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bicarbonate 33 articles

Fresenius fighting request to produce adverse event reports related to GranuFlo, NaturLyte

Fresenius Medical Care is fighting a request by plaintiffs for the dialysis products and services provider to produce hard copies of adverse event reports involving patients because it would require the company to sift through records at 2,100 clinics with a client base of 170,000 patients in 2013. The motion was filed in federal multidistrict litigation in Massachusetts alleging Fresenius withheld information that its dialysis concentrates GranuFlo and NaturaLyte could cause patients to suffer heart problems and deaths. GranuFlo and NaturaLyte are solutions used to maintain proper acid balance in patients’ blood when they undergo hemodialysis for the treatment of ... Read More

Louisiana sues Fresenius for marketing dangerous, defective dialysis products

Hundreds of people have filed wrongful death and personal injury lawsuits against dialysis products and services giant Fresenius Medical Care North America over alleged injuries and deaths caused by the company’s dialysis concentrates GranuFlo and NaturaLyte. Now the state of Louisiana is joining in, asking for its day in court in order to recover payments made through the state’s Medicaid program for the defective products. Louisiana is accusing Fresenius of deceptive trade practices and fraudulent marketing to sell its defective dialysis products, and claims the company has known since 2004 that the products were labeled with confusing instructions that could ... Read More

Louisiana AG lawsuit claims Fresenius products caused fatal heart attacks in dialysis patients

The Louisiana Attorney General has filed a lawsuit against Fresenius Medical Care North America and the nearly 100 Fresenius-owned dialysis clinics in the state alleging that its dialysis concentrates GranuFlo and NaturaLyte contributed to fatal heart attacks of dialysis patients. The lawsuit, filed in state district court in Baton Rouge, claims Fresenius violated Louisiana law and attempted to defraud dialysis clinics, physicians, the state and its residents with confusing labeling on its dialysis products, which resulted in patients suffering sudden cardiac arrest. Louisiana seeks civil penalties of $5,000 per violation and is asking the court to force Fresenius to pay ... Read More

Fresenius faces another GranuFlo wrongful death lawsuit

A West Virginia man has filed a lawsuit against Fresenius Medical Care claiming a dialysis concentrate manufactured by the company caused his wife’s death. Fresenius is the world’s largest provider of dialysis products and services. There are more than 1,800 Fresenius facilities nationwide. The company’s products are also used in non-Fresenius-owned clinics. James Stockton alleges that for nearly 10 years his wife Beverly underwent dialysis treatment during which she received GranuFlo, a solution used to balance electrolytes in patents undergoing dialysis. GranuFlo contains an ingredient that metabolizes in the body to bicarbonate. Elevated levels of bicarbonate have been linked to heart ... Read More

Recent actions call into question whether Fresenius cares about patient safety

Recent actions by Fresenius Medical Care suggest the world’s largest provider of dialysis products and services may not be too concerned about patient safety. One example is the case of Robert Hiller. In January, he filed a lawsuit against Fresenius alleging he was wrongfully fired for simply doing his job of putting “into effect the company’s manufacturing practices to ensure that they were safe and complied with federal and state laws.” He alleged that in 2010 he first raised concerns whether certain practices where harming the purity of some of the products, but Fresenius officials initially dismissed his concerns. He was ... Read More

Fresenius recalls defective dialysis machines

Fresenius Medical Care is recalling more than 111,000 hemodialysis machines sold throughout the United States, Canada and Mexico. The recall, which affects specific model numbers from the Fresenius 2008 Series hemodialysis machines, was issued due to complaints of the saline bags inappropriately filling during recirculation and setup. Dialysis machines are designed to cleanse and filter the blood of patients with kidney disease whose kidneys do not function properly. Nearly 400,000 people in the United States undergo this life-saving treatment every day. Fresenius is the world’s largest provider of dialysis products and services, providing dialysis treatments within its own facilities and ... Read More

Death rate among dialysis patients dropping, but still higher than general population

Fewer people with end-stage renal disease and who may also be on dialysis are dying, however the rate of death among those populations remains much higher than the general population, according to the 2013 Annual Data Report from the U.S. Renal Data System. The death rate of patients with end-stage renal disease dropped more than 30 percent from 1996 to 2011. During that same time, the mortality rate among the dialysis population dropped more than 26 percent. According to the data, among patients an average of 65 years of age, dialysis patients overall had an expected 6.2 years of remaining life, compared to the ... Read More

Two more GranuFlo lawsuits filed against dialysis giant Fresenius

Two new lawsuits have been filed against Fresenius Medical Care North America, joining more than 300 lawsuits that allege two of the company’s dialysis products caused patients to suffer deadly heart attacks. Fresenius, the world’s largest provider of dialysis services and products, manufactures GranuFlo and NaturaLyte, concentrates that are administered to patients prior to dialysis to balance electrolytes. The products are used both in Fresenius facilities as well as dialysis clinics owned by competitor companies. GranuFlo and NaturaLye contain an ingredient that metabolizes into bicarbonate. However, these products contain more of the ingredient than competitor brands. In March 2012, the ... Read More

Dialysis treatments for kidney failure growing faster than world population

The need for dialysis treatments for kidney failure is growing at a faster rate than the population as a whole, according to a study presented at the 2013 American Society of Nephrology Kidney Week. For the study, titled “The Rapidly Growing Global Burden of End-Stage Renal Disease – An Analysis of the Change in Maintenance Dialysis Prevalence between 1990 and 2010,” researchers examined data from the Global Burden of Disease database, the largest existing database for global causes of illness and death, as well as data from national and regional end-stage renal disease (ESRD) registries. They performed a literature review ... Read More

Fresenius urges dialysis patients to get flu shots despite mounting GranuFlo lawsuits

Fresenius Medical Care, the world’s largest provider of dialysis products and services, is strongly encouraging dialysis patients to get a flu shot. The company is even offering free flu vaccinations to all of its dialysis patients and employees, a generous offer considering the company’s poor track record with communicating important health issues to patients and staff. The company is currently facing numerous wrongful death, personal injury and false advertising lawsuits stemming from its dialysis concentrates GranuFlo and NaturaLyte. The products are used to help balance electrolytes in the blood during dialysis. One of the ingredients in the solutions converts to ... Read More