Fresenius sued by Kentucky over marketing of kidney dialysis product

The nation’s largest provider of kidney dialysis and renal care products is being sued by the state of Kentucky, alleging deceptive marketing of its GranuFlo blood screening product.

Kentucky Attorney General Steve Beshear’s lawsuit said Fresenius knew GranuFlo put patients at greater risk of heart attacks, strokes or arrhythmia thanks to increased bicarbonate levels while the product screened for impurities, but didn’t inform clinicians outside the company.

“It is incomprehensible that a company would knowingly jeopardize a patient’s health or life just to make a profit,” Beshear said in a statement. “These actions are unacceptable, and my office is determined to hold them accountable for their actions that took place in the more than 50 clinics across the state where Kentuckians were treated with GranuFlo.”

The lawsuit said in 2010, seven years after GranuFlo first became available, a Fresenius study of its dialysis centers found 941 cases of cardiopulmonary arrests among patients in its facilities, a figure “over six times higher than that of competing products.” After the FDA warned the company about inadequately responding to the safety issues, the lawsuit said the company’s chief medical officer, Raymond Hakim, MD, PhD, issued a “secret memo” in 2011 about the elevated risk to patients, but only to Fresenius’ own facilities, not to other dialysis clinics which had purchased GranuFlo.

That memo was leaked to FDA in March 2012, and in June, the agency issued a Class 1 recall of the product.

“It’s abundantly clear that, for several years, Fresenius withheld critical GranuFlo-related information from its own clinical staff and from the clinical staff of its customers, many of them right here in Kentucky,” Beshear said. “Had the company been ethical and not profit-hungry, many of the heart attacks or deaths could have been prevented.”

In a statement to the Lexington Herald-Leader, Fresenius spokesman Kent Jarrell said the FDA has never said GranuFlo “should be withdrawn from the market, that the product compositions should be changed in any way, or that the products are unsafe when used as directed and prescribed.”

Beshear’s lawsuit is seeking to recover some of the $16 million in billings to the state’s Medicaid program associated with GranuFlo, arguing if the company knowingly used and promoted a harmful product, it committed Medicaid fraud.

Fresenius is already facing similar lawsuits in Louisiana and Mississippi.