As a growing number of lawsuits continue to be filed against GranuFlo and NaturaLyte maker Fresenius Medical Care over complications like sudden cardiac arrest or heart attack, the manufacturing company has asked for additional time to establish the bellwether trial process. The complaints against Fresenius allege that the company concealed information from consumers and the medical community about the importance of monitoring bicarbonate levels during dialysis treatment with GranuFlo or NaturaLyte, which exposed patients to a risk of sudden heart injury and possibly even death. If you or a loved one has been adversely affected by alleged NaturaLyte or GranuFlo side effects, contact a reputable product liability lawyer in your area to explore your possible compensation options.
In April 2013, all complaints filed over potential side effects of GranuFlo and NaturaLyte were consolidated for pretrial proceedings as part of a multidistrict litigation (MDL). At that time, there were approximately 100 lawsuits pending against Fresenius in federal courts nationwide, all of which involved similar allegations that the manufacturing company failed to provide adequate warnings to consumers about the risk of serious heart problems that may occur during hemodialysis treatment with GranuFlo or NaturaLyte. According to a recent report, there are now at least 430 NaturaLyte and GranuFlo lawsuits involved in the litigation, and the number continues to increase every month.
Fresenius is one of the largest providers of hemodialysis services in the United States, and the company also manufactures many of the products used during dialysis treatment, including GranuFlo and NaturaLyte acid concentrates, which were designed to convert to bicarbonates in order to neutralize the build-up of acid in the blood that occurs during dialysis. However, both NaturaLyte and GranuFlo contain sodium acetate that has been found to convert to bicarbonates at a higher-than-expected level for most doctors, which allegedly puts hemodialysis patients at risk of side effects like sudden cardiac death during or shortly after treatment.
This serious risk became apparent to Fresenius several years ago, and the company issued an internal memo in November 2011, identifying at least 941 instances in 2010 alone in which dialysis patients using GranuFlo or NaturaLyte suffered sudden cardiac arrest. Although the memo was circulated to doctors in its own clinics, Fresenius failed to extend the warning to doctors in non-Fresenius clinics who continued using GranuFlo and NaturaLyte solutions during hemodialysis. It wasn’t until the memo was leaked to the FDA in March 2012 that Fresenius finally issued a warning letter to all medical professionals, which the FDA classified as a NaturaLyte and GranuFlo recall.
Estimates show that as many as several thousand product liability lawsuits could ultimately be filed against Fresenius Medical Care, on behalf of patients who suffered sudden cardiac arrest or other complications during or shortly after hemodialysis treatment with GranuFlo or NaturaLyte. If you underwent dialysis treatment with either GranuFlo or NaturaLyte, and you have since suffered from complications like heart attack or cardiac arrest, our consumer advocates at the Consumer Justice Foundation can help. We are dedicated to protecting the rights of consumers harmed by dangerous pharmaceutical drugs and medical devices, and can put you in touch with a qualified product liability attorney in your area.