GranuFlo and NaturaLyte are Fresenius products used during dialysis that have been linked to dangerous side effects including heart attack. Our law firm is working with some very experienced dangerous dialysis lawyers, who can file a dialysis lawsuit on your behalf, and will charge you no fee until you receive an award or settlement. Contact us online or call toll free 24/7 for a free legal consultation.
Fresenius Kidney Dialysis Products Linked with Life-Threatening Cardiovascular Injuries
Fresenius Medical Care, self-proclaimed as “the world leader in quality dialysis products and services,” has produced devices linked to serious, and sometimes deadly, heart complications. Among kidney dialysis patients, heart problems are the leading cause of death. Two products in particular, GranuFlo and NaturaLyte, have been linked to increased risk of cardiac arrest and death. GranuFlo is a dry acid concentrate used in dialysis, and NaturaLyte is its liquid counterpart. Both products are used to evenly distribute electrolytes in the blood during kidney dialysis. Additionally, these products are supposed to stabilize blood bicarbonate, which neutralizes acid buildup. In some cases however, these products have raised bicarbonate to dangerously high levels.
Timeline of Fresenius Kidney Dialysis Products: From Approval to Eventual Recall
In 2003, the Food and Drug Administration (FDA) approved Fresenius Medical Care’s kidney dialysis concentrates, GranuFlo and NaturaLyte, for sale on the market. Later, on November 4, 2011, the company issued an internal memo titled “Dialysate Bicarbonate, Alkalosis, and Patient Safety” detailing a year-long control study that had been conducted looking into the 941 cardiopulmonary arrest deaths that had been tied to use of the products. The study found that use of the product resulted in an average six-fold increase in risk of heart attack. The memo and its included results were released to various department heads within the company, but withheld from outside doctors and dialysis service providers. It was not until March 29, 2012 that Fresenius notified the FDA and other dialysis clinics of these risks. The FDA received a copy of the company memo and quickly issued a Class I recall (the most serious) for the products, which were removed from the market in June 2012. In spite of this, Fresenius Medical Care continues to advertise GranuFlo as “the safest dry acid product.”
Since the recall and release of the company memo and its conclusions, Fresenius has attempted to defend itself by arguing that proper warnings were present on the product labels. However, with new medical studies revisiting the conclusions of the internal Fresenius study and the company’s response about device warnings, Fresenius faces increased pressure and scrutiny on these types of products.
Risk Factors for Heart Attacks Related to Fresenius Kidney Dialysis
There are two important factors associated with the increased risk of heart attack, among these were:
- Low Potassium (Hypokalemia) – Low potassium can lead to heart attacks in healthy individuals, and the risk is even greater for patients on kidney dialysis. If serum potassium is low before dialysis, using GranuFlo and NaturaLyte can lead to potentially fatally low potassium levels.
- High Bicarbonate Levels – Bicarbonate is essential to blood chemistry and exists in GranuFlo and NaturaLyte in different concentrations. If this bicarbonate level is too high before dialysis, there can be too much in the blood, causing an imbalance in the body, which can lead to heart attack.
Low Potassium Level Risks Examined
GranuFlo and NaturaLyte can cause dangerously low potassium levels, which can result in a condition known as hypokalemia. Symptoms of this condition include: muscle cramps, irregular heartbeat, damage to kidneys, and paralysis causing organ failure. The most serious consequence of low potassium is death.
High Bicarbonate Level Risks Examined
High bicarbonate levels caused by GranuFlo and NaturaLyte can lead to serious heart problems such as: low blood pressure, heart attack, stroke, cardiac arrest, and death. Symptoms of these conditions may include shortness of breath, dizziness, and chest pain. In the event of a heart attack or stroke, survivors may suffer permanent damage afterwards. This permanent damage coupled with the human body’s response to a heart attack or stroke makes the re-occurrence of such cardiac events more probable.
Fresenius Dialysis Lawsuits
These products have been the target of intense governmental scrutiny and have become the subject of many large lawsuits. Numerous victims have filed dialysis lawsuits against Fresenius Medical Care alleging the company breached its duty to provide adequate warnings regarding the products’ risks and purposefully withheld information from the public regarding the products’ dangerous side effects. With the harsh recall and swift removal of these products from the market, litigation against Fresenius is on the rise.
Initially, Fresenius did fail to adequately warn consumers of the risks of these products. Furthermore, it failed to take reasonable steps to inform consumers about the inherent dangers of using the products. In one case, an Ohio woman’s husband went into cardiac arrest just minutes into undergoing dialysis. In another lawsuit, a Georgia man’s father died from a heart attack shortly after receiving dialysis. The decedent had been receiving dialysis treatment three times a week. Dialysis patients need treatment on such a regular basis that each use of GranuFlo and NaturaLyte compounded the risk of serious heart problems posed by the products.
Have You or a Loved One Suffered a Heart Attack After Fresenius Kidney Dialysis?
If you or a loved one has suffered a serious cardiac event following kidney dialysis using GranuFlo or NaturaLyte, you should speak with a personal injury attorney regarding a potential claim. The injury and disability lawyers at d’Oliveira & Associates are working with some of the more experienced dialysis lawyers in the country who may be able to file a Fresenius dialysis lawsuit or claim on your behalf.
Contact d’Oliveira & Associates at 1-800-992-6878 or fill out a contact form for a free legal consultation.