Fresenius Medical Care describes its dialysis product, GranuFlo, as both the “most widely-prescribed dry acid product in the dialysis industry” and as the “safest dry acid product.” GranuFlo is used to neutralize the build-up of acid that occurs as a byproduct of the dialysis process. While it promised to improve safety by eliminating the need for the hazardous Acetic Acid, it actually caused more than 900 people to suffer sudden and unexpected cardiac events.
Evidence indicates that Fresenius was aware that its GranuFlo product could cause heart attacks and life-threatening complications for dialysis patients, yet it marketed and sold the product anyway. A Class I recall in March of 2012 by the FDA finally made these dangers apparent, but many had already lost their lives. The manufacturer needs to be held accountable for this defective product and if you or a loved one was one of the many affected by GranuFlo complications, an experienced Boston dialysis drug lawyer at the Law Offices of Jeffrey S. Glassman can help you to take action.GranuFlo Dangers to Patients
There are approximately 400,000 patients with kidney problems in the United States who require dialysis to filter wastes from their bodies. Dialysis causes the build-up of acid in the body, so an alkaline substance must be added to dialysate, which is administered to a patient through a dialyzer that cleans the blood.
GranuFlo is an alkaline produced by Fresenius, a company that is a both a provider of dialysis drugs and the operator of approximately 1,800 dialysis clinics in the United States. Fresenius not only provides dialysis treatments to 138,000 in-house patients but also provides 1/3 of the dialysis products to all patients throughout the country.
Unfortunately, all of these patients were administered GranuFlo both in Fresenius clinics and in thousands of other clinics throughout the United States. When GranuFlo is administered as part of the dialysate, the body can convert the substance to bicarbonates. This can result in an unexpected overdose of bicarbonates, potentially leading to catastrophic injuries to the heart and to cardiovascular death. Fresenius may have been aware of this problem as far back as 2003.
This effect of GranuFlo was not explained and medical professionals and patients were not warned of the risk. By November of 2011, 941 patients experienced a cardiac event as a result, just in Fresenius clinics alone. Fresenius sent out a warning to its own clinics in a memo on November 4, 2011 about the risk of heart attack but did not alert outside clinics treating another 125,000 patients with GranuFlo.
The drug continued to be used and put patients at risk until the FDA issued a Class I recall in March of 2012. A Class I recall is the most serious of all recalls, reserved for situations where there is a risk of serious injury or death.Taking Legal Action
A heart attack or complications caused by GranuFlo can be fatal or can cause life-changing consequences for victims. A drug manufacturer who produces a dangerous product like GranuFlo can be held strictly liable for injuries and damage to patients, which means plaintiffs can obtain compensation for losses just by proving the drug was used as intended and harmed them.
If you or a loved one suffered a heart attack or cardiac injury, this means you may be able to pursue a claim for compensation against Fresenius Medical Care. Lawsuits are already pending against the company and there may be thousands more patients who have been harmed as a result of the dangerous drugs.
To learn more and for help taking legal action, contact the Boston dialysis injury lawyers at the law Offices of Jeffrey S. Glassman.