Granuflo Dialysate Lawsuits Set for Trial Against Fresenius in 2016

  • Written by: Austin Kirk

The U.S. District judge presiding over all federal Granuflo lawsuits pending against Fresenius Medical Care indicates that the first bellwether cases will be ready for trial to begin in early 2016.

Fresenius Medical Care currently faces more than 1,800 product liability lawsuits involving problems with their Granuflo and NaturaLyte dialysate solutions, which are pendings as part of a federal multidistrict litigation (MDL) before U.S. District Judge Douglas P. Woodlock in the District of Massachusetts.

All of the complaints involve similar claims that dialysis patients suffered sudden cardiac arrest or death following treatments involving Granuflo or NaturaLyte acid concentrates, alleging that Fresenius failed to provide adequate warnings about the importance of doctors monitoring bicarbonate levels during hemodialysis.

The cases are centralized to reduce duplicative discovery, avoid conflicting pretrial rulings and to serve the convenience of the parties, witnesses and courts.

As part of the coordinated pretrial proceedings, a small group of lawsuits are being prepared for early trial dates, known as “bellwether” cases, since they are designed to help the parties gauge how juries may respond to certain evidence and testimony that may be repeated throughout the litigation.

In a case management order (PDF) on June 6, Judge Woodlock indicated that the first Granuflo dialysate lawsuit will be scheduled for trial on January 11, 2016, with a second bellwether trial set to begin on February 16, 2016.

Fresenius Granuflo Litigation

Fresenius Medical Care not only manufactures Granuflo, NaturaLyte and other dialysis products, but the company also owns and operates many of the dialysis treatment centers throughout the United States.

Concerns about the link between NaturaLyte, Granuflo and heart problems surfaced in early 2012, after an internal Fresenius memo was leaked to the FDA.

In November 2011, Fresenius conducted an internal review of the use of the acid concentrates at their own clinics, identifying at least 941 instances where patients suffered sudden cardiac arrest during dialysis treatment in 2010.

While the company issued the memo only to doctors at their own clinics, warning about the importance of monitoring bicarbonate levels during treatments, they failed to provide the same information other clinics that used the products.

After the internal memo was leaked to the FDA in March 2012, Fresenius finally provided a warning letter to all healthcare providers on March 29 of that year, which the FDA determined constituted a GranuFlo and NaturaLyte recall.

According to allegations raised in lawsuits filed on behalf of former patients who have suffered injury or died, Fresenius knew or should have known about the risk of heart problems during dialysis treatment and withheld critical information from the medical community.

Following the bellwether trials, if Fresenius fails to reach settlements to resolve the Granuflo dialysate lawsuits, the company may face hundreds of individual trials throughout the country.

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  1. Margo Reply

    My father chose to discontinue dialysis as a result of having a heart attack that would have required in patient, constant care for the remainder of his life. He was a dialysis patient for 5 years, a difficult patient regarding hyperkalemia and alkalosis. I have documentation that Granuflo was used. His heart attack occurred January25th, 2009, a day after a very difficult dialysis session. When I became aware three years after my father’s passing of Granuflo’s recall, my hunch regarding the center;’s protocol to control bi-caroinate levels was supported. I knew my father’s death was a result of inappropriate dosing of granuflo. But, I also knew a little bit about statute of limitations..and knew we were too late to file a wrongful death claim. I miss my father…he would have known how to advise me. I am right …I am too late…aren’t I?

  2. Cassie Reply

    Margo, I would try to contact a Granuflo lawsuit lawyer. My dad died in June of 2012 and we contacted a lawyer 3-4 months ago and they accepted our case.

  3. Dawn Reply

    My father died as well in July of 2012, just a few hours after his dialysis treatment. We are currently working with an attorney (since 2013) I agree with Cassie, you should definitely speak to an attorney for further advice on your situation.

  4. Connie Reply

    My father had one dialysis treatment, he had never had any kidney problems and had never been in an ICU before until one day he wasnt feeling well and i took him to the emergency room and he was put in ICU, i think it was not only the dialysis but doctor error too and a week later he passed away at the same hospital that administered the dialysis. My father and I were close and I was an only child. My father and i joked and talked to each other during his treatment unknown to us he was being given a death sentence for a crime he never committed> My father was elderly and a wonderful caring trusting man, he passed away in March of 2014. I do have a lawyer since 2014 and am part of the class action lawsuit
    I want to comment how unthinkable this was along with evil and also the sloppiness and uncaring of our healthcare system

  5. Erica Reply

    my mom start taking Dialysis in march of june she went for her treatment,midway her treatment she starting having chest pains.she told the nurse her chest hurt an she wana go home..nurse words was ur treatment will be over soon mrs.coleman thn u can go home.soon as the nurse left my mom machine went they came in the room with codeblu.her bp start droping an they called it a Heart attact.she passed away rite there on the bed..i have a lawsuit its mdl….An I promise all
    of u this is killing me I feel so sad.

  6. Michael Reply

    I was setting beside my Father when he pass away after having Dialysis treatment we where looking TV when he grab my hand he went into Cardiac Arrest my Father just had on Sunday and pass away on New

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