DaVita Healthcare Caught in the GranuFlo Lawsuit Web

Denver, COThe basis for many a GranuFlo lawsuit is the alleged failure of GranuFlo manufacturer Fresenius Medical Care, headquartered in Germany and an operator of kidney dialysis clinics throughout the US, in communicating potential dosing errors to non-Fresenius clinics. However, that hasn’t stopped plaintiffs from launching litigation against DaVita, which similarly operates dialysis clinics that use Fresenius products.

According to Lawyers Weekly USA (3/25/13), four class-action lawsuits have been filed against DaVita Healthcare Partners Inc., alleging the operator should have known about the potential for Alkali Dosing Errors associated with GranuFlo powder and NaturaLyte Liquid Acid Concentrate.

The products were the subject of a NaturaLyte GranuFlo recall in March of last year.

According to the report, powdered GranuFlo and liquid NaturaLyte concentrate are mixed in clinics to facilitate the process of dialysis. Of utmost importance is the achievement of correct bicarbonate levels in the blood. Were bicarbonate levels to spike due to Alkali dosing errors, the results can lead to cardiac arrest.

Various lawsuits attest to that fact. In April of this year, the children of a Louisiana woman filed a GranuFlo lawsuit in Louisiana Western District Court (case no. 5:2013cv00829), alleging wrongful death after their mother suffered cardiac arrest while undergoing dialysis. The victim suffered a fatal heart attack a few hours later.

Yet another lawsuit was filed in March (case no. 3:2013cv01403, California Northern District Court) by two sisters who allege the wrongful death of their mother. According to PRWeb Newswire (5/28/13), GranuFlo and NaturaLyte lawsuits (numbering 161 as of May 15) have been consolidated into Multi-District Litigation No. 2428, US District Court for the District of Massachusetts. The allegation is that Fresenius Medical Care knew about the potential for Alkali Dosing Errors and notified its own clinics and doctors, but failed to communicate the concern with non-Fresenius clinics until an internal memo was leaked to the US Food and Drug Administration (FDA) last year.

Once the FDA became aware of the issue, a Fresenius Medical Care recall occurred soon after.

However, non-Fresenius clinics have not escaped the wrath of plaintiffs. Class actions against DaVita have been filed in Colorado federal court, at the same time as the Fortune 500 Company faces legal challenges on a different plane. The Denver Post (5/10/13) reports that DaVita Healthcare Partners Inc. has set aside $300 million to settle criminal and civil anti-kickback allegations unrelated to GranuFlo and NaturaLyte.

Last year, DaVita reportedly settled a whistleblower lawsuit for $55 million over claims of fraud. As of September 30, 2012, DaVita operated or provided administrative services at 1,912 outpatient dialysis centers in 43 states, according to their website.