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Fresenius Dialysis Treatment Lawsuit

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Fresenius Medical Care may have withheld important information about the potential side effects of NaturaLyte and GranuFlo acid concentrate drugs for dialysis treatment, which may have caused thousands of people to suffer:

  • Cardiac Arrest
  • Heart Attack
  • Sudden Death

STATUS OF FRESENIUS DIALYSIS LAWSUITS: These lawsuits are no longer being reviewed after Fresenius agreed to a $250 million settlement agreement to resolve the litigation.

>>SUBMIT INFO TO A LAWYER ABOUT A DIALYSIS INJURY<<

OVERVIEW: Granuflo dry acid concentrate and NaturaLyte liquid concentrate are used during dialysis treatment together with a bicarbonate buffer to help clean the blood for individuals suffering kidney or renal impairment.

These products are manufactured by Fresenius Medical Care, which operates thousands of dialysis clinics throughout the United States and also sells equipment and medications used at most other dialysis centers, including DaVita Dialysis Clinics, DCR, Renal Ventures and others.

Before 2012, individuals may have faced a serious risk of suffering a sudden heart attacks and cardiac arrest during dialysis treatment with Granuflo and NaturaLyte, due to Fresenius Medical Care’s failure to provide adequate warnings and instructions with their product.

Granuflo and NaturaLyte contain sodium acetate, which is converted into bicarbonate by the body during and shortly after dialysis treatment. However, the manufacturer failed to warn physicians that these products contain higher levels of acetate than most other dialysis treatment products, requiring physicians to carefully monitor and change bicarbonate buffers administered with Granuflo or NaturaLyte, to avoid a risk of cardiopulmonary arrest and sudden death from heart problems.

LAWSUITS OVER FRESENIUS DIALYSIS TREATMENTS: A number of families throughout the United States filed claims after their loved ones died or suffered a catastrophic heart injury during or within 48 hours after dialysis treatment.

According to allegations raised in Fresenius dialysis treatment lawsuits:

  • Fresenius Medical Care negligently manufactured and sold unreasonably defective products
  • Granuflo and NaturaLyte were insufficiently tested and unsafe as designed
  • Inadequate warnings and instructions were provided with Granuflo and NaturaLyte, which did not fully inform the medical community about the nature and extent of the risk of heart attack, cardiac arrest, sudden cardiac death and other health problems
  • Even after Fresenius Medical Care knew or should have known about the problems with Granuflo and NaturaLyte, they continued to sell the products and attempted to convert clinics to use of the products by offering pricing discounts and packaging Granuflo and NaturaLyte with other dialysis products
  • Fresenius Medical Care provided critical information about the risk of heart attacks and death from Granuflo and NaturaLyte to doctor’s at their own clinics before warning other dialysis centers that used their products
  • Information was withheld in an attempt to maintain Fresenius Medical Care’s market share and maximize profits, at the expense of the safety of dialysis patients receiving their products

FRESENIUS DIALYSIS TREATMENT PROBLEMS: According to an internal review of patients treated at Fresenius Medical Care clinics during 2010, there were at least 941 cases where patients suffered a sudden cardiopulmonary arrest at the dialysis center.

In November 2011, Fresenius Medical Care issued an internal memo to their own physicians warning about the potential concerns associated with Granuflo and NaturaLyte, and highlighting that bicarbonate buffers should be regularly monitored and adjusted to reduce the risk of heart attack, cardiac arrest and death. This same information was not provided to other clinics that used Granuflo and NaturaLyte.

In March 2012, after receiving an inquiry from the FDA about the internal memo, Fresenius Medical Care issued an alert to other dialysis clinics that may use their Granuflo or NatruaLyte products during hemodialysis treatment.

In May 2012, the FDA warned about the risk of hemodialysis dosing problems with NaturaLyte Liquid and Granuflo Acid Concentrate, indicating that these products can raise bicarbonate levels in patients going through dialysis treatments, causing a condition known as metabolic alkalosis, which can increase the risk of heart attack, cardiac arrest, stroke, low blood pressure and death.

In June 2012, it was reported that Fresenius dialysis problems have resulted in an FDA investigation, examining whether the manufacturer of Granuflo and NaturaLyte failed to adequately warn doctors that the products could cause heart attacks and other serious injuries during hemodialysis.

In February 2016, Fresenius proposed a $250 million settlement agreement that is expected to be accepted and funded by August 2016.


1,056 comments

  1. Arthur Reply

    Laurie, my letter was also dated Jan. 5 from Portland, Oregon. As I previously have posted. 175 points is what one of my friends has received as well. Death within 4 hours of treatment. I didn’t receive my letter till the early part of March. That’s only because I called to see if they had received a letter from the administrator. 175 points is more belIeveable then let’s say 209 points
    It’s just more attainable. I don’t think many people are going to achieve between 200-275 points unless the lab points come in

  2. Shan Reply

    Has anyone received their second letter stating what the point values are?

  3. Denice Reply

    Hi Authur, I think there could be more than one Denice on here, Naturalyte was never in the medical files for my loved one case, and that’s not my post, thanks.

  4. Denice Reply

    Laurie your attorney was very rude and unprofessional, you are not crazy, all of the attorneys just want another paycheck and they are clueless about the pain that we have all went through on this case. I hope that you were able to keep that email, I would use it to seek damages for emotional stress against the law firm. The fact that she apologized does not compensate for the stress it shows that she caused stress to you, please consult with an attorney about this matter.

  5. Kristine Reply

    I have been following this site since the beginning but have never posted. I found the information posted here very helpful but have just been informed by my lawyer that my case was denied due to failure to prove that granuflo was used. I was led to believe that I had a strong case. My case is being appealed. My husband had a cardiac arrest on Feb 11, 2010 and passed away within 24 hrs after his dialysis treatment. The dialysis center which was part of a health system network had an exclusive contract with Fresenius for granuflo and NaturaLyte at that time. Apparently that wasn’t good enough because my husbands record doesn’t indicate what was used. So much time has passed that no one can recall what was used. To top it off, DaVita has taken over this dialysis center in 2014 so they are not helpful. How have others been able to prove without question that granuflo was used? I do not hold out any hope that my appeal will go anywhere. This is so disheartening

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