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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.


375 comments

  1. Joe Reply

    Debra, if you are talking about the settlement level 1 and 2? For level 1 Granuflo not NaturaLyte would have to have been administered. Level 1 is the Granuflo compensation fund $215 million to $220 million. Level 2 A $5 million fund for people that took NaturaLyte only maximum payout 50% of what you would have received if you had qualified for level 1.

  2. Joe Reply

    Boston (February 8, 2017, 10:36 PM EST) — Fresenius Medical Care failed to train doctors or warn the public about the risks of its dialysis drug Naturalyte, leading to the death of a North Carolina diabetic, his relatives told a Massachusetts federal jury Wednesday in opening statements at the first bellwether trial for litigants who declined to take part in a $250 million case settlement.

    Attorneys for the estate of Carley Dial said that Fresenius knew for years that the dialysis drug could pose risks but did nothing to properly train doctors about it….

  3. Debra Reply

    Joe did you say you opted in or are one of the lucky ones that opted out?

  4. Joe Reply

    February 10, 2017 Day 2 of trail .

    9:00 AM

    Senior Judge Douglas P. Woodlock – Courtroom 1 – 3rd Floor

    CV-14:11101 Dial v. Fresenius Medical Care Jury Trial – Day Two

    (Barnes, Booker, )

  5. Joe Reply

    Not sure if everyone understands what this trail is all about. This is the first bellweather trial for those of you that were told the First bellweather trail was lost we’re lied to buy your attorneys. The people that should be the most interested in this case are the people that did not opt in. This is what you have been waiting for.

  6. John Reply

    When will people from mississippi here anything about their lawsuits I never recieved a letter to opt in or opt out what could that mean lawyer always say I will receive a letter in mail but never recieved that letter and its been a year now

  7. Joe Reply

    No I opted in, let me explain the reason behind that. After talking to my lawyer he explained to me that they could prove that Granuflo was taken in court and could probably prove inproper labeling what they were
    unsure of is if they could prove Granuflo actually caused the death. There lies the reason for my opt-in . I thought at the time and I still think now how is one going to prove that Granuflo actually caused the death. So I opted in. My lawyer did tell me at the time he thought there may be 10,000 cases I guess I didn’t believe that when he told me but it looks like it was pretty much true there are 12,000 total cases but around 7700 Have opted in. I still do not know how many are in each category. I do hope for the people that have not opted in that the trail does go their way. I am posting this information to be helpful, because I know the lawyers are not telling People very much..

  8. frank Reply

    Joe its on record about last years beweilther trail. I read it on 360 law i saw the scale on the amount of granuflo that was use its. Was a man joe if thats the case arent the attorneys in voliation of mis leading information that is a lawsuit against them call it false the surpreme court will strip there license to practice joe. Ima call the judge sec to verify

  9. Tammy Reply

    so you’re saying the people that opted in are screwed ! they put it ro me that if I didn’t opt in I could be charged for the cout fees up to that point !

  10. Marie Reply

    So your telling me that the lawyers lied to us about losing the first 2 trials? Isn’t that illegal? We have been scammed into opting in. Do we have any legal rights to go after the attorneys who lied to us?

  11. Debra Reply

    Joe I also opted in. They can prove my husband was given the Granuflo and died within 24 hours of cardic arrest. My attorney said that the current trial has to do with NaturaLyte cases which opted out of the settlement. Those that opted in the Defense has been granted additional time to trigger the settlement which now they have til 5/10/17 to decide if they want to move forward with the settlement since they did not get the 97%. They said that the settlement process is very complex. I just want to get this whole ordeal over with.

  12. Arthur Reply

    Yup, Marie. I will be looking into the legal ramifications of my Attorneys actions. I think we were being duped. Let’s see how the Dial trial comes out. Praying for the best outcome possible.

  13. Joe Reply

    Frank, show me the Proof or the article. People say they have seen something that stated the First bellwether trial already happened but they never show me proof. I will post something that states right in the article that this is the first bellwether trial 360 law. Please don’t show me some random case.that you think is the bellwether trial case.

  14. Joe Reply

    Read the article this is the first bellwether trail even stated it in the article. From 360law. Dated February 10, 2017 . So I don’t know why people keep telling me the first bellwether trail already took place that is not true, it is taking place right now.

    Law360, Boston (February 10, 2017, 7:27 PM EST) — An attorney for a diabetes patient’s next of kin who blame Fresenius Medical Care for his 2012 death questioned the man’s doctor Friday about the label of dialysis drug NaturaLyte, suggesting that the company mislabeled it, didn’t give the doctor enough training on how to use it and didn’t warn anyone about possible deadly confusion.
    The estate of North Carolina resident Carley Dial, in its questions to Dr. William Buchanan, sought to portray the dialysis drug’s label as contradictory and incorrect on some of the basics, like how much acid-fighting power it had. Fresenius, which runs clinics, sells the drug and makes dialysis machines, didn’t teach doctors like Buchanan how to use the drug safely, Dial’s family says in the first bellwether for people who have opted out of a $250 million settlement.

    Among the problems on the label, Dial says, is an ingredient list that’s incorrect.

    “Wouldn’t it help you if that label were accurate?” Robert Carey of Hagens Berman Sobol Shapiro LLP asked Buchanan, medical director at the Fresenius clinic where Dial was a patient. “That jug is nothing but acetic acid — wouldn’t that be the accurate representation?”

    “That would be more specific,” Buchanan said.

    The trial, which entered its second day Friday, includes some fundamental disputes, like how Dial died. Dial’s next of kin say he died of a cardiac arrhythmia caused by an overload of NaturaLyte. Fresenius argues that Dial’s death was due to a heart attack that had nothing to do with his dialysis treatment.

    But much of Friday’s testimony was ripped straight from the pages of a chemistry textbook, going over in great detail the difference between bicarbonates and acetates and they way they interact. Both are important parts of treating diabetes patients, whose kidneys can’t properly regulate the amount of acid in their systems. Bicarbonates help balance it out, and acetates can amplify the effect, turning into more bicarbonates in the body.

    According to Dial’s estate, even Fresenius was confused about how acetates worked to battle acid and how much medicine was being pumped into patients’ bodies. Dial’s family argues that the company magnified the problem with a label that was, in some respects, flat-out incorrect: Labels affixed to jugs of the liquid listed acetate as an ingredient, even though there was no actual acetate in the jugs — it was just acetic acid, or vinegar.

    Instead, acetate came later in the process as part of a chemical reaction.

    Buchanan testified that he understood exactly what the label meant and that what ultimately mattered was the end result.

    But, Carey suggested, his testimony could be shaped by his lucrative partnership with Fresenius — and the fact that the CEO of the company was in the courtroom.

    “Is it more difficult for you to criticize Fresenius when the highest level executive is here?” Carey said.

    “If I felt they dropped the ball, I’d say they dropped the ball,” Buchanan responded.

    Buchanan said when questioned by Fresenius’ attorney that the company has always been punctilious in its training of doctors, even on the question of bicarbonates versus acetates.

    “I thought Fresenius was very responsible,” Buchanan said when questioned by James Bennett of Dowd Bennett LLP. “They provided us with instruction, we had emails — every meeting, this was brought up.”

    Fresenius also circulated studies, some of which showed the dangers of having too much bicarbonates. At a medical meeting in Atlanta, the topic was widely discussed, Buchanan testified.

    But fundamentally, Buchanan said his medical school education, or even high school chemistry, could explain the basics of the Krebs cycle.

    “Did you need Fresenius to tell you acetate converted into bicarbonate?” Bennett
    asked.

    “No,” Buchanan said.

  15. Joe Reply

    You people need to understand a trial is not a bellwether trail. If the lawyer stated the first trial was lost But left out the word bellwether trail. Then unfortunate he or she did not lie to you because there was a trail that was lost but it was not a bellwether trail.

  16. Joe Reply

    Law360, Boston (February 8, 2017, 10:36 PM EST) — Fresenius Medical Care failed to train doctors or warn the public about the risks of its dialysis drug Naturalyte, leading to the death of a North Carolina diabetic, his relatives told a Massachusetts federal jury Wednesday in opening statements at the first bellwether trial for litigants who declined to take part in a $250 million case settlement.
    Attorneys for the estate of Carley Dial said that Fresenius knew for years that the dialysis drug could pose risks but did nothing to properly train doctors about it. Dial’s physicians, meanwhile, failed to act on dangerous blood test results while he was being treated with Naturalyte at a Fresenius clinic in North Carolina, causing him to suffer cardiac arrest, Robert Carey of Hagens Berman Sobol Shapiro LLP said.

    “We’re suing them because they did not provide adequate instructions,” Carey told the jury in Boston, where the 12,000-member multidistrict litigation is being hashed out. “There were known, persistent problems about how this product worked. It became a running joke at the company. We’ll present corporate documents that show that.”

    Fresenius reached a $250 million settlement in the MDL last February. Company lawyers have previously said that 97 percent of plaintiffs need to opt in to the case for the settlement to take effect.

    Dial is one of the holdouts, and the first to go to trial.

    His estate’s attorney said that Fresenius, its clinics and the doctors that used Naturalyte didn’t understand some of the finer points of the drug or how it interacted with a dialysis patient’s body.

    Diabetes patients’ kidneys can’t properly filter acid, causing buildups. In dialysis, patients sit in a chair for four hours as their blood is pumped into a machine and cleaned, while chemicals with ingredients called bicarbonates are added to do the job the kidneys can’t do.

    In addition to the bicarbonates, Naturalyte also has acetates, which, when they’re put in the human body, also raise bicarbonate levels, Carey said.

    But Fresenius, a company that runs clinics, sells the drug and makes the dialysis machines, didn’t adequately explain the interplay between bicarbonates and acetates, leaving doctors to botch addition and subtraction when they came up with dosing, Carey argued.

    “That confusion existed at the highest levels of the company,” Carey said. “The very top people on safety were confused about this concept and how to handle it.”

    While raising bicarbonate levels is good, it can also be dangerous at certain levels, particularly if patients already have low potassium levels. The body, with the abundance of bicarbonates, starts turning potassium into acid to balance it out, bringing potassium to dangerously low levels. The result, for Dial, was a condition called metabolic alkalization, and then cardiac arrhythmia, or an irregular heartbeat, that led to his death in February 2012, Carey said.

    Dial was on the highest possible amount of Naturalyte, Carey said, measured at 28 units in his blood. That increased his risk of death eightfold, Carey said. But his doctors chalked up the 28-unit measurement to a testing error, and didn’t reduce the dosage. Dial had five more treatments at the highest setting before he died, Carey said.

    That was in part due to the fact that Naturalyte’s label was a confusing “disaster,” and because Fresenius failed to train the doctors, Carey said.

    Referring to the instructions for use of the drug, Carey said, “It’s virtually impossible to figure out what they mean.”

    But an attorney for Fresenius contended that Dial’s lawyers were painting a distorted picture not just of Naturalyte, but of Dial’s own health.

    Fresenius has sold 300 million gallons of the drug since 1981, James Bennett of Dowd Bennett LLP said.

    ”Naturalyte is safe and effective,” Bennett said.

    Naturalyte’s competitors, Bennett said, contain the same amount of acetates. The company also adequately trained its network of clinics and doctors about the drug, Bennett argued.

    Bennett contended that Dial didn’t die because of cardiac arrhythmia but of a heart attack that was completely unrelated to his dialysis treatments.

    Dial had several underlying conditions that could contribute to a heart attack, including high blood pressure, obesity, chest pains that went untreated and coronary artery disease, Bennett said.

    In 2008, Dial’s doctors recommended that he get catheterization to deal with his heart issues, Bennett said. But he didn’t. Dial’s wife has acknowledged that he didn’t like going to the doctor, or doctors in general, Bennett said.

    All along while he was being treated at the Fresenius clinic, workers checked his potassium levels and his heart, Bennett said. His heartbeat always was at a regular rate, suggesting that a cardiac arrhythmia is not what killed him — a heart attack was, Bennett said. Although Dial denied having chest pains, that likely wasn’t true, Bennett argued.

    According to the American Heart Association, a heart attack occurs when an artery in the heart is blocked, cutting off blood. Cardiac arrest is an “electrical malfunction” that causes an irregular heartbeat, called cardiac arrhythmia. Although a heart attack can cause cardiac arrest, they’re distinct conditions.

    “We’re going to prove to you that the death of Mr. Dial had nothing to do with dialysis,” Bennett told the jurors.

    Fresenius is represented by James Bennett and Megan S. Heinsz of Dowd Bennett LLP, William Kettlewell, Sara Silva and Maria Durant of Collora LLP and Juanita Brooks and Roger Denning of Fish & Richardson.

    Dial’s estate is represented by Robert Carey and Molly Booker of Hagens Berman Sobol Shapiro LLP, Craig Valentine of Norton Frickey LP and Stuart Paynter of the Paynter Law Firm PLLC.

    The case is Dial v. Fresenius Medical Care Holdings Inc. et al., case number 1:14-cv-11101, in the U.S. District Court for the District of Massachusetts.

  17. Joe Reply

    Debra,your lawyer seems to be pretty honest my lawyer is also honest with me.trail is for Naturalyte but Granuflo and Naturalyte are the same lawsuit so it will affect everyone that did not opt in. My loved one also died within 24 hours and within the dates stated. The date your lawyer told you is somewhat correct it can be confusing so I am sure the way he saw it is the way he told it to you. Which is basically correct The opt-in date date is over no one can opt in at this point as far as I know. Now they have to determine if they are going to fund the settlement where are the people that have opted in. Here are some court documents, you will better understand it after looking these documents or orders over.

    These are court document.
    Extension of Settlement Program’s Opt-In and Voiding Deadlines1813 ALLOWED and adopted as follows: January 13, 2017 – Date by which plaintiffs may opt in to the settlement program; January 18, 2017 – Date by which all opt in data and documents will be supplied to Fresenius; May 10, 2017 – Date by which Fresenius may elect to void pursuant to the terms of the MSA; and, May 17, 2017 – Date by which Fresenius shall fund the settlement if not voided.

  18. frank Reply

    How much will each category recive Joe do u no

  19. Mary Reply

    Joe, I learned more from you than I have from anyone including my attorney’s. Thank you for posting. Husband died in 2011 while in dialysis.

  20. Angela Reply

    Joe, you seem to know more about this case & have been more informational than our own attorney’s. I’m asking on behalf of all involved if you would represent us in a petition? https://www.change.org/
    I too feel like I was duped by my attorney’s & told to take the opt in or nothing! We need to do something about this and not allow them to get away with what all involved have done to our family member’s. Please!

  21. Arthur Reply

    I really don’t think you need to do all that. Just sue them for legal malpractice or for misrepresentation. Either way you got them. Hopefully this Dial case comes out promising for everyone involved.

  22. Stephanie Reply

    I think that’s a very good idea Angela. I looked at your link. It couldn’t find the petition. Arthur- If it was that easy, more than half of us wouldn’t be in the predicament that we’re in now. What lawyer out here is willing to sue another lawyer for malpractice and misrepresentation? Really?!? Find one and we’ll ALL have a class action. By the way, no pun intended. #FACTS

  23. Joe Reply

    I know it may seem like I know a lot. All the stuff I am posting you can get online. It may be difficult but it can be done. A lot of people seem desperate. Let’s see how this turns out, it may not turn out the way people are predicting. Let’s wait and see what happens. This Dial v. Fresenius Case is a bigger deal than people realize.

  24. Joe Reply

    Chemical Overload Killed Fresenius Patient, Jury Told
    By Brian Amaral

    Law360, Boston (February 21, 2017, 6:08 PM EST) — A North Carolina man died from an excess of chemical ingredients in the Fresenius drug NaturaLyte, an expert witness testified Tuesday in a bellwether trial over the medication.
    Dr. Steven Borkan, testifying on direct examination for the plaintiff, said Carley Dial showed concerning levels of bicarbonate — which treats diabetes patients who are on dialysis — before he was treated yet again with NaturaLyte, on a dialysis machine with bicarbonate levels at the highest settings.

    He died in February 2012, the result of crashing potassium levels and an off-kilter blood pH level, causing his system to become dangerously alkalotic and shorting out his heart, Borkan said.

    “I believe Mr. Dial unfortunately died of a sudden cardiac arrest that more likely than not was due to excess delivery of bicarbonate,” Borkan told the jury.

    Bicarbonate is added to dialysis patients’ blood to help them regulate acid in their systems, doing a job that, because of diabetes, the unhealthy kidneys cannot do.

    Borkan, testifying in the third week of the first bellwether trial for holdouts after Fresenius Medical Care’s $250 million settlement of a multidistrict litigation, said he was surprised to learn that Dial’s doctors at a Fresenius clinic in North Carolina continued to give him the highest amount of ingredients possible even after he showed high levels of bicarbonate in his system, as well as reduced potassium.

    “I would have expected his dialysis prescription to deliver less bicarbonate,” said Borkan, a kidney specialist in Boston. “And I would have been very concerned about his falling potassium.”

    Dial’s next of kin say in their lawsuit that Fresenius failed to train and warn doctors about the risks and proper uses of NaturaLyte. The drug’s label was a confounding mess, Dial’s next of kin say, listing ingredients that weren’t actually in NaturaLyte.

    The suit claims that Fresenius didn’t clearly inform and train doctors about how one ingredient, acetate, worked to magnify the effect of the other ingredient, bicarbonate. Borkan pointed to the extra bicarbonate from acetate as the cause of Dial’s condition.

    Essentially, an overload of NaturaLyte overcorrected the attempts to regulate acid in the blood through dialysis, according to Dial’s suit.

    Fresenius’ attorneys have argued that Dial didn’t die of a cardiac arrest but instead died of a heart attack, a distinct killer. While cardiac arrest is likened to an electrical problem in the heart’s beat, a heart attack is often described as a plumbing problem, where an artery clogs and blocks the flow of blood.

    But Borkan, in his differential diagnosis, rejected that hypothesis, saying that all signs pointed to cardiac arrest.

    For example, seven or eight years of heart monitoring were stable for Dial, Borkan said. And while Dial’s doctors once suggested that he get his heart checked for artery health, Dial instead opted to self-regulate, without issues, Borkan said. Indeed, Dial was a model patient, who followed instructions to a T and drove himself to the clinic until his very last appointment, Borkan said.

    If the chest pains that Dial felt in the lead-up to his death were indeed the sign of a heart attack, rather than acid reflux, he’d have died much more quickly, Borkan said.

    During a brief cross-examination by Fresenius attorney Roger Denning of Fish & Richardson PC, Borkan acknowledged that he’d never been the medical director for a dialysis clinic, he’d never done any published paper on blood bicarbonate levels, nor was he a doctor who specialized in heart medicine.

    But Borkan stuck with his assessment that Dial’s doctors failed to recognize that acetate was contributing to the levels of bicarbonate in Dial’s system — despite not having seen the testimony of the doctor who treated Dial.

    “I only had to look at his prescription,” Borkan said.

    Fresenius is represented by James Bennett and Megan S. Heinsz of Dowd Bennett LLP; William Kettlewell, Sara Silva and Maria Durant of Collora LLP; and Juanita Brooks and Roger Denning of Fish & Richardson PC.

    Dial’s estate is represented by Robert Carey and Molly Booker of Hagens Berman Sobol Shapiro LLP, Craig Valentine of Norton Frickey LP and Stuart Paynter of the Paynter Law

  25. Kim Reply

    Can we find out how long after his last dialysis treatment he went into cardiac arrest?

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