Defective Drug Litigation

FDA Class One Recall of GranuFlo and NaturaLyte

According to the Centers of Disease Control, one in ten adults in America has some form of chronic kidney (renal) disease.1 And for those with end stage renal disease, nearly 400,000 people are treated with some form of dialysis, or blood filtering.2

Use of dialysis machines has become commonplace and is considered one of the most important modern medical breakthroughs3; however, in March 2012, the Food and Drug Administration (FDA) initiated a Class One recall against the major dialysis center operator, Fresenius, for the company’s dialysis machine concentrates, NaturaLyte® and GranuFlo®.4

Hemodialysis and acid concentrates?

During hemodialysis, blood flows slowly through a special filter in the dialysis machine.5 The filter removes extra fluids and waste from the body and the cleaned blood is then returned to the body.6

To help the machine filter harmful substances, acid concentrates, like NaturaLyte and GranuFlo, are used. These concentrates are bicarbonates and reduce acid in the blood. Once the blood is returned to the body, the expectation is that the blood regains its normal chemical balance. However, NaturaLyte and GranuFlo have been causing serious side effects.7

Side effects of NaturaLyte and GranuFlo concentrates

The current NaturaLyte and GranuFlo recall is significant, because GranuFlo and NaturaLyte concentrates have been linked to serious and sometimes life-threatening injuries. In one FDA adverse event report, patients suffered from a number of ailments, including swollen arms, leg weakness and swollen stomachs.8 More serious risks and side effects of using GranuFlo and NaturaLyte concentrates include:

  • Cardiac arrhythmia
  • Hypercapnia (too much carbon dioxide in the blood)
  • Hypoexmia (insufficient air in the blood)
  • Low blood pressure
  • Heart attack
  • Death
  • Metabolic alkalosis (too much bicarbonate in the blood)
  • Hypokalemia

These side effects primarily affect the blood, heart and lungs, and can result in lasting problems for a patient.

FDA recall

In 2011, Fresenius, the maker of GranuFlo and NaturaLyte concentrates, issued a warning letter to physicians about the harmful risk factors linked to their product. By 2012, the FDA took further action. A Class One recall is one of the most serious recall categories with the FDA.9

Contacting an attorney about NaturaLyte and GranuFlo

The recall impacts a large percentage of dialysis patients, because at least one third of all dialysis patients in America use Fresenius facilities. Currently, more than 100 actions have been filed in 16 federal districts, and GranuFlo and NaturaLyte cases are pending approval for Multi-District Litigation.10

If you or a loved one suffered from renal disease and have been injured from GranuFlo or NaturaLyte, you may have a right to legal compensation. Contact an experienced personal injury lawyer for help with your GranuFlo and/or NaturaLyte product liability suit.

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