GranuFlo and NaturaLyte are products used to treat kidney problems, such as renal failure. They are acid concentrates given to patients who require dialysis treatment. Despite being used in thousands of dialysis centers across the country, these products can do more harm than good. NaturaLyte and Granuflo are currently at the center of a safety recall by the Food and Drug Administration (FDA), with many patients filing lawsuits against the manufacturer, Fresenius Medical Care. It was classified as a Class I recall in March 2012, the most serious of its kind. This means that there is a high probability that death can result from the use of a product.
Fresenius Medical Care is under attack for putting public health and safety at risk. It is believed that the company was aware of the serious medical conditions that these dialysis products caused, but continued to market them anyway without informing doctors and patients. The manufacturer allegedly did not provide doctors with adequate instructions regarding proper dosage of the products. This resulted in dosage errors, with doctors administering the products at doses too high for human consumption.
Fresenius Medical Care, in November 2011, issued a memo stating that GranuFlo and NaturaLyte were associated with an increased risk of cardiac arrest, but that memo was issued internally only. It went to Fresenius centers and not to outside centers, doctors or the general public. This means that most of the patients were unaware of this information and were continuing to use the products despite its serious risks. Many argue that the manufacturer’s warning was not enough and much more could have been done to protect patients’ health and safety.
The products have been linked to a heart attack rate of up to eight times higher than other dialysis products. Just in 2010 alone, 941 cases of cardiac arrest associated with NaturaLyte and GranuFlo usage were reported. So far, victims and their families have filed federal lawsuits in numerous states, including Massachusetts, California, Ohio, New York, New Jersey, Alabama and Pennsylvania. Fresenius Medical Care recently settled a wrongful death lawsuit after a patient suffered from a hemorrhage after a dialysis treatment in 2009. This patient’s five children received a seven-figure settlement from the company.
A certain amount of bicarbonate in the body is needed in dialysis. GranuFlo and NaturaLyte, however, create an overabundance of bicarbonate, which leads to metabolic alkalosis. This, in turn, results in serious medical conditions such as low blood pressure, stroke, rapid heartbeat and lack of oxygen in the blood. These conditions lead to cardiac arrest. Many users of the products have suffered serious health problems, some of which have been fatal.
Those who have suffered a heart attack or other serious medical condition as a result of GranuFlo and NaturaLyte have the legal right to seek help from an attorney focused in product liability. Surviving family members whose loved ones have died from use of these products may be able to file wrongful death lawsuits as well and recover compensation.