BATON ROUGE, La. (AP) — Louisiana is suing drug maker Fresenius Medical Care North America and its nearly 100 Louisiana clinics over the use of two dialysis drugs, GranuFlo and NaturaLyte, that could contribute to fatal heart attacks.
The drugs have since been recalled by the federal government.
The Advocate reports (http://bit.ly/VvS77S ) the lawsuit, filed in state district court in Baton Rouge by the state Attorney General’s Office, says Fresenius violated Louisiana law in an effort to defraud dialysis clinics, physicians, the state and its residents.
Fresenius officials could not be reached for comment Friday.
The lawsuit seeks civil penalties of $5,000 per violation under Louisiana’s Unfair Trade Practices and Consumer Protection Law. Louisiana is also asking the court to force Fresenius to pay back any profit made on the sale of GranuFlo.
Fresenius knew as early as 2004 that its products, if not used properly, could elevate dialysis patients’ bicarbonate levels and increase the risk of a heart attack, according to the lawsuit. The company, based in Waltham, Massachusetts, also knew that its dialysis machines required special instructions when using GranuFlo to reduce those risks, the state claims.
But Fresenius didn’t warn patients or the roughly 1,500 non-Fresenius dialysis clinics using the drugs of the dangers, the lawsuit says. Fresenius tried to conceal the dangers from the public and the U.S. Food and Drug Administration, it said.
It wasn’t until March 2012, when the FDA initiated a Class I recall — the most serious type of recall where use of a product will cause serious health problems or death — that Fresenius warned the medical community about the products, the lawsuit said.
A Fresenius study found that in 2010, 941 dialysis patients at 667 of its clinics suffered a cardiac arrest during treatment.
A number of class-action lawsuits have been filed against Fresenius.
Information from: The Advocate, http://theadvocate.com
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