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GranuFlo and NaturaLyte

Posted on behalf of Arnold Law Firm in
The FDA has recalled popularly used dialysis products GranuFlo and NaturaLyte due to an increased risk of heart issues, specifically cardiopulmonary arrest and sudden cardiac death. The manufacturer of both these products, Fresenius Medical Care (FMC) is liable for a failure to warn doctors and patients of the risks associated with the pharmaceuticals until recently, despite documented evidence that the manufacturer was indeed aware of the risks. If you have used either of these drugs as a part of your dialysis treatment, we urge you to speak with a lawyer as soon as you can. To start exploring your legal options, contact our attorneys by completing our Free Case Review form on this page.

GranuFlo and NaturaLyte Side Effects

Both GranuFlo and NaturaLyte are chemicals used in dialysis equipment to help cleanse kidney patients’ blood. The formula in both products is designed for preventing dangerous acids that are usually filtered by a properly operating kidney from building up. Patients using GranuFlo and NaturaLyte report side effects including:
  • Stroke
  • Heart Attack
  • Low Blood Pressure
  • Sudden Cardiac Death
  • Hypoxemia
  • Hypercapnia
  • Cardiovascular Death
  • Cardiac Arrhythmia
  • Cardiopulmonary Arrest

Fresenius Medical Care – Feigned Ignorance

GranuFlo and NaturaLyte were both recalled by the Food and Drug Administration (FDA) on March 29, 2012. The FDA issued a Class 1 recall. Class 1 recalls are the most severe sort of recall, involving scenarios in which the risk of adverse health consequences or death is substantial, as is the case with GranuFlo and NaturaLyte. Fresenius Medical Care performed a case-control study between January 1 and December 31, 2010, evaluating the risk factors for patients on dialysis suffering from cardiopulmonary arrest in their facilities as compared to other patients in the facilities that were on dialysis. The study revealed that 941 patients in a total of 667 FMC facilities using GranuFlo or NaturaLyte suffered from cardiopulmonary arrest and consequently died. The data from those patients established that the risk for a cardiopulmonary arrest reached up to 6 times higher in patients with elevated level of bicarbonate prior to their dialysis procedure. An internal memo from FMC to its physicians and dialysis facilities alerted the recipients of the findings and recommended actions to take for patients presenting elevated levels of bicarbonite pre-dialysis. The  company made no attempt to inform the general public or even those outside of the company. This knowledge was only made public after a copy of the memo was leaked to the FDA.

Contact a GranuFlo Lawyer or NaturaLyte Attorney Today

About 400,000 Americans receive dialysis treatment each year. Over 30 percent of these patients are prescribed either GranuFlo or NaturaLyte, leaving them at a six fold increased and unnecessary risk of cardiopulmonary arrest and sudden cardiac death. At the Arnold Law Firm, we believe that manufacturers of dangerous pharmaceuticals should be held accountable for producing and marketing products that cause harm to consumers – especially when they did so while fully informed of the possible outcome. The manufacturers of GranuFlo & NaturaLyte knowingly put thousands of patients at risk. An experienced dangerous drug attorney at our firm can help you assess the merits of your claim and take it to court, if necessary. Our staff has the skills and resources required to gather all the evidence and present the strongest case possible so that you may recover the maximum compensation allowed under the law to recover your losses. Through our main office in Sacramento, we are here to help any California resident who believes that they may have a claim for a GranuFlo or NaturaLyte lawsuit. For more info on your legal rights as a user of GranuFlo or NaturaLyte, or to schedule a 100% free and confidential consultation with one of our pharmaceutical litigation attorneys, simply complete the FREE form at the top of this page.

Settlement - $3,767,000

Truck Accident

A 20-year-old man who had been married for just 12 days left home on his way to work. He was driving on Pleasant Grove Road in Sutter County in the early morning when he came upon a slow-moving truck. As he pulled out to pass the truck, the truck driver turned left in front of him. The young man attempted to steer back into his lane but his vehicle struck an un-flagged piece of metal extending from the back of the truck. He died in the resulting crash.

Expert witnesses brought in by the Arnold Law Firm proved that the truck, owned and operated by a hauling firm, should never have been on the highway that morning. Specifically, the rear and side turn signals did not work and the rear-view mirror was in a poor state of adjustment at the time of the collision. As a result, the driver, who had failed to properly inspect the vehicle before setting out that morning, couldn’t see the young man’s vehicle as it attempted to pass.

The poor condition of the truck, its lack of maintenance and the manner in which it was operated were found to be substantial factors in causing the collision that killed the young man. The testimony also established that the man had been making a lawful pass at the lawful speed limit and acted reasonably when he attempted to avoid the collision.

The man’s 20-year-old widow was awarded $3,767,000.77, his parents were awarded $185,131 and the family was reimbursed $11,899 in funeral expenses. Though money is a poor substitute for a young man’s life, this verdict demonstrates that drivers who endanger the lives of others will be held accountable for their actions.