GranuFlo Lawsuits at About 5,500 and Climbing

Waltham, MAIt appears as if the GranuFlo lawsuit portfolio is mushrooming, as more and more plaintiffs come forward with allegations that GranuFlo manufacturer Fresenius Medical Care not only knew about risks associated with GranuFlo and NaturaLyte for years, it also cared not to alert non-Fresenius dialysis clinics when the Waltham, Massachusetts company ramped up the concern over the potential for GranuFlo heart attack for its own clinicians, but not others.

According to the Boston Herald (7/17/14), there are well over 5,000 lawsuits -nearly 5,500, in fact. Plaintiffs bringing a Fresenius lawsuit have filed in Middlesex Superior Court (3,694 cases), with another 1,800 cases filed in US District Court in Boston, according to the latest figures. All cases in the two courts have been consolidated before US District Court Judge Douglas P. Woodlock and, in Middlesex, Superior Court Judge Maynard Kirpalani.

The allegations stem from an internal memo Fresenius forwarded to its own dialysis clinics and clinicians, warning of concerns with regard to the use of GranuFlo and NaturaLyte and a respective spike in cardiac events. It is alleged that the problem pertained to the product labeling, which sometimes allowed for Alkali Dosing Errors that could produce dangerously high levels of bicarbonate in the blood, leading to a potential GranuFlo heart attack.

At the time, Fresenius defended its actions given that, in its view, the observation was preliminary in nature and did not warrant a wider notification field to other non-Fresenius dialysis facilities - such as DaVita HealthCare Partners Inc. (DaVita) - also using GranuFlo and NaturaLyte. The problem allegedly led to many a DaVita Heart Attack as well.

When the Fresenius internal memo was leaked to the US Food and Drug Administration (FDA) in early 2012, the federal drug regulator was not amused and immediately launched an investigation. It led to a Class 1 GranuFlo recall with regard to the product’s labeling, together with a NaturaLyte Liquid Acid Concentrate recall. A Class 1 recall, according to the Boston Herald report, is a recall most pressing in nature. In the FDA’s own words, a Class 1 recall is issued “when there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”

A spokesperson for Fresenius, in a statement to the Boston Herald, noted that the FDA in its Class 1 Fresenius Medical Care recall did not issue a NaturaLyte GranuFlo recall of the actual product, but rather the labeling - requiring the product labeling to be changed.

“GranuFlo and NaturaLyte received appropriate FDA clearance before they were initially marketed, and that clearance remains in effect,” said Fresenius spokesperson Kent Jarrell, in a statement. “The FDA has not suggested any change in the production formulation or asked that the products be removed from the market or returned by clinics to Fresenius Medical Care.”

He added that both products continue to be safe and effective when used in accordance with their labels and instructions for use. There are almost 5,500 plaintiffs who take exception to that position.