If you’re a dialysis patient who has taken a drug known as GranuFlo during dialysis and later have experienced a sudden heart attack or stroke, Kentucky GranuFlo lawsuit attorneys want to warn you that the event may be connected to the use of GranuFlo. If so, you may be eligible to proceed with a Kentucky GranuFlo lawsuit to seek compensation for medical expenses, lost wages, and pain and suffering associated with the use of GranuFlo. Kentucky GranuFlo lawsuit attorneys experienced in representing patients who’ve been injured by the use of defective drugs and medical products can help you review your legal options.
What Is GranuFlo?
The function of your kidneys is to remove toxins from your body. If your kidneys fail, this toxin removal function must be carried out through a process called dialysis. An estimated half million Americans undergo dialysis routinely either at hospitals, in their homes, or in dialysis centers across the nation. Approximately one-third of all ambulatory dialysis centers in the United States are owned by a German pharmaceutical company called the Fresenius Medical Care Company.
Dialysis relies upon osmosis to clean the blood of toxic compounds. Waste products filter out into a solution called a dialysate until the dialysate reaches chemical equilibrium with the body’s own fluids. Dialysates also contain an alkaline compound called bicarbonate to reduce potentially dangerous acid levels in the blood.
Fresenius manufactures a product called GranuFlo. Until recently, GranuFlo was the most popular dialysate used in the U.S. GranuFlo, however, is manufactured differently than other dialysates. It contains an ingredient that produces bicarbonate in larger amounts than that produced by rival products. The result is that many dialysis patients end up with bicarbonate levels that are dangerously high. Elevated levels of bicarbonate have been linked in medial studies with much higher risks of heart attacks and strokes.
As one might expect, GranuFlo was the dialysate product of choice used in the Fresenius Medical Care Company’s own dialysis centers. GranuFlo was also used extensively in other dialysis situations as well. It has reportedly been estimated that as many as 125,000 patients in non-Fresenius clinics received GranuFlo as a dialysate.
Fresenius Warns Doctors
In November 2011, a physician working for Fresenius allegedly noticed a large increase in the number of dialysis patients who’d suffered heart attacks shortly after their dialysis treatments. In all, the physician unearthed 941 of these cases. He investigated the trend and found that physicians were not taking into account the fact that GranuFlo produced elevated levels of bicarbonate. These physicians were also prescribing bicarbonate, and patients’ cumulative bicarbonate amounts ran the risk of becoming dangerously high. An alleged internal memo containing this information was reported to have circulated among all the physicians working for Fresenius dialysis clinics. The information, however, was allegedly not made available to kidney specialists working at hospitals or other dialysis centers that were not owned by Fresenius.
It wasn’t until March 2012 that the Food and Drug Administration received a copy of the alleged internal memo and began its own investigation into the risks associated with the use of GranuFlo. During that 16-month interval, it is alleged that Fresenius knew the risks that dialysis patients at non-Fresenius clinics who were being treated with GranuFlo were being exposed to, and that the company chose to do nothing. During this time, the company also continued to market its GranuFlo product aggressively.
The FDA investigation prompted Fresenius to issue an Urgent Product Notification to non-Fresenius clinics and hospitals that were using the GranuFlo product. Shortly thereafter, the FDA issued a Class I recall for all GranuFlo products manufactured between January 2008 and June 2012. Class I is the FDA’s most serious recall status. It is reserved for products deemed to have a reasonable probability of an adverse health outcome or death.
Kentucky GranuFlo Lawsuit Attorneys Can Help
A growing number of lawsuits have been filed by Kentucky GranuFlo lawsuit attorneys on behalf of individuals who suffered cardiac events possibly associated with the use of GranuFlo during dialysis. There have also been wrongful death suits filed by loved ones of those who have died after using GranuFlo.
Many lawsuits allege that Fresenius deliberately acted to hide evidence that showed the dangers associated with the use of GranuFlo, and that this constitutes a type of fraud, along with negligence. However attorneys will tell you that the use of GranuFlo alone is not enough to bring a Kentucky GranuFlo lawsuit. Product liability lawsuits generally require that negligence or other fault be associated with an injury that would not have occurred but for that negligence. If you or a loved one have suffered a cardiac event while undergoing dialysis, it is important to speak with Attorney Group for Kentucky regarding possible claims that you may have.