Product News and Recalls

Louisiana Sues Fresenius over GranuFlo and NaturaLyte Use

GranuFlo manufacturer sued by the state of LouisianaThe state of Louisiana filed a lawsuit against Fresenius Medical Care North America alleging the clinics deceived patients through fraudulent marketing to sell substandard dialysate. The company has 100 clinics in the state of Louisiana that allegedly provided the dialysis products.

The state had made payments through their Medicaid program to Fresenius for the liquid bicarbonate dialysates. The state claims that under their Unfair Trade Practices and Consumer Protection Law, it should receive $5,000 per violation and that it should be paid back for any and all profits the company made from the sale of GranuFlo.

The lawsuit alleges that Fresenius advised its own clinics and physicians through a 2011 in-house memo that its GranuFlo product has been linked to a higher risk of heart failure and even death. It was not until March 2012 that the company warned non-Fresenius clinics and physicians about the potential complications associated with the dialysis product.

Fresenius recently recalled 56 lots of NaturaLyte for elevated levels of bacteria that increased during shelf life. The bacteria is known as Halmonas, and is typically found in water with a high salt concentration. The FDA has received reports of one death and two injuries from the dialysis product’s bacteria levels.

The Louisiana lawsuit comes after many NaturaLyte and GranuFlo lawsuits that claim injury or death. If you or a loved one has suffered injury or death after kidney dialysis, contact Lopez McHugh for a free consultation and we can help determine if Granuflo or NaturaLyte was used.