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On January 25, 2013, a 38-year-old Louisiana man filed a product liability lawsuit against Fresenius Medical Care, claiming he had suffered from life-threatening dialysis injuries. According to the GranuFlo and NaturaLyte lawsuit filed at the Louisiana east district court, Ronnie Glasper suffered from heart stroke, heart attack, and severe pain following hemodialysis treatment at Fresenius clinic in Ferriday. He was administered with two dialysates NaturaLyte and GranuFlo, manufactured by Fresenius, which have been linked to the substantial risk of cardiovascular problems, metabolic imbalance, and wrongful death.
The hemodialysis lawsuit is one of the three dozen similar litigation cases filed against Fresenius in various federal courts across the United States. The number of lawsuits is expected to grow into hundreds, and the motion for MDL consolidation has already been filed. Internal memos leaked in March 2012 revealed that Fresenius was aware of hundreds of deaths caused by improper doses of NaturaLyte and GranuFlo at its clinics in 2010, but continued to treat patients with these hemodialysis solutions without any warning or disclosure of safety concerns.
Powder GranuFlo and its liquid version NaturaLyte are produced by Fresenius Medical Care, the leading provider of hemodialysis solutions in the world. It supplies dialysis concentrates, equipment, and machines and runs a chain of clinics offering dialysis for patients suffering from kidney ailments. Patients with acute and chronic kidney failures are administered with these two alkaline concentrates to reduce acid buildup in their blood. However, a high amount of acetate ingredient in GranuFlo and NaturaLyte results in elevated bicarbonate in human body.
According to RenalWEB, GranuFlo and NaturaLyte comprise sodium diacetate and acetic acid while other hemodialysis concentrates mostly contain sodium acetate. Sodium diacetate leads to sharp rise in bicarbonate buildup, which, in turn, causes serious health hazards. Excessive bicarbonate results in a number of side effects, including cardiopulmonary arrest, arrhythmias, and stroke, that could result in death of patients.
Increased bicarbonate in the blood also results in metabolic alkalosis that distorts the pH level balance and increases alkaline concentration. Rise in alkalinity deprives body organs of hydrogen-ion and puts patients at a six-fold higher risk of heart attack, coma, and death. In 2010, about 900 patients in the United States experienced cardiac problems following use of GranuFlo and NaturaLyte during their hemodialysis. A number of patients also suffered from other dialysis side effects, such as hypotension, hypoxemia, neurological disorders, and severe pain.
The most reported NaturaLyte and GranuFlo side effects include
Fresenius introduced GranuFlo and NaturaLyte in 2003. However, the manufacturer did not prescribe any dose limit, usage instructions, or warnings despite the drugs having high amount of sodium diacetate and acetic acid concentrates. Though the manufacturer was aware of the drugs causing abnormally high bicarbonate levels in patients and related cardiovascular risks, it did not inform other clinics using these concentrates until 2012.
Fresenius resorted to aggressive marketing of these drugs, ignoring incidents of increase in bicarbonate levels and heart strokes in patients. Instead of monitoring GranuFlo and NaturaLyte ingredients and adjusting dose prescriptions, the manufacturer bundled these drugs with other dialysis products and offered them at a discounted price.
An internal review carried out by Fresenius in 2011 found many instances of abnormally high bicarbonate level causing heart stroke and hypotension. It found at least 941 of about 80,000 patients treated at its 667 dialysis centers in 2010 suffered from sudden cardiopulmonary arrest. Experts are of the opinion that the figures represented just a small fraction of total number of dialysis deaths and injuries linked to by NaturaLyte and GranuFlo.
In November 2011, Fresenius informed all its clinics about the findings and instructed them to monitor patients for sharp rise in bicarbonate levels and adjust dosage accordingly to prevent any kind of cardiac arrest and death. The internal memo highlighted that the drugs could increase the risk of heart attack by six to seven fold for patients with borderline alkalosis and bicarbonate levels prior to dialysis. Interestingly, Fresenius did not divulge this information to other clinics using NaturaLyte and GranuFlo hemodialysis concentrates and kept its dissemination restricted to its own clinics.
In March 2012, the FDA came to know about this internal memo and immediately asked Fresenius to report about GranuFlo and NaturaLyte side effects and the risk of dialysis problems linked to these drugs. On March 29, the FDA ordered for GranuFlo and NaturaLyte recall, classifying the concentrates as a Class I risk - the most serious type of drug side effects. This prompted Fresenius to notify all clinics about potential risk of heart attack, stroke, and death associated with GranuFlo and NaturaLyte concentrates.
According to a June 2012 report on the New York Times, the FDA ordered an investigation to ascertain if Fresenius violated federal laws by suppressing information on the potential dialysis treatment injuries associated with GranuFlo and NaturaLyte side effects. The regulator took a strong view of Fresenius issuing warnings only to its own clinics about drug side effects and not letting its entire customer base and other healthcare professionals becoming aware of the possible cardiac arrest, pain, and death caused by these drugs.
A number of GranuFlo and NaturaLyte lawsuits have been filed across the United States claiming product liability against Fresenius for
In July 2012, an Alabama woman sued Fresenius for the death of her husband. Johnny Williams, the victim, died of cardiac arrest in July 2010 after he was administered with GranuFlo during his dialysis treatment. The litigation that came two months after the FDA recall led to sharp rise in GranuFlo and NaturaLyte dialysis lawsuits. In August, another Alabama resident filed a product liability lawsuit against Fresenius claiming fraud, negligence, breach of trust, and endangering consumer safety for commercial gains. Her husband died of cardiopulmonary arrest following dialysis treatment with GranuFlo.
In September 2012, a lawsuit filed in a Georgia federal court claimed that plaintiff’s mother died of heart attack that was caused by GranuFlo and NaturaLyte she was administered with during the dialysis treatment. By the end of 2012, the total number of lawsuits stood at 37, and it is expected to run in thousands, as more and more people are coming forward following media publicity of GranuFlo and NaturaLyte side effects.
In January 2013, a Texas woman sued Fresenius claiming that GranuFlo and NaturaLyte side effects following hemodialysis led to the death of her husband. A motion for MDL consolidation of all GranuFlo and NaturaLyte dialysis lawsuits were filed at the District of Massachusetts in December 2012.
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