Granuflo Lawsuits - Recalls, Side Effects and Claims

Granuflo Lawsuits

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GranuFlo may increase a patient’s risk of cardiac arrest, heart attack and other heart-related side effects. Contact an experienced GranuFlo attorney if you believe you have suffered from side effects of the dialysis drug.

Recalled in May 2012, GranuFlo was once the most popular acid concentrate on the market, designed to neutralize the build-up of acid in the blood that typically occurs during dialysis treatment for chronic kidney failure. Today, GranuFlo is best known for its link to a six-times increased risk of cardiopulmonary arrest and sudden cardiac death, which it turns out, GranuFlo maker Fresenius Medical Care knew about for years before alerting the public and the FDA. If you underwent dialysis treatment with GranuFlo or NaturaLyte, and you have since suffered a heart attack, stroke, or another serious cardiovascular side effect, consult a knowledgeable GranuFlo lawyer today to explore your possible compensation options.

GranuFlo Dialysis Alternatives for Neutralizing Acids in the Blood

Dialysis tends to be the go-to treatment for patients diagnosed with chronic kidney failure, and, before it was removed from the market, GranuFlo was one of the more popular dry acid concentrates used during dialysis. There are, however, a number of natural treatment options for patients at all stages of kidney disease, which may help achieve optimum health without the use of potentially dangerous pharmaceutical drugs. These treatments include the following:

  • Sodium bicarbonate (baking soda) has been shown to dramatically slow the progress of chronic kidney disease
  • Fomentation, or the alternative use of hot and cold towels near the kidney area
  • Kidney pack, or the combination of hot and cold packs
  • Eliminating foods that produce a lot of by-products, which need to be filtered by the kidneys
  • Yoga and meditation to bring balance to the sympathetic nervous system and the parasympathetic nervous system

FDA, GranuFlo and Side Effects

January 9, 2004 – An adverse event report is submitted to the FDA involving a patient who received GranuFlo or NaturaLyte during dialysis, and suffered a fatal cardiac event as a result.

November 4, 2005 – The FDA receives an adverse event report highlighting a case where a patient experienced a cardiovascular event and died after being administered GranuFlo or NaturaLyte.

February 1, 2008 – An adverse event report is submitted to the FDA on behalf of a patient who was administered GranuFlo and/or NaturaLyte, and subsequently suffered a fatal cardiac event.

March 14, 2008 – The FDA receives an adverse event report involving a patient who experienced a sudden cardiac event after being treated with GranuFlo and/or NaturaLyte, and died on the same day.

Early 2012 – The FDA receives a copy of FMC’s internal memo from an anonymous source, and becomes aware of the potential for GranuFlo to cause severe cardiovascular problems and sudden cardiac death in patients.

March 2012 – The FDA issues a Class I recall warning the medical community about the potential for GranuFlo and NaturaLyte to cause metabolic alkalosis possibly leading to cardiopulmonary arrest and death.

May 25, 2012 – The FDA issues a safety recall for all hemodialysis dialysate concentrates containing acetate, acetic acid or citrate.

June 25, 2012 – FDA regulators issue a Class I recall of FMC’s NaturaLyte and GranuFlo dialysis products, due to the risk of bicarbonate overdose, heart attack, sudden cardiac arrest, metabolic alkalosis and death.

GranuFlo Side Effect Studies

2010 – Fresenius conducts a confidential study involving patients undergoing dialysis treatment, and finds nearly 1,000 patients who suffered heart attacks allegedly caused by GranuFlo or NaturaLyte. The study also finds that patients undergoing dialysis were six to eight times more likely to experience heart attacks and sudden death if they had elevated bicarbonate levels.

November 2011 – FMC issues an internal memo to doctors in its own clinics, warning about the potential for GranuFlo and NaturaLyte to cause heart attacks, strokes and sudden cardiac death, but does not report this risk to the FDA.

Why We Think FMC Should Be Held Liable for GranuFlo Side Effects

Despite the fact that Fresenius Medical Care became aware of the link between GranuFlo and sudden cardiac death as early as 2010, it was several years before the company reported this risk to federal regulators, and the FDA is currently investigating whether Fresenius Medical Care intentionally misled consumers and the medical community about the safety and effectiveness of GranuFlo. Lawsuits brought against FMC over cardiovascular injury or sudden death from GranuFlo allege that the drug maker:

  • Designed, manufactured and sold a defective medication.
  • Failed to adequately research the potential health risks of the dialysis product, namely the potential for GranuFlo to cause sudden cardiac death in patients.
  • Intentionally withheld information from consumers and doctors about the potential for GranuFlo to cause heart attack, stroke and other cardiovascular problems in dialysis patients.
  • Failed to alert federal regulators in a timely manner after becoming aware of the alleged link between GranuFlo and cardiac arrest.
  • Continued to market GranuFlo as a safe and effective medication, even after acknowledging in an internal memo that GranuFlo may pose serious risks for patients undergoing dialysis.

What should you do? If a loved one has suffered cardiac arrest or heart attack, you should contact an attorney as soon as possible to discuss filing a GranuFlo injury lawsuit.

Chronic kidney disease affects more than three million people in the United States every year, and many of these people undergo dialysis in an attempt to manage advanced and permanent kidney failure. Unfortunately, those who have received GranuFlo or NaturaLyte acid concentrates during dialysis may now be at risk for complications like heart attack, stroke and sudden cardiac death. If you or a loved one has suffered serious injuries while undergoing dialysis, GranuFlo and its manufacturer, FMC, may be to blame. GranuFlo lawyers across the United States are investigating GranuFlo side effect claims filed by consumers who experienced heart complications after receiving the dialysis drug. Contact an experienced GranuFlo attorney as soon as possible to discuss your legal options.

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