Dialysis Treatment Heart Attack Lawsuit Filed Against Fresenius, Davita
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By: Irvin Jackson | Published: August 10th, 2012
A product liability lawsuit has been filed against Fresenius Medical Care, the largest provider of dialysis services in the United States, alleging that the company knew that use of its Granuflo and NaturaLyte hemodialysis products were causing individuals to suffer heart attacks, cardiac arrests and sudden death, but failed to warn the medical community.
The wrongful death complaint (PDF) was filed by Arthurine Williams, whose husband, Johnny Williams, died in 2010 after receiving dialysis treatment.
The lawsuit was filed in the U.S. District Court for the Northern District of Alabama on July 27, naming Fresenius, Inc. and its subsidiaries as defendants, as well as DaVita, Inc., which ran the dialysis clinic where Williams received treatment with Granuflo and NaturaLyte.
Johnny Williams began receiving hemodialysis treatment at DaVita Ensley dialysis clinic in Birmingham, Alabama, on July 28, 2010, according to the complaint. The treatment included the use of GranuFlo and NaturaLyte; acid concentrates that are manufactured by Fresenius for use during the hemodialysis process. Williams died of a sudden heart attack on July 29, 2010.
Arthurine Williams alleges that the death of her husband was caused by side effects of NaturaLyte and GranuFlo, and that Fresenius Medical Care knew or should have known about the risk of heart problems from the hemodialysis treatments and failed to disclose that information to doctors and dialysis clinics using their products.
According to the complaint, the company has known about GranuFlo and NaturaLyte heart problems for years, but kept those problems under wraps.
Fresenius Dialysis Treatments Used At Clinics Throughout U.S.
Fresenius Medical Care is the largest chain of dialysis treatment centers in the United States, operating 1,600 dialysis clinics. However, the company is also a major supplier of dialysis drugs and equipment used at competing centers.
In November 2011, Fresenius issued an internal memo to its own facilities warning that inappropriate prescription of the dialysis drugs could result in a high sodium bicarbonate level, which can cause metabolic alkalosis. This can lead to a heart attack or death for dialysis patients. However, the memo did not go out to the other dialysis centers that use Fresenius products until March, leaving them uniformed about the possible risks to their patients for months.
The FDA decided that the warnings constituted a Class I medical device recall for Granuflo and Naturalyte, which means the agency believes the products are likely to cause severe injury and death.
In response to the problems, the FDA issued a safety communication in May 2012, warning about the risk of dosing problems during hemodialysis treatments with Granuflo and NaturaLyte, and urging doctors to consider the impact of the acetate levels in these dialysate concentrates when ordering or administering hemodialysis treatments.
An internal analysis by Fresenius has found at least 941 instances where individuals suffered a cardiopulmonary arrest within their dialysis centers between January 1, 2010 and December 31, 2010.
According to the complaint, it became irrefutably evident to Fresenius by 2010, but top executives chose not to properly report these complications or Granuflo risks and withheld important information in an attempt to maintain their market share and diffuse the legal risks.
Arthurine Williams accuses the defendants of strict liability, failure to warn, breach of warranty, fraud, negligence, wrongful death, unjust enrichment, and accuses Fresenius of wantonly and recklessly making and selling NaturaLyte and GranuFlo in spite of knowing the dangers of the two drugs. The lawsuit seeks both compensatory and punitive damages.
The complaint is believed to be the first dialysis treatment lawsuit filed against Fresenius Medical Care since information about the risk of heart problems from Granuflo and NaturaLyte has become widely reported.
Comment by PATRICIA on 15 August 2012:
my husband died march 3 2010 after hemodialysis treatment @frensenius dialysis center in st. louis mo. he was fine when he left home that morning for the clinic but i received a call stating he was rushed to the hospital when i got there he ad expired
Comment by Terriana on 15 August 2012:
My father died suddenly, while recieving dialysis treatment (the same day). I was informed that the products that was being used was thought to have played a part in his death by someone that saw an ad that named the company that he recieved his long term care from as a carrier of the products. If the company is responsible, and they knew it I think that is very very sad and down right inhumane.
Comment by Ben on 30 August 2012:
This needs to be a class action lawsuit, if they’ve had 941 cases of heart attack just in thier dialysis centers alone!!! I am currently a dialysis patient at 27 years old and would hope that if I passed away from someone else’s mistake my family would do what needed to be done. These companies aren’t going to learn there lesson and stop being so careless with other peoples lives, if people just let them get away with it.
Comment by Octavia on 10 September 2012:
My husband started hemodialysis in July 2010, during that year he went thur passing out at the center to once coming home after dialysis passed out and his heart stopped. not once but 9 times in a week. each time it stop after dialysis.I thank god for pace maker and defrualater.Which I believed save his life.
Comment by sherry on 12 September 2012:
my mother passed after the dyialysis center increased the amount of sodium they added to clear blood clots in their machines to the solutions they gave their patients in treatment.though we complained about how sick she was becoming they continued their treatment some patients died others became so sick they were close to dying. they were treated as studies not patients someone really need to investigate what these centers are doing to these patients its not right
Comment by patti on 19 September 2012:
my husband was on dialysis for approx 6 months and while he was on the machine – 6 different times his heart stopped – they got it started and was rushed to the hospital all 6 times. They did not know what caused it and finally in 2006 – they didnt get his heart started in time and after about a week – he never woke up and was found that he had no brain function and was condisered brain dead so we disconnected life support and he died 10 hours later. I just saw a ad on tv about this and called the 1-800 number – awaiting a call back from a attorney that is handling this law suit.
Comment by Diane on 4 December 2012:
Oh Patricia – happened to my husband; however, I was there during treatment – he too, died at a hospital. Such a sad situation, quite a mess to sort out
Comment by SUSAN on 6 February 2013:
I first want to begin by saying how sorry I am to hear that some of you lost your loved ones due to a medical company NEGLIGENTLY refusing to come forward with the hard truth that their product was undoubtably causing deaths to patients receiving Hemodialysis. (GranuFlo and Natural LYte)
I’m pretty certain, as most of you would agree, that there is no money amount that can fix the hurt and unjustice that has forever changed your life HOWEVER, PLEASE know that Fresenius is 100% at fault and guess what that means?? If you or anybody you know died during dialysis or even up to 48 hours after receiving dialysis there is a HUGE trust fund that has been set up to pay those applicable to what I have just mentioned. PLEASE email me if you think this applies to you or anyone you know. I am not a lawyer, rather a registered nurse who is working in collaboration with the top notch lawyers and we will not give up until we succeed with some kind of justice!
Thank you!!!!
Comment by Elecia Early on 21 February 2013:
My mother took dialysis at Forsenius in Gardendale Alabama. She had a hard time, its like they didnt have the recipe right in her treatments each time. They also perscribed her Bicarbonite pills at one time and forgot to take her off and when I called it to their attention she was taking them, they told me to stop giving them to her immediately! She had a major heart attack and passed away the beginning of November 2010, thirty minutes after her treatment at Forsenius. She did not die that same day, she laid in a coma for 2 weeks in ICU and died in Pallitive Care at St Vincent Hospital.
Comment by jeanette on 28 February 2013:
Mom died at home after receiving her weekly dialysis treatment. She was only home an hour then went into a coma like state then later that night was taken off life support.
Comment by Dustin on 15 April 2013:
My mother was on dialysis treatments and was hospitalized. She had been on dialysis for about 2 years and was in and out of the hospital. We had all been told that she was doing much better and that she would be able to return home very soon. The next day she had dialysis and that afternoon we received a phone call from the hospital claiming that her vital signs were failing and that we needed to come in to see her before she passed. When we arrived at the hospital we were told she had had a stroke and was non-responsive. She had a DNR on her medical file so the doctors could not fight to bring her back. I lost my mother that day when I was only 16 years old. I also lost my complete way of life and was diagnosed with PTSD because I was the last person to see her alive. I am now 21 years old soon to be 22 and I want to see justice done against these murderers who stole my mother from my family and I. Please if there are any attorneys out there who would take this case please contact me as soon as possible