Pharmaceutical

Louisiana sues Fresenius for marketing dangerous, defective dialysis products

dialysis Louisiana sues Fresenius for marketing dangerous, defective dialysis productsHundreds of people have filed wrongful death and personal injury lawsuits against dialysis products and services giant Fresenius Medical Care North America over alleged injuries and deaths caused by the company’s dialysis concentrates GranuFlo and NaturaLyte. Now the state of Louisiana is joining in, asking for its day in court in order to recover payments made through the state’s Medicaid program for the defective products.

Louisiana is accusing Fresenius of deceptive trade practices and fraudulent marketing to sell its defective dialysis products, and claims the company has known since 2004 that the products were labeled with confusing instructions that could deliver toxic levels of bicarbonate into patients’ blood and put them at risk of sudden cardiac arrest.

“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,” the complaint reads.

It wasn’t until March 2012 that the Food and Drug Administration (FDA) obtained an anonymous copy of an internal memo Fresenius sent to staff at its clinics informing of the confusing labels and the cardiovascular risks associated with misuse of NaturaLyte and GranuFlo. Only after this letter exposed the product risk did Fresenius issue a recall on the products.

Louisiana is seeking $5,000 per violation under the state’s Unfair Trade Practices and Consumer Protection Law. The state is also asking that the court force Fresenius to pay back any profits it received from sales of the defective products.

Source: Nephrology News & Issues