate from GranuFlo and NaturaLyte can cause these side effects:
- Heart attack;
- Low blood pressure;
- Low potassium in the blood;
- Low levels of oxygen in the blood;
- Excessive carbon dioxide in the blood;
- Cardiac arrhythmia (irregular heartbeat)
The the U.S. Food and Drug Administration (FDA) categorized the GranuFlo recall and the NaturaLyte recall as a “Class I recall.” The agency reserves that designation for the “most serious type of recall and [for instances that] involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death,” according to the FDA’s web site.
GranuFlo Lawsuits Claim Fresenius ‘Failed To Warn’ of Risks
Claimants have filed personal injury and wrongful death lawsuits against Fesenius in federal courts in many states, including New York, Massachusetts, Louisiana, Illinois, Georgia, Florida, Colorado, and Alabama. Several of the plaintiffs in these cases have moved to consolidate them into a multi-district litigation action (an “MDL”) in Massachusetts. An MDL is not a class action. Unlike the cases in a class action, MDL lawsuits are tried separately. The GranuFlo and NaturaLyte cases were ordered to be consolidated into an MDL in Massachusetts on March 29, 2013, but this will not have any effect on a new plaintiff’s ability to file a case.
Many of the plaintiffs who have filed GranuFlo lawsuits and NaturaLyte lawsuits cases were married or were somehow otherwise related to a patient who died after having been administered GranuFlo or NaturaLyte at a dialysis clinic. The lawsuits’ complaints allege that Fresenius “failed to provide adequate warnings and instructions to the ‘learned intermediaries’ [i.e., doctors and other healthcare workers] who used GranuFlo and NaturaLyte to treat dialysis patients.”
Indeed, GranuFlo and NaturaLyte had been used for almost 20 years before, in Nov. 2011, Fresenius sent an internal memo to the doctors in Fresenius’s own clinics warning them that the higher bicarbonate levels in GranuFlo had caused 941 heart attacks in the company’s own clinics in 2010, leading the company’s researchers to estimate that GranuFlo increases a patient’s risk of heart attack by six times. Even then, Fresenius did not send the memo to GranuFlo-using clinics that the company didn’t own. Only in late March 2012, after the FDA had anonymously received a copy of the internal memo that Fresenius had sent to its own dialysis clinics, did Fresenius warn other dialysis clinics about the heart attack risks GranuFlo and NaturLyte pose.
RLG’s GranuFlo Lawyers & NaturaLyte Lawyers Will Make Things Easier
Legal action is the best way to recover the most compensation for medical bills, lost wages, pain and suffering, and other damages.
If you believe that you or someone you love had a heart attack or died as a result of NaturaLyte or GranuFlo, submit this simple secure form and we will get back to you to evaluate your eligibility to file a GranuFlo lawsuit or a NaturaLyte lawsuit. The evaluation will be free and confidential.