Dialysis Injuries: GranuFlo® Powder and NaturaLyte® Liquid acid concentrate
Goldberg Persky and White lawyers are reviewing potential GranuFlo® Powder and NaturaLyte® Liquid acid concentrate lawsuits involving dialysis patients who were treated with GranuFlo and/or NaturaLyte and suffered serious injuries.
The following injuries have been reported by dialysis patients who were treated with GranuFlo or NaturaLyte:
- Heart attack
- Cardiac arrest
- Other cardiovascular problems
- Sudden cardiac death
If you or someone you know has suffered one of the above injuries as a result of taking GranuFlo and/ or NaturaLyte, please contact us immediately so we can review your case. You may be able to sue the manufacturer of GranuFlo to seek compensation for your losses. There is a strict time limit for filing Granuflo lawsuits, so do not hesitate to contact our firm today for a no obligation free case review.
GranuFlo and NaturaLyte Dialysis products are chemical products used in dialysis machines to help clean the blood of patients with kidney impairment. These products are used to control acid, sodium, potassium, calcium and magnesium levels in a dialysis patient’s blood . Fresenius Medical Care manufactures GranuFlo and NaturaLyte. Fresenius owns a majority share of the dialysis business and operates dialysis centers all over the country. Over 400,000 Americans go to Fresenius clinics for dialysis.
On Nov. 4, 2011, Fresenius sent an internal memo to its clinic doctors and medical directors warning them that NaturaLyte Liquid or GranuFlo may pose a greater risk for cardiopulmonary arrest and sudden cardiac death in certain patients:
Recent analyses performed using FMCNA hemodialysis (HD) patient safety data confirms that alkalosis is a significant risk factor associated with cardiopulmonary (CP) arrest in the dialysis unit, independent of and additive to the risk of CP arrest associated with pre-dialysis hypokalemia. The major cause of metabolic alkalosis in dialysis patients is inappropriately high dialysate total buffer concentration.
The memo detailed the potential dangers associated with GranuFlo and NaturaLyte, showing that 941 patients suffered cardiac arrest while being treated at Fresenius clinics in 2010.
Despite the internal memo, Fresenius did not share this information with the general public, the FDA, or any doctors and patients associated with a non Fresenius clinic Fortunately this internal memo was leaked to the FDA and on March 29, 2012, the FDA initiated a Class 1 recall for NaturaLyte and GranuFlobecause of their potential to cause cardiopulmonary arrest in dialysis patients. A Class I recall is the most serious kind of recall the FDA can issue, typically involving products the agency believes will cause serious medical problems or even death.
Granuflo/ NaturaLyte Lawsuits
It is unclear how many dialysis patients have been injured as a result of Fresenius� failure to warn. Those injured allege that Fresenius knew of the serious health risk associated with their product but withheld information from physicians who were therefore unknowingly putting their patients at risk. Claims against Fresenius are based on products liability as well as defective design to, breach of warranty and improper warnings.
On March 29, 2013, all federally-filed Granuflo lawsuits were consolidated to the U.S. Federal Court for the District of Massachusetts. Consolidations of the suits will allow these cases to be resolved more consistently, to conserve the resources of all parties involved, and to allow for a coordinated pretrial and discovery process. As of December 2013, there are 434 lawsuits pending against Fresenius in the Granuflo MDL.