Fresenius Medical Care (FMC) not only manufactures dialysis products, but also operates thousands of dialysis centers throughout the United States. Of the 400,000 dialysis patients in the U.S., approximately 260,000 patients are estimated to receive dialysis treatment using GranuFlo or NaturaLyte solutions. Despite its widespread and long-term use, on March 2012, the FDA recalled both GranuFlo and NaturaLyte products due to higher cardiacpulmonary risks associated with the product.
FMC Acid Concentrate Products
Unlike most acid concentrate products used in dialysate, GranuFlo and NaturaLyte uses both acetic acid and sodium acetate. The additional presence of sodium acetate in the dialysate can lead to higher-than-prescribed doses of bicarbonate in the bloodstream. Unlike acetic acid, when sodium acetate is processed through the patient’s tissues, the acid is converted to bicarbonate a greater speed and higher levels, increasing the risk of cardiac problems. Since 2003, thousands of patients have unwittingly been exposed to greater health risks by undergoing regular dialysis treatment using FMC’s GranuFlo and NaturaLyte.
Health Risks Associated with High Bicarbonate Levels
Patients with kidney problems undergo hemodialysis three times a week to filter their blood artificially. Each time a patient receives treatment using either GranuFlo or NaturaLyte, the patient may be at risk of serious complications due to increased levels of bicarbonate caused by the sodium acetate. Excessively high levels of bicarbonate may result in life-threatening side effects such as:
- Cardiac arrest
- Cardiopulmonary arrest
- Heart problems
- Metabolic alkalosis
- Low blood pressure
Cardiovascular Deaths for Dialysis Patients
For years, cardiovascular-related deaths have been the number one cause of death for dialysis patients, and in 2009, the medical community began to tie dialysis treatments to increased risks of heart problems. Since 2003, the acid concentrate products manufactured and sold by FMC had remained untested until 2010, when an internal study found that GranuFlo increased the risk of cardiac arrest by 4.7 times greater under certain conditions. The findings, based on the data of 941 patients who had died at FMC dialysis facilities, were not shared with the FDA or the general public until 2012, after thousands more patients have continued to receive GranuFlo and NaturaLyte dialysis treatments. While it is unclear how many patients have died because of the defective dialysate solution, at least some patients were unnecessarily put at 6.3 times greater risk of cardiopulmonary arrest.
Investigating GranuFlo and NaturaLyte Lawsuits
Because there are many legal issues involved in each case that is specific to the claimant’s state, it is important to take action and consult an attorney experienced in negotiating and litigating large medical companies such as Fresenius Medical Care. A prompt case review can ensure the statutes of limitations will not compromise your rightful compensation. The skilled product liability lawyers at Estey & Bomberger are currently screening potential lawsuits pertaining to GranuFlo and NaturaLyte complications or death. To learn how our attorneys can help you maximize your claim, please contact us today for a free consultation.