Following a Class I FDA Recall, GranuFlo and NaturaLyte Lawsuits on the Rise
Fresenius Medical Care is one of the largest manufacturers and suppliers of dialysis machines and disposable products. In addition to its own clinics, Fresenius also supplies many other dialysis treatment centers and clinics. GranuFlo is a powdered chemical that uses sodium diacetate to create bicarbonates. NaturaLyte is the same type of chemical but is administered in liquid form. High levels of bicarbonates are known to cause significant health problems. Dialysis patients receiving GranuFlo or NaturaLyte treatments may be six to eight times more likely to experience fatal cardiac arrest.
Following a dramatic increase in the number of complaints and adverse events linked to GranuFlo, the Food and Drug Administration (FDA) issued a Class I Recall on March 29, 2012. A Class I recall is the highest level of recall and is issued for products which present a strong danger of serious injury or death.
Currently, there are more than 1,800 pending lawsuits against GranuFlo and NaturaLyte with the first trial slated to begin in January 2016. These lawsuits allege that Fresenius “intentionally, recklessly and/or negligently concealed, suppressed, omitted and misrepresented the risks, dangers, defects and disadvantages of GranuFlo and NaturaLyte.”
Current evidence supports claims that Fresenius was aware of the dangers associated with GranuFlo, specifically an increased risk of cardiac arrest, and willfully failed to warn all clinics and doctors that used these chemicals. An internal memo from Fresenius claimed that 914 patients undergoing dialysis treatments at Fresenius-owned clinics experienced cardiac arrest in 2010. Company employees concluded that these patients all had excessive levels of bicarbonates in their blood.
If you or a loved one suffered health complications due to dialysis treatments you may be able to recover significant damages for:
- Medical expenses
- Lost wages
- Emotional and physical suffering
- Wrongful death
It is important to seek legal advice as soon as possible to ensure you have the best chance at receiving maximum compensation. Schedule a free initial consultation with the Florida medical product liability attorneys at Osborne & Associates to explore your options.We can be reached at 561-293-2600 or online.