Dialysis Problems with Fresenius Granuflo and NaturaLyte: Timeline of Warnings & Information
As a result of problems with dialysis treatments involving Fresenius Medical Care’s Granuflo Powder and NaturaLyte Liquid Acid Concentrates, which have been used as part of dialysate prescriptions at clinics throughout the United States in recent years, patients may have faced an increased risk of suffering a sudden heart attack, cardiac arrest or death during or shortly after hemodialysis.
▸ More Information: Fresenius Dialysis Heart Problems
Substantial questions have been raised about when Fresenius knew about the risk of these dialysis problems and why they delayed providing critical information to consumers and the medical community that could have saved hundreds of lives.
Fresenius Medical Care not only owns and operates thousands of dialysis clinics throughout the United States, but they also sell other facilities products used during treatment, including Granuflo and Naturalyte. These products are used as part of the dialysate prescription in combination with a bicarbonate buffer. However, Fresenius failed to provide adequate warnings and information about the importance of monitoring and adjusting bicarbonate buffers to avoid an substantial risk of patients suffering cardiopulmonary arrest or sudden death during dialysis treatment.
Although it appears that Fresenius knew or should have known about the risk of problems during dialysis with Granuflo and NaturaLyte shortly after the products were introduced, they certainly had knowledge of the problems for several years. However, they delayed providing any dialysis warnings, and when they did acknowledge the problems, they only informed doctors at their own clinics.
Full warnings and information about the risks was withheld from other dialysis clinics for several months, while hundreds of thousands of patients continued to be exposed to a risk of Granuflo and NaturaLyte being used inappropriately due to the inadequate instructions.
Time Line of Fresenius Dialysis Warnings and Problems
- 2003: Fresenius introduced Granuflo Dry Acid Concentrate without providing adequate warnings and instructions about the rate at which the sodium acetate contained in the product is converted to bicarbonate by the body.
- 2004-2011: Fresenius ignored signs of problems, including a steady increase in patient serum pre-dialysis bicarbonate levels, which they should have known would increase the risk of sudden heart problems during dialysis if dialysate prescriptions were not monitored and adjusted.
Although the manufacturer knew or should have known about the risk of these dialysis problems from their products, they continued to aggressively market Granuflo and NaturaLyte, attempting to convert clinics to use of the acid concentrates and bundling the products with other Fresenius dialysis products to provide pricing discounts.
- 2010: An internal review of patients treated at 667 Fresenius owned dialysis clinics found that there were at least 941 instances where individuals suffered a sudden cardiac arrest during treatment. This number likely only represents a small portion of the total number of deaths and serious health problems caused by Granuflo and NaturaLyte at dialysis clinics throughout the United States.
- November 2011: Fresenius Medical Care sent a detailed internal memo about the risk of NaturaLyte and Granuflo problems to their own clinics, warning about the importance of monitoring pre-dialysis bicarbonate levels and adjusting dialysate prescriptions to avoid the risk of cardiopulmonary arrest and death.
Despite a 6 to 7 fold increased risk of cardiac arrest or heart attack during dialysis for individuals with borderline pre-dialysis bicarbonate levels and overt alkalosis, Fresenius only provided this information to their owned and operated clinics. They failed to warn doctors and nurses at other clinics that used Granuflo and NaturaLyte about the risk of problems.
- March 2012: The FDA inquired about the risk of dialysis problems with Fresenius Granuflo and NaturaLyte treatments after receiving a copy of the internal memo from a source. Prior to this inquiry, Fresenius appears to have provided no information about the risks associated with their dialysis products.
- 3/29/2012: Fresenius sent an “Urgent Product Notification” to all clinics that purchased and used their products, finally warning about the “urgent” need to monitor bicarbonate levels and adjust dialysate prescriptions based on individual patients to avoid the risk of cardiac arrest and death during dialysis treatment.
- 3/29/2012: The FDA classified this warning letter as a NaturaLyte and Granuflo recall, indicating that the action was considered the most serious type of recall, involving a situation where there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
- 5/25/2012: In response to the NaturaLyte and Granuflo problems, the FDA issued a safety communication for healthcare professionals warning about the importance of recognizing the acetate, acetic acid and/or citrate levels in dialysate concentrates and the need to consider the impact of these products when administering dialysate prescriptions.
- 6/14/2012: The New York Times reported that the FDA is investigating whether Fresenius violated federal law by failing to warn about the risk of dialysis treatment problems with Granuflo and NaturaLyte as early as possible after they knew about the risks. In the article, the FDA director of compliance for medical devices indicated that they were “troubled” by the failure of Fresenis to issue warnings to their entire customer base when they provided warnings to their own clinics.
LAWSUITS FOR HEALTH PROBLEMS AFTER OR DURING DIALYSIS
The dialysis treatment lawyers at Saiontz & Kirk, P.A. are reviewing potential claims for individuals throughout the United States who suffered a sudden heart attack, cardiac arrest or death during or shortly after dialysis treatment involving Fresenius Medical Care’s Granuflo Powder or NaturaLyte Liquid Acid Concentrates, which have been used as part of dialysate prescriptions at clinics throughout the United States in recent years.
Due to problems with dialysis instructions and warnings provided with Granuflo and NaturaLyte, individuals faced an increased risk of serious and potentially life-threatening complications and financial compensation may be available through a Fresenius dialysis wrongful death lawsuit or individual injury claims.