Fresenius Medical Care (FMC) is the world’s largest provider of kidney dialysis services products and is responsible for the materials of thousands of dialysis centers across the United States. Recently, the company was obligated to recall two of its dialysates, GranuFlo and NaturaLyte.
On March 29, 2012 the Food and Drug Administration (FDA) delivered a Class I recall of the two FMC manufactured drugs due to their negative side effects on dialysis patients. Among the adverse effects caused by GranuFlo and NaturaLyte were cardiac arrhythmia and an increased risk of low blood pressure. The totality of the negative effects (caused by use of GranuFlo and NaturaLyte) led to serious health concerns, including but not limited to:
- Heart arrhythmia
- Heart attack
- Sudden Death
- Stroke
- Metabolic alkalosis
- Hypokalemia
- Myocardial infraction
- Hypertension
- Hypoxemia
- Hypercapnia
- Cardiopulmonary arrest
Currently, there are over 1,800 GranuFlo and NaturaLyte lawsuits. These claims have been consolidated into a multidistrict litigation in the District of Massachusetts heard by U.S. District Judge Woodlock. The claims range from compensation for lost wages to negligence of FMC for not having an appropriate warning label on the prescription drug.
In 2016, FMC reached an agreement in order to settle the staggering number of claims against them. The settlement amount totaled $250 million. In order for this settlement to be put into place, 97% of the Plaintiffs must agree to that amount by July 2016. The settlement amounts will reportedly be distributed in August 2016 if approved on time.
If you or a loved one has been prescribed and/or used GranuFlo or NaturaLyte in the past during dialysis and experienced any negative side effects/outcomes or show signs of unwanted side effects, please contact us at 616-227-8444 or via our web page at www.naumeslaw.com.