Fresenius Medical Care: GranuFlo and NaturaLyte Dialysis Products
If you, or someone you love, has been injured by Fresenius Medical Care's GranuFlo and NaturaLyte dialysis products, please contact the Law Firm of Audet & Partners today, to protect your legal rights. You may call us in confidence, toll-free, at 800.965.1461, or you may use the confidential and easy form on the right side of this page. Please act now, since your time to recover potential losses, and seek compensation under law, may be limited by various factors, including statutes of limitation.
Frequently Asked Questions (FAQs) about Granuflo® & NaturaLyte® Dialysis Medical Products
Our defective medical product attorneys at Audet & Partners, LLP are currently accepting cases from individuals who have suffered serious injury caused by the NaturaLtye and Granuflo medical products used in Fresenius dialysis centers, which is the largest network of dialysis centers in the U.S. Fresenius uses their own products when providing dialysis including the NaturaLyte and Granuflo products. If you have received dialysis at a Fresenius dialysis center and have suffered serious complications, you may have a right to seek legal compensation. The best way to obtain a free evaluation of your legal claim is to contact our Bay Area defective medical device attorneys, but we have provided answers to some common questions below.
What are the Granuflo and NaturaLyte medical products?
These substances are used in the treatment of kidney failure when patients undergo hemodialysis. These products are produced by Fresenius and until recently used in its dialysis centers, but the manufacturer also marketed the Granuflo and NaturaLyte product to other dialysis centers. These medical care products are designed to be used with three-stream dialysis machines, which are calibrated for proper concentration of bicarbonate and acid.
What types of harm may be caused by these dialysis products?
The FDA has issued a recall because these medical products contain substances that the body converts to bicarbonates that may result in excessive levels of bicarbonate in the blood stream. Because physicians may not be aware of these elevated levels of bicarbonate, the physician may prescribe too much bicarbonate. Abnormally high bicarbonate levels may result in cardiac problems and heart attack.
How serious is the risk of serious cardiac conditions posed by these Fresenius dialysis products?
Reports of adverse cardiac incidents at Fresenius dialysis centers revealed that the risk of heart attack was increased six-fold when patients received dialysis where the Granuflo product was utilized. The FDA has issued a recall of both substances because of the elevated rates of heart attack, serious cardiac issues and deaths related to the substances.
Was the manufacturer aware of the risks associated with the use of Granuflo and NaturaLyte?
Fresenius was so concerned with the potential risks of heart attack that the manufacturer sent letters to its dialysis centers in November 2011 that addressed the issue and indicated that there had been 941 cases of heart attack at its treatment facilities during 2010. Nonetheless, Fresenius did not inform patients of the risk until March 29, 2012. When the letter was sent to Fresenius dialysis clinics, the information was not disclosed to the FDA or to other dialysis centers that use the NaturaLyte and Granuflo dialysis products.
What types of injuries have been reported by those treated with these Fresenius dialysis medical products?
While serious cardiac problems, heart attack and death are the most significant injuries that have been associated with use of NaturaLyte and Granuflo during dialysis, other reported injuries include hypoxemia (poorly oxygenated blood), hypercapnia (abnormally high levels of carbon dioxide in the blood), low blood pressure and cardiac arrhythmia (irregular heart beat).
If you or someone you love has suffered a heart attack or other serious adverse effects that may be related to dialysis treatment with the Granuflo or NaturaLyte medical products, our experienced San Francisco medical products attorneys at Audet and Partners, LLP offer a free consultation so that we can evaluate your legal claim and advise you of your options. We invite you to call us at (800) 965-1461 or email the confidential case inquiry form on the right side of this page.
Serious Cardiac Incidents Prompt FDA Recall of Fresenius NaturaLyte® and GranuFlo® Dialysis Drugs
The FDA is currently investigating reports indicating that Fresenius Medical Care, which is the country’s largest operator of dialysis medical clinics, failed to disclose serious medical complications caused by its NaturaLyte®and GranuFlo®dialysis products. These dialysis medical products have been found to release excessive levels of bicarbonate which can promote unsafe elevated levels of alkaline. This is a medical condition referred to as metabolic alkalosis, which can cause serious cardiovascular-related incidents and sudden death. Cardiac incidents account for almost sixty percent of dialysis-related fatalities.
Because warnings were not provided to physicians that the GranuFlo®and NaturaLyte®products caused higher levels of bicarbonate than dialysis medical devices produced by other manufacturers, physicians may have prescribed additional amounts of bicarbonate resulting in overdosing the patient. These unnaturally high levels can cause severe cardiac problems and other symptoms, such as:
- > Stroke
- > Depressed blood pressure
- > Heart arrhythmia
- > Impaired mental functioning
- > Cardiac arrest
- > Hemodialysis cardiopulmonary arrest
- > Heart attack
- > Hemodialysis cardiac arrest
- > Death
The use of these dialysis products have been linked to a six-fold increase in sudden cardiac death and cardiopulmonary arrest. Lawsuits against the manufacturer are eminent because Fresenius was aware of the risk of dangerous cardio incidents and death associated with its product but failed to warn patients or physicians until 2012. Because of the excessive level of cardiac arrest incidents in Fresenius Medical Care facilities in 2010, the company circulated an internal memo to its individual clinic facilities in early November of 2011.
However, the company did not advise the public of the risks until the FDA received an anonymous copy of the November memo. It was only after the FDA became aware of the November 2011 memo that Fresenius warned the public of the risk of elevated bicarbonate levels and the attending risks of sudden cardiopulmonary arrest and sudden cardiac death. The company conducted a study and found that dialysis patients in their clinics were six times more likely to suffer a serious cardiac incident if they had elevated bicarbonate levels.
Because serious cardiac incidents and deaths have been linked to the GranuFlo®and NaturaLyte®dialysis products, the FDA issued a Class 1 recall of the dialysis products on March 29, 2012. Class 1 recalls are the most serious type of FDA recall reserved for situations where a medical product may cause adverse health consequences or death. If you received dialysis treatment at a Fresenius Medical Clinic and have experienced serious cardiac complications or a loved one has died, our experienced defective medical product attorneys at Audet and Partners, LLP offer a free consultation so that we can evaluate your legal claim and advise you of your options. We invite you to call us at (800) 965-1461 or email the confidential case inquiry form on the right side of this page.
Fresenius Medical Failed to Warn Thousands of Dialysis Patients of Heart Attack Risks
Locations of Fresenius Fresenius Vascular Care Centers
Audet and Partners, LPP, a national class action law firm with expertise in pharmaceuticals and defective medical devices, has published a new website at www.granuflodialysisrisk.com for those who have suffered adverse side effects from GranuFlo and/or Naturalyte used in dialysis. This site also lists all Fresenius Vascular Care Centers in the United States. For more information, please visit http://www.granuflodialysisrisk.com.
Patients Who Used GranuFlo or NaturaLyte Dialysis Products at Increased Risk of Heart Problems
Leaked Internal Memo From Fresenius Medical Regarding Granuflo and NaturaLyte Heart Attack Risk
Fresenius on U.S. Regulator's Radar Over Dialysis
Dialysis Company’s Failure to Warn of Product Risk Draws Inquiry
Dialysate Concentrates Used in Hemodialysis: Safety Communication - Alkali Dosing Errors
[UPDATED 06/27/2012] FDA issued a Class I Recall notice for Fresenius Medical Care North America Naturalyte Liquid Acid Concentrate and Naturalyte GranuFlo (powder) Acid Concentrate. Inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis. This may contribute to metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which, if not appropriately treated, may culminate in cardiopulmonary arrest. This product may cause serious adverse health consequences, including death.
Audet & Partners represents individuals, governmental entities, small businesses and institutional shareholders in product liability, tort, negligence, consumer, construction defect, investment fraud, securities, insider trading, antitrust, environmental, whistle blower, aviation and employment cases. In recognition of their outstanding abilities and commitment to the legal profession over the years, the firm and its members have served as Court-appointed Plaintiffs’ Counsel in dozens of federal and state cases throughout the United States.