Sept. 1, 2016 – San Diego, CA Kentucky Attorney General Andy Beshear filed a lawsuit today against Fresenius Medical Care Holdings Inc., the nation’s largest dialysis provider and maker of the dialysis solution GranuFlo, accusing the company of Medicaid fraud.
As reported Thursday by the Lexington Herald-Leader, the lawsuit claims Fresenius promoted GranuFlo as safe despite clinical trials showing it could be harmful and ignored the health risks associated with the product, which include heart attack, stroke and, in some cases, death.
Kentucky’s attorney general is reportedly seeking to recover millions of dollars the state’s Medicaid program paid for dialysis treatments using GranuFlo and for the medical costs associated with the treatment of those adverse health effects. Fresenius, based out of Waltham, Mass., reportedly operates more than 50 dialysis centers in the state of Kentucky alone.
The company has billed Kentucky’s Medicaid program $16 million related to the use of GranuFlo and treatments associated with it, the Herald-Leader reported.
Not only Attorney General Beshear seeking justice for his state of Kentucky, he is urging any resident treated with the product to seek a class action lawsuit or to hire a private attorney, according to the Herald-Leader.
Fresenius has “outright lied to promote their product while putting the health of Kentuckians at risk,” Beshear is reported saying.
He is also encouraging health care professionals and patients to report adverse side effects related to GranuFlo to the Food and Drug Administration’s MedWatch Safety Information and Adverse Event Reporting Program or call 800-332-1088.
GranuFlo is an acid concentrate used in dialysis treatments. It was approved by the FDA in 2003 but was recalled less than a decade later due to safety issues. GranuFlo was found to cause a potentially life threatening condition in patients called metabolic alkalosis, which occurs when a person’s blood contains too much bicarbonate. Metabolic alkalosis puts people on dialysis at an even greater risk for cardiac arrest.
Fresenius apparently knew GranuFlo could cause these serious side effects, but failed to warn physicians outside of their own network about the risk. In 2012, the FDA received a copy of an internal Fresenius memo from an anonymous source which warned its network of physicians of risks associated with the dialysis solution.
The memo, dated Nov. 4, 2011, cited a company-led trial which reportedly found a four- to six-fold increased risk of cardiac arrest in patients with high bicarbonate levels in their blood. The company, however, did not warn physicians outside its own network of this potential risk until the FDA received a copy of the memo over a year after it was written.
The FDA recalled GranuFlo in June 2012, merely months after the Fresenius memo was leaked and the company issued warning letters to all physicians across the country warning of its product’s risks.
Lawsuits were filed against Fresenius by patients harmed by the product or by family members on behalf of their loved ones. Cases were consolidated into a multidistrict litigation and were settled in August 2016 after Fresenius and plaintiffs agreed to pay $250 million.
With Beshear’s call for a class action or individual lawsuits, more lawsuits may be filed against Fresenius in the future.