Kentucky attorney general sues dialysis company over product

September 1, 2016

FRANKFORT, Ky. (AP) — Kentucky’s attorney general accused the nation’s largest provider of kidney dialysis services of Medicaid fraud Thursday in a lawsuit that says it promoted a harmful product for use in clinics.

The lawsuit against Fresenius Medical Care Holdings Inc. seeks to restore money spent by Kentucky’s Medicaid program for dialysis treatments that used the product called GranuFlo. It also aims to recoup costs to treat other health problems allegedly related to the product’s use.

Attorney General Andy Beshear said the company concealed serious risks posed by GranuFlo, which is used in screening blood to remove impurities during dialysis.

“Fresenius put Kentucky at risk, and they billed our Medicaid program while they were doing it. They will be held accountable,” Beshear said at a state Capitol press conference.

Beshear didn’t say how much he’ll seek to recoup for the Medicaid program but a press release from his office said it would be millions of dollars.

In response to the lawsuit, Fresenius spokesman Kent Jarrell said: “All the company’s actions involving these products were appropriate, responsible and consistent with the company’s commitment to patient safety.”

The product was subject to a 2012 recall by the U.S. Food and Drug Administration. The recall resulted in relabeling of the product, Jarrell said.

“The FDA has never suggested that the product should be withdrawn from the market, that the product compositions should be changed in any way, or that the products are unsafe when used as directed and prescribed,” the company spokesman said.

Beshear’s suit, filed in Franklin County Circuit Court, also seeks damages and civil penalties for the state. The suit says the company ignored health risks associated with use of GranuFlo.

Fresenius is the largest provider of kidney dialysis and renal care products, treatment and services in the U.S., Beshear said. It owns and operates more than 50 clinics in Kentucky, he said. The company also provided GranuFlo for use in independent clinics in Kentucky, he said.

Overall, the company owns and operates about 2,150 dialysis facilities in North America, Jarrell said. Its North American operations are based in Waltham, Massachusetts.

Beshear said the company concealed a clinical study that found risks associated with the product. Beshear said he doesn’t know if anyone died in Kentucky due to use of GranuFlo.

The company’s clinical study of 667 of its dialysis facilities in 2010 revealed that 941 patients had cardiopulmonary arrests, Beshear’s office said.

In 2011, Fresenius issued an internal memo disclosing limited results of its clinical trials that failed to clearly relay the severity of the problem, the AG’s office said.

The company shared the memo with its dialysis clinical staff but did not disclose it to independent clinics obtaining GranuFlo, Beshear’s office said.

“This concealment was a blatant disregard for human life, and we cannot tolerate it in this state,” Beshear said. “Fresenius put profits over human life.”

The company is fighting similar lawsuits in Louisiana and Mississippi, Beshear said.

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