Granuflo

  • Granuflo

Fresenius Medical Care manufactured GranuFlo and NaturaLyte dialysates used for dialysis in patients suffering from chronic kidney disease and renal failure. The Food and Drug Administration (FDA) approved GranuFlo in 2003 through a process called 510(k) of the Food, Drug, and Cosmetic Act. In this process, a premarketing submission is made which says that the device is substantially equivalent to a device already placed on the market.

Fresenius made a claim that GranuFlo was “substantially equivalent” to its dialysates which were already on the market since the 1990s; it was the first time when Fresenius had begun using sodium diacetate; however, in 1994, Fresenius increased the amount of sodium diacetate. Quite evidently, all the other dialysates had got approval in a similar way by FDA’s 510(k) process.

Fresenius issued an internal memo on November 4, 2011. According to this memo, more than 900 patients experienced heart attacks in Fresenius clinics during the previous year. Very strategically, this memo was sent only to Fresenius’ dialysis centers, and other centers were not informed.

Serious Alleged Injuries may include:

  • Hypoxemia or low levels of blood oxygen
  • Hypokalemia or low levels of blood potassium
  • Hypercapnia or high levels of blood carbon dioxide
  • Metabolic Alkalosis
  • Sudden cardiac arrest
  • Death

FDA SAFETY WARNINGS:

The FDA issued a Class I recall of GranuFlo and NaturaLyte on March 29, 2012, to revise the prescribing instructions related to life-threatening injuries.

A Class III recall was made by the FDA in 2013 due to discoloration found in a certain lot numbers of Fresenius Granuflo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis; the FDA determined the product was “nonconforming”.

Lawsuit Allegations:

In 2013, GranuFlo and NaturaLyte lawsuits were consolidated into a multidistrict litigation (MDL) 2428 presided by U.S. District Judge Douglas P. Woodlock in the District of Massachusetts (In re Fresenius GranuFlo/NaturaLyte Dialysate Litigation).

In February 2016, Fresenius finally accepted to provide a $250 million settlement amount for Granuflo lawsuits which was expected to be approved and funded by August 2016, for more than 4,000 plaintiffs awaiting trial. Fresenius has not disclosed how many cases the settlement will include.

The settlement was declined by a group of plaintiffs who continued with their litigation.

Fresenius Medical Care won the first bellwether trial in March 2017.

Evidences:

  • Granuflo and NaturaLyte Usage in patients before 2012
  • Evidence of increased bicarbonate levels
  • Cause of Death as Cardiac Arrest, in case of death
  • Details of Dialysis Facility

Medical Record Review and claim validation of Granuflo case should take approximately 3 hours in most instances; however, this approximation may vary in cases based on the volume of records.

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