Louisiana sues Fresenius to reclaim payment over GranuFlo use

Louisiana has filed a lawsuit against Fresenius Medical Care North America and its nearly 100 clinics in the state, saying the company used deceptive trade practices and fraudulent marketing to sell substandard dialysate made by the company. The litigation joins other class action suits filed by patients claiming injury and death over use of GranuFlo and NaturaLyte, but this appears to be the first state to join the litigation.

The suit is asking for recovery of payments made through Louisiana’s Medicaid program to Fresenius for the liquid bicarbonate dialysate, saying the company has known since 2004 that if not used properly, GranuFlo and NaturaLyte could elevate dialysis patients’ bicarbonate levels and increase the risk of a heart attack. And the company failed to notify its customers of the concerns until well after making changes at it own clinics.

“The Defendants purposefully advised their own clinics, practitioners, and physicians of the dangers of the product, but did not advise non-Fresenius clinics, practitioners, and physicians of the increased risk of (cardiopulmonary arrest) associated with the use of their products. Additionally, despite the knowledge that their product was unreasonably dangerous, and at the very least required an adjustment of the acetate value when entering the value in the operating settings in preparation for patient treatment, the Defendants continued to submit claims, or caused to be submitted claims, for reimbursement from the State of Louisiana in order to be paid for goods and services that they knew or should have known were of substandard quality.”

It wasn’t until March 2012, when the U.S. Food and Drug Administration initiated a Class I recall that Fresenius warned the medical community about the products, the lawsuit said.

The state is entitled to penalties of $5,000 per violation under Louisiana’s Unfair Trade Practices and Consumer Protection Law, the suit says, and the state is also asking the court to force Fresenius to pay back any profits made on the sale of GranuFlo.

FMC spokesperson Kent Jarrell told NN&I, “GranuFlo and NaturaLyte received appropriate FDA clearance before they were initially marketed, and that clearance remains in effect. The FDA has not suggested any change in the production formulation or asked that the products be removed from the market or returned by clinics to Fresenius Medical Care. Additionally, the FDA has not found or suggested a defect in the design or composition of GranuFlo and has not suggested or required any change in the composition of GranuFlo.”

Fresenius recently issue a voluntary recall of certain lots of NaturaLyte after discovering high bacteria levels. The FDA said it has received one report of death and two reports of injury that may be related to use of the recalled lots. FMCNA has identified the bacteria as Halmonas, Gram Negative bacteria, typically found in water with high salinity (salt concentration). The recall included 49 lots, announced April 4, but was expanded to include nine additional lots on May 1. On May 21, the recall was classified by the FDA as Class 1.