Puerto Rican Man Blames GranuFlo/NaturaLyte for Wife’s Death

In the Commonwealth of Puerto Rico, plaintiff Raul Vizcarrondo Velazquez is suing Fresenius Medical Care for the wrongful death of his wife, Ana Maria Soto Castro. Velaquez alleges that as a direct result of using GranuFlo and NaturaLyte, his wife died of sudden cardiac death.

According to the GranuFlo/NaturaLyte lawsuit, Castro had been receiving the products in question for dialysis treatments, and had undergone a routine procedure on Sept. 5, 2012. While the dialysis treatment proceeded normally, Castro’s reaction reportedly soon took a turn for the worst. On Sept. 6, 2012, Castro passed away due to a sudden heart attack.

Velazquez insists that he, his wife, and their physicians were unaware of the risks associated with the GranuFlo and NaturaLyte dialysis products. There were reportedly no warnings or indications on the products’ labels, nor were there any special instructions for the administrator. Velazquez stated that Fresenius had the responsibility to warn them of these possibilities, because they were relying on the information given to them about the dialysis products. Velazquez claims that if he and his wife had known about the side effects of these products, they never would have used them.

Velazquez is suing Fresenius Medical Care for being directly responsible for manufacturing, selling, distributing, and marketing a dangerous product. The charges in his GranuFlo/NaturaLyte lawsuit include negligence, false advertising, concealing information and misrepresenting a product.

Overview of GranuFlo and NaturaLyte Complications

GranuFlo and NaturaLyte were first approved as dialysate solutions by the U.S. Food & Drug Administration (FDA) in 2003 and 2007, respectively. After these products were released, they quickly rose in popularity, earning praise from the medical community and general public. As of now, GranuFlo is the most used dialysate concentrate in the United States, and is used to treat millions of dialysis patients worldwide. There are currently 1,080 Fresenius clinics in the United States, with 3,300 Fresenius GranuFlo and NaturaLyte suppliers, making Fresenius the largest dialysis treatment company in the world.

GranuFlo is a dry dialysate concentrate which is dissolved into the treatment solution. NaturaLyte is its liquid cousin, which is diluted down to be used for the same purpose. These products work by converting bicarbonate components into acetates, which are used to imitate kidney function. Unfortunately, this process increases the patient’s pH levels in the body, which slows down the blood flow and can lead to fatal side effects. The known GranuFlo and NaturaLyte side effects include:

• Cardiac arrhythmia
• Low blood pressure
• Low potassium
• Low blood oxygen
• Hypercapnia (too much carbon dioxide in the bloodstream)

Both GranuFlo and NaturaLyte were approved through the FDA’s 501(k) Premarket Notification process. This process only requires manufacturers to prove that a product can work at an equivalent level with a product already released on the market, without requiring pre-market testing. Many legal and medical experts believe that this policy has been the main contributor in the reported product failures.

The GranuFlo/NaturaLyte lawsuit is Raul Vizcarrondo Velazquez v. Fresenius Medical Care, Case No. 1:14-cv-10226-DPW, in the U.S. District Court for the District of Puerto Rico.

File a GranuFlo or NaturaLyte Lawsuit Today

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