GranuFlo is a dialysis treatment product that has been linked to hundreds of cases of cardiac arrest, heart attack, cardiopulmonary arrest, and death. The manufacturer is accused of failing to warn about these severe risks. The FDA only became aware of the problem when an internal memo was leaked in March 2012.
Do I Have a GranuFlo Lawsuit? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one has been diagnosed with a heart attack, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.
UPDATE: Fresenius Offers $250M to Settle GranuFlo Lawsuits
February 18, 2016 —Fresenius Medical Care has reached at $250 million settlement to resolve about 4,300 lawsuits involving heart attacks that occurred in patients who were given GranuFlo or NaturaLyte during dialysis. Click here to read more.
In 2013, federal judges has created a Multi-District Litigation (MDL No. 2428) to centralize lawsuits involving GranuFlo and NaturaLyte into one court. Over the next three years, over 4,000 lawsuits were filed. In addition, several class actions in California and Pennsylvania contain hundreds of lawsuits. DaVita HealthCare is also facing several class actions.
However, most of the lawsuits were filed by individuals who were injured or their family members:
- Louisiana man has failed lawsuit after suffering a heart attack, stroke, and severe pain following treatment at a Fresenius dialysis clinic. Click here to read more.
- Wrongful death lawsuit has been filed on behalf of a man from Texas who died of a sudden cardiac arrest after being treated with GranuFlo and Naturalyte. Click here to read more.
- Lawsuit has been filed in Ohio on behalf of a man who died of a cardiac arrest in 2010 after being given GranuFlo. Click here to read more.
- Wrongful death lawsuit has been filed in Georgia on behalf of a man who died of a sudden heart attack during dialysis treatment in 2010. Click here to read more.
- Wrongful death lawsuit has been filed in Georgia, on behalf of a woman who died of a cardiovascular event during dialysis treatment in 2010. Click here to read more.
- Two wrongful death lawsuits filed in the U.S. District Court for Alabama. Both lawsuits were filed by women whose husbands died of heart attacks after being given GranuFlo or Naturalyte during dialysis treatment. Click here to read more.
In May 2012, the FDA issued a Class 1 recall of GranuFlo and Naturalyte to update the label. The agency warned that dosing errors can cause a bicarbonate overdose, metabolic alkalosis, heart attack, sudden cardiac arrest, stroke, and death.
What is Granuflo?
GranuFlo is a dialysate product that helps balance the blood of patients undergoing hemodialysis. It is a dry acid that is mixed with water. When added to the blood, it helps evenly distribute electrolytes. It is similar to NaturaLyte, a liquid acid-neutralizing dialysis product.
What is the Problem?
Traditional treatment for dialysis patients involves giving them bicarbonate, which is used to neutralize acids that build up in the bloodstream. Unfortunately, the active ingredient in GranuFlo is converted into bicarbonate by the liver. If bicarbonate and GranuFlo are administered together, the combination of treatments could cause dangerously high levels of bicarbonate in the bloodstream.
High bicarbonate could cause metabolic alkalosis, a life-threatening condition that can cause the following side effects:
- Cardiac arrest
- Heart attack
- Cardiopulmonary arrest
- Low blood pressure
- Low potassium
- Low oxygen
- High carbon dioxide
- Irregular heart rhythm
Failure to Warn About Risks
Fresenius Medical Care, the largest dialysis treatment company in the United States, is accused of failing to warn about the risk of bicarbonate overdoses associated with GranuFlo. Failure to warn the public, doctors, and the FDA may have contributed to thousands of injuries and hundreds of deaths.
On November 4, 2011, Fresenius Medical Care sent an internal memo (PDF) to doctors at its clinics. The memo was not sent to other doctors at non-Fresenius clinics, or to the FDA. The memo warned that a sharp increase of patient injuries and deaths may be caused by improper doses of GranuFlo.
The FDA only became aware of the memo and the potential safety problem when an anonymous source sent it to the agency in March. Fresenius was aware that since 2010, there were 941 patients who had cardiac arrest in 667 Fresenius dialysis clinics. Not all of these injuries were caused by GranuFlo. However, patients who had high bicarbonate levels were 6-8 times more likely to have a cardiac arrest during dialysis compared to patients with low bicarbonate levels.
Do I have a GranuFlo Lawsuit?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact us for a free Texas GranuFlo lawsuit review.