GranuFlo and NaturaLyte Dialysis Injury Lawyers
NaturaLyte and Granuflo are used in the treatment of renal failure during hemodialysis. Both GranuFlo, as a dry concentrate, and NaturaLyte, as a liquid concentrate, are components of the final dialysis solution. NaturaLyte and GranuFlo are diluted with purified water and combined with sodium bicarbonate for cleaning a patient’s blood.GranuFlo® is the most-widely prescribed dry acid product used in dialysis treatment. Clinics that use GranuFlo are required to mix their own concentrations of the solution. NaturaLyte, also known as NaturaLyte Liquid Acid Concentrate, is a pre-mixed liquid solution.
Problems with GranuFlo and NaturaLyte
The use of these products in dialysis has been associated with low blood pressure and increased potassium build up in the body. This has led some people to develop abnormal heart rhythms and heart attacks. In fact, patients who undergo GranuFlo dialysis face a 6 to 8 times increased risk of suffering a heart attack or sudden cardiac death within 48 hours of treatment.
Who makes these products?
The manufacturer of GranuFlo and NaturaLyte is a German company, Fresenius Medical Care. They have an American base that is located in Waltham, Massachusetts, outside of Boston. Fresenius is a major provider of kidney dialysis services and kidney care products such as dialysis machines and dialyzers. They also own and operate dialysis centers across the country.
What adverse events have been reported?
In a memo published by the products’ manufacturer, Fresenius Medical Care, it was noted that 941 patients suffered cardiac arrest in 667 Fresenius facilities in 2010 alone. (This does not include the number of patients who may have been injured or died in clinics not owned or operated by FRESENIUS.)
Has the FDA done anything about this problem?
On March 29, 2012, at the direction of the FDA, Fresenius sent an Urgent Product Notification to their clinics and customers. This notification provided clinicians with prescribing information regarding the NaturaLyte Liquid and GranuFlo Acid Concentrate.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Why is Fresenius facing litigation over GranuFlo?
There are number of legal theories under which Fresenius could be found liable for injuries to patients, including defects in the design, manufacture, and marketing of GranuFlo and NaturaLyte. However, Fresenius’ most serious failure was its decision not to warn non-Fresenius facilities about the dangers of these drugs after it was clear that patients were at serious risk. In 2011, Fresenius issued an internal notice to its company-owned clinics, warning of the risks and side effects of the products; however, they failed to offer warnings to thousands of physicians and clinics not owned by Fresenius who continued to use their product. As a result of the memo leaked to the U.S. Food and Drug Administration in 2012, the FDA issued a Class I recall of all GranuFlo and NaturaLyte products.
If you or someone you care about suffered a heart attack shortly after dialysis, you need to speak with an attorney immediately. Each state has time restrictions in which you may bring a claim – called statute of limitations – so time may be running out for you. Contact us. Our product liability personal injury attorneys have experience dangerous drug and medical device claims and are available to speak with you regarding your legal rights and options.