Attorney General Andy Beshear filed a lawsuit Thursday against Fresenius Medical Care Holdings Inc., the nation’s largest kidney dialysis provider, which has more than 50 clinics in Kentucky and has served dozens of independent clinics in the state.
Beshear claimed in the suit filed in Franklin Circuit Court that Fresenius, headquartered in Waltham, Mass., promoted its kidney dialysis product, GranuFlo, as safe despite clinical trials finding it harmful.
The lawsuit seeks to recover damages and civil penalties for the state. It claims the company ignored the health risks associated with and the possibility of death from the use of GranuFlo.
Fresenius has “outright lied to promote their product while putting the health of Kentuckians at risk,” Beshear said.
Fresenius spokesman Kent Jarrell said in an email Thursday that GranuFlo continues to be a market leader for the company and that the Federal Drug Administration has never suggested that it “should be withdrawn from the market, that the product compositions should be changed in any way, or that the products are unsafe when used as directed and prescribed.”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 FDA issued a recall notice for Fresenius GranuFlo (powder) Acid Concentrate on June 25, 2012, citing “false and misleading” labeling, although that action did not remove the product from the market.
Fresenius is fighting similar lawsuits in Louisiana and Mississippi.
Beshear is seeking a refund of millions of dollars the Kentucky Medicaid Program paid for dialysis treatments using GranuFlo or for the medical costs to treat the adverse health consequences of GranuFlo — arrhythmia, heart attacks or strokes.
He said Forsenius has billed the state’s Medicaid program $16 million related to the use of GranuFlo and treatment associated with it.
Beshear did not know if any deaths have occurred in Kentucky due to GranuFlo.
His Office of Medicaid Fraud and Prevention charges that Fresenius committed Medicaid fraud for using a known harmful product in its dialysis machines around patients and employees.
Fresenius is the largest provider of kidney dialysis and renal care products, treatment and services in the nation with more than 2,200 dialysis clinics nationwide.
According to the lawsuit, Fresenius became aware but didn’t immediately or clearly divulge that GranuFlo could result in high bicarbonate levels in patients. These high levels were known to cause dialysis-related adverse cardiac events.
The lawsuit said in 2010 that Fresenius conducted a clinical study at 667 of its dialysis facilities and found that 941 patients had cardiopulmonary arrests.
In 2011, the lawsuit said, Fresenius issued an internal memo disclosing results of its clinical trials that did not clearly relay the severity of the problem. The company allegedly shared the memo with its dialysis clinical staff, but not with the independent clinics that purchased GranuFlo.
A copy of the memo was anonymously leaked to the U.S. Food and Drug Administration, which started investigating.
After the FDA inquiry, Beshear said, Fresenius released a two-page, “stripped-down, scientifically vague” memo to its clinic customers in 2012 that omitted critical information and references regarding the harmful side effects discovered in the clinical trials.
Beshear said individuals who were treated with GranuFlo should seek class action lawsuits or a private attorney.
He also said health care professionals and patients are encouraged to report adverse events or side effects related to GranuFlo to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program or call 800-332-1088.
Any civil penalties from Kentucky’s lawsuit would be returned to the state and its Medicaid program, said the state’s top law-enforcement official.