Fresenius Medical Care is one of the leading providers for kidney dialysis service and renal care products. The company provides 32 million dialysis treatments to over 215,000 patients around the world. This is a scary statistic since two of their most popular dialysis products, GranuFlo and NaturaLyte, have been associated with cardiopulmonary arrest and sudden cardiac death.
If GranuFlo and NaturaLyte were used during your dialysis treatment, you may be eligible for legal and financial recourse. Contact a knowledgeable product liability attorney today to explore your legal options.
About Fresenius Medical Care
Approximately two million people worldwide suffer from chronic kidney failure. Patients that have been diagnosed with kidney failure are treated through a process called dialysis. Fresenius Medical Care is one of the largest manufacturers of dialysis products, including the following products:
- Hemodialysis Machines
- Related disposable products
Fresenius Medical Care North America is the largest provider of dialysis services and products in the U.S. The company has over 1,800 dialysis centers throughout the country, which treats nearly 138,000 patients.
Fresenius Medical Care was Aware of its Products’ Dangers
On March 29, 2012, the Food and Drug Administration (FDA) issued a Class I recall for GranuFlo and NaturaLyte. A Class I recall is the most serious type of recall and involves situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Fresenius Medical Care conducted a study between January 1 and December 31, 2010 which studied the risk factors in dialysis patients who suffered from cardiopulmonary arrest at their dialysis facilities compared to other patients at the same facilities.
Researchers found that 841 patients in 667 Fresenius Medical Care centers suffered from cardiopulmonary arrests that resulted in the patients’ deaths. The study found that these patients had a six-fold higher risk for cardiopulmonary arrest if they had elevated bicarbonate levels before undergoing dialysis treatment.
Fresenius Medical Care notified its own physicians and facilities of the risk through an internal memo that advised action for patients with an elevated pre-dialysis bicarbonate levels. However, the company failed to alert the public about the risks associated with the products. The public was only notified after the memo was leaked to the FDA.
GranuFlo and NaturaLyte Side Effects
GranuFlo and NaturaLyte are used to prevent the buildup of acids that are naturally removed by properly functioning kidneys. Patients that were given GranuFlo and NaturaLyte have reported the following adverse side effects:
- Heart attack
- Low blood pressure
- Cardiopulmonary arrest
- Cardiac arrhythmia
- Sudden cardiac death
Contact a Defective Products Attorney
Each year, approximately 400,000 patients in the United States receive dialysis treatment. More than one-third of the patients are given GranuFlo and NaturaLyte during their dialysis, which puts them at risk for serious side effects, including death.
If you or a loved one has suffered from a heart attack or another adverse side after being given GranuFlo or NaturaLyte during dialysis, you may be entitled to compensation for your losses.
The attorneys at the Citrin Law Firm believe that manufacturers should be held accountable for the harm that their products causes, especially when they were fully aware of the dangers.
Contact our law firm today to receive a free and confidential case evaluation. During your legal consultation, our lawyers will evaluate the merits of your claim and advise you on the best course of action to pursue.
To schedule a legal consultation with Citrin Law Firm, complete the Free Case Review form on this page.