GranuFlo Lawsuit

Kidney dialysis drugs, GranuFlo and NaturaLyte, may have resulted in metabolic alkalosis, cardiac arrhythmia, heart attack and death due to dosing errors. Manufacturer Fresenius Medical Care North America has faced multiple NaturaLyte and GranuFlo lawsuits for serious injury or death caused by the medications.

Jump to topic
  • GranuFlo Lawsuit Overview
  • What is GranuFlo?
  • What is NaturaLyte?
  • Who Makes GranuFlo?
  • Has GranuFlo Been Recalled?
  • Why was Fresenius Accused of Misconduct?
  • What are the GranuFlo Lawsuit Claims?
  • Were there any GranuFlo Lawsuit Settlements?
  • Who can File a GranuFlo or NaturaLyte Lawsuit?

GranuFlo Lawsuit Overview

Evidence shows that frequent GranuFlo or NaturaLyte dosing errors took place in medical facilities used for kidney dialysis. These dosing errors led to dangerously increased level of bicarbonate in the blood. As a result of the dosing errors, a number of GranuFlo and NaturaLyte patients suffered metabolic alkalosis from the high bicarbonate levels. Metabolic alkalosis can cause conditions such as low blood pressure and cardiac arrhythmia and in severe cases, may lead to heart attack and death.

Many patients suffered severe side effects including cardiac arrest or death. A number of GranuFlo lawsuits have been filed against the manufacturer, Fresenius Medical Care North America.

What is GranuFlo?

GranuFlo is powdered citrasate concentrate used in dialysis treatments for patients with kidney failure or disease. GranuFlo is a powder medication which contains both acetic acid and sodium citrate to be reconstituted for use in the fluid exchange process of kidney dialysis.

What is NaturaLyte?

NaturaLyte is a liquid citrasate concentrate, similar to GranuFlo and intended to be used in dialysis. Like GranuFlo, it also contains both acetic acid and sodium citrate and is diluted to be used in the fluid exchange process of kidney dialysis.

Who Makes GranuFlo?

Both GranuFlo and NaturaLyte are manufactured by Fresenius Medical Care (FMC) North America. FMC is a primary supplier of dialysis machines and products, and also operates hundreds of dialysis clinics around the United States.

Fresenius products like GranuFlo and NaturaLyte are used in FMC clinics, but also in other stand-alone or healthcare system operated dialysis clinics that are not associated with Fresenius.

Has GranuFlo Been Recalled?

In 2012, the U.S. Food and Drug Administration (FDA) issued a Class I recall of GranuFlo and NaturaLyte. The recall was a reaction to the evidence of severe cardiovascular side effects from dosing errors in FMC and non-FMC dialysis clinics.

A Class I recall is the most serious recall level and indicates that a high chance of serious injury or death is possible from the drug. The GranuFlo and NaturaLyte recall was issued after alleged misconduct involving the company was discovered.

After changes in drug labelling on GranuFlo and NaturaLyte, the medications were returned to the market and are still available.

Why was Fresenius Accused of Misconduct?

GranuFlo and NaturaLyte were administered through dialysis treatments in thousands of medical facilities. These facilities included third-party hospitals and clinics, as well as clinics owned and operated by Fresenius.

In November 2011, Fresenius had issued an urgent internal company memo to Fresenius clinics administering GranuFlo and NaturaLyte. The memo reported that nearly 950 Fresenius clinic patients suffered heart attacks. The memos concluded that an excess level of blood bicarbonate significantly increased the risk of cardiac arrest.

Additionally, the memo linked GranuFlo treatment with increased bicarbonate levels and consequent heart attacks. However, Fresenius did not notify the FDA or distribute the memo to medical professionals outside of the Fresenius corporation.

In March 2012, the memo was anonymously leaked to the FDA. The FDA immediately launched an investigation and later issued a recall of the drugs. In defense, Fresenius stated that the information had not been reported to the FDA as it was too preliminary for public release.

What are the GranuFlo Lawsuit Claims?

Multiple GranuFlo lawsuits were filed against Fresenius Medical Care and against individual dialysis clinics. The GranuFlo and NaturaLyte lawsuits claimed that patients suffered serious health complications as a direct result of using the medications, in most cases due to a high risk of dosing errors.

GranuFlo and NaturaLyte dosing error can cause metabolic alkalosis which may lead to conditions such as hypoxemia, hypokalemia, hypercapnia, and cardiac arrhythmia. GranuFlo lawsuits alleged that despite knowledge of side effects and dosing errors, Fresenius continued to market and sell the drug without properly warning doctors and patients of the risks.

Injuries claimed in lawsuits included:

  • Metabolic alkalosis
  • High bicarbonate levels
  • Low potassium levels
  • Low oxygen levels
  • Low blood pressure
  • High carbon dioxide levels
  • Cardiac arrhythmia
  • Heart attack
  • Death

Additionally, plaintiffs alleged that Fresenius deliberately misled consumers regarding the safety of GranuFlo. Fresenius is accused of displaying a “conscious disregard” for the public’s safety in favor of sales and revenue.

Were there any GranuFlo Lawsuit Settlements?

In 2013, federal GranuFlo and NaturaLyte cases were consolidated into a multidistrict litigation (MDL) in the U.S. District Court, District of Massachusetts. The number of cases ultimately reached more than 4,000.

In February 2016, Fresenius Medical Care offered a $250 million settlement for members of the MDL, some of whom agreed to settle. Other plaintiffs declined to settle and continued in their lawsuits.

FMC won a state lawsuit in Massachusetts and in 2017, won the first of the bellwether trials but in 2018, a federal jury awarded $383 million to families of three patients who had died after GranuFlo treatment.

Who can File a GranuFlo or NaturaLyte Lawsuit?

Though most GranuFlo or NaturaLyte lawsuits have already been settled, those who have suffered a serious injury such as cardiac arrest should seek legal advice regarding a GranuFlo lawsuit. An experienced attorney can discuss each plaintiff’s case details and legal options.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA. 

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