GranuFlo Manufacturer, Fresenius Medical Centers, Knew of Sudden Cardiac Arrest in Dialysis Patien

Aug. 29, 2012 - PRLog -- On May 25, 2012 the Food and Drug Administration (FDA) issued a Safety Communication, warning of the dangers using dialysis equipment with dialysate concentrates such as GranuFlo. [1] Between 2008 and its recall in March 2012, GranuFlo was the most-widely prescribed dry acid dialysis product in the industry.  GranuFlo contains a higher concentration of the chemical that produces bicarbonate during dialysis. Sudden cardiac arrest and other heart problems can occur when someone has excessive bicarbonate in their blood.  Unfortunately, patients who received GranuFlo received double the amount of bicarbonate, substantially increasing their risk for heart problems including cardiovascular death, sudden cardiac death, cardiopulmonary arrest, heart attack, and other catastrophic cardiovascular injuries.

The manufacturer of GranuFlo, Fresenius Medical Care North America, treats about one-third of all Americans receiving dialysis in over 1,800 of its own clinics and provides the GranuFlo product to many other dialysis centers, including the popular Davita Dialysis which operates over 1600 centers nationwide.  Inexcusably, on November 4, 2011 Fresenius sent an internal memo only to its own doctors and treatment centers warning of the risks, noting that 941 hemodialysis patients using GranuFlo or NaturaLyte experienced cardiac arrest in 2010.  Not until the FDA received an anonymous copy of the internal memo in March 2012, were the other facilities using the GranuFlo and NaturaLyte products warned of the fatal dangers.  It is incredulous that Fresenius executives knew about the increased risk of cardiac arrest and death associated with Granuflo since at least 2010. Even more disturbing is that this information was held at the corporate level for 15 months before it was shared even to Fresenius’ own operating clinics, let alone the unsuspecting Public.  

Ennis & Ennis, P.A. continues to offer free, nationwide, confidential consultations to anyone who received the GranuFlo or NaturaLyte products and suffered a cardiac event by calling toll free 1-800-856-6405 or by going to www.ennislaw.com and completing an online case evaluation form.

Ennis & Ennis, P.A. is a nationwide law firm with offices in Ft. Lauderdale, Miami and Washington D.C. that concentrates its practice in mass torts and represents individuals against pharmaceutical companies and medical device makers.

Ennis & Ennis, P.A. has been representing clients individually since 1986 and has recovered over $100 million in settlements for its clients.

[1]  http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices...