Fresenius Dialysis Lawsuits

Fresenius Dialysis Attorneys

Kidney dialysis patients versus Fresenius Medical Care

The nation’s main supplier of hemodialysis pharmaceuticals, machines, and other dialysis-related products and biggest operator of hemodialysis clinics, Fresenius Medical Care, is being investigated by the Food and Drug Administration (FDA). The Germany-based company stands accused of failing to warn kidney dialysis patients of the elevated risk for health issues, especially deadly heart attacks, due to excessive dosing of sodium bicarbonate associated with the administration of GranuFlo and NaturaLyte pharmaceutical products through hemodialysis delivery systems.
The fatal heart attacks and other health issues brought on by bicarbonate overdose is a medical condition known as hemodialysis metabolic alkalosis, which leads to:

  • Arrhythmia
  • Death
  • Hemodialysis cardiac arrest
  • Hemodialysis cardiopulmonary arrest
  • Low blood pressure
  • Mental confusion
  • Stroke
  • Sudden and/or fatal heart attacks

Patients suffering the aforementioned conditions after receiving GranuFlo or NaturaLyte during hemodialysis, regardless of whether the pharmaceuticals were administered at a Fresenius-operated facility or a non-Fresenius facility that only uses the GranuFlo or NaturaLyte, may have compensation available to them and their families. Is important to contact an experienced attorney specializing in medical malpractice, product liability, personal injury, and wrongful death as quickly as possible if you, or a loved one, have suffered a cardiac event or other life-altering symptoms associated with the use of GranuFlo or NaturaLyte.

Renal patients, generally, are not informed respective to what drugs are placed in IVs or hemodialysis equipment and, therefore, embrace an expectation of trust that they are being treated with only the safest products in a medical facility that maintains the safety standards necessary to meet their hemodialysis needs. You need an experienced attorney to investigate your claim, determine what products were used in your hemodialysis treatments through a thorough review of medical reports created before and after you developed cardiac or other symptoms relating to GranuFlo or NaturaLyte usage, and thoroughly review company information on Fresenius Medical Care and their practices in the United States.

Missteps by Fresenius Medical Care, which resulted in injury and death to kidney dialysis patients dependent upon their products, are clear in this 10-year chronology:

  • 2003 Fresenius received FDA approval for use of GranuFlo and NaturaLyte in hemodialysis.
  • 2008 Employees were instructed by Fresenius to reduce the acetate level below the prescription dosage; yet, made no changes to the compounding formula.
  • 2009-2010 An instruction was added to the operator’s manual at Fresenius, instructing dialysis medical personnel to halve the acetate dosage.
  • November 2011 A memorandum is issued to select personnel with Fresenius Medical Care, warning that 941-patients suffered cardiac arrest in 2010 at Fresenius facilities after bicarbonate was unnecessarily added to GranuFlo and NaturaLyte.
  • March 2012 The FDA investigates a complaint alleging a high number of kidney dialysis patients were suffering cardiac events and even death following the use of GranuFlo and NaturaLyte during hemodialysis.
  • Early-May 2012 Fresenius issues an Urgent Product Notification to non-Fresenius facilities, informing them of the FDA investigation.
  • Late-May 2012 The FDA issues a nationwide recall of GranuFlo and NaturaLyte to hemodialysis facilities. This was not a voluntary recall by Fresenius.
  • 2013 Fresenius remains noncompliant with FDA directives to provide notice and educate clinicians who administer GranuFlo and NaturaLyte through dialysis delivery equipment, leaving hemodialysis patients at risk.

Fresenius Medical Care’s eventual compliance with FDA directives could have a major impact upon any legal claim that may be available to you. Compliance is the only recourse available to Fresenius in terms of a legal defense. Once Fresenius provides notice and education to clinics using GranuFlo and NaturaLyte in their hemodialysis delivery systems, any future heart attacks or strokes or other maladies brought on by these two Fresenius products may become moot. This is why it is important to contact an attorney knowledgeable in this area of law immediately after you, or a loved one, suffer injury or death as a result of having been administered GranuFlo or NaturaLyte products through a hemodialysis delivery system.

Get a Free, Confidential Fresenius Dialysis Legal Case Evaluation

Call Porter & Malouf, P.A. at 601-957-1173 right now to find out more about how you can recover monetary damages for your injuries. Our goals are to provide you with excellent representation and most importantly, to get your life back on track.



Facts that Fresenius Medical Care kept from patients

Over 2,100 kidney dialysis facilities throughout North America are operated by Fresenius Medical Care, which “provides renal services to hundreds of thousands of people throughout the United States,” according to the company’s website. In addition to doing business as Fresenius Medical Care, the company also operates kidney dialysis clinics doing business under other names where local identity was preserved following corporate acquisition.

Fresenius not only supplies GranuFlo, NaturaLyte, and other hemodialysis products to their own facilities, they provide these products to non-Fresenius clinics as well. The Germany-based company’s website describes, with seeming pride, statements that go to the heart of the fatal compounding problem: “With GranuFlo’s distinctive proportional component blend in each bag, you have made the safest choice for onsite concentrate mixing” and “The high level of quality that you have come to expect in [Fresenius] products is evident in our Naturalyte Liquid Bicarbonate product, which is designed to decrease treatment interruptions.”

This distinctive proportional component blend found in GranuFlo (a solid sodium diacetrate concentrate) and NaturaLyte (a liquid acetic acid concentrate) contain either sodium diacetate, citric acid, or acetic acid, depending upon the blend. These ingredients are converted by the body to higher bicarbonate levels than are ingredients in similar products manufactured by their pharmaceutical competitors. The bicarbonate’s alkalinity neutralizes the build-up of acid in a patient’s blood, which is essential to the dialysis process and is designed to cleanse toxic waste, such as urea and creatinine, accumulated in the blood of patients who suffer from renal failure. Proteins produce acid after being broken-down by the waste products.

The problem is that Fresenius neglected to inform patients and their physicians that GranuFlo and NaturalLyte contain a bicarbonate-elevating ingredient. Prescriptions were then written adding bicarbonate to the mixture. Unfortunately, Fresenius was aware that patients were effectively receiving fatal over-doses of bicarbonate, but chose to remain silent.

The safety of GranuFlo and NaturaLyte, as purported by Fresenius, is contradicted by the company’s internal memorandum dated November 4, 2011, warning that, in 2010, cardiac arrest was suffered by 941 patients at Fresenius facilities because unnecessary bicarbonate was prescribed, then added to GranuFlo and NaturaLyte. The memorandum also indicated that medical personnel with the company believed kidney dialysis patients were at a six-times greater risk of a cardiac event when the bicarbonate levels were high, as opposed to patients with lower bicarbonate levels.

The Food and Drug Administration (FDA) launched its investigation into Fresenius concerning the health risks of alkalosis brought on by high bicarbonate levels on March 27, 2012. Hemodialysis facilities throughout the United States were informed in May 2012, by Fresenius, that the FDA was investigating a complaint specific to errors in dosing alkali substances. The FDA subsequently issued a Class 1 recall for GranuFlo and NaturaLyte and ordered Fresenius to take corrective actions. The FDA’s highest level of recall is Class I, which is a classification reserved for the most dangerous situations posing serious health-risks or even death.  

The FDA targeted GranuFlo and NaturaLyte production lots which were stamped for dates covering January 2008 through June 2012, finding that these specific batches of the dialysis pharmaceuticals contained more excessive levels of bicarbonate compared with previous batches. One of the more troubling facts uncovered by the FDA is that Fresenius was aware that serious risks were associated with high bicarbonate levels when the company sought FDA approval of GranuFlo and NaturaLyte in 2003; yet, the company opted to withhold this information, failing to alert the FDA, hemodialysis clinics, or patients to this imminent danger.

Despite the FDA recall, Fresenius Medical Care, reportedly, remains noncompliant with the FDA’s 2012 directives to provide notice and education to hemodialysis clinics regarding the use of GranuFlo and NaturaLyte to prevent future bicarbonate overdosing. Fresenius’ refusal to follow FDA directives continues to place hemodialysis patients at risk.

If you, or a loved one, suffered a heart attack or another medical malady as the result of Fresenius Medical Care’s careless actions, promptly contacting an attorney specializing in medical malpractice, product liability, personal injury, and wrongful death is important.
Get a Free, Confidential Fresenius Dialysis Legal Case Evaluation

Call Porter & Malouf, P.A. at 601-957-1173 right now to find out more about how you can recover monetary damages for your injuries. Our goals are to provide you with excellent representation and most importantly, to get your life back on track.


Fresenius Medical Care fails to heed FDA warnings

The Food and Drug Administration (FDA) has issued seven warning letters

accessdata.fda.gov over the past 15-years to Fresenius Medical Care, which operates 2,100 kidney dialysis facilities throughout North America, in addition to manufacturing the supplies used by their own facilities and those of their competitors in the delivery of hemodialysis to patients.  
Hemodialysis is a booming business for the Germany-based company, which has effectively cornered the renal-care market in the US. The seeming monopoly held by Fresenius makes the company’s refusal take corrective action, or even respond to the FDA’s warning letters, that much more painful for patients suffering kidney failure whose survival hinges upon the medical services of this noncompliant corporation. Fresenius’ continued noncompliance places all hemodialysis patients at risk.

The judicial system offers a helping-hand for kidney dialysis patients (or surviving families) who have suffered injury or death due to the negligent actions of Fresenius Medical Care, its corporate holdings, and personnel. Fresenius has been willing to look the other way on patient safety, allowing hemodialysis patients to suffer and die because of their refusal to comply with federal laws, rules, and regulations designed to keep all Americans safe. Renal patients have the power to make a difference, where the FDA couldn’t: File a lawsuit and hold Fresenius Medical Care accountable for their negligent actions!

Each kidney dialysis patient, or surviving family members of a deceased kidney dialysis patient who, with the help of competent legal counsel, can prove Fresenius Medical Care is responsible for an injury or death, is entitled to compensation. This company, branded by a lackadaisical attitude toward hemodialysis patients and the FDA, “provides renal services to hundreds of thousands of people throughout the United States,” pursuant to the Fresenius Medical Care website. The only way to get Fresenius to pay attention and do the right thing and protect hemodialysis patients going forward, is to make them pay for their past wrongdoings. That which effects their bottom-line gets their attention.

This 15-year chronology demonstrates Fresenius Medical Care’s noncompliance with FDA warnings:

  • 1997 Fresenius Medical Care North America www.fda.gov was issued a warning letter specific to medical oxygen at the Watham, Massachusetts, facility.
  • 1999 Fresenius Hemotechnology, Inc. www.fda.gov was issued a warning letter due to the Concord, California, facility’s practice of importing adulterated therapeutic plasma exchange tubing devices then using them for domestic distribution.
  • 2002 Fresenius Medical Care www.fda.gov   was issued an FDA warning letter after it was discovered that NaturaLyte Acid Concentrate manufactured in the Deltran, New Jersey, facility had been adulterated.
  • 2010 Fresenius Medical Care Holdings, Inc. www.fda.gov was issued a warning letter after the FDA discovered Optiflux Dialyzers and Liberty Cycler Sets manufactured at the Watham, Massachusetts, facility had been adulterated.
  • 2011 Fresenius SE www.fda.gov was issued a warning letter sent to the Fresenius offices in Germany after the FDA discovered that the company had been “marketing the Red Blood Cell (RBC) Set, and the AS104 Blood Cell Separator (AS104) in conjunction with the RBC Set, in the United States (US) without marketing clearance or approval.”
  • 2011 Fresenius Medical Care Holdings, Inc. www.fda.gov was issued an FDA warning letter sent to the Germany offices for Fresenius after it was discovered that the company was “marketing the Fresenius Medical Care North America CombiSet Tru Flow Series Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors . . . (modified CombiSet) in the United States (US)” without first clearing the modifications with the FDA.
  • 2012 APP Pharmaceuticals, LLC www.fda.gov was issued a warning letter after the FDA “identified significant violations of the Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals” at the Grand Island, New York, facility “causing the product to be adulterated.” This FDA warning goes on to state that Fresenius Medical Care has not bothered to take corrective actions, nor respond to the FDA’s warnings, in any of the seven complaints investigated against the company. All seven complaints remain open. Subsequent to the 2012 warning letter, the FDA recalled the January 2008 through June 2012 lots of GranuFlo and NaturaLyte.

It is important to contact an attorney specializing in medical malpractice, product liability, personal injury, and wrongful death if you, or a loved one, have suffered a heart attack or even death after being administered GranuFlo or NaturaLyte through a hemodialysis delivery system, and to do so quickly. You and your family deserve the peace of mind compensation can bring.

Get a Free, Confidential Fresenius Dialysis Legal Case Evaluation

Call Porter & Malouf, P.A. at 601-957-1173 right now to find out more about how you can recover monetary damages for your injuries. Our goals are to provide you with excellent representation and most importantly, to get your life back on track.