The Food and Drug Administration, in early 2012, announced that using the products GranuFlo inappropriately could lead to a high serum bicarbonate level in dialysis patients, causing dangerous symptoms such as low blood pressure, and cardiac arrhythmia. If not properly treated, these symptoms could lead to cardiac arrest and even death, leading to the potential for many Tennessee GranuFlo lawsuits.
One issue facing the FDA is whether Fresnius, the company that manufactures GranuFlo was aware, but neglected to inform customers that these risks existed. An internal memo, issued in November 2011, warned clinics that using GranuFlo improperly contributed to the risk of sudden death in patients receiving dialysis, further indicating the possibility of Tennessee GranuFlo lawsuits. An anonymous source provided the FDA with a copy of the internal memo, causing them to question the company. Only then did the German-based company release a general safety communication regarding the risks.
According to the FDA, the product contains acetic acid, acetate or citrate, and healthcare professionals were not warned that these chemicals existed in the product. These substances sometimes convert to bicarbonate in the body, causing metabolic alkalosis, a condition in which pH in body tissue is elevated., Because patients with a blood pH of 7.55 have a mortality rate of 45 percent, while patients with pH greater than 7.65, have a mortality rate of 80 percent. These dangerous levels may be evidence in Tennessee GranuFlo lawsuits.
Because they had no way of notifying non-company clinics about the dangers, Fresnius claimed they could only provide warnings to their own clinics. However, many experts claim that Fresnius not only had a duty to warn their own clinics, but customers who had purchased the products in good faith. Failure to warn customers of a known, potentially dangerous side effect constitutes negligence, and is grounds for Tennessee GranuFlo lawsuits.
Tennessee GranuFlow Lawsuits
More than 300 lawsuits throughout the United States have been filed against Fresnius claiming that the company knew, or had cause to know, the dangers of the product. The suits have been filed by dialysis patients who used the product and suffered side effects, or by family members of those who died as a result of using the product. More Tennessee GranuFlo lawsuits are expected as more patients and families learn that their adverse side effects could possibly have been caused by the use of GranuFlo without being warned beforehand. Because internal information indicates that Fresnius was well aware of the problem before healthcare professionals began reporting injuries, and even deaths, after using the product, they could be found negligent, further indicating the need for Tennessee GranuFlo lawsuits to proceed.
If you or a loved one have used GranuFlo and experienced any side effects, or if a loved one has died after using the product, contact Attorney Group for Tennessee today to learn whether you qualify for Tennessee GranuFlo lawsuits. If you have suffered loss and it could be because of this drug, you should not have to face a large drug company alone. The Attorney Group for Tennessee is here to answer any legal questions you may have and help you decide if you want to pursue a claim, all at no cost to you. Contact us today for more information.