GranuFlo and NaturaLyte Settlements

GranuFlo and NaturaLyte are two brands of dialysates manufactured by German pharmaceutical company Fresenius. Fresenius is the world’s largest provider of kidney health and dialysis products. If you’re going to a dialysis center, it’s more than likely that it’s a Fresenius center.

These two dialysates are intended to treat patients with diminished kidney function or renal failure. In the dialysis procedure, dialysates are used to remove waste products from the patient’s blood. With clean blood, patients can lead a more functional, more comfortable lifestyle.

GranuFlo and NaturaLyte were recalled by the FDA on March 29, 2012, due to a slew of complaints about complications caused by the medicines. The associated complications include low blood pressure, cardiac arrhythmia, hypoxemia, cardiac arrest, and even death. In light of these problems, the FDA ordered a revision of prescribing instructions as well as the recall.

Along with claims made by patients, evidence that Fresenius was aware of potential risks was circulated around the company in a memo from November, 2011. This memo reported that of patients taking the drugs in question, over 900 had suffered heart attacks. Doctors monitoring these patients came to the conclusion that patients taking GranuFlo or NaturaLyte were more likely to have increased bicarbonate levels in the blood stream, which can correlate to a higher incidence of cardiac arrest. In fact, those with higher bicarbonate levels are six times more likely to face cardiac arrest than those with normal bicarbonate levels. These findings correlate with a report issued by the FDA when the drug was recalled. The FDA report stated that GranuFlo and NaturaLyte both have high concentrations of acetic acid or acetate, and that such high concentrations can cause patients to have a higher serum bicarbonate levels.

The sheer amount of patients who took GranuFlo or NaturaLyte and then experienced complications led to a series of lawsuits against Fresenius. Plaintiffs allege that Fresenius products GranuFlo and NaturaLyte cause injuries and health complications that could lead to high medical bills, lost wages due to illness, mental and physical anguish, and potentially death. Plaintiffs also allege that Fresenius has been criminally negligent because of the company’s awareness of the risks and dangers presented by GranuFlo and NaturaLyte. In addition, Fresenius has blatantly disregarded the safety of its patients by failing to warn health care providers and clinics of the dangers inherent to the drugs.

Lawsuits against Fresenius were consolidated into multi-district litigation (MDL) in Massachusetts. These cases were drawn from New York, Ohio, New Jersey, and Georgia, amongst other states. At present, Fresinius has announced a $250 million settlement to resolve the thousands of lawsuits now pending. That settlement will take effect by July if ninety-seven percent of all plaintiffs agree to the terms.

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