GranuFlo or Naturalyte are dialysis treatment products that have been linked to hundreds of injuries and deaths. The products were marketed and sold until June 2012, when the FDA issued a Class 1 recall due to the serious risk of sudden cardiac arrest and death. Fresenius Medical Care, the manufacturer of GranuFlo and Naturalyte, is currently under investigation for allegedly failing to warn about deadly side effects.
Need a Texas Dialysis Injury Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one has been injured during kidney dialysis treatment, you should contact our lawyers immediately. You may be entitled to compensation by filing a dialysis injury lawsuit.
What are GranuFlo and Naturalyte?
GranuFlo Dry Acid Concentrate and Naturalyte Liquid Acid Concentrate are two dialysis treatment products manufactured by Fresenius Medical Care, the largest dialysis company in the world. The products are added to the dialysate solution, which is added to the blood of patients undergoing dialysis treatment.
GranuFlo or Naturalyte are combined with a bicarbonate concentrate, which is supposed to balance the acidity of the blood before it is returned to a patient. Unfortunately, improper doses of GranuFlo or NaturaLyte can contribute to a bicarbonate overdose, metabolic alkalosis, sudden cardiac arrest, and death.
What’s the problem?
Fresenius Medical Care, the manufacturer of GranuFlo and Naturalyte, is under investigation from the U.S. Food and Drug Administration (FDA) for allegedly withholding risk information.
In November 2011, Fresenius allegedly sent an internal memo to warn their own doctors about the risk of sudden cardiac arrest in patients using Naturalyte or GranuFlo — but they did not warn the FDA, other doctors, or the public.
Both products were associated with 941 deaths at Fresenius clinics in 2010. Improper doses were also associated with a 6 to 8-fold increased risk of cardiac arrest and death.
The FDA did not learn about the danger of Naturalyte or GranuFlo until an anonymous source leaked the memo in 2012. On March 29, 2012, Fresenius sent a warning to all physicians about the risks associated with GranuFlo and Naturalyte. The products were marketed and sold until the FDA issued a Class 1 recall in June 2012.
GranuFlo and Naturalyte were sold from January 2008 until June 2012.
Side Effects and Complications
Contact a dialysis injury lawyer today if you or your loved one suffered a serious dialysis side effect, such as:
- Elevated bicarbonate level
- Metabolic alkalosis
- Irregular heart rhythm
- Cardiopulmonary arrest
- Low blood pressure
- Cardiac arrest
Texas Dialysis Injury Lawyers
If your dialysis injury was caused by GranuFlo or Naturalyte, contact a Texas dialysis injury lawyer at The Clark Firm, LLP today.
You could be eligible to file a lawsuit against Fresenius Medical Care. Dozens of lawsuits have already been filed, and the litigation continues to grow as more people seek justice for their injuries. You could potentially receive compensation for your pain and suffering, medical expenses, permanent disability, lost wages, and more.
Do I Have a Dialysis Injury Lawsuit?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $60 million in verdicts and/or settlements. Please use the form below to contact us for a free dialysis injury lawsuit review.