GranuFlo and NaturaLyte Accused in Heart Attacks [Video]
Kristian Rasmussen accuses the world’s largest provider of dialysis products and services of knowingly endangering dialysis patients’ lives. A partner at Cory Watson Crowder & DeGaris in Birmingham, Ala., Kristian filed the first products liability cases in the country against the German company, Fresenius, over GranuFlo and NaturaLyte.
Fresenius manufactures these products, used to clean and filter blood of people whose kidneys have failed. Kristian asserts GranuFlo and NaturaLyte increase the risks of atrial fibrillation (irregular heartbeats), heart attacks and cardiac deaths, during or soon after dialysis. Watch our video to see his interview with Lawyers.com.
Fresenius received multiple reports of dialysis patients suffering from heart problems and even dying, so conducted its own internal studies and found patients six to eight times more likely to experience a serious adverse cardiac events says Kristian.
With GranuFlo and NaturaLyte, the body creates bicarbonate to neutralize acid buildup in the blood of dialysis patients. These products increase bicarbonate levels in patients at a faster rate than other dialysis treatments. Bicarbonate overdose can lead to heart attack, cardiac arrest and sudden death.
Kent Jarrell, spokesperson for Fresenius, provided a written statement to Lawyers.com: “Fresenius Madical Care’s actions related to its GranufFlo and NaturaLyte dialysate products were appropriate and consistent with the company’s commitment to patient safety. GranuFlo and NaturaLyte are safe and effective when used in accordance with their label and instructions for use. Both products are essential to dialysis, a life support treatment for patients who have chronic kidney disease and end stage renal disease.”
Fresenius says that in the preliminary analysis, no conclusion was made that GranuFlo or NaturaLyte caused cardiopulmonary arrest (CPA) in the patients. “Our subsequent reviews of specific patients suggest that other factors unique to each patient caused the CPA. Dialysis patients with advanced and permanent kidney failure often have other serious illnesses, including heart or lung disease.”
Both plaintiffs’ lawyers and the defendant refer to a Nov. 4, 2011 Fresenius internal memo. It analyzes the data of 941 hemodialysis patients who suffered CPA in 667 Fresenius facilities in 2010.
The memo indicates alkalosis (excessive alkali in the blood) is a significant risk associated with CPA. It notes a progressive shift toward higher pre-dialysis bicarbonate levels, implying more patients have alkalosis prior to dialysis but an even higher percentage have alkalosis, post-dialysis. The memo says, “Borderline elevated pre-dialysis bicarbonate levels and overt alkalosis are significantly associated with 6 to 8 fold greater risk of CP arrests and sudden cardiac deaths in the dialysis facility.”
Kristian ties these increased risks to GranuFlo and NaturaLyte, and says the company failed to warn doctors and patients outside of their clinics.
Fresenius says it communicated in memos to its clinics the benefits of individualized, patient-specific decisions concerning prescriptions. The memos also provided reminders of the potential role that its dialysates including GranuFlo and NaturaLyte can play in allowing doctors to achieve targeted bicarbonate levels in patients. The spokesman noted that the FDA required label changes for GranuFlo and NaturaLyte but has not suggested any change in formulation nor asked that clinics return the products to Fresenius.
Kristian says Fresenius has attempted to delay and evade the truth. He wants his clients to receive compensation for their losses and Fresenius to be held accountable for patients’ injuries and deaths. Kristian has filed the lead petition requesting consolidation of all the GranuFlo and NaturaLyte lawsuits in the country before a federal judge in Mississippi.