After agreeing to settle thousands of injury and wrongful death lawsuits brought on behalf of dialysis patients who experienced problems with their Granuflo dialysate solution, Fresenius Medical Care now faces a claim brought by Kentucky’s Attorney General, which alleges the company defrauded the state by failing to warn that side effects of GranuFlo may increase the risk of cardiac arrest.
In a complaint (PDF) filed last week, Kentucky’s Attorney General Andy Beshear seeks millions in civil penalties and damages on behalf of the state Medicaid program, claiming Fresenius Medical Care Holdings Inc. engaged in “unlawful, unfair, false, misleading and deceptive practices related to GranuFlo Dry Acid Concentrate.”
In early 2012, Fresenius issued a GranuFlo recall and updated warnings provided to physicians about the importance of monitoring bicarbonate levels among dialysis patients receiving the product. However, the action was taken months after the company warned doctors using Granuflo at Fresenius-owned dialysis centers, after recognizing that a large number of patients were suffering sudden cardiac arrest or death during or shortly after treatments.
Following several years of litigation, Fresenius agreed to pay $250 million to settle lawsuits filed by individuals who suffered an injury and families of those who died, resolving about 4,300 case that alleged the problems could have been avoided if Fresenius had provided earlier warnings to physicians.
Beshear claims that Kentucy Medicaid program has paid millions of dollars for kidney dialysis treatments, as well as emergency room admissions, hospitalizations and rehabilitation services for individuals injured by GranuFlo, seeking to recover damages against Fresenius under the Kentucky Consumer Protection Act, the Kentucky Medical Assistance Fraud Statute, the Kentucky Medicaid Fraud Statutes and other laws.
“It is incomprehensible that a company would knowingly jeopardize a patient’s health or life just to make a profit,” Beshear said in the press release announcing the lawsuit. “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 complaint claims that Fresenius withheld vital and critical information about the risks associated with GranuFlo for years, alleging that many individuals in Kentucky may have avoided heart attacks or deaths if the company had behaved appropriately.