GranuFlo and NaturaLyte

granuflo lawsuitGranuFlo is a powdered drug that treats acute renal failure and chronic kidney disease. It is used as a chemical component of dialysis treatment for these conditions. GranuFlo received approval from the U.S. Food and Drug Administration (FDA) in 2003. Its manufacturer, Fresenius Medical Care (FMC), dominates the dialysis market in the United States. In 2011, FMC netted $12.8 billion in revenue from its disposable products and dialysis machines.

Roughly 400,000 Americans who suffer kidney disease undergo dialysis treatment to filter their blood several times each week. Of these 400,000, it is estimated that nearly half use GranuFlo or its liquid counterpart NaturaLyte. A number of these GranuFlo treatments are administered in FMC clinics. However, patients who are given incorrect dosages are six to eight times more likely to suffer cardiac arrest. FMC now faces mounting lawsuits for death and injury resulting from the use of GranuFlo and NaturaLyte.

What Is Dialysis?

During dialysis treatment, a patient’s blood is removed, filtered of harmful substances, then returned to the body. The kidney is typically responsible for this filtration process. However, kidney disease and renal failure render the kidneys incapable of performing this essential function.

During the dialysis process, a solution called dialysate is used to clean the patient’s blood. Bicarbonate is an important substance in the dialysate solution. GranuFlo contains acetate and sodium diacetate, which produce bicarbonate. Many dialysis machines today are three-stream. This means that they mix dialysate using bicarbonate, filtered water, and acid concentrate.

When the process is complete, the filtered blood is returned to the body, along with additional bicarbonate. It is important that the dialysis machines are properly calibrated in order to account for the bicarbonate already present in the GranuFlo dialysate solution.

Side Effects of GranuFlo

The main side effect of GranuFlo and NaturaLyte is an excess of bicarbonate in the bloodstream. This bicarbonate surplus can lead to potentially deadly conditions, including metabolic alkalosis. Metabolic alkalosis occurs when the body’s pH level is elevated beyond a normal level. In some cases, these heightened bicarbonate levels can lead to death.

Excess bicarbonate from GranuFlo can also cause:

  • Low blood pressure
  • Cardiac arrest
  • Cardiac arrhythmia, or irregular heartbeat
  • Hypoxemia, or lowered blood oxygen
  • Hypokalemia, or lowered blood potassium
  • Hypercapnia, or increased blood carbon dioxide

GranuFlo Recall

In November 2001, FMC’s North American office sent out an internal memo to doctors who used GranuFlo and NaturaLyte in FMC’s dialysis clinics. This memo notified doctors that in 2010, 941 patients suffered cardiac arrest from GranuFlo and NaturaLyte use. Additionally, the memo outlined specific guidelines for physicians when administering GranuFlo and NaturaLyte. Unfortunately, FMC did not send this memo to non-FMC clinics.

In March 2012, the FDA sent an inquiry to FMC regarding the side effects of alkalosis. Shortly afterward, an Urgent Product Notification was sent to non-FMC clinics. The FDA then issues a Class I recall for GranuFlo and NaturaLyte products that were manufactured from January 2008 and June 2012 that were used in three-stream dialysis machines.

A Class I recall is the most serious FDA recall. It alerts the public of adverse health reactions and possible death. The recall did not require that GranuFlo and NaturaLyte were removed from clinics. Instead, it required that proper dosing procedures and label updates were implemented. The recall also warned doctors of inaccurate dosage dangers.

GranuFlo Lawsuits

A number of GranuFlo and NaturaLyte lawsuits have been filed. Many of these cases involve the death of a loved one from using these dialysis products. Plaintiffs claim that consumers were not adequately warned of the dangers of using GranuFlo and NaturaLyte. It is recommended that victims of these FMC dialysis products immediately seek a qualified and experienced attorney. An attorney can help discuss legal options and file a claim.

View Sources
  1. "D. Miller & Associates, PLLC Announcing Class 1 FDA Recall on GranuFlo." Obesity, Fitness & Wellness Week 10 Nov. 2012: 353. Academic OneFile. Web. 16 Mar. 2013.
  2. "Fresenius Medical Care North America, Naturalyte and Granuflo Acid Concentrate." U.S. Food and Drug Administration. U.S. Department of Health and Human Services, 19 Nov 2012. Web. 16 Mar 2013. http://www.fda.gov/medicaldevices/safety/listofrecalls/ucm309990.htm
  3. “GranuFlo Material Safety Data Sheet.” Frenesius Medical Care North America. Frenesius Medical Care North America, 6 Apr 2010. Web. 16 Mar 2013. http://www.fmcna-concentrates.com/concentrate_new_content/acid/acetic/granuflo_dry/material_safety_data_sheet/7%20Granuflo%20section_MSDS%20subsection_1%20Oct.pdf
  4. "Legal Action Against Fresenius Draws Nearer Over GranuFlo[R] and NaturaLyte[R] Controversy." Obesity, Fitness & Wellness Week 6 Oct. 2012: 686. Academic OneFile. Web. 16 Mar. 2013.
  5. Peterson, Gary. “Dialysis Patient Survival Is Better at Fresenius Medical Care Clinics Because...”RenalWEB. RenalWEB, 14 May 2012. Web. 16 Mar 2013. http://www.renalweb.com/writings/alkalosis/BetterFMCOutcomes.htm
  6. Pollack, Andrew. “Dialysis Company’s Failure to Warn of Product Risk Draws Inquiry." New York Times, 14 Jun 2012, B3. Web. 16 Mar. 2013. http://www.nytimes.com/2012/06/15/health/fda-investigates-fresenius-for-failure-to-warn-of-risk.html