Widow Sues Fresenius Medical Care for Husband’s Death

Blossom was administered NaturaLyte and/or GranuFlo as prescribed by his physician, according to the GranuFlo lawsuit. Blossom started hemodialysis on or about November 2010. He was treated three times a week at a Fresenius clinic until April 6, 2011. Within hours of receiving hemodialysis treatment from Fresenius, Blossom suffered a massive heart attack. It is alleged in the lawsuit that as a direct result of her use of NaturaLyte and/or GranuFlo, Blossom experienced metabolic alkalosis, cardiac arrest, severe pain and suffering, and death.

NaturaLyte and GranuFlo Recalls

Fresenius is the manufacturer, designer, distributor, seller, and/or supplier of NaturaLyte and GranuFlo. It is alleged in the lawsuit that the NaturaLyte and GranuFlo acid concentrates manufactured, designed, and sold by Fresenius were defective in design such that they were “unreasonably dangerous, not fit for the ordinary purpose for which they were intended, and/or did not meet the reasonable expectations for an ordinary consumer.” 

In June 2012, the FDA issued a Class I Recall notice for Fresenius’ NaturaLyte and GranuFlo acid concentrates. Class I recalls are the most serious type of recall issued by the FDA and involve situations in which there is a reasonable probability that use of the recalled products will cause serious health consequences or death. The FDA issued the NaturaLyte/GranuFlo recall with the following notice: 

“The manufacturer is cautioning clinicians to be aware of the concentration of acetate or sodium diacetate (acetic acid plus acetate) contained in Fresenius’ NaturaLyte Liquid and GranuFlo Dry Acid Concentrate. Inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis. This may contribute to metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which, if not appropriately treated, may culminate in cardiopulmonary arrest. This product may cause serious adverse health consequences, including death.” 

Fresenius Hid Dialysis Product Risks

It is alleged that Fresenius knew of the risks of GranuFlo and NaturaLyte long before it issued its March 2012 notice and the FDA issued its June 2012 recall. Some believe that Fresenius knew about the health effects associated with their acid concentrates as early as 2001. 

In 2010, there were there were 941 deaths caused by GranuFlo and/or NaturaLyte at their Fresenius clinics alone. Fresenius never knew exactly how much bicarbonate levels are actually introduced into the bloodstream, but still proceeded to sell their product, putting thousands at risk, the lawsuit states.

The GranuFlo wrongful death lawsuit is Tina Nunn v. Fresenius Medical Care Holdings Inc. Case 3:13-cv-03986-JSC, in the United State District Court for the Northern District of California Oakland Division

Get the Legal Action You Deserve at no Cost to You

If you believe that you or a loved one has been the victim of a kidney dialysis injury, you have legal options. Please visit the Kidney Dialysis, GranuFlo & NaturaLyte Class Action Lawsuit Settlement Investigation. There, you can submit your claim for a free legal review and if it qualifies for legal action, a seasoned GranuFlo lawyer will contact you for a free, no-obligation consultation. You will be guided through the litigation process with no out-of-pocket expenses or hidden fees. The kidney dialysis lawyers working this investigation do not get paid until you do.