GranuFlo and NaturaLyte

Recall and Lawsuit Information

The FDA has issued a Class I recall, the most serious level of recall, on two dialysis treatment drugs produced by Fresenius Medical Care, GranuFlo and NaturaLyte. The company allegedly failed to warn doctors and clinics about the proper use of GranuFlo and NaturaLyte which have been proven to increase the risk of heart problems such as cardiac arrest. According to Fresenius Medical Care, the misuse of these two drugs has been associated with an increased risk of sudden cardiac death during dialysis treatment of 6 to 8 times the normal level. A leaked memo, which was reported in the New York Times, led the FDA to believe that Fresenius Medical Care was warning its own doctors about the significant and immediate risks, but failed to warn doctors and clinics that were not part of the company.

If you or a loved one has suffered from heart problems during or after dialysis treatment, you may be entitled to compensation from the maker of GranuFlo and NaturaLyte. For help with evaluating whether or not you qualify for compensation, you can call us at 1-800-THE-EAGLE (1-800-843-3245) for a no-cost evaluation of your claim.

About the FDA Issued Recall

In 2012, the FDA issued a Class I recall of GranuFlo and NaturaLyte due to improper labeling. A Class I recall is a very serious recall and indicates that the FDA considers there to be “a reasonable possibility that the use of or exposure to a violative product will cause serious adverse health consequences or death.” After the recall was issued, Fresenius announced that it plans on continually updating the labels on both GranuFlo and NaturaLyte to remain in compliance, a process which began in early 2012.

Uses of GranuFlo and NaturaLyte in Dialysis

Dialysis is a procedure that patients undergo to clear toxins and waste from the blood when the kidneys can no longer function properly. The procedure is an important one and needs to be repeated at regular intervals to make sure toxins and waste don’t build up in the blood, which can cause the patient to become ill. During dialysis, bicarbonates, or chemicals that convert to bicarbonates, are administered to lower the acidity of the patient’s blood. Both GranuFlo and NaturaLyte are products that contain ingredients which are converted into bicarbonates in the body. They both act as agents to lower the levels of acid in the blood of patients undergoing dialysis.

The problem is that both GranuFlo and NaturaLyte are converted to bicarbonates at much higher rates than similar products in use by medical professionals. Clinics and doctors were unaware of this different rate and administered much higher doses of bicarbonates to patients than necessary. High levels of bicarbonate have been proven to drastically increase the risk of cardiac arrest and other heart issues.

Fresenius Knew of the Dangers and Failed to Respond Appropriately

On November 4th, 2011, Fresenius issued an internal memo to all of its clinics where GranuFlo and NaturaLyte were administered describing the dangers of current usage practices of both drugs. In the memo, recommendations were made for adjusting dosing and prescriptions for patients because of the immediate dangers of sudden cardiac death. The findings were significant and the warnings contained in the memo emphasized the “prompt immediate review of dialysate bicarbonate prescription.” However, despite the findings in the internal memo, Fresenius failed to notify outside clinics of any dangers.

It wasn’t until March of 2012, when the FDA was notified of the Fresenius internal memo, that Fresenius issued a warning to outside clinics where more than 100,000 dialysis patients were being treated. But even though Fresenius issued a warning to outside clinics, it failed to include some important details and the urgency that was present in the internal memo. Because of this, the FDA has begun an investigation into the company to determine if federal laws were broken in regards to adequately warning customers and clinics of the dangers.

Potential Side Effects of GranuFlo and NaturaLyte

According to the FDA, the negligence of Fresenius Medical Care can cause several severe side effects in patients that were treated with GranuFlo and NaturaLyte during dialysis. The following health issues have been reported by some patients:

  • Cardiac Arrest (heart attack)
  • Stroke
  • Low blood pressure
  • Cardiac arrhythmia
  • Low oxygen levels in blood
  • Low potassium levels in blood
  • High levels of carbon dioxide in the blood

Types of Monetary Recovery Available to Victims and Their Families

Each case will vary in the amount and types of monetary recovery, but some of the recovery that may be available in a case include:

  • Medical bills
  • Lost wages
  • Funeral expenses
  • Pain and suffering
  • Mental anguish

How to Get Legal Help

If you or a loved one suffered serious heart problems during or after any dialysis treatment, please contact us immediately at 1-800-THE-EAGLE (1-800-843-3245). You can also submit your information safely in the online form below. You may be entitled to compensation from the manufacturer of GranuFlo and NaturaLyte and our personal injury lawyers years of experience can help you get the compensation you need and deserve. All states have time limits that restrict how long you have to act before your case is forever barred. Contact us today.

You can also view our dangerous drug page here.

 


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Email us information about your potential claim, or give us a call 24/7 at 1-800-THE-EAGLE (1-800-843-3245) for a free, no obligation consultation.
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