GranuFlo and NaturaLyte are brand names of dialysates manufactured by Fresenius Medical Care – the world’s largest provider of kidney dialysis services and products – and used in thousands of dialysis centers to treat Americans with kidney disease or failure. However, after investigating the harmful effects of these products, the Food and Drug Administration (FDA) issued a Class I recall of GranuFlo and NaturaLyte on March 29, 2012, to revise prescribing instructions. According to the recall, use of these two products can lead to low blood pressure and cardiac arrhythmia. These conditions “may culminate in cardiopulmonary arrest” or other conditions, including death.
Evidence surfaced that Fresenius was aware of the dangers of these drugs and did not share this information with health care providers or consumers. An internal company memo from Nov. 4, 2011, reported that more than 900 patients had experienced heart attacks in Fresenius clinics during the previous year. The memo states that the company’s medical staff reached the conclusion that patients with excessive levels of bicarbonate in their blood were six times more likely to have cardiac arrest than those with normal levels. The memo also linked GranuFlo use to increased bicarbonate levels and heart attacks.
The growing number of people injured by these dangerous products resulted in lawsuits filed against Fresenius. These lawsuits claim GranuFlo and NaturaLyte caused severe, permanent injuries and damages including: mental and physical pain, cost of medical care, loss of wages and future earning capacity, and death. Plaintiffs allege that the manufacturer “intentionally, recklessly and/or negligently concealed, suppressed, omitted and misrepresented the risks, dangers, defects, and disadvantages of GranuFlo and NaturaLyte.”
Status of GranuFlo and NaturaLyte Lawsuits
Nearly 200 GranuFlo and NaturaLyte lawsuits were consolidated into multidistrict litigation (MDL) in the District of Massachusetts under U.S. District Judge Douglas P. Woodlock. The U.S. Judicial Panel on Multidistrict Litigation decided to consolidate cases from Pennsylvania, California, Florida, Georgia, Louisiana, Mississippi, New Jersey New York and Ohio in March 2013.
Waltham, Mass.-based Fresenius did not object to the MDL being created in Massachusetts.
According to transfer order, “All the actions share common factual questions arising out of the allegations that plaintiffs suffered injury or death caused by the use or GranuFlo and/or NaturaLyte products during hemodialysis, which allegedly may cause metabolic alkalosis in patients resulting in low blood pressure. Hypokalemia, hypoxemia, hypercapnia, cardiac arrhythmia or cardiopulmonary arrest.”
Some attorneys are claiming hundreds more clients across several more states are ready to file suit.
Why People File Claims over GranuFlo and NaturaLyte
In lawsuits filed by plaintiffs injured by GranuFlo and NaturaLyte, several allegations are brought against Fresenius — specifically, that the company knew of the dangerous nature of these products and failed to inform the public. Fresenius is also accused of intentionally putting patients in harm’s way by failing to warn health care providers and properly train them in the safe use of these dialysis products.
|In a complaint filed in September 2012, injured parties claim that Fresenius:|
|Failed to dutifully warn health care providers and patients of the significant risk of cardiac arrest and death associated with GranuFlo and NaturaLyte despite the fact that the company knew of these risks when it introduced these products.|
|Intentionally withheld risks of adverse cardiac events and did not properly report them to the FDA or the public.|
|Intentionally withheld adverse event information from non-Fresenius physicians and clinics.|
|Failed to warn of the increased risks for “acute” dialysis patients.|
|Continued to actively market and sell GranuFlo and NaturaLyte despite knowledge of significant safety risks.|
|Failed to release adequate product-related warnings and instructions to treating health care providers.|
|Misled consumers about the safety of the product in order to continue selling it.|
|Intentionally failed to address the known defects of GranuFlo and NaturaLyte prior to marketing them to the public.|
|Displayed “a conscious disregard for the safety of the public.”|
The exact number of lawsuits related to GranuFlo and NaturaLyte is not known, but families that lost a loved one to cardiac arrest filed lawsuits related to how the products create an overabundance of bicarbonate. While bicarbonate is an essential part of the dialysis regimen, excessive bicarbonate can lead to serious health problems, including an increased risk of cardiac arrest and death. The chemical composition of GranuFlo and NaturaLyte encourages the overproduction of bicarbonate.
In July 2012, Alabama resident Arthruine Williams filed a lawsuit against Fresenius on behalf of her late husband, Johnny, in the U.S. District Court in the Northern District of Alabama. According to the claim, Johnny Williams underwent a dialysis treatment that used GranuFlo in July 2010 and died of a heart attack the following day. His widow says that Fresenius officials knew that the use of GranuFlo and NaturaLyte posed a significant increased risk of cardiac arrest and death.
A month later, Betty Lemmond sued in the same court on behalf of her late husband, Dizzy Dean Lemmond. Her husband died of a heart attack in August 2010, the same day that he received a dialysis treatment with GranuFlo. Betty Lemmond’s lawsuit accuses Fresenius of negligence, wantonness, fraud, unjust enrichment and failure to warn patients about the dangers of GranuFlo and NaturaLyte.
In September 2012, Waddell Bishop filed a lawsuit against Fresenius on behalf of his late mother, Frances Carol Bishop, in the U.S. District Court for the Southern District of Georgia. Frances Carol Bishop had received a dialysis treatment in early September 2010 and died of a heart attack later that month. Waddell Bishop said his mother’s death “directly resulted from using GranuFlo and/or NaturaLyte,” according to the lawsuit.
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Dialysis and Cardiac Side Effects of GranuFlo and NaturaLyte
For patients with diminished kidney function or renal failure, hemodialysis treatment allows them to lead somewhat normal lives. The treatment, which typically is performed three times a week, involves removing blood from the patient and running it through a dialyzer — a filtering machine sometimes called an artificial kidney. A chemical solution known as a dialysate removes waste products and cleanses the blood, which is then pumped back into the patient.
GranuFlo is a powdered compound that creates bicarbonate, a major ingredient in the dialysis process. NaturaLyte works in much the same way but in liquid form. When excessive bicarbonate builds up in patients who use GranuFlo or NaturaLyte, serious problems stemming from the compounds’ chemical compositions can occur. RenalWEB, a site that tracks the dialysis industry, found that the compositions of GranuFlo and NaturaLyte “are unique in that they use sodium diacetate” rather than the traditional sodium (mono)acetate. This special composition can lead to the production of higher levels of bicarbonate when the products are administered at the same dosage levels as the typical dialysate.
An increase of bicarbonate in the bloodstream can lead to a condition known as metabolic alkalosis, which occurs when the pH level in the blood tends toward the alkaline end of the scale. Because kidneys are largely responsible for maintaining the acid/alkali balance in the bloodstream, maintaining bicarbonate levels during dialysis is a crucial part of the process. Just as excessive acid in the blood (acidosis) can cause serious damage to internal organs, alkalosis also can lead to significant health problems, including heart arrhythmia, heart attack, coma and even death.