The Hasbrook & Hasbrook law firm is investigating possible legal actions on behalf of people in Oklahoma who have experienced sudden cardiac arrest or death after receiving dialysis at a Fresenius Medical Care dialysis facility or at any facility that uses FMC dialysis products.
Hundreds of lawsuits have been filed around the country by or on behalf of kidney patients who were treated with GranuFlo and Naturalyte dialysates during dialysis and who subsequently experienced cardiac arrest, and in some cases, death. A dialysate is a chemical compound used during dialysis.
GranuFlo and Naturalyte are manufactured by Fresenius Medical Care North America. FMCNA, based in Waltham, MA, is a division of Fresenius Medical Care, Germany, which describes itself as “the world’s largest integrated provider of products and services for individuals undergoing dialysis because of chronic kidney failure.”
The lawsuits contend that GranuFlo and Naturalyte caused metabolic alkalosis, which can lead to low blood pressure, irregular heartbeat, cardiac arrest and death. The lawsuits further allege that FMC knew about the dangers of its dialysis products but failed to make that information public so that health providers and patients could make an informed decision about the risks of treatment.
About 26 million U.S. adults have chronic kidney disease. About 571,000 of them have End State Renal Disease. People with ESRD require a kidney transplant or continuing dialysis treatments to survive. About 400,000 kidney patients in the U.S. are receiving dialysis.
FMC performs more than a third of those dialysis procedures. The company operates more than 2,100 dialysis facilities across the country, including 29 in the Oklahoma City area, Tulsa area, Lawton, Enid, Stillwater, Muskogee and other Oklahoma towns. FMC also contracts to provide renal services at more than 1,000 hospitals.
In addition to the dialysis facilities it owns or operates, FMC sells GranuFlo and Naturalyte to other hospitals and facilities. FMC describes GranuFlo as “the most widely prescribed dry acid product in the dialysis industry.”
Granuflo and Naturalyte
GranuFlo and Naturalyte are mixed with blood during dialysis to do what damaged kidneys are failing to do: remove waste and excess water from the blood and add necessary minerals and other components. In hemodialysis, blood is pumped out of a patient’s body and passed through a dialyzer, which filters the blood. The dialysate carries off the filtered waste and excess water and adds necessary minerals, and the “cleaned blood” is returned to the body.
Plaintiffs in the pending lawsuits allege that GranuFlo Dry Acid Concentrate and Naturalyte Liquid Acid Concentrate produce excess bicarbonate in the blood, resulting in metabolic alkalosis. The products contain high levels of sodium diacetate, which allegedly generates twice as much bicarbonate as the formulations of other dialysates. Metabolic alkalosis has been linked to low blood pressure, irregular heartbeat, sudden cardiac arrest and death.
FMC Internal Memo
FMC distributed a memo, dated Nov. 4, 2011, which the New York Times has published online. The document is stamped “Internal Memo” and is addressed to the “medical directors and attending physicians” of FMC’s dialysis facilities across the country. The memo reports that 941 patients at FMC facilities in 2010 experienced sudden cardiac arrest after receiving dialysis treatment with GranuFlo and Naturalyte.
The memo said doctors had been underestimating the amount of “buffer” (bicarbonate) contained in GranuFlo and Naturalyte. “In light of these troubling findings,” the document said, medical directors of its dialysis facilities were advised to immediately begin adjusting their dialysate prescription levels.
FMC took action to decrease the risk at the facilities it owned, but the company did not make the information public or send the memo to the many facilities to which it sells its dialysate products.
Four months later, in March 2012, the FDA received a copy of the memo, which prompted an immediate FDA Class 1 recall of GranuFlo and Naturalyte products. The recall notice said “inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis,” which can contribute to metabolic alkalosis, which can in turn lead to low blood pressure, irregular heartbeat, cardiac arrest and death.
Class I recalls are the most serious type of FDA recall, used when the continued use of a product could cause serious health consequences or death.
Injury Lawsuits Linked to Use of Granuflo and Naturalyte
Since the FDA recall and public knowledge of the adverse effects of GranuFlo and Naturalyte, hundreds of lawsuits have been filed on behalf of kidney patients who have experienced cardiac arrest and death. As of Nov. 18, 393 federal lawsuits are pending in a multidistrict litigation in Federal Court for the District of Massachusetts, with District Judge Douglas P. Woodlock presiding. That total is up from 312 one month ago.
Another 300 GranuFlo lawsuits are pending in Massachusetts state court. Those cases have been consolidated in a multicounty litigation in Middlesex County Superior Court under Judge Maynard M. Kirpalani.
Our Oklahoma City Personal Injury Attorneys can Help
If you or a loved one has experienced cardiac arrest, heart attack, stroke or death soon after receiving dialysis treatment, contact our law office for a free consultation. You may contact Hasbrook and Hasbrook by telephone (866-416-4737), email (email@example.com) or by using our website contact form.