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Fresenius Settlement to Result in $250M Payment in GranuFlo, NaturaLyte Dialysis Lawsuits

  • Written by: Irvin Jackson
  • 20 Comments

Following several years of litigation over an increased risk of cardiac arrest of death linked to side effects of GranuFlo and NatruaLyte dialysis treatments, Fresenius Medical Care has agreed to pay $250 million to resolve thousands of claims filed by individuals throughout the U.S.

There are currently at least 4,300 Fresenius dialysis lawsuits pending in the Federal court system, with hundreds more pending in Massachusetts and other state court systems.

Each of the complaints raised similar allegations that the dialysis treatment provider failed to adequately warn doctors about the importance of closely monitoring patients receiving GranuFlo or NaturaLyte diaysate solutions, which have been found to raise bicarbonate levels and increasing the risk of sudden cardiac arrest or death during or shortly after hemodialysis.

In a press release issued February 17, a Fresenius settlement was announced that may resolve the litigation if 97% of all plaintiffs agree to accept the offer by July 2016.

Fresenius is offering to pay $250 million to settle NaturaLyte and GranuFlo lawsuits, with the medical provider’s insurance carrier funding about $220 million of the cost.

The agreement in principal reached with plaintiffs’ lawyers appointed to leadership roles in the litigation, calls for the settlement to be funded by August 2016 if the required threshold of claims are resolved.

Since April 2013, the federal Fresenius dialysis litigation has been centralized before U.S. District Judge Douglas P. Woodlock in the District of Massachusetts, as part of an MDL or multidistrict litigation, where a series of cases were being prepared for “bellwether” trials, which were designed to help the parties gauge how juries may respond to certain evidence and testimony that would be repeated throughout the cases. However, with the Fresenius settlement offer pending, those trials are likely to be deemed unnecessary.

Fresenius Dialysis Problems

All of the lawsuits stem from a March 2012 recall issued after federal health regulators discovered that Granuflo and Naturalyte solutions may increase the risk that dialysis patients suffer sudden cardiac arrest or die during or shortly after treatment. The complaints allege that Fresenius failed to adequately warn doctors about the importance of monitoring bicarbonate levels when using Granuflo or Naturalyte.

While Fresenius is the largest operator of dialysis centers in the U.S., it also manufactures products used at other clinics as well, including GranuFlo and NaturaLyte dialysate solutions.

According to allegations raised in the lawsuits, Fresenius knew or should have known that Granuflo and NaturaLyte convert to bicarbonate at higher rates than other products, but failed to warn doctors about the importance of monitoring levels during treatment. As a result, during the years before the recall, many patients suffered sudden cardiac arrest or died at dialysis clinics due to side effects of the products..

Concerns about the link between NaturaLyte, Granuflo and cardiac arrest reports first surfaced in early 2012, after an internal Fresenius memo was leaked to the FDA.

Although the company indicated in the internal memo that it was aware of at least 941 instances where patients suffered sudden cardiac arrest during dialysis treatment at their own clinics in 2010, Fresenius failed to take actions to ensure that all doctors using Granuflo or NaturaLyte were aware of the problems.

In November 2011, the company issued warnings to doctors at Fresenius clinics, indicating that doctors should closely monitor bicarbonate levels during treatments. However, the same warnings were not provided to other clinics that used GranuFlo and NaturaLyte. In addition, lawsuits allege that the manufacturer knew or should have known about the risk of problems long before the internal memo was issued.

Fresenius finally provided a warning letter to all healthcare providers in March 2012, which the FDA classified as a recall of GranuFlo and NaturaLyte.

As is noted in the press release announcing the Granuflo and NaturaLyte settlement, the Fresenius products remain on the market and unchanged, but doctors are now aware of the importance of monitoring bicarbonate levels.

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20 comments

  1. Arthur Reply

    I doubt that it will receive 97% of required signatures to accept the settlement. Fresinus last year had revenues In between 15-16 billion. The 250,000,000.00 settlement is a drop in the bucket for Fresinus. Also I read that there could be more than 10,000 lawsuits. At least 2,400 wrongful death lawsuits. My next question is how would they divide the money?

  2. Dean Reply

    A large number of these case’s are wrongful death lawsuits 2900 to 3000 this settlement offer is an insult!! it should be 10 times the 250mil to start>>>

  3. NATHANIEL Reply

    Now That A $250 Million Settlement Has Been Reached In Granuflo/Naturlyte Suit And If By July 26th The 96% Has Agreed What Happens No One Gets Anything Or What’s Next!

  4. Arthur Reply

    Now I read an article that the settlemen which will be decided on relevant facts pertaining to their cases. This will take a few months to achieve. Still doesn’t specify what monetary value to each case. This still seems very unfair to everyone. I think they should do every case on an individual basis and if not you litigate in court. Take your chance.

  5. Jivon Reply

    This is a slap in the face to me and all of the families. So you are saying that the death of our love one was only worth $25,000. I’m not accepting that. You can keep your crumbs. Do you realize that our love ones suffered until they passed. So you think, Oh we will give them $25,000 and we will just go away. I challenge all families involved in this case not to accept this offer. We want $250 Billion! Now try again Fresenius! P.S Don’t forget the Attorney Fee

  6. Constance Reply

    Does anyone know if this is just for Fresenius clinics or any clinics and hospitals, i am so confused and my lawyer really doesnt look closely at my case which was filed 1 1/2 years ago approx. , My father passed in 2014 one week after having one dialysis, which i dont think he even needed, i am just so sick over this.

  7. Kay Reply

    I just read about this pittance of an offering from Fresenius. I hope no one agrees to this joke! I did not realize this offer was made. My mom fought back from an almost three month long hospitalization and came home in December 2011, two days before Christmas. She needed a minor surgical procedure. She went into the hospital February 10,2012 for a minor uncomplicated surgical procedure.She died suddenly in her sleep February 12 after having problems with dialysis the day before. I was asleep on the couch in her room when the nurse woke me calling to her and she didn’t respond. I started CPR. I had to tell my dad his love was gone, over the phone, my brothers too. It makes me so sad. I miss talking to her every day. Fresenius needs to pay for pain and suffering.

  8. Hervy Reply

    This hole thing is an insult. I lost my wife 12 hours after treatment from a massive Heart Attack. I thought I had a good team of lawyers. I been told to wait, for what 25000. That is crazy and an insult

  9. Jane Reply

    Yes, this is an insult, maybe if it were in the media more Fresenius would take it seriously. Heck even the NFL settled for a more realistic settlement. Fresenius is BILLION $ company our loved ones meant way more than $25,000!!

  10. Arthur Reply

    I just called my Attorney to see if there was an update on my case. She told me every case is being reviewed if your case does not meet the criteria for the review then your case will be rejected and dismissed. How many clients received GranuFlo as opposed to some other products. What was the date of the client’s injury /death? How many hours after dialysis did the client suffer injury /death? What injury did each client suffer. Good luck to everyone.

  11. tamara Reply

    Yes this is a slap in our faces I lost my husband a day and a half two days after dialysis he died of a sudden cardiac arrest but prior to that he was having to come home with oxygen because he could not breathe we did not know why this was happening I will not sign I would rather get nothing then to take that slap in my face I lost the love of my life over this and this is pure ridiculous that they even come at us like this it’s got to be the hardest thing any person could ever experience waking up to their loved one dead in the bed next to him no like I said before I will not sign I need a lawyer that will take them head-on

  12. Rhonda Reply

    My husband died at the age of 33. He had Lupus Nephritis which attacked his kidneys. I’m still waiting on information on the settlement. Some of you have more information than I received from my attorney. Where are you getting it from and can you provide a link or website I should be looking at

  13. Arthur Reply

    Pretty much Ronda my above comment states what they are looking at, as far as the criteria. Mainly time of death after treatment. After 24 hours your case will be dismissed. Also if the person used Granuflo during their treatments. Also what happened either during treatments or within 24 hours, either death or injury. I just talked to my Attorney and they may be running later than the July deadline. 97% of the claiments have to approve, if not they’ll probably start the bellwether cases again. The money settlement was merely something Fresinus wanted to do to save some money instead of the costly court fees to try all these cases individually.

  14. Robin Reply

    We need to start a petition, like on (change.org) to force that greedy legal community thats selling us out whole sale to stop this madness and remind them just who’s suffering here and remind them who they are suppose to be representing. That settlement is an insult to us all who lost love ones.

    They are counting on us to tuck our tales and give up!

    Is that what you mother, husband, brothers and daughters……. would want?

    Don’t sign that crap!

    CHANGE.ORG

  15. Grace Reply

    Although this company has billions if they are not willing to give it up it does none of us any good. My husband died because he was given this drug and no amount of money will bring him back. Going on and on fighting with them is only going to give the lawyers more money.

  16. Pam Reply

    My mother had a heart attack while getting dialysis she died at Debussy dialysis place

  17. Janet Reply

    I opted in but now I am wondering if I should have. My mother went into cardiac arrest while in the chair. They brought her back with paddles. As a result they had to put in a pace maker and a defibrillator in her chest. She suffered for a year. She kept having the defibrillator go off shocking her over and over. Probably because she kept being given the Granuflo! A week before she died it went off 20 times before they could get her to the hospital and get it to stop. At that point when I saw her she was catatonic. It was like living with a time bomb in her chest. At that point she wanted to die and decided to stop dialysis. She didn’t want to live anymore. They told her they’d turn the defibrillator off in the morning. Well I left the hospital after trying to tell her not to end her life. I was 15 minutes away when the defibrillator went off and the hospital staff said they weren’t able to revive her. All I can think of is how she must have suffered with that stupid thing shocking her until she died. I didn’t realize, until I just read in an article, that Fresenius made 12.5 billion in revenue just in 2010 and their insurance company is paying 220 of the 250 million. Now I’m feeling the same as many of you. Seems someone should be going to jail never mind hurting them financially.

  18. Ellen Reply

    Today we r meant to have a result from fresenius abt the settlement which is not at the 97% they required to fund this settlement. This has and is a terrible representation by attorneys. And there has been little explanation of what is going on.. this system needs changes. And if “they” want to do MDL’s then “they” need to set more standards and early criteria. How much are lives, when these companies hv wronged people n been caught doing so and why can we not discuss the case once finished and absolve them of all wrong doing.

  19. Vattica Reply

    I think we all should start a Petition for our lost loved ones.This is a shame. I will sign. #CHANGE

  20. Marguerite Reply

    This whole thing is discussing … You reply to these law suit commercials the law firm takes your case, you sign papers give all records of your loved one, you call them to see there progress, they tell you they are in the first part of the law suit and it will take awhile y I Vaal them back eight months later and they said they sent you paper work but
    You never sent it back. Which was a lie I never receive anything and the Law suit has been settled. Webster law firm. There is nothing you can do they said… They didn’t have any problem calling me to get the case. Why didn’t they call to see if I got paper work which I didn’t at all.

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