GranuFlo Dialysis Lawsuit Center
Our dialysis lawsuit lawyers are investigating legal claims on behalf dialysis patients who suffered catastrophic heart side effects, including heart attacks and sudden cardiac death, following administration of either GranuFlo or NaturaLyte, two dialysis drugs manufactured by Fresenius Medical Care. Both drugs were recalled in March 2012, after they were tied to an increased risk of sudden cardiac death, heart attack, stroke, and other cardiac side effects. Since then, Fresenius Medical Care has been named in scores of dialysis lawsuits that accuse the company of failing to disclose the dangerous heart side effects associated with GranuFlo and NaturaLyte.
Dialysis lawsuits may provide a means of obtaining compensation for victims of serious GranuFlo and NaturaLyte heart complications, including:
- Cardiac arrhythmia (irregular heart beat)
- Cardiopulmonary arrest
- Heart Attack
If you or a loved one experienced dangerous and sudden heart problems within 48 hours of a GranuFlo or NaturaLyte dialysis treatment, it is important to act now to ensure your legal rights are protected. To discuss your potential dialysis lawsuit with one of our experienced GranuFlo lawyers, please contact Bernstein Liebhard LLP today.
GranuFlo and NaturaLyte Recall
Both GranuFlo and Naturalyte are acid concentrates used in dialysis to remove toxins from the blood. While GranuFlo is a liquid concentrate and NaturaLyte is a powder, plaintiffs in dialysis lawsuits charge that both contain an ingredient that converts into bicarbonate at far greater rates than are typically seen with rival products. The higher bicarbonate levels associated with GranuFlo and NaturaLyte can cause a condition called metabolic alkalosis, which puts dialysis patients at risk for catastrophic heart problems, including fatal heart attacks and strokes. In March 2012, Fresenius Medical Care issued an “Urgent Product Notification” to its customer clinics warning of possible heart risks associated with the products. The U.S. Food & Drug Administration (FDA) would later deem Fresenius’ notification a Class I GranuFlo recall, its most urgent type of recall. Class I FDA recalls are only issued for medical products that could foreseeably cause serious health complications or death.
Dialysis lawsuits claim that Fresenius Medical Care knew about the heart dangers associated with GranuFlo and NaturaLyte long before it issued its Urgent Product Notification in March 2012. Among other things, plaintiffs point out that in 2004, Fresenius was in possession of an internal study that showed patients receiving Granuflo during dialysis had much higher bicarbonate levels than patients receiving a different acetate formula. According to dialysis lawsuit filings throughout the country, the company did not notify the FDA or the medical community of the risks associated with their product.
In November 2011, Fresenius finally issued a memo to dialysis clinics within its own network warning doctors practicing at those facilities that GranuFlo had been associated with serious heart side effects, and advised the physicians to adjust dosage in order to avoid excessive levels of bicarbonate in the blood. Among other things, the document warned that 941 patients had experienced sudden cardiac arrest after undergoing dialysis treatments at Fresenius-owned clinics in 2010. The memo further warned that dialysis patients with elevated bicarbonate levels faced a six-fold increased risk of suffering a heart attack or sudden cardiac death.
However, the thousands of dialysis clinics outside of Fresenius Medical Care’s network were not issued any kind of warning until March 2012, and presumably continued using GranuFlo and NaturaLyte in the intermittent months. According to a New York Times report published in June 2012, Fresenius only issued the March notification after the FDA learned of its November 2011 memo from an anonymous source and began asking questions. The FDA is now investigating Fresenius Medical Care over its failure to issue a similar warning to other dialysis clinics that used GranuFlo and NaturaLyte at that time.
Dialysis Lawsuits Mounting in Federal Court
Fresenius Medical Care is the largest provider of dialysis services and products in the world. It not only owns thousands of its own dialysis clinics throughout the U.S., it also provides dialysis supplies – including GranuFlo and NaturaLyte – to thousands of independent facilities. As of March 29, 2013, at least 130 dialysis lawsuits had been filed in federal courts throughout the U.S. All of the complaints allege Fresenius Medical Care knew or should have known of the substantially increased risk of cardiopulmonary arrest from rapid and dangerous increases in bicarbonate levels associated with the use of GranuFlo and NaturaLyte. The dialysis lawsuits further allege that Fresenius marketed, distributed and sold the products without adequate warnings and instructions concerning their risks and proper usage. The complaints further claim that Fresenius was motivated to do so by a desire to protect the profits it earned from sales of GranuFlo and NaturaLyte.
In anticipation of a large number of filings, the U.S. Judicial Panel on Multidistrict Litigation (JPML) ordered that all federal dialysis lawsuits involving GranuFlo and NaturaLyte be transferred to the U.S. District Court, District of Massachusetts. The JPML established the multidistrict litigation after determining that all of the GranuFlo and NaturaLyte claims shared common allegations of facts. The Panel stated that consolidation of the dialysis lawsuits in the District of Massachusetts would serve the convenience of the parties and witnesses, and promote efficient progress in the litigation.
Dialysis Lawsuit Consultations for Victims of GranuFlo and NaturaLyte
Victims of GranuFlo and NaturaLyte may be entitled to compensation for damages related to their injuries, including:
- Medical Bills
- Lost Wages
- Pain and Suffering
- Emotional Distress
- Wrongful Death
Bernstein Liebhard LLP is currently offering free dialysis lawsuit consultations to individuals who suffered a heart attack, stroke, or other sudden and life-threatening cardiac problem within 48 hours of a dialysis treatment that involved GranuFlo or NaturaLyte. Our GranuFlo lawyers will take the time to answer all of your questions, and will be with you every step of the way as you navigate the complex legal process. To learn more about the GranuFlo and NaturaLyte recall, and to discuss your potential dialysis lawsuit with one of our GranuFlo attorneys, please give Bernstein Liebhard LLP a call at today.
Since 1993, our lawyers have recovered more than $3 billion on behalf of injured victims, including patients harmed by defective drugs and medical devices. Should you choose Bernstein Liebhard LLP to represent you in your lawsuit, you will have a highly experienced team of attorneys, paralegals and investigators on your side, all committed to protecting your legal rights and working to ensure your physical, emotional and financial recovery.