Granuflo/Naturalyte

The Granuflo Problem

Dialysis is a treatment for patients who no longer have enough function in their kidneys to remove the waste products from the blood. During dialysis blood is removed from the patient's body and is circulated through a dialysis machine called a dialyzer. The solution that actually cleans and filters the blood and replaces necessary nutrients inside the dialyzer is referred to as the dialysate. The dialysate is a mixture of water, bicarbonate and acid as well as other chemicals.

Granuflo and Naturalyte are dialysate products made by Fresenius Medical Corporation (FMC). Fresenius also makes the dialysis machines and, most profitably, runs dialysis centers.

The dialysate contain sodium diacetate. Because of the way sodium diacetate is metabolized by the body patients using Granuflo and/or Naturalyte receive more bicarbonate than needed and more than that which was prescribed by a physician. When a patient receives too much bicarbonate they can develop a condition called metabolic alkalosis. This condition affects the electrolytes and increases the risk of heart attacks, stroke and sudden death.

These dangers were known by FMC since 2004. Despite such knowledge Fresenius failed to notify the medical community of the risks and dangers associated with Granuflo and Naturalyte until years later.

When the problem was studied and became apparent to Fresenius a corporate decision was made not to report the problem to the FDA and to not relay this information to physicians and clinics using Granuflo and Naturalyte but who were not part of the FMC family. Instead, on November 4, 2011 Fresenius sent a 6 page memo to their own physicians and medical directors outlining the dangers of cardiac arrest while using their Granuflo and Naturalyte and issued safety precautions. After this memo was leaked to the FDA Fresenius provided a 2 page memo on March 29, 2012 to all those physicians and facilities using their products. Coincidentally this was the same date the FDA issued a Class I recall on Granuflo and Naturalyte.

It is unknown at present the number of deaths and the amount of harm caused by the decision by Fresenius to hide the fact their products were dangerous. Hundreds of cases have been filed nationwide and may have been consolidated in the Federal Court in Boston, Massachusetts.

Ball & Bonholtzer are representing clients nationwide who have either had heart attacks or lost loved ones immediately after a dialysis treatment using Granuflo and Naturalyte. Please let us know is we can help.

About Fresenius
Fresenius Medical Care is a German Company that makes dialysis machines, dialysis products such as Granuflo and Naturalyte and runs dialysis centers around the world. They derive most of their 9 billion North American income from dialysis related goods and services.

Links
http://annualreport2012.fresenius.com/reports/fresenius/annual/2012/gb/English/105010/fresenius-medical-care.html) (Fresenius 2012 annual report)
FMC Nov 4 2011.pdf – Internal FMS memo to FMC Physicians, CP arrest risk, specific lab values mentioned, specific actions urged)
FMC Mar 29 2012 – External memo to non-FMC clinics, no specific lab values mentioned, no specific actions urged)
http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm309990.htm (March 29, 2012 recall notice from the FDA)
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm305477.htm (May 25, 2012 Safety Notice from the FDA)
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm305630.htm
http://www.nytimes.com/2012/06/15/health/fda-investigates-fresenius-for-failure-to-warn-of-risk.html?_