About Granuflo & NaturaLyte

Produced by Fresenius Medical Care, NaturaLyte and GranuFlo are dialysates that have been used at clinics across the country. These acid concentrates are used to treat patients with acute and chronic renal failure during hemodialysis. The acid concentrate is formulated for use with a three-stream hemodialysis machine, which is calibrated for acid and bicarbonate concentrates.

More than 2.1 million people across the world suffer from chronic kidney failure. Since 2003, hundreds of thousands of Americans suffering from kidney disease have received treatment with either NaturaLyte or GranuFlo. However, both are causing concern in the medical community, as the products have been linked to an increased risk of metabolic alkalosis, a condition causing cardiac arrhythmia, low blood pressure, cardiac arrest, hypoxemia, hypercapnia, cardiac arrest and even untimely death.

The dialysis process

Doctors have been treating patients suffering from kidney disease with dialysis for more than 65 years. The dialysis process emulates a healthy functioning kidney by filtering excess fluid and waste in the patient’s bloodstream using dialysates. These dialysates are a mixture of water and chemicals designed to extract toxins from the body, without also removing vital proteins and blood cells.

There are two main types of dialysis ─ peritoneal and hemodialysis:

• Peritoneal dialysis: This type of dialysis can be completed at home. The blood remains in the body and a catheter is inserted into the abdomen, slowly filling it the dialysate.
• Hemodialysis: Using this form of dialysis, an artificial kidney redirects the patient’s blood through a catheter, removing waste, unwanted chemicals, and fluid. Patients must come to a dialysis center three to four times per week to receive this treatment. Both GranuFlo and NaturaLyte are often used in this type of treatment.

About Fresenius Medical Care

According to the Fresenius Medical Care website, the company operates more than 2,100 dialysis centers in North America. They also claim to be the largest provider of dialysis products and services in the world. Fresenius North America makes its corporate headquarters in Waltham, Massachusetts, while its parent company, Fresenius Medical Care is based in Germany.

The company received FDA clearance to market and manufacture GranuFlo and Naturalyte in 2003. Fresenius Medical Care is expected to earn a net income of $1 billion to $1.05 billion in 2014.

Incriminating Fresenius memo leaked

Fresenius conducted a case-control study from January 1, 2010 to December 31, 2010, to evaluate the risks among hemodialysis patients treated with their products who had suffered from cardiopulmonary arrest, compared with other patients. The company chose to conduct the study due the increasing number of adverse cardiac events associated with patients using GranuFlo and NaturaLyte. Results from the study revealed that individuals who were given Granuflo and/or NaturaLyte products experienced higher pre-dialysis serum bicarbonate levels, implying that an increased number of patients were experiencing alkalosis prior to dialysis, and an even higher number of patients were experiencing alkalosis post-dialysis.

On November 4, 2011 Fresenius sent an internal memo to its medical directors and attending physicians, cautioning that 941 hemodialysis patients from 667 centers had experienced cardiac arrest in 2010. Fresenius performed an analysis comparing these dialysis patients to 80,000 additional patients receiving treatment in the same centers. The memo noted dosing errors provided in packaging instructions and offered updated instructions to physicians, implying that incorrect dosages of NaturaLyte or GranuFlo could cause a patient to be six to eight times more likely to experience cardiopulmonary arrest and sudden death.

Fresenius chose not to send this letter to other clinics using NaturaLyte and GranuFlo or make any attempt to inform the public of this information.

NaturaLyte and GranuFlo recalled by FDA

The Fresenius internal memo was leaked to the FDA in March 2012, causing the company to send a warning letter to all providers using the products. The FDA refers to this letter as the GranuFlo and NaturaLyte recall.

On the FDA website, the administration notes that “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.”

Hundreds filing GranuFlo and Naturlyte lawsuits

As of early 2014, more than 515 complaints have been filed by plaintiffs claiming that their hemodialysis treatment with GranuFlo or NaturaLyte led to a sudden cardiac arrest, heart attack or death. The US Judicial Panel on Multidistrict Litigation has ordered that all lawsuits be centralized in for pre-trial proceedings, under U.S. District Judge Douglas P. Woodlock in Massachusetts.

Combining the cases under multidistrict litigation will help to eliminate conflicting rulings, minimize court costs, and conserve resources. While these cases are combined under the MDL, each lawsuit is treated separately, remaining eligible for its own pre-trial settlement or jury award. If a settlement is not reached between defendants and Granuflo attorneys representing plaintiffs, to resolve the cases, the lawsuits could go back to the courts where they were originally filed.

A GranuFlo wrongful death lawsuit was recently filed in Puerto Rico, by the next of kin of a man who died of severe and permanent injuries caused by the dialysates after being treated at a Fresenius clinic. Since the FDA enacted its Class I recall of the products, more injured patients are taking legal action against Fresenius, arguing the company failed to warn of potential risks.

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