Attorney for Fresenius (GranuFlo & NaturaLyte Products) Dialysis Treatment Lawsuits: Recall and Potential Claims


    Learn Your Legal Rights...

    If you or a loved one suffered complications after receiving dialysis treatment, share what happened with our GranuFlo lawsuit attorneys now - you may be entitled to significant compensation. Recalled by the FDA, treatment mixture GranuFlo & NaturaLyte (widely used in thousands of Fresenius and other dialysis clinics nationwide) may be responsible for your complications.

    If you or a loved one suffered a cardiac event, stroke, death and other complications after dialysis, share what happened with our lawyers now to find out if you qualify to sue the manufacturer for compensation.

    • Find out if you have a legal claim
    • Get the latest recall information
    • Ensure your claims are heard

    GranuFlo Recall Information

    Dialysis patients should be aware that the U.S. Food and Drug Administration (FDA) has recently issued a recall on 2 dialysis products. Both GranuFlo and Naturalyte, products of Fresenius Medical Care Holdings, Inc., have had a Class I recall issued due to possible adverse health consequences, including death and cardiac events (heart attacks, sudden cardiac arrest, and other cardiovascular injuries).

    When compared to similar products the risks for bicarbonate overdose linked to heart problems, which has led to the GranuFlo recall..

    GranuFlo and Naturalyte are liquid acid compounds which are used during the hemodialysis procedure in patients who have chronic or acute renal failure. Both compounds have been recalled from consumer use due to a discovered significant risk for sudden cardiac arrest and other cardiovascular problems. GranuFlo lawyers have alleged in pending litigation that the manufacturer failed to warn doctors of the potential risks to patients prior to use.

    See Also:
    Safety claims have been raised involving the antidiabetic medication Invokana. An FDA Black Box safety advisory was issued after a clinical study revealed an increased risk for amputations in patients and pending Invokana lawsuit court documents allege the manufacturer failed to warn healthcare professionals and patients of the harmful risks.

    Further adding to the controversy, the FDA has made allegations that the manufacturer was aware of the risks of cardiac arrest associated with the use of the bicarbonate mixtures, yet may not have adequately warned dialysis treatment centers about the possible risks.

    Our GranuFlo attorney may be able to help if you or a family member have suffered a cardiac arrest following or during dialysis treatment you may have a claim that entitles you to compensation.

    If someone you loved died, you may have grounds for a possible wrongful death suit.

    Even if you don't know if these products were used, our dangerous drug attorneys can help investigate to determine if they were and if you have grounds for an injury claim.

    All eyes are on a pair of bellwether trials starting early in 2016, in which plaintiff product liability claims against the defendant will be fought. If the plaintiffs (over 2,100 and climbing) are successful in the pending MDL Fresenius Lawsuit, it may result in significant compensation for injury victims.

    If you have a potential dialysis treatment lawsuit, our experienced medical injury lawyer can begin the determination process to see if you have a claim which may entitle you to recovery.

    Share what happened today using the form above to find out if you have a case.


    GranuFlo Lawsuit Injury Allegations

    First, we need to understand the process of hemodialysis. This process uses a machine to filter excess salt and water from the blood of those whose kidney's no longer function properly. One part of the process involves neutralizing the acids in the blood. This is accomplished by introducing an alkaline substance, most usually bicarbonate.

    When used in small doses this works well to neutralize acids, however an overdose of bicarbonate can lead to heart problems, including cardiac arrest and is what the product liability attorneys are primarily focused on.

    Many of the concentrates used in dialysis contain ingredients that are converted to bicarbonate in the liver of the patient. GranuFlo and Naturalyte use the same ingredient that competing products use, however, they have the ingredient in a higher concentration.

    This means that proper dosage and administration must be followed to avoid an overdose during the hemodialysis process. Dialysis operators in Fresenius facilities were not notified of potential risks (revealed in an internal memo) and dialysis patients were put at alleged risk of serious harm claim plaintiffs' attorneys in the GranuFlo lawsuits.

    Reports that have contributed to the recall of GranuFlo and Naturalyte state that many doctors, operators, and physicians may not have been adequately informed of the higher concentrations of bicarbonate in these two products.

    This has led to over administration which GranuFlo lawyers allege has lead to potential heart and cardiovascular problems in patients.

    If you lost someone you love, who was a dialysis patient, share the details of what happened now to learn your legal options.

    Review My Case Now

    Dialysis Lawsuit Lawyers: Linking Damages & Liability

    The best product injury attorneys know it's not enough to have simply sufferend health problems resulting from dialysis or any pre-existing medical conditions. For a successful lawsuit liability must be established, meaning it's the use of these dangerous drugs which may entitle you to financial recovery. Your injury law firm will need to establish a causal link between these products and how you were adversely affected.

    These specific products have been linked to a six-to-eight fold increase in cardiac arrest risks. If your lawyer is indeed, during investigation, to determine they were used during your dialysis treatment you may have grounds for a lawsuit for injuries suffered.

    Additionally, the FDA Class I recall reports that high levels of bicarbonate in the bloodstream (GranuFlo side effects) can contribute to a condition known as metabolic alkalosis. This condition can be serious and a potential Fresenius lawsuit will be reviewed for the following claims:

    • Low blood pressure
    • Low blood oxygen pressure
    • Low blood potassium levels
    • Cardiac arrhythmia

    Because any of the side effects, when not identified and treated properly can lead to serious complications, the FDA has issued the GranuFlo recall. Complications identified include heart problems, cardiac arrest, and death in some cases and when encountered after receiving treatment symptoms should be taken very seriously.

    Pharmaceutical and medical products companies in the U.S. are obligated to ensure their products are not only safe for consumers, but also to ensure that they provide proper instructions for use and warnings of possible dangers associated with their products to both consumers and to medical practitioners.

    When this does not occur, the offending companies can be held liable for any resulting damages from the use of their products. In the case of Fresenius, the fact that they were aware of the cardiac risks associated with their treatment mixtures, and failed to notify or warn those outside their company, has resulted in legal action.

    A successful GranuFlo claim may entitle you to recovery for damages including: medical bills, pain & suffering, anguish, lost wages and lifelong earning potential, just to name a few.

    The pending multi-district litigation may result in a significant GranuFlo settlement amount, which may be made available for you to claim. Whether you would be better served filing an individual lawsuit against Fresenius or not will depend on the details of your case.

    Share how you were affected, and find out exactly rightful options to seek financial compensation may be available.


    Review My Case Now

    Fresenius Litigation Claims

    According to FDA records, Fresenius did conduct its own investigations into the safety of GranuFlo and Naturalyte.

    Those investigations were conducted based on data from Fresenius' own dialysis centers. The investigations found that high blood serum bicarbonate levels placed patients at a higher risk for cardiac arrest.

    The company distributed an internal memo showing that 941 patients who were treated at their own dialysis centers experienced cardiac arrest in 2010.

    This memo confirmed that many of the cases were caused by a physician improperly prescribing GranuFlo or Naturalyte, and went on to state that the issue should be "addressed urgently."

    Though the memo was distributed internally to Fresenius' dialysis centers in November 2011, no attempt was allegedly made by the company to inform external customer clinics about the potential dangers associated with use of the mixtures until March 2012, potentially putting more than 100,000+ dialysis patients at risk.

    Furthermore, external customers were only made aware of the cardiac arrest dangers of GranuFlo and Naturalyte after their own internal memo was leaked to the FDA.

    This oversight has prompted the FDA to begin an investigation into Fresenius to determine if they broke federal regulations by failing to advise customers of the potentially adverse risks associated with the use of its products.

    Your Potential Fresenius GranuFlo Lawsuit Claim

    If you or someone you love suffered a heart attack, sudden cardiac arrest or other health problem related to dialysis treatment share the details of what happened with our product liability attorney immediately.

    Your initial consultation is free, and you are under no obligation to file a lawsuit. If your case qualifies, and you choose to pursue legal action, you pay nothing out of pocket unless your case wins. If you don't win, you don't pay - period.

    Share what happened, get your legal options explained clearly and simply so you can determine what is best for you and your family. Your family has suffered, your health may have been put at risk unknowingly. You deserve legal representation that cares about your recovery.

    If you have questions about a potential GranuFlo lawsuit, fill out the form completely below to schedule your initial consultation - take the first steps toward justice & compensation now.


      External Resources

      Health Alert Facts