GranuFlo, NaturaLyte Lawsuits Increase, Lawyers Ready for class Action

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Legal experts say the legitimacy of GranuFlo and NaturaLyte heart attack lawsuits will certainly be boosted by the fact that the U.S. Food and Drug Administration earlier this year announced a nationwide Class 1 recall of concentrates used in the kidney dialysis products.

GRANUFLO, NATURALYTE LIFE-THREATENING DANGERS OUTLINED IN FDA CLASS 1 NATIONWIDE RECALL NOTICE


The FDA describes Class I recalls as the most serious type of recall and involve situations in which there is a reasonable probability that use of the products being recalled will cause serious adverse health consequences or death.

Serious heart problems that could lead to death are being linked to the use of GranuFlo and NaturaLyte kidney dialysis products. Surprisingly, these alarming statistics are coming from internal documents that circulated in the offices of Fresenius Medical Care, the company that manufactures the drugs. Now circulating through numerous consumer-oriented web sites is a Fresenius memo that includes data about cardiac arrests suffered by over 900 patients who were being treated in 2010 in Fresenius clinics across the country. The number of cardiac incidents could actually be larger because the statistics in the memo do not include the large number of patients receiving Fresenius dialysis treatments in independent clinics.


Legal experts say that it is almost certain that lawyers for victims who have filed GranuFlo and NaturaLyte lawsuits will use the information contained in the memo to substantiate their claims the products had dangerous side effects that Fresenius did not adequately disclose. The GranuFlo and NaturaLyte victims claim in their class action lawsuits that they have suffered serious health problems because of the problems and would not have used them had they known that they were putting themselves at higher risk of suffering cardiac problems.

The Food and Drug Administration recently announced a Class 1 Recall of certain lots of the NaturaLyte and GranuFlo Dry Acid Concentrate used in the treatment of acute and chronic renal failure during hemodialysis. The concentrate is formulated to be used with a three-stream hemodialysis machine, which is calibrated for acid and bicarbonate concentrates.  
The FDA said the recall was initiated by Fresenius. Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Lawyers for victims of these serious side effects are now preparing GranuFlo and NaturaLyte lawsuits in which they will seek damages for these victims in cases in which, according to the company’s own internal documents, there have been nearly 1,000 patients who suffered cardiac arrest. If you are one of these patients or one who has been a victim of other side effects involved with these products our lawyers are offering free consultations about the legal options that may be available to you.

The company that provides treatment for over one-third of the country’s dialysis patients is facing an investigation by the Food and Drug Administration over concerns that some of its products could cause life-threatening heart problems. Germany-based Fresenius Medical Care, long at the forefront of dialysis care and the largest operator of dialysis centers in the United States is also defending itself against serious ethical questions about its responsibility to inform its patients of deadly dangers of cardiac arrest, heart attack, stroke, arrhythmia and other serious health conditions that could lead to a wave of lawsuits against the company.


Health risks associated with the use of these dialysis products:

  • Cardiac arrest
  • Cardiac arrhythmia
  • Significant drop in blood pressure
  • Hypercapnia
  • Hypokalemia
  • Hypoxemia
  • Confusion (altered mental status)
  • Death

As is the case in most pharmaceutical cover-ups, it was the uncovering by the media of internal company documents that has made public questionable decisions by officials at Fresenius in not making a full disclosure of the health problems associated with its products GranuFlo and NaturaLyte. The internal documents uncovered by The New York Times show that company officials used startling language about “troubling findings” and “this issue needs to be addressed urgently” in their confidential discussions about the devastating side effects that some patients of these products were suffering.

Why was GRANUFLO AND NATURALYTE recalled?


The FDA said the recall was initiated by Fresenius. Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

The FDA also noted that Fresenius is cautioning clinicians to be aware of the concentration of acetate or sodium diacetate (acetic acid plus acetate) contained in Fresenius' NaturaLyte Liquid and GranuFlo Dry Acid Concentrate.  Officials said that inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis.

What was not noted in the official announcement was that FDA officials have confirmed that they are conducting an investigation into whether Fresenius may have violated federal regulations by failing to inform health care professionals and customers at outside clinics about this problem. Also not mentioned were media reports that company officials were aware of dangers from these products and did not inform all patients or clinics that might have been using the products.

The FDA said that this may contribute to metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which, if not appropriately treated, may culminate in cardiopulmonary arrest. This product may cause serious adverse health consequences, including death, the FDA said.

The FDA said it has issued a general safety communication related to inappropriate prescription and resultant alkali dosing errors in the dialysate concentrates used in hemodialysis.

AM I ELIGIBLE FOR A DIALYSIS LAWSUIT?

If you were administered GranuFlo or NaturaLyte as part of your dialysis treatment your health, if fact, your life may have been put at risk. The fact that the manufacturers of these products were aware and even discussing the dangerous side effects the products were causing could be an important element in pursuing legal action against those responsible. Our attorneys are very experienced the laws involved in defective drugs and medical device lawsuits and aggressively pursue the rights of those who have been victimized in such cases.

Please contact us as soon as possible for a free consultation about the merits of your case or that of a loved one and what legal options may be available to you. Our resources and familiarity with these types of cases has resulted in successful out-of-court settlements and jury awards on behalf of our clients and we are available to provide personalized, sensitive representation for your needs.

If you or a loved one has undergone dialysis treatment and suffered any of these health problems or have suffered serious side effects from any other medication or medical device please contact us as soon as possible in order to provide us the opportunity to immediately begin working on your case.

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Granuflo Recall Notice - class action lawsuit page updated on 8/23/2013