GranuFlo and NaturaLyte Kidney Dialysis Recall

Injured by Dangerous Medication?

GranuFlo and NaturaLyte are acid concentrates produced by Fresenius Medical Care. The medications are used in dialysate, which is administered to patients undergoing kidney dialysis. Unfortunately, GranuFlo and NaturaLyte can significantly increase the chances of a cardiac event, including a potentially fatal heart attack.

Evidence indicates that Fresenius Medical Care was aware of the potential dangers of GranuFlo and NaturaLyte but failed to take action to warn the majority of dialysis clinics throughout the United States. In March of 2012, the FDA issued a Class I Recall Notice providing warning but many patients had already suffered life-threatening or fatal complications by this time.

Those who were harmed by GranuFlo or NaturaLyte or individuals who lost loved ones due to the dangerous medications may have a legal claim against Fresenius Medical Care. David C. Rash P.A. is representing injured victims in GranuFlo and NaturaLyte kidney dialysis recall cases against Fresenius Medical Care to obtain monetary compensation. Attorney Rash has been named among the Top 100 Trial Lawyers in the United States and has been recognized among South Florida’s Top Lawyers for mass tort litigation.

GranuFlo and NaturaLyte Complications

GranuFlo and NaturaLyte convert to bicarbonates in the body, which can cause an overdose of bicarbonates in many patients. A bicarbonate overdose can cause metal alkalosis, which is a condition of elevated pH levels. Complications associated with metal alkalosis include:

  • Irregular heart-beat
  • Cardiac arrest
  • Confusion
  • Light-headedness
  • Dizziness
  • Low blood pressure
  • Muscles that twitch or spasm
  • Tingling or numbness
  • Hypoexmia (low oxygen levels)
  • Hypercapnia (high carbon dioxide levels)
  • Hypokalemia (low potassium)
  • Death

Evidence indicates that Fresenius may have been aware of the dangers of GranuFlo and NaturaLyte as far back as 2003 at the time when the drugs were approved. By November of 2011, it was clear that Fresenius knew of these complications since more than 900 patients had experienced cardiac events in the company’s own dialysis clinics.

Fresenius warned of the risks in an internal memorandum sent to the company’s 1,800 dialysis clinics in the U.S., which treated more than 138,000 patients. Unfortunately, as many as 125,000 patients who were treated at independent clinics did not receive a warning. Therefore, these dialysis patients continued to be exposed to dangerous medications long after the dangers were recognized.

David C. Rash P.A. Can Help Injured Dialysis Victims

Under the law, when a drug manufacturer releases a product, the public must be warned of any dangers, and the manufacturer must ensure that the medication is safe prior to distribution. In this case, Fresenius failed to live up to its legal obligations. Injured victims who suffered complications due to GranuFlo and NaturaLyte may pursue a claim for damages and those who lost loved ones may pursue a wrongful death case.

David C. Rash P.A. can help those who have been harmed to seek compensation through a class action, multi-district litigation or other claim against Fresenius Medical Care. Contact us today to set up your free consultation and learn how we can help.

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