Attorney General Andy Beshear has filed a consumer protection lawsuit against Fresenius Medical Care Holdings Inc. for promoting 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, a product used in the dialysis process.
Beshear is seeking restoration for the 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.
Beshear’s Office of Medicaid Fraud and Prevention is charging that Fresenius committed Medicaid fraud for using a known harmful product in its dialysis machines around patients and employees.
“It is incomprehensible that a company would knowingly jeopardize a patient’s health or life just to make a profit,” Beshear said.
“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.”
Fresenius, headquartered in Massachusetts, 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, including more than 50 clinics in Kentucky. Fresenius also sold GranuFlo to independent clinics in Kentucky.
GranuFlo was on the market from 2003 until 2012 when it was recalled by the federal government.
According to the lawsuit, Fresenius knew but did not divulge that the use of GranuFlo in the dialysis process resulted in dangerously increased bicarbonate levels. These high levels were known to cause dialysis-related adverse cardiac events like arrhythmia, heart attacks, strokes or even death.
According to the lawsuit:
· In 2010, Fresenius conducted a clinical study of 667 of its dialysis facilities. The study revealed that 941 patients had cardiopulmonary arrests, and that these patients’ risk of cardiopulmonary arrest was up to six times higher if they had elevated pre-dialysis bicarbonate level.
· In 2011, Fresenius issued an internal memo disclosing limited results of its clinical trials that did not clearly relay the severity of the problem. The company shared the memo with its dialysis clinical staff, but did not disclose it to the independent clinics that purchased GranuFlo. A copy of the memo was anonymously leaked to the U.S. Food and Drug Administration, causing the FDA to inquire about the GranuFlo memo.
· After the FDA inquiry, Fresenius released a two-page, stripped-down, scientifically-vague memo to its independent clinic customers in 2012 that omitted critical information and references regarding the harmful side effects discovered in its clinical trials.
· In June 2012, the FDA issued a class one recall of GranuFlo. A class one recall is the most serious recall the FDA issues.
“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.”
The lawsuit is the result of an investigation into Fresenius by Beshear’s Office of Medicaid Fraud and Prevention, Control Division.
Beshear said individuals who were treated with GranuFlo should seek class action lawsuits or a private attorney. Health care professionals and patients are encouraged to digitally 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. A copy of the lawsuit can be viewed here.
(story provided by the Commonwealth of Kentucky Attorney General's Office)
