Attorney general sues largest provider of dialysis services, alleging Medicaid fraud over recalled product
09/01/2016 03:35 PM
FRANKFORT — Attorney General Andy Beshear is suing the largest provider of dialysis and renal care products and services, accusing the company of using a kidney dialysis product it knew brought health risks to patients and defrauding Medicaid.
The German company continued using a product called GranuFlo despite conducting a clinical study at its dialysis clinics in 2010 and finding that 941 patients suffered heart attacks on the drug.
Beshear, in a Capitol news conference Thursday, said Kentucky patients at 50 of Fresenius’ clinics and dozens of independent clinics depended on Fresenius with their lives.
“Fresenius broke that trust by knowingly and deceptively marketing a product called GranuFlo Dry Acid Concentrate,” Beshear said. “GranuFlo, as it’s known, is a product used in screening the blood to remove impurities during the dialysis process — what your kidneys are supposed to do.
“GranuFlo was recalled in 2012 by the FDA because it can have serious effects on patients, such as heart attacks, strokes, arrhythmia and even death.”
Fresenius spokesman Kent Jarrell said acid concentrates offered by the medical company “continue today to be market leaders, as they have been for many years.”
“The FDA has never suggested that either product (GranuFlo and Naturalyte) should be withdrawn from the market, that the product compositions should be changed in any way, or that the products are unsafe when used as directed and prescribed,” Jarrell said in a statement.
The Food and Drug Administration recalled GranuFlo in 2012 after it received a leaked copy of an internal memo on Fresenius’ clinical trials.
The medical company has been sued by two other states, Mississippi and Louisiana, and in February, it settled thousands of lawsuits over GranuFlo for $250 million.
“Fresenius knew the harm its product was causing, but it was covering its own behind,” Beshear said.
It’s unclear how many Kentuckians were affected by GranuFlo, and Beshear urged those who used the product to contact an attorney.
“Understand that dialysis is common in Kentucky,” he said. “We have over 50 Fresenius clinics and dozens of independent clinics.”
Unclear, too, is how much Medicaid money is involved.
Beshear said that will be revealed as the case moves forward in Franklin Circuit Court.
“Fresenius at large billed over $16 million to Medicaid,” he said. “Now, once we are in discovery and in the litigation, the actual recovery figure that we’ll seek may become more definite, but we are talking significant funds.”
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