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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.


406 comments

  1. debra Reply

    So Joe, what happens to those that opted in if Granuflo and Naturalyte should win 5 bellwethers? Do they accept ours and then make another deal with those that opted out?

  2. Troy Reply

    PEOPLE THERE IS NO MORE. SO 7,700 PEOPLE HAVE OPT IN SO FAR .ONLY 250 MILLION .NO MATTER HOW YOU PUT IT ONLY THE STAGES FIRST 250,OOOPLUS.SECOND50,000TO75,000.THIRD1500,PEOPLE YOUR ONLY HAVE 250 MILLION DOLLARS TO SPLIT UP AMONG 7,700PEOPLE WHO OPT IN.JOE I FIRED MY LAWYER. HE SAID I CAN NOT OPT IN OR CASE DISMISSED. ONLY HAVE UNTIL MARCH 29TH.ONLY HOLD ON THE 16TH AN PRESSURE TATIC.

  3. Joe Reply

    It’s possible if we win a majority of the bellwether trials they may offer another settlement to the people that have not opted in.It has happened in other MDL’s. I do not know if it will happen in this MDL. My opinion is they are going to approve this settled. They will get rid of over 7700 cases.That is just my opinion.

  4. Joe Reply

    I have tried to post details of the verdict from 360 law but this Website Will not let me post it. I have tried multiple times

  5. Joe Reply

    The company is gratified by the outcome in Dial. The verdict in this case, by itself, does not directly impact the previously-announced comprehensive settlement of the Acid Concentrate litigation,” said Kent Jarrell, spokesman for Fresenius Medical Care. “The Dial family plaintiffs elected not to participate in the comprehensive settlement and are now barred from doing so. Under current agreements and court orders, FMCNA is required to confirm or void the $250 million comprehensive settlement on May 10, 2017. No decision has been made whether to confirm or void the comprehensive settlement. The date for confirmation is subject to change.

  6. Joe Reply

    Troy did you receive a lone Pine order stating you needed causation and expert testimony. It seems like what you wrote implies that you did get a lone Pine order. You must send in your doctors expert testimony from whoever you can get it from any doctor you have went to it doesn’t just have to be your kidney doctor any doctor can write this for you it can be very basic. Send in your lab work also as far as I know March 29 is the deadline. If you do not send something in your case will be dismissed. You better get a move on fax it to them or in the letter you received there should be a email address. You do not have much time left are your cases going to be dismissed.

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